Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sodium alginate; Sodium bicarbonate; Calcium carbonate
Reckitt Benckiser Healthcare (UK) Ltd
A02BX
Sodium alginate; Sodium bicarbonate; Calcium carbonate
250mg ; 106.5mg ; 187.5mg
Chewable tablet
Oral
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 01010201; GTIN: 5011417571163 5011417571149 5011417578285
CUSTOMER INFO: Minimum Point Size = 9.00pt TR1636091 A 10 mm 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160 170 180 190 200 210 220 230 240 250 PACKAGE LEAFLET INFORMATION FOR THE USER GAVISCON DOUBLE ACTION MIXED BERRIES FLAVOUR CHEWABLE TABLETS. SODIUM ALGINATE, SODIUM HYDROGEN CARBONATE AND CALCIUM CARBONATE. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. • Keep this leaflet. You may need to read it again • Ask your pharmacist if you need more information or advice. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. • You must talk to a doctor if you do not feel better or if you feel worse after 7 days. What is in this leaflet: 1. What are Gaviscon Double Action Mixed Berries Flavour Chewable Tablets and what are they used for? 2. What you need to know before taking Gaviscon Double Action Mixed Berries Flavour Chewable Tablets? 3. How to take Gaviscon Double Action Mixed Berries Flavour Chewable Tablets? 4. Possible side-effects. 5. How to store Gaviscon Double Action Mixed Berries Flavour Chewable Tablets? 6. Contents of the pack and further information. 1. WHAT ARE GAVISCON DOUBLE ACTION MIXED BERRIES FLAVOUR CHEWABLE TABLETS AND WHAT ARE THEY USED FOR? Gaviscon Double Action Mixed Berries Flavour Chewable Tablets are a combination of two antacids (calcium carbonate and sodium hydrogen carbonate) and an alginate and work in two ways: 1. Neutralising excess stomach acid to relieve the pain and discomfort 2. Forming a protective barrier over the stomach contents to soothe the burning pain in your chest which may last for up to four hours. This medicine is used for the treatment of acid related symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion which may occur, for example, follo Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gaviscon Double Action Mixed Berries Flavour Chewable Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains sodium alginate 250 mg, sodium hydrogen carbonate 106.5 mg and calcium carbonate 187.5 mg. Excipient(s) with known effect: Aspartame (E951) Carmoisine Lake (E122) Sucrose Sodium For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Chewable tablet. A flat, circular, bi-layer tablet with bevelled edges. One layer of the tablet is pink and slightly mottled, and the other white. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of acid related symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion, for example following meals or during pregnancy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration, after being thoroughly chewed. Adults and children 12 years and over: Two to four tablets after meals and at bedtime, up to four times per day. Children under 12 years: Should be given only on medical advice. Elderly: No dose modifications necessary for this age group. Hepatic Impairment: No dose modification necessary. Renal Insufficiency: Caution if highly restricted salt diet is necessary (see section 4.4). 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 listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE This medicinal product contains 223.56 mg (9.72 mmol) sodium per 4 tablet dose, equivalent to 11.18 % of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent to 44.71% of the WHO recommended maximum daily intake for sodium. This product is considered high in sodium. This should be particularly taken into account for those on a low salt diet (e.g. in some cases of congestive heart failure and renal impairment). Each 4 tablet dose contains 300 mg (7.5 mmol) of calciu Прочетете целия документ