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[Hurdity]

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

[Conolly]

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??? 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

[Hurdity]

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

[SueLW]

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. 

[SueLW]

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.

[Conolly]

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

[Hurdity]

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

[Conolly]

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

[sheila99]

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.

[SueLW]

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. 

[Hurdity]

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

[donnacrichton]

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 ?

[Hurdity]

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

[donnacrichton]

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

[Conolly]

Hello ladies,

I'd like to ask the ladies who actually use Oestrogel/Oestrodose to say which one of these do you have:

1   2
3 4 

5

If you have a different one, could you please post a photo?

Thank you,


Conolly X