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MAG-T-CO TABLETS

Active substance(s): DRIED ALUMINIUM HYDROXIDE GEL / MAGNESIUM TRISILICATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Compound Magnesium Trisilicate Tablets BP
Mag-T-Co Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Magnesium Trisilicate BP 250 mg
Dried Aluminium Hydroxide Gel BP 120 mg
For a full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Tablet.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the relief of Dyspepsia.
For oral administration.

4.2

Posology and method of administration
Unless directed by a physician
Adults: One or Two tablets to be chewed after meals or when symptoms arise.

4.3

Contraindications
Hypersensitivity to the active substances or to any of the excipients.

4.4

Special warnings and precautions for use
Caution is necessary when giving to patients receiving antacids. Gastrointestinal absorption can be reduced by absorption of insoluble antacids or

changes in gastric emptying time and the effects of a drug may be diminished
or enhanced in the intestinal pH, or by the formation of complexes.
Caution should be taken in the case of a patient with impaired renal function,
as there may be sufficient accumulation of magnesium to produce toxic effects
This product contains Lactose. Patients with rare hereditary problems of
galactose intolerance, the Lapp lactase deficiency or glucose-galactose
malabsorption should not take this medicine.
This product also contains Sucrose. Patients with rare hereditary problems of
fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase
insufficiency should not take this medicine.

4.5

Interaction with other medicinal products and other forms of interaction
Reduced absorption of the following drugs is experienced when concomitantly
administered with antacids:
Cimetidine, Diflunisal, Chlorpromazine, Betoconazole, Pivampicillin,
Tetracyclines, Penicillamine.
Concomitant administration of antacids may increase plasma concentration of
mexiletine.

4.6

Pregnancy and lactation
Data on a large number of exposed pregnancies indicate no adverse effects of
Compound Magnesium Trisilicate Tablets BP on pregnancy or on the health of
the foetus/newborn child. To date, no other relevant epidemiological data are
available. Although there is no definite proof of Teratogenicity, it has been
suggested that administration of antacids should be avoided during pregnancy.

4.7

Effects on ability to drive and use machines
None stated.

4.8

Undesirable effects
Antacids affect bowel mobility and secretions. Aluminium Hydroxide may
cause constipation. There is a risk of renal rickets or osteomalacia in persons
with a low phosphate diet or in the case of excessive doses due to the reaction
between the soluble aluminium chloride and dietary phosphate to form an
insoluble aluminium Phosphate. Magnesium Trisilicate may give rise to
diarrhoea due to the formation of soluble salts of magnesium.

4.9

Overdose
Symptoms are unlikely and treatment is rarely required.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Antacid
ATC code: A02AD
Compound magnesium Trisilicate is an antacid indicated for the relief of
gastric hyperacidity, indigestion, and heartburn, which may be associated with
peptic ulcer. The pharmacology of the ingredients is as follows:
Magnesium Trisilicate acts as antacid and absorbent. The reaction that takes
place in the stomach is:
2MgO 3SiO2 x H2O+4HCl
2MgCl2 + 3SiO2 (x+ 2) H2O
The reaction of the Trisilicate is slow and prolonged, and the silica formed is
in the gelatinous colloidal state. The antacid action is accordingly slow in
onset but it is prolonged and powerful. The absorbent properties of the product
are possibly due to the formation of the silica gel, which provides a protective
coating over the walls of the stomach. Aluminium Hydroxide gel has
neutralising and absorbent actions. It does not completely neutralise the
stomach contents, but the pH achieved (3.4 to 4.0) is sufficient to inhibit the
proteolytic action of pepsin. There is also some evidence that the aluminium
ion may inhibit pepsin action independently of its pH effect.

5.2

Pharmacokinetic properties
Aluminium and Magnesium ions are not completely absorbed. Unreacted
insoluble antacids pass through the intestines largely as such and are excreted
in the faeces. The reacted portion of the antacids enters the intestine in the
form of the cation. In the intestine, some of the cation is absorbed; that which
is absorbed has the same effect on the systemic bicarbonate pool as an
equivalent amount of NaHCO3 because an equivalent amount of HCO3
returns to the systemic bicarbonate pool. Unabsorbed cation does not spare
enteric NaHCO3 because an equivalent amount of HCO3 or CO2 is consumed
in the formation of insoluble Hydroxides or Carbonates. Al3+ may be thought

of as reacting with CO32- to form an unstable Al2 (CO2)3 intermediate which
is then transformed into basic Aluminium Carbonates, Aluminium Hydroxide
and oxyaluminium Hydroxide. Some of Mg is eliminated in the faeces as
Mg(OH)2. The remainder of unabsorbed Mg 2+ is eliminated mostly as
soluble salts such as the Chloride and Bicarbonate. Small amounts of the
cations are also eliminated as sundry other insoluble compounds such as
soaps, Phosphates, and so forth.

5.3

Preclinical safety data
None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Sucrose BP
Saccharin Sodium BP
Starch (maize) BP
Povidone (K30) BP
Magnesium Stearate BP
Peppermint Oil BP
Lactose (DC21)

6.2

Incompatibilities
None stated.

6.3

Shelf life
3 Years.

6.4

Special precautions for storage
None stated.

6.5

Nature and contents of container
(1000), (500), (100), (50), (25) Tablets - Polypropylene/Polyethylene
Containers
(96), (48), (24), (12) Tablets
- Paper Strips
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
None stated.

7

MARKETING AUTHORISATION HOLDER
BRISTOL LABORATORIES,
UNIT 3, CANALSIDE,
NORTHBRIDGE ROAD,
BERKHAMSTED HP4 1EG,
UNITED KINGDOM

8

MARKETING AUTHORISATION NUMBER(S)
PL 17907/0379

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
30th September 1996
14th September 1998

10

DATE OF REVISION OF THE TEXT
11/01/2011

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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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