Leaflet: information for the user

Micetal 10 mg/ml skin spray solution

flutrimazol

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

This medicationis indicated for the treatment, in adults and children over 10 years,in the treatmentof the following superficial skin infections:

- Ringworm (in its different varieties, depending on the affected skin area: beard, body, feet, groin area, or scalp): skin infections caused by dermatophytes.

- Cutaneous candidiasis: skin infections caused by yeasts.

- Pityriasis versicolor.

No 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.

Solely for external use. Do not ingest.

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

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

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

Appropriate hygiene measures should be maintained to prevent 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 old.

Other Medications and Micetal

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

Pregnancy, Breastfeeding and Fertility

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

As a precaution, 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.

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

Driving and Operating Machines

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

Micetal contains ethanol

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

It may cause a burning sensation on injured skin.

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

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 aged 10 years and aboveis once a day, for a period of 1 to 4 weeks.Your doctor will indicate the treatment duration based on the type of injury or infecting microorganism and its location.

Method of Use

Cutaneous use.

Thoroughly clean and dry the affected areas 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 the entire trunk in patients diagnosed with pityriasis versicolor.

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

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

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 at 915 620 420, indicating the medication and amount ingested.

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

If you forgot to use Micetal

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

If you interrupt treatment with Micetal

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

Like all medications, this medication may produce adverse effects, although not all people will 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 that does not appear in this leaflet. You may also communicate them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not store above 25 °C.

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.

Medications should not be disposed of through drains or in the 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 packaging and unused medications. By doing so, you will help protect the environment.

Composition of Micetal

-The active ingredient is flutrimazol. Each milliliter of topical solution contains 10 milligrams of flutrimazol.

-The other components (excipients) are octyldodecanol, macrogol 400, tromethamine and ethanol.

Appearance of the product and content of the packaging

Topical spray solution. Clear solution with a light yellow color and an alcohol odor.

Topaz glass vial with a screw-on dosing pump with a diffuser and a transparent stopper containing 30 milliliters of topical solution.

Holder of the marketing authorization

Laboratorios ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain

Responsible for manufacturing

Galenica Pharmaceutical Industry S.A.

Asklipiou 4-6 Kryoneri, Attiki

14568 - Greece

Last review date of this leaflet: February 2023.

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