NOTICE
ANSM - Updated on : 18/04/2023
Product name
PERCUTAFEINE, gel
Caffeine
Box
Please read this leaflet carefully before using this medicine, as it contains important information for you.
You must always use this medicine in strict accordance with the information provided in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is PERCUTAFEINE gel and what is it used for?
2. What do I need to know before using PERCUTAFEINE, gel?
3. How do I use PERCUTAFEINE, gel?
4. What are the possible side effects?
5. How should PERCUTAFEINE gel be stored?
6. Package contents and other information.
1. WHAT IS PERCUTAFEINE, gel AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - ATC code: Dermatological drugs - D11AX26.
The active substance in this medicine is caffeine, which is applied to the skin.
This medicine is indicated for adults and adolescents over 15 years of age in the symptomatic treatment of localized subcutaneous adipose overload (localized excess fat).
You should consult your doctor if you do not feel any improvement or if you feel less well.
2. WHAT DO I HAVE TO KNOW BEFORE USING PERCUTAFEINE, gel?
Never use PERCUTAFEINE, gel:
- if you are allergic to the active substance or to any of the other ingredients of this product, as listed in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before using PERCUTAFEINE, gel.
Be careful with PERCUTAFEINE, gel:
- Do not apply to irritated or damaged skin,
- Stop treatment immediately if red, itchy patches appear.
- Frequent application to the skin may cause irritation and dryness.
- Due to the presence of 96% ethanol as an excipient (4 g for an application of 10 g of gel), Percutaféine may cause skin irritation.
- Due to the 96% ethanol content of the gel, it should not be used in patients treated with disulfiram (ESPERAL),
- This treatment is not intended as a primary treatment for obesity.
Children and adolescents
PERCUTAFEINE gel may be used by adolescents aged 15 and over.
Other drugs and PERCUTAFEINE, gel
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or may take/use any other medicines.
In view of the ethanol content (96%), do not use Percutafeine if you are being treated with disulfiram, as a slight reddening of the skin may occur.
PERCUTAFEINE, gel with food, drink and alcohol
Not applicable.
Pregnancy, lactation and fertility
Percutaféine should not be applied to pregnant or breastfeeding women.
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 use of machinery
Not applicable.
PERCUTAFEINE, gel contains 96% ethanol.
This medicine contains 4g of alcohol (ethanol) per dose. This may cause a burning sensation on damaged skin.
3. HOW DO I USE PERCUTAFEINE, gel?
WARNINGS :
Flammable product.
Keep away from heat, hot surfaces, sparks, open flames and all other sources of ignition.
Do not smoke when using or handling the tube.
Always use this medicine exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dermal route.
Use on clean, dry skin.
The recommended dose is 10 to 20 g to be applied 1 to 2 times a day for one month.
Massage into affected areas (thighs, buttocks, hips, abdomen).
Wash hands thoroughly after each use.
Use in children and adolescents
PERCUTAFEINE gel may be used by adolescents aged 15 and over.
If you have used more PERCUTAFEINE, gel than you should have
Not applicable.
If you forget to use PERCUTAFEINE, gel
Not applicable.
If you stop using PERCUTAFEINE, gel
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, this product may cause undesirable effects, but they do not occur systematically in everyone. The following undesirable effects may occur with undetermined frequency (cannot be estimated on the basis of available data):
- Reddening of the skin
- Itching (pruritus)
Stop treatment immediately if red, itchy patches occur (see section 2).
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 - Website: https://signalement.social-sante.gouv.fr.
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO USE PERCUTAFEINE, gel?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the label or packaging after {EXP}. The expiration date refers to the last day of that month.
Do not refrigerate.
Do not dispose of any medicine down the drain with household waste. Ask your pharmacist to delimit medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What PERCUTAFEINE gel contains
- The active substance is :
Caffeine ........................................................................................................................ 5,000 g
For 100 g of gel.
- The other excipient components are : Carbomer (synthalene K), trolamine, cocoate of macrogol 7 glycerol (CETHIOL HE), 96% ethanol, purified water.
What PERCUTAFEINE gel is and what it contains
Percutaféine comes as a smooth, slightly opalescent gel in tubes of 20 g, 72 g, 80 g, 96 g, 144 g, 150 g, 192 g.
Not all presentations may be marketed.
Marketing authorization holder
PIERRE FABRE MEDICAMENT
Les Cauquillous
81500 Lavaur
Marketing authorization holder
PIERRE FABRE MEDICAMENT
PARC INDUSTRIEL DE LA CHARTREUSE
81100 CASTRES
Manufacturer
PIERRE FABRE MEDICAMENT PRODUCTION
SITE PROGIPHARM
RUE DU LYCEE
45500 GIEN
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]
< {MM/YYYY}>< {month/YYYY}.>
Other
Detailed information on this drug is available on the ANSM (France) website.