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MAGNESIUM TRISILICATE COMPOUND POWDER BP

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Magnesium Trisilicate Compound Powder BP

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Magnesium Trisilicate BP 25.0% w/w
Sodium Bicarbonate BP 25% w/w

3

PHARMACEUTICAL FORM
Powder

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the relief of Dyspepsia and excessive acidity.
For oral administration.

4.2

Posology and method of administration
Dosage:
Adults, Elderly and Children over 14 years:
10ml three times a day, usually after food.
Children aged 10 to 14 years:
5ml three times daily.
Children under 10 years:
Not recommended.

4.3

Contraindications
Renal failure, hypophosphataemia

4.4

Special warnings and precautions for use
If renal function is impaired, Hypermagnesaemia may result. Symptoms of
hypermagnesaemia may include flushing of the skin, thirst, hypotension due to
peripheral vasodilation, drowsiness, confusion, loss of tendon reflexes due to
neuromuscular blockade, muscle weakness, respiratory depression, cardiac
arrhythmias, coma and cardiac arrest.

4.5

Interaction with other medicinal products and other forms of interaction
Antacids are known to interfere with the absorption of a wide variety of drugs
including Warfarin, Antiarrhythmics, Phenytoin, Tetracyclines and Iron.

4.6

Fertility, Pregnancy and lactation
Safety of Magnesium Trisilicate Mixture has not been established. However,
as with all medicines, use during early pregnancy should be avoided. Use
during later pregnancy and lactation is not considered to be a hazard.

4.7

Effects on ability to drive and use machines
None stated

4.8

Undesirable effects
Diarrhoea.

4.9

Overdose
Overdose (or excessive or prolonged intake) may give rise to
hypermagnesaemia, with symptoms as described in other special warnings and
precautions above. Treatment: Calcium Gluconate injection 10% should be
administered intravenously in a dose of 10 to 20ml to counteract respiratory
depression 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 if patients with renal impairment or severe hypermagnesaemia.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Magnesium trisilicate is an antacid with slow acid neutralising action and mild
laxative action.

5.2

Pharmacokinetic properties
Magnesium Trisilicate is broken down to magnesium chloride and hydrated
silica gel by neutralisation in the stomach. About 5% of the magnesium is
absorbed and traces of the liberated silica may be absorbed and excreted in the
urine.

5.3

Preclinical safety data
None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Chalk BP
Heavy Magnesium Carbonate BP

6.2

Incompatibilities
None stated

6.3

Shelf life
36 months

6.4

Special precautions for storage
None Stated.

6.5

Nature and contents of container
200g, 100g Cardboard or Plastic box with a plastic closure, if required.

6.6

Special precautions for disposal
None Stated.

7

MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited,
11 Boumpoulinas, 3rd Floor,
P.C. 1060
Nicosia.
Cyprus

8

MARKETING AUTHORISATION NUMBER(S)
PL 28444/0089

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
11/03/2009

10

DATE OF REVISION OF THE TEXT
11/10/2012

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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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