BREVOXYL Cream Ref.[6450] Active ingredients: Benzoyl peroxide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Beecham Group PLC trading as Stiefel, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Therapeutic indications

Brevoxyl is indicated for the treatment of moderate acne vulgaris.

Posology and method of administration

Adolescents and Adults

Apply a thin film to the whole of the affected area once or twice daily, preferably after washing and drying the skin. The patient should start with one application daily, preferably in the evening, and then gradually increase to two times daily (morning and evening) if tolerated.

If excessive dryness or peeling occurs, frequency of application should be reduced or application temporarily interrupted at the physicians instructions or according to patient tolerability.

Improvement can generally be seen after 4-6 weeks of treatment. However, longer use may be necessary.

Maximum lesion reduction may be expected after approximately eight to twelve weeks of drug use. Continued use is normally required to maintain a clinical response.

Paediatric population

The safety and efficacy of Brevoxyl has not been established in children under the age of 12 since acne vulgaris rarely presents in this age group.

Overdose

Topically applied benzoyl peroxide is not generally absorbed in sufficient amounts to produce systemic effects.

Excessive application may result in severe irritation. In this event, discontinue use and wait until the skin has recovered.

Cold compresses can provide relief from irritation due to excessive application.

Accidental ingestion of topical benzoyl peroxide should be managed clinically or as recommended by the National Poisons Centre, where available.

Shelf life

Shelf life: 18 months.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Lacquered aluminium or laminated tubes with white polypropylene or polyethylene screw caps.

Pack sizes: 5g, 6g, 15g, 30g, 40g and 50g.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

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