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POLYTAR SCALP SHAMPOO

Active substance(s): COAL TAR SOLUTION / COAL TAR SOLUTION / COAL TAR SOLUTION

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Tarmed shampoo
Polytar Scalp Shampoo

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
100g shampoo contain 4g coal tar solution (4%w/w)
For excipients, see 6.1.

3

PHARMACEUTICAL FORM
Shampoo.
Viscous brown homogeneous liquid.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
The medicine is indicated for the treatment of scalp disorders including:
psoriasis,
seborrhoeic dermatitis,
eczema,
pruritus and scaling associated with psoriasis, seborrhoeic
dermatitis and eczema
itchy, oily scalp,
dandruff.

4.2

Posology and method of administration
Adults and Adolescents
This medicine is for topical application to the scalp. The hair should be wetted
and sufficient amount applied to produce abundant lather. The scalp and
adjacent areas should be vigorously massaged with the fingertips. The hair
should be then 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. This medicine should be used once or twice
weekly for the treatment of scalp disorders. 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.
Use in the Elderly
The dosage instructions given above are suitable for the elderly.
Use in Children
Not established for use in children under the age of 12 years.
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.

Use in Renal/Hepatic Impairment
No dosage adjustment is necessary

4.3

Contraindications
• Known hypersensitivity to the active substance or to any of the excipients.
• Infected open skin lesions.
Sore or acute pustular psoriasis

4.4

Special warnings and precautions for use
This medicine is 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.
Contact with the eyes should be avoided. If contact occurs rinse eyes
thoroughly with water.
• This medicine 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.
• This medicine 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.

4.5

Interaction with other medicinal products and other forms of interaction
This medicine should be used with caution if the patient is also taking drugs
known to be photosensitisers (e.g. thiazides, tetracyclines, fluoroquinolones,
phenothiazines, sulfonamides) because of the increased possibility of
augmented photosensitivity.

4.6

Fertility, Pregnancy and lactation
Fertility
There are no data on the effects of topical coal tar preparations on human
fertility.

This medicine should be used in pregnancy only when clearly necessary.
Pregnancy
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).
Use of this medicine during pregnancy should only be considered if the
expected benefit to the mother outweighs the potential risk to the foetus.
The use of this medicine should be avoided in the first trimester of pregnancy.
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
No effect on the ability to drive and use machines have been observed.

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).

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 administration site conditions
Not known
Application site hypersensitivity, application site pain, application site rash, localised
oedema.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via www.mhra.gov.uk/yellowcard.

4.9

Overdose
Symptoms and signs
Topical coal tar overdose may increase the rate of skin irritation and
photosensitivity. (see section 4.8).
Treatment
Management should be as clinically indicated or as recommended by the national
poisons centre, where available

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
ATC Code: D05AA
Tar preparations have been used extensively for over 50 years in the management of
various skin conditions such as psoriasis, eczema and other dermatoses. The precise
mechanism of action is uncertain. Coal tars are known to suppress DNA synthesis in
hyperplasic skin, inhibiting mitotic activity and protein synthesis. They decrease
epidermal proliferation and dermal infiltration and thus promote a return to normal

keratinisation. Coal tar has anti-inflammatory, antibacterial, antipruritic, keratolytic,
keratoplastic and vasoconstrictive effects.
This is of significance in the management of psoriasis and other dermatoses
associated with increased cell replication, such as dandruff. The use of coal tar
preparations in products for scalp disorders is well established and such treatments
have generally been shown to be safe and effective.

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.
The potential for systemic absorption of coal tar from this medicine, containing 4%
Coal Tar Solution BP, when used as wash-off shampoo is extremely low.

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
Sodium Lauryl Ether Sulphate

Cocamidopropyl Betaine
Disodium Phosphate Dihydrate
Citric Acid Monohydrate
Benzyl Alcohol
Macrogol 150 Distearate
Hexylene Glycol
Oleyl Alcohol
Polyquaternium-10
Fruitier Timotei Fragrance AF17050
Purified Water

6.2

Incompatibilities
None

6.3

Shelf life
3 years.

6.4

Special precautions for storage
Do not store above 25° C.

6.5

Nature and contents of container
High density polyethylene bottles fitted with polypropylene caps.
Licensed pack sizes: 25ml, 150ml, 250ml.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
There are no special instructions for use or handling of Tarmed.

7

MARKETING AUTHORISATION HOLDER
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,

trading as:
Stiefel
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 44673/0051

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
14th November 1995/14th November 2005

10

DATE OF REVISION OF THE TEXT
27/05/2016

Expand Transcript

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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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