NOTICE
ANSM - Updated on : 30/05/2024
Product name
MADECASSOL 1 PER CENT, cream
Hydrocotyle
Sidebar
Please read this leaflet carefully before using this medicine, as it contains important information for you.
Always use this medicine exactly as your doctor or pharmacist has instructed you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any of the side effects, please tell 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 afterwards.
- Keep out of the reach of children.
What does this leaflet contain?
1. What is MADECASSOL 1 PER CENT, cream and what is it used for?
2. What do I need to know before using MADECASSOL 1 PER CENT, cream?
3. How do I use MADECASSOL 1 PER CENT, cream?
4. What are the possible side effects?
5. How should MADECASSOL 1 PER CENT cream be stored?
6. Package contents and other information.
1. WHAT IS MADECASSOL 1 PER CENT, cream AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - CUTANEOUS PROTECTIVE (D. Dermatology)
Local adjunctive treatment of skin ulcerations.
2. WHAT DO I HAVE TO KNOW BEFORE USING MADECASSOL 1 PER CENT, cream?
Never use MADECASSOL 1 PER CENT, cream:
- if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine, as listed in section 6,
- If you suffer from superinfected lesions,
- In children with a history of convulsions, whether or not due to fever (due to the presence of terpene derivatives in the formula).
Warnings and precautions
Talk to your doctor or pharmacist before using MADECASSOL 1 PER CENT, cream.
This product is not suitable for ophthalmic use.
This product contains terpene derivatives which, in excessive doses, may cause neurological accidents such as convulsions in infants and children.
Follow the instructions for use:
- Never apply more than the recommended dose (see section 3.),
- Do not apply to large areas of the body,
- Follow recommended frequency and duration of treatment.
Avoid use on lesions which tend to macerate.
In case of old or recent epilepsy, ASK YOUR DOCTOR FOR ADVICE.
Children and adolescents
Not applicable.
Other medicinal products and MADECASSOL 1 PER CENT, cream
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
MADECASSOL 1 PER CENT, cream with food, drink and alcohol
Not applicable.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
If you are breast-feeding, it is preferable not to use this medicine, and under no circumstances should it be applied to the breasts.
Sportsmen
Not applicable.
Driving and use of machines
Not applicable.
MADECASSOL 1 PER CENT cream contains terpene derivatives (see section 4) and propylene glycol.
This medicine contains 300 mg propylene glycol per 1 g of cream.
3. HOW DO I USE MADECASSOL 1 PER CENT, cream?
Apply as required, generally 1 to 2 times a day.
Apply to the skin.
If you have used more MADECASSOL 1 PER CENT, cream than you should have :
Not applicable.
If you forget to use MADECASSOL 1 PER CENT, cream :
Not applicable.
If you stop using MADECASSOL 1 PER CENT, cream :
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.
- risk of allergy
Due to the presence of terpene derivatives as excipients, and if recommended doses are not followed:
- risk of convulsions in children and infants,
- possibility of agitation and confusion in the elderly.
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 Regional Pharmacovigilance Centers.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO USE MADECASSOL 1 PER CENT, cream?
Keep out of sight and reach of children.
Do not use after the expiration date indicated on the box after EXP. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 30°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 MADECASSOL 1 PER CENT, cream contains
- The active substance is :
Hydrocotyle* (reconstituted dry extract titrated to 40% dasiaticoside and 60% madecassic and asiatic acids) 1.0 g
Per 100 g of cream
*Centella asiatica
- Other ingredients: ethylene glycol palmitostearate (mono and diesters), propylene glycol, liquid kerosene, lavender essential oil, geranium essential oil, purified water.
What MADECASSOL 1 PER CENT, cream is and what it contains
This medicine comes in the form of a cream. Tube of 10 g, 25 g or 40 g.
Not all presentations may be marketed.
Marketing authorization holder
BAYER HEALTHCARE SAS
1 RUE CLAUDE BERNARD
59000 LILLE
Marketing authorization holder
BAYER HEALTHCARE SAS
33, RUE DE LINDUSTRIE
74240 GAILLARD
Manufacturer
DELPHARM BRETIGNY
Usine du Petit Paris
91220 BRETIGNY SUR ORGE
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 later by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.