GlaxoSmithKline (Ireland) Ltd

Betnovate-C 0.1% / 3% w/w Cream

Betamethasone 0.1% w/w (as betamethasone Valerate)

Clioquinol 3% w/w

Also contains chlorocresol 0.1% w/w and Cetostearyl alcohol 7.2% w/w

For a full list of excipients, see section 6.1

Cream.

A pale yellow, homogenous aqueous based cream.

Betnovate-C cream is indicated in the management of corticosteroid sensitive dermatoses, actually or potentially complicated by infection due to micro-organisms sensitive to the anti-infective contained therein.

A small quantity should be applied gently to the affected area two or three times daily until improvement occurs. It may then be possible to maintain improvement by applying once a day or even less often. Betnovate-C Cream is often appropriate for moist or weeping surfaces.

In the more resistant lesions, such as the thickened plaques of psoriasis on elbows and knees, the effect of Betnovate-C can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response in such lesions. Thereafter, improvement can usually be maintained by regular application without occlusion.

Rosacea, acne vulgaris and peri-oral dermatitis. Perianal and genital pruritus primary cutaneous viral infections (e.g. herpes simplex, chicken pox)

Use in the presence of untreated infections of bacterial, viral, tubercular or fungal origin.

Hypersensitivity to any component of the preparation or to iodine.

Dermatoses in children under one year of age, including dermatitis and napkin eruptions.

Long-term continuous topical therapy should be avoided where possible, particularly in infants and children, as adrenal suppression can occur even without occlusion.

The face, more than other areas of the body, may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids. This must be borne in mind when treating such conditions as psoriasis, discoid lupus erythematosus and severe eczema.

If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as glaucoma might result.

Topical corticosteroids may be hazardous in psoriasis for a number of reasons, including rebound relapses, development of tolerance, risk of generalized pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis, careful patient supervision is important.

If infection persists, systemic chemotherapy is required. Any spread of infection requires withdrawal of topical corticosteroid therapy.

Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and the skin should be cleansed before a fresh dressing is applied.

Products which contain antimicrobial agents should not be diluted.

Betnovate-C may stain hair, skin or fabric and the application should be covered with a dressing to protect clothing.

There have been a few reports in the literature of the development of cataracts in patients who have been using corticosteroids for prolonged periods of time. Although it is not possible to rule out systemic corticosteroids as a known factor, prescribers should be aware of the possible role of corticosteroids in cataract development.

There is a theoretical risk of neurotoxicity from the topical application of clioquinol, particularly when Betnovate C is used for prolonged periods or under occlusion.

None known.

Topical corticosteroids have induced teratogenic effects in animals. Similar effects have not been conclusively demonstrated with use during pregnancy in human beings.

However, this product should not be used during pregnancy or lactation unless considered essential by the physician and only for the shortest period possible.

None known.

Prolonged use of an anti-infective may result in the development of superinfection due to organisms, including fungi, resistant to that anti-infective. Prolonged and intensive treatment with highly active corticosteroid preparations may cause local atrophic changes in the skin such as thinning, striae, and dilation of the superficial blood vessels, particularly when occlusive dressings are used or when skin folds are involved.

The anti-infective present may be toxic if absorbed from open surfaces.

As with other topical corticosteroids, prolonged use of large amounts, or treatment of extensive areas, can result in sufficient systemic absorption to produce the features of hypercorticism. The effect is more likely to occur in infants and children, and if occlusive dressings are used. In infants the napkin may act as an occlusive dressing. In rare instances, treatment of psoriasis with corticosteroids (or its withdrawal) is thought to have provoked the pustular form of the disease.

The Betnovate preparations are usually well tolerated, but if signs of hypersensitivity appear, application should stop immediately.

There are reports of local skin burning, pruritus, pigmentation changes, hypertrichosis and allergic contact dermatitis with topical steroids. Exacerbation of symptoms may occur

Acute overdosage is very unlikely to occur. However, in the case of chronic overdosage or misuse, the features of hypercorticism may appear and in this situation topical steroids should be discontinued gradually under medical supervision because of the risk of adrenal insufficiency.

Betamethasone valerate is an active corticosteroid with topical anti-inflammatory activity.

Clioquinol is an anti-infective agent which has both anti-bacterial and anti-fungal activity.

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings on the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids.

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systematically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolised primarily by the liver and are then excreted by the kidneys.

No further data.

Chlorocresol,

Cetomacrogol 1000,

Cetostearyl Alcohol,

White Soft Paraffin,

Liquid Paraffin,

Sodium Dihydrogen Phosphate dihydrate,

Phosphoric Acid (for pH adjustment),

Sodium Hydroxide (for pH adjustment),

Purified Water

Not applicable

3 years.

Do not store above 30^oC.

Betnovate-C cream is supplied in 30g collapsible aluminium tubes.

No special requirements

GlaxoSmithKline (Ireland) Limited,

Stonemasons Way,

Rathfarnham,

Dublin 16,

Ireland

PA 1077/2/1

27^th October 1983 / 27^th October 2008

October 2009