CICLOPIROX OLAMINE ISDIN 15 mg/g SHAMPOO

Introduction

Package Leaflet: Information for the User

Ciclopirox Olamine ISDIN 15 mg/g Shampoo

Ciclopirox Olamine

Read the package leaflet carefully before starting to use this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Ciclopirox Olamine ISDIN and what is it used for
2. What you need to know before using Ciclopirox Olamine ISDIN
3. How to use Ciclopirox Olamine ISDIN
4. Possible side effects
5. Storage of Ciclopirox Olamine ISDIN
6. Contents of the pack and further information

1. What is CICLOPIROX OLAMINA ISDIN and what is it used for

This medicine belongs to the group of topical antifungal dermatological agents.

This medicine is indicated for the treatment of seborrheic dermatitis of the scalp.

2. What you need to know before using CICLOPIROX OLAMINA ISDIN

Ciclopirox Olamine ISDIN is intended exclusively for external use.

As with all shampoos, avoid contact with the eyes. In case of accidental contact with the eyes, rinse with plenty of water.

This product has not been tested in children.

Do not use Ciclopirox Olamine ISDIN

If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

If you observe persistent skin irritation. In this case, treatment should be discontinued.

If you have known sensitivity to fragrance, you should avoid using this shampoo.

Consult your doctor or pharmacist before starting to use Ciclopirox Olamine ISDIN.

Using Ciclopirox Olamine ISDIN with other medicines

No data on medicinal interactions are available. However, given the low level of systemic absorption, interactions are unlikely.

Tell your doctor or pharmacist that you are using, have recently used, or might use any other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Given the short contact time with the skin and the low level of systemic absorption, Ciclopirox Olamine ISDIN can be used during pregnancy. Your doctor will assess the need to use this medicine.

Ciclopirox Olamine ISDIN can be used during breastfeeding.

Driving and using machines

Ciclopirox Olamine ISDIN 15 mg/g shampoo does not affect the ability to drive or use machines.

Important information about some of the ingredients of Ciclopirox:

This medicine contains fragrance with the following allergens: limonene, geraniol, benzyl alcohol, citral, and linalool. These may cause allergic reactions.

3. How to use CICLOPIROX OLAMINA ISDIN

Follow exactly the administration instructions of this medicine as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Remember to use your medicine.

Your doctor will indicate the duration of your treatment with Ciclopirox Olamine ISDIN. Do not stop treatment before, as the medicine may not be effective.

If you think the effect of Ciclopirox Olamine ISDIN is too strong or too weak, tell your doctor or pharmacist.

Apply a sufficient amount of Ciclopirox Olamine ISDIN to produce a rich lather to damp hair. Massage the scalp and adjacent areas vigorously with your fingertips. Then, rinse your hair thoroughly and repeat the process. Leave the shampoo in contact with the scalp for 3-5 minutes.

Ciclopirox Olamine ISDIN should be used two or three times a week.

The recommended treatment period is 4 weeks.

4. Possible side effects

Like all medicines, Ciclopirox Olamine ISDIN can cause side effects, although not everybody gets them.

Ciclopirox Olamine ISDIN may rarely cause skin irritation. If persistent irritation occurs, treatment should be discontinued.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of CICLOPIROX OLAMINA ISDIN

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Once the pack is opened, the shampoo should be used within 8 weeks.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Ciclopirox Olamine ISDIN 15 mg/g Shampoo

The active substance is ciclopirox olamine. Each gram of shampoo contains 15 milligrams of ciclopirox olamine.

The other ingredients are: sodium lauryl ether sulfate 70%, cocamidopropyl betaine, disodium phosphate dodecahydrate, citric acid monohydrate, hexylene glycol, oleyl alcohol, polysorbate 80, polyquaternium 10, sodium hydroxide, purified water, fragrance Rifskin 54193 (contains limonene, geraniol, benzyl alcohol, citral, and linalool).

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Appearance of the product and contents of the pack

Ciclopirox Olamine ISDIN 15 mg/g shampoo is a colorless to yellowish viscous solution. Each pack contains 100 ml of shampoo.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Isdin SA

Provençals 33

08019 Barcelona

Spain

Manufacturer

Laboratorios Feltor

Polígono Industrial Molí de les Planes

C/ Roques Blanques 3-5

08470 Sant Celoni (Barcelona)

Spain

Date of last revision of this package leaflet: September 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/