Fungisdin 8.7 mg/ml solution for cutaneous spray
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Fungisdin 8.7 mg/ml cutaneous spray solution
Miconazole
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, consult 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 effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet:
- What Fungisdin is and what it is used for
- Before you use Fungisdin
- How to use Fungisdin
- Possible side effects
- How to store Fungisdin
- Further information
1. What Fungisdin is and what it is used for
Fungisdin contains the active substance miconazole, which belongs to a group of medicines known as antifungals. Miconazole works by preventing the growth of fungi that cause infections.
Fungisdin is used to treat skin infections caused by dermatophytes, yeasts, and other fungi.
- Dermatophytoses such as: Tinea pedis (athlete's foot), T. corporis, T. cruris (Hebra's marginated eczema), T. manuum, T. unguium (onychomycosis), T. barbae.
- Candidiasis such as: Intertrigo, perianal lesions, onychia and paronychia, angular stomatitis (cheilitis, angular cheilosis), balanopostitis.
- Fungal infections caused by various fungi such as: Pityriasis versicolor.
Fungisdin may be used for the treatment of fungal infections secondarily infected by gram-positive bacteria sensitive to miconazole.
2. What you need to know before starting Fungisdin
Do not use Fungisdin
if you are allergic to the active substance, to other similar antifungal medicines, or to any of the other components of this medicine (listed in section 6).
- if you have liver problems;
- if you suffer from allergic asthma;
- if you are taking any of the following medicines (see section “Use of Fungisdin with other medicines”):
- some allergy medicines: terfenadine, astemizole, mizolastine;
- cisapride, a medicine used to treat certain digestive problems;
- some medicines used to lower cholesterol, for example simvastatin and lovastatin;
- midazolam taken orally and triazolam, medicines used for anxiety or to help sleep (tranquilizers);
- pimozide and sertindole, medicines used to treat disorders related to disturbances in thoughts, feelings, and behavior;
- halofantrine, an antimalarial medicine;
- some medicines used to treat migraine such as ergot alkaloids: ergotamine, dihydroergotamine, ergometrine;
- some medicines used to treat irregular heartbeats: bepridil, quinidine, dofetilide.
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Fungisdin.
Fungisdin may cause serious allergic reactions. You should be aware of the signs of an allergic reaction when taking or applying this medicine (see section “Possible side effects”).
Before applying Fungisdin, consider the following:
- This medicine is for external use only. Do not swallow.
- Avoid contact with eyes, mucous membranes, and open wounds.
- Do not use on large areas of skin. Apply only to the affected area.
- Do not apply Fungisdin to the same area where other medicines have been applied.
- Due to its ethanol content, frequent application of this medicine may cause skin irritation and dryness.
- If you are taking oral anticoagulants such as warfarin, stop using Fungisdin immediately and consult your doctor or pharmacist if you experience unexpected bleeding or bruising, nosebleeds, coughing up blood, blood in the urine, black tarry stools, or vomiting that looks like ground coffee during treatment with Fungisdin. Close monitoring of International Normalized Ratio (INR) levels is required during treatment with Fungisdin, under the supervision of a healthcare professional.
Treatment should be discontinued if a hypersensitivity or irritation reaction occurs.
Use of Fungisdin with other medicines
Inform your doctor, pharmacist, or dentist if you are taking, have recently taken, or might need to take any other medicines.
Some medicines may affect how Fungisdin works or increase the likelihood of side effects. Fungisdin may also affect how other medicines work.
If you are taking any of these medicines or others, consult your doctor or pharmacist before starting to use Fungisdin:
- Oral anticoagulants (medicines used to thin the blood), such as warfarin, may be affected by Fungisdin.
Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
The use of this medicine does not affect your ability to drive or operate machinery.
3. How to use Fungisdin
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Fungisdin is a cutaneous medication intended for external use only (on the skin).
The recommended dose is:
Apply one spray of the solution to the affected area 1 to 2 times daily, and gently massage to enhance penetration.
In case of nail infections, the nails should be trimmed as much as possible. Apply 1 or 2 times daily to the infected nail and surrounding area, and cover the nail with an occlusive dressing.
Wash your hands after each application.
If you use more Fungisdin than you should
Because it is used externally (on the skin), episodes of intoxication are unlikely.
Symptomatic and supportive treatment should be administered. There is no known specific antidote against miconazole.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.
If you forget to use Fungisdin
Do not take a double dose to make up for missed doses.
4. Possible adverse effects
Like all medicines, Fungsidin can cause adverse effects, although not everyone will experience them.
Uncommon adverse effects
May affect up to 1 in 100 people:
Hypopigmentation (change in skin coloration)
Localized allergic reactions: swelling, erythema (redness), urticaria, contact dermatitis, rash, pruritus (itching), burning sensation, irritation
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 Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Fungisdin
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use Fungisdin after the expiry date stated on the packaging.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.
6. Package contents and additional information
Composition of Fungisdin
- The active substance is miconazole. Each millilitre of Fungisdin contains 8.7 mg of miconazole.
- The other components are: Caprylic/capric macrogol glycerides, Macrogol 300, Ethanol 99.8%.
Appearance of the product and contents of the container
Fungisdin is available as a 125 ml and 50 ml non-aerosol spray bottle.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Isdin SA
Provençals, 33
08019 Barcelona
Spain
Manufacturer:
TOWA Pharmaceutical Europe, S.L.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain
This leaflet was approved in September 2025
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.es/.