1. Name Of The Medicinal Product
Alphosyl HC Cream
2. Qualitative And Quantitative Composition
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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 Contraindications
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.
4.4 Special Warnings And 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 Interaction With Other Medicinal Products 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
4.8 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).
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*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 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.
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
6.5 Nature And Contents Of Container
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.
6.6 Special Precautions For Disposal And Other 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(S)
PL 00036/0026R
9. Date Of First Authorisation/Renewal Of The Authorisation
17/1/1997
10. Date Of Revision Of The Text
11/03/2011
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