MICETAL 10 mg/g GEL

Introduction

Package Leaflet: Information for the User

Micetal 10 mg/g Gel

Flutrimazol

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 Micetal and what is it used for
2. What you need to know before you start using Micetal
3. How to use Micetal
4. Possible side effects
5. Storage of Micetal
6. Contents of the pack and other information

1. What is Micetal and what is it used for

Flutrimazol belongs to a group of medicines called topical antifungals (imidazole derivatives) used to treat skin infections caused by fungi and yeasts.

This medicine is indicated for the treatment of the following superficial skin infections:

• Pityriasis capitis(dandruff).
• Seborrhoeic dermatitis (a disease that mainly affects the face and chest, causing redness and skin scaling).

2. What you need to know before you start using Micetal

Do not use Micetal

• if you are allergic to the active substance (flutrimazol), to other imidazole antimycotics, or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Micetal.

For external use only. Do not apply to eyes or mucous membranes.

In case of allergic reaction, treatment should be discontinued and a doctor consulted.

Children

Do not apply to children under 10 years of age.

Using Micetal with other medicines

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

No interaction studies have been performed.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

As a precautionary measure, it is preferable to avoid using this medicine during the second and third trimesters of pregnancy. In the first trimester of pregnancy, it should only be used when the doctor considers it necessary for the patient's health.

It is not known whether flutrimazol passes into breast milk. Your doctor will decide whether to stop breastfeeding or stop treatment after considering the benefit of breastfeeding to the baby and the benefit of treatment to the mother.

Driving and using machines

Micetal has no or negligible influence on the ability to drive and use machines.

Micetal gel contains benzoic acid (E-210), castor oil, and Peru balsam

This medicine may be slightly irritating to the skin, eyes, and mucous membranes because it contains benzoic acid.

This medicine may cause skin reactions because it contains castor oil.

This medicine may cause skin reactions because it contains Peru balsam.

3. How to use Micetal

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

The recommended dose and duration of treatment for adults and children from 10 yearsis 3 times a week, for a period of 4 weeks.

Method of use

For cutaneous use.

Apply the gel in sufficient quantity to the scalp and adjacent areas by gentle massage or friction. Leave it to act for 3 to 5 minutes before rinsing with plenty of water.

If symptoms improve after the first few days of treatment, do not interrupt treatment until the period indicated by your doctor is completed. And if after 4 weeks of treatment the symptoms do not improve, consult your doctor again.

If you use more Micetal than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount ingested.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• General disorders and administration site conditions:local irritation or burning after the first applications.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Micetal

Store below 30°C.

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

Do not use this medicine after the expiry date which is stated on the packaging after ‘CAD’. The expiry date is the last day of the month shown.

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

6. Contents of the pack and other information

Composition of Micetal

• The active substance is flutrimazol. Each gram of gel contains 10 milligrams of flutrimazol.
• The other components (excipients) are polysorbate 20 (E-432), caprylyl/capryl glucosides, cocamidopropyl betaine, acrylates/stearyl acrylate copolymer, diazolidinyl urea, propyl PG-betaína dimethicone, sodium hydroxide, citrus perfume (a mixture of flavoring substances, benzoic acid (E-210), castor oil, and Peru balsam) and purified water.

Appearance and packaging of the product

White bottle of 100 grams of gel, made of polyethylene with a polypropylene cap.

Marketing authorisation holder

LABORATORIOS ERN, S.A.

Perú, 228

08020 Barcelona, Spain

Manufacturer

Ferrer Internacional, S.A.

C/ Joan Buscallà 1-9

08190 Sant Cugat del Vallès (Barcelona), Spain

O

Manufacturer

LABORATORIOS ERN, S.A.

Gorgs Lladó, 188

08210 Barberá del Vallés, Barcelona, Spain

Date of last revision of this package leaflet: 09/2019

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