Alphosyl HC Cream

Cream for topical application.

For the treatment of psoriasis by topical administration.

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

Not recommended for children under 5 years.

Tuberculosis or fungal lesions of the skin (e.g. athlete's foot), acne vulgaris, herpes simplex (cold sores), vaccinia or varicella, and 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. Avoid mucosa, genital or rectal areas and broken or inflamed skin.

Use sparingly, discontinue use if sensitivity occurs.

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 intertriginous areas topical steroids may cause skin atrophy manifesting as striae, thinning and telangiectesia.

- 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.

None

Topical administration of corticosteroids to pregnant animals can cause abnormality of foetal development. Topical steroids should not be used extensively during pregnancy, i.e. in large amounts or for long periods because of the risk of teratogenic effects or significant absorption causing suppression of the HPA axis.

None

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.

Not applicable

Coal tar is a standard antipruritic and keratoplastic agent used in the treatment of psoriasis and other skin affections.

Allantoin is a chemical dedrider; stimulates cell proliferation, epithelization and granulation, and hence hastens wound healing.

Steroids are standard in the treatment of various skin disorders.

Not applicable

Several animal studies have demonstrated that the non-carcinogenic toxicity profile of medicinal coal tar is acceptable.

Coal tar preparations have been shown to contain chemicals with a known relationship to the development of malignant tumours in experimental models. Animal studies, where coal tar has been applied topically, have consistently given positive results.

However, it is consistently clear that epidemiological studies in man have not confirmed this carcinogenic potential. Where isolated case studies have related the use of medicinal coal tar to tumour induction, well controlled retrospective studies have not confirmed the relationship. The individual case reports are not well documented as to causation.

Beeswax Yellow

Cetyl Alcohol

Citric Acid

Maize Oil

Glycerol Monostearate

Isopropyl Palmitate

Liquid Base CB 3929

Methyl Hydroxybenzoate

Oleyl Alcohol

Propyl Gallate

Propyl Hydroxybenzoate

PEG-400 Dilaurate

Sodium Citrate

Sqaulene

Lecithin, Vegetable

Triethanolamine

Phenethyl Alcohol

Water Purified

None known

18 months

Store between 4°C and 25°C

Alphosyl HC Cream is packaged in decorated, 30 g or 100 g collapsible aluminium tubes with a phenolic/epoxy resin liner and latex end seal. The nozzle is closed with a high density polyethylene screw on cap.

For all patients, apply sparingly twice a day to psoriatic plaques and rub in well until the cream is no longer visible. Alphosyl HC Cream is not recommended for children under 5 years.

Stafford-Miller Limited

980 Great West Road

Brentford, Middlesex

TW8 9GS

United Kingdom

Trading as: GlaxoSmithKline Consumer Healthcare, Brentford TW8 9GS, UK

PL 00036/0026R

17/1/1997

11/03/2011