1. Name Of The Medicinal Product
Cream of Magnesia BP
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
A white emulsion.
4. Clinical Particulars
4.1 Therapeutic Indications
For the relief of indigestion and constipation.
4.2 Posology And Method Of Administration
As an antacid
Adults and children over 12 years: 5 to 10ml (1 to 2 teaspoonfuls)
Children 6 to 12 years: 2.5 to 5 ml (0.5 to 1 teaspoonful) according to age.
These doses should be taken in a little water after meals or when required.
Elderly: Dosage may need to be reduced.
As a laxative
Adults and children over 12 years: 25 to 50ml (5 to 10 teaspoonfuls).
Children 6 to 12 years: 5 to 15ml (1 to 3 teaspoonfuls) according to age.
These doses should be taken in a little warm water at bedtime.
Children up to 6 years: As recommended by the doctor.
Elderly: Dosage may need to be reduced.
For oral administration.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special Warnings And Precautions For Use
Caution should be exercised in the elderly and in patients with renal impairment.
Laxatives should not be taken where there is severe abdominal pain or used regularly for prolonged periods, except on medical advice.
If symptoms persist consult your doctor.
Keep all medicines out of the reach of children.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Cream of magnesia may interfere with the absorption of cimetidine, diflunisal, digoxin, indomethacin, iron salts and tetracyclines. Absorption of buffered or enteric coated aspirin is increased by simultaneous administration of antacids. Blood concentrations of salicylates will be reduced by antacid-induced changes in urinary pH, increasing urinary excretion.
4.6 Pregnancy And Lactation
There is no adequate human data from the use of magnesium oxide and magnesium sulphate in pregnant women.
Studies in animals have not been done.
Caution should therefore be exercised when taken by pregnant women.
Although some magnesium may be secreted in breast milk, the concentration is too small to be harmful.
4.7 Effects On Ability To Drive And Use Machines
No adverse effects known.
4.8 Undesirable Effects
May cause diarrhoea. In patients with impaired renal function there may be sufficient accumulation of magnesium to produce toxic effects.
4.9 Overdose
Symptoms of overdosage include gastrointestinal irritation and watery diarrhoea. Severe poisoning may produce hypermagnesaemia, symptoms of which include nausea, vomiting, flushing, thirst hypotension, drowsiness, confusion, loss of tendon reflexes, muscle weakness, respiratory depression, cardiac arrhythmias, coma and cardiac arrest.
Treatment consists of intravenous administration of calcium gluconate injection 10% in a dose of 10-20ml to counteract respiratory depression or heart block if renal function is normal, adequate fluids should be given to assist removal of magnesium from the body. Dialysis may be necessary in patients with renal impairment or severe hypermagnesaemia.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Magnesium hydroxide has antacid and laxative properties.
Magnesium sulphate has saline laxative properties.
5.2 Pharmacokinetic Properties
Magnesium hydroxide reacts rapidly with gastric acid to form magnesium chloride. Approximately 15-30% of the magnesium chloride formed is absorbed from the small intestine and is rapidly excreted by the kidneys in patients with normal renal function. Approximately 15-30% of an orally administered dose of magnesium sulphate is absorbed from the small intestine.
5.3 Preclinical Safety Data
Not applicable.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Chloroform
Purified water
6.2 Incompatibilities
None stated.
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
Protect from freezing.
6.5 Nature And Contents Of Container
A white or amber glass bottle having an aluminium pilfer-proof cap with flowed-in PVC liner or an expanded polyethylene liner or with an unlined polypropylene cap.
Pack size: 200, 500ml
Amber glass winchester having a thermoset plastic cap with a steran faced pulpboard liner.
Pack size: 2000 ml
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
8. Marketing Authorisation Number(S)
PL 0014/5304R
9. Date Of First Authorisation/Renewal Of The Authorisation
22 August 1990
10. Date Of Revision Of The Text
September 2002
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