Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ALGINIC ACID SODIUM BICARBONATE ALUMINIUM HYDROXIDE DRIED MAGNESIUM TRISILICATE
Reckitt Benckiser Ireland Ltd
Tablets Chewable
1996-01-03
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gaviscon 250 Lemon Flavour 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250 mg alginic acid (Ph. Eur.), 85 mg sodium bicarbonate (Ph. Eur.), 50 mg dried aluminium hydroxide (Ph. Eur.) and 12.5 mg magnesium trisilicate (Ph. Eur.). For excipients, see 6.1. 3 PHARMACEUTICAL FORM Chewable tablet. Circular matt, off-white to cream chewable tablet, with a lemon odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Relief of heartburn and indigestion. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION For oral administration, after being thoroughly chewed. The dose can be rinsed down with a quantity of water. Adults and children over 12 years: Two tablets as required. Children under 12 years: Not recommended. 4.3 CONTRAINDICATIONS None known. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Sodium content of a tablet is 23.5 mg (1.02 mmol). This may be of importance when a highly restricted salt diet is required as in some renal and cardiovascular conditions. Aluminium hydroxide may lead to a phosphate depletion syndrome, particularly in patients on a low phosphate diet, e.g. malnutrition. Aluminium may cause constipation due to its astringent action; this effect may be balanced by the cathartic effect of the magnesium salts. Magnesium salts may cause central nervous system depression in the presence of renal insufficiency and should not be used in patients with renal failure. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 22/09/2005_ _CRN 2014941_ _page number: 1_ 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Aluminium hydroxide may form complexes with certain drugs including those used in pregnancy, e.g. tetracyclines, digoxin and vitamin Read the complete document