Menopause Matters Forum
Menopause Discussion => All things menopause => Topic started by: Hurdity on August 05, 2018, 08:14:54 AM
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Although I don't use estradiol gel myself (I tried Sandrena for a short while) I have been puzzled and intrigued by this ongoing discussion about Oestrogel vs Oestrodose and the alleged differences so I decided to write to the manufacturers about it.
Therefore I wrote to Besins asking very specific questions and have had several e-mails in reply.
The upshot is – THEY ARE EXACTLY THE SAME PRODUCT!
There have been posts on this forum talking about different carrier ingredients in the two products and inferior manufacture (of Oestrodose) in Asia, a cheaper product etc – but none of this is true. It is all manufactured by Besins in France.
Here is the explanation (I am quoting from their various e-mails):
“Oestrodose is the same as Oestrogel. In the UK the product is branded Oestrogel, some other countries such as France call the product Oestrodose. In the UK the parallel imports of Oestrogel are all sourced from France and are labelled Oestrodose.
All of the Besins Oestrogen Gels have exactly the same qualititative and quantitative compositions and are all manufactured at Besins Healthcare, Belgium.
... all of the products are identical in terms of the composition, packaging supplied and manufacturer and so there is no difference in hot/cold countries.â€
“ Canisters for Oestrodose and Oestrogel are different shapes but the products (UK and French, as well as all Besins Oestrogel products) are tested to the same finished product specification and are considered identical.
The bottles/canisters of Oestrogel and Oestrodose are both made from polypropylene. The gel is held within a pouch inside the canister and both Oestrodose and Oestrogel use a low-density polyethylene (LDPE) pouch.
The pump mechanism of both products dispense the same amount per individual pump. I can confirm that both pump mechanisms dispense 1.25mg of gel per depression and provide 64 doses per bottle.â€
There is only one formulation for manufacturing this product and the stabilities on the product, whether Oestrodose or Oestrogel, are all compliant. There was no significant difference in the past 20 years in stability studies for this product. However, the stability studies are made on products not leaving the factory and stored in the optimum conditions for the complete shelf-life period, although we have stability studies for the following conditions: 25℃ & 30℃ for 36 months and 40℃ for 6 months.
The product Oestrogel distributed in the UK is managed by Besins Healthcare from the manufacturing facility to your distributor in the UK.
“Both products are manufactured and filled/packaged by Besins before arriving in the UK.
The importer (a parallel import company) will receive the French Oestrodose product. They remove the Besins carton and leaflet, add their own label to the bottle and re-pack the bottle into their own carton with their own leaflet. When Oestrogel is received in the UK, no changes are made to the packaging or leaflets.
This also accounts for the relabelling some women have noticed ie there are 3 different containers for the estradiol gel all manufactured by Besins in France: the one labelled Oestrogel packaged by Besins for UK; the one labelled Oestrodose packaged by Besins for France, and the one labelled Oestrodose by the parallel import company which repackages the France Oestrodose. Only the outer packaging (the bottle you see) and the information leaflet changes – the inner pouch containing the gel is not touched.
I would suggest that differences in ambient temperature may cause a difference in consistency in the same product – I have noticed this myself with testosterone gel – sometimes it seems runny and sometimes not and I think this is due to room temperature.
This doesn't explain the perceived difference between the two (Oestrogel and Oestrodose) by some women and unless the parallel importer stores the product at higher temperatures than the stability studies (ie more than 40 deg for 6 months) this is unlikely to account for any differences. I have written to the parallel importer as well to ask about this but have yet to receive a reply....Stellajane wrote to them last year about the packaging issue where Chemilines gave a brief explanation – which she posted but still the myth about differences continue. I'll update all the threads where I can find this discussed just to reassure women!
I do hope this reassures many of you who have been worried about this and concerned to get the “superior†Oestrogel – this is a myth and you can apply your oestrogen gel - whether it be labelled as Oestrodose or Oestrogel with confidence that it will work (or not) for you – and if not, it has nothing to do with the name on the label!
Hope this is helpful :)
Hurdity x
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This is so much more than helpful Hurdity! This is brilliant. I have been worrying, as a new Oestrogel user, that when I have to open my new bottle of Oestrodose, it won't work the same. And as I have so many hormonal imbalances going on at once, it's critical that loose spanners are not thrown into the mix if possible.
You have really set my mind at rest. I am printing this out for the future.
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Thanks for taking the time to research this Hurdity. It will be really helpful for women who may believe that the two products are different.
Taz x :thankyou:
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Hi Hurdity
Thanks for your detailed information on the 2 gels.
I too, have an Oestradose in my cupboard which I have put off using in case it was sub-standard!
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Thank you so much for this clarification. I have recently started this again and my pharmacist has had trouble getting estrogel. The fear I had was irrational. This makes me feel so much better. ;D
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I wonder why Besins didn't have the common sense to give the product just one name, then none of this would have been necessary ::)
JP x
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I remember checking the full ingredients a year or so ago on the the Besins website when someone was asking about it and they were different. It may have simply been something to do with the packaging as some require more preservatives than others. Maybe they started off slightly different products but legally had to make them the same if they are now showing the same ingredients.
This may explain why some found the product to be more runny.
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They were different when I checked too, Dangermouse. I was also informed that the Oestrodose was a bulk repackaged product - shipped in bulk from the manufacturer and repackaged by various distributors in the UK. At the time, the original Estrogel was packaged at manufacturing source. I believe certainly at that time, it was affecting the consistency of the product.
Things may well have changed since. xxxx
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As per my post - the product is not repackaged from the raw material - so the information can't have come from Besins otherwise they would have said in their correspondence, surely? I have never read anything (including a year or more ago) which suggests that the constituents are or were different in Oestrodose and Oestrogel and members on here have had both patient information leaflets which have shown exactly the same ingredients! Besins do not list the ingredients on their website (that I can find anyway) and the agency which lists all the product information leaflets and SPC details (eMC) has never listed Oestrodose to my knowledge - because what we get is the same product - Oestrogel in UK - whatever the label says! I have written to them again just to clarify finally - although my questions were very specific and they would surely have said if formulations have changed in the past year?
I wonder why Besins didn't have the common sense to give the product just one name, then none of this would have been necessary ::)
JP x
I imagine it would be the recipient/importing country that specifies the name - if you look at Besins website the same thing happens with utrogestan - called Prometrium in some countries and there is also another name for oestrogel too - which I have never heard of! Oestrodose was the original name it seems - as this is what it's called in France - unless we have just retained the original name and they decided to change it in France - who knows?
Anyway the important thing is a mystery has been cleared up hopefully!!! I do like to get to the bottom of things ::)
Hurdity x
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Thanks Hurdity, well done! :medal:
JP x
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I did a search for when discussed before and it was the excipients that differed (the Carbomer one) which they don't have to list in the ingredients. The link no longer exists on their website. It may have been why some found it more watery at that time and I remember they stated that one of them was manufactured in Asia.
It may just have been like Cadbury's where they add the non-melting chemicals in the hot countries!
“Besins list them separately here http://www.besins-healthcare.com/index.php?mode=product&submode=2&group=2
and the only detailed ingredients I could find for both are:
Oestrodose:
The drug brand named Oestrodose contains generic salt-Estradiol Hemihydrate and is manufactured by Besins.
Generic Salts
Estradiol Hemihydrate
Available types of drugs
Gel; Topical; Estradiol Hemihydrate 0.06%
Oestrogel:
of gel contains 0.6 mg of estradiol (as estradiol hemihydrate); excipients: carbomer 980, triethanolamine, 96% ethanol, purified waterâ€
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When I did the post about these products I posted extracts from my correspondence with Besins rather than produce the letters in full so here is the bit about Asia and manufacture elsewhere – which actually is covered in their statement I did post ie “All of the Besins Oestrogen Gels have exactly the same qualititative and quantitative compositions and are all manufactured at Besins Healthcare, Belgiumâ€.
This is the other bit from one of their letters “We do not manufacture any products in the Phillipines and all of the products are identical in terms of the composition, packaging supplied and manufacturer and so there is no difference in hot/cold countries.â€
Rest assured dangermouse I asked several very specific questions including the bit about hot countries as this was the only reason I could think of that there could be different ingredients.
The post you quote from maybe a year ago I also read at the time.
Here is the up-to-date link to Besins products with all the alternative names for their identical products – the ingredients were not listed on there at the time of that post: https://www.besins-healthcare.com/products/#womens
The first bit of that list which you have requoted is not a list of ingredients – it is a description of what Oestrodose is ie topical gel whose active ingredient is estradiol hemihydrate. The second is the list of ingredients of all their estradiol gel including Oestrodose. As far as I know they have to list all of the ingredients because of possible allergies.
I also remember that post and did my own research at the time and there was no list of ingredients for Oestrodose separately. It was all rumour and supposition and inference as far as I can make out.
Because the subject has been raised yet again – this is when I decided to contact the manufacturers.
The parallel importers Chemilines was founded by two Asian brothers and have offices globally including Asia – this is presumably the origin of the rumours that Oestrodose is manufactured in Asia. As I said I have written to them just to find out what happens to the Oestrodose destined to be repackaged as Oestrogel – but I doubt it is transported to Asia and in any case as I quoted there have been stability studies carried out on the product to 40 deg for 6 months. http://www.chemilines.com/about-2/
Since the product has a three year date on it (I think) – some of the current preparations will have been manufactured a while ago and if the products used to be different (and may still be in use) then Besins would clearly have said so.
I did this investigation because the subject continues to be raised and as I said in my first post – because I was puzzled at the whole idea of two different products being sold as the same if they weren't – as Stellajane pointed out. I have also written to Besins again as I said in my previous post.
The idea was to reassure women who have used or continue to use these two products, not to continue the controversy and leave questions as to any differences. If there is anything different in responses from the companies that suggests there has been a difference - I will post them!
Hurdity x
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Thanks for this invaluable info! Love this site. x
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I stopped using oestrogel because when they'd run out I was given oestrodose. Within 3 days off using it I suffered with chronic headaches of which I've never had before this lasted 5 days and I went to the gp who told me to stop all oestrogen for 3 days. Within 2 days the headaches had stopped and I felt well again. I was then given oestrogel again and all was well. I however decided to go back into patches of which suit me so much better. I could not take the risk of being given oestrodose again. So I would absolutely dispute that they are the same alongside many others that have had bad side effects from using the oestrodose. The oestrodose was thinner and smelt strongly of alcohol and took longer to dry. Whether a carrier agent would cause this I don't know. I'm afraid unless you've tried it and felt the difference you could believe they are the same by the info they're giving however there have been too many reports from too many women, of side effects to swallow this information and I've lived and breathed it. Very unpleasant experience I wouldn't wish on anyone 👎🏼
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I can't explain why you experienced this Optimist - but it is clear from the information given by Besins that they are not and cannot be different products - as the gel is put into the inner pouches only at Besins in France (according to their info) - and only the outer packaging changes. Besins only make one such product so the carrier agents in both are identical. The only possibility is the way the product has been stored and whether the parellel importer shunts the different boxes of the stuff around the world and stores it in unfavourable conditions eg if occasionally if there is a shortage of the French Oestrodose for the UK market - maybe some is brought from elsewhere and repackaged again. I can't imagine this would happen often if at all (but maybe?) and it wouldn't alter the actual contents though - unless it was "fake" oestrodose?!!! As I said I contacted Chemilines to ask about it but haven't had a reply!
Are you saying you think Besins are not providing the correct information? This would be quite serious if so, for medical reasons. They do say that they have no control over the product once it leaves their premises - Oestrogel and Oestrodose.
I'm sorry to hear about your reaction and headaches but the cause seems to be a mystery for the time being! Even though I don't use it myself I was intrigued as to what, if any, difference there could be!
Hurdity x
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I had an itchy area on my back whilst on oestrodose, but never on oestrogel and I used it with a really open mind that they were the same
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I agree there's is a difference to some women I was on oestrogel and doing ok went on oestrodose and had awful migraines. Put it down to hrt to start with saw gynaecologist and he had never heard of Oestrodose wasn't in his book. Really struggled so tried oestrogel and no headaches I am also taking progestrone all the time as he said fluctuations of hormones don't help. But I'm sure it was the oestrodose.
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Good morning
Having used both products I have to agree with Optimist
Ostrodose was thinner(almost the consistency of water) smelt strongly of alcohol and took forever to dry I have no idea why this should be but I am not willing to give it another try and will continue with Oestrogel.
Have a nice day
Lanzalover x
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This is so confusing!
My Oestradose seems thicker than the oestrogel! For me, there doesn't seem to be a difference smell wise.
Could it be that we are seeing differences in the products dependent on how we store it and how full the container is?
I and many others, will hope/need that the products be exactly the same!!
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I agree there's is a difference to some women I was on oestrogel and doing ok went on oestrodose and had awful migraines. Put it down to hrt to start with saw gynaecologist and he had never heard of Oestrodose wasn't in his book. Really struggled so tried oestrogel and no headaches I am also taking progestrone all the time as he said fluctuations of hormones don't help. But I'm sure it was the oestrodose.
The reason the gynae hadn't heard of Oestrodose is because the estradiol gel produced by Besins is not known by this name in UK - it is known as Oestrogel. If you read my first post in this thread you will see that it is given different names in different companies with different outer packaging (ie the pump pack and the carton - sometimes the leaflet) but the inner pouches containing the estradiol gel are all the same and produced and filled by Besins in Belgium (according to what they've told me). Therefore there is no option to buy Oestrodose - it is Oestrogel! The leaflet (and the pump pack) should say manufactured by Besins.
Hurdity x
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This is so confusing!
My Oestradose seems thicker than the oestrogel! For me, there doesn't seem to be a difference smell wise.
Could it be that we are seeing differences in the products dependent on how we store it and how full the container is?
I and many others, will hope/need that the products be exactly the same!!
I would suggest this is the most likely explanation. My tube of Testim gel for example varies in consistency - this morning it was really thick - this is the same small tube that was runny when it was warmer - so this will affect how quickly it dries and how much is absorbed. I can imagine this effect would be magnified the greater the quantities of gel you use.
Hurdity x
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Hello ladies,
A quick look on the internet shows both Oestrogel and Oestrodose (Estrogel in the US, Gynokadin in Germany) leaflets with minor inconsistencies regarding the 'inactive' ingredients.
Some say carbomer 934p, others say carbopol 980nf, some say alchool 95% (ethanol), others say 96%.
Besins International is a global company with manufacturing plants in France, Belgium, Spain and Thailand so it's very likely that the 'inactive' ingredients (carbomer or carbopol, ethanol, purified water and triethanolamine) are not manufactured by the same plant. If the Oestrogel sold in the UK comes mostly from the same plant and the Oestrodose comes mostly from another plant that could explain the difference.
Carbomer or Carbopol (brand name) are carbon polymers used as thickeners and the number means their molecular weight, so 934 is different from 980 thus the difference in consistency. I have also found that they ARE DIFFERENT. According to the manufacturer the 934p has BENZENE and the 980 doesn't! https://www.lubrizol.com/Life-Sciences/Products/Carbopol-Polymer-Products
I think Besins may have changed it recently, so there must be some old ones still on the market.
