Polytar Emollient

1. Name Of The Medicinal Product

Polytar Emollient

2. Qualitative And Quantitative Composition

Tar Blend 25.00% w/w, Light Liquid Paraffin 35.00% w/w

Tar Blend comprises:

Pine tar BP 30% w/w, Cade oil BPC 30% w/w, Coal Tar Solution BP 10% w/w, Arachis Oil extract of Coal Tar BP 30% w/w.

3. Pharmaceutical Form

Liquid bath additive.

4. Clinical Particulars

4.1 Therapeutic Indications

Topical.

Polytar Emollient is indicated in the treatment of psoriasis, eczema, atopic and pruritic dermatoses. The use of Polytar Emollient may be combined with ultraviolet radiation and other adjunctive therapy. Polytar Emollient is also of value in removing loose psoriatic scales and paste following dithranol treatment.

4.2 Posology And Method Of Administration

Adults, children and the elderly:

Two to four capfuls of Polytar Emollient should be added to an 8 inch bath and the patient instructed to soak for 20 minutes.

4.3 Contraindications

None.

4.4 Special Warnings And Precautions For Use

Patients should be instructed to guard against slipping when entering or leaving the bath. If skin irritation occurs and persists, discontinue use and consult your doctor. Tar products may stain baths and fabrics.

Polytar Emollient 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 Emollient.

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 the safety of Polytar Emollient in human pregnancy and lactation but it has been in wide use for many years without apparent ill consequence.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Tar products may cause skin irritation, rashes and rarely, photosensitivity. In the event of such a reaction, discontinue use and consult your doctor.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Tar preparations have keratoplastic and antipruritic activity and are widely used as topical therapy for a range of dermatoses. The use of emollient bath oils in the management of widespread dry and itching skin is well established. Mineral oil exerts its emollient effect by skin absorption. The combination of tar blend with an emollient therefore provides a pharmacological active product with emollient properties.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Octyiphenoxypolythoxy Ethanol

Sorbitan Monooleate

Polyethylene Glycol 400 Dilaurate

Isopropyl Palmitate

6.2 Incompatibilities

None.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Polyvinyl chloride bottles fitted with a screw cap containing 350ml, 500ml, 600ml, 1000ml.

6.6 Special Precautions For Disposal And Other Handling

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

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 19494/0079

9. Date Of First Authorisation/Renewal Of The Authorisation

31^st August 2006

10. Date Of Revision Of The Text

16 March 2011