Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ALGINIC ACID MAGNESIUM TRISILICATE ALUMINIUM HYDROXIDE GEL, DRIED SODIUM BICARBONATE
Reckitt Benckiser Ireland Ltd
500/25/100 Milligram
Tablets Chewable
1998-04-01
License Part II Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Gaviscon Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500mg Alginic acid, 170 mg sodium bicarbonate, 100 mg Aluminium Hydroxide Gel and 25mg Magnesium Trisilicate. For excipients, see 6.1 3 PHARMACEUTICAL FORM Chewable tablet. Circular, flat, off-white to cream, bevel-edged tablets, 0.9 inches in diameter with an odour and flavour of peppermint, with ‘Gaviscon’ and sword motif imprinted on both faces. 4 CLINICAL PARTICULARS 4.1 Therapeutic Indications Gastric reflux, reflux oesophagitis, heartburn, hiatus hernia, heartburn (including heartburn of pregnancy) and similar gastric distress. 4.2 Posology and method of adminstration Oral. Adults and children over 12 years: One or two tablets after meals and at bedtime. Children 6 to 12 years: One tablet after meals and at bedtime. 4.3 Contraindications None known. 4.4 Special warnings and special precautions for use Sodium content of a tablet is 47 mg (2.04 mmol). This should be taken into account when a highly restricted salt diet is required as in some renal and cardiovascular conditions. Products containing aluminium hydroxide should be used with caution in patients with renal dysfunction or hypophosphataemia. Aluminium hydroxide may cause constipation due to its astringent action; this effect may be balanced by the cathartic effect of t Read the complete document