FUNGISDIN 8.7 mg/ml CUTANEOUS SPRAY SOLUTION

Introduction

Patient Information Leaflet

Fungisdin 8.7 mg/ml cutaneous spray solution

Miconazole

Read this leaflet carefully before starting to use 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, as it may harm them, even if their symptoms are the same as yours.

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Fungisdin and what is it used for
2. Before using Fungisdin
3. How to use Fungisdin
4. Possible side effects
5. Storage of Fungisdin
6. Additional information

1. What is Fungisdin and what is it used for

Fungisdin contains the active ingredient miconazole, which belongs to a group of medicines called 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.

• Dermatophyte infections such as: Tinea pedis (athlete's foot), T. corporis, T. cruris (marginated eczema of Hebra), T. manuum, T. unguium (onychomycosis), T. barbae.
• Candidiasis such as: Intertrigo, perianal lesions, onychia and paronychia, angular stomatitis (perleche, cheilitis), balanoposthitis.
• Fungal infections caused by various fungi such as: Pityriasis versicolor.

Fungisdin can be used to treat fungal infections that are superinfected with gram-positive bacteria sensitive to miconazole.

2. What you need to know before using Fungisdin

Do not use Fungisdin

if you are allergic to the active ingredient, to other similar antifungals, or to any of the other components of this medicine (listed in section 6).

• if you have liver problems;
• if you have allergic asthma
• if you are taking any of the following medicines (see section "Using Fungisdin with other medicines"):
• • some allergy medicines: terfenadine, astemizole, mizolastine;
  • cisapride, a medicine used to treat some digestive problems;
  • some cholesterol-lowering medicines, such as simvastatin and lovastatin;
  • midazolam administered orally and triazolam, medicines used for anxiety or to help you sleep (tranquilizers);
  • pimozide and sertindole, medicines used to treat diseases related to thought, feeling, and behavior disorders;
  • halofantrine, an antimalarial medicine;
  • some medicines used to treat migraine, such as ergot alkaloids: ergotamine, dihydroergotamine, ergometrine;
  • some medicines used to treat heart rhythm disorders: bepridil, quinidine, dofetilide;

Warnings and precautions

Consult your doctor or pharmacist before starting to use Fungisdin.

Fungisdin can cause severe allergic reactions. You should be aware of the signs of an allergic reaction when taking or administering this medicine (see section "Possible side effects").

Before applying Fungisdin, consider:

• This medicine is for external use only. Do not ingest.
• avoid contact with eyes, mucous membranes, and wounds
• do not use on large areas. Use only on 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 the medicine may cause skin irritation and dryness.

Treatment should be discontinued if a sensitivity or irritation reaction occurs.

Using Fungisdin with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Some medicines may affect the way Fungisdin works or make it more likely to cause side effects. Fungisdin may also affect the way other medicines work.

If you are taking any of these medicines or others, consult your doctor or pharmacist before starting to use Fungisdin:

• the anticoagulant medicine warfarin.

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.

Driving and using machines

Using this medicine does not affect your ability to drive or operate machines.

3. How to use Fungisdin

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Fungisdin is a medicine for external use only (on the skin).

The recommended dose is:

Apply a spray of the solution to the affected area 1 to 2 times a day and gently massage to facilitate penetration.

In case of nail infections, the nails should be cut as short as possible. Apply 1 or 2 times a day to the infected nail and surrounding area and cover with an occlusive dressing.

Wash your hands after each application.

If you use more Fungisdin than you should

Due to its external use (on the skin), it is unlikely to cause overdose episodes.

Symptomatic and supportive treatment will be applied. There is no known specific antidote for miconazole.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Fungisdin

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, Fungisdin can cause side effects, although not everyone gets them.

Uncommon side effects

May affect up to 1 in 100 people:

Hypopigmentation (change in skin color)

Localized allergic reactions: inflammation, erythema (redness), urticaria, contact dermatitis, rash, pruritus (itching), burning sensation, irritation

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

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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 expiration date stated on the packaging.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Fungisdin

• The active ingredient is miconazole. Each milliliter of Fungisdin contains 8.7 mg of miconazole.
• The other ingredients are: Macrogolglycerides of capric/caprylic acid, Macrogol 300, Ethanol 99.8%

Appearance and packaging of the product

Fungisdin is presented in a 125 ml and 50 ml gas-free 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 June 2018

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/.