This information is intended for use by health professionals

1. Name of the medicinal product

Kaolin and Morphine Mixture BP

2. Qualitative and quantitative composition

Active Ingredient

%w/v

Irradiated light kaolin BP

20

Morphine Hydrochloride Ph Eur

0.0092

3. Pharmaceutical form

A slowly separating buff suspension with the odour and taste of chlorodyne.

4. Clinical particulars
4.1 Therapeutic indications

For the relief of occasional diarrhoea.

For oral administration.

4.2 Posology and method of administration

Adults and children over 12 years: 10ml (two teaspoonfuls) in water.

May be repeated three times a day until the condition is relieved.

Children under 12 years: Not recommended for children under 12 years.

Elderly: There is no need for dosage reduction in the elderly.

4.3 Contraindications

Hypersensitivity to any of the ingredients. Respiratory depression, acute alcoholism, head injuries and conditions in which there is raised intracranial pressure. Impaired liver function.

4.4 Special warnings and precautions for use

Should be used with caution in patients with inflammatory or obstructive bowel disorders.

Keep all medicines out of the reach of children.

Warning: Do not exceed the stated dose.

If diarrhoea does not stop in 24 hours, talk to your doctor.

Suitable for the symptomatic relief of diarrhoea only. No substitute for rehydration therapy. Drink plenty of fluids if you have diarrhoea.

May cause drowsiness. If affected do not drive or operate machinery.

4.5 Interaction with other medicinal products and other forms of interaction

Clinically significant interactions may occur in patients taking maoi's concurrently or within 14 days of such treatment and these reactions may be serious. The depressant effects of morphine may enhance depressants of the central nervous system such as alcohol, hypnotics, sedatives and phenothiazines. The absorbent properties of kaolin may influence the gastrointestinal absorption of other drugs.

4.6 Pregnancy and lactation

The safety of kaolin and morphine during pregnancy and lactation has not been established, though no special precautions are thought necessary provided the recommended dose is taken.

4.7 Effects on ability to drive and use machines

Kaolin and morphine mixture may cause drowsiness in certain individuals and may therefore interfere with the ability to drive or operate machinery.

4.8 Undesirable effects

Common side effects which may occur include nausea, vomiting, constipation, drowsiness, dry mouth, sweating, facial flushing and miosis.

4.9 Overdose

Symptoms of overdosage may include nausea, vomiting, drowsiness, confusion, dry mouth, sweating, facial flushing, bradycardia, palpitations, orthostatic hypotension and miosis. Respiratory depression, circulatory failure, deepening coma and convulsions may also occur.

Treatment consists of emptying the stomach by aspiration and lavage. A saline purgative such as sodium sulphate, 30g in 250ml of water may be given to aid peristalsis.

The specific narcotic antagonist naloxone may be used to rapidly counteract the respiratory depression and coma. Otherwise treatment should be symptomatic and supportive.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Light kaolin is absorbent and when given orally absorbs toxic and other substances from the gastrointestinal tract and increases the bulk of the faeces.

Morphine in small doses increases tone and contraction in both the small and large bowel without analgesic effect and thereby delays intestinal transit.

5.2 Pharmacokinetic properties

Kaolin is not absorbed from the gastrointestinal tract. Morphine is absorbed from the gastrointestinal tract and undergoes significant first pass metabolism in the liver. Morphine is widely distributed.

Metabolism occurs in the liver, principally to morphine 3- and 6- glucuronides, although smaller amounts of morphine undergo n-demethylation and o-methylation. About 10% of morphine is secreted in the bile and eliminated in the faeces, while the remainder is excreted in the urine, mainly as conjugates.

5.3 Preclinical safety data

Not applicable.

6. Pharmaceutical particulars
6.1 List of excipients

Sodium bicarbonate

Black treacle

Liquorice liquid extract

Peppermint oil

Alcohol 96%

Anaesthetic ether

Chloroform

Liquid sugar

Purified water

6.2 Incompatibilities

Not applicable

6.3 Shelf life

36 months

6.4 Special precautions for storage

Keep tightly closed

6.5 Nature and contents of container

A 2000ml amber-coloured glass bottle with a wadless polypropylene cap.

A 200ml amber-coloured glass bottle, screwneck and a pilfer-proof aluminium roll-on cap with a PVC flowed in liner or triseal (LDPE/EPE/LDPE) liner.

6.6 Special precautions for disposal and other handling

Not applicable.

7. Marketing authorisation holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

Trading as: BCM

8. Marketing authorisation number(s)

PL 0014/5783R

9. Date of first authorisation/renewal of the authorisation

30 November 1990

10. Date of revision of the text

January 2010