SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Canesten Bifonazole Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

The cream contains 1% w/w bifonazole.

For full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Cream

A white cream.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Bifonazole is a broad spectrum antifungal agent.

It is indicated for the treatment of fungal skin infections due to dermatophytes (e.g. Trichophyton species), yeasts (e.g. candida species), moulds and other fungi. These include ringworm (tinea) infections, athlete's foot, pityriasis versicolor.

The preparation is not for vaginal use.

4.2 Posology and method of administration

For cutaneous use.

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.

4.3 Contraindications

History of hypersensitivity to imidazole antifungal agents or any of the excipients. Treatment of infants with nappy rash.

4.4 Special warnings and precautions for use

None stated.

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

None known.

4.6 Pregnancy and lactation

After oral administration to animals at high doses, bifonazole was not teratogenic, but embryotoxic and foetotoxic effects were observed. Bifonazole cream for topical administration should not normally be used in pregnancy. As no information is available on the effect of bifonazole on lactation, it should not be used in nursing mothers.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Skin reactions (usually transient slight irritation, reddening, peeling or burning) occur frequently (more than 1.0%). The development of contact dermatitis has been reported infrequently (more than 0.1%). These side-effects are reversible after discontinuation of the treatment.

Very rarely, systemic hypersensitivity reactions may occur.

4.9 Overdose

In the event of accidental oral ingestion, routine measures such as gastric lavage should be performed as soon as possible after ingestion.

5.1 Pharmacodynamic properties

ATC code: D01AC10 Antifungals for Topical Use

Bifonazole is a broad spectrum imidazole antifungal agent. It is effective against dermatophytes, yeasts, moulds and other fungi.

5.2 Pharmacokinetic properties

After a single application (topical) of 15.2mg [¹⁴C] bifonazole cream, and subsequent occlusion for six hours, 0.6±0.3% of the dose was absorbed. The absorption rate was approximately 0.008mg/100cm² per hour. In inflamed skin these values were higher by a factor of four. Similar results were obtained after the application of bifonazole as a 1% solution.

Plasma levels up to 16ng/ml were obtained in babies with nappy rash after a single 5g application of the cream.

After intravenous administration of 0.016mg/kg [¹⁴C] bifonazole, tissue uptake was rapid. Bifonazole is, however, rapidly metabolised with only 30% of an intravenous dose remaining unaltered 30 minutes post-dose.

Elimination of the metabolites is biphasic (T._/2 of eight and 50 hours). Within five days of administration 45% of the administered dose has been excreted renally, with 40% being eliminated via the liver and bile (faeces).

5.3 Preclinical safety data

Toxicological studies showed good local tolerability. However, for bifonazole cream and solution slight skin irritant effects were observed which could be attributed to the additives 2-octyldodecanol (cream) and isopropyl myristate (solution), respectively. There were no indications of changes caused specifically by the active substance, and no signs of any systemic effects were observed. Studies on reproductive toxicity showed no evidence of teratogenic activity, however embryotoxic effects were seen in rabbits at high oral doses (30mg/kg bodyweight). Bifonazole had no influence on fertility and showed no mutagenic properties.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sorbitan stearate Polysorbate 60

Cetyl palmitate Cetostearyl alcohol 2-Octyldodecanol Benzyl alcohol Purified Water

6.2 Incompatibilities

None known.

6.3 Shelf life

60 months.

6.4    Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5    Nature and contents of container

Aluminium tubes containing 15g and 50g of cream.

6.6 Special precautions for disposal

No special requirements.

MARKETING AUTHORISATION HOLDER

Bayer plc

Consumer Care Division Bayer House Strawberry Hill Newbury Berkshire

RG14 1JA.

MARKETING AUTHORISATION NUMBER(S)

PL 00010/0616

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

06/07/2009

10    DATE OF REVISION OF THE TEXT

21/05/2010