1. WHAT IS MYCOSEDERMYL 1 PER CENT CREAM AND WHAT IS IT USED FOR?
Pharmacotherapeutic Class
This medicinal product contains an antifungal agent for dermatological use of the imidazole family.
Therapeutic indications
This medicine is recommended for the treatment or adjunctive treatment of certain skin disorders caused by fungi (mycosis).
2. WHAT YOU SHOULD KNOW BEFORE USING MYCOSEDERMYL 1 PER CENT, cream
List of information needed before taking the medicine
Not applicable.
Contraindications
Never use MYCOSEDERMYL 1 PER CENT cream if you are allergic to any of the ingredients.
IF IN DOUBT, SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Precautions for use; special warnings
Use caution with MYCOSEDERMYL 1 PER CENT, cream:
Precautions for use
Avoid application near the eyes.
It is recommended that acidic soaps not be used (acidity promotes the growth of candida).
In case of application in children, on a large surface, or on damaged skin, it is imperative to respect the recommendations and dosage indicated by your doctor because of the greater penetration of the product in these circumstances.
Due to the presence of benzoic acid, this medicine may cause irritation to the skin, eyes and mucous membranes.
This medicine contains butylated hydroxyanisole (E320) and butylated hydroxytoluene (E321) and may cause local skin reactions (eczema) or irritation of the eyes and mucous membranes.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other medicines
Taking or using other medicines
Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Not applicable.
Sportsmen
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
This medicine contains benzoic acid, butylated hydroxyanisole (E320) and butylated hydroxytoluene (E321).
3. HOW TO USE MYCOSEDERMYL 1 PER CENT, cream
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
Apply to affected areas and their periphery twice daily, after cleansing and drying the skin. Follow the application with a gentle and regular massage until complete penetration.
Method of administration
DERMAL ROUTE
Duration of treatment
The duration of treatment is 2 to 4 weeks depending on the mycosis, it may be longer for certain areas. Regular use of the product throughout the treatment period is crucial to the success of the treatment.
Symptoms and instructions in case of overdose
Not applicable.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, MYCOSEDERMYL 1 PER CENT cream may have side effects, although not everyone is susceptible:
Itching, irritation, burning, redness and in very rare cases, allergic reactions such as eczema have been observed.
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW DO I USE MYCOSEDERMYL 1 PER CENT CREAM?
Keep out of the reach and sight of children.
Expiry date
Do not use MYCOSEDERMYL 1 PER CENT cream after the expiry date stated on the carton.
Storage conditions
Store at a temperature not exceeding 25°C.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of the medicine in the sewer or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does MYCOSEDERMYL 1 PER CENT cream contain?
The active substance is:
Econazole nitrate ................................................................................................................................. 1 g
For 100 g of cream.
The other ingredients are:
Ethylene glycol polyoxyethylene glycol palmitostearate (Tefose 63), oleic macroglycerides (Labrafil M 1944 CS), light liquid paraffin, benzoic acid, butylated hydroxyanisole (E320), perfume (essential oils of lavandin, orange, mandarin, linalyl acetate, citronellol, butylated hydroxytoluene (E321), dipropylene glycol), purified water
Pharmaceutical form and content
What is MYCOSEDERMYL 1 PER CENT cream and what does it contain?
This medicine is in the form of a cream. Tube of 30 g.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
COOPERATION pharmaceutique francaise
Place Lucien AUVERT
77020 MELUN Cedex
Français
English
