Summary of medicine characteristics - WELL PHARMACEUTICALS TRIPLE ACTION COUGH ORAL SOLUTION, NUMARK TRIPLE ACTION COUGH ORAL SOLUTION, LLOYDS PHARMACY TRIPLE ACTION COUGH ORAL SOLUTION, KILKOF, SAINSBURYS TRIPLE ACTION COUGH ORAL SOLUTION, SUPERDRUG TRIPLE ACTION COUGH ORAL SOLUTION, BELLS
1 NAME OF THE MEDICINAL PRODUCT
1 NAME OF THE MEDICINAL PRODUCTKilkof
Bells Healthcare Triple Action Cough Oral Solution Lloyds Pharmacy Triple Action Cough Oral Solution Numark Triple Action Cough Oral Solution
Superdrug Triple Action Cough Oral Solution Sainsbury’s Triple Action Cough Oral Solution
Well Pharmaceuticals Triple Action Cough Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains:
Capsicum Tincture 0.022 ml
Benzoin Tincture 0.083 ml
Cetylpyridinium Chloride 1.5 mg
3 PHARMACEUTICAL FORM
3 PHARMACEUTICAL FORMOral Liquid
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
For the relief of coughs, colds and sore throats
4.2 Posology and method of administration
Oral administration
Children 10–14 years old: One 5 ml spoonful
Adults : Two 5m1 spoonfuls
Dose may be repeated three times daily and at bedtime
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special warnings and special precautions for use
Keep out of reach of children. If cough persists consult your doctor. Shake bottle.
4.5 Interactions with other medicinal products and other forms of interaction
No specific interactions reported
4.6 Pregnancy and lactation
No evidence exists that suggests that this medicine adversely effects pregnancy, however as with all avoidable medicines it is advised not to take Kilkof during pregnancy.
4.7 Effects on ability to drive and use machines
Unlikely to affect ability to drive or use machines.
4.8 Undesirable effects
No undesirable effects have been reported at these dosage levels.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
4.9 OverdoseExcessive dose may have an irritant effect. Removal of medication should alleviate symptoms. If not, activated charcoal may be given followed if necessary by gastric lavage.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Tincture of Capsicum produces an irritant action on the mucous membranes of the mouth and digestive tract which induces a feeling of warmth.
Benzoin Tincture has a soothing effect on mucous membranes and has been used for the treatment of catarrh of the upper respiratory tract.
Cetylpyridinium Chloride is a quaternary pyridinium antiseptic and is used for the treatment of superficial mouth and throat infections.
5.2 Pharmacokinetic properties
In the small doses present the active drugs will be absorbed through mucous membranes.
5.3 Preclinical safety data
5.3 Preclinical safety dataNone available
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Liquorice Liquid Extract
Acetic Acid 80%
Tolu Tincture
Ether Anaesthetic
Star Anise Oil
Honey Pure Pale Amber
Treacle
Caramel
Sucrose
Liquid Glucose
Methyl Hydroxybenzoate
Xanthan Gum
Purified Water
6.2 Incompatibilities
None known
6.3 Shelf life
36 months in unopened container
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
Bottle: Amber (Type III) glass
Closures: Child resistant closure (CRC) fitted with low density polyethylene EPE/AL/PET liner
OR
Roll on pilfer proof (ROPP) screw cap fitted with low density polyethylene EPE/AL/PET liner
Size: 100 ml, 125 ml, 150 ml, 200 ml.
30 ml CE marked polypropylene measuring cup with 2.5 ml, 3.3 ml 4 ml, 5 ml, 7.5 ml, 10 ml, 15 ml, 20 ml and 25 ml graduations.(May not be included in all marketed products) Not all packs may be marketed.
6.6 Instructions for use/handling
Shake bottle before use
7. MARKETING AUTHORISATION HOLDER
Bell, Sons & Co (Druggists) Ltd
Gifford House
Slaidburn Crescent
Southport
Merseyside
PR9 9AL
8. MARKETING AUTHORISATION NUMBER
PL 03105/0044
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATIONDate of grant 4th September 1985
Date of renewal 1st June 1994