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.

Just to add - if it hasn't already been said - that Sandrena gel is nearly twice as concentrated as Estrogel - Sandrena is 0.1% and Estrogel is 0.06%, as well as being a different consistency as Jingling said, with different "fillers" (excipients). It is therefore a completely different product in this sense, despite the active ingredient beibg the same, and will be absorbed differently. It is not possible to make a direct comparison in terms of total oestrogen. The higher concentration means also I think, that it may not need to be spread on such a wide area as Estrogel but haven't checked this?

A better comparison to look for equivalents would be to compare the steady state estradiol level in a trial group of women after a given dose and from there extrapolate to the equivalent dose between them. This may well have been compared by the powers that be eg BMS in order to arrive at their equivalence information ( but I haven't checked).

I'm still weighing and getting erratic amounts. I am going to complete the 2 forms from Bessons one UK and one European and return the bottle as requested.

@Abra1t yes CBT will cure all - it can all be rectified by mind control and coping strategies . Let's apply that to erectile dysfunction and prostate issues too ?

Indeed! 😆

I’ve increased the Sandrena to 3 sachets (so the equivalent of 4 pumps of Oestrogel, which is what I was on before) and I do feel better. The muscle pain is less excruciating but I still don’t feel as good as I did on the old Oestrogel.

I’m wondering whether I’m on enough Utrogestan to oppose this dose though? (200mg for 2 weeks a month).

I’ve got a GP appointment in a couple of weeks so I will see what she says about this but she gives the impression she is just guessing. Private not an option.

Hi all, I received a new prescription of oestrogen which contained both the new and the old packaging. I decided to use one pump from each bottle and here are the results!! On the back of seeing this marked difference, I have reported this issue through the yellow card system as well.

Here we go with new one yesterday. Erratic or what? 0.11 was the first one after priming the pump.

and the other two

Thank you for sharing @LastHives was this from the new packaging pump?
Will definitely need to buy those jewellery scales 🙈

Yes. It takes me so much longer in the morning to apply as I am weighing. 😄I am about to complete the forms required from the company. In fact they have just sent me a reminder.

I can imagine @LastHives, 🤦🏾‍♀️some of my friends and colleagues have resorted to 3 pumps a day with the new packaging. Like myself, they too have reported it through the yellow card system.

I have received an email from Besins, they want me to give permission for them to contact my healthcare professionals about the issue:

We take the safety and quality of our products seriously. As part of a pharmaceutical company’s statutory requirement imposed by the regulatory authorities, Besins Healthcare is required to follow up on any suspected adverse events that we become aware of concerning our medicines. This helps us to monitor the safety profile of our medicines.

For this reason, it would be useful for Besins Healthcare UK to contact your doctor or another healthcare professional regarding this report. In order for us to do this, we require you to complete the consent form attached and return it by email: drugsafety@besins- healthcare.com. If this is difficult for you via email, we can send out a paper copy with a prepaid envelope, if you would like to provide your address in order to be able to contact your HCP.

The consent form says:

I confirm I give my permission for Besins Healthcare (UK) Ltd to contact my doctor, nurse or pharmacist, whose details I give below, about the reaction that I have reported following treatment with Oestrogel.

They also want my age, weight and height.

I will update when I've had a further response. Think we will need a new thread soon!

Is there some kind of allowable variation between pump measures? I mean, it can't be EXACTLY the same... so I wonder what variation is permissible when we measure down to the smallest degree...

I’m now on a low dose patch and topping up with gel because the gel by itself just isn’t cutting it and all my symptoms return. My menopause nurse says that’s fine, my Gp is saying it’s far too much oestrogen yet I feel I can just about cope (still highly irritable at the end of the day though) on the patch and gel. I haven’t found or heard of any pharmacy now in my area stocking the old bottle type. It’s demoralising to be facing this every day but to feel as though the company that make it aren’t even addressing or acknowledging this issue is soul destroying. I’m extremely sensitive to any changes in hormones unfortunately and the thought of switching again when I’m trying to work, run a home and parent a teen is not filling me with hope or joy. I feel Besins are hoping we’ll just all go away and get on with it.

I did this @JuJuHeyHey over a year ago and also twice this year. I got the same message back nothing wrong with the gel some women’s hormone treatments need adjusting so go back to your healthcare professional and get them to check you. Or words to this effect.
I’ll be very surprised if you get a reply that’s any different. I’ll be overjoyed if you do get a proactive and accountable response! But I won’t hold my breath. If you have time to go back to the beginning of this thread you’ll see it’s been going on for ages sadly.
I hope you get a better response 😊🤞🏼🤞🏼🤞🏼

Cheers @Lotusflower75 I've been following the thread since the start so I won't be holding my breath! But you have to go through the motions I guess.

You just have to hope that enough women reporting on the yellow card (which I've done as well) starts getting some proper attention in the NHS.

The only way to know is to contact the manufacturer of the pump, Lablabo. I've sent a message on their website months ago but they haven't replied.

The bottle has 80 g of gel, but it not equals 80 ml, because the gel density is around 0.8-0.9 mg/ml which equals 65-88.8 ml.

The 65ml bottle comes with a 1.25 ml pump and would deliver 1 g of gel which is not what the patient information leaflet says.

To deliver 1.25 g of gel as per patient information leaflet, the pump should dispense approximately 1.5 ml.

Therefore the model used is the 90 ml bottle with a 1.5 ml pump.

They are called metering pumps (valves) for a reason. It means that the dosage variation should be minimal.

Their website says 'Dose accuracy and repeatability'

Kudos for the research!!!

Anyone noticed any difference in symptoms on the funnel bottle with the swirl on the label?

I'd managed to get a supply of my original funnel bottle (green square) for a few months and was doing well. Have avoided cylindrical bottles and went from pharmacy to pharmacy to get funnel shaped ones.

Came home with some a few weeks ago, didn't realise til I got it out that the label was different but assumed would be fine as the dosage would be the same. Within a week or so symptoms have taken a major turn for the worse. How can this be?!

My cheap crappy scales have packed up from so much use.😂

So it's true that the swirl is back. Oh dear, no wonder the European Medicines Agency hasn't authorised Oestrogel. They wouldn't allow this constant change in packaging. Not to mention 10 different patient information leaflets, 4 by Besins and 6 by parallel importers.

Yes they would, EMA’s role is to ensure safety, quality and efficacy of medicines, like all the national regulatory agencies like MHRA. They aren’t going to prevent companies changing packaging, and it happens a lot due to packaging suppliers changing their specs on a regular basis. I’ve got colleagues who do nothing but update licenses for packaging and leaflets in existing products.

As long as Besins have provided necessary data to support the additional new packaging, it will be approved.

Oh, and if a product already is approved by even one national agency in the EU, it is generally not eligible for approval via the centralised procedure of EMA. It’s one approval route or the other.

@funnelfan I have written to the EMA. This was their response. Check one of my previous posts. I will copy and paste it if you can't find it.

New thread as we are at 999 posts!

https://www.mumsnet.com/talk/menopause/4950480-oestrogel-new-packaging-yet-again-thread-2

What EMA said to you is exactly what I put in my post.