Wilko Antiseptic Cream Cetrimide 0.5% W/W
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.
4.3
Contraindications
Hypersensitivity to cetrimide or any of the ingredients.
4.4 Special warnings and precautions for use
Use this medicine only on your skin.
Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis)
E214, E216 and E218 may cause allergic reactions (possibly delayed).
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.
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
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.
6.4 Special precautions for storage
None.
6.5 Nature and contents of container
15g, 30g, 45g, 50g and 60g lacquered metal tubes with plastic cap.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
OTC Concepts Limited 2 Park Stree Woburn Bedfordshire MK17 9PG United Kingdom.
8 MARKETING AUTHORISATION NUMBER(S)
PL 20338/0002.
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
8th July 2003
23/02/2016