Canesten 1% 30g cream

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

INDICATIONS

Cream and skin spray solution Mycosis of the skin and skin folds, such as pityriasis versicolor, cutaneous candidiasis, tinea pedis or athlete's foot, tinea corporis. Skin dust Topical treatment of moist mycoses of the skin and skin folds, especially if located in covered or poorly ventilated areas (for example: tinea pedis or athlete's foot, tinea cruris, tinea inguinalis).

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS FOR USE

Avoid contact with eyes. Do not ingest. The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. In this case, you must stop treatment and consult your doctor or pharmacist. In diaper rash, the use of diapers with an occlusive effect after applying the drug is not recommended. In case of relapses, consult your doctor. After three to four weeks of continuous use without appreciable results, consult your doctor. Canesten skin spray solution: avoid spraying in the eyes. Important information about some excipients Canesten cream contains: • cetostearyl alcohol which can cause local skin reactions (e.g. contact dermatitis); • 20 mg/g of benzyl alcohol: - may cause allergic reactions; - may cause mild local irritation. Canesten Spray 1% cutaneous solution (multidose container with dosing pump) contains 546 mg/ml of propylene glycol: - may cause skin irritation. Because this medicine contains propylene glycol, do not use it on open wounds or large areas of damaged skin (such as burns) without talking to your doctor or pharmacist.

INTERACTIONS

No notes

SIDE EFFECTS

The following adverse reactions have been identified since the approval of clotrimazole. Since these reactions derive from spontaneous reports from a population of uncertain size, the frequency cannot be defined on the basis of the available data. Immune system disorders: angioedema, anaphylactic reaction, hypersensitivity Vascular pathologies: hypotension, syncope. Respiratory, thoracic and mediastinal disorders: dyspnoea Skin and subcutaneous tissue disorders: blisters, contact dermatitis, erythema, paraesthesia, peeling of the skin, itching, rash, urticaria, stinging skin pain, burning sensation of the skin. Systemic disorders and conditions relating to the administration site: application site irritation, application site reaction, edema, pain. 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 reaction via the national reporting system of the Italian Medicines Agency Website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.