POLYTAR LIQUID
Active substance: PINE TAR
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SUMMARY OF PRODUCT CHARACTERISTICS
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. 4.1
CLINICAL PARTICULARS 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. Interaction with other medicinal products and other forms of interaction
None stated.
4.5
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
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Oleyl alcohol Coconut diethanolamide Hexylene glycol Polysorbate 80 Triethanolamine 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 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
14/03/1990 / 27/02/2009
10
DATE OF REVISION OF THE TEXT
16/03/2011
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. 4.1
CLINICAL PARTICULARS 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. Interaction with other medicinal products and other forms of interaction
None stated.
4.5
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
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Oleyl alcohol Coconut diethanolamide Hexylene glycol Polysorbate 80 Triethanolamine 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 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
14/03/1990 / 27/02/2009
10
DATE OF REVISION OF THE TEXT
16/03/2011
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
