Micetal 10 mg/g cutaneous powder
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Micetal 10 mg/g cutaneous powder
flutrimazole
Read the entire 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, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Micetal is and what it is used for
- What you need to know before using Micetal
- How to use Micetal
- Possible adverse effects
- How to store Micetal
- Contents of the pack and other information
1. What Micetal is and what it is used for
Flutrimazole belongs to a group of medicines called topical antifungal agents (imidazole derivatives) used to treat infections caused by fungi and yeasts.
This medicine is indicated in adults for the local treatment of the following superficial skin infection:
- Tinea pedis (also known as athlete's foot)
2. What you need to know before using Micetal
Do not use Micetal
- if you are allergic to the active substance (flutrimazole), to other imidazole antifungals, or to any of the other components of this medicine (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 in the eyes or on mucous membranes. In case of contact with the eyes, rinse thoroughly with water and consult an ophthalmologist if necessary.
Do not use occlusive or non-breathable dressings, as they may promote the growth of yeasts.
If an allergic reaction or irritation occurs in the treated area, discontinue treatment and consult your doctor.
Appropriate hygiene measures should be maintained to prevent transmission and reinfections.
Children and adolescents
Do not apply to individuals under 18 years of age.
Other medicines and Micetal
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
As a precautionary measure, it is preferable to avoid using this medicine during the second and third trimesters of pregnancy. During the first trimester of pregnancy, it should only be used if considered necessary by the physician for the patient's health.
It is unknown whether flutrimazole passes into breast milk; therefore, your doctor will decide whether it is necessary to interrupt breastfeeding or discontinue treatment, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.
Driving and using machines
The effect of Micetal on the ability to drive and use machines is none or negligible.
3. How to use Micetal
Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose and treatment duration for adults is twice daily (morning and night) for a period of 4 weeks.
Method of administration
Topical use.
Clean and thoroughly dry the affected areas before applying the medicine.
Apply the powder gently and evenly over the affected area, making sure to cover a surrounding area of healthy skin. Dust Micetal inside shoes and socks.
If symptoms improve after the first few days of treatment, do not stop treatment until the period indicated by your doctor has been completed. If symptoms do not improve after 4 weeks of treatment, 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 at 915 620 420 immediately, indicating the medicine and the amount ingested.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
If you forget to use Micetal
If you miss a dose, wait until the next scheduled dose. Do not apply a double dose to make up for the missed dose.
If you stop using Micetal
If you stop treatment, the fungi may not have been eliminated. If you have any further questions about the use of this medicine, ask your doctor.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
General disorders and administration site reactions
Common (≥ 1/100 to < 1/10): itching at the site of administration.
Rare (≥ 1/10,000 to < 1/1,000): contact dermatitis.
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Micetal
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Micetal
- The active substance is flutrimazole. Each gram of powder contains 10 milligrams of flutrimazole.
- The other components are zinc oxide and maize starch.
Appearance of the product and contents of the container
Cutaneous powder. White or almost white, odourless, fine, non-gritty, adherent powder.
White polyethylene bottle with screw cap containing 30 grams of powder.
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.
Gorgs Lladó, 188
08210 Barberà del Vallès, Barcelona, Spain
Date of the most recent revision of this leaflet: February 2023.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.