Of course temperature is also important. A friend of mine who lives in South America keeps her Oestrogel bottle in the fridge. Temperatures above 25 C happen throughout the year.
I think your personal experiences are fascinating. All of you who have actually used the product should send Besins an email with a detailed account of your experience. I think this is the scientific approach, instead of just trusting their word on the matter.
Best wishes,
Conolly X
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Blimey - it's a minefield (in terms of all the different products etc)! As for Besins itself - yes it's huge! However when I started to look into it I ignored looking at similar products in other continents (eg US which manufacture Estrogel - not sure if it's by Besins) because of what Besins said about the UK supply which is all we have to go on. I haven't come across differences in the Carbomer (nor the alcohol percentage) - all the ones I've looked at say 980 including Gynokadin (which I hadn't heard of!) which seems to be made in Germany by a company (Dr Kade) working in partnership with Besins - but has the same ingredients - and presumably just for the German market.
Yes I said I thought temperature was important re consistency right at the beginning and to me is the most obvious explanation. I agree as I said earlier that it is intriguing and puzzling that differences in response continue to be reported but only by some women. Side effects such as allergic reactions are different and potentially much more serious in terms of the product - re potential fraud if there is a "fake" product on the market with different ingredients than listed.
I had prepared a long post suggesting along similar lines (re going back to the manufacturer) - and I was listing all the possible explanations I could think of accounting for perceived differences but a bit busy at the moment. In it I was also going to suggest that anyone who has side effects from it or who notices consistent differences in consistency ( which can't be explained by temperature) to go back to the manufacturer or send a sample to whoever monitors this sort of thing - for testing, because if it is not what it says it is or what Besins says/thinks it is - then there is possible fraud being committed or at least deliberate obfuscation!
Those who finish their pump pack should be able to remove ( break?) the plastic pump pack bottle and get down to the inner pouch which surely will have a batch number or identifier on it - which would help trace its provenance? Gosh maybe we're going to uncover a scandal or at least some shady dealings?!
In the meantime I think we do have to accept the only explanation we have been given - that the products are exactly the same - at least for most of the time and that variation in consistency may be due to temperature. According to what I've read about absorption of the gel anyway – it is takes longer to dry then it will actually be MORE effective, not less because the amount absorbed is related to the drying time. This is why it musn't be spread over as thin an area as possible so that it remains on the skin for long enough for maximum estradiol to be absorbed. Or maybe if it's runnier it is spread more thinly to dry it quicker? You could always experiment on yourselves.....re temperature. area spread etc.....
Aaagh! Hope everyone's well today :)
Hurdity x
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Perhaps anyone believing they haven't been given the genuine product or anyone who has a bad reaction should report this to the Medicines and Healthcare products Regulatory Agency under the yellow card scheme:
https://yellowcard.mhra.gov.uk/
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Hello Jenna,
Brilliant! Thank you.
Conolly X
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I've had another reply from Besins. They haven't changed their manufacturing etc at all in recent years so the formula for Oestrodose and Oestrogel is still exactly the same as it has been for many years (re the products manufactured in Belgium and supplied to UK).
As I've written several times asking them all these questions they now say they have passed my comments onto the Product Complaints Dept (eeek!) so if they get back to me I might be asking for all of your comments and dates etc. I didn't ask them to do this nor make a complaint - I just commented! Do keep any boxes/packs of Oestrodose that you think are different and maybe not genuine Oestrodose, or have given you side effects which have resolved when you have started Oestrodose (as they might need to be sent to them or else the batch numbers etc maybe?). This is all a bit odd since I have never used the stuff but was speaking on all of your behalf!
Hurdity x
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Ive been using Oestrogel since March, gradually increasing from 1 to 3 pumps and feeling much better on it. For the last 3 weeks I've been using Oestrodose and for the last 2 weeks i've been feeling increasingly nauseous in the mornings and evenings, tiredness and lack of energy returning and now headaches.
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I said I wasn't going to comment on the forums again, but I feel VERY strongly about this as I was probably one of the first to notice it nearly 2 years ago. They are NOT the same in delivery - and I developed urticaria on the Oestrodose.
As the packaging/pump is different, if it's not the ingredients then I have a theory that the product in Oestrodose is perhaps seperating and it may be a packaging issue. Because SOMETHING is definitely amiss!
xxxx
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Welcome back, Tempest :)
I think we have to believe the ladies who say there is a difference . My consultant told me to always get Oestrogel x
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I said I wasn't going to comment on the forums again, but I feel VERY strongly about this as I was probably one of the first to notice it nearly 2 years ago. They are NOT the same in delivery - and I developed urticaria on the Oestrodose.
As the packaging/pump is different, if it's not the ingredients then I have a theory that the product in Oestrodose is perhaps seperating and it may be a packaging issue. Because SOMETHING is definitely amiss!
xxxx
Hi Tempest
Yes I had the same albeit a small itchy patch on my back (I applied to thighs). I didn't think too much about it but when I next collected my script and it was oestrogel the itchy back stopped and I've never had oestrodose or the itchy back since x
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Hello ladies,
Tempest, glad you're back. Hope you're ok.
As I said above, they are different. If you Google Oestrodose + 934p you will have many hits. If you Google Oestrogel + 934p you won't have any. If you Google Oestrodose + 980 or Oestrogel + 980 you will have many hits. Meaning... some Oestrodose (and also Estrogel, sold in US and other countries) has the 934p thickener which is not as thick ie runnier, as the 980 that has been developed later to replace the 934p which contains BENZENE, a very toxic substance.
https://knowledge.ulprospector.com/7868/pcc-carbomers-slideshow/ (https://knowledge.ulprospector.com/7868/pcc-carbomers-slideshow/)
Saying that ‘All Oestrogel/Oestrodose sold to/in the UK is produced in the Belgium Besins plant' doesn't mean the inactive ingredients are produced by this plant. They are not. So... maybe there are some old batches of Oestrodose still on the market that have the 934p carbomer/carbopol thickener.
Conolly X
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... maybe the ladies could ask your Pharmacist to read the ingredients on the label whether it's Oestrodose or Oestrodose repackaged as Oestrogel. Some will only show ‘carbomer', unfortunately, what is, imho, unacceptable.
Conolly X
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Hello Daisydot,
Glad you're back 😏. Your experience is much appreciated! I have never used these gels but I have been using many other cosmetics and medication and I'm horrified to read what sort of ‘pharmacological inactive' ingredients are used, not to mention the horrendous tests that were performed in animals until very recently 🤬
This subject really puzzles me. How can 4 daily pumps of 96% ethanol be ‘pharmacologically inactive'? Maybe for gin drinkers 😂 but certainly not for non drinkers or allergic people. I know it's supposed to dry quickly and evaporate etc but of course there will be some absorption through the skin. It's a mine field and a very profitable business...
I am very careful nowadays regarding pharmaceutical products, I read everything before using them. Same with packaged food, which I'm trying to avoid but it's hard. Maybe the UK laws regarding leaflets and labels could be changed to avoid these generic statements about ‘inactive' ingredients.
Conolly X
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:drunk: :rofl:
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Benzene?!? :-\ Good grief!!
Thanks very much for your research Connolly, you deserve a medal. This explains it all.
Best wishes,
JP x
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Hello Joanipat,
Thanks, you're very kind. I don't know if it explains it all, but it's a start.
I think that regardless of the real reason for the ladies experiencing the inconsistencies, the important thing is that the inconsistencies are regarded as real. Haha, that's weird... ;D
Take care,
Conolly X
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Thank you, girls. :)
I'll pop in from time to time. Connolly - you are one very smart cookie. I always knew you were anyway! What a brilliant bit of detective work. :)
Daisydot, I really resent being told that it's 'all in my head' too. Annie and I are the 'allergy twins' - we both suffer anaphylaxis so we know our stuff! And both of us have had the same reaction to Oestrodose but not Estrogel. Coincidence? I think not.....So glad you're here again btw, dear heart! :) xxxx
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Hello again Tempest,
Thank you, good to see you posting 8)
Speaking of allergy, my last blood tests results show high levels of eosinophils again, this has been going since February and none of the... hmmm...let me see...5 doctors have been investigating it. So fed up with their lack of consistency! I wish there was a thicker carbomer suppository for them! Sorry. ;D
Conolly X
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;D ;D ;D ;D Brilliant!!!!
I had raised eosinophils throughout peri when my estrogen was high, and was having crazy ovarian cysts and all manner of other weirdness. My anaphylaxis consultant (yes - I had one of those too, girls ;)) explained that estrogen increases histamine release through activation of mast cells. Hence why I was an itchy, swelling, anaphylaxis prone wreck with rhinitis thrown in for good measure for a while.....Fun, innit??? :o xxxx
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As Hurdity has suggested, I'm going to break open the packaging once my cannisters are finished to get the serial numbers. Maybe this could give us a picture of whether all of it is made the same or not.
I'll report back later as I have an empty one!
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I don't understand the complexity of HRT but I certainly understand that allergic reaction can occur with anything we take. This can happen even if it is something you have been taking for some while. My mum had a severe allergic reaction to a medication she had been taking for two years.
Looks like we have to watch our own back on issues like this. Listen to our bodies. Do our own research and not get fobbed off by medics.
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;D ;D ;D ;D Brilliant!!!!
I had raised eosinophils throughout peri when my estrogen was high, and was having crazy ovarian cysts and all manner of other weirdness. My anaphylaxis consultant (yes - I had one of those too, girls ;) ) explained that estrogen increases histamine release through activation of mast cells. Hence why I was an itchy, swelling, anaphylaxis prone wreck with rhinitis thrown in for good measure for a while.....Fun, innit??? :o xxxx
Oh, thank you, itching and rhinitis are back again, I thought this was a perimenopause thing but it's just the same as 2 years ago... my blood tests show all hormones are flat, only luteinising hormone is high and it has been increasing in the last couple of years. Any thoughts on that?
Conolly X
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;D ;D ;D Daisydot, you KILL me!!! ;D ;D ;D
Yup - blinkin' mast cells are the root of all trouble with interstitial cystitis. Now I know some of you must be thinking - bloody hell! Tempest must be making this up, no one can be that unlucky - but I had to get bladder stretches done on 2 occasions during peri for this very reason, so I GET YOU, Daisydot!!
I'm a tellin' you - I don't want to 'female' any more, it sucks!!! Jokingly one night, I said to Hubby 'would you mind if I asked to transgender and start taking testosterone and then we could be blokey buddies instead and just hang out in the pub'? And he said as long as he never had to hear the word 'menopause' again, it was fine with him......I LOVE that guy..... ;D ;D xxxx
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Hmmmm - i'll have to get 'boffy' on that one, Conolly! ;) Daisydot and I have 'ology's in this meno. stuff, but we is forever learning. We are like sponges of knowledge, I tell ye! ;) xxxx
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:rofl: :rofl:
Your husband must be lovely...
DD, I have just bought an old book (1997) that has just been released as e-book 'The Other Within Us - Feminist explorations of women and aging' edited by Marilyn Pearsall and contributors include: Susan Sontag, Germaine Greer, May Sarton, Paula Gunn Allen and Ursula K. Le Guin.
The chapter on menopause is 'Heresy in the female body: the rhetorics of menopause' by Jacquelyn N. Zita.
Brilliant stuff!
Sorry for the squint ;D
Conolly X
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Just another thought about the 2 gels, if I was to purchase at the online clinic based in London, get a private prescription filled at a BMI hospital or Gypsy Rose Lee would get it from Studd's pharmacy, you'd get estrogel.
If I go to my local Lloyds or Boots, I get Oestradose more often that not.
How much of this is about money?
Are Besins creating a two tier product maybe?
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I live in Wales so our prescriptions are free. I normally get my Estrogel from the Lloyds chemist in Sainsburys but as i was in Boots i took my presciption there. It was only a few days later when i opened the bag i saw that I had been given Oestrodose. I asked them in Boots to change it, they wouldnt. I asked if i gave it back could I have my prescription back and they said no. Hoping to get an appointment with GP tomorrow to get another prescription so I can get some Estrogel but not sure they will as they prescribed me 3 months worth. I feel lousy and so upset because it has taken me since March to get the dosage right and feel myself again.
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Hello ladies,
That's interesting and worth investigating. Have you ever asked the NHS why it works that way?
Conolly X
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It's definitely a money thing. The bulk, repackaged in the UK gel (as stated on the sticky label, it IS repackaged here) would be cheaper to import. And thus cheaper to supply on NHS prescription.
Just as a note - Hurdity, you REALLY have to see the bottles of Oestrodose yourself in person to see what we mean. Us, the users, know what we're talking about. Regardless of what Besins may have emailed you - it does state (as I said above) on a sticker on the bottles that it is repackaged in the UK. I have bottles of both here at the moment and have pumped out both on a cool tile to do an experiment earlier. I waited 30 minutes and the Oestrodose gel started 'spreading' whereas the Estrogel pump of gel stayed in a firmer cosistency. (Wish we could post photo's on this forum - hey, those of us who developed rashes could even have compared those too if it were possible)!
So - there is a consistency problem at least. I can also have access to very precision measuring equipment too via a biochemist relative, and i'm going to have the dose sizes analysed. I'll post the results here.
I'm not letting this one go, i'm afraid! I also mean to find out what some of us are reacting to in the Oestrodose - again, I can ask for professional advice on this. Conolly has given me some great suggestions on where to start. xxxx
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Wow, that's great! That's proper investigation 🤓
Conolly X
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Sometimes, I think I have too much time on my hands....... ;) ;D xxxx
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Thank you Tempest, this is going to be so interesting. My nausea has gradually subsided throughout the day but i applied my 3 pumps of Oestrogel just over an hour ago and I feel sick again. I can only describe it as feeling like i have morning sickness.
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Is it worth contacting your local area health authority. Surely someone is making the decision to supply the Alternatives.
I smell a dirty great big rat 🐀.
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This is but one of many cost saving exercises. I just don't get it........
Call me a cynic, but I see that there is much talk about promoting support for women in menopause by the NHS in some quarters and elsewhere via the media etc. on one hand (in tandem with the government who are desperate to keep women in menopause in the workplace, thus ensuring their tax contributions), yet they are not supplying us with the 'tools' we need. It seems like bluster, to me.
Why bother with the guidelines etc. if GP's are not up to speed with prescribing HRT, HRT products are sporadically available - i.e. supply problems with some types of patches and now the Estrogel/Oestrodose fiasco? And that the guidelines are being totally ignored when it comes to testosterone replacement, especially for young women and those in surgical menopause?
What is the British Menopause Society doing to liaise with the NHS to address these issues? Are they even aware? I for one would really like to know..........xxxx
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Its so frustrating and i hear conflicting information from all of them. On a more cheery note i managed to get an appointment this morning and the GP i saw was great. She gave me another prescription, took it to Lloyds and i now have Estrogel 😁. She is the only GP/ Pharmacist i have spoken to who hasnt insisted that there is no difference between them and said if there is a difference in consistency i could be absorbing them differently and perhaps not getting the correct dosage.
