Polytar Plus
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Polytar Plus.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tar Blend 1%w/w.
3 PHARMACEUTICAL FORM
Medicated shampoo for topical use.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Polytar Plus is indicated as an aid in the treatment of scalp disorders such as psoriasis, seborrhoea, pruritus, and dandruff. Polytar Plus 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 Plus 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. Taking both of these shampoo applications into consideration, the total leave on time for the shampoo should be 3-5 minutes.
Polytar Plus should be used once or twice weekly for the treatment of scalp disorders. The normal duration of use is 4 weeks, after which the condition should improve. Longer duration of therapy should be continued under the supervision of a physician.
Paediatric population
The safety and efficacy of Polytar Plus in children under 12 years of age have not been established.
Polytar Plus should be used with caution in children and only on the recommendation of a doctor or pharmacist.
Coal tar preparations have been used, for many years, when recommended by a doctor to treat children, however, there is very little documented clinical data in this patient population
4.3 Contraindications
Known hypersensitivity to coal tar, arachis oil (peanut oil) or to any of the excipients in the preparation (see section 6.1 for List of Excipient)As there is a possible relationship between allergy to peanut and allergy to soya, patients with soya allergy should also avoid Polytar Plus The following conditions should not be treated with Polytar Plus:
• Infected open skin lesions
• Sore or acute pustular psoriasis
4.4 Special warnings and precautions for use
For cutaneous use only.
Coal tar preparations may cause irritancy, therefore contact with sensitive areas, such as broken or very inflamed skin, should be avoided.
If irritation develops, treatment should be discontinued.
Avoid contact with the eyes. If contact occurs rinse eyes thoroughly with water.
Polytar Plus can stain skin and clothes. Contact with clothes should be avoided. Skin stains will wear off after treatment is stopped.
In rare instances, temporary hair colour changes may occur.
As Polytar Plus may cause increased sensitivity to sunlight, sunlamps should not be used and deliberate or prolonged exposure of the scalp to sunlight should be avoided or minimised.
Polytar Plus should be used with caution if the patient is also taking drugs known to be photosensitisers (e.g. thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulphonamides) because of the increased possibility of augmented photosensitivity.
Polytar Plus contains the excipient imidurea which releases traces of formaldehyde as a breakdown product. Formaldehyde may cause allergic sensitization or irritation upon contact with the skin.
4.5 Interaction with other medicinal products and other forms of interaction
None stated.
4.6 Pregnancy and lactation Fertility
There are no data on the effects of topical coal tar preparations on human fertility.
Pregnancy
The use of coal tar products should be avoided in the first trimester of pregnancy.
Use of coal tar preparations during pregnancy should only be considered if the expected benefit to the mother outweighs the potential risk to the foetus.
There are limited data from the use of coal tar preparations in pregnant women.
Coal tar has been shown to be foetotoxic and teratogenic to the offspring of laboratory animals when administered topically, orally or by inhalation at high and maternally toxic doses (see section 5.3 Pre-clinical data).
Lactation
The safe use of topical coal tar preparations during lactation has not been established.
It is not known whether the topical application of coal tar preparations could result in sufficient systemic absorption to produce detectable amounts in breast milk.
Use of coal tar preparations during lactation should only be considered if the expected benefit to the mother outweighs the potential risk to the infant.
If used during lactation, patients should be advised to ensure that any residual product is fully washed off the breast prior to breast-feeding in order to avoid accidental ingestion by the infant.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (>1/10), common (>1/100 and <1/10), uncommon (>1/1,000 and <1/100), rare (>1/10,000 and <1/1,000), very rare (<1/10,000), including isolated reports and not known (cannot be estimated from the available data).
Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive postmarketing experience at therapeutic/labelled dose and considered attributable are given below by system class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to Polytar Plus are rare and serious reactions are very rare.
Post-marketing data
|
Immune system disorders |
Not known |
Hypersensitivity (including pruritus, angioedema, dyspnoea) |
|
Eye disorders |
Not known |
Eye irritation |
|
Skin and subcutaneous tissue disorders |
Not known |
Alopecia, dermatitis, hair colour changes, abnormal hair texture, photosensitivity reaction, skin irritation (including dry skin, erythema, and skin burning sensation) |
|
General disorders and administrations site conditions |
Not known |
Application site hypersensitivity, application site pain, application site rash, localised oedema. |
4.9 Overdose
Symptoms and signs
Topical coal tar overdose may increase the rate of skin irritation and photosensitivity. (see section 4.8 Undesirable effects).
Treatment
Management should be as clinically indicated.
5 PHARMACOLOGICAL PROPERTIES
ATC Code: D05AA Tars
5.1 Pharmacodynamic properties Mechanism of action
Coal tars suppress DNA synthesis in hyperplastic skin inhibiting mitotic activity, protein synthesis and cell reproduction.
Coal tar decreases epidermal proliferation and dermal infiltration and thus promotes a return to normal keratinisation. Coal tar has anti-inflammatory, antibacterial, antipruritic, keratolytic, keratoplastic and vasoconstrictive effects.
5.2 Pharmacokinetic properties
In a study using a variety of coal tar preparations total urinary poly aromatic hydrocarbons were significantly elevated in patients treated dermally for different forms of dermatoses. The treatment period was for an average of 7 days using 1.5% - 40% coal tar preparations over a body surface area that ranged from 9 to 90%. Therefore some of the hydrocarbons present in coal tar may be absorbed through the skin. The highest levels absorbed depend largely on the body surface area treated and on the duration of exposure.
Many of the hydrocarbons will be subject to extensive metabolic transformation by both oxidation and conjugation. Drug-metabolizing enzymes (both in the skin and systemically) may be induced by coal tar application.
5.3 Preclinical safety data
Carcinogenesis and Mutagenesis
No long term studies have been conducted with the product formulations.
Coal tar contains certain chemicals that are mutagenic to microorganisms and mammalian cells in vitro. Topical and oral administration of high doses of coal tar to laboratory animals induces DNA adduct formation.
High dose administration of coal tar to laboratory animals is carcinogenic However, epidemiological evidence that includes prospective and retrospective studies in thousands of patients receiving coal tar therapy followed for more than 40 years do not suggest a potential increased risk of skin or systemic cancer.
Reproductive Toxicology
Coal tar is foetotoxic and teratogenic at maternally toxic doses following dermal application, oral administration, or inhalation.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Coconut di ethanol amide, Hexylene glycol, Volpo N10, Oleyl alcohol, Polysorbate 80, Triton X100, Fragrance 5412, Polypeptide SF, Imadozolidinyl Urea, Triethanolamine Lauryl Sulphate, Citric acid, Purified water
6.2 Incompatibilities
None stated.
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
None.
6.5 Nature and contents of container
Polyethylene screw top bottles of 25ml, 65ml, 125ml, 150ml, 250ml, 350ml, 500ml, 600ml.
6.6 Special precautions for disposal
No Data Held
7 MARKETING AUTHORISATION HOLDER
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 44673/0050
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
02/12/1977 / 25/06/2004
10 DATE OF REVISION OF THE TEXT
23/08/2016