This information is intended for use by health professionals

1. Name of the medicinal product

Selsun Shampoo 2.5%

2. Qualitative and quantitative composition

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

3. Pharmaceutical form

Shampoo

Smooth, pale yellow to beige uniform suspension.

4. Clinical particulars
4.1 Therapeutic indications

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

4.2 Posology and method of administration

Apply topically to the scalp.

Adults and the elderly:

After thoroughly wetting the hair massage Selsun in to form a lather. Rinse after 2 to 3 minutes.

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:

As for adults.

Children under 5 years of age:

Not recommended.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

Do not allow contact with broken or severely inflamed skin.

4.4 Special warnings and precautions for use

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 (see Section 4.2).

4.5 Interaction with other medicinal products and other forms of interaction

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.

4.6 Fertility, pregnancy and lactation

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.

4.7 Effects on ability to drive and use machines

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

4.8 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

4.9 Overdose

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

5. Pharmacological properties
5.1 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).

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

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

6. Pharmaceutical particulars
6.1 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.

6.2 Incompatibilities

None known.

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 wadless caps, containing 50, 100 or 150ml.

6.6 Special precautions for disposal and other handling

Not applicable.

7. 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

8. Marketing authorisation number(s)

PL 04425/0683

9. Date of first authorisation/renewal of the authorisation

16 December 2002

10. Date of revision of the text

31 July 2014