Oestrogel: new packaging (yet again)?

[Cosmetichamster]

Hi ladies,

Just got this month's prescription for Oestrogel, and I have been issued with a bottle that is new (to me at least). Have a look at the photo: left is what I have known and used since June this year, on the right is the new bottle, also from Besins, same labels, same ingredients, and long use by date (07/25). Obtained from a reputable pharmacy, which has filled all my previous HRT prescriptions.

Has anyone seen this sort of thing? Slightly freaked out here.

Has anybody tried their MP? I’m thinking of writing to mine this weekend.

I’ve heard back from Besins who just said to take it up with my health provider. It was my doctors and chemist that said to contact Besins 🤷‍♀️

Great idea 👍🏻

@BatshitCrazyWoman I was told by my doctor to go up to 6 pumps of the new bottle and sadly it didn't work. I had weeks of hell waiting for it to work. Me personally the new bottles seems to have nothing in them apart from gel. Every single menopause symptoms came back. I slapped on a patch and they settled down within 24 hours.
I am currently trying sandrena and 2 sachets of the 1mg isn't enough for me, but I will give it a few more days before I up it to 3 sachets.

Thanks I’m already at my wits end with brain fog and all sorts …it’s good to have some support on here 🙂! I’ve really struggled and my doctor’s aren’t on the ball at all…

Blimey, our MP doesn't even reply if you email him about local issues, I can't imagine him giving a shit about my menopause meds 😂

Hi it was me that asked as I've never had one Dr mention Sandrena until the supply and inconsistency issues. It's always been Oestrogel. I wondered why they seem to favour this transdermal product.

@gabbyaggy I'm going to have to go back to the Oestrogel even though it's not great. I feel really ill on the Sandrena

I too have noticed this and feel reassured I’m not going mad. I changed over and my symptoms (migraine sweats insomnia and joint pains) reappeared within a few days having been well controlled for years on the old style packaging. I continued for 2 months then found an old style bottle and my symptoms disappeared again. Now back to the new packaging and they’ve returned 😕 I’m a GP and whilst the BMS and Besins say it is the same product I am convinced it is not being absorbed in the same way. My brain seems to be quite sensitive to changes in oestrogen levels - migraines are triggered easily. With other medicines (such as anti epileptics) it’s recommended they are prescribed by brand ONLY as generic versions can and do vary, causing breakthrough symptoms. I am sure this is what’s happening here. I have reported to MHRA and am going to try Sandrena or go back to patches.

@AnnieG71 this id interesting. I am also taking anticonvulsants (tegretol) for trigeminal neuralgia. I have been in a flair up since being on the cylindrical gel. This pain out ways the symptoms of menopause its horrendous. I have always said mine is triggered through hormone fluctuations. I dont know whats worse 😩

Why would new packaging mean a change in ingredients?

It's not the fact that it's a new packaging, it's the fact that now the gel has 2 different manufacturers, Besins Manufacturing Belgium and Laboratoires Besins International in Montrouge, France, and there's no way of knowing which one you have because it's not specified in the packaging or leaflet.

@Muttley47 how did sandrena make you feel ill? Is it side effects? I'm interested as I have just started on this gel 🙃

@Hartieharts Initial couple days I thought I'd be ok. I just had a stuffy sort of headache and my head felt sort of hot like you got too hot in the night type feeling. But then the headache got bad and was constant, my mood was stressy/angry, eyes and lids twitchy and sensitive to the light. It felt a bit precursor to a migraine aura starting. I had to stop after a week. The minute I did these symptoms stopped. I had the same ones but even more intensely on an Evorel patch. I must be hyper sensitive. This is so frustrating as I felt wonderful on the Oestrogel of old, before all this inconsistency. I'll muddle on with this Oestrogel and pray that someone at Besin listens and fixes it. I had truly hoped Sandrena would be what I could move over to. We're all different, there are people very happy with it. I hope it works for you. 😊

@Muttley47 thanks for your reply. I get awful headaches every time I swap HRT. I used to get migraines all the time and now I can clearly see that was due to the contraceptive pills I was on for many years.
I think everyone has their own issues with new things. I got on so well with the oestrogel before the bottle changed.
Fingers crossed it works as I'm running out of options.
Hopefully someone will actually listen and sort out the ostrogel soon.

The more people who fill out the yellow card (it’s a government scheme for reporting problems with medication) via the MHRA website the more likely something will get done. I encourage you or anyone else affected to do it. https://yellowcard.mhra.gov.uk/

I have been phoning round and spoken to 15 local pharmacies. They either only had the clear lid or would not open the boxes. I'm on my last blue lid bottle and starting to get stressed about my options once it runs out.

There is a private online pharmacy that is happy to prescribe the blue lid but that costs. Ironically they were also extremely receptive to my concerns a few months ago but the difference between the bottles and confirmed they had previous people making the same request. So frustrating.

@Mickymoomoo77 are you able to tell me which private pharmacy has some as I’m willing to pay after the moment! After weeks of sleepless nights on the new packaging I feel I’m getting desperate :-(

I’ve been weighing my dosage for over a week now to get consistent accurate doses but it’s still not working, I feel like it’s getting worse so I don’t think it’s just down to the incorrect measurements.

I have noticed that if you don’t put the stopper back on you get a lot less in a dose (1.00mg) but if the stopper is on when storing you get a bigger dose next time but still not 1.25g

I’m waiting on oestrogen blood results to back up that this stuff just really isn’t working! :-(

Sure it's oxford pharmacy online. You will have to fill out an online questionnaire but if you've been on HRT before you'll be fine. I'd phone them first to ask if they have stock before putting in an order as they will put a note on your account that you only want blue lid gel.

