NOTICE
ANSM - Updated on : 22/01/2024
Product name
PROGESTOGEL 1 PER CENT, gel for topical application
Progesterone
Box
Please read this leaflet carefully before using this medicine, as it contains important information for you.
Always use this medicine exactly as instructed in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been personally prescribed for you. Do not give it to other people. It could harm them, even if the signs of their illness are the same as yours.
- If you experience any undesirable effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
What does this leaflet contain?
1. What is PROGESTOGEL 1 PER CENT, topical gel and what is it used for?
2. What do I need to know before using PROGESTOGEL 1 PER CENT, topical gel?
3. How do I use PROGESTOGEL 1 PER CENT, topical gel?
4. What are the possible side effects?
5. How should PROGESTOGEL 1 PER CENT topical gel be stored?
6. Package contents and other information.
1. WHAT IS PROGESTOGEL 1 PER CENT, gel for topical application AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - ATC code: PROGESTATIVE - G: Genitourinary system and sexhormones .
This medicine is indicated for benign breast pain and disease.
2. WHAT DO I HAVE TO KNOW BEFORE USING PROGESTOGEL 1 PER CENT, gel for topical application?
Never use Progestogel:
- if you are allergic to the active substance or to any of the other ingredients of this product, as listed in section 6,
- if you have, have had or are suspected of having hormone-sensitive breast cancer.
Warnings and precautions
Wash hands after use.
Children and adolescents
Not applicable.
Other drugs and Progestogel
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
Progestogel with food and drink
Not applicable.
Pregnancy and breast-feeding
This drug may be prescribed during pregnancy.
Progesterone may be used during breastfeeding.
If applied to the breasts, wash thoroughly before each feed.
If you are pregnant or breastfeeding, think you might be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not applicable.
Progestogel contains 1.2 g alcohol (ethanol) per 2.5 g gel. This may cause a burning sensation on damaged skin.
This medicine may be flammable until the product dries.
3. HOW DO I USE PROGESTOGEL 1 PER CENT, topical gel?
Always use this product exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
The recommended dose is one measure of the applicator on each breast.
Treatment should preferably be continuous, every day of the month, including during menstruation.
Apply to each breast after washing, until the product has penetrated.
Wash hands after application.
If you have used more Progestogel than you should have
Not applicable.
If you forget to use Progestogel
Do not take a double dose to make up for the one you forgot to take.
If you stop using Progestogel
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, Progestogel may cause undesirable effects, but these do not always occur in everyone.
Undesirable effects whose frequency cannot be determined
- Allergic reaction (hypersensitivity) at the application site
- Irritation or reaction at the application site
- Irregular menstrual cycles
- Breast pain
- Breast swelling
- Redness of the skin (erythema)
- Itching (pruritus)
- Skin rash
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO USE PROGESTOGEL 1 PER CENT, gel for topical application?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the box, tube or bottle. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What Progestogel contains
- The active substance is :
Progesterone ....................................................................................................................... 1 g
For 100 g of gel.
- Other ingredients are: octyldodecanol, carbomer 980, macrogolglycerol hydroxystearate, trolamine, alcohol, purified water.
What Progestogel is and what it contains
Gel for topical application.
80 g aluminum tube, internally varnished (epoxyphenolic varnish).
75 g bottle (PE/Polypropylene) with metering pump (60 doses).
Not all presentations may be marketed.
Marketing authorization holder
BESINS HEALTHCARE FRANCE
3, RUE DU BOURG L'ABBE
75003 PARIS
Marketing authorization holder
BESINS HEALTHCARE FRANCE
17 RUE PERIER
92120 MONTROUGE
Manufacturer
BESINS MANUFACTURING BELGIUM
GROOT-BIJGAARDENSTRAAT 128
1620 DROGENBOS
BELGIUM
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.