Canesten Unidie 1% cream 30g

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

INDICATIONS

Treatment of dermatomycosis caused by dermatophytes, saccharomyces, other pathogenic fungi: mycosis of the foot and hand, mycosis of the trunk (tinea corporis), mycosis of the skin folds (tinea inguinalis), onychomycosis, pityriasis versicolor, superficial candidiasis.

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients, listed in paragraph 6.1.

WARNINGS AND PRECAUTIONS FOR USE

The use, especially if prolonged, of products for topical use, can give rise to sensitization phenomena which manifest themselves with redness and itching; in this case, it is necessary to interrupt treatment and institute appropriate therapy. The same will be done in the event of the development of resistant microorganisms. Patients with known hypersensitivity reactions to other imidazole antifungals (e.g. econazole, clotrimazole, miconazole) should use medicinal products containing bifonazole with caution. Canesten Unidie contains cetylstearyl alcohol: may cause local skin reactions (e.g. contact dermatitis). Canesten Unidie contains sorbitan monostearate: may cause local skin reactions (e.g. contact dermatitis). Canesten Unidie contains 20mg/g benzyl alcohol: - may cause allergic reactions; - may cause mild local irritation. Canesten Unidie contains polysorbate 60: may cause local skin reactions (e.g. contact dermatitis). Avoid contact with eyes. Do not ingest

INTERACTIONS

The available data suggest a possible interaction between topical bifonazole and warfarin with an increase in prothrombin time. If Canesten Unidie is used in patients receiving warfarin therapy, they should be monitored appropriately.

SIDE EFFECTS

The following adverse reactions derive from spontaneous post-marketing reports and it is not possible to define their frequency. Systemic pathologies and conditions relating to the administration site Pain at the administration site, peripheral edema (at the administration site). Pathologies of the skin and subcutaneous tissue Contact dermatitis, allergic dermatitis, erythema, pruritus, rash, urticaria, blisters, skin exfoliation, eczema, dry skin, skin irritation, skin maceration, burning sensation. These side effects are reversible after discontinuation of treatment. 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.