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MAGNESIUM TRISILICATE MIXTURE B.P.

Active substance(s): MAGNESIUM CARBONATE LIGHT / MAGNESIUM TRISILICATE / SODIUM BICARBONATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Magnesium Trisilicate Mixture B.P.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Magnesium Trisilicate B.P. 250 mg/5 ml
Light Magnesium Carbonate B.P. 250 mg/5 ml
Sodium Bicarbonate B.P. 250 mg/5 ml

3.

PHARMACEUTICAL FORM
Oral liquid

4.

CLINICAL PARTICULARS

4.1.

Therapeutic Indications
Symptomatic relief of dyspepsia.
Symptomatic relief of reflux oesophagitis.
Symptomatic relief of gastric and duodenal ulcer.

4.2.

Posology and Method of Administration
Adults and the elderly
Dose: 10 ml
The dose may be repeated every four (4) hours up to 4 times daily.
It should be used with caution in the elderly.
Children
It is not recommended for children.
Route of administration – oral

4.3.

Contra-indications
Hypertension, renal impairment, patients on sodium restricted diet (in heart
failure, hepatic and renal impairment and during pregnancy). It should be
avoided in metabolic or respiratory alkalosis, hypocalcaemia and
hypochlorhydria.

4.4.

Special Warnings and Precautions for Use
None

4.5.

Interactions with other Medicaments and other forms of Interaction
Gastrointestinal absorption of some drugs such as tetracyclines, digoxin,
vitamins and iron may be reduced by adsorption; magnesium containing
products may potentiate tubocurarine during anaesthesia. The effects of some
drugs may be diminished or enhanced by alterations in intestinal pH or by the
formation of complexes.

4.6.

Pregnancy and Lactation
Like many other medicines, this product should be avoided during the first
three months of pregnancy. This product has a high sodium content and
should be used cautiously in patients on a sodium-restricted diet, and in
toxaemia of pregnancy.

4.7.

Effects on Ability to Drive and Use Machines
None.

4.8.

Undesirable Effects
Magnesium salts may cause diarrhoea. Sodium bicarbonate and light
magnesium carbonate may cause flatulence. Prolonged use of magnesium
trisilicate may lead to development of siliceous calculus. Prolonged use of
sodium bicarbonate may cause metabolic alkalosis.

4.9.

Overdose
Hypermagnesaemia has rarely been reported after excessive use of, or
overdosage with, magnesium containing antacids and laxatives, especially in
the presence of renal insufficiency. Symptoms include flushing of the skin,
thirst, hypotension, drowsiness, confusion, loss of tendon reflexes due to
neuromuscular blockade, muscular weakness, respiratory depression, cardiac
arrhythmia and cardiac arrest. Excessive bicarbonate may lead to
hypokalaemia and metabolic alkalosis, especially in patients with impaired
renal function. Symptoms may include mood changes, tiredness, shortness of
breath, muscle weakness, and irregular heart beat. Muscle hypertonicity,
twitching and tetany may develop especially in hypocalcaemic patients.
Excessive doses of sodium salts may cause sodium overloading and
hyperosmolality.
Hypermagnesaemia may be treated by intravenous injection of calcium
gluconate to counteract respiratory depression or heart block. In normal renal
function, adequate fluids should be given to assist magnesium removal but
dialysis may be necessary in renal impairment or severe hypermagnesaemia.
Treatment of metabolic alkalosis and hypernatremia consists mainly of
appropriate correction of fluid and electrolyte balance.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic Properties
Magnesium trisilicate, light magnesium carbonate and sodium bicarbonate
neutralise gastric acid.

5.2.

Pharmacokinetic Properties
Magnesium salts are poorly absorbed following oral absorption. They are
widely distributed and excreted unchanged mainly in the urine with very little
faecal loss. Small amounts also cross the placenta and are excreted in breast
milk.
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.

5.3.

Preclinical Safety Data

No relevant data.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients
Nipastat Sodium HSE
Chloroform BP
Peppermint Oil BP
Potable Water HSE

6.2.

Incompatibilities
None.

6.3.

Shelf Life
Three years.

6.4.

Special Precautions for Storage
Store below 25oC.

6.5.

Nature and Contents of Container
Dispensing pack
2 litre amber glass bottle with a white plastic screw cap with an EPE liner
faced with aluminium.
Patient packs or OTC packs as appropriate
200 ml and 300 ml amber glass bottles with white plastic Jay cap closures.
500 ml amber glass bottles with white plastic screw caps with an EPE liner
faced with aluminium.

6.6.

Instruction 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(S)
PL 18374/0041

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
24/02/2009

10

DATE OF REVISION OF THE TEXT
24/02/2009

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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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