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AROMATIC MAGNESIUM CARBONATE MIXTURE B.P

Active substance(s): CARAWAY OIL / CARDAMOM OIL / CINNAMON OIL / CLOVE OIL / GINGER TINCTURE STRONG / MAGNESIUM CARBONATE LIGHT / SODIUM BICARBONATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Aromatic Magnesium Carbonate Mixture B.P.

2.

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.

3.

PHARMACEUTICAL FORM
Oral solution

4.

CLINICAL PARTICULARS

4.1.

Therapeutic Indications
Symptomatic relief of dyspepsia.

4.2.

Posology and Method of Administration
Adults
Dose: 10 ml in water
The dose may be repeated three times a day.
The elderly
Should be used with caution.

Children
Not recommended.

4.3.

Contra-indications
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
bicarbonate content.

4.4.

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
receiving corticosteroids.

4.5

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
phenothiazines.

4.6.

Pregnancy and Lactation
The safety of Aromatic Magnesium Carbonate Mixture B.P. has not been
established.
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.

4.7.

Effects on Ability to Drive and Use Machines
None known.

4.8.

Undesirable Effects
Release of carbon dioxide in the stomach may cause discomfort. Magnesium
salts may cause diarrhoea.

4.9.

Overdose
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.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic Properties
Light magnesium carbonate and sodium bicarbonate neutralise gastric acid.
Cardamom oil, caraway oil, cinnamon oil, clove oil and strong ginger tincture
have 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 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
plasma deficit.
No pharmacokinetic data are readily available on cardamom oil, caraway oil,
cinnamon oil, clove oil or strong ginger tincture

5.3.

Pre-clinical Safety Data
No relevant data.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients
Nipastat Sodium
Chloroform
Ethanol 96% v/v
Potable Water

6.2.

Incompatibilities
None.

6.3.

Shelf Life
Three years unopened. Six months in use.

6.4.

Special Precautions for Storage
Do not store above 25ÂșC.

6.5.

Nature and Contents of Container
Dispensing pack

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.

6.6.

Instructions for Use/Handling
No special instructions.

7.

MARKETING AUTHORISATION HOLDER
Wise Pharmaceuticals Limited
Hani Wells Business Park
Unit 7
Hardicker Street
Manchester
M19 2RB
United Kingdom.

8.

MARKETING AUTHORISATION NUMBER
PL 18374/0040

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
14th April 2005

10

DATE OF REVISION OF THE TEXT
14/04/2005

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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