Riik: Iirimaa
keel: inglise
Allikas: 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+213 mg+325 milligram(s)
Oral suspension
Product not subject to medical prescription
Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD); alginic acid
Marketed
2010-10-01
PEEL & REVEAL LABEL TEXT Gaviscon Extra Oral Suspension Sodium Alginate 500mg Sodium bicarbonate 213mg Calcium carbonate 325mg 150ml 300ml 600ml Mint Flavour Each 10ml contains sodium alginate 500mg, sodium bicarbonate 213mg and calcium carbonate 325mg. Also contains methyl (E218) and propyl (E216) parahydroxybenzoates, sodium and calcium. See leaflet for further information Consult your doctor if you are over 40 years and have never suffered with heartburn and indigestion before. High in sodium – see leaflet for further details. Contains calcium. If you have been advised to follow a diet restricted in either of these please consult your doctor before taking this product. DOSAGE: For oral use. Shake well before use. Read the package leaflet before use. KEEP OUT OF THE REACH & SIGHT OF CHILDREN ADULTS INCLUDING THE ELDERLY AND CHILDREN 12 YEARS AND OVER: 10 to 20 mls after meals or at bedtime, or as directed up to four times a day. CHILDREN UNDER 12 YEARS OLD: Should only be taken on medical advice. If symptoms persist after 7 days consult your doctor. Do not store above 30 o C and store in the original package. Do not freeze or refrigerate. Do not use after the expiry date (EXP: month/year) shown. Use within 6 months of opening. PA 979/15/11 PA Holder: Reckitt Benckiser Ireland Ltd, Dublin 24. LEAFLET TEXT PACKAGE LEAFLET: INFORMATION FOR THE USER Gaviscon Extra Oral Suspension Sodium alginate 500mg Sodium bicarbonate 213mg Calcium carbonate 325mg 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 wor Lugege kogu dokumenti
Health Products Regulatory Authority 11 May 2021 CRN00C4M4 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gaviscon Extra Oral Suspension Sodium alginate 500 mg Sodium bicarbonate 213 mg Calcium carbonate 325 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 ml dose contains sodium alginate 500 mg, sodium bicarbonate 213 mg and calcium carbonate 325 mg. Excipients: Methyl parahydroxybenzoate (E218) 40mg/10ml Propyl parahydroxybenzoate (E216) 6mg/10ml For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Oral suspension. 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 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 255.76mg sodium per 20ml dose, equivalent to 12.79% 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 daily maximum intake for sodium. This product is considered high in sodium and this should be taken into account by those who have been advised to follow a low salt diet by their doctor e.g in some cases of congestive cardiac failure and renal impairment. Each 10 ml contains 130 mg (3.25 mmol) of calcium. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal Lugege kogu dokumenti