Micetal 10 mg/g cream
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Micetal 10 mg/g cream
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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet
- 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 antifungals (imidazole derivatives) which are 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 components of this medicine (listed in section 6).
Warnings and precautions
Talk to 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 eye contact, 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 at the application site, discontinue treatment and consult your doctor.
Appropriate hygiene measures should be maintained to prevent transmission and reinfection.
Children
Do not use in children under 10 years of age.
Other medicines and Micetal
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may 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. In the first trimester of pregnancy, it may 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 operating machinery
The effect of Micetal on the ability to drive and operate machinery is none or negligible.
Micetal contains benzyl alcohol and cetostearyl alcohol
This medicine contains 10 mg of benzyl alcohol in each gram of cream.
Benzyl alcohol may cause allergic reactions and moderate local irritation.
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetostearyl alcohol.
3. How to use Micetal
Follow exactly the administration instructions for 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 from 10 years of age 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 lesion or infecting microorganism and its location.
Method of use
Cutaneous use.
Clean and thoroughly dry the affected areas before applying the medicine.
Apply a sufficient amount of cream to cover the extent of the lesion and adjacent areas, promoting its 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 area, it is advisable to apply a small amount of cream, preferably at night, to avoid skin maceration.
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 after 4 weeks of treatment symptoms have not improved, 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 or pharmacist immediately, or call the Toxicology Information Service at 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 eradicated. 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 produce adverse effects, although not everyone 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 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 or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any questions, ask your pharmacist how to dispose of medicines and containers you no longer need. 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 cream contains 10 milligrams of flutrimazole.
- The other components (excipients) are: benzyl alcohol, ceteareth-20-22 cetostearyl ether, cetostearyl alcohol, glycerol monostearate 40-50, diisopropyl adipate, disodium hydrogen phosphate, sodium dihydrogen phosphate dihydrate, macrogol 400 and purified water.
Appearance of the product and contents of the container
Cream. A white or almost white odourless hydrophilic cream. It is available in:
Aluminium tube containing 30 g of cream.
Aluminium tube containing 60 g of cream.
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.
C/Gorgs Lladó, 188
Pol. Ind. Can Salvatella
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 for Medicinal Products and Medical Devices (AEMPS) http://www.aemps.gob.es/.