Micetal 10 mg/g gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Micetal 10 mg/g gel
Flutrimazole
Read all of 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, 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 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.
Leaflet contents:
- What Micetal is and what it is used for
- What you need to know before using Micetal
- How to use Micetal
- Possible side 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) used to treat skin infections caused by fungi and yeasts.
This medicine is indicated for the treatment of the following superficial skin infections:
- Pityriasis capitis (dandruff).
- Seborrheic dermatitis (a condition that primarily affects the face and chest, causing redness and flaking of the skin).
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. Must not be applied to the eyes or mucous areas.
If an allergic reaction occurs, treatment must be discontinued and you should consult your doctor.
Children
Do not use in children under 10 years of age.
Using Micetal with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
No interaction studies have been conducted.
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. 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 breastfeeding should be interrupted or treatment discontinued, after considering the benefits of breastfeeding for the child and the benefits of treatment for the mother.
Driving and using machines
The influence of Micetal on the ability to drive and operate machinery is none or negligible.
Micetal gel contains benzoic acid (E-210), castor oil, and Peru balsam
This medicine may be slightly irritating to the skin, eyes, and mucous membranes because it contains benzoic acid.
This medicine may cause skin reactions because it contains castor oil.
This medicine may cause skin reactions because it contains Peru balsam.
3. How to use Micetal
Follow exactly the instructions for administration 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 over is 3 times a week, for a period of 4 weeks.
Instructions for use
For cutaneous use.
Apply a sufficient amount of gel onto the scalp and adjacent areas with gentle massage or friction. Allow it to act for 3 to 5 minutes before rinsing thoroughly with plenty of water.
If symptoms improve after the first few days of treatment, do not stop the treatment before completing the period indicated by your doctor. If after 4 weeks of treatment symptoms have not improved, consult your doctor again.
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 product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.
- General disorders and application site reactions: local irritation or burning sensation after the first applications.
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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Micetal
Store below 30°C.
Keep this medicine out of the sight and reach of children.
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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. 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 gel contains 10 milligrams of flutrimazole.
- The other components (excipients) are polysorbate 20 (E-432), caprylyl/capryl glucosides, cocamidopropyl betaine, acrylates and methacrylates copolymer with stearyl polyoxyethylene 20 ether, diazolidinyl urea, propyl PG-betaine dimethicone, sodium hydroxide, citrus fragrance (a mixture of aromatic substances, benzoic acid (E-210), castor oil and Peru balsam), and purified water.
Appearance of the product and contents of the pack
White 100-gram polyethylene tube with polypropylene cap.
Marketing Authorization Holder
LABORATORIOS ERN, S.A.
Perú, 228
08020 Barcelona, Spain
Manufacturer
Ferrer Internacional, S.A.
C/ Joan Buscallà 1-9
08190 Sant Cugat del Vallès (Barcelona), Spain
Or
Manufacturer
LABORATORIOS ERN, S.A.
Gorgs Lladó, 188
08210 Barberà del Vallès, Barcelona, Spain
Date of the most recent revision of this leaflet: 09/2019
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/