1. Name Of The Medicinal Product
Indigestion Tablets (Original) or Boots Indigestion Relief Tablets Original
2. Qualitative And Quantitative Composition
|
|
|
|
|
|
|
|
|
|
3. Pharmaceutical Form
A tablet.
4. Clinical Particulars
4.1 Therapeutic Indications
For the symptomatic relief of occasional indigestion, heartburn, excess acidity and flatulence.
4.2 Posology And Method Of Administration
For oral administration.
Adults and children over 12 years:
Suck or chew one or two tablets after meals, at bedtime or when required.
Children 5 to 12 years
Suck or chew one tablet after meals, at bedtime when required.
Children under 5 years: Not recommended.
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
Because of the high sodium content, caution should be observed in patients with impaired renal function, heart failure, hypertension and in those on a low sodium diet.
Keep all medicines out of the reach of children.
If symptoms persist for more than 5 days, talk to your doctor.
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 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 therapeutic response.
Antacids should preferably not be taken at the same time as other drugs since they may impair absorption. Interactions may be minimised by giving antacids and other medication at least 2 to 3 hours apart.
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, magnesium trisilicate 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 exerted in breast milk, the concentration is too small to produce an effect on the neonate.
4.7 Effects On Ability To Drive And Use Machines
Not adverse effects known.
4.8 Undesirable Effects
This product may cause diarrhoea, flatulence, gastrointestinal irritation and metabolic alkalosis.
Prolonged use may lead to the development of 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
Magnesium trisilicate, heavy magnesium carbonate, calcium carbonate and sodium bicarbonate have antacid properties.
Ginger has carminative properties.
5.2 Pharmacokinetic Properties
Magnesium carbonate reacts with gastric acid to form soluble magnesium chloride and carbon dioxide in the stomach. Some magnesium is absorbed but is mainly excreted rapidly in the urine.
Magnesium trisilicate reacts with gastric acid to form magnesium chloride and silicon dioxide. Some magnesium is absorbed and traces of the liberated silicon dioxide may be absorbed and excreted in the urine.
Calcium carbonate 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
Not applicable.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Purified water
Industrial methylated spirit
Icing sugar
Flav P 110 690 FOI
Isopropyl alcohol
Stearic acid BPC PDR
Magnesium stearate
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
None.
6.5 Nature And Contents Of Container
4 aluminium/paper rolls of 20 tablets in a cardboard carton. Pack size 20 tablets.
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 0014/5261R
9. Date Of First Authorisation/Renewal Of The Authorisation
15 January 1991
10. Date Of Revision Of The Text
October 2002
No comments:
Post a Comment