CLARELUX Cutaneous foam Ref.[7162] Active ingredients: Clobetasol propionate

Posology

Use in adults

CLARELUX 500 micrograms/g, cutaneous foam in pressurised container is a highly potent topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used.

Route of administration: for cutaneous use.

CLARELUX 500 micrograms/g, cutaneous foam in pressurised container should be applied to the affected area twice daily. There are no data from clinical studies evaluating the efficacy of once daily application.

Paediatric population

CLARELUX is not recommended for use in children less than 12 years old (see section 5.1).

Method of administration

For cutaneous use.

The foam application has been designed so that the preparation spreads easily without being too fluid and allows easy application direct to the affected area.

Note: for proper dispensing of foam, hold the container upside down and depress the actuator.

Invert the container and dispense a small amount (of the size of a walnut or one teaspoon) of CLARELUX directly on the lesions, or dispense a small amount into the cap of the container, onto a saucer or other cool surface, taking care to avoid contact with eyes, nose, and mouth. Dispensing directly onto hands is not recommended, as the foam will begin to melt immediately upon contact with warm skin. Gently massage into affected area until the foam disappears and is absorbed. Repeat until entire affected area is treated. Move the hair away from the affected area so that the foam can be applied to each affected area.

Avoid contact with eyes, nose and mouth.

Do not use near a naked flame.

No overdoses have been reported. Topically applied CLARELUX in pressurised container can be absorbed in sufficient amounts to produce systemic effects. If features of hypercorticoidism appear topical steroids should be discontinued gradually and, because of the risk of acute adrenal suppression, this should be done under medical supervision (see section 4.4).

36 months.

Do not store above 25°C. Do not refrigerate. Store upright.

The canister contains a pressurised, flammable liquid. Do not use near a naked flame. Do not expose to temperatures higher than 50°C or to direct sunlight. Do not pierce or burn the canister, even when empty.

Pressurised aluminium container closed with an inverted valve, containing 50g or 100g of foam. The inside of the can is lined with a double coated, clear epoxy-phenolic lacquer. Each filled canister is fitted into a spout actuator with dust cap.

Not all pack sizes may be marketed.

No special requirements.