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Thank you Daisydot! I was lucky today. There are 12 GPs in my practise and some havent got a clue. Im actually excited about using my gel tonight lol. I might crack open a Merlot to celebrate. What do I do with the 3 unopened bottles of Oestrodose? Seems such a waste to bin them. Can i take them back to the pharmacy?
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Hi if you take them back to the pharmacy they will just throw them away. Hang onto them just as Daisydot says x
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Jiggy lol 😂. Am a single parent to a nearly 6 year old. The closest i get to any 'jiggy' is watching Magic Mike 😘
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My daughter keeps on at me to watch magic Mike, I might just do on my day off !!! X
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The film itself is dire. You dont watch it for the plot though 😉
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Hello ladies,
Back to the Oestrodose v Oestrogel...
Hurdity, what email have you used to contact Besins? I couldn't find any on the main website. The 'Contact Us' only show a Monaco address.
Oh, and I have found an old article when Oestrodose had just been released on the market and it definitely had the carbomer 934p with benzene.
Conolly X
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https://besinshealthcare.co.uk/contact-us/
There is an email here . X
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It's definitely a money thing. The bulk, repackaged in the UK gel (as stated on the sticky label, it IS repackaged here) would be cheaper to import. And thus cheaper to supply on NHS prescription.
Just as a note - Hurdity, you REALLY have to see the bottles of Oestrodose yourself in person to see what we mean. Us, the users, know what we're talking about. Regardless of what Besins may have emailed you - it does state (as I said above) on a sticker on the bottles that it is repackaged in the UK. I have bottles of both here at the moment and have pumped out both on a cool tile to do an experiment earlier. I waited 30 minutes and the Oestrodose gel started 'spreading' whereas the Estrogel pump of gel stayed in a firmer cosistency. (Wish we could post photo's on this forum - hey, those of us who developed rashes could even have compared those too if it were possible)!
So - there is a consistency problem at least. I can also have access to very precision measuring equipment too via a biochemist relative, and i'm going to have the dose sizes analysed. I'll post the results here.
I'm not letting this one go, i'm afraid! I also mean to find out what some of us are reacting to in the Oestrodose - again, I can ask for professional advice on this. Conolly has given me some great suggestions on where to start. xxxx
I've only just seen that there are lots of different posts on this thread - was away and busy.
Tempest - yes I know I haven't seen the gels but I have a friend who has been using them for 11 years and has either Oestrogel or Oestrodose 50% of the time and has not observed any difference in consistency and has seen them and pumped them out side by side. Obviously this is not a precision measurement though.... however Besins report that the two products are identical.
You said earlier about repackaging - I reported from Besins that repackaging consists of changing the pump mechanism and outer box. The inner pouch of Oestrodose/Oestrogel remains as it was when it left Besins - with estradiol gel inside it. It doesn't really matter where this is carried out if it is done using the estradiol gel manufactured by Besins in Belgium.
I also reported that Besins do state that they have no control over storage conditions of the product once it leaves their premises although stability studies have been carried out to high temperatures.
As I also said if anyone has an allergic reaction - this is serious and does suggest that something fishy is going on - and this could be with the parallel importer. I am sure I reported that Besins themselves want to know of any such instances so any bottles etc should be kept.
I would be intersted to hear the results of any further investigations!
Hurdity x
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Hello ladies,
Back to the Oestrodose v Oestrogel...
Hurdity, what email have you used to contact Besins? I couldn't find any on the main website. The 'Contact Us' only show a Monaco address.
Oh, and I have found an old article when Oestrodose had just been released on the market and it definitely had the carbomer 934p with benzene.
Conolly X
Connolly - I used this address which was on one of the product info sites - maybe the SPC? [email protected]. My replies come from: Medical Information Department ProPharma Group on behalf of Besins Healthcare (UK) Ltd. The actual letter is on Besins headed "paper".
Re the different ingredients - my correspondence established that according to Besins all the estradiol gel suppled to UK France and Belgium is manufactured in Belgium in their lab and their formulation has not changed for many years so the carbomer issue should not be a factor even though Oestrodose is manufactured elswehere in the world for different markets. I haven't asked specifically about this though and could do so.
I haven't checked all my posts but I'm pretty sure I also said that if there is a difference - and an allergic reaction to one not the other - this would ba a crucial mark of something going on which is why the product should be retained and the manufacturers contacted.
I also said that I did contact the parallel importer (a global company) about this issue but have had no reply.....
There remains the possibility ( did I also mention this?) that the parallel import company could be repackaging Oestrodose/Oestrogel manufactured elsewhere in the world as if it were Besins Oestrodose from Belgium - which is the genuine stuff! This is where any investigation should focus I think as well as reporting any allergic reactions.
Connolly - glad you're taking this one too - perhaps between us we can get to the bottom of it ::) - do pm me if you want any info on my correspondence. Do let me know if you write to one of these and who you have written to!
Hurdity x
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Also there were some remarks further back about perceived differences and posts about this being about views and whether someone was right or wrong. It is absolutely not about this at all!!!!
From my point of view I was genuinely puzzled about all of this - as I have said several times, and especially as I have a friend who has used the two products for years so wanting to get to the bottom of things and amidst all the rumours of what was going on and stuff being imported from elsewhere or an inferior product being manufactured - wrote to Besins. I have no axe to grind whatsoever but as a scientist (retired!) am intrigued. I thought I would do this to try to help and attempt to solve an ongoing controversy...
Re perceived differences - as is said frequently – we are all individuals, so we will respond differently to different types of HRT such as gel, patches, and tablets – and one particular method and dose (or a combination of methods) will suit us best – at one particular phase of our lives or all of it. We will also individually respond differently to other women to the same product such as estradiol gel even the same product at the same concentration. Equally we will respond differently ourselves on different occasions to exactly the same product – which in the case of estradiol gel could be: where we are in menopause, products on our skin, the ambient temperature, our body temperature (skin surface) the location on the body of the gel application, and the size of area that it is spread on – and probably other factors too. All these may affect how quickly and how much of the product is absorbed and therefore systemic levels of the estradiol in our body.
Therefore when using Oestrogel/Oestrodose – there are likely to be variations in how much is absorbed, and this will vary from woman to woman and from time to time, with some women noticing the difference and others not.
As mentioned on the other thread, there is also likely to be a strong placebo effect (in some women) re Oestrogel and Oestrodose and the apparent “superiority†of Oestrogel. This does NOT mean that any PERCEIVED difference is imaginary – far from it – but that the EXPECTATION that Oestrogel is superior (because this was the name given to the estradiol gel for the UK market - that was originally named Oestrodose in Belgium/France as I understand) leads to the ACTUAL result that it has a superior effect. As I said on the other thread, the placebo effect is responsible for a large (and very important) part of any response to a treatment (conventional or alternative) which is why placebo controlled trials are essential for measuring the effectiveness of any treatment that results from that treatment alone.
The notion that Oestrodose is inferior to Oestrogel is quite natural – as they are packaged completely differently – and in the absence of any other information, it is only natural to think that this was a differently manufactured generic product which did not perform as well as the real original (UK) branded product Oestrogel. This was compounded by all the rumours about where Oestrodose was manufactured compared to Oestrogel.
The correspondence I had with Besins established that the two products are exactly the same – Oestrodose is just the French name given to Oestrogel, and also used in other countries. I have had four letters from them which are quite detailed and the contents of which I posted on the other thread. The aim was to find out the facts behind the two products (partly for my own curiosity!) and then to reassure women who were using Oestrodose, NOT to expect any difference whatsoever (other than difference to the same product or because they are respondingly differently for reasons given above).
As I said in the post below - there still remains a possible explanation in some cases, that there is some shady business going on that Besins are unaware of – that the parallel importer when repackaging (btw this does not mean filling the inner pouches – it just means putting the inner pouches in different outer plastic pump mechanism and carton and changing the leaflet) is occasionally using batches of Oestrogel imported from elsewhere in the world which could account for some difference - (and worryingly an allergic reaction to a different ingredient) and also if it was happening sporadically - would also explain why some women experience a difference sometimes and not others. As I said before - Besins want to know about this....
The difference in consistency - if consistently different ::) - is a starting point but easy to resolve in terms of batch numbers as MIS71MUM suggests.
Hurdity x
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Hi, this may be going off topic slightly but I could really do with some advice. I am 57 and stopped Elleste Duet 2mg about 2 months ago due to not being able to cope with the progestin part. After a consultation with prof Studd I have been on 3 pumps of estrogel per day, testim and 7 days utrogestan for about 12 weeks now. My problem is that although I have been applying the estrogel correctly (upper arms, inner thighs etc) it feels as though some of my previous menopausal symptoms are returning-bladder weakness, weepiness, depression, insomnia etc. I was ok on the 7 days utrogestan and it does help me to sleep. Although my libido is a little better, I just don't feel as good as I did on when I was on oral estradiol. It feels like the estrogel isn't strong enough to deal with my symptoms. I have been applying all 3 pumps in the morning to see if this helps, but the effects seem to vary day to day as regards my menopausal symptoms breaking through? What I would like to know is do you think it would be possible to use the utrogestan and testim with 2mg oral estradiol and would prof stud sanction/ prescribe this when I next see him, or should I increase the estrogel to 4 pumps and give it another month? I am really fed up that it doesn't seem to be as effective as I hoped, as I would much prefer to stay on biodential estradiol.
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Hello ladies,
Thank you Dotty and Hurdity for the links. I'll keep you posted on my investigation 🕵🏻♀️😎.
Here's the article I have quoted above [size=78%]http://www.em-consulte.com/en/article/114046 (http://www.em-consulte.com/en/article/114046)[/size]
I speak a bit of French so if anyone is interested I can translate it 😂
Hello happysappy1,
I'm not on HRT so can't help you, sorry. Maybe you should start a new thread or post on one of the many Prof Studd regimen threads. Hope you find helpful advice for your issues.
Conolly X
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As I said above, they are different. If you Google Oestrodose + 934p you will have many hits. If you Google Oestrogel + 934p you won't have any. If you Google Oestrodose + 980 or Oestrogel + 980 you will have many hits. Meaning... some Oestrodose (and also Estrogel, sold in US and other countries) has the 934p thickener which is not as thick ie runnier, as the 980 that has been developed later to replace the 934p which contains BENZENE, a very toxic substance.
https://knowledge.ulprospector.com/7868/pcc-carbomers-slideshow/ (https://knowledge.ulprospector.com/7868/pcc-carbomers-slideshow/)
Saying that ‘All Oestrogel/Oestrodose sold to/in the UK is produced in the Belgium Besins plant' doesn't mean the inactive ingredients are produced by this plant. They are not. So... maybe there are some old batches of Oestrodose still on the market that have the 934p carbomer/carbopol thickener.
Conolly X
Thanks for the link in your last post Connolly - I also speak some French and the page was also automatically translated for me! It is interesting historically - ie that Besins changed their formulation of Oestrodose in 2000 or thereabouts when they changed the carbomer you referred to - but the comparison in the paper was with a completely different gel anyway. This is consistent with their (Besins) explanation to me that the formulation has not changed in recent times. Another change in carbomer would consitute a change in formulation.
It is extremely unlikely that any Oestrodose made before 2000 is still on the market!! I think we can discount that explanation on the basis of information given so far.
What are you intending to ask Besins - I can let you know the specific questions I have asked and had answered, to save going over the same ground if you like?
Hurdity x
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Its so frustrating and i hear conflicting information from all of them. On a more cheery note i managed to get an appointment this morning and the GP i saw was great. She gave me another prescription, took it to Lloyds and i now have Estrogel 😁. She is the only GP/ Pharmacist i have spoken to who hasnt insisted that there is no difference between them and said if there is a difference in consistency i could be absorbing them differently and perhaps not getting the correct dosage.
Hi allie007 - yes as I also said, if there was a difference in consistency then this would affect absorption but I doubt the pharmacy has the information from Besins which I obtained recently which clarified that the two products are exactly the same - ie Oestrogel is Oestrodose repackaged for UK market by the parallel importer (pump mechanism and carton only). Remember that the consistency may also be affected by the storage conditions for the gel and also your own body temeprature - if your skin is warmer it will appear runnier (most likely!).
Hurdity x
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Just another thought about the 2 gels, if I was to purchase at the online clinic based in London, get a private prescription filled at a BMI hospital or Gypsy Rose Lee would get it from Studd's pharmacy, you'd get estrogel.
If I go to my local Lloyds or Boots, I get Oestradose more often that not.
How much of this is about money?
Are Besins creating a two tier product maybe?
Hi MIS71MUM - the purpose of my research and correspondence with Besins was to find out about this and the one thing I have established is that fortunately Besins are not creating a two tier product - if you have a look at the first few posts in this thread! They are exactly the same and it's just the name that is different. The only question mark we have is whether there is a problem with the paraellel importer - all the Oestrodose/Oestrogel in UK is the same but some has been repackaged by the parallel importer and the pump mechanism/carton changed. All the info we have states that this is manufactured by Besins so unless there is something fishy going on re the parellel importer - which would be fraudulent - we have to assume they are identical. If not the packages must be returned to the manufacturer or if an allergic reaction is found - reported to the appropriate authorities. Yes it is about money because the parallel import is cheaper - I think it's similar eg to Weetabix or other branded foods - you can buy the branded stuff which is more expensive or you can get the supermarket one "Wheat biscuits" which I presume is the same stuff repackaged and sold cheaper. it doesn't mean it's inferior!
Hurdity x
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I don't understand the complexity of HRT but I certainly understand that allergic reaction can occur with anything we take. This can happen even if it is something you have been taking for some while. My mum had a severe allergic reaction to a medication she had been taking for two years.
Looks like we have to watch our own back on issues like this. Listen to our bodies. Do our own research and not get fobbed off by medics.
That's a very good point - but doesn't explain why the Oestrodose caused an allergic reaction and stopped when returning to the Oestrogel - which is why, if this occurs, the carton and product needs to be retained and reported to the authorities because it could mean something illegal going on.
Hurdity x
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As I said above, they are different. If you Google Oestrodose + 934p you will have many hits. If you Google Oestrogel + 934p you won't have any. If you Google Oestrodose + 980 or Oestrogel + 980 you will have many hits. Meaning... some Oestrodose (and also Estrogel, sold in US and other countries) has the 934p thickener which is not as thick ie runnier, as the 980 that has been developed later to replace the 934p which contains BENZENE, a very toxic substance.
https://knowledge.ulprospector.com/7868/pcc-carbomers-slideshow/ (https://knowledge.ulprospector.com/7868/pcc-carbomers-slideshow/)
Saying that ‘All Oestrogel/Oestrodose sold to/in the UK is produced in the Belgium Besins plant' doesn't mean the inactive ingredients are produced by this plant. They are not. So... maybe there are some old batches of Oestrodose still on the market that have the 934p carbomer/carbopol thickener.
Conolly X
Thanks for the link in your last post Connolly - I also speak some French and the page was also automatically translated for me! It is interesting historically - ie that Besins changed their formulation of Oestrodose in 2000 or thereabouts when they changed the carbomer you referred to - but the comparison in the paper was with a completely different gel anyway. This is consistent with their (Besins) explanation to me that the formulation has not changed in recent times. Another change in carbomer would consitute a change in formulation.
