CANESPOR Cream Ref.[50290] Active ingredients: Bifonazole

Patients with a history of hypersensitivity reactions to other imidazole antifungal agents (e.g. econazole, clotrimazole, miconazole) must take bifonazole containing products with caution.

Antimycotic treatment of the skin of the nail bed with Canespor Cream can only be carried out after keratolytic removal of the infected nail.

If symptoms worsen or persist after the recommended duration of treatment, medical advice should be sought.

This product contains benzyl alcohol which may cause mild local irritation.

This product contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).

Patients on warfarin therapy should be monitored when bifonazole is used concomitantly (see section 4.5).

Diabetic patients should seek medical advice before using Canespor Cream due to the potential risk of a more severe course of infection.

Do not use occlusive bandages in the affected skin area after the application of Canespor 10mg/g Cream.

Absorption of orally administered imidazole antimycotics may lead systemic toxicity. Studies with bifonazole suggest a low level of absorption after topical application to healthy skin. The preparation should only be used with care on areas of denuded or broken skin.

Avoid contact with the eyes. Do not swallow.

Limited data suggest that an interaction between topical bifonazole and warfarin may be possible, leading to increases in INR. If Canespor Cream is used in a patient on anticoagulant therapy, such as warfarin, caution should be exercised and the anticoagulant effect should be monitored (see section 4.4).

Pregnancy

There are no or limited amount of data from the use of bifonazole in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Canespor cream is not recommended during pregnancy and in women of childbearing potential not using contraception.

Breast-feeding

It is unknown whether bifonazole is excreted in human milk. Available pharmacodynamic/ toxicological data in animals have shown excretion of bifonazole/metabolites in milk (for details see 5.3). A risk to newborns/infants cannot be excluded. Canespor 10 mg/g Cream should not be used during breast-feeding.

Fertility

Preclinical studies gave no evidence that bifonazole can impair male or female fertility (see section 5.3).

Canespor Cream has no or negligible influence on the ability to drive or use machines.

Frequencies of side-effects observed in clinical studies are defined according to the MedDRA frequency convention: 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). The adverse reactions designated as frequency ‘not known’ have been identified during post-approval use of bifonazole. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.

General disorders and administration site conditions

Uncommon: localized oedema (peripheral)

Not known: administration site pain

Immune system disorders

Not known: allergic dermatitis/hypersensitivity

Skin and subcutaneous tissue disorders

Very common: burning skin/burning sensation.

Uncommon: erythema, eczema, (skin) irritation and pruritus.

Not known: dermatitis contact, rash, urticaria, blister, skin exfoliation, dry skin, skin maceration.

These side effects are generally reversible after discontinuation of the treatment.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

Not applicable.