GlaxoSmithKline (Ireland) Ltd

Betnovate Cream 0.1% w/w

Betamethasone 0.1%^w/_w (as betamethasone valerate).

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

For a full list of excipients, see section 6.1

Cutaneous cream.

A white, homogenous, aqueous based cream.

Betnovate cream is indicated in the topical management of corticosteroid responsive dermatoses such as eczema, including atopic, infantile and discoid eczemas, prurigo nodularis, psoriasis (excluding widespread plaque psoriasis), neurodermatoses, including lichen simplex; lichen planus; seborrhoeic dermatitis; contact sensitivity reactions; discoid lupus erythematosus and they may be used as an adjunct to systemic steroid therapy in generalized erythroderma, insect bite reactions and prickly heat.

A small quantity of Betnovate should be applied to the affected area one to three times daily or as directed by the physician until improvement occurs. It may then be possible to maintain improvement by applying once a day, or even less often. Betnovate Cream is especially appropriate for moist or weeping surfaces and Betnovate Ointment for dry, lichenified or scaly lesions, but this is not invariably so.

In the more resistant lesions, such as the thickened plaques of psoriasis on elbows and knees, the effect of Betnovate 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, primary cutaneous viral infections, perianal and genital pruritus and peri-oral dermatitis.

Use in the presence of untreated infections of bacterial, viral, tuberculous or fungal origin. Use in primary cutaneous viral infections (e.g. herpes simplex, chickenpox). Hypersensitivity to any ingredients of the preparations.

(Dermatoses in children under one year of age, including dermatitis and napkin eruptions). Widespread plaque psoriasis.

Prolonged use of uninterrupted occlusion (including napkins) or use with extensive occlusive dressing may suppress adrenocortical function. Long-term continuous topical therapy should be avoided where possible, particularly in infants and children, as adrenal suppression can occur even without occlusion. Continuous treatment for longer than three weeks should be avoided in patients under the age of three years because of the possibility of adrenocortical suppression and growth retardation.

The face more than any 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 with Betnovate.

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

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.

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

As with other corticosteroids, prolonged use of large amounts or treatment of extensive areas can result in systemic absorption to produce features of hypercorticism.

Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions, which have become infected. Any spread of infection requires withdrawal of topical corticosteroids therapy and systemic administration of antibacterial agents. Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and so the skin should be cleansed before a fresh dressing is applied.

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

None reported.

Animal studies have shown teratogenic effects. To date similar effects have not been shown to occur in man. These products should not be used during pregnancy or lactation unless considered essential by the physician.

None reported.

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (1/10), common (1/100 and <1/10), uncommon (1/1000 and <1/100), rare (1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports. Very common, common and uncommon events were generally determined from clinical trial data. The background rates in placebo and comparator groups were not taken into account when assigning frequency categories to adverse events derived from clinical trial data, since these rates were generally comparable to those in the active treatment group. Rare and very rare events were generally determined from spontaneous data.

Immune system disorders

Very rare: *Hypersensitivity.

If signs of *hypersensitivity appear, application should stop immediately.

Endocrine disorders

Very rare: *Features of hypercortisolism.

*As with other corticosteroids, prolonged use of large amounts or treatment of extensive areas, can result in sufficient systemic absorption to produce the *features of hypercortisolism. This 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.

Vascular disorders

Very rare: *Dilatation of the superficial blood vessels.

*Prolonged and intensive treatment with highly active corticosteroid preparations may cause *dilatation of the superficial blood vessels, particularly when occlusive dressings are used or when skin folds are involved.

Skin and subcutaneous tissue disorders

Common: *Local skin burning and *pruritus.

Very rare: *Thinning, *striae, *pigmentation changes, *hypertrichosis, allergic contact dermatitis, pustular psoriasis, *exacerbation of symptoms.

*Prolonged and intensive treatment with highly active corticosteroid preparations may cause *local atrophic changes in the skin such as *thinning, and *striae, particularly when occlusive dressings are used or when skin folds are involved.

In very rare instances, treatment of psoriasis with corticosteroid (or its withdrawal) is thought to have provoked the pustular form of the disease.

Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse, the features of hypercorticisolism 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

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 additional data.

Chlorocresol

Macrogol cetostearyl ether

Cetostearyl Alcohol

White Soft paraffin

Liquid Paraffin

Sodium Dihydrogen Phosphate Dihydrate

Phosphoric Acid (for pH adjustment),

Sodium Hydroxide (for pH adjustment),

Purified water

None Known

3 years.

Do not store above 25°C.

30 g and 100g collapsible aluminium tubes

Not all pack sizes may be marketed

No special instructions.

GlaxoSmithKline (Ireland) Limited

Stonemasons Way,

Rathfarnham,

Dublin 16.

PA 1077/1/1

13^th December 1983 / 13^th December 2008

October 2009