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.

No, I don’t know, sorry. It could simply be a branding/marketing thing. I try and avoid anything to do with labelling, it’s a nightmare. Every single detail has to be approved and correct for every single market, eg the postcode changes for the factory so you put through the change for every single market where it’s sold. Then you’ll get the branding/marketing team who come up with an idea to tweak something that then causes another round of changes. It’s continuous. You have to coordinate the lead times of the artwork, the regulatory authorities, the factories, the supply chain in each country. You spend every day getting it in the neck from everyone!

I think someone mentioned upthread that the different colours mean one is manufactured in France and the other in Belgium. I can't think which colour correlates to which country off hand, but that was the explanation 🙂

@funnelfan it sounds a nightmare!
@Skinnybluebody thanks I did wonder if it was that.

Id just like to agree this is an issue and for me it seems really straight forward. A pump from the old bottle is at least a 1/3 bigger than from the new one. I still had an old one and did a direct comparison. I wish I had taken a photo now. The pump action on the sloping bottles is deeper and you get more. Nothing will convince me otherwise !

I found exactly the same thing. Also did a pump from each as a comparison. It seems more stays in the actual nozzle bit as the sloping bottle hole is tiny and the cylindrical one is a bigger round hole. Definitely dispensing less per pump.

So I thought I had this sorted and had been using the 🟧 pumps. I searched chemists for this the other day only to discover the new boxes are green squares and that’s all I have. Now I know this is totally defective as I kept the bottle that hugely affected me and now don’t know what to do.
I have a cylindrical bottle but I’m sure this isn’t right either! Now I should be sleeping not stressing about my medication at this time of the morning but feel totally sick. I have only just started to feel better since last defective bottle argh 😠

Hi all orange square bottles batch numbers start with 7 and the green square bottles batches start with 1, this is on the boxes i have this on my notes at the pharmacy that I only want 7’s, but my last batch 7 bottle (no coloured square), but cylinder my symptoms came back. I didn’t want to up my pumps to four, as when I did this on the green square bottle I started to bleed. I’m back on orange square, batch beginning with 7 and guess what symptoms gone again after approx 2 weeks. The whole thing is stressful.

Did you weigh them? I don't have any old bottles to compare.

Thank you, helswatts that info is correct on my bottles. No idea how to get the chemists to sort this. They have been quite unhelpful tbh.
I did try to weigh the pumps from both bottles but it both weighed same amount though I thought they looked different..
question is how much of the cylindrical bottles do we need to use to get the same dose?
it’s crazy that we should need to ask this. The manufacturer should be sorting this it’s a major issue for all of us women. Menopause has been pure hell so far. But it’s not going to win !

@@Birdwithaview73 i agree we shouldn’t have to be messing with our doses to try and feel normal. I think it must be a headache for chemists to have to check batch numbers if they may be asked a few times a day but that said it’s a fairly simple request! I’m dreading it because it reminds me of schlepping around from chemist to chemist during the shortage trying to find one that was in stock. My HRT journey began with being refused HRT and then questioning every time I asked for a repeat prescription for years until I complained to the practice manager. Than the shortage. Now this. It’s a nightmare tbh all to be able to feel well in yourself. I tried upping my usual dose by one more pump on the defective gel/bottle and still felt horrific. I guess you have to try different doses (half a pump, 1 full one etc) till you feel ok. But I’m still not convinced it’s the bottle alone. My gut is it’s a different manufacturing site and minute variations in formula due to that.

Hi yes the amount looked the same, but gel from the cylinder bottle didn’t look as thick. It shouldn’t be this hard.

my hrt was stopped after being on it a week, due to a blood clotting gene but if I knew what I know now I’d of pushed for it. I got 2 months supply and we had to call when we had a months worth, to have a telephone consultation with the nurse each time, total waste of ours and the nurses time, when I said other surgeries don’t do this, she gave me 7 months worth. Definitely to do with different manufacturing sites, France being one of them, the bottles could be stored differently and transported differently, Besins have no control once they leave the manufacturers.

