LOMEXIN * NEBUL FL 30ML 2%
Therapeutic indications
Lomexin 2% cream, Lomexin 2% cutaneous spray, solution, Lomexin 2% cutaneous solution, Lomexin 1% and 2% cutaneous 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. - 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 molds); only if no eardrum lesions are present. - Erythrasma. - Mycosis with bacterial superinfections (from Gram positive bacteria).
Dosage and method of use
Lomexin 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. 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 preferably used 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% cutaneous spray, solution and 2% cutaneous solution - they are 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. Lomexin 1% and 2% cutaneous powder - it is used for athlete's foot and in general for intertriginous areas and wet lesions, both as a single treatment and as a complement to the cream. In foot infections it is recommended to 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 reinfection, it is advisable to continue the above treatment for one or two weeks after the symptoms have disappeared.Lomexin 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, Lomexin 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 reactionsReporting 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 systemwww.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:Lomexin 2% cream, Lomexin 2% cutaneous spray, solution, Lomexin 2% cutaneous 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).
Pregnancy and breastfeeding
Although the percutaneous absorption of fenticonazole is rather poor, it is recommended not to use the medicine during pregnancy.
Expiry and retention
None.
Interactions with other drugs
None known.
Overdose
No cases of overdose have been reported.
Active principles
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% 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. Lomexin 2% cutaneous solution 100 ml of solution contain 2 g of fenticonazole nitrate. Excipient with known effects: 100 ml of solution contain 77.50 g of propylene glycol. Lomexin 1% cutaneous powder 100 g of powder contains 1 g of fenticonazole nitrate. Lomexin 2% cutaneous 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% cutaneous spray, solution Alcohol Propylene glycol Purified water. Lomexin 2% cutaneous solution Alcohol Hydroxypropylcellulose Purified water Propylene glycol. Lomexin 1% cutaneous powder Colloidal silica hydrates Zinc oxide Talc. Lomexin 2% cutaneous powder Colloidal silica hydrates Zinc oxide Talc.