Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
ALGINIC ACID SODIUM BICARBONATE ALUMINIUM HYDROXIDE GEL MAGNESIUM TRISILICATE
Reckitt Benckiser Ireland Ltd
ALGINIC ACID SODIUM BICARBONATE ALUMINIUM HYDROXIDE GEL MAGNESIUM TRISILICATE
500/170/10 Milligram
Tablets Chewable
Withdrawn
2008-10-01
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gaviscon Tablets - Lemon Flavour 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500mg Alginic Acid, 170mg Sodium Bicarbonate, 100mg 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 with a sword logo on each face and an odour of lemon. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gastric reflux, reflux oesophagitis, heartburn, hiatus hernia, flatulence associated with gastric reflux and heartburn of pregnancy. All cases of epigastric and retrosternal distress where the underlying cause is gastric reflux. Treatment of regurgitation. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION For oral administration, after being thoroughly chewed. Adults and children over 12 years: One or two tablets after meals and at bedtime. Elderly: No dose modification is required in this age group. Children 6 to 12 years: One tablet after meals and at bedtime. Children 2 to 6 years: Should be given only on medical advice. Dose - one tablet after meals and at bedtime. Infants: Not recommended. 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. Aluminium hydroxide may cause constipation due to its astringent action; this effect may be balanced by the cathartic effect of the magnesium salts. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 22/09/2005_ _CRN 2014941_ _page number: 1_ Aluminium hydroxide may lead to a phosphate depletion syndrome, particularly Přečtěte si celý dokument