SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Cetrimide Cream BP Bells Antiseptic Cream Wilko Antiseptic 0.5% w/w Cream Galpharm Medical Antiseptic Cream Asda Antiseptic First Aid Cream Numark Antiseptic Cream Vantage Antiseptic 0.5%w/w Cream

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Cetrimide BP 0.5% w/w

3.    PHARMACEUTICAL FORM

Cream

4.    CLINICAL PARTICULARS

4.1    Therapeutic indications

For application to minor burns, minor wounds, cuts, grazes, minor abrasions and minor scalds to prevent infection.

4.2    Posology and method of administration

For topical application to the affected areas, there is no difference in use for children, adults or the elderly.

Contra-Indications

Avoid contact with eyes, brain, meninges and middle ear. Do not use in body cavities or as an enema.

4.4 Special warnings and Special precautions for use

None stated

4.5 Interactions with other Medicinal Products and other Forms of interaction

None stated

4.6 Pregnancy and lactation

None stated

4.7 Effects on ability to drive and use machines

None stated

4.8 Undesirable effects

Some patients may become hypersensitive to cetrimide on repeated application.

4.9 Overdose

Overdose may cause nausea and vomiting. The product has depolarising muscle relaxant properties and toxic symptoms including dyspnoea and cyanosis (due to paralysis of the respiratory muscles and possibly leading to asphyxia), depression of the central nervous system, hypotension and coma may also occur. Treatment of poisoning is symptomatic.

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Cetrimide is a quaternary ammonium disinfectant with properties and uses typical of cationic surfactants. These surfactants dissociate in aqueous solution into a relatively large and complex cation, which is responsible for the surface activity, and a smaller inactive anion. In addition to the emulsifying and detergent properties, Cetrimide has bactericidal activity against gram positive and some gram negative organisms.

5.2 Pharmacokinetic properties

Plasma concentrations for topical applications are extremely low, therefore clinically not significant.

5.3 Preclinical safety data

None stated

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Cetostearyl Alcohol BP Liquid Paraffin BP

Nipastat^*

Purified Water BP

* Nipastat is a mixture of Methyl, Ethyl, Propyl, iso-Butyl and n-Butyl Hydroxybenzoates.

6.2. Incompatibilities

None stated

6.3. Shelf life

2 years

6.4.    Special precautions for storage

Store below 25 °C.

6.5.    Nature and contents of container

15g, 30g and 50g aluminium tubes.

6.6.    Instruction for Use, Handling and Disposal

None stated.

7 MARKETING AUTHORISATION HOLDER

Ecolab Ltd,

Lotherton Way,

Garforth,

Leeds,

LS25 2JY

8.    MARKETING AUTHORISATION NUMBER

PL 04509/0007

9.    DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

1^st March 2003

10 DATE OF REVISION OF THE TEXT

06/03/2011