Selsun

Overdose

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

Shelf life

3 years.

Incompatibilities

None known.

List of excipients

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.

Undesirable effects

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

Preclinical safety data

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

Pharmacodynamic properties

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).

Pharmacokinetic properties

Not applicable.

Date of revision of the text

31 July 2014

Marketing authorisation holder

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

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

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

Marketing authorisation number(s)

PL 04425/0683

Special precautions for disposal and other handling

Not applicable.

Date of first authorisation/renewal of the authorisation

16 December 2002