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Stiefel
Stockley Park West, , Uxbridge, Middlesex, UB11 1BT , UK Telephone: +44 (0)800 221 441 Fax: +44 (0)208 990 4328 Medical Information e-mail: customercontactuk@gsk.com Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 22/03/2011

SPC	Polytar Emollient

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

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1. NAME OF THE MEDICINAL PRODUCT

Polytar Emollient

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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.

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3. PHARMACEUTICAL FORM

Liquid bath additive.

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4. CLINICAL PARTICULARS

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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.

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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.

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4.3 Contraindications

None.

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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.

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4.5 Interaction with other medicinal products and other forms of interaction

None known.

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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.

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4.7 Effects on ability to drive and use machines

None.

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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.

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4.9 Overdose

Not applicable.

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5. PHARMACOLOGICAL PROPERTIES

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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.

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5.2 Pharmacokinetic properties

Not applicable.

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5.3 Preclinical safety data

None stated.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Octyiphenoxypolythoxy Ethanol

Sorbitan Monooleate