Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
SODIUM ALGINATE SODIUM BICARBONATE CALCIUM CARBONATE
Reckitt Benckiser Ireland Ltd
Oral Powder
2007-07-13
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gaviscon Sachets Oral Powder Fresh Tropical Flavour 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains sodium alginate 500 mg, sodium hydrogen carbonate 267 mg and calcium carbonate 160 mg. Excipient: Aspartame E951. For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Oral powder in sachet. Cream coloured powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion (related to reflux), for example, following meals, or during pregnancy, or in patients with symptoms related to reflux oesophagitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral administration. Adults and children 12 years and over: One to two single dose containers after meals and at bedtime. The product is taken orally without water. Elderly: No dose modifications necessary for this age group. Hepatic Impairment: No modifications necessary. Renal Insufficiency: Caution if highly restricted salt diet is necessary. No data available for children under 12. 4.3 CONTRAINDICATIONS This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The sodium content of a single dose container is 123 mg (5.3 mmol). This should be taken into account when a highly restricted salt diet is recommended, e.g. in some cases of congestive cardiac failure and renal impairment. Each single dose container contains 160 mg (1.6 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi. Due to its aspartame content this Leggi il documento completo