SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Neutrogena T/Gel Therapeutic Shampoo.

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

The shampoo contains Neutar solubilised coal tar extract 20mg/ml (equivalent to 5mg/ml coal tar) as the active ingredient.

For a full list of excipients see section 6.1.

3    PHARMACEUTICAL FORM

Shampoo

A translucent amber solution

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

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

4.2    Posology and method of administration

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.

4.3 Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

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

4.4    Special warnings and precautions for use

If irritation develops, discontinue use and consult a physician.

Contact with eyes should be avoided.

In rare instances, temporary discoloration of blond, 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 parahydroxybenzoates which may cause allergic reactions (possibly delayed).

Contains esters of benzoic acid and benzyl benzoate which can mildly irritate the skin, eyes and mucous membranes.

Contains butylated hydroxytoluene, which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

4.5    Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6 Fertility, pregnancy and lactation

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.

4.7 Effects on ability to drive and use machines

Not relevant.

4.8 Undesirable effects

Adverse drug reactions (ADRs) identified during post-marketing experience with coal tar are presented in Table 1. In this table, 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

Table 1: Adverse Drug Reactions Identified During Post-Marketing Experience with Coal Tar by Frequency Category estimated from Spontaneous Reporting Rates

Body system	Incidence	Reported adverse event
Immune System Disorders	Not known	Angioedema Hypersensitivity (including Urticaria, Photosensitization)
Skin and Subcutaneous Disorders	Not known	Hair loss Dry Hair Rash
General Disorders and Administrative Site Conditions	Not known	Application site reactions (including burning sensation, irritation, pruritus and dry scalp)

Other Adverse Drug reactions identified in published literature include:

Skin and subcutaneous tissue disorders

Acne like skin eruptions

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

4.9 Overdose

Not applicable.

5 PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Medicated Shampoo, ATC code: D11AC30 No new data are presented

5.2    Pharmacokinetic properties

No new data are presented

5.3 Preclinical safety data

No new data are presented

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Macrogol lauryl ether (4)

Sodium lauryl ether sulfate Cocodiethanolamide Cocamidopropyl betaine Imidazolidinyl urea Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Tetrasodium EDTA Citric acid

Fragrance FUGIO 242156 Sodium chloride Purified water

*The constituents of the fragrance include esters of benzoic acid, benzyl benzoate and butylated hydroxytoluene (E321).

6.2 Incompatibilities

Not applicable

6.3 Shelf life

3 years

6.4    Special precautions for storage

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

6.5    Nature and contents of container

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

Not all pack sizes may be marketed.

6.6    Special precautions for disposal

No special requirements.

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

7    MARKETING AUTHORISATION HOLDER

Johnson & Johnson Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

8    MARKETING AUTHORISATION NUMBER

PL 08874/0014

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 30 April 1996 Date of latest renewal: 06 February 2004

10 DATE OF REVISION OF THE TEXT

27/06/2016