Compound Magnesium Trisilicate Tablets Bp
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 AI2 (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