NOTICE
ANSM - Updated on : 27/05/2025
Product name
MYCOSTER 1 PER CENT, powder for cutaneous application
Ciclopirox olamine
Box
Please read this leaflet carefully before using this medicine, as it contains important information for you.
Always use this medicine exactly as it is described 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 of the side effects listed above, 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.
What does this leaflet contain?
1. What is MYCOSTER 1 PER CENT, powder for cutaneous application and what is it used for?
2. What do I need to know before using MYCOSTER 1 PER CENT, powder for cutaneous application?
3. How do I use MYCOSTER 1 PER CENT, powder for cutaneous application?
4. What are the possible side effects?
5. How do I keep MYCOSTER 1 PER CENT, powder for cutaneous application?
6. Package contents and other information.
1. WHAT IS MYCOSTER 1 PER CENT, powder for cutaneous application AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: Antifungal agents for topical use - ATC code: D01AE14.
This drug contains the active substance ciclopirox olamine, which is a cutaneous antifungal agent.
It is indicated for the treatment of skin infections caused by fungi (dermatophyte mycoses) located between the toes.
Note: this product is not indicated for the treatment of other folds.
2. WHAT DO I HAVE TO KNOW BEFORE USING MYCOSTER 1 PER CENT, powder for cutaneous application?
Never use MYCOSTER 1 PER CENT, powder for cutaneous application:
- if you are allergic to ciclopirox olamine 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 MYCOSTER.
- Do not swallow.
- Avoid contact with eyes.
- Candidiasis (fungal infections): do not use soaps with an acidic pH, as they encourage the multiplication of candida (fungus).
- In the event of an allergic reaction, discontinue use immediately, carefully remove MYCOSTER and contact a doctor.
Children
Not applicable.
Other medicinal products and MYCOSTER 1 PER CENT, powder for cutaneous application
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
MYCOSTER 1 PER CENT, powder for cutaneous application with food and drink
Not applicable.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There are insufficient data on the use of ciclopirox olamine in pregnant women.
As a precautionary measure, MYCOSTER should not be used during pregnancy.
Lactation
There are no adequate data on the excretion of ciclopirox olamine into breast milk.
As a precautionary measure, MYCOSTER should not be used during breast-feeding.
Driving and use of machinery
MYCOSTER has no effect on the ability to drive and use machines.
MYCOSTER 1 PER CENT, powder for cutaneous application contains
Not applicable.
3. HOW DO I USE MYCOSTER 1 PER CENT, powder for cutaneous application?
Always use this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
Apply once a day.
Method and route of administration
Dermal route.
For external use only.
Powder the lesions to be treated, sweeping over the entire affected area.
Duration of treatment
Treatment lasts an average of 4 weeks.
If you have used more MYCOSTER 1 PER CENT, powder for cutaneous application than you should have
Not applicable.
If you forget to use MYCOSTER 1 PER CENT, powder for cutaneous application
Do not use a double dose to make up for the one you forgot to apply.
If you stop using MYCOSTER 1 PER CENT, powder for cutaneous application
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 drug may cause undesirable effects, but they do not occur systematically in everyone.
Undetermined frequency (cannot be estimated on the basis of available data)
- Contact dermatitis (skin rash such as eczema).
- Local allergic skin reactions (hypersensitivity), irritation, redness (erythema), itching (pruritus) and sensations such as numbness, tingling or pins and needles (paresthesia).
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 are helping to provide more information on drug safety.
5. HOW TO CONSERVE MYCOSTER 1 PER CENT, powder for cutaneous application?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date shown on the bottle after EXP. The expiry date refers to the last day of that month.
Store at a temperature not exceeding 30°C.
Medicines must not be disposed of in the sewage system or with household waste. Ask your pharmacist what to do with unused medicines. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What MYCOSTER 1 PER CENT, powder for cutaneous application contains
- The active substance is :
Ciclopirox olamine..........................................................................................................1 g
Per 100g
- The other ingredients are :
Colloidal anhydrous silica, modified corn starch (or pregelatinized phosphated corn starch).
What MYCOSTER 1 PER CENT, powder for cutaneous application is and what it contains
This medicine comes in the form of a powder for cutaneous application.
15 g or 30 g polyethylene bottle with powder nozzle (low-density polyethylene) and screw cap (high-density polyethylene).
Marketing authorization holder
PIERRE FABRE MEDICAMENT
LES CAUQUILLOUS
81500 LAVAUR
Marketing authorization holder
PIERRE FABRE MEDICAMENT
PARC INDUSTRIEL DE LA CHARTREUSE
81100 CASTRES
Manufacturer
LABORATOIRES M. RICHARD
Rue du Progrès
ZI des Reys de Saulce
26270 SAULCE SUR RHONE
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].
Other
Detailed information on this drug is available on the ANSM (France) website.