Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
Sodium alginate; Sodium bicarbonate; Calcium carbonate
Reckitt Benckiser Ireland Ltd
A02BX; A02BX13
Sodium alginate; Sodium bicarbonate; Calcium carbonate
250 mg/106.5 mg/187.50 milligram(s)
Chewable tablet
Product not subject to medical prescription
Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD); alginic acid
Marketed
2010-10-01
PATIENT LEAFLET INFORMATION FOR THE USER GAVISCON DOUBLE ACTION TABLETS Sodium alginate, Sodium bicarbonate and calcium carbonate. Please read this leaflet carefully before you take 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 you feel worse after 7 days. What is in this leaflet: 1. What are Gaviscon Double Action Tablets and what are they used for? 2. What do you need to know before taking Gaviscon Double Action Tablets 3. How to take Gaviscon Double Action Tablets 4. Possible side-effects 5. How to store Gaviscon Double Action Tablets 6. Contents of the pack and further information. 1. WHAT ARE GAVISCON DOUBLE ACTION TABLETS AND WHAT ARE THEY USED FOR? Gaviscon Double Action Tablets are 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. Reckitt Benckiser 0025 NL H 4534 001 GI Jane 1.3.1 Package Leaflet clean Gaviscon Double Action MRP Peppermint Tablets 0041116 Page 1 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, following meals, or during pregnancy. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GAVISCON DOUBLE ACTION TABLETS : DO NOT TAKE GAVISCON DOUBLE ACTION TABLETS : If you are allergic to any of the ingredients of this medicine (listed in section 4). TALK TO YOUR DOCTOR Izlasiet visu dokumentu
Health Products Regulatory Authority 09 April 2020 CRN009K2L Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gaviscon Extra Chewable TabletsSodium alginate 250mgSodium bicarbonate 106.5mgCalcium carbonate 187.5mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains sodium alginate 250 mg, sodium bicarbonate 106.5 mg and calcium carbonate 187.5 mg. Excipients: Aspartame (E951) 5.863mg per tablet Carmoisine Lake (E122) 0.375mg per tablet Sucrose 0.5 mg per tablet 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 If symptoms do not improve after seven days, the clinical situation should be reviewed. Prolonged use should be avoided. POSOLOGY 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. METHOD OF ADMINISTRATION For oral administration after being thoroughly chewed 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 Each tablet dose contains 75 mg (1.88 mmol) of calcium. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi. This medicinal product contains 55.89 mg sodium per tablet, equivalent to 2.80% of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent t Izlasiet visu dokumentu