1. Name Of The Medicinal Product
Peppermint Indigestion Tablets or Boots Indigestion Relief Tablets Peppermint
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Tablets
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
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 or 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
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 consult your doctor.
Keep all medicines out of the 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 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.
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 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 secreted in the 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
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.
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
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in the other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Icing sugar
Purified water (not detected in final product)
Industrial methylated spirits (not detected in final product)
Peppermint oil
Terpeneless lemon oil
Isopropyl alcohol (not detected in final product)
Stearic acid
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
Waxed paper laminated to aluminium foil, as roll pack with printed label.
Pack size: 20
or
Waxed paper laminated to aluminium foil, as roll pack with printed pack label.
Four roll packs are packed in a printed cardboard carton.
Pack size: 80
6.6 Special Precautions For Disposal And Other Handling
Not applicable
7. Marketing Authorisation Holder
The Boots Company PLC
Nottingham
NG2 3AA
8. Marketing Authorisation Number(S)
PL 0014/0261
9. Date Of First Authorisation/Renewal Of The Authorisation
Date of first authorisation: 14 August 1981
Date of last renewal: 10 January 1992
10. Date Of Revision Of The Text
October 2002
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