Leaflet: information for the user

Micetal 10 mg/g cream

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 known as 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.

Do not use Micetal

• if you are allergic to the active ingredient (flutrimazol), to other imidazolic antimycotics or to any of the other components ofthis 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 abundant water and consult an ophthalmologist if necessary.

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

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

Adequate hygiene measures should be maintained to avoid contagion and reinfection.

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 need to use any other medication.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, 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.During 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 benzyl alcohol and cetoestearic alcohol

This medication contains 10 mg of benzyl alcohol in each gram of cream.

Benzyl alcohol may cause allergic reactions and moderate local irritation.

This medication may cause local skin reactions (such as contact dermatitis) due to the presence of cetoestearic alcohol.

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 and olderis 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.

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

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

If symptoms improve after the first few days of treatment, do not interrupt treatment until the indicated period 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 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, 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 forgot to use Micetal

In case of forgotten 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 prospectus. You may also report 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.

No special storage conditions are required.

Do not usethis medicationafter 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 the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Micetal

- The active principle is flutrimazol. Each gram of cream contains 10 milligrams of flutrimazol.

- The other components (excipients) are: benzyl alcohol, cetostearyl ether of macrogol 20-22, cetostearyl alcohol, glyceryl monostearate 40-50, diisopropyl adipate, disodium hydrogen phosphate, dihydrate sodium dihydrogen phosphate, macrogol 400, and purified water.

Appearance of the product and contents of the packaging

Cream. White or almost white, odorless, hydrophilic cream. It is presented in:

Aluminum tube containing 30 g of cream.

Aluminum tube containing 60 g of cream.

Holder of the marketing authorization

Laboratorios ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain

Responsible for manufacturing

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

Last review date of this leaflet: February 2023.

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/.