NOTICE
ANSM - Updated on : 27/05/2025
Product name
MYCOSTER 1%, solution for cutaneous application
Ciclopirox olamine
Box
Please read this leaflet carefully before using this medicine, as it contains important information for you.
You must always use this medicine in strict accordance with the information provided 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 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 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%, solution for cutaneous application and what is it used for?
2. What do I need to know before using MYCOSTER 1%, solution for cutaneous application?
3. How do I use MYCOSTER 1%, solution for cutaneous application?
4. What are the possible side effects?
5. How do I keep MYCOSTER 1%, solution for cutaneous application?
6. Package contents and other information.
1. WHAT IS MYCOSTER 1%, solution for cutaneous application AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: topical antifungal agents - ATC code: D01AE14.
This drug contains the active substance ciclopirox olamine, which is a cutaneous antifungal agent.
It is indicated for the treatment of fungal infections (mycoses) of the skin (dermatoses, whether or not superinfected by bacteria) or nails (onychomycoses).
2. WHAT DO I HAVE TO KNOW BEFORE USING MYCOSTER 1%, solution for cutaneous application?
Never use MYCOSTER 1%, solution 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 infection): do not use soaps with an acidic pH, as they encourage the growth 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%, solution for cutaneous application
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
MYCOSTER 1%, solution 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 , MYCOSTERshould 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 vehicles and use machines.
MYCOSTER 1%, solution for cutaneous application contains
Not applicable.
3. HOW DO I USE MYCOSTER 1%, solution for cutaneous application?
Always use this product exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
Skin mycoses: 2 applications daily for approximately 21 days.
Nail mycoses: apply solution alone or in combination with another treatment for several months.
Method and route of administration
Cutaneous route.
For external use only.
Clean and dry areas to be treated.
Wash hands thoroughly before and after each application.
Apply MYCOSTER to the areas of skin to be treated and massage gently.
If you have used more MYCOSTER 1%, solution for cutaneous application than you should have
Not applicable.
If you forget to use MYCOSTER 1%, solution 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%, solution 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.
Common side effects (may affect up to one in 10 people)
- Temporary worsening (for a limited time) of certain local adverse reactions at the application site, such as redness (erythema), itching (pruritus), which is generally transient and does not require treatment to be discontinued.
- Burning sensation.
These side effects may appear after the first applications. If these symptoms persist, consult a physician.
Uncommon side effects (may affect up to one person in 100)
- Local blister-like reactions.
- Generalized allergic reactions (hypersensitivity), which may be severe, in which you may experience swelling (edema), itching (pruritus), an itchy or non-itchy rash (urticaria) or difficulty breathing (dyspnea). If these effects occur, you should stop taking this drug immediately and contact a doctor as soon as possible.
Undetermined frequency (cannot be estimated on the basis of available data)
- Contact dermatitis (eczema-like rash).
If you apply MYCOSTER over a long period of time to a large surface area, to injured skin, to mucous membranes or under an occlusive (covering) dressing, the effects associated with the passage of the drug into the bloodstream should be taken into consideration: seek medical advice.
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%, solution for cutaneous application?
Keep out of sight and reach of children.
Do not use after the expiration date indicated on the bottle after EXP. The expiration date refers to the last day of that month.
Polyethylene bottle : Do not use this medicine more than 1 month after first opening.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What MYCOSTER 1%, solution for cutaneous application, contains
- The active substance is :
Ciclopirox olamine............................................................................................................1,000 g
Per 100 ml solution
- The other components are :
Macrogol 400, isopropanol, purified water.
What MYCOSTER 1%, solution for cutaneous application is and what it contains
This medicine comes in the form of a colorless or slightly yellow solution for cutaneous application.
Glass or polyethylene bottle of 30 ml or 45 ml closed by a stopper.
Marketing authorization holder
PIERRE FABRE MEDICAMENT
LES CAUQUILLOUS
81500 LAVAUR
Marketing authorization holder
PIERRE FABRE MEDICAMENT
PARC INDUSTRIEL DE LA CHARTREUSE
81100 CASTRES
Manufacturer
PIERRE FABRE MEDICAMENT PRODUCTION
SITE PROGIPHARM
RUE DU LYCEE
45500 GIEN
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.