Ciclopirox olamine Serra 15 mg/g shampoo

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

CICLOPIROX OLAMINE SERRA 15 mg/g shampoo

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 and must not be given to other people, even if they have the same symptoms as you, since it could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Leaflet contents:

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

1. What Ciclopirox Olamine Serra is and what it is used for

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

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

2. What you need to know before using Ciclopirox Olamine Serra

Ciclopirox Olamine Serra 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 abundant water.

This product has not been tested in children.

Do not use Ciclopirox Olamine Serra

If you are allergic (hypersensitive) to the active substance or to any of the other components 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, avoid using this shampoo.

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

Use of Ciclopirox Olamine Serra with other medicines

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

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

Pregnancy and breastfeeding

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 duration of skin contact and the low level of systemic absorption, Ciclopirox Olamine Serra may be used during pregnancy. Your doctor will assess the necessity of using this medicine.

Ciclopirox Olamine Serra may be used during breastfeeding.

3. How to use Ciclopirox Olamine Serra

Follow exactly the instructions given by your doctor or pharmacist for using this medicine. If in doubt, consult your doctor or pharmacist again.

Remember to use your medicine as directed.

Your doctor will determine the duration of your treatment with Ciclopirox Olamine Serra.

Do not stop the treatment early, as the medicine will not be effective otherwise.

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

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

Ciclopirox Olamine Serra 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 Serra may produce adverse effects, although not everyone experiences them.

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

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

5. Storage of Ciclopirox Olamine Serra

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

No special storage conditions are required.

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.

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

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

6. Contents of the pack and other information

Composition of Ciclopirox Olamine Serra

The active substance is Ciclopirox Olamine. Each g of shampoo contains 15 mg of Ciclopirox Olamine.

The other components are: Sodium laureth sulfate 70%, Cocamidopropyl betaine, Disodium hydrogen phosphate dodecahydrate, Citric acid monohydrate, Hexylene glycol, Oleyl alcohol, Polysorbate 80, Polyquaternium-10, Sodium hydroxide, Purified water, Fragrance Rifskin 54193.

Nature of the product and pack contents

Ciclopirox Olamine Serra 15 mg/g shampoo is a viscous solution ranging from colourless to yellowish. Each container contains 100 ml of shampoo.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios SERRA PAMIES, S.A.

Carretera de Castellvell, nº24

43206 REUS

Tarragona

Manufacturer

Laboratorios Feltor

Polígono Industrial Molí de les Planes

C/Roques Blanques 3-5

08470 Sant Celoni

Barcelona

Date of the most recent revision of this leaflet: July 2022

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