Alphosyl '2 in 1' Shampoo

1. Name Of The Medicinal Product

Alphosyl '2 in 1' Shampoo

2. Qualitative And Quantitative Composition

Alcoholic extract of coal tar 5.00% w/w

For excipients see 6.1

3. Pharmaceutical Form

Medicated Shampoo

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of Psoriasis, Seborrhoeic dermatitis, scaling and itching (often associated with eczema), and dandruff

4.2 Posology And Method Of Administration

Adults, children and the elderly:

Wet hair thoroughly, then briskly rub a liberal amount of shampoo into the hair and scalp. Rinse thoroughly and repeat the procedure massaging the scalp for several minutes and working the shampoo into a rich lather. Rinse thoroughly.

Dandruff: Once or twice weekly as necessary or as directed by a physician.

Psoriasis, Seborrhoeic dermatitis, scaling and itching: Use every 2 or 3 days or as directed by a physician.

4.3 Contraindications

Sensitivity to coal tar or to any of the excipients

4.4 Special Warnings And Precautions For Use

For external use only

Discontinue if irritation develops

Avoid contact with eyes

Keep out of reach of children

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

There is no or inadequate evidence of safety of coal tar in human pregnancy but it has been in wide use for many years without apparent ill consequence. However, use in the first trimester of pregnancy is best avoided.

4.7 Effects On Ability To Drive And Use Machines

None known

4.8 Undesirable Effects

Adverse events are tabulated below by system class. The frequency of these adverse events is not known, but post marketing experience indicates that adverse reactions are rare or very rare.

Body System	Undesirable effect
Skin and subcutaneous tissue disorders	Skin irritation Photosensitivity
Immune system disorders	Hypersensitivity (including rash, itching, dyspnoea and angioedema)

These undesirable effects resolve when treatment is stopped.

4.9 Overdose

Alphosyl shampoo is a topical medicine which has no known systemic effects. Effects of overdose may increase the rate of skin irritation and photosensitivity but it is unlikely to have a systemic effect.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Coal tar has keratolytic and keratoplastic properties which aids treatment by slowing the excessive epidermal cell turnover.

5.2 Pharmacokinetic Properties

Not applicable

5.3 Preclinical Safety Data

Not applicable

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium lauryl sulphate solution

Ammonium lauryl sulphate solution

Lauramide DEA

Herbal Fragrance 41.423

Hydroxy Propyl Methyl Cellulose

Citric acid anhydrous

Guar Hydroxy Propyl Trimonium Chloride

Methyl Parahydroxybenzoate

Propyl Parahydroxybenzoate

Patent Blue V dye

Purified Water

6.2 Incompatibilities

None known

6.3 Shelf Life

24 months

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

Alphosyl '2 in 1' shampoo is packaged in white opaque polypropylene bottles with wadded cap and pack sizes; 20, 100, 125, 250, 500 and 1000 ml

or

White opaque polypropylene bottles with a white polypropylene flip top cap and pack sizes 125 and 250ml.

It is also packaged in white opaque polypropylene tubes with screw cap and pack sizes 20, 100, 125, 250, 500 and 1000 ml.

It is also packaged in 10 ml PETP/PE/Foil Surlyn sachets.

6.6 Special Precautions For Disposal And Other Handling

None stated

7. Marketing Authorisation Holder

Stafford-Miller Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

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

8. Marketing Authorisation Number(S)

PL 00036/0052

9. Date Of First Authorisation/Renewal Of The Authorisation

13/11/1991 / 28/05/2003

10. Date Of Revision Of The Text

24/11/2010