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GlaxoSmithKline UK
Stockley Park West, Uxbridge, Middlesex, UB11 1BT Telephone: +44 (0)800 221 441 Fax: +44 (0)208 990 4328 Medical Information e-mail: customercontactuk@gsk.com Need to contact this company?

Summary of Product Characteristics last updated on the eMC: 21/08/2009

SPC	Polytar AF

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 AF

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Tar Blend 1% w/w, Zinc Pyrithione 1% w/w in a shampoo base

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 AF is indicated in the topical treatment of scalp disorders such as dandruff, seborrhoeic dermatitis and psoriasis.

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4.2 Posology and method of administration

Shake the bottle before use. Wet the hair and massage Polytar AF into the hair, scalp and surrounding skin. Leave for 2-3 minutes, then rinse thoroughly.

Polytar AF should be used two or three times weekly for at least 3 weeks or until the condition clears.

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4.3 Contraindications

Polytar AF should not be used by patients with known hypersensitivity to any of the ingredients.

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4.4 Special warnings and precautions for use

Avoid contact with the eyes. Tar products may cause skin irritation, rashes and, rarely, photosensitivity. Zinc pyrithione may cause dermatitis, should this occur, Polytar AF should be discontinued.

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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

The safety of Polytar AF in human pregnancy and lactation has not been established.

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4.7 Effects on ability to drive and use machines

None.

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4.8 Undesirable effects

None.

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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 blend:

Tars suppress DNA synthesis in hyperplastic skin, this inhibits mitotic activity and protein synthesis. By decreasing proliferation and dermal infiltration, they promote a return to normal keratinisation. Tars also have vasoconstricting astringent and antipruritic properties.

Zinc Pyrithione:

Zinc Pyrithione has antibacterial and antifungal properties. It is fungicidal against the pathogenic yeasts of the pityrosporum genus which are implicated in dandruff and seborrhoeic dermatitis.

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5.2 Pharmacokinetic properties

Not Applicable.

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5.3 Preclinical safety data

Not Applicable.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Coconut diethanolamide

Triethanolamine Lauryl Sulphate