Ciclopirox olamine Isdin 15 mg/g shampoo

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ciclopirox olamine ISDIN 15 mg/g shampoo

Ciclopirox olamine

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Ciclopirox Olamine ISDIN is and what it is 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. How to store Ciclopirox Olamine ISDIN
6. Contents of the pack and other information

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

This medicine belongs to the group of topical antifungal agents used in dermatology.

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

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

Ciclopirox Olamine Isdin is intended for external use only.

As with all shampoos, contact with the eyes should be avoided. In case of accidental contact with the eyes, rinse thoroughly 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 experience persistent skin irritation, 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.

Use of Ciclopirox Olamine Isdin with other medicines

There are no data available on drug interactions. However, given the low level of systemic absorption, interactions are unlikely.

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Pregnancy, breastfeeding and fertility

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

Due to the short contact time with the skin and the low level of systemic absorption, Ciclopirox Olamine Isdin may be used during pregnancy. Your doctor will assess the necessity of using this medicine.

Ciclopirox Olamine Isdin may be used during breastfeeding.

Driving and using machines

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

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 for this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again. Remember to use your medicine as directed.

Your doctor will indicate how long you should treat with Ciclopirox Olamina Isdin. Do not stop the treatment earlier, as the medicine would not be effective.

If you think that the effect of Ciclopirox Olamina Isdin is too strong or too weak, inform your doctor or pharmacist.

Apply to wet hair a sufficient amount of Ciclopirox Olamina Isdin to produce abundant foam. Vigorously massage the scalp and adjacent areas with the fingertips. Then rinse the hair thoroughly and repeat the process. Leave the shampoo in contact with the scalp for 3 to 5 minutes.

Ciclopirox Olamina Isdin should be used two or three times a week.

The recommended treatment period is 4 weeks.

4. Possible adverse effects

Like all medicines, Ciclopirox Olamine Isdin can cause adverse effects, although not everyone will experience them.

Ciclopirox Olamine Isdin may, in rare cases, cause skin irritation. If persistent irritation occurs, treatment should be discontinued.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of CICLOPIROX OLAMINE ISDIN

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

No special storage conditions are required.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other 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 components are: sodium laureth 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 viscous solution, colorless to yellowish. Each container holds 100 ml of shampoo.

Marketing Authorization Holder and Manufacturer

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 the most recent revision of this leaflet: September 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/