Label: Information for the User

Micetal 10 mg/g Gel

Flutrimazol

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Flutrimazol belongs to a group of medications called topical antifungals (imidazolic derivatives) used for the treatment of skin infections caused by fungi and yeasts.

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

• Pityriasis capitis(dandruff).
• Seborrheic dermatitis (a condition primarily affecting the face and chest, causing redness and skin peeling).

Do not use Micetal

• if you are allergic to the active ingredient (flutrimazol), to other imidazolic antimycotics, or to any of the other components of this medication (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, discontinue treatment and consult a doctor.

Children

Do not apply to children under 10 years old.

Use of Micetal with other medications

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

No interactions studies have been conducted.

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 medication.

As a precaution, it is recommended to avoid using this medication during the second and third trimesters of pregnancy. In the first trimester of pregnancy, it can only be used when the doctor considers it necessary for the patient's health.

The passage of flutrimazol to breast milk is unknown, so your doctor will decide whether to interrupt breastfeeding or discontinue treatment after considering the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and operating machinery

The influence of Micetal on the ability to drive and operate machinery is negligible or insignificant.

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

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

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

This medication may cause skin reactions because it contains Peruvian balsam.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose and treatment duration foradults and children 10 years of age and olderis 3 times a week for a period of 4 weeks.

Method of Use

Topical use.

Apply the gel in sufficient quantity to the scalp and adjacent areas using a gentle massage or friction. Leave it to act for 3 to 5 minutes before rinsing with abundant 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 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 Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Store below 25°C.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Unused medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Micetal

• The active principle is flutrimazol. Each gram of gel contains 10 milligrams of flutrimazol.
• The other components (excipients) are polisorbate 20 (E-432), caprylyl/capryl glucosides, cocamidopropyl betaine, polyacrylate and methacrylate copolymer of stearyl ether of polyoxyethylene 20, diazolidinyl urea, propyl PG-betaine dimethicone, sodium hydroxide, citrus fragrance (a mixture of fragrances, benzoic acid (E-210), castor oil, and Peru balsam) and purified water.

Appearance of the product and contents of the packaging

White 100-gram gel bottle made of polyethylene with a polypropylene cap.

Holder of the marketing authorization

LABORATORIOS ERN, S.A.

Perú, 228

08020 Barcelona, Spain

Responsible for manufacturing

Ferrer Internacional, S.A.

C/ Joan Buscallà 1-9

08190 Sant Cugat del Vallès (Barcelona), Spain

O

Responsible for manufacturing

LABORATORIOS ERN, S.A.

Gorgs Lladó, 188

08210 Barberá del Vallès, Barcelona. Spain

Last review date of this leaflet: 09/2019

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/