FALVIN * SPRAY CUT 30ML 2%

  • Recordati Industria Chimica e Farmaceutica S.p.A.
  • 025982051

Skin spray with antifungal and antibacterial action.

Fenticonazole-based spray.

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FALVIN * SPRAY CUT 30ML 2%

Therapeutic indications

Falvin 2% cream, Falvin 2% cutaneous spray, solution: - Dermatomycosis due to dermatophytes (Trichophyton, Microsporum, Epidermophyton) at different locations: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 (fromPityrosporum orbiculareAndP. ovale). - Otomycosis (from Candida or mold), only if there are no lesions of the eardrum. - Erythrasma. - Mycosis with bacterial superinfections (from Gram-positive bacteria).

Dosage and method of use

Falvin should be applied 1-2 times a day, according to the doctor's opinion, after washing and drying the injured part, using the formulation suitable for the location of the lesion. Falvin 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. Falvin 2% cutaneous spray, solution - it is indicated for locations 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.Falvin is non-greasy, non-staining and can be easily removed with water.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Pregnancy (see section 4.6).

Side effects

When used as recommended, Falvin is only poorly absorbed and no systemic side effects are expected. Prolonged use of topical products can cause sensitization phenomena (see section 4.4). Undesirable effects are presented in the table below, listed by MedDRA system organ class and frequency: very common (≥1 / 10); common (≥1 / 100,

System and organ classification Frequency Preferred term
Skin and subcutaneous tissue disorders Very rare Erythema, Pruritus, Rash, Erythematous rash, Skin irritation, Skin burning sensation
Reporting of suspected adverse reactions

Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Special warnings

At the time of application on the lesion, a modest burning sensation may be found which disappears quickly. The use, especially if prolonged, of products for topical use, can give rise to sensitization phenomena. In this case, stop the treatment and consult your doctor to establish a suitable therapy.Important information about some of the ingredients:Falvin 2% cream and Falvin 2% cutaneous spray, solution contain propylene glycol. They can cause skin irritation. Falvin 2% cream contains cetyl alcohol. May cause local skin reactions (e.g. contact dermatitis). Falvin 2% cream contains hydrogenated lanolin. can cause local skin reactions (eg contact dermatitis).

Pregnancy and breastfeeding

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

Expiration and retention

Store at a temperature below 25 ° C.

Interactions with other drugs

None known.

Overdose

No cases of overdose have been reported.

Active principles

Falvin 2% cream 100 g of cream contains 2 g of fenticonazole nitrate. Excipients with known effects: 100 g of cream contain 5 g of propylene glycol, 3 g of cetyl alcohol, 1 g of hydrogenated lanolin. Falvin 2% cutaneous spray, solution 100 ml of solution contain 2 g of fenticonazole nitrate. Excipient with known effects: 100 ml of solution contain 35 g of propylene glycol. For the full list of excipients, see section 6.1.

Excipients

Falvin 2% cream Propylene glycol Hydrogenated lanolin Refined almond oil Polyglycolic ester of fatty acids Cetyl alcohol Glyceryl monostearate Sodium edetate Purified water. Falvin 2% cutaneous spray, solution Alcohol Propylene glycol Purified water.

Data sheet

Packaging
2% cutaneous spray bottle 30 ml
Product Type
HUMAN DRUG
ATC code
D01AC12
ATC description
Fenticonazole
Therapeutic Group
Antifungals
Active principle
fenticonazole nitrate (FU)
Class
C.
Pharmaceutical form
spray
Type of Administration
topical
Container
spray / can
Quantity
1 spray
Capacity
30 milliliters
Quantity of the Active Ingredient
20MG
Recipe required
SOP - non-prescription medicine
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