1. Name Of The Medicinal Product
Cream of Magnesia Tablets
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Tablet
4. Clinical Particulars
4.1 Therapeutic Indications
For fast relief of acid indigestion, flatulence and heartburn.
For oral adinistration.
4.2 Posology And Method Of Administration
Adults and children over 12 years:
Chew 2 tablets after meals, at bedtime or when required.
Children 5-12 years:
Chew 1 tablet after meals, at bedtime or when required. Alternatively the tablets may be taken crushed in milk or water.
Not recommended for children under 5 years.
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.
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 Tablets 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 concentration of Salicylates will be reduced by antacid-induced changes in urinary PH, increasing urinary excretion.
4.6 Pregnancy And Lactation
The safety of Cream of Magnesia Tablets during pregnancy and lactation has not been established but occasional use during these periods is not considered to constitute a hazard.
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 the 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.
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.
5.3 Preclinical Safety Data
Not applicable.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Icing sugar
Sodium saccharin pdr
Idustrial Methylated Spirit
Purified water
Dried maize starch pdr
Magnesium stearate
Blanose sodium
Carboxymethyl cellulose 7MF
Peppermint oil SL 2367
or
Peppermint oil BP black leaf
Spearmint oil
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
36 months
6.4 Special Precautions For Storage
Glass bottle: None
HDPE bottle and Blister: Store below 30EC in a dry place
6.5 Nature And Contents Of Container
An amber glass bottle with a polypropylene lectraseal screw cap or a white tin plate screw cap fitted with a waxed pulpboard liner.
Pack sizes: 50, 150 tablets.
A white high density polyethylene bottle with a polypropylene cap fitted with an induction heat seal membrane.
Pack sizes: 50, 150 tablets.
An Aluminium/PVC blister pack.
Pack sizes: 12, 24, 36, 48, 60 tablets.
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
8. Marketing Authorisation Number(S)
PL 0014/5376R
9. Date Of First Authorisation/Renewal Of The Authorisation
Date of First Authorisation: 30 January 1990
Date of Last Renewal: 17 January 1996
10. Date Of Revision Of The Text
September 2000.
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