CICLOPIROX OLAMINE SERRA 15 mg/g SHAMPOO

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

CICLOPIROX OLAMINE SERRA 15 mg/g shampoo

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should 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 leaflet.

Contents of the package leaflet:

1. What Ciclopirox Olamine Serra is and what it is used for.
2. What you need to know before you start using Ciclopirox Olamine Serra.
3. How to use Ciclopirox Olamine Serra.
4. Possible side effects.
5. Storing Ciclopirox Olamine Serra.
6. Package contents and further information.

1. What Ciclopirox Olamine Serra is and what it is 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 you start using Ciclopirox Olamine Serra

Ciclopirox Olamine Serra 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 Serra

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

Warnings and precautions

If you notice persistent skin irritation, you should discontinue treatment.

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

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

Using Ciclopirox Olamine Serra with other medicines

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

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

Pregnancy and breastfeeding

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 Serra may be used during pregnancy. Your doctor will assess the need to use this medicine.

Ciclopirox Olamine Serra may be used during breastfeeding.

3. How to use Ciclopirox Olamine Serra

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Remember to use your medicine.

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

Do not stop treatment prematurely, as the medicine may not be effective.

If you think 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 a rich lather. Massage vigorously into the scalp and adjacent areas 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 Serra 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 Serra can cause side effects, although not everybody gets them.

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

If you experience side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.

5. Storing 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 is the last day of the month stated.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and further information

Composition of Ciclopirox Olamine Serra

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

The other ingredients are: Sodium lauryl ether 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.

Appearance of the product and package contents

Ciclopirox Olamine Serra 15 mg/g shampoo is a colorless to yellowish viscous solution. Each package 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 last revision of this leaflet: July 2022

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/