Falvin Cutaneous Spray 2% Fenticonazole Nitrate 30ml

NAME
FALVIN CREAM - SKIN SPRAY, SOLUTION

PHARMACOTHERAPEUTIC CATEGORY
Topical antifungals.

ACTIVE PRINCIPLES
Fenticonazole nitrate.

EXCIPIENTS
2% cream: propylene glycol; hydrogenated lanolin; refined almond oil; polyglycol ester of fatty acids; cetyl alcohol; glyceryl monostearate; sodium edetate; purified water. Skin spray, 2% solution: alcohol; propylene glycol; purified water.

INDICATIONS
Dermatomycosis caused by dermatophytes (Trichophyton, Microsporum, Epidermophyton) of different localization: tinea capitis, tinea corporis, tinea cruris, tinea pedis (athlete's foot), tinea manuum, tinea faciei, tinea barbae, tinea unguium; skin candidiasis (intertrigo, perleche, facial candidiasis, diaper, perineal and scrotal candidiasis); balanitis, balanoposthitis; onychia and paronychia; pityriasis versicolor (from Pityrosporum orbiculare and P. ovale); otomycosis (from Candida or from molds), only if there are no lesions of the eardrum; erythrasma; mycosis with bacterial superinfections (from Gram-positive bacteria).

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance or to any of the listed excipients; pregnancy.

DOSAGE
The medicine should be applied 1-2 times a day, according to medical opinion, after washing and drying the injured part, using the formulation suitable for the location of the lesion. 2% cream: it is indicated for the treatment of hairless skin, skin folds and mucous membranes; it is applied by rubbing lightly. The preferential use of the cream is for dry mycoses: pityriasis versicolor, erythrasma, onychomycosis (in onychomycosis the cream should be applied with an occlusive bandage); the cream is suitable for use in male genital mycosis. Skin spray, 2% solution: it is indicated for localizations on the scalp and for skin areas covered with hair. Furthermore, the cutaneous spray solution is easy and convenient to use for extensive mycosis and for areas that are difficult to reach. The drug is not greasy, does not stain and is easily removable with water.

STORAGE
Store below 25 degrees C.

WARNINGS
At the time of application on the lesion, a modest burning sensation may be found which disappears rapidly. The use, especially if prolonged, of products for topical use, can give rise to sensitization phenomena. In this case, stop the treatment and institute appropriate therapy. The cream and skin spray, solution contain propylene glycol. They can cause skin irritation. The cream contains cetyl alcohol. It can cause local skin reactions (eg contact dermatitis). It also contains hydrogenated lanolin. can cause local skin reactions (eg contact dermatitis).

INTERACTIONS
None known.

SIDE EFFECTS
When used as recommended, the drug is only poorly absorbed and no systemic side effects are expected. Prolonged use of topical products can cause sensitization phenomena. Side effects listed below are listed by MedDRA system organ class and frequency: very common (> = 1/10); common (> = 1/100, <1/10); uncommon (> = 1 / 1,000, <1/100); rare (> = 1 / 10,000, <1 / 1,000); very rare (<1 / 10,000); not known. Skin and subcutaneous tissue disorders. Very rare: erythema, pruritus, rash, erythematous rash, skin irritation, skin burning sensation. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

PREGNANCY AND BREASTFEEDING
Although the percutaneous absorption of fenticonazole is rather poor, it is recommended not to use the medicine during pregnancy.