I think the amount dispensed from the straight-sided bottles may be slightly less but I, too, think it’s more than that. There is something different about the product. I told my GP and was asked for the batch number of the defective bottle but I’d thrown it away! I have two other similar bottles - with different numbers. I guess I just need to grit my teeth and use them to see if the same thing happens again 😬

I feel for us all it’s total hell of a journey with huge hope to jump through. Managed to convince surgery to issue me with yet another script today. Now just to locate some of the correct one and bottle. This should be fun hey!
see above ladies for the batch numbers. The one we want starts with a 7. Though ideally not the cylinder bottle. Please yellow card it and report to manufacturer so they have to look into this. I have bottles and batch numbers if anyone needs them. Take care all x

Yes, the cylindrical bottles (white cap) and the conical bottles (turquoise cap) with an orange square and lot numbers starting with 7 have been manufactured by the manufacturing site in Drogenbos, Belgium, (BMB) owned by Besins until 2012 when it was sold to Delpharm and recently re-acquired by Besins due to the shortages (https://manufacturingchemist.com/news/article_page/Besins_acquires_site_in_Belgium_to_prevent_HRT_supply_line_issues/201902)

The conical bottles with a green square and lot numbers starting with 1 have been manufactured in Montrouge, France by Laboratoires Besins International (LBI), in a frustrated attempt to relocate gel production to France.

This manufacturing site had been producing solely Androgel (testosterone) for the US market and probably Oestrodose for the French market, and currently only opens during weekends (check on Google).

Some women started HRT on the green square bottles and felt fine because they had never used the other one, but some women felt the difference if they had been on the orange square bottles.

I have already mentioned earlier on this thread the reason why the gels could be different despite having the same formulation. The suppliers of the ingredients are probably different because Belgium and France are different countries under different laws.

I also suspect that the Delpharm team had the experience and expertise to produce different batches within more consistent parameters, while the Besins team is still acquiring those skills.

In short, the 'new' cylindrical bottles with a white cap and lot numbers starting with 7 are not the same as the 'old' cylindrical bottles, in the sense that the gel inside them has been manufactured by the Besins team, not the Delpharm team.

The bottles and pumps have different manufacturers as well. The cylindrical (white cap) are manufactured by Lablabo and the conical (turquoise cap) are manufactured by Rexam (currently called Nemera).

You can check this on the MHRA product site by serching Oestrogeln and ticking the disclaimer box.

Tere are 3 different leaflets for the 'official' product (Oestrogel sold and distibuted by Besins in the UK).

All 3 leaflets have the code PL (Product Licence) while the ones imported by other distributors have the code PLPI (Product Licence Parallel Import).

The 3 PIL (Patient Information Leaflets) for the Oestrogel PL are labeled:

1. Proposed Leaflet-PIL-Oestrogel-BMB-Lablabo
2. Proposed Leaflet-PIL-Oestrogel-BMB-Rexam
3. Proposed Leaflet-PIL-Oestrogel-LBI-Rexam

Number 1 is the cylindrical bottle (white cap), number 2 is the conical bottle (turquoise cap) with an orange square and number 3 is the conical bottle (turquoise cap) with a green square.

I suspect Besins is dedicating the Drogenbos site to the manufacturing of Oestrogel from now on and hopefullly the batches will be more consistent.

Until then, all we can do is tweak the dose (for some women, also the dosage) until we find that sweet spot where most symptoms are being controlled, but since we can't anticipate which of the 3 currently available versions we will be given, I would recommend you talk to your chemist to request/stock always the same version, whether it's the cylindrical (white cap) bottle or the conical (turquoise cap) with an orange square.

The green square version is probably not going to be available for a long time in the UK; I suspect the Montrouge manufacturing site is either idle or only producing Oestrodose for the French market.

