Lomexin 20 mg/g 30 ml cutaneous spray solution

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Lomexin 2% cream, Lomexin 2% skin spray, solution, Lomexin 2% skin solution, Lomexin 1% and 2% skin powder: • 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. – Candidiasis of the skin (intertrigo, perleche, facial candidiasis, "nappy" candidiasis, perineal and scrotal); balanitis, balanoposthitis; onychia and paronychia. – Pityriasis versicolor (from Pityrosporum orbiculare e P. oval). – Otomycosis (from Candida or mold); only if there are no eardrum lesions present. – Erythrasma. – Mycosis with bacterial superinfections (from Gram positive bacteria).

ACTIVE INGREDIENTS

Lomexin 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. Lomexin 2% skin spray, solution 100 ml of solution contains 2 g of fenticonazole nitrate. Excipient with known effects: 100 ml of solution contains 35 g of propylene glycol. Lomexin 2% cutaneous solution 100 ml of solution contains 2 g of fenticonazole nitrate. Excipient with known effects: 100 ml of solution contains 77.50 g of propylene glycol. Lomexin 1% skin powder 100 g of powder contains 1 g of fenticonazole nitrate. Lomexin 2% skin powder 100 g of powder contains 2 g of fenticonazole nitrate. For the full list of excipients, see section 6.1.

EXCIPIENTS

Lomexin 2% cream Propylene glycol Hydrogenated lanolin Refined almond oil Polyglycolic ester of fatty acids Cetyl alcohol Glyceryl monostearate Sodium edetate Purified water. Lomexin 2% skin spray, solution Alcohol Propylene glycol Purified water. Lomexin 2% cutaneous solution Alcohol Hydroxypropyl cellulose Purified water Propylene glycol. Lomexin 1% skin powder Hydrated colloidal silica Zinc oxide Talc. Lomexin 2% skin powder Hydrated colloidal silica Zinc oxide Talc.

CONTRAINDICATIONS AND SIDE EFFECTS

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

DOSAGE

Lomexin should be applied 1-2 times a day, according to the doctor's opinion, after having washed and dried the injured part, using the formulation suitable for the location of the lesion. Lomexin 2% cream – it is indicated for the treatment of hairless skin, skin folds and mucous membranes; it is applied by rubbing lightly. It is used preferentially 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. Lomexin 2% skin spray, solution and 2% skin solution – they are indicated for localizations on the scalp and for skin areas covered by hair. Furthermore, the solution skin spray is easy and convenient to use for extensive mycosis and for difficult to reach areas. Lomexin 1% and 2% skin powder – It is used for athlete's foot and in general for intertriginous areas and moist lesions, both as a single treatment and as a complement to the cream. In foot infections it is recommended to also sprinkle the inside of socks and shoes with Lomexin powder. Lomexin 1% cutaneous powder is indicated for the prophylaxis of reinfections. In athlete's foot and onychomycosis, in order to avoid reinfections, it is advisable to continue the above treatment for one or two weeks after the disappearance of the symptoms. Lomexin is not greasy, does not stain and is easily removable with water.

CONSERVATION

None.

WARNINGS

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

INTERACTIONS

None known.

SIDE EFFECTS

When used as recommended, Lomexin is only poorly absorbed and no systemic side effects are expected. Prolonged use of products for topical use may cause sensitization phenomena (see paragraph 4.4). The table below shows the undesirable effects, listed by system organ class according to MedDRA and by 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 (frequency cannot be estimated from the available data).

Skin and subcutaneous tissue disorders - Frequency: Very rare. Preferred term: Erythema, Pruritus, Rash, Rash erythematous, Skin irritation, Burning sensation of the skin.

Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance 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.

OVERDOSE

No cases of overdose have been reported.

PREGNANCY AND BREASTFEEDING

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

EFFECTS ON DRIVING ABILITY

Lomexin does not affect the ability to drive or use machines.