Polytar Plus (Stiefel)

1. Name Of The Medicinal Product

Polytar Plus

2. Qualitative And Quantitative Composition

Tar Blend 1% w/w

3. Pharmaceutical Form

Medicated shampoo for topical use.

4. Clinical Particulars

4.1 Therapeutic Indications

Polytar Plus is indicated as an aid in the treatment of scalp disorders such as psoriasis, seborrhoea, pruritus and dandruff. Polytar Plus is also of value in the removal of ointments and pastes used in the treatment of psoriasis.

4.2 Posology And Method Of Administration

The following dosages and schedules are applicable for adults, children and the elderly.

The hair should be wetted and sufficient Polytar Plus applied to produce an abundant lather. The scalp and adjacent areas should be vigorously massaged with the fingertips. The hair should then be thoroughly rinsed and the procedure repeated.

Polytar Plus should be used once or twice weekly.

4.3 Contraindications

None stated.

4.4 Special Warnings And Precautions For Use

Polytar Plus contains arachis oil (peanut oil) and should not be used by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to soya, patients with soya allergy should also avoid Polytar Plus.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

There are no restrictions on the use of Polytar Plus during pregnancy or lactation.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

None stated.

4.9 Overdose

None stated.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

While the mode of action of tars are not fully established, their therapeutic effect has been observed over many years. It has been postulated that tars work by exerting a cytostatic action following an initial cytoproliferative effect. This slowing of the keratinisation process in the epidermal layer and reduction in the rate of epidermal turnover promoting a return to normal keratinisation.

5.2 Pharmacokinetic Properties

Not applicable. The product acts at the site of application.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Coconut diethanolamide, Hexylene glycol, Volpo N10, Oleyl alcohol, Polysorbate 80, Triton X100, Fragrance 5412, Polypeptide SF, Imadozolidinyl Urea, Triethanolamine Lauryl Sulphate, Citric acid, Purified water

6.2 Incompatibilities

None stated.

6.3 Shelf Life

a) For the product as packaged for sale

3 years

b) After first opening the container

Comply with expiry date

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

Polyethylene screw top bottles of 25ml, 65ml, 125ml, 150ml, 250ml, 350ml, 500ml, 600ml

6.6 Special Precautions For Disposal And Other Handling

There are no special instructions for use or handling of Polytar Plus.

7. Marketing Authorisation Holder

GlaxoSmithKline UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

Trading as Stiefel

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

8. Marketing Authorisation Number(S)

PL 19494/0053

9. Date Of First Authorisation/Renewal Of The Authorisation

2^nd December 1977/2^nd December 1982/2^nd December 1987/2^nd December 1992

10. Date Of Revision Of The Text

16 March 2011