NOTICE
ANSM - Updated on : 29/07/2025
Product name
CICLOPIROX OLAMINE VIATRIS 1.5%, shampoo
Ciclopirox olamine
Sidebar
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 after 1 month.
What does this leaflet contain?
1. What is CICLOPIROX OLAMINE VIATRIS 1.5%, shampoo and what is it used for?
2. What do I need to know before using CICLOPIROX OLAMINE VIATRIS 1.5%, shampoo?
3. How do I use CICLOPIROX OLAMINE VIATRIS 1.5%, shampoo?
4. What are the possible side effects?
5. How to store CICLOPIROX OLAMINE VIATRIS 1.5%, shampoo?
6. Package contents and other information.
1. WHAT IS CICLOPIROX OLAMINE VIATRIS 1.5%, shampoo AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: topical antifungal - ATC code: D01AE14
VIATRIS CICLOPIROX OLAMINE shampoo contains a compound called ciclopirox olamine. It belongs to a group of drugs known as "antifungals".
CICLOPIROX OLAMINE VIATRIS shampoo is recommended for scaly, red and itchy scalps (known as seborrheic dermatitis).
2. WHAT DO I HAVE TO KNOW BEFORE USING CICLOPIROX OLAMINE VIATRIS 1.5%, shampoo?
Never use CICLOPIROX OLAMINE VIATRIS 1.5%, shampoo
if you are allergic to ciclopirox olamine or to any of the other ingredients listed in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before using CICLOPIROX OLAMINE VIATRIS 1.5%, shampoo.
Take special care with CICLOPIROX OLAMINE VIATRIS 1.5%, shampoo:
- CICLOPIROX OLAMINE VIATRISshampoo is for external use only.
- CICLOPIROX OLAMINE VIATRISshampoo may, in rare cases, alter the color of your hair if you have gray, white or chemically damaged hair (e.g. due to hair coloring). Check with your doctor or pharmacist before using CICLOPIROX OLAMINE VIATRIS shampoo if this applies to you. Your doctor or pharmacist will tell you whether CICLOPIROX OLAMINE VIATRIS shampoo is suitable for you.
- CICLOPIROX OLAMINE VIATRIS is not recommended for children under 12 years of age, as safety and efficacy are not known in this age group.
- Try to avoid contact between CICLOPIROX OLAMINE VIATRIS shampoo and your eyes. It may cause stinging and irritation. In the event of accidental contact with your eyes, rinse the affected area with water.
Children
Not applicable.
Other drugs and CICLOPIROX OLAMINE VIATRIS 1.5%, shampoo
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
CICLOPIROX OLAMINE VIATRIS 1.5%, shampoo with food and drink
Not applicable.
Pregnancy and breast-feeding
Do not use this product if you are pregnant or breast-feeding.
There is no information on the safety of CICLOPIROX OLAMINE VIATRIS shampoo in pregnant women.
- If you are pregnant or planning to become pregnant, talk to your doctor.
- If you become pregnant while taking CICLOPIROX OLAMINE VIATRIS shampoo, talk to your doctor.
Driving and use of machinery
There are no restrictions on driving or operating machinery during treatment with CICLOPIROX OLAMINE VIATRIS shampoo.
CICLOPIROX OLAMINE VIATRIS 1.5%, shampoo contains
Not applicable.
3. HOW DO I USE CICLOPIROX OLAMINE VIATRIS 1.5%, shampoo?
Always use this medicine exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
- Use CICLOPIROX OLAMINE VIATRIS shampoo 2 to 3 times a week for 4 weeks.
- Use CICLOPIROX OLAMINE VIATRIS shampoo only on your hair, scalp and adjacent areas if necessary.
- You may use a mild shampoo on days when you are not using CICLOPIROX OLAMINE VIATRIS shampoo .
How do I use CICLOPIROX OLAMINE VIATRIS shampoo?
1. Wet hair.
2. Use enough CICLOPIROX OLAMINE VIATRIS shampoo to cover your scalp and hair and adjacent areas, if affected.
3. Massage the scalp and adjacent areas if necessary, using your fingertips.
4. Rinse scalp and hair thoroughly.
5. Repeat steps 2 to 4. CICLOPIROX OLAMINE VIATRIS shampoo should be in contact with your scalp for a total of three to five minutes for both applications.
Take care not to get CICLOPIROX OLAMINE VIATRIS shampoo in your eyes. If this happens, rinse thoroughly with clean water.
If you accidentally swallow CICLOPIROX OLAMINE VIATRIS 1.5%, shampoo :
The ingredients of CICLOPIROX OLAMINE VIATRIS shampoo are not known to be harmful if swallowed in small amounts. If you accidentally get CICLOPIROX OLAMINE VIATRIS shampoo in your mouth, rinse immediately with water. If you accidentally swallow a large amount of CICLOPIROX OLAMINE VIATRIS shampoo, ask your doctor or pharmacist for advice.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this product may cause undesirable effects, but they do not occur systematically in everyone.
Undesirable effects may occur at different frequencies, which are defined as follows:
- very common: may affect more than 1 in 10 people.
- frequent: may affect up to 1 in 10 people.
- rare: may affect up to 1 in 1000 people.
The following adverse reactions have been observed with CICLOPIROX OLAMINE VIATRIS shampoo:
Very common:
- skin irritation*,
- itching*.
Common:
- rash*,
- burning sensation,
- redness at the application site*.
Rare:
- allergic reaction,
- skin peeling*,
- eczema (itchy rash)*,
- hair loss*,
- hair color changes,
- changes in hair texture (dry, matted, dull hair).
Some of these effects (indicated by *) may also be symptoms of the disease you are treating. However, if you notice these side effects for the first time after using CICLOPIROX OLAMINE VIATRIS shampoo, or if the irritation, redness or itching worsens, stop using CICLOPIROX OLAMINE VIATRIS shampoo and inform your doctor or pharmacist.
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 1.5%, shampoo?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the bottle and outer packaging. The expiration date refers to the last day of that month.
No special storage precautions are required.
Do not dispose of any medicine in the drain or with 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 1.5% shampoo contains
- The active substance is :
Ciclopirox olamine................................................................................................ 1.50 g (1.5% w/w)
Per 100 g.
- The other components are :
Sodium laureth sulfate, cocamidopropyl betaine, disodium phosphate dodecahydrate, citric acid monohydrate, coco diethanolamide, hexylene glycol, oleic alcohol, polysorbate 80, polyquaternium 10, perfume, sodium hydroxide, purified water.
What CICLOPIROX OLAMINE VIATRIS 1.5% shampoo is and what it contains
CICLOPIROX OLAMINE VIATRIS 1.5%, shampoo is a straw-yellow to orange shampoo in 100 mL bottles.
Marketing authorization holder
VIATRIS SANTE
1 Rue de Turin
69007 Lyon, France
Marketing authorization holder
VIATRIS SANTE
1 Rue de Turin
69007 Lyon
Manufacturer
DELPHARM BLADEL B.V.
INDUSTRIEWEG 1,
BLADEL,
5531AD,
NETHERLANDS
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.