FALVIN*SPRAY CUT 30ML 20MG/G

Falvin 20 mg/g cream
Falvin 20 mg/ml cutaneous spray, solution
fenticonazole nitrate

What it is and what it is used for
Falvin contains the active ingredient fenticonazole nitrate.
It belongs to a group of medicines called antifungals for cutaneous use and works against infections caused by fungi.

Falvin is used locally (topical use) for the treatment of the following conditions:
• skin infections caused by fungi called dermatophytes (dermatomycosis from Trichophyton, Microsporum, Epidermophyton) located in different parts of the body: ringworm of the scalp (tinea capitis), ringworm of the body (tinea corporis), ringworm of the groin (tinea cruris), ringworm of the foot (tinea pedis also called athlete's foot), ringworm of the hand (tinea manuum), ringworm of the face (tinea faciei), ringworm affecting hair follicles (tinea barbae), ringworm of the nails (tinea unguium);
• skin infections caused by candida fungi (candidiasis such as intertrigo, perleche, facial candidiasis, diaper candidiasis, perineal and scrotal candidiasis);
• infections located in some parts of the male genitals (balanitis, balanoposthitis);
• infections located on the nails (onychomycosis and paronychia);
• infection caused by fungi called pityriasis versicolor (from Pityrosporum orbiculare and P. ovale);
• ear infections caused by fungi (otomychosis from Candida or molds), only if there are no lesions of a part of the ear called the eardrum;
• skin infection called erythrasma;
• fungal infections (mycoses) that also have bacterial superinfections (from Gram-positive bacteria).

Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

What you need to know before taking the medicine
Do not use Falvin:
- if you are allergic to fenticonazole nitrate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor or pharmacist if:
- you are pregnant or breastfeeding, in both cases Falvin should be used under medical supervision (see section Pregnancy, breastfeeding and fertility);
- you experience any irritation or sensitivity to the product, because treatment should be discontinued; consult your doctor who will recommend appropriate therapy;
- prolonged use, for example 3-4 weeks, of medicines for local use (topical use) can cause allergic reactions (sensitization phenomena).

Falvin is for cutaneous use only, for external use, do not apply to mucous membranes or broken/damaged skin. Avoid contact with eyes; if this happens, rinse thoroughly with water. Falvin contains excipients with known effects that require special warnings and precautions (see section Important information about some excipients).

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

When used as recommended, Falvin is only sparingly absorbed and no side effects that can affect the entire body (systemic effects) are expected. Prolonged use of medicines for local use (topical use) can cause sensitization phenomena (see section Warnings and precautions).

The following side effects have been observed with Falvin:

Very rare (may affect up to 1 in 10,000 people):
• skin redness (erythema);
• itching;
• skin rash;
• rash and skin redness (erythematous exanthema);
• skin irritation;
• burning sensation of the skin.

Not known (frequency cannot be estimated from the available data):
• hypersensitivity.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.