1. Name Of The Medicinal Product
Indigestion Mixture
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Suspension
4. Clinical Particulars
4.1 Therapeutic Indications
For the symptomatic relief of occasional indigestion, heartburn, excess acidity and flatulence.
For oral administration.
4.2 Posology And Method Of Administration
Adults and children over 12 years
10ml after meals, at bedtime or when required.
Children 5 to 12 years
5ml after meals, at bedtime or when required.
Children under 5 years
Not recommended.
Elderly
There is no need for dosage reduction.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special Warnings And Precautions For Use
Caution should be observed in patients with impaired renal function, heart failure, hypertension and in those on a low sodium diet.
If symptoms persist for more than 5 days, talk to your doctor.
Keep medicines out of the sight and reach of children.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
This product may interfere with the absorption of tetracyclines when these are given concomitantly. May enhance the cardiac effects of digitalis glycosides. Will alkalinise the urine and reduce the urinary excretion of amphetamines, methadone, quinidine and quinine. Will reduce the effectiveness of hexamine compounds, which are only effective as urinary antiseptics in acid urine. 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
Although problems have not been documented with sodium bicarbonate, there are no adequate human data from the use of magnesium carbonate and calcium carbonate in pregnant women. Studies in animals have not been done. Caution should be exercised when taken by pregnant women.
Although some magnesium, calcium and sodium may be secreted in breast milk, the concentration is too small to produce an effect in the neonate.
4.7 Effects On Ability To Drive And Use Machines
No adverse effects known.
4.8 Undesirable Effects
The product may cause diarrhoea, flatulence, gastrointestinal irritation and metabolic alkalosis. Prolonged use may lead to elevated serum levels of calcium and magnesium, particularly in the presence of renal impairment.
4.9 Overdose
Symptoms of overdosage include gastrointestinal irritation, diarrhoea, flatulence and metabolic alkalosis. In severe cases, symptoms of hypermagnesaemia and hypercalcaemia may develop. Treatment should be symptomatic and supportive.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Light magnesium carbonate, calcium carbonate and sodium bicarbonate have antacid properties.
5.2 Pharmacokinetic Properties
Magnesium carbonate administered by mouth reacts with gastric acid to form soluble magnesium chloride and carbon dioxide in the stomach. Some magnesium is slowly absorbed from the gastrointestinal tract and is eliminated in the urine, otherwise excretion is via the faeces.
Calcium carbonate is converted is converted to calcium chloride and carbon dioxide by gastric acid. Some of the calcium is absorbed but about 85% is reconverted to insoluble calcium salts, such as the carbonate and is excreted in the faeces.
Sodium bicarbonate is converted to sodium chloride and carbon dioxide by gastric acid. Some sodium is absorbed.
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
Chloroform
Peppermint oil
Purified water
6.2 Incompatibilities
None
6.3 Shelf Life
36 months
6.4 Special Precautions For Storage
None
6.5 Nature And Contents Of Container
White flint glass bottle, with an unlined polypropylene cap or roll-on pilfer proof cap with a flowed in liner or triseal (LDPE/EPE/LDPE) liner.
Pack size: 200ml
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 00014/5409R
9. Date Of First Authorisation/Renewal Of The Authorisation
First authorisation: 7 October 1988
Date of last renewal: 18 January 1999
10. Date Of Revision Of The Text
February 2003
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