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Mag-T-Co Tablets

Document: spc-doc_PL 28395-0107 change

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 NHCO3 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

Pharmadreams Ltd Old Police Station,

Church Street,

Swadlincote,

DE11 8LN United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 28395/0107

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

30th September 1996 14th September 1998

10 DATE OF REVISION OF THE TEXT

30/08/2016