Kaolin Mixture for Children

1. Name Of The Medicinal Product

Kaolin Mixture for Children or Children's Diarrhoea Mixture

2. Qualitative And Quantitative Composition

Kaolin light (grade A1) BP 1.0g per 5ml.

3. Pharmaceutical Form

Solution/mixture

4. Clinical Particulars

4.1 Therapeutic Indications

For relief of the symptoms of diarrhoea and upset stomachs in children.

4.2 Posology And Method Of Administration

Oral.

Recommended doses

Children up to 1 year of age: one 5ml spoonful.

Children 1 – 5 years of age: two 5ml spoonfuls.

Directions for use: shake the bottle.

To be repeated every four hours as required.

4.3 Contraindications

Contraindicated in intestinal obstruction; and in patients with known hypersensitivity to kaolin or any of the other constituents.

4.4 Special Warnings And Precautions For Use

Rehydration therapy may be necessary because of fluid and electrolyte depletion.

Keep all medicines out of the reach and sight of children.

If symptoms persist for more than 3 days consult your doctor.

Use with medical advice for infants under 1 year.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

As kaolin is an adsorbent, the absorption of other drugs from the gastrointestinal tract administered concomitantly may be reduced.

4.6 Pregnancy And Lactation

Although not relevant in childrens use, as with all medicines the use of this product should be avoided in pregnancy and lactation unless advised by a doctor.

4.7 Effects On Ability To Drive And Use Machines

None, although not relevant in children.

4.8 Undesirable Effects

None known.

4.9 Overdose

In the unlikely event of overdose, treatment should be symptomatic.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Kaolin is an adsorbent, it adsorbs toxic and other substances from the alimentary tract and increases the bulk of the faeces.

5.2 Pharmacokinetic Properties

Kaolin is not absorbed following oral administration. It remains unchanged throughout transit of the gastrointestinal tract.

5.3 Preclinical Safety Data

None.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Raspberry juice concentrated BP, syrup BP, benzoic acid BP, propylene glycol BP, chloroform BP and purified water BP.

6.2 Incompatibilities

None

6.3 Shelf Life

100ml: 36 months unopened, discard 8 weeks after first opening.

500ml: 36 months unopened, discard 8 weeks after first opening.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

100ml: Amber glass bottle with plastic lined cap or polypropylene child-resistant cap with saranex faced EPE liner or white 28mm Child-resistant cap with Tamper Evident band and EPE/Saranex Liner.

500ml: Amber glass bottle with plastic lined cap or polypropylene child-resistant cap with saranex faced EPE liner or white 28mm Child-resistant cap with Tamper Evident band and EPE/Saranex Liner.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

L.C.M Ltd

Linthwaite Laboratories

Huddersfield

HD7 5QH

8. Marketing Authorisation Number(S)

PL 12965/0020

9. Date Of First Authorisation/Renewal Of The Authorisation

07 January 1994

10. Date Of Revision Of The Text

10/11/2008