It is extremely unlikely that any Oestrodose made before 2000 is still on the market!! I think we can discount that explanation on the basis of information given so far.
What are you intending to ask Besins - I can let you know the specific questions I have asked and had answered, to save going over the same ground if you like?
Hurdity x
http://agence-prd.ansm.sante.fr/php/ecodex/notice/N0303717.htm
This is from 2017. Maybe I need some French lessons 😂
Conolly X
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I finished a bottle of Estrogel last week and started a bottle of Estrodose. The consistency is identical.
During the heatwave the Estrogel was looser, wetter and dried faster as I would expect.
I am struggling with some symptoms, mainly bloating and low mood. But these are just as likely to be a random dip as anything or my body trying to get to grips with the new HRT route I'm using.
I was worried about the switch to Estrodose until Hardily put her research out. Then I decided all was well and just got on with it.
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Well that is very confusing Conolly because Besins have repeatedly said that the product is one and the same - and have said that the formulation has not changed for many years. Definitely needs clarification. Also as I reported ealrier Oestrogel is Oestrodose labelled for the UK market as Oestrogel. They use the words exactly the same - a different carbomer is not exactly the same!
Not sure what you mean about the French lessons? :-\
SueLW - most women do not notice any difference - and as you say, as i also pointed out there will be differences in consistency with different ambinet and body temperatures - inresting that you noticed this. I also noticed it with my testosterone gel too - sometimes when hot it would almost drip off my leg whereas others eg now it's cooler it stays in a blob and I can rub it in. I'm glad it's all working well for you :)
Hurdity x
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Hello Hurdity,
It was just s joke 😬
There are some inconsistencies regarding the carbomer, no doubt about that. As I said before, Estrogel (same Besins) in the US and other markets still has the 934 carbomer
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21166_EstrogelTOC.cfm
Maybe during the latest shortage of both Oestrogel (UK) and Oestrodose (February, France), they had resorted to batches from other plants as an emergency measure?
Just a thought.
Conolly X
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Hi there - I've written to Besins re the carbomer issue - mainly for clarification - as our correspondence is ongoing! It may well be that the spc on the web is for oestrodose sold outside Europe or something?
Re the using other batches - this is what I have suggested several times on this thread that the only explanation (since Besins say the two products are identical and have never mentioned supplying stocks from elsewhere) is that the parallel importer is using batches manufactured elsewhere without Besins' knowledge and this would be fraudulent since the leaflet says it is manufactured at Besins in Belgium (France?). It wouldn't just be recently if this has occurred because this issue has been ongoing for several years and also would not be universal since most women don't notice any difference anyway so must have the correct batches. This is only an idea as you say and I have written to the parallel importer again for clarification and also to Besins asking for the correct e-mail address. Hopefully we will get to the bottom of this eventually - but in the meantime we must assume that they are as Besins says - identical - but any adverse reaction to either product needs reporting.
Hurdity x
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;D ;D ;D ;D Brilliant!!!!
I had raised eosinophils throughout peri when my estrogen was high, and was having crazy ovarian cysts and all manner of other weirdness. My anaphylaxis consultant (yes - I had one of those too, girls ;) ) explained that estrogen increases histamine release through activation of mast cells. Hence why I was an itchy, swelling, anaphylaxis prone wreck with rhinitis thrown in for good measure for a while.....Fun, innit??? :o xxxx
Oh, thank you, itching and rhinitis are back again, I thought this was a perimenopause thing but it's just the same as 2 years ago... my blood tests show all hormones are flat, only luteinising hormone is high and it has been increasing in the last couple of years. Any thoughts on that?
Conolly X
Hello ladies,
I'm quoting myself, not going nuts though, lol.
Just to say that I'm looking forward to reading this article.
https://www.frontiersin.org/articles/10.3389/fendo.2018.00544/abstract
Conolly X
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Update - next episode in the thrilling saga ::)
I have heard back from Besins and the letter does confirm what they said all along - there is no difference between the two products. Any difference in carbomer on the leaflets is an error! Here is what they say:
"Our Regulatory Department have confirmed that the leaflet in the Oestrodose pump packs (French pack) have an error in them. The carbomer was changed in 1999 to Carbopol 980 but the change to the leaflet was missed in error and has only just been noticed. The leaflets have now been changed and will be implemented in future productions. The parallel importer will therefore also need to update their leaflet."
This does not suprise me although attention to detail is pretty important when it comes to everything medical/scientific so someone hasn't checked properly.
(As an aside this also occurred with utrogestan (error in leaflet not being updated) when they stopped producing the 200 mg dose for HRT but continued to use the leaflet for 100 mg without updating for cyclical HRT - I know we're not talking about utrogestan but this is just another example of errors in leaflets!).
I wrote to Chemilines again but still no reply and on re-reading the responses from Besins, the supply chain is a bit longer than I originally understood - the Oestrodose/Oestrogel (ie the packs of their 0.06% estradiol gel), in its boxes/canisters as produced by Besins, is sold to a wholesaler and shipped to the parallel importer in UK, so presumably Chemilines (also known as S and M Medical Ltd) buy it from the wholesaler - and then do the repackaging (of the outer bottle/pump-pack/rewriting of the leaflet).
This at least completely confirms what they said earlier that the product produced by Besins in France (Belgium?) is just one product - exactly the same but given different names) and that the product repackaged by the parallel importer is Oestrodose/Oestrogel - the same gel - unless the parallel importer on occasion buys a similar product produced elsewhere - although Besins told me they do not produce any gel elswhere in the world. This is what they said in their first e-mail (which I quoted at the start of this thread):
"All of the Besins Oestrogen Gels have exactly the same qualititative and quantitative compositions and are all manufactured at Besins Healthcare, Belgium"
Still not got to the bottom of the parallel importer ie whether on occasion something fishy (and fraudulent) is going on though but if Besins do not manufacture elsewhere I can't see how.... :-\ but do hope this is helpful and of interest to those who were still wondering!
Hurdity x
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The saga continues. I've been using Estrodose for a couple of weeks or so now and without considering it, I have been feeling worse. This week has been rubbish.
I've just had an appointment with Dr Louise Newson. She's lovely! So different to the other private doctor I've been seeing. So gentle and didn't tell me to diet or threaten me with certain diabetes if I didn't! And as I would expect from a doctor training doctors in the ways of HRT, very knowledgeable.
Anyway, she wants me to increase my gel dose and will confirm by how much when the blood test results come back next week. But I mentioned I was now using Estrodose and she said she wanted me on Estrogel because the Estrodose is weaker! 2 pumps are only about 1.5 pumps of Estrogel and could be the reason I've been sliding again. I queried her on that and she said it's a European import and she doesn't want me on it. So I have a good supply of Estrogel and instructions to send my NHS prescriptions through to an online pharmacy for fulfilment as they will only supply Estrogel.
Weird. Now we know of 2 specialists (Studd being the other) that want patients only on Estrogel.
I will see how I feel over the weekend when I go back to Estrogel.
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I have a plentiful supply of Estrogel now and will hang onto the Estrodose in case of emergencies and use a bit more of it if I have to.
I don't think I can report it as such. I have definitely felt more unwell, but it could be anything. My testosterone level is flat on the deck so that won't be helping. I will see if I notice any improvement this week as I switch, but I will be starting to use the testosterone as soon as I get it so I might not be able to tell reliably.
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Update - next episode in the thrilling saga ::)
I have heard back from Besins and the letter does confirm what they said all along - there is no difference between the two products. Any difference in carbomer on the leaflets is an error! Here is what they say:
"Our Regulatory Department have confirmed that the leaflet in the Oestrodose pump packs (French pack) have an error in them. The carbomer was changed in 1999 to Carbopol 980 but the change to the leaflet was missed in error and has only just been noticed. The leaflets have now been changed and will be implemented in future productions. The parallel importer will therefore also need to update their leaflet."
This does not suprise me although attention to detail is pretty important when it comes to everything medical/scientific so someone hasn't checked properly.
(As an aside this also occurred with utrogestan (error in leaflet not being updated) when they stopped producing the 200 mg dose for HRT but continued to use the leaflet for 100 mg without updating for cyclical HRT - I know we're not talking about utrogestan but this is just another example of errors in leaflets!).
I wrote to Chemilines again but still no reply and on re-reading the responses from Besins, the supply chain is a bit longer than I originally understood - the Oestrodose/Oestrogel (ie the packs of their 0.06% estradiol gel), in its boxes/canisters as produced by Besins, is sold to a wholesaler and shipped to the parallel importer in UK, so presumably Chemilines (also known as S and M Medical Ltd) buy it from the wholesaler - and then do the repackaging (of the outer bottle/pump-pack/rewriting of the leaflet).
This at least completely confirms what they said earlier that the product produced by Besins in France (Belgium?) is just one product - exactly the same but given different names) and that the product repackaged by the parallel importer is Oestrodose/Oestrogel - the same gel - unless the parallel importer on occasion buys a similar product produced elsewhere - although Besins told me they do not produce any gel elswhere in the world. This is what they said in their first e-mail (which I quoted at the start of this thread):
"All of the Besins Oestrogen Gels have exactly the same qualititative and quantitative compositions and are all manufactured at Besins Healthcare, Belgium"
Still not got to the bottom of the parallel importer ie whether on occasion something fishy (and fraudulent) is going on though but if Besins do not manufacture elsewhere I can't see how.... :-\ but do hope this is helpful and of interest to those who were still wondering!
Hurdity x
Hello Hurdity,
If that's just a leaflet error then why a completely different product has the same carbomer 934?
http://base-donnees-publique.medicaments.gouv.fr/affichageDoc.php'specid=68001518&typedoc=N
Conolly X
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Ooer Conolly not sure why you are asking me to explain why a company puts a particular carbomer in a medical product - I'm just writing to the manufacturer to get info and reporting back! ::). However that's a completely different product so not relevant to this discussion!!! I think we've gone as far as we can with the carbomer issue - there was a problem with discrepancies in listings online, I wrote to Besins - they are correcting it. The two products (well they are not two products) - should I say the estradiol gel called Oestrodse or Oestrogel depending on where it is destined for in Europe, contains the carbomer 980 - according to Besins. Incidentally I had already found another error about 10 days ago in that very database you linked to (the French equivalent of eMC - base-donnees etc), for oestrodose where the SPC listed a different carbomer (980) than the PIL for the same product (which gives the old carbomer) and I wrote to the database pointing it out and it has now been corrected!!! So the error is (was) all over the internet!
SueLW - so glad you had a good appointment with Dr Newson but sorry to hear you had a rough week - and hope you are feeling better? Also hope that the testosterone works for you! Not sure why she would have said that the dose is weaker though because they are exactly the same formulation and exactly the same concentration as well as the same pumped dose ie 0.06% estradiol gel with 0.75 mg estradiol per pumped dose. She surely would not have had a different response from Besins - or maybe has not written? Would be interesting to find out!!! If you feel the dose you had was different then do rip open the outer bottle with the pumped mechanism to get to the inner vacuum packed pouch of gel as that will have a product or batch number which will determine its origin. I am happy to write again to Besins with this if you like as I have an ongoing correspondence with them ( anyone else can too!!). However as you yourself noticed the consistency does very with ambient temperature and temperature of your skin so this will have an effect as well as other factors determining how you feel day to day, week to week. I answered about testosterone on the other thread and gave a link to the long-running T thread in Private Lives...). Take care :)
Hurdity x
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Hello Hurdity,
I wasn't asking you to explain anything, only arguing why would the same Besins plant (Besins Manufacturing Belgium) still be using the 934p carbomer on a different and yet similar product, ie testosterone gel, which has the same inactive ingredients as Oestrodose/Oestrogel.
As I have already said on a previous post, the 934p carbomer has benzene and the manufacturer has invented a replacement without benzene, carbopol 980. https://www.lubrizol.com/Life-Sciences/Products/Carbopol-Polymer-Products
My take on this is that in France the carbomers haven't been replaced, probably because the local regulation hasn't changed yet, so there may be some Oestrodose gel with carbomer 934p still on the market and maybe some of those were bought by the parallel importers in the UK.
As for going 'as far as we can with the carbomer issue', speak for yourself, I'm not convinced yet. I think all the ladies who actually use the products and have felt a difference deserve to know exactly what they are using every single day, probably for the rest of their lives.
As a side note, Besins partner in the US (Ascend and DPT Labs) still use the 934p carbomer.
Conolly X
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Thank you Hurdity for taking the time to investigate. I've just got oestrodose repackaged as oestrogel and was wondering if it was OK. This has set my mind at rest.
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SueLW - so glad you had a good appointment with Dr Newson but sorry to hear you had a rough week - and hope you are feeling better? Also hope that the testosterone works for you! Not sure why she would have said that the dose is weaker though because they are exactly the same formulation and exactly the same concentration as well as the same pumped dose ie 0.06% estradiol gel with 0.75 mg estradiol per pumped dose. She surely would not have had a different response from Besins - or maybe has not written? Would be interesting to find out!!! If you feel the dose you had was different then do rip open the outer bottle with the pumped mechanism to get to the inner vacuum packed pouch of gel as that will have a product or batch number which will determine its origin. I am happy to write again to Besins with this if you like as I have an ongoing correspondence with them ( anyone else can too!!). However as you yourself noticed the consistency does very with ambient temperature and temperature of your skin so this will have an effect as well as other factors determining how you feel day to day, week to week. I answered about testosterone on the other thread and gave a link to the long-running T thread in Private Lives...). Take care :)
Hello Hurdity
Sorry, I didn't see your reply here. I am feeling better, but I'm on a higher dose so it's not really possible to tell if it's the switch back to Estrogel or the increased dose that is helping. It's been a bit up and down for me, but I have had a horrible cold and cough going on for over 2 weeks now and I don't think that has helped.
Dr Louise has announced an open day at her new clinic on 18th October. I have registered interest in going because it's quite close to where I live and if I get a place, I will try to ask Louise or her partner doctors about the Estrogel/Estradose issue and see what they say.
I am currently experiencing a spell of bleeding, but I'm hoping it will stop soon. I had this for about 3 months on the Mirena at the start and she did warn me that this current regime might give me bleeds for 3-4 months so I just have to put up with it.
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Hello Hurdity
Sorry, I didn't see your reply here. I am feeling better, but I'm on a higher dose so it's not really possible to tell if it's the switch back to Estrogel or the increased dose that is helping. It's been a bit up and down for me, but I have had a horrible cold and cough going on for over 2 weeks now and I don't think that has helped.
Dr Louise has announced an open day at her new clinic on 18th October. I have registered interest in going because it's quite close to where I live and if I get a place, I will try to ask Louise or her partner doctors about the Estrogel/Estradose issue and see what they say.
I am currently experiencing a spell of bleeding, but I'm hoping it will stop soon. I had this for about 3 months on the Mirena at the start and she did warn me that this current regime might give me bleeds for 3-4 months so I just have to put up with it.
Glad you're feeling better but sorry to hear about the bleeding - have just recommended you on another thread where someone was talking about thyroid meds - maybe Bo?
