Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Potassium bicarbonate; Sodium alginate
Reckitt Benckiser Ireland Ltd
A02BX; A02BX13
Potassium bicarbonate; Sodium alginate
500/100 milligram(s)
Chewable tablet
Product not subject to medical prescription
Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD); alginic acid
Marketed
2006-02-10
LEAFLET TEXT PACKAGE LEAFLET: INFORMATION FOR THE USE Gaviscon Advance Chewable Tablets Sodium alginate 500 mg, Potassium hydrogen carbonate 100 mg 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 us 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 THIS LEAFLET: 1. What Gaviscon Advance Chewable Tablets are and what they are used for 2. What you need to know before taking Gaviscon Advance Chewable Tablets 3. How to take Gaviscon Advance Chewable Tablets 4. Possible side effects 5. How to store Gaviscon Advance Chewable Tablets 6. Contents of the pack and other information 1. WHAT GAVISCON ADVANCE CHEWABLE TABLETS ARE AND WHAT THEY ARE USED FOR Gaviscon Advance Chewable Tablets belong to a group of medicines called “reflux suppressants”. This product forms a protective layer that floats on top of the stomach contents. This layer prevents reflux and keeps the stomach contents away from the lining of the food pipe to relieve the symptoms of heartburn and acid indigestion. 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 oesophagitis. You must talk to a doctor if you do not feel better or if you feel worse after 7 days. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GAVISCON Прочитайте повний документ
Health Products Regulatory Authority 09 February 2023 CRN00DC3L Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gaviscon Advance Chewable Tablets Sodium alginate 500 mg, Potassium hydrogen carbonate 100 mg. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains sodium alginate 500 mg and potassium hydrogen carbonate 100 mg. Excipient with known effect: Aspartame (E951) (4.5mg per tablet). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable tablet. An off-white to cream, circular, flat with bevelled edges tablet with the odour and flavour of peppermint. Each tablet is imprinted with a Sword and Circle on one side and GA 500 on the reverse 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 tablets after meals and at bedtime. 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 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 Health Products Regulatory Authority 09 February 2023 CRN00DC3L Page 2 of 4 If symptoms do not improve after seven days, the clinical situation should be reviewed. Each tablet contains 1.0 Прочитайте повний документ