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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

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


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1. NAME OF THE MEDICINAL PRODUCT

Polytar Liquid


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Tar Blend 1% w/w

Tar Blend comprises:

Pine tar, Cade Oil, Coal Tar Solution, Arachis Oil extract of Coal Tar.


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3. PHARMACEUTICAL FORM

Medicated Shampoo


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Polytar Liquid is indicated in the treatment of scalp disorders including psoriasis, dandruff, seborrhoea, eczema and pruritus. Polytar Liquid is also of value in the removal of ointments and pastes used in the treatment of psoriasis.


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4.2 Posology and method of administration

The hair should be wetted and sufficient Polytar Liquid 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 Liquid should be used once or twice weekly.


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4.3 Contraindications

Patients with a known hypersensitivity to any of the ingredients should not use the product.


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4.4 Special warnings and precautions for use

Polytar Liquid 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 Liquid.


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4.5 Interaction with other medicinal products and other forms of interaction

There are no known interactions with other medicaments or other forms of interaction.


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4.6 Pregnancy and lactation

There is no, or inadequate evidence of the safety of Polytar Liquid 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

The use of this product will not affect the ability to drive and to use machines.


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4.8 Undesirable effects

Tar products may cause skin irritation, rashes and rarely, photosensitivity. If irritation occurs and persists, treatment should be discontinued.


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4.9 Overdose

The product is intended for external use only. It is applied to the scalp and rinsed off. Use of an excessive quantity is not a cause for concern.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Tars suppress DNA synthesis in hyperplastic skin, inhibiting mitotic activity and protein synthesis. They decrease epidermal proliferation and dermal infiltration and thus promote a return to normal keratinisation.

Tars also have vasoconstrictor, antipruritic and antiseptic properties.


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5.2 Pharmacokinetic properties

The product is applied topically and acts at the site of application. The potential for systemic absorption from a wash off shampoo is extremely low.


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5.3 Preclinical safety data

Tar preparations have been in widespread use for many years and their safety in humans has been established.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Oleyl alcohol

Coconut diethanolamide

Hexylene glycol

Polysorbate 80

Triethanolamide Lauryl Sulphate

Sodium chloride

Citric acid

Octylphenoxypolyethoxy ethanol

Imidurea

Fragrance 5412

Purified Water


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6.2 Incompatibilities

There are no known incompatibilities


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6.3 Shelf life

a) For the product as packaged for sale

3 years

b) After first opening the container

Comply with expiry date


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6.4 Special precautions for storage

There are no special precautions for storage.


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6.5 Nature and contents of container

High density polyethylene bottles of 65ml, 150ml, 200ml, 250ml, 350ml, 400ml, 500ml, 600ml, 1000ml.


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6.6 Special precautions for disposal and other handling

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


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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


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8. MARKETING AUTHORISATION NUMBER(S)

PL 19494/0080


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

14th March 1990/11th May 2000/11th May 2005/27th February 2009


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10. DATE OF REVISION OF THE TEXT

16 March 2011



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/21661/SPC/


Active Ingredients/Generics

 
   tar blend