Remember that many distributors in the UK will acquire Oestrodose or Oestrogel from European countries to sell them in the UK as parallel imports, but that doesn't mean the product is different, only that they might be manufactured in Montrouge, i.e. the green square version.

Hope this helps!

@Azaleah this is great thank you although my head is now slightly scrambled with 3 different things re flag and bottle shape. 🤯😂
im completely with you about the women who recently started oestrogel not noticing a difference as there was no experience of anything else to compare it to and therefore were feeling better anyway. It makes sense.
I’m going to read it more carefully and sort out the bottles I’ve kept. Interestingly I started a new old shaped bottle recently with a green flag and I’ve gone downhill a bit. It’s all a bit pants! But thank you for this. Seriously considering Sandrena, Estrodot and Lenzetto if I can’t work out which batch I need to be on.
Asking a chemist for consistency is definitely not asking for the moon on a stick. I have an appointment with my GP tomorrow so I shall ask her about it too. I suppose there is a hope that this is just a hiccup in the manufacturing process and by reporting it via yellow card they will eventually iron out any problems between plants/bottles/materials. she says 🤞🏻🤞🏻🤞🏻

@Lotusflower75 You're welcome 🤗 and sorry for the typos, it's confusing enough as it is 😂

@Azaleah I live in Belgium. Belgium and France apply EU laws, so more or less the same.

See photos for my current bottle.
I had an issue with a previous batch of 3. Flagged it to Besins. Never heard back from them.

@Catsfriend You're right about EU laws, but last time I checked them (very complex), there's a rule on the same product being manufactured at different locations that are specific to different countries. The pharmaceutical companies have a period of time to adjust to the new rules, and I think Besins is still working on it.

I was referring to the pharmaceutical industry, and mainly to the production line, with different suppliers and machinery.

Your current bottle was probably manufactured in France according to what I have researched and posted before.

Have you ever had the cylindrical bottle?

@Azaleah only the first pack of three bottles. I started last September, so until Christmas. The second pack of 3 disagreed with me (second bottle) so had to stop using it for a month while my consulting physician did some bloodwork and my body started behaving again. Have not had any issues with this batch - on second bottle. I threw away the other two bottles from the batch that didn’t work for me.

Don't know of what relevance if any, but I'm in Paris and have been using the gel for nearly a year now. Always had the same as quote posted here in January. I've been fine but then nothing has changed for me as always getting the same product (no sight of orange anywhere and no change in bottle shape).

Ah the photo didn't post. It's on page 2 of this thread.

Then as been previously said, it’s the way it’s transported to the UK from France that is causing the issue.

@Helswatts Not necessarily. If @Mayflier has been using Oestrodose for a year she might be getting the same batches manufactured at the same facility (Montrouge or Dogenbros) and wouldn't be feeling any difference between them.

Moreover, the Oestrodose bottle has been the same for decades (Rexam now Nemera's Sof'bag conical bottle) unlike the Oestrogel ones (Lablabo for the cylindrical and Rexam/Nemera for the more recent conical bottles). Lablabo has also changed owners and probably the bottle/pump model in the last decade.

The PIL is clear that no specific storage conditions are necessary. This is particularly due to the inner pouch where the gel is contained, which is supposed to collapse as the pump is pressed on. The thing is: Nemera's pouch material and pump mechanism are not exactly the same as the Lablablo's ones.

That said, it's possible that inadequate transport could be one of the causes but I wouldn't say it's the primary source of the problem because if no special storage conditions are necessary the way it is transported would be irrelevant if the bottles have no signs of being damaged or tampered.

So I’ve searched most but not all the local chemists and most have the cylindrical bottle in stock. I’m still holding out for the orange square 🟧 ones but not sure I can get them. I’ve had trouble with these too but is it the case that we need to add an extra pump etc?
live had a few bleeds so they want me to have a scan now … it really never ends does it.