Lomexin 20 mg/g 30 ml cutaneous spray solution

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 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).

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS FOR USE

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).

Classification by systems and organs | Frequency | Preferred term

Skin and subcutaneous tissue disorders | Very rare | 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.