SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Alphosyl HC Cream

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Allantoin    2.0%    W/W

Alcoholic Extract of Coal Tar    5.0% W/W

Hydrocortisone    0.5%

3    PHARMACEUTICAL FORM

Cream for topical application.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the treatment of psoriasis by topical administration.

4.2.    Posology and Method of 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.

4.3.    Contra-indications

Tuberculosis or fungal lesions of the skin (e.g. athletes 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.

4.4. Special Warnings and Special Precautions for Use

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

4.5. Interactions with other Medicaments and other forms of Interaction

None

4.6. Pregnancy and Lactation

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.

4.7. Effects on Ability to Drive and Use Machines

None

Undesirable Effects

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).

Body System	Undesirable effect
Immune system disorders	Hypersensitivity (including rash, itching, dyspnoea and angioedema) Allergic reactions*
Skin and subcutaneous tissue disorders	Skin irritation and acne like eruptions Photosensitivity

*Allergic reactions may be delayed.

4.9. Overdose

Not applicable

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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.

5.2    Pharmacokinetic Properties

Not applicable

5.3    Preclinical Safety Data

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 studied 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.

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

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

6.2    Incompatibilities

None known

6.3 Shelf Life

18 months

6.4 Special Precautions for Storage

Store between 4°C and 25°C

Nature and Contents of Container

Alphosyl HC Cream is packaged in decorated, 30g or 100g 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.

6.6 Instruction for Use/Handling

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.

7    MARKETING AUTHORISATION HOLDER

Stafford-Miller Limited 980 Great West Road Brentford, Middlesex TW8 9GS United Kingdom

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

8 MARKETING AUTHORISATION NUMBER

PL 00036/0026R

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

17/1/1997 11/03/2011