Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Sodium alginate; Sodium bicarbonate; Calcium carbonate
Reckitt Benckiser Ireland Ltd
A02BX; A02BX13
Sodium alginate; Sodium bicarbonate; Calcium carbonate
500 mg/10 ml + 213 mg/10 ml + 325 milligram/ 10 millilitre
Oral suspension in sachet
Product not subject to medical prescription
Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD); alginic acid
Not marketed
2012-12-14
PACKAGE LEAFLET: INFORMATION FOR THE USER Gaviscon Extra Liquid Sachets Peppermint Flavour Oral Suspension Sodium Alginate 500 mg / 10 ml, Sodium Bicarbonate 213 mg / 10 ml Calcium Carbonate 325 mg / 10 ml 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 any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. • You must talk to a doctor if you do not feel better or if you feel worse after 7 days. WHAT IS IN THE LEAFLET 1. What are Gaviscon Extra Liquid Sachets Peppermint Flavour and what are they used for? 2. What you need to know before you take Gaviscon Extra Liquid Sachets Peppermint Flavour 3. How to take Gaviscon Extra Liquid Sachets Peppermint Flavour 4. Possible side-effects. 5. How to store Gaviscon Extra Liquid Sachets Peppermint Flavour 6. Contents of the pack and other information. 1. WHAT ARE GAVISCON EXTRA LIQUID SACHETS PEPPERMINT FLAVOUR AND WHAT THEY ARE USED FOR? Gaviscon Extra Liquid Sachets Peppermint Flavour is a combination of two antacids (calcium carbonate and sodium bicarbonate) and an alginate which works 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 4 hours. This medicine is used for the treatment of acid related symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion, for example following meals or during pregnancy. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GAVISCON EXTRA LIQUID SACHETS PEPPERMINT FLAVOUR DO NOT TAKE GAVISCON EXTRA LIQUID SACHETS PEPPERMINT FLAVOUR IF YOU know you are ALLERGIC (hypersensitive Baca dokumen lengkapnya
Health Products Regulatory Authority 10 September 2020 CRN009J21 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gaviscon Extra Liquid Sachets Peppermint Flavour Oral SuspensionSodium Alginate 500 mg/10 ml Sodium Bicarbonate 213 mg/10 ml Calcium Carbonate 325 mg/10 ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 ml dose (sachet) contains sodium alginate 500 mg, sodium bicarbonate 213 mg and calcium carbonate 325 mg. Excipients with known effects: Methyl parahydroxybenzoate (E218) 40 mg Propyl parahydroxybenzoate (E216) 6 mg Sodium 127.88 mg For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Oral suspension in sachet. An off white suspension with the odour and flavour of peppermint 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. Adults and children 12 years and over: 10-20 ml (1 to 2 sachets) 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. 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 127.88 mg sodium per 10 ml / 1 sachet dose, equivalent to 6.39% of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent to 51.15% of the WHO recommended maximum daily intake for sodium. This product is considered high in sodium. 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 10 ml (sachet) contains 130 mg (3.25 mmol) of calcium. C Baca dokumen lengkapnya