Stiefel Ireland

Brevoxyl 4% cream

1g cream contains 40mg benzoyl peroxide (4 % w/w) as hydrous benzoyl peroxide.

The cream also contains the following excipients:

For a full list of excipients, see section 6.1

Cream

A white to off white cream

Brevoxyl is indicated for the treatment of mild to moderate acne vulgaris.

Adolescents and Adults

Apply to the whole of the affected area once or twice daily. Wash with soap and water prior to application.

Paediatric use

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

Elderly patients

There are no specific recommendations. Acne vulgaris does not present in the elderly.

Initial application of the product may be varied at the physician's instructions to reflect the patient's skin type and to avoid undesirable effects.

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

Patients with known hypersensitivity to any of the ingredients should not use this product.

Avoid contact with the eyes, mouth and other mucous membranes. Care should be taken when applying the product to the neck and other sensitive areas. Propylene glycol alginate may cause skin irritation. Stearyl alcohol and cetyl alcohol may cause local skin reaction (e.g. contact dermatitis).

It is recommended that exposure to sun or sunlamps should be minimised.

Simultaneous use of other keratolytics such as salicylates or sulphur may increase occurrence of skin irritation.

During the first weeks of treatment, a sudden increase in peeling and reddening will occur in most patients; this is not harmful and will normally subside in a day or two if treatment is temporarily discontinued.

The product may bleach coloured or dyed fabrics.

Simultaneous application of Brevoxyl and topical acne preparations containing vitamin A derivatives should be avoided.

The safety of benzoyl peroxide in human pregnancy is not established. During pregnancy and lactation Brevoxyl should be used only with special caution and after the physician's assessment of benefit and risk. In the last month of pregnancy Brevoxyl should not be used.

There is no knowledge about the excretion of Brevoxyl in breast milk.

None.

In normal use, a mild burning sensation will probably be felt on first application and a moderate reddening and peeling of the skin will occur within a few days. During the first few weeks of treatment a sudden increase in peeling will occur in most patients; this is not harmful and will normally subside in a day or two if treatment is temporarily discontinued. The patient may also experience temporary pruritus, facial oedema, dermatitis or rash. As for other benzoyl peroxide preparations allergic contact dermatitis could occasionally occur.

Not applicable.

Benzoyl peroxide has antibacterial activity against Propionibacterium acnes, the organism implicated in acne vulgaris. It has keratolytic activity and is sebostatic, counteracting the hyperkeratinisation and excessive sebum production associated with acne.

After topical application, benzoyl peroxide is absorbed in varying quantities through the skin of man and animals.

Radio-labelled studies have shown that absorption of benzoyl peroxide through the skin can only occur following its conversion to benzoic acid. Benzoic acid is mostly conjugated to form hippuric acid which is excreted via the kidneys.

Animal toxicity studies of benzoyl peroxide have shown that the compound is non-toxic when applied topically.

Benzoic acid, to which benzoyl peroxide is converted prior to absorption, has a wide margin of safety. Benzoic acid is an approved food additive.

Benzoyl peroxide is a free radical generating compound. The release of oxygen during its conversion to benzoic acid may be implicated in a tumour promoting effect seen in mouse skin.

Benzoyl peroxide at high doses (>20 times the normal human dose) has been shown to increase the tumour growth initiated by dimethyl benzanthracene (DMBA) in mice. DMBA is a powerful chemical carcinogen to which patients are unlikely to be exposed. The relevance of these results to man is limited. Studies in mice have also shown that benzoyl peroxide does not increase the growth of tumours initiated by ultra violet light.

No reproductive toxicology studies have been performed. Up to date there are no indications that the topical use of Brevoxyl causes damage to the unborn child.

Cetyl alcohol

Promulgen G (which consists of stearyl alcohol and macrogol cetostearyl ether)

Simethicone emulsion

Propylene glycol alginate

Dimethyl isosorbide

Fragrance X-23304

Purified water

None.

18 months

Do not store above 25°C.

Lacquered aluminium or laminated tubes with white polypropylene screw caps

Pack size: 40g

No special requirements

GlaxoSmithKline (Ireland) Ltd

Stonemasons Way

Rathfarnham

Dublin 16

Ireland

Trading as Stiefel

PA 1077/119/001

27 May 2011