PAEDIATRIC KAOLIN MIXTURE BP (CHILDRENS DIARRHOEA MIXTURE)
NAME OF THE MEDICINAL PRODUCT
Paediatric Kaolin Mixture BP (Children's Diarrhoea Mixture)
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mixture containing light Kaolin 20 % w/v
Posology and method of administration
Infants under 1 year:
Infants 1-5 years:
One 5 ml spoonful by mouth
Two 5ml spoonfuls by mouth
Hypersensitivity to any of the listed ingredients.
Special warnings and precautions for use
Shake the bottle. Consult a doctor if symptoms persist for 24 hours. Earlier
medical attention may be advisable for infants under 1 year.
Suitable for the symptomatic relieve of diarrhoea only. Not substitute for
Interaction with other medicinal products and other forms of interaction
The absorbent properties of kaolin may influence the gastrointestinal
absorption of drugs.
Hydroxychloroquine, phenothiazines, quinidine, and tetracyclines.
Fertility, pregnancy and lactation
Effects on ability to drive and use machines
Light kaolin is an absorbent and when given by mouth absorbs toxic and other
substances from the alimentary tract and increases the bulk of the faeces.
The light kaolin absorbs toxic and other substances from the alimentary tract
and increases the bulk of the faeces.
Preclinical safety data
Kaolin is well-established for its pharmacological and toxicological properties. There
are no pre-clinical data of clinical concern.
List of excipients
* amaranth solution BP
* benzoic acid solution BP
* raspberry syrup BP (prepared in situ from) concentrated raspberry juice,
sucrose, potable water
* double strength chloroform water BP (prepared in situ from) chloroform BP,
* sodium methyl hydroxy benzoate BP
* sodium propyl hydroxy benzoate BP
Special precautions for storage
Keep out of the reach and sight of children.
Nature and contents of container
Amber glass bottle with a plastic cap containing 100ml, 250ml, 500ml
White plastic bottle with a plastic cap containing 1000ml, 2000ml
Special precautions for disposal
MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited,
11 Boumpoulinas, 3rd Floor,
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
19th September 1986 / 21st January 1997
DATE OF REVISION OF THE TEXT