Sunday, 7 October 2012

Polytar AF





1. Name Of The Medicinal Product



Polytar AF


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.



3. Pharmaceutical Form



Medicated Shampoo



4. Clinical Particulars



4.1 Therapeutic Indications



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



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.



4.3 Contraindications



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



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.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



None known.



4.6 Pregnancy And Lactation



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



4.7 Effects On Ability To Drive And Use Machines



None.



4.8 Undesirable Effects



None.



4.9 Overdose



Not applicable.



5. Pharmacological Properties



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.



5.2 Pharmacokinetic Properties



Not Applicable.



5.3 Preclinical Safety Data



Not Applicable.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Coconut diethanolamide



Triethanolamine Lauryl Sulphate



Carbomer



Sodium Hydroxide



Hypromellose



Octoxinol



Glycerol



Imidurea



Purified Water



6.2 Incompatibilities



None



6.3 Shelf Life



24 months



6.4 Special Precautions For Storage



Store below 25oC



6.5 Nature And Contents Of Container



High density polyethylene bottles of 25ml, 65ml, 150ml, 250ml, 350ml, 400ml, 1000ml



6.6 Special Precautions For Disposal And Other Handling



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



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 19494/0061



9. Date Of First Authorisation/Renewal Of The Authorisation



16th March 1992.



10. Date Of Revision Of The Text



20 December 2010




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