Good luck with getting into the Open Day - too far for me I'm afraid. Re the topic in hand - if she wants to see my correspondence from Besins I will happily share it!!! ;)
No probs sheila99 - there are always variations in how we feel with any HRT - even the same dose of the same product - from day to day and week to week. Hope the gel is working for you. In your case I think this will have come directly from Besins (unless the leaflet inside says it has been repackaged in UK?). This will be the Oestrodose (estradiol gel) they package for the French/European market (which is where it started so this is the original stuff) and labeled as Oestrogel because this is the name given to it in UK - "Oestrodose" as a product/name does not exist in UK and is not listed, because it is all estradiol gel made by Besins so I can see how confusing it is ( was) though!
Hurdity x
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Hi I started estrogel again 14 weeks ago. I done 4 weeks at 2 pumps had severe flushing as had been on 175mcg patch so advised to go up to 3 pumps. I have just don't 10 weeks on 3 pumps and still struggling. I have burning shoulders headache and sore breasts. I have still been flushing. I am so close to 12 weeks is it likely another 2 weeks which takes it to 12 weeks will make any difference?
I have found out today I can't get estrogel and only estrodose. I have been following this thread and just still a bit nervous. Should I hold fire until 12 weeks ?
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I really wouldn't worry about it donnacrichton - the thread goes off on various meanders, but the main point of it was to try to reassure women like you who may (reasonably!) think they have been given a different product - there was only speculation before, which is why I decided to write to Besins. The information I was given from Besins shows that they only manufacture one type/formulation of estradiol gel at their lab/processing plant in Belgium (France?) - and it is usually called Oestrodose but is called Oestrogel for the UK market and packaged in different container - who knows why - but different countries seem to have different names for the same product! The formulation of the European/British estradiol gel (the carbomers that are referred to in this thread) was changed way back in 1997 or thereabouts (before it was available in UK I imagine) and has remained the same since then and this would have run out long ago - it probably has a three year "shelf-life" or similar. Hope this reassures you :)
I can see why 2 pumps may not equate to 175 mcg although women seem to vary so much in how well they absorb oestrogen from the different preparations available. Hope you manage to find the right dose of gel to alleviate your symptoms soon.
Hurdity x
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Thank you for the reassurance. I've picked up the estradose and it is now packaged differently than 4 years ago. It is now in a different bottle and labelled estrogel. This was not the case a few years ago. I will stick it out the next two weeks I've got this far x
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Hello ladies,
I'd like to ask the ladies who actually use Oestrogel/Oestrodose to say which one of these do you have:
1 (https://i.imgur.com/Z9wQZDKl.jpg) 2 (https://i.imgur.com/fKnhs24l.jpg)
3 (https://i.imgur.com/gStnDJml.jpg) 4 (https://i.imgur.com/mN2kdfNl.jpg)
5 (https://i.imgur.com/uxVfNUxl.jpg)
If you have a different one, could you please post a photo?
Thank you,
Conolly X
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Hi Conolly, I have picture number 4, I get a private GP to prescribe it, in the past when I got it from the NHS GP, I always got prescribed picture number 3.
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Hello Abba Fan,
Thank you very much. Sorry if you have already said this before, but I would like to know if you have ever felt any difference between #4 and #3 and also if the writings on the box/pump are exactly as the ones you see on these photos regarding composition and repackaging companies.
Conolly X
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Hi conolly my box is similar to number 4 but all in English.Sorry I can't post photo but if you want to pm me your email I can send you a screen shot.xx D.D
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Hello DD,
Will do, thank you.
Conolly X
PS: Actually a link to my email address is right below my avatar ::) ;D
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Hi Conolly, it's number 5 I get on private prescription, sorry for the confusion. I always insist I get number 5 because yes I have had problems with absorption using number 3.
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Hi Connolly, my pictures are: the Box front = 1/the box back = 2 and the bottle back = 3.
Mine is an NHS prescription and I live in Northern Ireland
I have never had anything different so I don't know if there is a different absorption rate.
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I used to have estrogel but recently got ostradose repackaged as estrogel (1&3). I have found no difference. I actually prefer the ostradose pump, the first squirt of estrogel was always a bit small because the gel disappeared up the spout. I don't think they would be able to repackage it unless it was exactly the same.
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Hi Conolly, it's number 5 I get on private prescription, sorry for the confusion. I always insist I get number 5 because yes I have had problems with absorption using number 3.
Thank you, Abba Fan. What exactly do you mean by 'problems with absorption'? Have your symptoms returned? Have you had to increase the dose?
Conolly X
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Hi Connolly, my pictures are: the Box front = 1/the box back = 2 and the bottle back = 3.
Mine is an NHS prescription and I live in Northern Ireland
I have never had anything different so I don't know if there is a different absorption rate.
Hello Ladybt28,
Thank you. So your front box says Oestrodose, the box back says Oestrogel repackaged by Doncaster Pharma and the bottle is the French (with a neck) style or just the print (#3)[size=78%]? [/size]
Conolly X
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Yes symptoms returned such as dizziness, nausea, hot flushes and anxiety. I had a blood test done and my levels were around 400, I don't feel well under 800. I increased from 3 pumps to 4 pumps for another month and I still had the same problems. I then went to the private GP and insisted that he write me a script for number 5 as I've never had any problems with absorption while using it. Btw, I only use 3 pumps of picture number 5, I've never had to increase the dose. I'm postmenopause so don't know if that makes a difference.
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I used to have estrogel but recently got ostradose repackaged as estrogel (1&3). I have found no difference. I actually prefer the ostradose pump, the first squirt of estrogel was always a bit small because the gel disappeared up the spout. I don't think they would be able to repackage it unless it was exactly the same.
Hello sheila99,
Thank you. Do you have the straight bottle or the one with a neck?
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Yes symptoms returned such as dizziness, nausea, hot flushes and anxiety. I had a blood test done and my levels were around 400, I don't feel well under 800. I increased from 3 pumps to 4 pumps for another month and I still had the same problems. I then went to the private GP and insisted that he write me a script for number 5 as I've never had any problems with absorption while using it. Btw, I only use 3 pumps of picture number 5, I've never had to increase the dose. I'm postmenopause so don't know if that makes a difference.
Thanks Abba Fan. I think your experience is interesting precisely because you are postmenopausal. If you were still in peri your own hormonal fluctuations would have interfered in the process.
Conolly X
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It's the same stuff! 0.06% estradiol gel with exactly the same ingredients. There should be no difference in absorption at all - only in that individual women vary from day to day week to week and month to month even on the same HRT.....we read about it all the time. That is in itself interesting! The ingredients are all the same. It's not like Sandrena gel vs Oestrogel/Oestrodose or Testim vs Testogel - these are different formulations and sometimes different concentrations. According to Besins it is all in the labelling. The repackaging is the EXTERNAL packaging and it is all (ie the gel) put into the same inner pouch. It's not the outer carton you want to be looking at - it would be the inner pouch which should have a batch number. I haven't seen any of these though!
The original gel they (Besins) make is/was Oestrodose. That is the "proper" stuff. In UK (and some other EU countries - looks like Greece too judging by the picture) we seem to want to call their Oestrodose "Oestrogel" so the plastic packaging reflects what it's called here or it is just relabelled because that's what it's known as in UK!!! I mean this is the case for lots of pharmaceutical products - Utrogestan, Estradot patches and all sorts of tablet HRT types - we become aware of it on this forum when we compare products and find they have different names although the same formulation by the same company. If it was a different formulation it would be listed on eMC as a different product and Besins have explained the position in several e-mails which I have reported here.
The only possible issue is that one of the parallel importers is procuring from elsewhere outsidie the EU with a different formulation and lying that it is Besins gel but the pharmaceutical industry is very heavily regulated. Anyone who feels there is a difference should report the product they think is inferior through the yellow card scheme after first opening the plastic packaging and noting the batch numbers.
Hurdity x
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Hello ladies,
I know that most of you don't care if there are minor differences between the batches. I respect that. I just like to get to the bottom of things. I have been reading a lot about Pharmaceutical companies and markets and I am personally interested in the business. I have found some inconsistencies in information so far regarding the carbomers. In theory the 934p shouldn't be marketed in Europe, but it is licensed in the US, all Estrogel produced by Ascend Therapeutics (a Besins Healthcare affiliate) has the 934p. Some Oestrogel cartons have the 934p listed, some have the 980 NF, some just say carbomer. If this is a leaflet error (as Besins have told Hurdity) this has been happening for 19 years... wot?
I agree that the batch number is also important, so if you could post the numbers after finishing the bottle, I'd appreciate that.
Oestrodose is not the 'original' product. It's just the French trade mark. Oestrogel is the name marketed all around the world, except for the US (Estrogel) and some Asian countries. I agree that names, carton, bottles are irrelevant but that's what we have to compare, otherwise we have to 'believe' Besins. I'm not a believer. It's business and it's about money. We are the guinea pigs, with brains.
Conolly X
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I used to have estrogel but recently got ostradose repackaged as estrogel (1&3). I have found no difference. I actually prefer the ostradose pump, the first squirt of estrogel was always a bit small because the gel disappeared up the spout. I don't think they would be able to repackage it unless it was exactly the same.
Hello sheila99,
Thank you. Do you have the straight bottle or the one with a neck?
Estrogel was pic 5. Ostradose bottle has a shaped neck, nozzle is flat instead of round, original writing in French on the bottle, English label on top.
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Thank you, sheila99, that makes sense.
Conolly X
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Good morning, ladies!
I've just received an email from Animed saying they don't stock Oestrodose/Oestrogel atm.
I've already spoken to someone at Doncaster Pharma who said their ‘Oestrodose repackaged as Oestrogel' has the carbomer 934p (which could be a leaflet error, according to Besins).
Still waiting for Kasei Pharma's response.
Conolly X
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My lovely pharmacist has been trying for 2 weeks plus now to try and fill my prescription but still no stocks of oestrogel anywhere. thankfully I have spare that id bought privately for just exactly this scenario and i don't need it right now anyway.we all know which one we would prefer as experienced users but sometimes choices are taken out of our hands sadly.x
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Interesting thread to follow - at least if you're not bothered which one you get or don't actually use the gel. Probably causing a good deal of anxiety to some though.
Hello Stellajane,
That's not my intention. I'm sure that what really matters is that menopause symptoms are being controlled and if that's the case, don't bother reading this thread. If someone genuinely feels that they don't have the same benefits from the parallel import products, then I think it's important to clarify what could be causing this. If the products are the same, it's a powerful placebo effect which is also important to verify.
Speaking for myself, I am a hypersensitive person, prone to allergies and also migraines and a recent diagnosis of fibromyalgia. The benzene content of carbomer 934p is 100 ppm and 980 is 0.50 ppm, which was enough to convince the European authorities to prohibit the 934p.
I'm still considering HRT and Estradiol gel + Utrogestan would be my first choice, so I guess I'm qualified to investigate. I travel a lot and the equivalence of Besins products around the world is a real issue for me.
Conolly X
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Hello ladies,
I know that most of you don't care if there are minor differences between the batches. I respect that. I just like to get to the bottom of things. I have been reading a lot about Pharmaceutical companies and markets and I am personally interested in the business. I have found some inconsistencies in information so far regarding the carbomers. In theory the 934p shouldn't be marketed in Europe, but it is licensed in the US, all Estrogel produced by Ascend Therapeutics (a Besins Healthcare affiliate) has the 934p. Some Oestrogel cartons have the 934p listed, some have the 980 NF, some just say carbomer. If this is a leaflet error (as Besins have told Hurdity) this has been happening for 19 years... wot?
I agree that the batch number is also important, so if you could post the numbers after finishing the bottle, I'd appreciate that.
Oestrodose is not the 'original' product. It's just the French trade mark. Oestrogel is the name marketed all around the world, except for the US (Estrogel) and some Asian countries. I agree that names, carton, bottles are irrelevant but that's what we have to compare, otherwise we have to 'believe' Besins. I'm not a believer. It's business and it's about money. We are the guinea pigs, with brains.
Conolly X
Well I certainly do care which is why I started the investigation! Exactly as you say - like you "I just like to get to the bottom of things." - and I have said as much many times!
re the labelling of the leaflets - the leaflets in UK don't have the actual carbomer on them and I have no idea what the actual printed leaflets in the rest of Europe listed. However I can well believe that certain errors may well have persisted once the first error ( lack of proper checking) had been made.
For example the Base Donnees entry (in France)for Oestrodose I reported in August (I think) had a different carbomer listed for the equivalent of the PIL compared to that for the SPC for the same product. This was clearly an error - which has now been rectified!
If someone genuinely feels that they don't have the same benefits from the parallel import products, then I think it's important to clarify what could be causing this. If the products are the same, it's a powerful placebo effect which is also important to verify.
Conolly X
This is exactly the point - no-one is suggesting that it isn't important to find out.
There is no reason not to "believe" Besins - we may all be suspicious of big pharma but there is very strict regulation of products in the pharmaceutical industry which would make it unlikely that a large reputable company would simply make it up and just use any old carbomer that came to hand.
The only thing that has not yet been established and which I have referred to many times including in my last post - is whether any of the parallel importers are getting their oestrogel/oestrodose from outside the EU (or storing it in unfavourable conditions) and not manufactured by Besins in their Belgium ( France?) plant. The leaflet in all these products will say where the gel was manufactured and according to Besins it is by them.
Some of the parallel importers appear only to be repackaging minimally - ie procuring estradiol gel (Oestrodose) and sticking a label over it for the UK market. Again the key to its origin and manufacture is in the leaflet - I have said several times that if the leaflet says it is made by Besins in Belgium ( or France - can never remember which!) and it isn't - this is fraud and our own regulatory system would want to know about it as well as Besins I imagine.
Interesting thread to follow - at least if you're not bothered which one you get or don't actually use the gel. Probably causing a good deal of anxiety to some though.
Oh dear! I started this thread with the intention of alleviating any anxiety not to cause it! Until I wrote to Besins and established something about what's going on there were all sorts of rumours going around about what Oestrodose was and I hope I have clarified this at least!
re the batch numbers - I've had a message from a friend (not a member of this forum) who says that it is very difficult to break open the plastic containers and get at the inner pouch but there are batch numbers on the packaging. I first asked for these back in August and so far no-one has posted any!
Also please if anyone has got any Oestrodose which they think is not proper Oestrodose and notices a marked difference in consistency or has an allergic reaction - please do report it and keep the bottle. Since I started this thread again no-one seems to have reported anything :-\ - on here at least. It would be helpful to do so as we are all trying to understand what's going on even if placebo which I think I referred to right at the start as a possibility!
Connolly I am puzzled by your response from Doncaster Pharma but as there have been several errors in info on the web - this could also be an error as besins have assured me it was a very long time ago that they stopped using this carbomer.
Incidentally - and I think I mentioned this earlier somewhere - from what I read about carbomers the 934 would be very different from 980 and it would not be a "minor difference" - they seem to be designed for different purposes so I think the gel would have behaved and appeared very differently. It would be very interesting to get hold of some of the American Estrogel (which has the 934 ?) and UK/French Oestrogel/Oestrodose with the 980 and squirt them/rub into skin side by side....
The saga continues....
