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KAOLIN AND MORPHINE MIXTURE BP

Active substance(s): CHLOROFORM AND MORPHINE TINCTURE / IRRADIATED LIGHT KAOLIN / LIGHT KAOLIN STERILISED / MORPHINE HYDROCHLORIDE / CHLOROFORM AND MORPHINE TINCTURE / IRRADIATED LIGHT KAOLIN / LIGHT KAOLIN STERILISED / MORPHINE HYDROCHLORIDE / CHLOROFORM AND MORPHINE TINCTURE / IRRAD

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SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Kaolin and Morphine Mixture BP

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredient Irradiated light kaolin BP Morphine Hydrochloride Ph Eur % w/v 20 0.0092

3.

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

4. 4.1.

CLINICAL PARTICULARS 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.

Contra-Indications

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 Special 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. Interactions with other Medicinal Products and other Forms of Interaction Clinically significant interactions may occur in-patients taking maois 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. 5.1.

PHARMACOLOGICAL PROPERTIES 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 6glucuronides, 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.

Pre-clinical Safety Data Not applicable.

6
6.1

PHARMACEUTICAL PARTICULARS
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 Content 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.

Instructions for Use, Handling and Disposal Not applicable.

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MARKETING AUTHORISATION HOLDER The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA

Trading as: BCM Almus 8. MARKETING AUTHORISATION NUMBER PL 0014/5783R

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 30 November 1990

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DATE OF REVISION OF THE TEXT
17/05/2010

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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