FALVIN 20 MG/G CREAM TUBE 30 G

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


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

Falvin is used locally (topical use) to treat the following conditions:
• skin infections caused by fungi called dermatophytes ( Trichophyton , Microsporum , Epidermophyton dermatomycosis) located in different parts of the body: ringworm of the hair ( 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 the hair follicles ( tinea barbae ), ringworm of the nails ( tinea unguium );
• skin infections caused by fungi of the Candida genus (candidiasis such as intertrigo, perleche, facial candidiasis, diaper candidiasis, perineal and scrotal candidiasis);
• infections localized in some parts of the male genitals (balanitis, balanoposthitis);
• localized nail infections (onychia and paronychia);
• infection caused by fungi called "pityriasis versicolor" (from Pityrosporum orbiculare and P. ovale );
• ear infections caused by fungi (Candida or mold otomycosis), only if there are no lesions in a part of the ear called the eardrum;
• skin infection called "erythrasma";
• infections caused by fungi (mycosis) which also present bacterial superinfections (from Gram-positive bacteria).

Talk to your doctor if you do not feel better or if you feel worse after a short time 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
Talk to your doctor or pharmacist if:
- you are pregnant or breastfeeding, in both cases Falvin must be used under the supervision of a doctor (see section "Pregnancy, breastfeeding and fertility");
- if you experience any irritation or sensitivity to the product, 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 external use only. Do not apply to mucous membranes or broken/damaged skin. Avoid contact with eyes; if this occurs, 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 poorly absorbed, and no systemic side effects are expected. Prolonged use of topical medications may cause sensitization (see "Warnings and Precautions" section).

The following side effects have been observed with Falvin:

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