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.

So are we saying the gel does not have any oestrogen in it. I can't smell it like I used to either.

I am convinced the new bottles contain no estrogen!

Something would have gone exceptionally wrong in the manufacturing for there to be no oestrogen as every single batch is tested.

however, it could well be that the specification that they test to, and/or their analytical methods are not discriminatory enough to pick up on “good” vs “bad” batches due to an issue they haven’t thought about. So the release testing will (should) confirm the presence of oestrogen at the correct amount in the gel. However it does seem that patients are not receiving the correct dose. My bet is that it is a combination of the pump not delivering the gel reliably and some kind of a change in gel meaning oestrogen isn’t absorbed through the skin in the same way.

another voice saying please use the yellow card and also the Besins helpline as they have to record every call they get and analyse & report if they get a spike in calls.

Just some background - it is widely known that not all medicines work for all people. Which is why we should always go back to the doctor if a prescribed drug doesn't work for you or gives bad side effects as in most cases there are alternatives they can suggest instead.

I am also wondering if there is a wide variability in people's ability to absorb oestrogen through the skin, and some people are much more sensitive than others to (what should be) minor changes such as a change in pump design and/or the location of the factory. And that could be why some of us are so badly affected than others - just because that's how their bodies are. This paper certainly suggest this is a factor to consider https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3465120/ - there are papers out there on similar theme but I don't have the time to go through them all at the moment.

I am also having problems with the new gel not working and all my symptomshave returned. I have one old conical bottle with a blue lid that I have now restarted and all the symptoms have immediately gone again.

On the new stuff I have not been able to sleep due to hip pains, had chest pains, itchy dry eyes, and anger problems.

I have filled in a yellow card submission and emailed Besins, but I really don't know what I'm going to do when this bottle runs out. It makes it really difficult for me to function at work when my hrt isn't working.

I posted the other day with my weighings. Today the first pump was 1.10 and it felt like this was not a full pump. I have noticed this before when you go back to use - the first pump seems to be an issue. The subsequent were fine. Sorry photo is crap.

The photo is great 😊

I think that hydroalcoholic gels tend to slowly slide downwards under the force of gravity if the dosing pump is not used frequently, and maybe it should be 'primed' again, which is obviously not the case with women using it daily.

I've read somewhere (LinkedIn or Instagram), that once the gel is not coming out properly you should start another bottle but don't discard the old one because once the gel 'settles' you will be able to pump it out again. I think the poster said there's a lot of gel left in the pouch. 😳

My referral to a specific online pharmacy was because they are acutely aware of the issues and are keeping stock of blue lidded bottles for those who specifically ask for it.

If the cylindrical bottle has been introduced precisely to 'boost' supply as Besins says, why is the conical bottle disappearing from the pharmacies? Or does that only apply to NHS prescriptions?

If you're affected by issues with Oestrogel you could contact Besin...(see images)

Omg I have been feeling so irritable and shaky recently. I started on the new cylindrical oestrogel about a month ago!

I have been weighing my gel. I've even gone up to three pumps! My reflux, restless legs, mood have all come back. But when I have four pumps I spot so I must be absorbing something. I don't think it's entirely the pump. I think the gel is weaker and I still can't smell it.

The gel never had any smell because it' s only the alcohol that has the smell. (I think there is some statement about the smell of alcohol on the product information somewhere - possibly for medical professionals.)

Why not consider swapping to Sandrena or a patch?

If you feel gel is not right any more, is it worth talking to your GP and swapping?

I have a close friend working in pharmaceutical quality control. It would be illegal to reduce the dose of the active ingredients. All products are checked and triple checked, by several people over several stages, before they are released.

Keep contacting Besins if you think there is an issue.

Just because it’s illegal to reduce the dose of the active ingredient doesn’t mean that a fault in the new bottle means the amount dispensed is less.

I’ve more or less sorted mine by increasing the dose; what I don’t understand is the women saying they’ve done this and still have symptoms.

Besins says, why is the conical bottle disappearing from the pharmacies? Or does that only apply to NHS prescriptions?

It isn't just for NHS prescriptions.

It's the same for private prescriptions at private hospital pharmacies. They source their products from the same wholesalers.

@JinglingXmasbells thank you. Why you're not a menopause specialist I'll never know. You have been so helpful to so many of us on here. I had thought about asking to change. I'll have a chat with the doc x

I agree with you @Namddf

It's important to note that the amount of estrogen in each pump of gel is 0.75mgs, although the gel (1 pump) weighs 1.25mgs.

So if the gel pump is delivering 10% less in weight, the actual reduction of the active ingredient is 0.075mgs.

This would usually be within the bounds of variation found when applying it because there is always some residue left on hands and a variation in thickness when spreading on arms or thighs.

It IS a concern if there is something amiss because some women use HRT for bone protection and there is a minimum dose that's needed for effectiveness. With gel, it's 2 pumps to reach the level required.

@mrsnjw I've been a health journalist writing for major websites and publications which means researching and talking to medical professionals. (And my own experience of HRT.)

i just moved on to this gel and utrogestan pills after being on evorel conti patched …I’m feeling v dizzy and sick like travel sickness is this normal?

i just moved on to this gel and utrogestan pills after being on evorel conti patched …I’m feeling v dizzy and sick like travel sickness is this normal?

Oh dear!
It might be best to start your own thread so you can discuss side effects and get more replies.

Dizziness is a listed side effect but is less if you take Utrogestan at bedtime. It can take a little while for your body to get used to it.

All Oestrogel patient information leaflets have been updated on the MHRA products website https://products.mhra.gov.uk/search/?search=oestrogel&page=1 and now they all say the gel is produced in Belgium OR France, but they have one very interesting (if not serious) discrepancy between them.

Some say the active ingredient is estradiol ANHYDROUS, others say HEMIHYDRATE, and the most recent ones say just estradiol. They all say 0.06% or 750 mcg.

Oestrodose patient notice (in French) says estradiol ANHYDRE.

Gynokadin Beipackzettel (in German) is the only leaflet that is correct (in chemical terms):

Was Gynokadin Dosiergel enthält
Der Wirkstoff ist: Estradiol.
1 g Gel enthält 0,62 mg Estradiol-Hemihydrat (entsprechend 0,6 mg Estradiol).
Die sonstigen Bestandteile sind: Carbomer 980 NF, Ethanol 96 %, Trolamin und gereinigtes Wasser

So Besins, which one(s) is(are) being sold in the UK? The gel with 0.6 mg of estradiol ANYDROUS or 0.6 mg estradiol HEMIHYDRATE or 0.62 mg of estradiol HEMIHYDRATE?

Confusing? Hell yeah.

@Muttley47 Thanks! It's odd that Besins wants to contact patients instead of just doing their job testing the pumps and publishing the results. If they are functioning correctly Besins could just say we're doing something wrong, like someone mentioned that if you don't put the stopper back on the pump it seems to dispense less than expected.

Having bought scales and measured my daily oestrogel doses out for about a week now I have found that you need to press the pump down quite hard and quickly to get close to/ the correct dosage. If you press it slowly it releases way less gel. Since doing this my symptoms have been miles better so I was underdosing for about 3 weeks (basically ever since I finished my last bottle of the blue topped oestrogel. I personally think the issue is definitely with the pump and it being so hit and miss which is absolutely rubbish. There must be countless women out there who aren’t aware of this and suffering with symptoms returning and not understanding what is going on.

@vicie Thanks, it makes sense regarding the pump mechanism. Good job! 👏 It doesn't explain the difference between the green and orange square bottles, but apparently that's in the past as it appears only cylindrical bottles are available.