CANESTEN BIFONAZOLE ONCE DAILY Cream Ref.[6518] Active ingredients: Bifonazole Clotrimazole

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

If unsure of diagnosis, the patient should seek the advice of a doctor or pharmacist before using this product.

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

Limited data suggest that an interaction between topical bifonazole and warfarin may be possible, leading to increases in INR. If bifonazole is used in a patient on warfarin therapy they should be appropriately monitored.

Closer monitoring may be required in cases of occlusion and/or application to a large surface area or to broken and damaged skin.

Pregnancy

There are no clinical data from the use of bifonazole in pregnant women. Studies in animals have shown reproductive toxicity at high oral doses (see section 5.3) however these effects should not be anticipated at the low systemic exposures observed following topical bifonazole administration (see section 5.2).

Bifonazole should only be used during pregnancy after an evaluation by a doctor of the benefit to the patient and the risk to the fetus.

Lactation

It is unknown whether bifonazole is excreted in human breast milk after topical application.

Bifonazole is excreted in milk after intravenous administration in animals (see section 5.3).

A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue bifonazole therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

During the lactation period bifonazole should not be applied to the chest area.

Fertility

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

Bifonazole cream has no or negligible influence on the ability to drive or use machines.

Immune system disorders: Very rarely, systemic hypersensitivity reactions may occur.

The following adverse drug reactions are based on spontaneous reports, thus the frequency of individual events is not known (cannot be estimated from data).

General disorders and administration site conditions: Administration site pain, oedema peripheral (at administration site).

Skin and subcutaneous tissue disorders: Dermatitis contact, dermatitis allergic, erythema, pruritus, rash, urticaria, blister, skin exfoliation, eczema, dry skin, skin irritation, skin maceration, skin burning sensation.

These side effects are 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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

None known.