Micetal 10 mg/ml solution for cutaneous spray
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Micetal 10 mg/ml cutaneous spray solution
flutrimazole
Read the entire leaflet carefully before you start using this medicine, as 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 must not be given to other people, even if they have the same symptoms as you, since it could harm them.
- If you experience any adverse reactions, consult 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 for the treatment, in adults and children over 10 years of age, of the following superficial skin infections:
- Tinea (in its different forms, depending on the affected skin area: beard, body, feet, groin, or scalp): skin infections caused by dermatophytes.
- Cutaneous candidiasis: skin infection caused by yeasts.
- Pityriasis versicolor.
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 ingredients 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 or around 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 reinfection.
Flammable. Avoid use near flames, lit cigarettes, or certain devices such as hair dryers.
Children
Do not use in children under 10 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 may be pregnant, or plan 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 doctor for the patient's health.
It is unknown whether flutrimazole passes into breast milk; therefore, your doctor will decide whether breastfeeding should be interrupted or treatment discontinued, 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 operate machinery is none or negligible.
Micetal contains ethanol
This medicine contains 320 mg of alcohol (ethanol) per ml of solution, equivalent to 32% w/v.
It may cause a burning sensation on damaged skin.
In newborns (premature and full-term newborns), high concentrations of ethanol may cause severe local reactions and systemic toxicity due to significant absorption through immature skin (especially in case of occlusion).
3. How to use Micetal
Follow exactly the instructions for use of this medicine given 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 aged 10 years and older is once daily, for a period ranging from 1 to 4 weeks. Your doctor will determine the duration of treatment depending on the type of infection, the causative microorganism, and its location.
Method of use
Cutaneous use.
Clean and thoroughly dry the affected areas before applying the medicine.
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 to the entire trunk in patients diagnosed with pityriasis versicolor.
If symptoms improve within the first few days of treatment, do not stop treatment until the full 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, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 915 620 420, 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 completely eradicated. If you have any further questions about using this medicine, consult your doctor.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.
General disorders and administration site reactions
Common (≥ 1/100 to < 1/10): mild burning, irritation, itching, and erythema at the application site.
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.
Do not store above 25 °C.
Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If in doubt, 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
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The active substance is flutrimazole. Each ml of cutaneous solution contains 10 milligrams of flutrimazole.
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The other components (excipients) are octyldodecanol, macrogol 400, tromethamine, and ethanol.
Nature of the product and contents of the container
Cutaneous spray solution. A slightly yellowish, clear solution with an alcoholic odor.
Amber glass bottle with a screw-thread metered pump dispenser, diffuser, and 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 most recent revision of this package leaflet: February 2023.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.