MICETAL 10 mg/ml CUTANEOUS SPRAY SOLUTION

Introduction

Prospectus: information for the user

Micetal 10 mg/ml solution for cutaneous spraying

flutrimazol

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

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

Contents of the prospectus

1. What is Micetal and what is it used for
2. What you need to know before starting to use Micetal
3. How to use Micetal
4. Possible adverse effects
5. Storage of Micetal
6. Package contents and additional information

1. What is Micetal and what is it used for

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

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

• Tinea (in its different varieties, depending on the area of skin affected: beard, body, feet, groin area, or scalp): skin infections caused by dermatophytes.
• Cutaneous candidiasis: skin infection caused by yeasts.
• Pityriasis versicolor.

2. What you need to know before starting to use Micetal

Do not use Micetal

• if you are allergic to the active ingredient (flutrimazol), other imidazole antimycotics, 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 contact with eyes, rinse with plenty of water and consult an ophthalmologist if necessary.

Do not use occlusive dressings or those that do not allow breathing, as this may favor the development of yeasts.

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 avoid contagion and reinfection.

Flammable. Avoid use near flames, lit cigarettes, or some devices such as hair dryers.

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 preferable 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.

It is unknown whether flutrimazol passes into breast milk; therefore, your doctor will decide whether it is necessary 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's influence on the ability to drive and use machines is nil or insignificant.

Micetal contains ethanol

This medication contains 320 mg of alcohol (ethanol) per ml of solution, which is equivalent to 32% p/v.

It may cause a burning sensation on damaged skin.

In newborns (premature and full-term), high concentrations of ethanol can cause severe local reactions and systemic toxicity due to significant absorption through immature skin (especially in cases of occlusion).

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 yearsis 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.

Form of use

For cutaneous use.

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

Apply the solution in sufficient quantity to cover the extent of the lesion and adjacent areas in patients diagnosed with dermatophytosis and cutaneous candidiasis, and on the entire trunk in patients diagnosed with pityriasis versicolor.

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 avoid 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 doubts 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 make up for the forgotten dose.

If you interrupt treatment with Micetal

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

General disorders and administration site conditions

Frequent (≥ 1/100 to <1>

Reporting adverse effects

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

5. Storage of Micetal

Keep this medication out of sight and reach of children.

Do not store at a temperature above 25 °C.

Do not use this medication after the expiration date shown on the packaging after "CAD". 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 medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Micetal

• The active ingredient is flutrimazol. Each ml of cutaneous solution contains 10 milligrams of flutrimazol.

• The other components (excipients) are octyl dodecanol, macrogol 400, tromethamine, and ethanol.

Appearance of the product and package contents

Cutaneous spray solution. Clear solution with a slightly yellow color and an alcohol odor.

Brown glass bottle with a metering pump and a transparent cap containing 30 milliliters of cutaneous solution.

Marketing authorization holder

Laboratorios ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain

Manufacturer

Galenica Pharmaceutical Industry S.A.

Asklipiou 4-6 Kryoneri, Attiki

14568 - Greece

Date of the last revision of this prospectus: 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/.