Summary of medicine characteristics - NUMARK ANTISEPTIC CREAM CETRIMIDE 0.5% W/W,MORRISONS CETRIMIDE ANTISEPTIC FIRST AID CREAM,TESCO HEALTH CETRIMIDE ANTISEPTIC 0.5% W/W CREAM,WILKO ANTISEPTIC CREAM CETRIMIDE 0.5% W/W,CETRIMIDE ANTISEPTIC FIRST AID CREAM,SUPERDRUG CETRIMIDE ANTISEPTIC 0.5% W
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 Health Cetrimide Antiseptic 0.5% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Cetrimide 0.50 % w/w.
Excipients of known effect:
Cetostearyl alcohol, 0.5% w/w
Ethyl parahydroxybenzoate E214, 0.032% w/w
Propyl parahydroxybenxoate E216, 0.016% w/w
Methyl parahydroxybenzoate E218, 0.124% w/w.
For full list of excipients, see section 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 and minor cuts.
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 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
4.9 OverdoseOverdosage 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
5.3 Preclinical safety dataNo 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
6.1 List of excipientsLiquid Paraffin
Cetostearyl Alcohol
Phenonip [containing Phenoxyethanol, Methyl parahydroxybenzoate (E218),
Ethyl parahydroxybenzoate (E214), Butyl parahydroxybenzoate, Iso butyl 4-hydroxybenzoate
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.