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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
Polytar AF
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