4.1. Therapeutic indications

Treatment of athlete's foot.

The preparation is not for vaginal use.

4.2. Posology and method of administration

The cream should be thinly applied and rubbed into the affected areas once daily, preferably at night before retiring, for two to three weeks.

The affected areas should be washed and dried thoroughly before the cream is applied.

A physician or pharmacist should be consulted if symptoms do not improve within seven days.

4.3. Contraindications

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

Treatment of infants with nappy rash.

Treatment of nail and scalp infections.

4.4. Special warnings and precautions for use

This product contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis). The cream also contains benzyl alcohol which may cause allergic reactions and mild local irritation.

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.

4.5. Interaction with other medicinal products and other forms of interaction

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.

4.6. Fertility, pregnancy and lactation

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).

4.7. Effects on ability to drive and use machines

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

4.8. Undesirable effects

• 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

No risk of acute intoxication is seen as it is unlikely to occur following a single dermal application of an overdose (application over a large area under conditions favorable to absorption) or inadvertent oral ingestion.

However, in the event of accidental oral ingestion, routine measures such as gastric lavage should be performed only if clinical symptoms of overdose become apparent (e.g. dizziness, nausea or vomiting). Gastric lavage should be carried out only if the airway can be protected adequately.