Polytar Emollient
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Polytar Emollient
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tar Blend 25.00% w/w, Light Liquid Paraffin 35.00% w/w
Tar Blend comprises:
Pine tar BP 30% w/w, Cade oil BPC 30% w/w, Coal Tar Solution BP 10% w/w, Arachis Oil extract of Coal Tar BP 30% w/w.
3 PHARMACEUTICAL FORM
Liquid bath additive.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Topical.
Polytar Emollient is indicated in the treatment of psoriasis, eczema, atopic and pruritic dermatoses. The use of Polytar Emollient may be combined with ultraviolet radiation and other adjunctive therapy. Polytar Emollient is also of value in removing loose psoriatic scales and paste following dithranol treatment.
4.2 Posology and method of administration
Posology
Adults, adolescents and the elderly:
Two to four capfuls of Polytar Emollient should be added to a bath containing 20 cm (8 inches) of water and the patient instructed to soak for 20 minutes.
Paediatric population
The safety and efficacy of Polytar Emollient in children under 12 years of age have not been established.
Polytar Emollient 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), soya or to any of the excipients listed (see section 4.4.Warnings and Precautions and List of Excipients in section 6.1)
The following conditions should not be treated with Polytar Emollient:
• 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 Emollient 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 Emollient may cause increased sensitivity to sunlight, exposure to artificial sources of UV light, such as sunlamps should be avoided unless the UV is being used as part of a treatment regimen.
When exposure to strong sunlight cannot be avoided, patients should be advised to use a sunscreen product and wear protective clothing. Due to the potential for photosensitivity, resulting in greater risk for sunburn, Polytar Emollient should be used with caution in patients with a personal or family history of skin cancer.
If a patient has sunburn, this should be resolved before using Polytar Emollient .
Polytar Emollient 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 Emollient may make the bath slippery therefore the patient should be advised to use care, to avoid slipping in the bath.
Polytar Emollient contains arachis oil (peanut oil) and should not be used by patients known to be allergic to peanuts. As there is a possible relationship between allergy to peanut and allergy to soya, patients with soya allergy should also avoid Polytar Emollient
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, 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 5.3. Pre-clinical safety 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.
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) and very rare (<1/10,000), including isolated reports. 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 post-marketing 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. |
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
5.1 Pharmacodynamic properties ATC code: D05AA Tars
Mechanism of action
Coal tars suppress DNA synthesis in hyperplastic skin inhibiting mitotic activity, protein synthesis and cell reproduction
Light liquid paraffin exerts an emollient effect by forming an occlusive film in the stratum corneum.
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.
Light liquid paraffin is chemically and biologically inert; percutaneous absorption is low following topical application and is not likely to cause significant systemic levels.
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
Octylphenoxypolythoxy Ethanol Sorbitan Monooleate Polyethylene Glycol 400 Dilaurate Isopropyl Palmitate
6.2 Incompatibilities
None.
6.3 Shelf life
36 months
Special precautions for storage
None.
6.5 Nature and contents of container
Polyvinyl chloride bottles fitted with a screw cap containing 350ml, 500ml, 600ml, 1000ml.
6.6 Special precautions for disposal
There are no special instructions for use or handling of Polytar Emollient.
7 MARKETING AUTHORISATION HOLDER
Beecham Group PLC 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 00079/0711
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30/11/1989 / 31/08/2006
10 DATE OF REVISION OF THE TEXT
25/07/2013