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[Conolly]

Thank you, sheila99, that makes sense.


Conolly X

[Conolly]

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

[Droopeydrawers]

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

[Conolly]

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

[Hurdity]

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

[Conolly]

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


Conolly X

[Conolly]

Hello Stellajane,

Sorry, you're right. Sometimes I get a bit carried away. I'm an Aspie, it happens often 


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/ )


Thank you for your help,


Conolly X

[Conolly]

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

[Hurdity]

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

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

[Conolly]

Hello Hurdity,


That photo is from Besins website 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'... 


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/

So it's a bit more complicated than I've thought.

Conolly X

[Conolly]

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

That Chinese company is listed here as not inspected by USFDA 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

Conolly X

[Jenna]

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/

[Annie0710]

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

[Hurdity]

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

[Optimist]

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