Thursday, 9 August 2012

Polytar Liquid





1. Name Of The Medicinal Product



Polytar Liquid


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.



3. Pharmaceutical Form



Medicated Shampoo



4. Clinical Particulars



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.



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.



4.3 Contraindications



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



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.



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.



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.



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.



4.8 Undesirable Effects



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



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.



5. Pharmacological Properties



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.



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.



5.3 Preclinical Safety Data



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



6. Pharmaceutical Particulars



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



6.2 Incompatibilities



There are no known incompatibilities



6.3 Shelf Life



a) For the product as packaged for sale



3 years



b) After first opening the container



Comply with expiry date



6.4 Special Precautions For Storage



There are no special precautions for storage.



6.5 Nature And Contents Of Container



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



6.6 Special Precautions For Disposal And Other Handling



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



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 19494/0080



9. Date Of First Authorisation/Renewal Of The Authorisation



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



10. Date Of Revision Of The Text



16 March 2011




No comments:

Post a Comment