Država: Irska
Jezik: angleščina
Source: 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+267 mg+160 milligram(s)
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
2010-10-01
Page 1 PACKAGE LEAFLET: INFORMATION FOR THE USER Gaviscon Liquid Sachets Oral Suspension Sodium alginate 500mg, Sodium bicarbonate 267mg, Calcium carbonate 160mg READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you will still need to take this medicine carefully to get the best results from it. Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse 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, pharmacist or nurse. 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 THE LEAFLET 1. What are Gaviscon Liquid Sachets and what are they used for? 2. What you need to know before taking Gaviscon Liquid Sachets 3. How to take Gaviscon Liquid Sachets 4. Possible side-effects 5. How to store Gaviscon Liquid Sachets 6. Contents of the pack and other information. 1. WHAT ARE GAVISCON EXTRA LIQUID SACHETS AND WHAT THEY ARE USED FOR? Gaviscon Liquid Sachets belongs to a group of medicines called “reflux suppressants”, which act rapidly (in 3 minutes) to form a protective layer on top of the stomach contents for up to 4 hours to prevent stomach acid escaping from the stomach where it works into the food pipe causing pain and discomfort. This medicine is used for the 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 oesophatitis. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GAVISCON LIQUID SACHETS DO NOT TAKE GAVISCON LIQUID SACHETS: If you know that you are allergic (hypersensitive) to any of the ingredients of Gaviscon Liquid Sachet Preberite celoten dokument
Health Products Regulatory Authority 19 July 2022 CRN00CZ9Q Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gaviscon Liquid Sachets Oral Suspension Sodium alginate 500mg, Sodium bicarbonate 267mg, Calcium carbonate 160mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Gaviscon contains 500mg sodiumalginate, 267mg sodium bicarbonate and 160mg calcium carbonate per 10 ml dose. Excipients: methyl parahydroxybenzoate (E218) 40 mg/10ml and propyl parahydroxybenzoate (E216) 6 mg/10 ml. For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Oral suspension in sachets. An off-white suspension with the odour and flavour of peppermint. 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 POSOLOGY Adults and children 12 years and over: One to two sachets after meals and at bedtime (up to four times a day). Children under 12 years: Should be given only on medical advice. Duration of treatment: If symptoms do not improve after seven days, the clinical situation should be reviewed. SPECIAL PATIENT GROUPS Elderly: No dose modifications necessary for this age group. Hepatic impairment: No modifications necessary. Renal Insufficiency: Caution if highly restricted salt diet is necessary (see section 4.4). METHOD OF ADMINISTRATION For oral administration 4.3 CONTRAINDICATIONS This medicinal product is contraindicated in patients with known or suspected hypersensitivity to sodium alginate, sodium bicarbonate, and calcium carbonate,or to any of the excipients listed ins ection 6.1, including methylparahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) (see section 4.4). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If symptoms do not improve after seven days, the clinical situation should be reviewed. This medicin Preberite celoten dokument