Hurdity x
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Hello ladies,
There's an older thread on the matter (actually 2 threads)
https://www.menopausematters.co.uk/forum/index.php/topic,35279.0.html (https://www.menopausematters.co.uk/forum/index.php/topic,35279.0.html)
Conolly X
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Hello Stellajane,
Sorry, you're right. Sometimes I get a bit carried away. I'm an Aspie, it happens often :D
So... All ladies that have or had an issue with different batches of Oestrogel (Besins UK, Poland St. London) or Oestrodose repackaged as Oestrogel by parallel import companies (there are many as you can see on the MHRA website) could post on this thread which product(s) have inconsistencies (texture or efficacy), the name on the label (Oestrodose/Oestrogel or just Oestrogel), the bottom part of the leaflet where the manufacturer and import company are listed. If possible, tell us the batch number on the cannister.
Regarding the carbomer... it's not necessary to say which one is listed, because recent leaflets don't specify which one, they just say carbomer (all leaflets are listed on the MHRA website, you just have to search for Oestrogel http://www.mhra.gov.uk/spc-pil/ (http://www.mhra.gov.uk/spc-pil/) )
Thank you for your help,
Conolly X
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On a side note... inconsistencies are also being felt with other Besins products
https://community.macmillan.org.uk/cancer_types/testicular-cancer/f/testicular-cancer-forum/158451/testogel--first-time-user?Page=1 (https://community.macmillan.org.uk/cancer_types/testicular-cancer/f/testicular-cancer-forum/158451/testogel--first-time-user?Page=1)
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Hello ladies,
There's an older thread on the matter (actually 2 threads)
https://www.menopausematters.co.uk/forum/index.php/topic,35279.0.html (https://www.menopausematters.co.uk/forum/index.php/topic,35279.0.html)
Conolly X
Haha! Well spotted! it goes back way further than this too - it's been rumbling on for years - maybe almost as long as I've been on this forum. Those threads you referred to are mainly anecdotal reports of inconsistencies and speculation as to the origin and ingredients of the Besins estradiol gel, and whether there are generics and inferior products being manufactured etc. This is why I decided to look into it properly - well as properly as is possible by correspondence. I did get confirmation from Besins that the products are identical - both Oestrodose and Oestrogel are different brand names according to the destination (European) country - and there is no generic of this product being produced that we know of.
The main thing for gel users (Oestrodose) to note is:
1 Where the product is manufactured (and the manufacturer - but assuming it will be Besins, Belgium?)
2 The name of the parallel importer/repackaging company
3 The batch number/date
4 Some basic info about the carton, leaflet and bottle
It would be good to compile this info even if you have noticed no difference - in fact especially if you haven't as well!
I know I suggested posting all of this but maybe best not to clog up this thread with the info so I am happy to collate it by pm if anyone wants to send me the stuff/info as I can report back to Besins? Maybe I'll start another one?
Connolly - I am puzzled by the Greek bottle of Oestrodose - you said you don't use HRT so did you get this from the web or has someone been given this on prescription in UK?
Hurdity x
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Hello Hurdity,
That photo is from Besins website https://www.besins-healthcare.com/products/#womens (https://www.besins-healthcare.com/products/#womens)
Click on the Oestrogel/Estrogel/Oestrodose/Gynokadin link and the photo will appear. Now, it's odd that the link says 'womens'... :o
On a previous post you wrote that you had received emails/letters from ProPharma Group on behalf of Besins Healthcare UK. ProPharma Group is an American company that provides compliance consulting to pharmaceutical companies across the world. I wonder if they actually 'know' what happens inside the manufacturing plants, mainly during the recent shortages of both products. I'd rather have an email response directly from Drogenbos manufacturing plant in Belgium, where supposedly all Oestrogel and Oestrodose are produced, but I have recently found that that manufacturing plant had been bought by Delpharm in 2012.
http://www.delpharm.com/en/the-group/history/ (http://www.delpharm.com/en/the-group/history/)
So it's a bit more complicated than I've thought.
Conolly X
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Hello again, ladies
Well, I've been investigating this issue and what I have found so far is this:
Besins Healthcare claims to have manufacturing plants in France, Belgium, Spain and Thailand when in fact they rely on Third Party companies in these countries to 'manufacture' their products. Actually, some of Besins products are manufactured at these plants, but not all of them. According to this very detailed information from New Zealand medical authorities, the real manufacturer of Utrogestan (Besins) is a Chinese manufacturer (Changzhou Jiaerke Pharmaceuticals Group Corp Ltd). All 'Besins manufacturing plants', including Drogenbos, Belgium (Delpharm), Spain and Thailand (they are actually Third Party companies that have a business deal with Besins), are listed as responsible for further steps of the manufacturing process, testing, dosing, labeling, packaging.
http://www.medsafe.govt.nz/regulatory/ProductDetail.asp?ID=13679 (http://www.medsafe.govt.nz/regulatory/ProductDetail.asp?ID=13679)
That Chinese company is listed here as not inspected by USFDA https://www.pharmacompass.com/manufacturers-suppliers-exporters/utrogestan (https://www.pharmacompass.com/manufacturers-suppliers-exporters/utrogestan) I wonder if some of the dreadful Utrogestan side effects must be caused by contaminants.
Unfortunately, it seems that there is no Oestrogel/Estrogel/Oestrodose currently being marketed in NZ, so we could have the same detailed information regarding Estradiol gel.
Apparently, only Sandrena gel is marketed in NZ
http://www.medsafe.govt.nz/regulatory/ProductDetail.asp?ID=4941 (http://www.medsafe.govt.nz/regulatory/ProductDetail.asp?ID=4941)
Conolly X
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As a matter of interest, has anyone ever reported noticing differences between Oestrogel and Oestrodose using the Yellow Card Scheme? Or reported any allergies/rashes etc. from Oestrodose?
This explains how the scheme can help:
https://yellowcard.mhra.gov.uk/the-yellow-card-scheme/
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I had itching on my back whilst using the one and only bottle I had on oestrodose, but I am going back to last year. I had a spare oestrogel so started using that instead but told pharmacist after that that I'd prefer oestrogel. I didn't yellow card as I didn't use it long enough to be sure it was that but the itching went as soon as I used oestrogel
Just to add: I'm usually ok on generic medication, and not a stippler for the brand names so I know I didn't talk myself into the itching x
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That's great to remind everyone of that Jenna! Also as you sensibly say Annie - you can't be sure whether your rash had anything to do with the Oestrodose, or something to do with your own sensitivity. I don't suppose you still have the carton/bottle and leaflet somewhere?
Also to reiterate - that it has been established that Oestrodose is NOT a generic medication but a brand name given by Besins to their 0.06% estradiol gel (produced in Belgium) for most of the EU, with the brand name given to exactly the same product in UK as Oestrogel.
If it were a generic medication it would be called "Estradiol 0.06% gel" or similar, and may not have the same excipients (the other stuff in the product besides estradiol), and may or may not be produced by the same company. All the ingredients would still be listed to identify them.
Hurdity x
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Jenna, something a lot of us likely fail to do is report on the yellow card scheme! I wish I'd kept the oestrodose to look at batch numbers etc but sorry to say it went straight in the bin.
Back on patches now and much happier, would never want my experience on oestrodose repeated and just couldn't take the chance of manufacturing problems with oestrodose again x
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Hello again,
According to https://www.gov.uk/government/collections/parallel-import-licences-lists-of-approved-products (https://www.gov.uk/government/collections/parallel-import-licences-lists-of-approved-products) since 2014 there are 3 parallel import licences granted to Oestrogel, none to Oestrodose. The companies that have been granted the licences are G-Pharma Ltd in 2014, Ginova Ltd in 2016 and Quadrant Pharmaceuticals in 2018.
Quadrant Pharmaceuticals is a non trading company that is part of a group called Walkboost, along with Maxearn Ltd and Eaststone Ltd https://www.eaststone.co.uk/wp-content/uploads/2018/05/Walkboost-Group-Overview-August-2017.pdf (https://www.eaststone.co.uk/wp-content/uploads/2018/05/Walkboost-Group-Overview-August-2017.pdf)
The most recent Oestrogel leaflet listed at MHRA website says:
'Manufactured by: Besins Manufacturing Belgium N.V., GrootBijgaardenstraat, 128-1620 Drogenbos, Belgium.Procured from within the EU. Product Licence Holder: QuadrantPharmaceuticals Ltd, Lynstock House, Lynstock Way, Lostock,Bolton, BL6 4SA. Repackaged by: Maxearn Ltd, Bolton, BL6 4SA.PL 20774/1551 Oestrogel Pump Pack Leaflet revision date: 11th January 2018'
I have sent them an email asking about Oestrodose.
Conolly X
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Hello again...
A great article on Parallel Imports
https://www.alscg.com/brexit-parallel-imports-end-era/ (https://www.alscg.com/brexit-parallel-imports-end-era/)
Conolly X
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Yes there seem to be several parallel import companies based on the information given by women on here who use Oestrogel/Oestrodose.
The reason there isn't an import license granted to Oestrodose is I presume because the license is given for a parallel import of Oestrogel - the product labelled as such in Europe for the UK market ( amongst other countries maybe too?). There is no entry for Oestrodose in UK as it is not known by this name here so the license is given to import Oestrogel - and presumably it is cheaper for the import company to buy the estradiol gel packagaed as Oestrodose rather than maybe the more limited stocks of estradiol gel marketed as Oestrogel?
Not sure what you are asking Besins Connolly?
I asked them about the parallel import company and they didn't seem to have information - this is what they said:
There is only one formulation for manufacturing this product and the stabilities on the product, whether Oestrodose or Oestrogel, are all compliant. There was no significant difference in the past 20 years in stability studies for this product.
However, the stability studies are made on products not leaving the factory and stored in the
optimum conditions for the complete shelf-life period, although we have stability studies for the following conditions: 25℃ & 30℃ for 36 months and 40℃ for 6 months.
The product Oestrogel distributed in the UK is managed by Besins Healthcare from the
manufacturing facility to your distributor in the UK.
However, the product Oestrodose distributed in the UK is not monitored by Besins. Once the product leaves the distribution warehouse in France, we do not know what happens to the product when it is with the wholesaler in France and when it is shipped to the importer in the UK. Therefore, it is not possible for us to confirm that this is just a perception as there is a part of the time where the product has been out of our control and we do not know what conditions the product has been exposed to.
I would advise that you contact the importer of the product from France for further information on storage conditions of Oestrodose.
Their point was that if the product was stored in unfavourable conditions, this could account for apparent differences. I have mentioned this several times in the thread. Also that they did not hold contact details of the parallel importers as it went to a wholesaler first.
At this point I lose interest!
If you want to identify the whole supply chain and interrogate each parallel importer to ensure that all their stocks originate from Besins and are always stored in favourable conditions - then good luck to you!
I am satisfied from my correspondence with Besins as well as accounts from a number of long-standing post-menopausal users of the gel, that at least for most of the time it is proper Oestrodose (Oestrogel). Whether on occasion a parallel importer gets it from somewhere else far afield and not manufactured in Belgium remains to be seen and I would suggest a good way to sort this out as suggested many times on here is to keep the packaging and batch numbers of any Oestrodose that differs in consistency from other Oestrodose/Oestrogel, or causes an allergic reaction and report to the MHRA or Besins themselves for analysis.
I would be interested to know what you have asked Besins Connolly, and their response, especially if it adds to what I have already established.
Hurdity x
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Bumping for Donna-paul
Conolly X
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Copied from the other thread
Hello Hurdity,
Actually only in the UK Oestrodose is relabelled as Oestrogel. Oestrodose is only available in France and the Phillipines. All other EU countries have Oestrogel or Gynokadin (Germany) and Estrogel in the US.
I don't understand why Besins UK can't provide Oestrogel for the whole UK market. The only explanation for many parallel importers trading Oestrodose is because it's cheaper to buy it from France or the Phillipines.
The reason why the pump-pack is called Oestrodose in France is because Besins had already launched Oestrogel tube over there.
Conolly X
Just to reiterate – as reported in the first post on this thread, Besins Belgium have stated that they do not manufacture Oestrodose in the Phillipines and no such product from there reaches UK. All the Oestrodose in UK is imported through parallel importers who purchase it from wholesalers supplied by Besins Belgium (the supply chain may be even longer than this?). The manufacturer of the Oestrodose you receive in UK will be given on the Patient information leaflet, and probably also the canister and the box and there will be a batch number.
I agree it is confusing to produce an identical product with two different names to the same country and it should ideally be called one or the other for whole of EU countries they supply!
Hurdity x
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Hello again,
Just to be clear... I never said Oestrodose is manufactured in the Philippines. I said that Oestrodose, as a brand name, is only available in France and the Philippines. I don't know how can you be so sure that parallel importers buy all Oestrodose from France. After all, if both are manufactered at the same plant (Drogenbos), it doesn't matter if they are imported from France or the Philippines.
Regarding the brand names, it's quite common to have the same product with different names around the world, it's just about international trademark registrations.
What I REALLY don't understand is why Besins UK can't provide Oestrogel for the whole UK market.
Conolly X
P.S. Oestrodose is also marketed in Tunisia and Lebanon by Besins.
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UPDATE FOLLOWING RECENT DISCUSSION WITH DR LOUISE NEWSON
There has been continued speculation about the differences between Oestrogel and Oestrodose at various times and on various threads on this forum.
Just to recap – Besins manufacture both Oestrogel and Oestrodose at their plant in Belgium and they report that these are both the same product with different names, and have been tested extensively at different temperatures etc. Oestrogel is for the UK market and Oestrodose is for the French and other markets. The Oestrodose in the UK is imported via parallel import companies and repackaged (outer carton and pump pack, not the inner pouch containing the gel). Although stability studies (in terms of storage time and temperature) have been carried out using the Oestrodose/Oestrogel at Besins lab, they have stated they have no control over the product once it leaves their factory so cannot comment on storage conditions.
In view of the ongoing controversy surrounding this, and because she has been mentioned by forum members in the context of this debate at various times, I have been in discussion with Dr Louise Newson and she is happy for me to post her views on this forum.
She tells me that she has personally spoken to Besins several times about the gels, and that she has been given exactly the same information that I have – that the Oestrogel and Oestrodose that they manufacture there are identical in composition and just named differently.
In addition she says the following:
“Many women do not notice the difference between the two types. However, I certainly have several women who have told me that their symptoms have returned with using the oestrodose instead of the oestrogel. I wonder whether the pump action is slightly different so they receive slightly less of the gel. It is for this reason that I only dispense oestrogel in my clinic. So as a general rule if women use the alternative preparation which they have obtained from their GP without any problems then I would not be concerned but if they experience symptoms then I would encourage them to go back to using oestrogel. They can use their NHS prescription www.theindependentpharmacy.co.uk who usually only dispense oestrogel.
I think women should know that most of them will be fine but if they notice a difference then they should get the original pump packsâ€
I raised the issue of the pump pack previously with Besins and they assured me that their pump pack delivered exactly the same amount. However as Louise points out there remains the possibility that the pump packs produced by some of the parallel importers are slightly different meaning some women might get less of the gel – and which some women may be more sensitive to?
