MycoSédermyl 1% Cream 30g Tube is a drug indicated for adjunctive treatment of certain skin diseases caused by fungi (mycoses).
For warnings, precautions for use and contraindications, please consult the instructions for use.
MycoSédermyl 1% Cream Tube 30g is recommended in the treatment or adjunct treatment of certain skin conditions due to fungi (mycoses) .
A yeast infection is a disease caused by the development of tiny fungi in one part of the body. Yeast infections can affect many areas of the body, particularly the digestive tract, genitals, nails and more generally the skin. Warm and humid environments favor its multiplication, which explains their frequent localization at the level of the feet or areas of folds at the cutaneous level. A common kind of microorganism involved is candida albicans.
Dermal.
2 times per day.
Econazole nitrate: 1g per 100g of cream
30g tube of cream
Attention, the drug is not a product like the others. Read the package leaflet carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 07/07/2014
MYCOSEDERMYL 1 PER CENT, cream
Econazole Nitrate
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult your doctor.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
In this notice :
1. WHAT IS MYCOSEDERMYL 1 PER CENT, cream AND WHAT CASES IS IT USED FOR?
2. BEFORE YOU USE MYCOSEDERMYL 1 PER CENT, cream?
3. HOW TO USE MYCOSEDERMYL 1 PER CENT, cream?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE MYCOSEDERMYL 1 PER CENT, cream?
6. ADDITIONAL INFORMATION
1. WHAT IS MYCOSEDERMYL 1 PER CENT, cream AND WHAT CASES IS IT USED FOR?
This medicinal product contains an antifungal for dermatological use in the imidazole family.
This medication is recommended for the treatment or adjunctive treatment of certain cutaneous diseases caused by fungi (mycoses).
2. BEFORE YOU USE MYCOSEDERMYL 1 PER CENT, cream?
List of information needed before taking the medication
Not applicable.
Never use MYCOSEDERMYL 1 PER CENT, cream if you are allergic to any of the ingredients.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with MYCOSEDERMYL 1 PER CENT, cream:
Precautions for use
· Avoid application near eyes.
· It is recommended not to use an acid soap (acidity favoring the multiplication of candida).
· In case of application in children, on a large surface or on injured skin, it is imperative that you observe the recommendations and the dosage indicated by your doctor because of the greater penetration of the product in these circumstances.
· Due to the presence of benzoic acid, this medicinal product may cause irritation to the skin, eyes and mucous membranes.
· This medicinal product contains butylhydroxyanisole (E320) and butylhydroxytoluene (E321) and may cause local skin reactions (eczema) or irritation of the eyes and mucous membranes.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Interaction with other medicines
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Not applicable.
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
This medicine contains benzoic acid, butylhydroxyanisole (E320) and butylhydroxytoluene (E321).
3. HOW TO USE MYCOSEDERMYL 1 PER CENT, cream?
Not applicable.
Dosage
Apply to the affected areas and their periphery 2 times a day, after washing and drying the skin. Follow the application of a gentle and regular massage until complete penetration.
Administration mode
DERMAL
Duration of the treatment
The duration of treatment is 2 to 4 weeks depending on the mycosis, it may be longer for some localizations. Regular use of the product throughout the course of treatment is critical to successful treatment.
Symptoms and Instructions for Overdose
Not applicable.
Instructions for omission of one or more doses
Not applicable.
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, MYCOSEDERMYL 1 PER CENT, cream is likely to have unwanted effects, although not everyone is subject to it:
Itching, irritation, burning sensation, redness and in very rare cases, allergic reactions with eczema type have been observed: IT MUST BE TESTED BY YOUR DOCTOR.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE MYCOSEDERMYL 1 PER CENT, cream?
Keep out of the reach and sight of children.
Do not use MYCOSEDERMYL 1 PERCENT, cream after the expiry date stated on the carton.
Store at a temperature not exceeding 25 ° C.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
Full list of active substances and excipients
What contains MYCOSEDERMYL 1 PER CENT, cream?
The active substance is:
Econazole Nitrate .............................................. .................................................. ................................. 1 g
For 100 g of cream.
The other components are:
Palmitostearate of ethylene glycol and polyoxyethylene glycols (Tefose 63), oleic macrogolglycerides (Labrafil M 1944 CS), light liquid paraffin, benzoic acid, butylhydroxyanisole (E320), perfume (essential oils of lavandin, orange, mandarin, linalyl acetate , citronellol, butylhydroxytoluene (E321), dipropylene glycol), purified water.
Pharmaceutical form and content
What is MYCOSEDERMYL 1 PERCENT, cream and contents of the pack?
This medication is in the form of a cream. Tube of 30 g.
French Pharmaceutical Co-operation
Place Lucien AUVERT
77020 MELUN Cedex
French Pharmaceutical Co-operation
Place Lucien AUVERT
77020 MELUN Cedex
93 ROAD OF CURRENCY
37210 VOUVRAY
OR
THEPENIER PHARMA INDUSTRIE
ALENÇON ROUTE
ST LANGIS-LES-MORTAGNE
61400 MORTAGNE
OR
French Pharmaceutical Co-operation
Place Lucien AUVERT
77020 MELUN Cedex
OR
French pharmaceutical cooperation
2 rue de la saussaie
77310 saint fargeau ponthierry
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Not applicable.
Local antifungal
econazole
. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
MYCOSEDERMYL: cream; 30 g tube.
-
French Pharmaceutical Cooperation Laboratory
| p 100 g | |
| Econazole nitrate | 1 g |
Usual dosage:
1 application, 2 times a day.
