SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Cetrimide Antiseptic First Aid Cream Morrisons’ Cetrimide Antiseptic First Aid Cream Wilko Antiseptic Cream Cetrimide 0.5% w/w Numark Antiseptic Cream Cetrimide 0.5% w/w Superdrug Cetrimide Antiseptic 0.5% w/w Cream Tesco Cetrimide Antiseptic 0.5% w/w Cream

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Cetrimide 0.50 %w/w For excipients, see 6.1.

3    PHARMACEUTICAL FORM

Cream

Smooth opaque white cream

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

An antiseptic cream for chapped hands, minor skin abrasions, minor cuts and nappy rash.

4.2    Posology and method of administration

For all ages.

For general use, clean surrounding skin and apply cetrimide cream directly or on a piece of clean lint or gauze.

Contraindications

Hypersensitivity to cetrimide or any of the ingredients.

4.4    Special warnings and precautions for use

For external use only.

“Keep all medicines out of reach of children”.

Prolonged and repeated applications of cetrimide are inadvisable as hypersensitivity may occur.

Avoid contact with the eyes.

4.5    Interaction with other medicinal products and other forms of interaction

None.

4.6    Fertility, pregnancy and lactation

No special precautions.

4.7 Effects on ability to drive and use machines

No or negligible influence.

4.8 Undesirable effects

Hypersensitivity reactions may occasionally occur in certain individuals and present as localised contact dermatitis.

4.9 Overdose

Overdosage with Cetrimide Cream B.P. is extremely unlikely. The ingestion of very large quantities of cetrimide and other quaternary ammonium compounds can cause nausea, vomiting, dyspnoea, cyanosis, CNS depression (sometimes preceded by excitement and convulsions), hypotension and coma. The fatal dose of quaternary ammonium compounds has been estimated to be 1 to 3 grams (equivalent to 200 -    600 grams of Cetrimide

Cream B.P. 0.5% w/w).

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

D08A J04 - Antiseptics & Disinfectants Quaternary Ammonium Compounds Contains Cetrimide which is a topical disinfectant.

5.2    Pharmacokinetic properties

Not applicable.

5.3    Preclinical safety data

No data of relevance to the prescriber, which is additional to that included in other sections of the SPC.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Liquid Paraffin Cetostearyl Alcohol

Phenonip [containing Phenoxyethanol, Methyl parahydroxybenzoate (E218), Ethyl parahydroxybenzoate (E214), Butyl parahydroxybenzoate, Iso butyl 4-hydroxyb enzoate

Propyl parahydroxybenzoate (E216)]

Purified Water

6.2    Incompatibilities

Not applicable.

6.3    Shelf life

As packaged for sale 48 months.