ALPHOSYL HC CREAM

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.

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.

None known.

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

None known.

skin irritation and acne like eruptions, photosensitivity.

Hypersensitivity reactions may occasionally occur. May cause allergic reactions (possibly delayed) in certain individuals.

Not applicable.

Coal tar is a standard antipruritic and keratoplastic agent used in the treatment of psoriasis and other skin disorders. Allantoin is a chemical debrider; it stimulates cell proliferation, epithelization and granulation, and hence hastens wound healing. Steroids are standard in the topical 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

Cetyl alcohol

Citric acid

Corn oil

Glyceryl monostearate

Isopropyl palmitate

Mineral oil and lanolin alcohol

Methyl paraben

Oleyl alcohol

Propyl gallate

Propyl paraben

PEG 400 dilaurate

Sodium citrate

Squalane

Lecithin

Triethanolamine

Phenylethyl alcohol

Water

None known.

18 months

Store between 4°C and 25°C.

Alphosyl HC Cream is packaged in decorated, 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

Trading as: GlaxoSmithKline Consumer Healthcare

PL 0036/0026R

17/01/1997

March 2002