MICETAL 10 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Micetal 10 mg/g Cream

Flutrimazole

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are 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 using Micetal
3. How to use Micetal
4. Possible side effects
5. Storage of Micetal
6. Package Contents and Additional Information

1. What is Micetal and what is it used for

Flutrimazole belongs to the group of medications known as topical antifungals (imidazole derivatives) used to treat fungal and yeast infections.

This medication is indicated for the treatment of superficial skin infections in adults and children over 10 years of age, including:

• Ringworm (in its various forms, depending on the affected skin area: beard, body, feet, groin, or scalp): skin infections caused by dermatophytes.
• Cutaneous candidiasis: skin infection caused by yeast.
• Pityriasis versicolor.

2. What you need to know before using Micetal

Do not use Micetal

• if you are allergic to the active ingredient (flutrimazole), other imidazole antifungals, or 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 ingest.

Do not apply to eyes or mucous membranes. In case of eye contact, rinse with plenty of water and consult an ophthalmologist if necessary.

Do not use occlusive dressings or those that do not allow the skin to breathe, as this may promote the development of yeast.

In case of allergic reaction or irritation in the treated area, treatment should be discontinued and a doctor consulted.

Adequate hygiene measures should be taken to prevent contagion and reinfection.

Children

Do not apply to children under 10 years of age.

Other Medications and Micetal

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

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 precautionary measure, it is recommended to avoid using this medication 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 flutrimazole passes into breast milk; therefore, your doctor will decide whether to interrupt breastfeeding or treatment after considering the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and Using Machines

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

Micetal contains benzyl alcohol and cetoestearic alcohol

This medication contains 10 mg of benzyl alcohol per gram of cream.

Benzyl alcohol may cause allergic reactions and moderate local irritation.

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetoestearic alcohol.

3. How to use Micetal

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

The recommended dose and duration of treatment for adults and children over 10 years of ageis once a day, for a period that can range from 1 to 4 weeks. Your doctor will indicate the duration of treatment based on the type of lesion or infectious microorganism and its location.

Method of use

For cutaneous use.

Clean and dry the affected areas thoroughly before applying the medication.

Apply the cream in sufficient quantity to cover the extent of the lesion and adjacent areas, favoring its penetration through gentle massage. If the infection is between the fingers of the hands or feet, under the breasts, or in the groin, it is advisable to apply a small amount of cream, preferably at night, to avoid maceration of the skin.

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

General hygiene measures should be taken to control sources of infection and prevent possible relapses.

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 medication and the amount ingested.

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

If you forget to use Micetal

In case of forgetting a dose, wait for the next one. Do not apply a double dose to compensate for the forgotten dose.

If you interrupt treatment with Micetal

If you interrupt treatment, the fungus may not have disappeared. If you have any other questions about the use of this medication, ask your doctor.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

General disorders and administration site conditions

Frequent (≥ 1/100 to <1>

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Micetal

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

No special storage conditions are required.

Do not use this medication after the expiration date stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Micetal

• The active ingredient is flutrimazole. Each gram of cream contains 10 milligrams of flutrimazole.
• The other components (excipients) are: benzyl alcohol, macrogol 20-22 cetoestearic ether, cetoestearic alcohol, glycerol monostearate 40-50, diisopropyl adipate, disodium hydrogen phosphate, sodium dihydrogen phosphate dihydrate, macrogol 400, and purified water.

Appearance of the Product and Package Contents

Cream. White or almost white hydrophilic cream without specific odor. It is presented in:

Aluminum tube containing 30 g of cream.

Aluminum tube containing 60 g of cream.

Marketing Authorization Holder

Laboratorios ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain

Manufacturer

Noucor Health, S.A.

Av. Camí Reial, 51-57

08184 Palau-solità i Plegamans (Barcelona – Spain)

or

Laboratorios ERN, S.A.

C/Gorgs Lladó, 188

Pol. Ind. Can Salvatella

08210 Barberá del Vallés (Barcelona), Spain

Date of the last revision of this package leaflet: February 2023.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.