NOTICE
ANSM - Last updated: 17/08/2017
Name of the medicinal product
MYCOAPAISYL 1 PER CENT, cream
Econazole Nitrate
framed
Please read this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· 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 talk to your doctor if you do not feel better or feel less well.
What is in this leaflet?
1. What is MYCOAPAISYL 1 PER CENT, cream and in which cases is it used?
2. What should I know before using MYCOAPAISYL 1 PER CENT, cream?
3. How to use MYCOAPAISYL 1 PER CENT, cream?
4. What are the possible side effects?
5. How to store MYCOAPAISYL 1 PER CENT, cream?
6. Package contents and other information.
1. WHAT IS MYCOAPAISYL 1 PER CENT, cream AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group: ANTIFUNGALS FOR TOPICAL USE, ATC code: D01AC03.
This medication is a cream for topical application containing an antifungal agent of 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 MYCOAPAISYL 1 PER CENT, cream?
Never use MYCOAPAISYL 1 PER CENT, cream:
· if you are allergic to the active substance or to any of the other ingredients of this medication mentioned in section 6.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Warnings and Precautions
· Avoid applications near the eyes.
· In case of application in children, on a large surface or on injured skin, it is imperative to adhere to the recommendations and the dosage indicated by your doctor due to the greater penetration of the product in these circumstances.
· Avoid applications in situations where the phenomenon of local occlusion can reproduce (eg elderly subjects, pressure sores, intertrigo under breast).
· Due to the presence of benzoic acid, this medicinal product may cause irritation to the skin, eyes and mucous membranes.
· This medicine contains butylhydroxyanisole and butylhydroxytoluene and may cause local skin reactions (eczema) or irritation of the eyes and mucous membranes.
· This medicine contains dipropylene glycol and may cause skin irritation.
IN CASE OF DOUBT DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
children
NEVER LEAVE TO CHILDREN.
Other medicines and MYCOAPAISYL 1 PER CENT, cream
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including non-prescription medicines, especially if you are taking oral anticoagulants.
MYCOAPAISYL 1 PER CENT, cream with food and drink
Not applicable.
Pregnancy and breast feeding
Ask your doctor or pharmacist for advice before taking any medicine .
Driving and using machines
Not applicable.
MYCOAPAISYL 1 PER CENT, cream contains benzoic acid, butylhydroxyanisole, butylhydroxytoluene, dipropylene glycol
3. HOW TO USE MYCOAPAISYL 1 PER CENT, cream?
Always use this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Posology and method of administration
Medicinal products for local use:
· 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.
Duration of the treatment
The duration of the 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.
IN ALL CASES CONFORM TO THE ORDER OF YOUR DOCTOR STRICTLY.
If you used more MYCOAPAISYL 1 PER CENT, cream you should not have
Not applicable.
If you forget to use MYCOAPAISYL 1 PER CENT, cream
Not applicable.
If you stop using MYCOAPAISYL 1 PER CENT, cream
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· itching, irritation, burning, redness: tell your doctor.
If you notice any side effects not listed in this leaflet, or if certain side effects become serious, please tell your doctor or pharmacist.
Declaration of side effects
If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE MYCOAPAISYL 1 PER CENT, cream?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the package.
No special storage conditions.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What MYCOAPAISYL contains 1 PER CENT, cream
· The active substance is:
Econazole Nitrate .............................................. .................................................. .............. 1 g
For 100 g.
· The other components are:
(LABRAFIL M 1944 CS), light liquid paraffin, benzoic acid, butylhydroxyanisole, perfume (essential oils of lavandin, orange and mandarin, linalyl acetate, lithium acetate), polyoxyethylene glycol palmitostearate (TEFOSE 63), polyglycolysedes citronellol, butylhydroxytoluene, dipropylene glycol), purified water
What MYCOAPAISYL 1 PER CENT, cream and contents of the pack
This medication is in the form of a cream. Tube of 30 g.
Marketing Authorization Holder
MERCK MEDICATION FAMILIALE SAS
37, RUE SAINT-ROMAIN
69379 LYON CEDEX 08
Marketing Authorization Operator
MERCK MEDICATION FAMILIALE
18C, BOULEVARD WINSTON CHURCHILL
21000 DIJON
Maker
FAMAR LYON
29, AVENUE CHARLES DE GAULLE
69230 SAINT GENIS LAVAL
Or
CHEMINEAU LABORATORIES
93, ROAD OF CURRENCY
37120 VOUVRAY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
<{MM / YYYY}> <{YYYY month}.>
Other
Not applicable.