국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
Sodium bicarbonate; Calcium carbonate; Sodium alginate
Reckitt Benckiser Ireland Ltd
A02AX; A02AX13
Sodium bicarbonate; Calcium carbonate; Sodium alginate
500mg/10 ml+267mg/10ml+160 milligram/ 10 millilitre
Oral suspension
Product not subject to medical prescription
Antacids, other combinations; Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD)
Marketed
1978-05-03
LEAFLET TEXT PACKAGE LEAFLET: INFORMATION FOR THE USER Gaviscon Liquid Aniseed Flavour Oral Suspension Sodium alginate 500mg/10ml, Sodium bicarbonate 267mg/10ml, Calcium carbonate 160mg/10ml 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 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 this leaflet 1. What is Gaviscon Liquid and what is it used for? 2. What you need to know before taking Gaviscon Liquid 3. How to take Gaviscon Liquid 4. Possible side-effects 5. How to store Gaviscon Liquid 6. Contents of the pack and other information. 1. WHAT GAVISCON LIQUID IS AND WHAT IT IS USED FOR? Gaviscon Liquid belongs 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. 2. WHAT YOU NEED TO KNOW BEFORE TAKING GAVISCON LIQUID DO NOT TAKE GAVISCON LIQUID: If you know you are allergic (hypersensitive) to any of the ingredients in this product (see “further information” for 전체 문서 읽기
Health Products Regulatory Authority 04 May 2021 CRN00C7ZY Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gaviscon Oral Suspension 500mg/10ml Sodium Alginate 267mg/10ml Sodium Bicarbonate 160mg/10ml Calcium Carbonate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE INGREDIENTS MG/10ML Sodium alginate 500 Sodium bicarbonate 267 Calcium carbonate 160 Excipients with known effect: Sodium 142.6mg (6.2 mmol) / 10ml. Total maximum daily dose (MDD) is 1140.8mg (49.6 mmol) Benzyl alcohol 1.1mg / 10ml, present in fennel flavour Methyl parahydroxybenzoate (E218) 40mg / 10 ml Propyl parahydroxybenzoate (E216) 6mg / 10 ml For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral suspension An opaque, pink, viscous oral suspension with an odour of fennel. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the management of gastric reflux, reflux oesophagitis, hiatus hernia, heartburn (including heartburn of pregnancy) and similar gastric distress. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY ADULTS AND CHILDREN OVER 12 YEARS: 10-20 ml(two to four 5 ml spoonfuls) after meals and before retiring. CHILDREN UNDER 12 YEARS: Should only be given on medical advice. CHILDREN 6-12 YEARS: 5-10 ml (one to two 5 ml spoonfuls) after meals and before retiring. SPECIAL PATIENT GROUPS ELDERLY: No dosage modification is required in 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. Health Products Regulatory Authority 04 May 2021 CRN00C7ZY Page 2 of 5 DURATION OF TREATMENT If symptoms do not improve after seven days, the clinical situation should be reviewed. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or any of the excipients listed in section 6.1, including methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) (see section 4.4). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE As with all medicine 전체 문서 읽기