EUMOVATE Cream Ref.[7164] Active ingredients: Clobetasone

Route of administration

Cutaneous.

Adults, Elderly, Children and Infants

Creams are especially appropriate for moist or weeping surfaces.

Apply thinly and gently rub in using only enough to cover the entire affected area once or twice a day until improvement occurs, then reduce the frequency of application or change the treatment to a less potent preparation. Allow adequate time for absorption after each application before applying an emollient.

Therapy with topical corticosteroids should be gradually discontinued once control is achieved and an emollient continued as maintenance therapy.

Rebound of pre-existing dermatoses can occur with abrupt discontinuation of topical corticosteroids especially with potent preparations.

Duration of treatment for adults and elderly

Continuous daily treatment for longer than four weeks is not recommended. If the condition worsens or does not improve within four weeks, treatment and diagnosis should be re-evaluated.

Paediatric population

Use in children under 12 years should be on the advice of a doctor.

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

Duration of treatment for children and infants

When clobetasone is used in the treatment of dermatoses in children, extreme caution is required and treatment should not normally exceed 7 days.

If the condition worsens or does not improve within 7 days, treatment should be reviewed.

Once the condition has been controlled, the frequency of application should be reduced to the lowest effective dose for the shortest time possible.

Continuous daily treatment for longer than 4 weeks is not recommended in children.

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 and signs

Topically applied clobetasone 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).

Treatment

In the event of overdose, clobetasone 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.

36 months.

Store below 25°C.

Internally lacquered aluminium tubes with latex band and wadless polypropylene cap.

30 and 100gm tubes are available (25gm pack is also registered).

Patients should be advised to wash their hands after applying Eumovate, unless it is the hands that are being treated.