Junior Kao-C Diarrhoea Suspension
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Junior KAO-C Diarrhoea Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Light Kaolin BP 500mg Calcium Carbonate BP 250mg
3 PHARMACEUTICAL FORM
Oral Suspension
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of mild diarrhoea of short duration.
4.2 Posology and method of administration
Route of administration: Oral
Children
1-5 years: One 5ml spoonful
5-14 years: Two 5ml spoonfuls
Over 14 years: Four 5m1 spoonfuls
To be taken three times daily.
4.3
Contraindications
None stated.
4.4 Special warnings and precautions for use
If the diarrhoea has not cleared up within three days, consult your doctor.
Keep out of the reach of children.
4.5 Interaction with other medicinal products and other forms of interaction
Junior KAO-C Suspension may influence the gastro-intestinal absorption of other drugs e.g. Linomycin, Tetracyclines, Aspirin, Diflunisal, Ciprofloxacin, Pivampacillin, Rifampicin and Penicillamine.
It may enhance the cardiac effects of Digitalis Glycosides.
4.6 Fertility, pregnancy and lactation
May be used.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
Large doses may cause hypercalcaemia and alkalosis. Flatulence and eructation may occur.
4.9 Overdose
Symptomatic treatment should be given.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Antacid, adsorbent.
5.2 Pharmacokinetic properties
None stated.
5.3 Preclinical safety data
None stated.
|
List of excipients | |
|
Cinnamon Oil |
BP |
|
Nutmeg Oil |
BP |
|
Clove Oil |
BP |
|
Avicel RC-501-(Microcrystalline cellulose |
USP |
|
and carboxymethyl cellulose) | |
|
Carmellose Sodium |
BP |
|
Sodium Cyclamate 1968 |
BP |
|
Sodium Saccharin |
BP |
|
Vanillin |
BP |
|
Methylhydroxybenzoate |
BP |
|
Propylhydroxybenzoate |
BP |
|
Chloroform |
BP |
|
Water |
HSE |
6.2 Incompatibilities
None known.
6.3 Shelf life
5 years.
6.4 Special precautions for storage
None.
6.5 Nature and contents of container
Amber sloping shoulder glass bottle with polypropylene cap containing 100ml of product.
6.6 Special precautions for disposal
None stated.
7 MARKETING AUTHORISATION HOLDER
Torbet Laboratories Limited
14D Wendover Road
Rackheath Industrial Estate
Norwich
Norfolk
NR13 6LH
8 MARKETING AUTHORISATION NUMBER(S)
PL 00287/0019
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9th April 2002
10 DATE OF REVISION OF THE TEXT
12th April 2002