CANESPOR Cream Ref.[50290] Active ingredients: Bifonazole

Source: Health Products Regulatory Authority (IE)  Revision Year: 2018  Publisher: Bayer Limited, The Atrium, Blackthorn Road, Dublin 18, Ireland

4.1. Therapeutic indications

Canespor 10mg/g Cream is indicated in adults for the treatment of tinea pedis including treatment of an exposed nailbed following keratolytic removal of the nail.

4.2. Posology and method of administration

Posology

To achieve a lasting cure, treatment with Canespor Cream must be carried out reliably and over an adequate period.

The usual periods of treatment are summarized in the table below:

IndicationDuration of treatment
Tinea pedis (Athlete’s Foot)) 3 weeks
Antimycotic treatment of the nail bed after keratolytic removal of the nail4 weeks

Paediatric population

Canespor Cream should only be used on infants and children under medical supervision.

Method of administration

Canespor Cream is used once a day, preferably in the evening, before retiring. It should be applied thinly to the affected skin area and rubbed in gently.

A small amount of cream is generally sufficient to treat an area of about the size of the palm of hand.

4.9. Overdose

Absorption of orally administered imidazole antimycotics may lead to 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.

6.3. Shelf life

5 years.

After opening, Canespor Cream can be used for up to 16 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 tube with inner lacquer (epoxy phenolic resin) and polyethylene (PE) screw cap. A membrane is also included to guarantee the first opening of the tube.

Pack sizes of 20 g or 30 g.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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