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ALPHOSYL HC CREAM

Active substance(s): ALLANTOIN / COAL TAR ALCOHOLIC EXTRACT / HYDROCORTISONE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Alphosyl HC Cream

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Allantoin
Alcoholic Extract of Coal Tar
Hydrocortisone

3

2.0% W/W
5.0% W/W
0.5%

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

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).
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

6.5

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

10

DATE OF REVISION OF THE TEXT

11/03/2011

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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