Trosyd 1 % 30 g skin emulsion

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

TROSYD 1% Cream - 1% Skin powder - 1% Skin emulsion Dermatomycosis caused by dermatophytes, yeasts and other fungi sensitive to tioconazole. Skin infections caused by drug-sensitive Gram-positive bacteria. Due to the concomitant antifungal and antibacterial activity, it is particularly indicated in mixed skin infections. TROSYD 28% Cutaneous solution for nail use Onychomycosis caused by dermatophytes and yeasts. Due to the concomitant antibacterial activity, it is particularly indicated in mixed nail infections. TROSYD 1% Cutaneous solution Topical antifungal treatment of skin infections caused by fungi (dermatophytes and yeasts), even if associated with superinfections by Gram-positive bacteria sensitive to the medicine, as an adjunct to therapy with other specific topical preparations. The cutaneous solution allows greater ease of application in more extensive dermatomycosis and provides a medicated cleansing of glabrous or hairy skin. Furthermore, by allowing the treatment of a large skin surface, it makes it possible to eliminate the pathogen not only where morphological skin changes are detectable but also where the skin is apparently healthy.

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the other components of this medicinal product listed in section 6.1. Trosyd 28% Cutaneous solution for nail use is contraindicated in pregnancy (see section 4.6).

WARNINGS AND PRECAUTIONS FOR USE

The application of topical medicines, especially if prolonged, can give rise to sensitization phenomena. Important information on some excipients: TROSYD 1% Cream and 1% Skin Emulsion contain cetostearyl alcohol which can cause local skin reactions (e.g. contact dermatitis). TROSYD 1% Skin emulsion contains 175 mg propylene glycol in 2.5 g of emulsion equivalent to 70 mg/g. Propylene glycol may cause skin irritation. TROSYD 1% Cream and 1% Emulsion each contain 25 mg benzyl alcohol in 2.5 g of product equivalent to 10 mg/g. Benzyl alcohol may cause allergic reactions and may cause mild local irritation.

INTERACTIONS

No interactions or incompatibilities with other medicines are known so far.

SIDE EFFECTS

In very rare cases, mild and transient local irritation has been observed. However, in the presence of hypersensitivity reactions, treatment should be discontinued and appropriate therapy instituted. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse