GlaxoSmithKline (Ireland) Ltd

Betnovate Scalp Application 0.1% w/w Cutaneous Solution

Contains Betamethasone Valerate equivalent to 0.1%^w/_w Betamethasone.

For a full list of excipients, see section 6.1

Cutaneous solution.

A colourless, hazy slightly viscous liquid.

Betamethasone valerate is a topical corticosteroid used in the management of steroid-responsive dermatoses of the scalp, such as psoriasis, seborrhoea capitis and inflammation associated with severe dandruff.

A small quantity of Betnovate Scalp Application should be applied to the scalp night and morning until improvement is noticeable. It may then be possible to sustain improvement by applying once a day, or even less frequently.

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

Hypersensitivity to the preparation.

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

Use in acne vulgaris, rosacea or in perioral dermatoses.

Prolonged use of uninterrupted occlusion (including napkin) or use with extensive occlusive dressings may suppress adrenocortical function.

Continuous treatment for longer than three weeks on use of occlusion (including napkins) should be avoided in patients under the age of three years because of the possibility of adrenocortical suppression or of growth suppression, systemic absorption and hypercorticism.

Care must be taken to keep the preparation away from the eyes.

Do not use near a naked flame.

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

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

Topical corticosteroids may be hazardous in psoriasis for a number of reasons, including rebound relapses, development of tolerances, risk of generalised 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.

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.

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.

None reported.

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 in pregnancy or lactation unless considered essential by the physician and only for the shortest period possible.

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

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

Endocrine disorders

*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.

Skin and subcutaneous tissue disorders

*Local atrophy may occur after prolonged treatment.

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 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 metabolized primarily by the liver and are then excreted by the kidneys.

No additional data.

Carbomer

Isopropyl Alcohol

Sodium Hydroxide (For Ph adjustment)

Purified water

None known

2 years.

Do not store above 25°C. Store in the original package.

Betnovate Scalp Application is supplied in polyethylene bottles and nozzles with caps of 30ml and 100ml.

Not all pack sizes may be marketed

No special requirements

GlaxoSmithKline (Ireland) Limited

Stonemasons Way,

Rathfarnham,

Dublin 16

PA 1077/1/3

5 March 1984 / 5 March 2009

July 2009