AROMATIC MAGNESIUM CARBONATE MIXTURE B.P
NAME OF THE MEDICINAL PRODUCT
Aromatic Magnesium Carbonate Mixture B.P.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Light Magnesium Carbonate 150 mg/5 ml
Sodium Bicarbonate 250 mg/5 ml
Cardamom Oil 0.00045 ml/5 ml
Caraway Oil 0.0015 ml/5 ml
Cinnamon Oil 0.0015 ml/5 ml
Clove Oil 0.0015 ml/5 ml
Strong Ginger Tincture 0.009 ml/5 ml
For excipients, see 6.1.
Symptomatic relief of dyspepsia.
Posology and Method of Administration
Dose: 10 ml in water
The dose may be repeated three times a day.
Should be used with caution.
Hypersensitivity to any of the ingredients, renal impairment,
hypophosphataemia and patients on a sodium restricted diet (in heart failure,
hepatic and renal impairment and during pregnancy). Hypocalcaemia,
hypochlorhydria, metabolic and respiratory alkalosis because of the sodium
Special Warnings and Special Precautions for Use
If symptoms persist, consult your doctor. Caution should be exercised in
elderly or debilitated patients, patients with hypertension and patients
Interaction with other medicinal products and other forms of interaction
The gastrointestinal absorption of some drugs may be reduced including
warfarin, antiarrythmics, phenytoin, antibiotics, iron, chloroquine and
Pregnancy and Lactation
The safety of Aromatic Magnesium Carbonate Mixture B.P. has not been
There are no adequate data on the use of the ingredients in pregnant women.
Animal studies are insufficient with respect to effects on pregnancy,
embryonal/foetal development, parturition and postnatal development.
Aromatic Magnesium Carbonate Mixture B.P. should not be used during
pregnancy unless clearly necessary.
Effects on Ability to Drive and Use Machines
Release of carbon dioxide in the stomach may cause discomfort. Magnesium
salts may cause diarrhoea.
If renal function is impaired or with prolonged or excessive intake,
hypermagnesaemia may result. This may include flushing of the skin, thirst,
hypotension due to peripheral vasodilutation, drowsiness, confusion, loss of
tendon reflexes due to neuromuscular blockade, muscle weakness, respiratory
depression, cardiac arrhythmias, coma and cardiac arrest.
Metabolic alkalosis may result from overdosage of sodium bicarbonate.
Symptoms include shortness of breath, muscle weakness and irregular
heartbeat. Muscle hypertonicity and tetany may develop. Excessive doses may
lead to sodium loading and hyperosmolarity.
Treatment of metabolic alkalosis consists mainly of appropriate fluid and
electrolyte balance. Treatment with calcium gluconate injection 10% should
be administered intravenously in a dose of 10 to 20 ml to counteract
respiratory or heart block. If renal function is normal, adequate fluids should
be given to assist removal of magnesium from the body. Dialysis may be
necessary in patients with renal impairment or severe hypermagnesaemia.
Light magnesium carbonate and sodium bicarbonate neutralise gastric acid.
Cardamom oil, caraway oil, cinnamon oil, clove oil and strong ginger tincture
have carminative properties.
Magnesium carbonate reacts with gastric acid to form soluble magnesium
chloride and carbon dioxide in the stomach. Some magnesium is absorbed but
is usually excreted rapidly in the urine. Small amounts are excreted in breast
milk and saliva. Magnesium crosses the placenta.
Any sodium bicarbonate, not neutralised in the stomach, is absorbed and
excreted as bicarbonate and sodium ions in the urine in the absence of a
No pharmacokinetic data are readily available on cardamom oil, caraway oil,
cinnamon oil, clove oil or strong ginger tincture
Pre-clinical Safety Data
No relevant data.
List of Excipients
Ethanol 96% v/v
Three years unopened. Six months in use.
Special Precautions for Storage
Do not store above 25ºC.
Nature and Contents of Container
2 litre and 500 ml amber glass bottles with white plastic screw caps with an
EPE liner faced with aluminium.
Patient packs or OTC packs as appropriate
200 ml and 300 ml amber glass bottles with plastic Jay cap closures.
Not all pack sizes may be marketed.
Instructions for Use/Handling
No special instructions.
MARKETING AUTHORISATION HOLDER
Wise Pharmaceuticals Limited
Hani Wells Business Park
MARKETING AUTHORISATION NUMBER
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
14th April 2005
DATE OF REVISION OF THE TEXT
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