1. Name Of The Medicinal Product
Boots Magnesium Trisilicate Mixture BP
2. Qualitative And Quantitative Composition
Active ingredients |
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Sodium bicarbonate EP |
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3. Pharmaceutical Form
Oral Suspension
4. Clinical Particulars
4.1 Therapeutic Indications
For the relief of indigestion.
4.2 Posology And Method Of Administration
For oral administration.
Adults and children over 12 years
10ml (2 teaspoonfuls) 3-4 times a day in a little water, after meals or as required.
Children 5 to 12 years
5ml (1 teaspoonful) 3-4 times a day in a little water, after meals or as required.
Children under 5 years
Not recommended except on the advice of a doctor.
Elderly
There is no need for dosage reduction in the elderly.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special Warnings And Precautions For Use
If symptoms persist for more than 5 days, talk to your doctor.
Because of the sodium content, Magnesium Trisilicate Mixture should be used with caution in patients with renal impairment, heart failure, hypertension and in those on a low sodium diet.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Magnesium Trisilicate Mixture may interfere with the absorption of the tetracyclines when these are taken concurrently. The renal excretion of lithium appears to be increased by sodium bicarbonate and this could lead to reduced plasma levels of lithium and impairment of the therapeutic response.
4.6 Pregnancy And Lactation
The safety of Magnesium Trisilicate Mixture during pregnancy and lactation has not been established but 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
Magnesium Trisilicate Mixture may cause diarrhoea and flatulence.
4.9 Overdose
Symptoms of overdosage include diarrhoea, flatulence and gastrointestinal irritation.
Treatment need only be symptomatic.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Magnesium trisilicate, magnesium carbonate and sodium bicarbonate have antacid properties.
5.2 Pharmacokinetic Properties
Magnesium trisilicate is converted to magnesium chloride and silicon dioxide during neutralisation of gastric acid. Some magnesium is absorbed and traces of the silicon dioxide may be absorbed and excreted in the urine.
Magnesium carbonate reacts with gastric acid to form magnesium chloride and carbon dioxide in the stomach. Some magnesium is absorbed, but is usually excreted rapidly in the urine.
Sodium bicarbonate causes neutralisation of gastric acid with the production of carbon dioxide. Any bicarbonate not involved in that reaction is absorbed and in the absence of a deficit of bicarbonate in the plasma, bicarbonate ions are excreted in the urine that is rendered alkaline and there is an accompanying diruresis.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sodium methyldroxybenzoate
Sodium propylhydroxybenzoate
Peppermint oil
Tween 20
Chloroform
Purified water
6.2 Incompatibilities
None stated.
6.3 Shelf Life
18 months.
6.4 Special Precautions For Storage
Store below 25°C.
6.5 Nature And Contents Of Container
An amber medical glass bottle fitted with a rolled on pilfer proof cap with a flowed in liner or a triseal (LDPE/EPE/LDPE) liner, alternative cap: a wadless polypropylene screw cap.
Pack size: 200 ml.
6.6 Special Precautions For Disposal And Other Handling
None stated.
7. Marketing Authorisation Holder
The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
8. Marketing Authorisation Number(S)
PL 00014/0310
9. Date Of First Authorisation/Renewal Of The Authorisation
Date of First Authorisation: 31 May 1984
Last Renewal: 27 January 1995
10. Date Of Revision Of The Text
September 1999.
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