The issue of itching is an entirely different matter and remains unresolved – there is no evidence to suggest there is a difference but as we have said several time before anyone experiencing a persistent allergic reaction only on the one product which resolves on changing and re-appears when Oestrodose is used – should report this to the MHRA, take a note of the batch number and also report to Besins because a compositional difference would imply fraud as the patient leaflets clearly state the ingredients, which are identical.
I hope this helps to clarify some of the issues raised. My intention in researching this was to help other women and reassure those who were concerned as well as to dispel rumours about the origins and composition of Besins Oestrodose which turned out to be unfounded.
Here's to a continued flush-free experience girls using whatever product you choose! :)
Hurdity x
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See itching Hurdity - Oestrogel has ethanol in it as part of the delivery mechanism which is where this sort evaporating alcohol consistency comes from. Maybe it is the ethanol which some women don't get on well with on their skin. Bit like skin cleansers and products that have alcohol type chemicals in them? Does Oestrodose have the same?
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Yes that's the whole point re the ingredients - they are exactly the same! They are not different products - that was the whole point of my writing to Besins to find out and then posting on this thread - to find this out. I completely get your point re the alcohol and women not getting on with or being allergic to some ingredients but there is as yet no explanation for anyone who experiences itching on one (Oestrodose) and not another (Oestrogel). For this to be attributable to one of the products - it would have to keep happening every time the product was switched, rather than just the once.
Hurdity x
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Sorry Hurdity - I must have missed the threads where itching was complained of with one product not the other - I thought the itching was a general gel issue and being discussed as such in amongst the thread and not as a product specific issue. It doesn't affect me anyway I always get given a box which says oestrodose but has a bottle that says oestrogel which has been re-packaged in Doncaster. I have never had "pure oestrodose" to compare it with.
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No problem Ladybt!
Yes what you are getting is one and the same - what everyone else is getting - ie when you don't get the Oestrogel in the Oestrogel pack direct from Besins, you get Oestrodose from Besins made in the same plant, either repackaged or just re-labelled as Oestrogel in a variety of different ways depending on which company is importing it I think. So yes it's pure Oestrodose - which is pure Oestrogel because we don't call that product Oestrodose in UK hence it all has to be relabelled (As far as I know they all have to be relabelled as Oestrogel with the oestorgel pil - as Oestrodose is not listed in the EMC).
As Conolly said a few posts back - why these companies have to call the same product by different names for different countries is beyond me - but must be something to do with the medicines regulator in each country or something to do with what appeals in different languages and cultures?? Who knows but it doesn't half cause confusion!!!
Hurdity x
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Thank you Hurdity and thank you Conolly for diving into this so deeply.
I live in India and sourcing my estradiol gel is always a great struggle.
I used Estrogel from 2004 to 2016. I used to buy it in France - it came in a toothpaste-sized tube, not a pump. It controlled my symptoms more or less. A few times during that period I was given Oestrodose in a pump bottle (straight not with a neck) and I found it did not work as well although I cannot remember the exact symptoms now that reared their ugly heads. I made sure I was only given the tube not the pump after that.
France switched to Oestrodose, pumps sometime last year I think and the toothpaste -like Estrogel is no longer available to my knowledge. I did not do well on the pumps at all.
I am now using Oestraclin - made and sold in Spain over the counter - which is listed as the same as Estrogel, although not made by Besins. I am struggling with many symptoms, mainly brain fog, depression and cystitis- like urethral and bladder symptoms (which I am starting Vagifem for). Sorry if this is too detailed for this thread.
I do not know if my continued symptoms is due to the switch or simply increased needs of my body.
I think the investigations you have both done Hurdity and Conolly are brilliant. I don't believe Besin's replies entirely although I don't disbelieve them entirely either.
I am puzzled as to why some doctors seem to think the two preparations are different. Thank you Hurdity for checking with Dr. Louise. I wonder why Dr Stubbs only prescribes Estrogel? It might be good if one of his patients could ask what his evidence is for this. Also, I have seen the statement that oestrodose is weaker than estrogel in so many places - not on this site, but on many other websites - , and I simply don't know what the evidence for that is. Also, Dr Louise was quoted as saying that to someone on this thread (? I am very puzzled)
Thank you again for all the effort you have put into this and to everyone who replied with their experiences
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Kkay - I appreciate your comments!
However there is more likely to be a difference between Oestralcin and Oestrogel/Oestrodose (which are the same even if different pump packs), because as you say Oestraclin is not made by Besins. It does however have the same ingredients and concentration of estradiol. Mary G swears by it so it must be good ;). Although not the subject of this thread, however I would suggest though that anyone who is very sensitive to differences in these products as some users clearly are - should not use this substitute as it is not manufactured by Besins and could be subject to slight differences in the ingredients. Everyone else who is happy on any product would be fine!
Stellajane has answered your Q about private practitioners which I agree with. I have reported Louise Newson's reply to me verbatim in italics. Don't forget I did not write to her as a patient. She does not believe the products are different (because she also wrote or spoke to Besins herself), subject to possible caveat re potential slight difference in amount dispensed although Besins say their own packaged Oestrodose and Oestrogel pump packs dispense exactly the same amounts. She will no doubt respond to her patients as tactfully as possible and give them what they want. As for Dr Stubbs - do you mean John "the Prof" Studd? Who knows what he says to his patients at great expense (!) but it doesn't alter what I have reported from Besins and Dr Newson.
Not sure what it is about Besins you don't entirely believe? The patient information leaflets of all of these products should give the manufacturers as well as the importer. Once one goes into the realms of not accepting the statements from the companies about the origin of their products - well there is nothing further that can be done short of conducting your own detailed analysis of the product itself.
You will have read about one being weaker as hearsay and personal anecdotal evidence from forum and gel users. That is the evidence. There is no actual objective evidence. Third party reports of what someone may have said do not constitute evidence. If you read this thread you will see that no-one is disputing that some gel users notice a difference but that does not mean that the products are different, and users' experiences are genuine. The various possible explanations for this have been given on the thread.
Anyway glad the Oestraclin is working for you Kkay :). Long may that last!!!
Hurdity x
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Hi all
I know the title of this thread is that they are exactly the same, but I just wanted to add my experience.
I was give oestrodose and started using it about 2.5 weeks ago. I have been feeling worse and worse. Headaches, achy, hot flushes... anxiety ramping even higher.
So, I picked up my new prescription and they have given me one of each! I switched back to oestrogen and hopefully things will improve (only on day 2). I just think that maybe I wasn't absorbing the oestrodose, which is thin and smells strongly of alcohol.
I spoke to a friend who used to work in a pharmacy and told me to take the unused oestrodose back and tell them that it is a parallel import, and that I cant take it, as I have a bad reaction, and they should change it (box is still sealed and my prescription definitely says oestrogel).
Jeeper xx
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Hi Jeepers - sorry to hear about your problems. Just because it is a parallel import doesn't mean it's different. I explained all of that ( from my correspondence with Besins) at the beginning of, and at intervals throughout the thread. Alcohol is the main ingredient of this estradiol gel (my testogel smells the same!).
If you have a reaction to the oestrogel packaged as Oestrodose then you must report it through the MHRA yellow card scheme and possibly also contact Besins with the batch number or whatever it is so that they can investigate that batch?
If you have only just started using gel then there are likely to be teething problems as your body adjusts, and also if you are peri-menopausal too. Hope you feel better soon :)
Hurdity x
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Hi Hurdity
Thanks for your reply :-)
I should have said that the oestrodose smells much more strongly of alcohol, so much so, that my partner remarked on it. I know you explained a lot,fab, and it makes sense, but I definitely felt different on it, so its all a bit strange. I will look up the yellow card scheme, thanks for the heads up.
Oh, and I'm 4 years post meno, but only on HRT for 18 months
Jeepers xx
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Hi Jeepers,
My sister has been on Oestrogel for ages and the only time she was given Oestrodose she felt there was a difference. I wonder if this could be due to the fact that at least until 2016 there were 2 different sites of manufacturing, one in France (Montrouge) and other in Belgium (Drogenbos). Now they all seem to be manufactured in Belgium. Do you have the lot/batch number of this Oestrodose bottle?
BeaR.
(https://i.imgur.com/L7LkvIcl.jpg)
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Hi
The bottle says Lot: 72420
Exp: 07/2021
PL: 20774/1551
ECMA: 3400933829247
Jeepers xx
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Thank you, Jeepers.
According to the expiry date it has been manufactured in 07/2018, probably in Belgium, but maybe some batches are still from France. Are you going to keep using it?
BeaR.
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Here we go again....
This issue has been rumbling on for several years irrespective of where whatever batches have been manufactured at which of the besins plants. You're (bear) trying to look for unlikely explanations for potentially minute differences bear. As far as we know they are all manufactured in either France or Belgium by Besins to exactly the same recipe ( well they haven't counted the molecules ;D ). The previous discussion centred around manfacturing sub-standard products in Asia, Oestrodose being a cheaper generic, even weird discontinued ingredients like benzene from old formulations that were stopped in the 90's etc etc. Besins' answers debunked that. Let's not go over all the same ground again.
What is important is Jeepers reaction. Jeepers - like I said - I would send that info to Besins along with the consistent differences in symptoms and sdie effects you experience on that batch (and for consistency i would try a couple of weeks or something back on it again so that you are sure it's not coincidence) and also the details of the yellow card scheme are here:
https://yellowcard.mhra.gov.uk/
It is important to report to them and to Besins so that they know if there is a difference and can perhaps explain to you? You could also write to them with that information. Their e-mail address will be on your patient leaflet - or if not, on the emc website here:
https://www.medicines.org.uk/emc/product/353/smpc#companyDetails
Also the licence number (the PL bit - 20774/1551) shows it was given to Quadrant pharmaceuticals in Jan 2018 for the import of oestrogel pump pack! So I would defo write to Besins with the batch number etc... Let us know what they say - whatever it is :)
Hurdity x
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BeaR, i have used Estrogel for 3 years and in that time i have ended up with Osterodose three times and that has concided with a flare up of my symptoms.
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BeaR, i have used Estrogel for 3 years and in that time i have ended up with Osterodose three times and that has concided with a flare up of my symptoms.
Hi Tinkerbell,
That's exactly what happened to my sister. They are supposed to be identical, but if there was any change in manufacturing sites, even if the 'recipe' is the same, the raw materials and fillers may have come from different sources and small differences (legal) are bound to occur. I suppose Besins has already established that the manufacturing facility at Drogenbos in Belgium is the sole source of Oestrogel/Oestrodose now and as the UK has its own Besins headquarters and the paralllel import of Oestrodose might decrease after Brexit, Oestrogel will be dispensed more frequently. I hope your symptoms are being under control now.
BeaR.
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Hi all
Thank you for the replies.
BeaR, I won't be using it again, my symptoms/side effects are horrendous, palpitations are back with a vengeance. I'll stick to the oestrogen , and then see (hope) that everything settles down. I'll feed all of that back to basins and the yellow card scheme, hurdity.
Hi tinker bell, which symptoms flared up?
Thanks jeepers xx
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Bumpity bump!
All the info and previous correspondence about oestrogel and oestrodose with Besins is on this thread including information about stability stuides at different temperatures etc ::)
Some pictures of the bottles were also posted by ex-member Conolly but they have disappeared.
Happy reading folks! Also some of the punctuation has been replaced by weird symbols - must be when the forum was migrated to the new server...
Hurdity x :)
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Hello all, this is my first post here on MM.
Before anything I want to say a MASSIVE thank you to all the posters, and Hurdity in particular, for the posts/advice/knowledge and patience. My HRT journey started 6 weeks ago, despite having been offered it by my GP nine months before then. I feel so much more knowledgeable, reassured and better prepared for what my body might do next :)
I wanted to add to this Oestrogel/Oestrodose thread, but in no way to contradict what has come before.
My first two gel packs were Oestrogel. All fine. I went to collect my next prescription the other day and was given Oestrodose. I questioned it in the pharmacy and the pharmacist told me it was the French brand name but was exactly the same product, but if I wasn't happy to come back. I felt reassured so came home.
I read the threads here and Hurdity's feedback that Besins said it was the same product, and yes the ingredients appeared to be the same. The order in which the ingredients were listed on original labels on the bottle varied (and I thought in EU countries at least the order was significant?). The other thing was that the Oestrogel contained triethanolamine whereas the Oestrodose contained trolamine. Google is a bit ambiguous but it looks like they are the same thing. But I don't know for sure. Despite my nervousness about trying the Oestrodose I did think it was worth giving it a go. I primed the pump and the consistency seemed to be the same as Oestrogel so again I felt reassured.
Even though I still have a few days worth of Oestrogel in my pump I decided to try the Oestrodose today. Two pumps. It absolutely stank of alcohol in a way that Oestrogel doesn't. And the alcohol smell lingered/tingled as it dried on my arm. I don't normally get that.
Again I decided that I shouldn't let myself be influenced by what might be small variations (I'm an asthmatic and I know that as much I prefer getting Ventolin there are other salbutamol products that work just as effectively...). But I started looking at the labels for the two products to see what was different. The Oestrodose bottle is identical in size, shape and colour scheme to the Oestrogel. The pump seemed the same too. The only noticeable packaging differences are the box and the label on the pump pack. The UK importer (B&S) had added their own label onto the bottle (which said Oestrogel on the label) and that's when I noticed that the PL numbers on the Oestrogel and Oestrodose were different. The Oestrodose new label says that the product has been repackaged by B&S Healthcare. B&S' website says they: "hold the UK's largest Parallel import licence portfolio, controls bespoke specials manufacturing laboratory, is the country's largest independent distributor of generics"
Oestrogel was PL 28397/0002
Oestrodose was PL 18799/2141
According to Huffington Post and Martin Lewis (and no, neither of these are specialist medical sites, but...) the PL number is an important indicator of what's in the product (https://blog.moneysavingexpert.com/2018/07/martin-lewis--a-drugs-bust-up---stop-letting-big-pharmaceuticals/)
"While the active ingredient is what does the business, there can be other differences, such as how it's delivered. Even then, often inside the packaging, tablets are IDENTICAL - not just the same active ingredient.
On the side of the pack you'll see a product number (or PL number) - this is a unique licence number given exclusively to a particular drug made by a particular manufacturer (eg, PL 12063/0104 is a cold and flu remedy). If two have the same number, they're the exact same product. They have the same active ingredient AND the same formulation."
I took the Oestrodose back to the pharmacy and pointed out that the PL number was different from the Oestrogel, and that even Dr Newsom's website says that some women report that Oestrodose is less effective, and they exchanged them for me.
Surely if the two products were identical, and from the same manufacturer, the PL numbers would be the same? I have pictures of both bottles but don't seem to be able to add them here.
As I said, not trying to challenge what has been said before but genuinely puzzled by all this!
anneaug
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Hi anneaug,
Welcome to the forum. :)
As you can see here...
https://imedi.co.uk/oestrogel-pump-pack#
... all products imported from the EU can have different product licences, depending on where they are sourced by a particular parallel import company. In this case they have a PLPI code number.
https://www.gov.uk/guidance/medicines-apply-for-a-parallel-import-licence
The difference perceived by gel users are real though, IMHO.
Keep us posted!
