Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Sodium alginate; Sodium hydrogen carbonate; Calcium carbonate
Reckitt Benckiser Ireland Ltd
A02BX; A02BX13
Sodium alginate; Sodium hydrogen carbonate; Calcium carbonate
Chewable tablet
Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD); alginic acid
Not marketed
2023-10-27
PACKAGE LEAFLET: INFORMATION FOR THE USER GAVISCON EXTRA MIXED BERRIES CHEWABLE TABLETS SODIUM ALGINATE 250 MG, SODIUM HYDROGEN CARBONATE 106.5 MG, CALCIUM CARBONATE 187.5 MG 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 Extra Mixed Berries Chewable Tablets and what are they used for? 2. What you need to know before taking Gaviscon Extra Mixed Berries Chewable Tablets. 3. How to take Gaviscon Extra Mixed Berries Chewable Tablets. 4. Possible side-effects. 5. How to store Gaviscon Extra Mixed Berries Chewable Tablets. 6. Contents of the pack and further information. 1. WHAT ARE GAVISCON EXTRA MIXED BERRIES CHEWABLE TABLETS AND WHAT ARE THEY USED FOR? Gaviscon Extra Mixed Berries Chewable Tablets are a combination of an alginate and two antacids (calcium carbonate and sodium hydrogen carbonate) which works in two ways: 1. Forming a protective barrier over the stomach contents to soothe the burning pain in your chest which may last for up to 4 hours. 2. Neutralising excess stomach acid to relieve the pain and discomfort. This medicinal product is used for the treatment of acid related symptoms of gastro- oesophageal reflux such as heartburn, acid regurgitation and indigestion, for example following meals, or during pregnancy. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GAVISCON EXTRA MIXED BERRIES CHEWABLE TABLETS DO NOT TAKE THIS MEDICINE IF: - you know you are allergic to any of the ingredients of this medicine (listed in section 6). WAR Lue koko asiakirja
Health Products Regulatory Authority 31 January 2024 CRN00F39C Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gaviscon Extra Mixed Berries Flavour Chewable Tablets Sodium alginate 250 mg Sodium hydrogen carbonate 106.5 mg Calcium carbonate 187.5 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains 250 mg sodium alginate, 106.5 mg sodium hydrogen carbonate and 187.5 mg calcium carbonate. Excipient(s) with known effect: Aspartame (E951) 5.86 mg per chewable tablet Carmoisine Lake (E122) 0.375 mg per chewable tablet Sucrose 1.59 mg per chewable tablet Sodium 55.936 mg per chewable tablet For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Chewable tablet. A 15 mm flat, circular, bi-layer chewable tablet with bevelled edges. One layer of the chewable tablet is pink and slightly mottled with GDB surface markings, and the other white with sword and circle surface markings. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of acid related symptoms of gastro-oesophageal reflux such as heartburn, acid regurgitation and indigestion, for example following meals or during pregnancy. The product is indicated in adults and children aged 12 years and over. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY: Adults and children 12 years and over: Two to four chewable tablets after meals and at bedtime, up to four times per day. PAEDIATRIC: Children under 12 years: Treatment of children younger than 12 years of age is not recommended. 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 after being thoroughly chewed. DURATION OF TREATMENT: Health Products Regulatory Authority 31 January 2024 CRN00F39C Page 2 of 5 The recommended maximum duration of use without medical intervention is 7 days. If symptoms do not improve after 7 days, the clinical situation Lue koko asiakirja