Package Insert: Information for the Patient

Fungisdin 8.7 mg/ml Topical Solution for Pulverization

Miconazole

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.

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

Fungisdin contains the active ingredient miconazole, which belongs to a group of medications called antifungals. Miconazole acts by preventing the growth of fungi that cause infections.

Fungisdin is used for the treatment of skin infections caused by dermatophytes, yeasts, and other fungi.

- Dermatophytes such as:Tinea pedis(athlete's foot),T. corporis, T.cruris(ringworm),T. manuum, T. unguium(onychomycosis),T. Barbae.

- Candidiasis such as: Intertrigo, perianal lesions, onychomycosis, and perionychia, angular stomatitis (angular cheilitis, perleche), balanoposthitis.

- Fungal infections caused by various fungi such as: Pityriasis versicolor.

Fungisdin may be used for the treatment of fungal infections overinfected by gram-positive bacteria sensitive to miconazole.

Do not use Fungisdin

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Fungisdin.

Fungisdin may cause severe allergic reactions. You must be aware of the signs of an allergic reaction when taking or administering this medication (see section “Possible side effects”).

Before applying Fungisdin, consider the following:

• This medication is for external use only. Do not ingest.
• avoid contact with the eyes, mucous membranes, and wounds
• do not use on extensive areas. Use exclusively on the affected area
• do not apply Fungisdin on the same area where other medications have been applied
• due to its ethanol content, frequent application of the medication may cause skin irritation and dryness.

Treatment should be interrupted in case of sensitivity or skin irritation reactions.

Use of Fungisdin with other medications

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

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

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

• the anticoagulant medication 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 medication.

Driving and operating machinery

The use of this medication does not affect the ability to drive and operate machinery.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Fungisdin is a medication 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 perform a gentle massage to facilitate penetration.

In case of nail infections, they should be cut as much as possible. Apply 1 or 2 times a day to the infected nail and surrounding area and place a occlusive dressing on the nail.

Wash your hands after each application.

If you use more Fungisdin than you should

Since its use is external (on the skin), it is unlikely that episodes of intoxication will occur.

Symptomatic and supportive treatment will be applied. No specific antidote is known for miconazol.

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

If you forgot to use Fungisdin

Do not take a double dose to compensate for the missed doses.

Like all medications, Fungsidin may cause adverse effects, although not everyone will experience them.

Less Common Adverse Effects

They may affectup to 1 in 100 people:

Hypopigmentation (change in skin color)

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

Reporting 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 can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use Fungisdin after the expiration date shown on the packaging.

Do not dispose of medications through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Fungisdin

• The active principle is miconazole. Each milliliter of Fungisdin contains 8.7 mg of miconazole.
• The other components are: Caproil caproyl macrogolglycerides, Macrogol 300, 99.8% Ethanol.

Appearance of the product and contents of the packaging

Fungisdin is presented in a 125 ml and 50 ml gas-free atomizer bottle.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Isdin SA

Provençals, 33

08019 Barcelona

Spain

Responsible for manufacturing:

TOWA Pharmaceutical Europe, S.L.

C/ de Sant Martí, 75-9708107

Martorelles (Barcelona)

Spain

This prospectus was approved in June 2018

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/.