Unfortunately, I’m not sure it’s just the straight-sided bottles that are a problem. I think it may be to do with batch numbers, as someone mentioned earlier. If it helps though, the packaging for the conical bottle is larger - 18cm as opposed to 16.5cm

Hey all, just been following this saga for months and it seems to have no ending. Let me fill you all in on my disheartening journey dealing with Besins for the last 9 months.
In November 2022 I was given the new cylindrical bottles and( like a previous poster who said she is sensitive to changes in the gel) within a week I knew something was SERIOUSLY off! I had a total return of my debilitating symptoms. You name it I had it!. I knew the only change was the new bottles so I got my estrogen levels checked and sure enough they had dropped to below 100 from a previous steady 350. I decided to go to every pharmacy in Ireland and stock up on the old blue top bottles. I contacted HPRA and wrote a detailed letter. Never heard back. In the meantime, the old bottle worked immediately and I had 6 months supply which lasted until Jul/August this year. In March the HPRA contacted me and asked for the bottle which I had complained about. She also informed me that there had been numerous complaints lodged. I sent off the bottle and by July I had heard back with the below attached letters.
As you can see it states that "no sample " was actually used in the investigation!
Anyway, fast forward to 1st October I have to start using the new bottles and yet again within days ...symptoms all back with a vengeance. I got so angry at my kids one day that dislodged a piece of my TMJ and now need a mri of my jaw. My husband twigged immediately and said it must be the gel. I upped my dose to no avail. I called every pharmacy again and managed to get 2 old bottles. Felt normal within 24 hours. Now am stuck in the situation that there are no blue bottles left...I .Will pay ANY amount to get the blue tops back now.
So please everyone lodge your complaint with the relevant authorities. This is unacceptable. The new gel bottles contain nothing but alcohol and empty gel.

I really don't know if it's as easy as requesting a 'blue top' bottle. Or if it's a private prescription or a private pharmacy that makes any difference.

My private prescription (this was 2 months ago) was for some bottles of Oestrogel and the pharmacist at the private hospital explained that the new bottle was all they had, in order to give me enough. I accepted a mix of the old and new bottles. (This is not some out-in-the-sticks pharmacy and I'd expect them to get whatever patients wanted.)

Maybe if I'd said I would wait till they could track down the blue top I could have, but I knew at the time there was an issue with gel anyway due to demand so I was happy to take whatever was available.

I’m new to all this as I’ve been on patches. Just started the gel and utrogestan…I went to talk to my pharmacy after reading on here and they said that is all that’s available they don’t have blue top bottles. I have to take what I’m given. It seems like a v muddled situation they say it’s same product as it’s always been …they must have quality control at these companies surely they should keep the product consistent despite the bottle changing.

This is the reply from the European Medicines Agency (EMA) regarding my enquiry: One specific brand medicine with two different manufacturing sites.

Note: I have no idea why they have assumed I'm 'based in Belgium' 😂

This was my enquiry: I would like to know the specific regulation that applies to a case where the brand medicine, in this case called Oestrogel, marketed by Besins Healthcare, can be either manufactured in one facility in Belgium or in another facility in France, as stated in the patient information leaflet. The patient/user can't know where exactly the product has been manufactured and many are experiencing a return of symptoms when starting to use a new bottle of the gel. The products come in 4 different packaging and all of them are supposed to be the same medicine, but that doesn't seem to be the case in terms of some patients' experiences. My specific question is: where can I find the regulation that allows the same product (same brand name) to be produced by two different manufacturing facilites and if the MAH has to differentiate them in the packaging.

'Thank you for contacting the European Medicines Agency (EMA) regarding legislation governing the way a medicine’s manufacturer is mentioned in the package leaflet.
Article 59(1)(f)(vii) of Directive 2001/83/EC and Article 14(1)(a) of Regulation (EU) 2019/6 require that the marketing authorisation holder should always state the manufacturer responsible for the batch release in the original package leaflet.
Please see below the links where you can find the full texts of the Directive and the Regulation:
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02001L0083-20210526
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02019R0006-20220128
Accordingly, the printed package leaflet of the medicine must clearly identify the manufacturer responsible for the release of the concerned batch or mention only the specific manufacturer responsible for the release of that batch. The package leaflet printed locally in each Member State need only include the manufacturing site(s)specific to that Member State.
The medicine you are taking – Oestrogel – was not authorised by EMA, but was authorised at national level, via national procedures, by the national medicines agency in the individual EU countries. As you are based in Belgium, we would recommend that you contact the Belgian medicines agency (FAMHP, www.famhp.be) directly for more information on this particular medicine and the way the information on its manufacturer is presented in the package leaflet.
We hope you find this information useful.
Kind regards
D. Lupescu, Stakeholders and Communication'

So, now you have to contact the MHRA in the UK, the lady living in Belgium could contact the FAMHP, the lady living in France the ANSM and so on. I will contact the health agency in Brazil, ANVISA.

@Newyorkdollmama Thanks! I can't read the letter in the attached photo though, it's a bit out of focus or maybe it's my poor eyesight 😂

After a steady return of symptoms when using the new cylindrical bottle I moved from 2 pumps (old bottle) to 4 pumps and then to 5 pumps. Still had night sweats, early wake ups etc. I then took a break for 1 week and started using my LAST (precious) old style bottle that I'd saved for the rainy day. It's taking 1.5 pumps for me to have 9 hours of uninterrupted sleep with no night sweats.

I'm speechless!