DERMOVATE Scalp application Ref.[2666] Active ingredients: Clobetasol propionate

Clobetasol propionate belongs to the most potent class of topical corticosteroids (Group IV) and prolonged use may result in serious undesirable effects (see section 4.4). If treatment with a local corticosteroid is clinically justified beyond 4 weeks, a less potent corticosteroid preparation should be considered. Repeated but short courses of clobetasol propionate may be used to control exacerbations (see details below).

Route of administration: Topical, on the scalp.

Owing to the flammable nature of the product, Dermovate Scalp Application should be kept away from open fire and flames and all sources of ignition, including smoking, during and immediately after use.

Adults, Elderly and Children over 1 year

A small quantity of clobetasol 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 less frequently.

Paediatric population

Children are more likely to develop local and systemic side effects of topical corticosteroids and, in general, require shorter courses and less potent agents than adults.

Care should be taken when using clobetasol propionate to ensure the amount applied is the minimum that provides therapeutic benefit.

Duration of treatment for children and infants

Courses should be limited if possible to a few days and reviewed weekly.

Elderly

Clinical studies have not identified differences in responses between the elderly and younger patients. The greater frequency of decreased hepatic or renal function in the elderly may delay elimination if systemic absorption occurs. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.

Renal / Hepatic Impairment

In case of systemic absorption (when application is over a large surface area for a prolonged period) metabolism and elimination may be delayed therefore increasing the risk of systemic toxicity. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.

Symptoms

Topically applied clobetasol may be absorbed in sufficient amounts to produce systemic effects. Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse the features of hypercortisolism may occur (see section 4.8).

Management

In the event of overdose, clobetasol should be withdrawn gradually by reducing the frequency of application or by substituting a less potent corticosteroid because of the risk of glucocorticosteroid insufficiency.

Further management should be as clinically indicated or as recommended by the national poisons centre, where available.

Unopened: 24 months.

Opened: 3 months.

Do not store above 30°C.

Keep container tightly closed when not in use. Contents are flammable. Keep away from fire, flame or heat. Do not leave Dermovate Scalp Application in direct sunlight.

White High Density Polyethylene (HDPE) container with a white low density polyethylene (LDPE) nozzle and a white HDPE screw cap.

Pack size: 25ml, 30ml, 100ml.

Not all pack sizes may be marketed.

Patients should be advised to wash their hands after applying Dermovate Scalp Application.

For detailed instructions for use refer to the Patient Information Leaflet in every pack.

Do not use near a naked flame.