NOTICE
ANSM - Updated on : 27/03/2025
Product name
CICLOPIROX OLAMINE VIATRIS 1%, cream
Ciclopirox olamine
Sidebar
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, pharmacist or nurse.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- 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. 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 CICLOPIROX OLAMINE VIATRIS 1% cream and what is it used for?
2. What do I need to know before using CICLOPIROX OLAMINE VIATRIS
1% cream?
3. How do I use CICLOPIROX OLAMINE VIATRIS 1%, cream?
4. What are the possible side effects?
5. How should CICLOPIROX OLAMINE VIATRIS 1% cream be stored?
6. Package contents and other information.
1. WHAT IS CICLOPIROX OLAMINE VIATRIS 1%, cream AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: topical antifungals, ATC code: D01AE14.
This drug is recommended for the treatment of :
- fungal infections of the skin or nails, whether or not superinfected by bacteria;
- mild to moderate seborrheic dermatitis of the face.
2. WHAT DO I HAVE TO KNOW BEFORE USING CICLOPIROX OLAMINE VIATRIS 1% cream?
Never use CICLOPIROX OLAMINE VIATRIS 1%, cream:
- if you are allergic to ciclopirox olamine or to any of the other ingredients of this medicine, as listed in section 6.
Warnings and precautions
Consult your doctor or pharmacist before use. CICLOPIROX OLAMINE VIATRIS 1%, cream.
Precautions for use
Do not swallow.
Do not use near the eyes, on mucous membranes or on open wounds.
Candidiasis (infection caused by fungi): do not use soaps with an acid pH, as they encourage the multiplication of candida (fungus).
Children and teenagers
Not applicable.
Other drugs and CICLOPIROX OLAMINE VIATRIS 1%, cream
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
CICLOPIROX OLAMINE VIATRIS 1% cream with food and drink
Not applicable.
Pregnancy, breast-feeding and fertility
Pregnancy
There are insufficient data on the use of ciclopirox olamine in pregnant women.
As a precautionary measure, the use of CICLOPIROX OLAMINE VIATRIS 1% cream should be avoided during pregnancy.
Breast-feeding
There are no adequate data on the excretion of ciclopirox olamine into breast milk.
As a precautionary measure, the use of CICLOPIROX OLAMINE VIATRIS 1% cream should be avoided during breast-feeding.
If you are pregnant or breastfeeding, think you might be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and use of machinery
Not applicable.
CICLOPIROX OLAMINE VIATRIS 1%, cream contains :
- stearyl alcohol and cetyl alcohol, which may cause local skin reactions (e.g. contact dermatitis);
- 10 mg benzyl alcohol per gram of cream, i.e. 300 mg per tube. Benzyl alcohol may cause allergic reactions and, on topical application, mild local irritation;
- polysorbate may cause allergic reactions.
3. HOW TO USE CICLOPIROX OLAMINE VIATRIS 1% cream?
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
If you feel that the effect of CICLOPIROX OLAMINE VIATRIS 1% cream is too strong or too weak, consult your doctor or pharmacist.
Skin mycoses: 2 applications daily for approximately 21 days.
Nail fungus: apply cream for several months.
Mild to moderate seborrheic dermatitis of the face:
- initial treatment (2 to 4 weeks): 2 applications per day;
- beyond that, as maintenance treatment: 1 application per day for 28 days.
FOLLOW YOUR DOCTOR'S PRESCRIPTION.
Method and route of administration
Cutaneous, for external use only.
Duration of treatment
Follow your doctor's advice.
If you have used more CICLOPIROX OLAMINE VIATRIS 1%, cream than you should have
Not applicable.
If you forget to use CICLOPIROX OLAMINE VIATRIS 1%, cream
Not applicable.
If you stop using CICLOPIROX OLAMINE VIATRIS 1%, cream
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 (between one in 100 and one in 10 people) :
- on first applications, signs of local transient exacerbation at the application site (burning sensation, redness, pruritus); these phenomena are temporary: do not interrupt treatment.
Uncommon adverse reactions (between one in 1000 and one in 100 people):
- local blister-like reactions which may lead to severe allergic reactions: stop treatment immediately and consult your doctor.
Undetermined frequency (cannot be estimated on the basis of available data):
- contact dermatitis (eczema-like rash);
- Although no systemic effects have been reported, this possibility should be taken into account in the event of prolonged treatment over a large surface area, on injured skin, mucous membranes or under an occlusive dressing.
Reporting side effects
If you experience any side effects, please tell 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: 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 USE CICLOPIROX OLAMINE VIATRIS 1%, cream?
Keep out of sight and reach of children.
Do not use after the expiration date indicated on the tube and box.
Store at a temperature not exceeding 25°C.
Once the tube has been opened for the first time, this medicine should be stored for a maximum of 3 months.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. This will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What CICLOPIROX OLAMINE VIATRIS 1% cream contains
- The active substance is :
ciclopirox olamine.......................................................................................................... 1,000 g
per 100 g of cream.
- Other ingredients include: octyldodecanol, light liquid kerosene, stearyl alcohol, cetyl alcohol, myristic alcohol, copra fatty acid diethanolamide, polysorbate 60, sorbitan stearate, benzyl alcohol, lactic acid, purified water.
What CICLOPIROX OLAMINE VIATRIS 1% cream is and what it contains
This medicine comes in the form of a cream in a 30 g tube.
Marketing authorization holder
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
Marketing authorization holder
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
Manufacturer
FARMACLAIR
440, AVENUE DU GENERAL DE GAULLE
14200 HEROUVILLE-SAINT-CLAIR
FRANCE
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
Not applicable.