BeaR
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Thank you BeaR :-)
As I said in my last post, I did notice that the order ingredients were listed were different. My understanding was that ingredients are listed in order of predominance, with the ingredients used in the greatest amount first?
Aside from the active ingredient which I am sure must be the same...
Oestrogel says: carbomer, ethanol, triethanolamine, purified water
Oestrodose says: carbomer, trolamine, ethanol, purified water
I'm not a scientist so I don't know what difference that might make, but it also suggests to me that if the ingredients are listed in a different order that the overall product is not identical!
Anne
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Hi again Anne,
Trolamine and Triethanolamine are synonyms.
Have a look at this other thread
https://www.menopausematters.co.uk/forum/index.php/topic,46689.msg752698.html#msg752698
BeaR.
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Hi BeaR
I'd worked that out, thanks. My point in my last post was that the order in which the ingredients are listed is not the same; and that my understanding is that ingredients should be listed in order of predominance?
Anne
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Hi BeaR
I'd worked that out, thanks. My point in my last post was that the order in which the ingredients are listed is not the same; and that my understanding is that ingredients should be listed in order of predominance?
Anne
Sorry, maybe you're right! But I suspect the leaflets provided by parallel import companies may have some minor printing errors?
BeaR
PS. I don't know if the the ingredients have to be listed in order of predominance, but I have checked old leaflets and there is this version as well:
'Excipients: ethanol, carbomer, triethanolamine and purified water'
If this rule really exists, I suspect it could be different in other ( ::)) EU countries and the translation won't be necessary following the UK rule.
https://imedi.co.uk/oestrogel-pump-pack'doc=5
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Hi anneaug
:welcomemm: and the mad and not so mad world of menopausal women on HRT!
It would be great if you could tell us how old you are and how far along the menopause journey you are - what your periods have been doing in the months leading up to your starting HRT and any other relevant info, including what symptoms you are hoping to alleviate with HRT?
As you know from this long-running thread this issue has run and run. I contacted Besins to clear up some of the wild rumours circulating about generics and inferior products and inferior gels manufactured in Asia etc and as you will have seen at the beginning of this thread and at intervals - reported pretty much verbatim what Besins reported. I think the issue of Parallel licences has already been covered in this long thread!
See below the post where I reported back from my correspondence with Dr Louise Newson. AS she sees most women in a private capacity then obviously if they tell her they preceive a difference in Oestrogel from Oestrodose she will give them what they ask for - after all they are paying - so she's not going to aruge with them!
Note she was wondering about the pump mechanism not any smell of alcohol but Besins assured me that the amount dispensed is identical - after all it would have to be to comply with it being permitted as a parallel import i would say since the amount dispensed per pump and the amount of active ingredient is the same. Any very minute differences (and even human action could lead to this) would not be noticed.
UPDATE FOLLOWING RECENT DISCUSSION WITH DR LOUISE NEWSON
There has been continued speculation about the differences between Oestrogel and Oestrodose at various times and on various threads on this forum.
Just to recap – Besins manufacture both Oestrogel and Oestrodose at their plant in Belgium and they report that these are both the same product with different names, and have been tested extensively at different temperatures etc. Oestrogel is for the UK market and Oestrodose is for the French and other markets. The Oestrodose in the UK is imported via parallel import companies and repackaged (outer carton and pump pack, not the inner pouch containing the gel). Although stability studies (in terms of storage time and temperature) have been carried out using the Oestrodose/Oestrogel at Besins lab, they have stated they have no control over the product once it leaves their factory so cannot comment on storage conditions.
In view of the ongoing controversy surrounding this, and because she has been mentioned by forum members in the context of this debate at various times, I have been in discussion with Dr Louise Newson and she is happy for me to post her views on this forum.
She tells me that she has personally spoken to Besins several times about the gels, and that she has been given exactly the same information that I have – that the Oestrogel and Oestrodose that they manufacture there are identical in composition and just named differently.
In addition she says the following:
“Many women do not notice the difference between the two types. However, I certainly have several women who have told me that their symptoms have returned with using the oestrodose instead of the oestrogel. I wonder whether the pump action is slightly different so they receive slightly less of the gel. It is for this reason that I only dispense oestrogel in my clinic. So as a general rule if women use the alternative preparation which they have obtained from their GP without any problems then I would not be concerned but if they experience symptoms then I would encourage them to go back to using oestrogel. They can use their NHS prescription www.theindependentpharmacy.co.uk who usually only dispense oestrogel.
I think women should know that most of them will be fine but if they notice a difference then they should get the original pump packsâ€
I raised the issue of the pump pack previously with Besins and they assured me that their pump pack delivered exactly the same amount. However as Louise points out there remains the possibility that the pump packs produced by some of the parallel importers are slightly different meaning some women might get less of the gel – and which some women may be more sensitive to?
The issue of itching is an entirely different matter and remains unresolved – there is no evidence to suggest there is a difference but as we have said several time before anyone experiencing a persistent allergic reaction only on the one product which resolves on changing and re-appears when Oestrodose is used – should report this to the MHRA, take a note of the batch number and also report to Besins because a compositional difference would imply fraud as the patient leaflets clearly state the ingredients, which are identical.
I hope this helps to clarify some of the issues raised. My intention in researching this was to help other women and reassure those who were concerned as well as to dispel rumours about the origins and composition of Besins Oestrodose which turned out to be unfounded.
Here's to a continued flush-free experience girls using whatever product you choose! :)
Hurdity x
You said you took back the gel because of the smell so haven't tried it? I suggest you might be overthinking it! The amount of research you have done is admirable but perhpas muight cause oyu anxiety if you worry about it too much.
I would say - get using the gel - whichever name it has on it, and concentrate on feeling well now that you have started on your hRT journey!
All the best and here's to a long and flush free post-menopausal life!
Hurdity x
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Yes, I am sure I am probably overthinking it, that wouldn't be uncharacteristic :) That said, the Oestrodose did smell much more, and the ingredients - while the same as Oestrogel - are presented in a different order on the bottles (on the original labels, don't know about the leaflets). If ingredients do have to be listed by predominance then it might suggest a slight difference in formulation which might explain why the Oestrodose has a more alcohol-y smell. Anyway, I know you and others have been investigating this for some time and so I don't suppose I'm raising anything that hasn't been discussed before...
I don't think I'd fully appreciated how much of an impact (peri)menopause was having on me, and for how long, until I started HRT and those symptoms began to disappear/lessen. Like many women, I am sure, I don't want to go back to that place and so the prospect of a (perceived or real) less effective drug that saves the NHS pence rather than pounds is troubling.
I used the Oestrodose for one day before returning it, so no, not long enough to say what difference if any it might have had. I read, either on this thread or another one, that some women related more relief for emotional/psychological symptoms in addition to physical ones with Oestrodose. So maybe I should have persisted! Let's see what the pharmacist gives me next time...
I have moved the rest of this post to https://www.menopausematters.co.uk/forum/index.php/topic,46860.0.html at Hurdity's suggestion.
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Hi again anneaug
Thanks for all that info! Sorry I should have suggested you started a new post as it would be good to have a thread of your own to talk about your particular situation rather than this one as I want to try to keep it to the oestrodose/Oestrogel question - for future reference if possible, and for others to see as well. My fault!
Anyway - if you are peri-menopausal then notwithstanding any perceived differences in alcohol content (!), you will experience ups and downs anyway due to youre own cycle as HRT does not suppress it, so you wouldn't be able to attribute any changes definitively to anything really.
re the actual gels - well there is no reason to suppose they are different because of what Besins have told us and also because the gel is packaged into a sealed polyproylene pouch - and only afterwards has the outer plastic bottle thingy and pump mechanism put on. Having seen some of these TV programmes inside the factory (fascinating) - I can picture all the processes going on - the big vat where all the ingredients are put together, mixed up and cooked and made into the gel - then off it goes to be squeezed into all the pouches. Then I imagine all the pouches going off to a completely different part of the factory where the outer carton is fixed on - and this would be a different conveyor belt depending what it was going to be called for which country....
The issue raised by Mis71mum the other day is different ie have they recently changed the formulation of oestrogel itself - but personally I wouldn't have thought so as they would then have to do another load of testing, and stability studies - Besins told me they did 3 year stability studies re temeprature to ascertain shelf life. Anyway all sort sof issues raised here. However we'll wait to hear about that one.
Why don't you start a new thread - even repeating the information about yourself that you have put here - so that more members can welcome you and answer as your post will get lost in here as not many read this thread I don't think? - It's a bit esoteric!!! Members probably think here we go again - I certainly do ;D
All the best :)
Hurdity x
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Good point, Hurdity, I have moved the stuff about my symptoms etc to here: https://www.menopausematters.co.uk/forum/index.php/topic,46860.0.html to keep this thread about Oestrogel and Oestrodose.
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I'm bumping this as it's come up again so anyone interested can read the tale!
Hurdity x
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No, they are not exactly the same!!! I was doing great on oestrogel, then was given the parallel import by my pharmacy and went rapidly downhill. Got a fresh prescription and insisted on the uk non-parallel import (pharmacist now looks out for my prescription and makes sure she doesn't get the import) ... back to feeling great again.
Don't listen to ANYONE who insists there's no difference - THERE IS!!
And you don't need to take my word for it - follow this link, which takes you to a post from the eminent menopause expert Dr Louise Newson explaining why:
https://www.menopausedoctor.co.uk/menopause/oestrodose#
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Hi hrthelps68
:welcomemm:
I'm sorry to hear that you went downhill when you changed your HRT prescription. There are all sorts of reasons why this might be, not necessarily to do with the preparation you were using. Perhaps you could introduce yourself either in this or the new members section and tell us something about yourself, and where you are on the menopause journey, and we might be able to help?
I have looked at the link and in fact nothing that Dr Newson says in that article confirms that any difference whatsoever has been demonstrated and in fact her wording very carefully avoids this. She uses the word "version" - without specifiying and it has been established that the difference is in naming and packaging - the identical Besins gel manufactured by them for some other EU countries and supplied as a parallel import to UK is called Oestrodose. If you read the thread (which unfortunately goes off on somewhat fanciful and irrelevant tangents sometimes as I recall) you will see that I was in touch with Dr Newson about this and I quoted her response which I will repost here for the benefit of other members.
As previously advised on this thread and more recently on her website by Dr Newson herself - anyone who experiences any form of side effects or allergic reaction on the parallel import Oestrodose rather than Oestrogel - must report it through the yellow card scheme because it is only through this that any improper practices by the importers that might sometimes take place, would come to light.
This thread (and my investigation) was originally started because there were all sorts of odd theories going about eg that Oestrodose was a generic estradiol gel with different ingredients and formulation manufcatrued in Asia or elsewhere, leading to marked differences in absorption and therefore estradiol levels. The detailed correspondence I had with Besins established that in fact this was not the case.
Many members were concerned that they were being given a product that would not work and was inferior and in fact recent media hype by some sort of celeb menopause/health person (can't remember her name) calling this a scandal, only served to cause needless additional worry to probably thousands of women.
My aim was to establish what was known, report on what I found and hopefully allay women's fears at a time in their lives when they need to have confidence in the product they are using. This is not to minimise any ongoing distressing symptoms that some women are experiencing which they feel can only be explained by the change to the parallel import. So far, though we have not got any actual evidence of any differences, notwithstanding women's personal experiences.
I hope everyone who is struggling to find the correct regime and dose of HRT is able to do so in order to feel the best they can as they progress along this sometimes difficult journey :)
Hurdity x
UPDATE FOLLOWING RECENT DISCUSSION WITH DR LOUISE NEWSON
There has been continued speculation about the differences between Oestrogel and Oestrodose at various times and on various threads on this forum.
Just to recap – Besins manufacture both Oestrogel and Oestrodose at their plant in Belgium and they report that these are both the same product with different names, and have been tested extensively at different temperatures etc. Oestrogel is for the UK market and Oestrodose is for the French and other markets. The Oestrodose in the UK is imported via parallel import companies and repackaged (outer carton and pump pack, not the inner pouch containing the gel). Although stability studies (in terms of storage time and temperature) have been carried out using the Oestrodose/Oestrogel at Besins lab, they have stated they have no control over the product once it leaves their factory so cannot comment on storage conditions.
In view of the ongoing controversy surrounding this, and because she has been mentioned by forum members in the context of this debate at various times, I have been in discussion with Dr Louise Newson and she is happy for me to post her views on this forum.
She tells me that she has personally spoken to Besins several times about the gels, and that she has been given exactly the same information that I have – that the Oestrogel and Oestrodose that they manufacture there are identical in composition and just named differently.
In addition she says the following:
“Many women do not notice the difference between the two types. However, I certainly have several women who have told me that their symptoms have returned with using the oestrodose instead of the oestrogel. I wonder whether the pump action is slightly different so they receive slightly less of the gel. It is for this reason that I only dispense oestrogel in my clinic. So as a general rule if women use the alternative preparation which they have obtained from their GP without any problems then I would not be concerned but if they experience symptoms then I would encourage them to go back to using oestrogel. They can use their NHS prescription www.theindependentpharmacy.co.uk who usually only dispense oestrogel.
I think women should know that most of them will be fine but if they notice a difference then they should get the original pump packsâ€
I raised the issue of the pump pack previously with Besins and they assured me that their pump pack delivered exactly the same amount. However as Louise points out there remains the possibility that the pump packs produced by some of the parallel importers are slightly different meaning some women might get less of the gel – and which some women may be more sensitive to?
The issue of itching is an entirely different matter and remains unresolved – there is no evidence to suggest there is a difference but as we have said several time before anyone experiencing a persistent allergic reaction only on the one product which resolves on changing and re-appears when Oestrodose is used – should report this to the MHRA, take a note of the batch number and also report to Besins because a compositional difference would imply fraud as the patient leaflets clearly state the ingredients, which are identical.
I hope this helps to clarify some of the issues raised. My intention in researching this was to help other women and reassure those who were concerned as well as to dispel rumours about the origins and composition of Besins Oestrodose which turned out to be unfounded.
Here's to a continued flush-free experience girls using whatever product you choose! :)
Hurdity x
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I'm now on oestrodose and I'm doing really well on it. Can't said I've noticed much of a difference only that the oestrodose is a bit more liquid than the oestrogel but I know some have had problems with it.
S x
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Hi, I also noticed a difference over the last three years between gels but on checking the ingredients and manufacturer I thought it must have been my own hormonal fluctuations.
Then I was doing well, losing weight and reducing hot flushes for two months and started a new gel and within a few days I was anxious, bloating and flushing. After a week I felt so desperate that I went to my pharmacy to ask about it and was asked which version I was struggling with, I checked the packaging and was told that yes, this was what they expected me to say as other women had come and said the same things: estrodose just doesn’t work in the same way as estrogel. So weird???
My Doctor agreed to change my prescription immediately and I started afresh with estrogel. Symptoms improved rapidly.
I understand the logic put forward by Hurdity, I had ignored the issue myself as it seemed impossible for this to be the cause of the change in my response. However the reality is: it did make a vast difference.
I feel relieved that I now have the gel that works for me but also wish I had found out sooner after two years of wildly fluctuating symptoms that I blamed on myself rather than the actual cause of two gels that were frankly not performing the same for my body.