Treatment for seborrhoeic dermatitis of the scalp, dandruff and scalp psoriasis.

Posology

Liberal amounts of Neutrogena T/Gel Therapeutic Shampoo should be applied and massaged into the wet scalp and left for several minutes. The scalp should be rinsed, the application repeated and then the scalp rinsed thoroughly. Neutrogena T/Gel Therapeutic Shampoo should be used two to three times weekly for the treatment of scalp disorders.

Treatment usually lasts for 6 weeks, after which time improvement should be seen. Longer periods of treatment should only take place under the supervision of a doctor.

Paediatric population

Neutrogena T/Gel Therapeutic shampoo is not recommended for use in children below 12 years of age due to insufficient data on safety and efficacy in this age group.

Method of administration

For cutaneous use only.

Hypersensitivity to coal tar or to any of the excipients listed in section 6.1.

Acutely inflamed or broken skin, erythrodermic or generalized pustular psoriasis.

If irritation develops, discontinue use and consult a physician.

Contact with eyes should be avoided. If contact occurs, rinse eyes thoroughly with water.

In rare instances, temporary discoloration of grey, blonde, bleached or tinted hair may occur.

Coal tar may have a photosensitising action and caution should be exercised in exposing skin to sunlight after use.

Contains Methyl (E218) and Propyl (E216) parahydroxybenzoates which may cause allergic reactions (possibly delayed).

Esters of benzoic acid, benzyl benzoate and butylated hydroxytoluene (E321) may cause local skin reactions (e.g contact dermatitis), or irritation to the eyes and mucous membranes.

This medicine contains fragrance with the following components which may cause allergic reactions: Alpha-Isomethyl-ionone, Amyl Cinnamal, AmylCinnamyl Alcohol, Benzyl Benzoate, Benzyl Cinnamate, Benzyl Salicylate, Cinnamal, Cinnamyl Alcohol, Citral, Citronellol, Eugenol, Farnesol, Geraniol, Hexyl Cinnamal, Hydroxycitronellal, Isoeugenol, Limonene and Linalool.

No interaction studies have been performed.

There are no studies to demonstrate the safety of Neutrogena T/Gel Therapeutic Shampoo in human pregnancy.

It is recommended that Neutrogena T/Gel Therapeutic Shampoo is not used during pregnancy or while breast-feeding, unless the risks and benefits have been evaluated and discussed with a physician.

Not relevant.

Adverse drug reactions (ADRs) identified during clinical trials and post-marketing experience with coal tar are listed below by System Organ Class (SOC). The frequencies are provided according, to the following convention:

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

Not known - cannot be estimated from the available data

ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as 'Not known'.

Other Adverse Drug Reactions identified in published literature include:

Skin and subcutaneous tissue disorders

Dermatitis acneiform

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not applicable.

Pharmacotherapeutic group: Medicated Shampoo, ATC code: D11 AC 30

Coal tar suppresses DNA synthesis in hyperplastic skin by inhibiting mitotic activity and protein synthesis. It reduces epidermal proliferation and dermal infiltration, thus producing a return to normal hornification. Tar also has (cellular) proliferation-inhibiting, vasoconstrictive, antipruritic and antiseptic properties. This is of significance in the treatment of skin disease where there is increased cell partition, such as dandruff.

Little is known about the percutaneous absorption, residence time and excretion of coal tar, although there is an epidermal metabolism of polyaromatic hydrocarbons, and the urine of patients undergoing therapy with high levels of raw coal tar contains substances which apparently originate from the raw coal tars used. The potential for a systematic absorption of coal tar from shampoo is extremely low because it is washed off after use.

Effects in non-clinical studies were observed only at exposures considered sufficiently in, excess of, the maximum human exposure indicating little relevance to clinical use.

Coal tar contains certain chemicals that are mutagenic and high dose administration of coal tar to laboratory animals is carcinogenic. However, epidemiological evidence from patients receiving coal tar therapy do not suggest a potential for an increased risk of skin or systemic cancer.

Macrogol lauryl ether (4)

Sodium lauryl ether sulfate

Cocodiethanolamide

Cocamidopropyl betaine

Imidazolidinyl urea

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Tetrasodium EDTA

Citric acid

Fragrance*

Sodium chloride

Purified water

*The constituents of the fragrance include esters of benzoic acid, benzyl benzoate, butylated hydroxytoluene (E321) and other allergens (refer to section 4.4).

Not applicable

3 years

Store away from direct sunlight. Do not store above 25° C.

Clear plastic bottle with plastic pop-up cap, or screw top, containing 15 ml, 125 ml, 250 ml or 2 x 250 ml solution.

Not all pack sizes may be marketed.

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.