1. Name Of The Medicinal Product
Health Salt or Boots Effervescent Health Salts
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Powder for oral solution
4. Clinical Particulars
4.1 Therapeutic Indications
For upset stomach, heartburn and indigestion.
For the relief of occasional constipation.
4.2 Posology And Method Of Administration
Adults and children over 12 years: For upset stomach, heartburn and indigestion:
One teaspoonful in half a tumbler of water. Repeat every three or four hours if necessary.
As a laxative: Three or four teaspoonfuls in a tumbler of water on rising.
Children under 12 years: Not recommended.
Elderly: The normal adult dosage is appropriate in the elderly.
4.3 Contraindications
Should not be taken where there is severe abdominal pain, nausea or vomiting or for prolonged periods, except on medical advice.
4.4 Special Warnings And Precautions For Use
This medicine should be administered with caution to patients with congestive cardiac failure, peripheral or pulmonary oedema, hypertension or impaired renal function.
Keep all medicines out of the reach of children.
Laxatives should not be taken when there is severe abdominal pain or used regularly for prolonged periods, except on medical advice.
If symptoms persist for more than 5 days, consult your doctor.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
This medicine may alkalinise the urine and reduce the urinary excretion of amphetamines, methadone, quinidine and quinine. This medicine may 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.
May interfere with the absorption of tetracyclines when these are given concomitantly. May enhance the cardiac effects of digitalis glycosides.
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 sulphate in pregnant women.
Studies in animals have not been done. Caution should therfore be exercised when taken by pregnant women.
Although some magnesium 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
Not applicable.
4.8 Undesirable Effects
May cause diarrhoea and flatulence.
Prolonged use may result in hypermagnesaemia, hypernatraemia, metabolic acidosis and respiratory alkalosis particularly in patients with renal impairment.
May also cause belching due to liberated carbon dioxide.
4.9 Overdose
Overdosage may lead to hypermagnesaemia and hypernatraemia symptoms of which may include restlessness, weakness, drowsiness, hyporeflexia, thirst, reduced salivation and lacrimation, swollen tongue, flushing of the skin, pyrexia, dizziness, headache, oliguria, hypotension, tachycardia, cardiac arrhythmias, hyperpnoea, respiratory arrest, delirium and cardiac arrest.
Initial treatment consists of emesis or gastric lavage together with symptomatic and supportive measures. Intravenous administration of hypotonic saline or sodium free solutions and the intravenous administration of calcium gluconate to reduce elevated serum magnesium levels. In severe cases, peritoneal or haemodialysis should be considered.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Magnesium sulphate is a saline purgative. In dilute solution it produces an osmotic reduction in the water absorbed from the intestine with the result that the intestinal contents distend the bowel and stimulate peristalsis.
Sodium bicarbonate has antacid properties and neutralises excess gastric acid.
5.2 Pharmacokinetic Properties
Not available.
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
Anhydrous citric acid gran
Tartaric acid gran
Salt, pure, vacuum dried
Pulverised sugar
6.2 Incompatibilities
Not applicable
6.3 Shelf Life
36 months
6.4 Special Precautions For Storage
Do not store above 25°C. Store in original package.
6.5 Nature And Contents Of Container
Tin with tin lever lid or lever-lid, foil-lined composite drum with tamper evident paper membrane, or polyethylene lever-lid, foil lined composite drum with foil membrane.
Pack sizes: 110g, 225g, 350g
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)
PL0014/5650R
9. Date Of First Authorisation/Renewal Of The Authorisation
First authorisation: 17 March 1988
Last renewal: 8 July 1993
10. Date Of Revision Of The Text
September 2003
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