Selsun

Selsun Shampoo 2.5%

Each 100 ml of suspension contains 2.5 g of Selenium Sulphide Ph. Eur.

Shampoo

Smooth, pale yellow to beige uniform suspension.

In the management of simple dandruff and seborrhoeic dermatitis of the scalp.

Apply topically to the scalp.

Adults and the elderly:

Usage should be twice a week for the next two weeks to control the condition. After this initial course of treatment Selsun should not be used more often than necessary.

Children aged 5 - 14 years:

Children under 5 years of age:

Hypersensitivity to any of the ingredients.

Do not allow contact with broken or severely inflamed skin.

Gold, silver and other metallic jewellery should be removed prior to use, since discolouration may be caused.

For external use only. Keep out of eyes; if Selsun gets into the eyes, wash thoroughly with cold water.

Do not leave the shampoo in contact with the hair or skin for more than the recommended duration as irritation, burning sensation or blistering may occur and do not use more often than recommended.

Selsun should be very thoroughly rinsed from the hair before dyeing, tinting, or permanent waving the hair. It should not be applied for a period of two days before or after any of these procedures.

There are no adequate data from the use of selenium sulphide in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, foetal development and postnatal development.

Avoid during pregnancy and breastfeeding.

No studies on the effects on the ability to drive or use machines have been performed.

Application to the skin or scalp may produce irritation or sensitisation, sometimes described as a burning sensation. Rarely, blistering can occur, especially if the shampoo is kept in contact with the skin for longer than the recommended duration. An increase in the amount of normal hair loss can occur. Discoloration of the hair may occur; this can be avoided or minimised by thorough washing of the hair after treatment. As with other shampoos, oiliness or dryness of hair and scalp may occur. Non-specific allergic reactions, including rash and urticaria, have been reported rarely

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

If ingested, vomiting should be provoked and general supportive measures given.

Selenium sulphide appears to have a cytostatic effect on cells of the epidermis and follicular epithelium, thus reducing corneocyte production. Selsun acts as an antiseborrhoeic agent which effectively controls itching and scaling dandruff. It has activity against certain dermatophytes including Pityrosporum orbiculare, the organism causing pityriasis versicolor (tinea versicolor).

Not applicable.

No additional preclinical information, relevant to the indication, is presented.

Bentonite, titanium dioxide, citric acid, sodium dihydrogen phosphate dihydrate, glyceryl monoricinoleate S, monoethanolamine lauryl sulphate, Empigen BB, perfume, sodium chloride, sodium hydroxide for pH adjustment, purified water.

None known.

3 years.

Do not store above 25°C.

High density polyethylene bottles fitted with wadless caps, containing 50, 100 or 150ml.

Not applicable.

Aventis Pharma Limited

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

Or trading as:

sanofi-aventis or Sanofi

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

PL 04425/0683

16 December 2002

31 July 2014