Antipsoriatics / corticosteroids (topical steroids).

Coal tar extract, allantoin, hydrocortisone

Active ingredientsQuantity (% w/w) Alcoholic extract of coal tar 5.0 Hydrocortisone 0.5 Allantoin 2.0

Cream for topical application.

For the treatment of psoriasis by topical administration.

For all patients, apply sparingly twice daily to psoriatic plaques and rub in well until the cream is no longer visible.

Not recommended for children under 5 years.

Under 5 years, not recommended; over 5 years, apply twice daily.

Tuberculosis or fungal lesions of the skin (eg. athletes foot), acne vulgaris, herpes simplex (cold sores), vaccinia or varicella or a history of hypersensitivity to any of the ingredients.

Not for use in sore, acute or pustular psoriasis or in the presence of infection.

For external use only, avoid contact with the eyes.

Discontinue use if sensitivity occurs. Avoid mucosa, genital or rectal areas and broken or inflamed skin

Use sparingly.

The following results of steroid use are uncommon at this dosage, however:

- When used over large areas or for prolonged periods systemic side effects can result.

- Under occlusive dressings or in intertriginous areas, topical steroids may cause skin atrophy manifesting as striae, thinning and telangiectasia.

- Viral, bacterial or fungal infection of the skin may be substantially exacerbated by topical steroid treatment unless accompanied by appropriate therapy.

- Wound healing can be significantly retarded.

Adverse events derived from post-marketing data are tabulated below by system organ class. The frequency of these adverse events is not known (cannot be estimated from the available data).

*Allergic reactions may be delayed.

GlaxoSmithKline Consumer Healthcare

(POM)

11 November 2011