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PAEDIATRIC KAOLIN MIXTURE BP (CHILDRENS DIARRHOEA MIXTURE)

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Paediatric Kaolin Mixture BP (Children's Diarrhoea Mixture)

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Mixture containing light Kaolin 20 % w/v

3

PHARMACEUTICAL FORM
Liquid mixture

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Diarrhoea.

4.2

Posology and method of administration
Infants under 1 year:
Infants 1-5 years:

4.3

One 5 ml spoonful by mouth
Two 5ml spoonfuls by mouth

Contraindications
Hypersensitivity to any of the listed ingredients.

4.4

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
Rehydration therapy.

4.5

Interaction with other medicinal products and other forms of interaction
The absorbent properties of kaolin may influence the gastrointestinal
absorption of drugs.
Kaolin
possibly
reduces
absorption
of
aspirin,
chloroquine,
Hydroxychloroquine, phenothiazines, quinidine, and tetracyclines.

4.6

Fertility, pregnancy and lactation
Not applicable.

4.7

Effects on ability to drive and use machines
None stated.

4.8

Undesirable effects
None stated.

4.9

Overdose
None.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
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.

5.2

Pharmacokinetic properties
The light kaolin absorbs toxic and other substances from the alimentary tract
and increases the bulk of the faeces.

5.3

Preclinical safety data
Kaolin is well-established for its pharmacological and toxicological properties. There
are no pre-clinical data of clinical concern.

6

PHARMACEUTICAL PARTICULARS

6.1

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,
potable water
* sodium methyl hydroxy benzoate BP
* sodium propyl hydroxy benzoate BP

6.2

Incompatibilities
None.

6.3

Shelf life
12 months.

6.4

Special precautions for storage
Keep out of the reach and sight of children.

6.5

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

6.6

Special precautions for disposal
None.

7

MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited,
11 Boumpoulinas, 3rd Floor,
P.C. 1060
Nicosia.
Cyprus

8

MARKETING AUTHORISATION NUMBER(S)
PL 28444/0062

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
19th September 1986 / 21st January 1997

10

DATE OF REVISION OF THE TEXT
23/01/2012

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