NOTICE
ANSM - Updated on : 25/10/2024
Product name
MYCOSTER 10 mg/g, shampoo
Ciclopirox
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 after 4 weeks.
What does this leaflet contain?
1. What is MYCOSTER, 10 mg/g shampoo and what is it used for?
2. What do I need to know before using MYCOSTER, 10 mg/g shampoo?
3. How do I use MYCOSTER, 10 mg/g shampoo?
4. What are the possible side effects?
5. How should MYCOSTER, 10 mg/g shampoo be stored?
6. Package contents and other information.
1. WHAT IS MYCOSTER 10 mg/g, shampoo AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: ANTIFUNGAL - ATC code: D01AE14 (other antifungals for topical use).
What is MYCOSTER shampoo?
The name of your medicine is MYCOSTER 10 mg/g, shampoo (called "Mycoster, shampoo" in this leaflet). MYCOSTER, shampoo contains an active substance called "ciclopirox", which is an antifungal agent (kills fungi and yeast).
What is MYCOSTER shampoo used for?
MYCOSTER, shampoo is used to treat a scalp disorder called "seborrheic dermatitis": an inflammation of the scalp causing scaling, burning and itching.
How does MYCOSTER, shampoo work?
MYCOSTER, shampoo works by killing the fungi and yeasts present on the superficial layers of the skin. These fungi and yeasts are one of the main causes of seborrheic dermatitis.
2. WHAT DO I HAVE TO KNOW BEFORE USING MYCOSTER 10 mg/g, shampoo?
Never use MYCOSTER 10 mg/g, shampoo:
- if you are allergic to ciclopirox, ciclopirox olamine or any of the other ingredients listed in section 6.
If in doubt, ask your doctor or pharmacist for advice before using MYCOSTER shampoo.
Warnings and precautions
Talk to your doctor or pharmacist before using MYCOSTER 10 mg/g, shampoo.
Avoid contact of MYCOSTER shampoo with eyes. In case of accidental contact with eyes, rinse thoroughly with water.
If you accidentally swallow MYCOSTER, shampoo, consult a doctor or pharmacist immediately.
You may experience changes in hair color, especially if your hair is damaged by chemical agents, such as hair coloring, or if it is gray or white in color.
Children
Not applicable.
Other drugs and MYCOSTER 10 mg/g, shampoo
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
MYCOSTER 10 mg/g, shampoo with food and drink
Not applicable.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this product.
There are insufficient data on the use of MYCOSTER shampoo in pregnant women. As a precautionary measure, MYCOSTER shampoo should not be used during pregnancy.
It is not known whether ciclopirox passes into breast milk. Consequently, MYCOSTER shampoo should not be used during breast-feeding.
No studies have been conducted on the effect of ciclopirox on human fertility; however, a reduction in fertility was observed in rats after oral administration.
Driving and use of machinery
Not applicable.
MYCOSTER 10 mg/g, shampoo contains benzoic acid (E210) and sodium benzoate (E211).
This medicine contains 0.525 mg sodium benzoate and 1.08 mg benzoic acid per 1 g shampoo, equivalent to a total of 1.678 mg/mL (corresponding to 0.548 mg/mL sodium benzoate and 1.13 mg/mL benzoic acid).
Benzoic acid/benzoate salt may cause local irritation.
Benzoic acid/benzoate salt may increase the risk of dicterus (yellowing of the skin and eyes) in neonates (up to 4 weeks of age).
3. HOW TO USE MYCOSTER 10 mg/g, shampoo
Always use this medicine exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Method of administration
- MYCOSTER shampoo should only be used on the scalp.
- Wet hair and scalp and apply MYCOSTER, shampoo.
- Work the shampoo into a lather, massaging thoroughly into the scalp.
- Leave the shampoo on for approximately 3 minutes.
- Then rinse with water.
Dosage
Use the cap of the MYCOSTER shampoo bottle to measure your dose.
The usual dose is one capful (about 5 mL) of MYCOSTER, shampoo. Up to 2 caps (about 10 mL) may be used if hair is longer than shoulder-length.
Treatment time
- To begin with, use the shampoo 1 or 2 times a week, depending on the severity of your symptoms. Continue for 4 weeks until symptoms disappear.
- You can then continue to use the shampoo 1 or 2 times a week for up to 12 weeks. This will help prevent the recurrence of symptoms.
In all cases, continuous use of MYCOSTER shampoo is limited to a maximum of 16 weeks.
Use in children
MYCOSTER shampoo has not been studied in children.
If you have used more MYCOSTER 10 mg/g, shampoo than you should have
If you have used more MYCOSTER shampoo than you should, adverse reactions are unlikely. There are no data on overdosage with ciclopirox-containing drugs.
If you forget to use MYCOSTER 10 mg/g, shampoo
Not applicable.
If you stop using MYCOSTER 10 mg/g, shampoo
You should not stop using MYCOSTER shampoo without consulting your doctor, as stopping too soon may reduce the effectiveness of the treatment.
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.
The following side effects may occur with this drug:
Uncommon (affecting less than 1 in 100 patients)
- Skin reactions on the scalp, including skin irritation or eczema (inflamed skin with itching, a rash and often blisters that ooze and form scabs) or discomfort such as burning or itching.
- Hair problems, such as slight hair loss, bleached, matted, dull or slightly dry hair.
Rare (affecting less than 1 in 1,000 patients)
- Rash at the application site (allergic contact dermatitis).
Stop using MYCOSTER, shampoo if you develop skin or scalp reactions such as irritation or sensitization (allergic reactions) after prolonged use, and consult your doctor. Your doctor may prescribe another treatment.
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please inform your doctor or pharmacist.
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 contribute to providing more information on drug safety.
5. HOW TO CONSERVE MYCOSTER 10 mg/g, shampoo?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the box and bottle after EXP. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 30°C.
After first opening, shampoo can be used for up to 8 weeks.
Do not dispose of any medication in the drain or with household waste. Ask your pharmacist to identify any medicines you no longer use. This will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What MYCOSTER 10 mg/g, shampoo contains
- The active substance is :
Ciclopirox......................................................................................................................... 10mg
For 1 g of shampoo
- The other components are :
27% sodium dodecyl-di (oxyethylene) sulfate solution*, 33% disodium dodecyl-poly (oxyethylene) -3 - 2 sulfosuccinate solution**, macrogol lauryl ether, sodium chloride, purified water.
*Composed of: Sodium dodecyl-di (oxyethylene) sulfate; purified water; benzoic acid (E210).
**Composedof: Dodecyl-poly(oxyethylene) - 3 - 2 disodium sulfosuccinate; sodium benzoate (E211); purified water.
What MYCOSTER 10 mg/g, shampoo is and what it contains
This medicine comes as an almost colorless to slightly yellow shampoo in a plastic bottle.
Box of 1 or 2 bottles of 60 mL.
Not all presentations may be marketed.
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
This medicinal product is authorized in the member states of the European Economic Area under the following names: In accordance with current regulations.
[To be completed subsequently by the holder].
The last date on which this leaflet was revised was :
[to be completed later by the holder]
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Other
Detailed information on this drug is available on the ANSM (France) website.