국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
Sodium alginate; Sodium bicarbonate; Calcium carbonate
Pinewood Laboratories Ltd
B05CB; B05CB04
Sodium alginate; Sodium bicarbonate; Calcium carbonate
500mg+267mg+160 milligram/ 10 millilitre
Oral suspension
Product not subject to medical prescription
Salt solutions; sodium bicarbonate
Marketed
1998-06-26
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ACIDEX ORAL SUSPENSION SODIUM ALGINATE 500 MG SODIUM BICARBONATE 267 MG CALCIUM CARBONATE 160 MG/10 ML READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take 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 doctor or 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 Acidex is and what it is used for 2. What you need to know before you take Acidex 3. How to take Acidex 4. Possible side effects 5. How to store Acidex 6. Contents of the pack and other information 1. WHAT ACIDEX IS AND WHAT IT IS USED FOR Acidex 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 indigestion. Acidex 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 YOU TAKE ACIDEX DO NOT TAKE ACIDEX: If you are allergic to sodium alginate, sodium bicarbonate or calcium carbonate or any of the other of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS TAKE SPECIAL CARE WITH ACIDEX IF YOU: are on a sodium restricted diet CONSULT YOUR DOCTOR IF YOU ARE OVER 40 YEARS AND HAVE NEVER SUFFERED WITH HEARTBURN AND ACID INDIGESTION BEFORE. IF SYMPTOMS PERSIST AFTER 7 DAYS CONSULT YOU 전체 문서 읽기
Health Products Regulatory Authority 11 November 2021 CRN00CND3 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Acidex Oral Suspension, Sodium Alginate 500mg, Sodium Bicarbonate 267mg, Calcium Carbonate 160mg/10ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 ml dose contains: Sodium Alginate 500 mg Sodium Bicarbonate 267 mg Calcium Carbonate 160 mg Excipients with known effect Each 10 ml dose contains 143 mg sodium, 15.0 mg ethyl parahydroxybenzoate (E214), 5.50 mg propyl parahydroxybenzoate (E216) and 2.5 mg butyl parahydroxybenzoate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral Suspension Aniseed flavoured pink suspension. 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 at bedtime. The maximum daily dose is 80 ml. 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 at bedtime. The maximum daily dose is 40 ml. CHILDREN UNDER 6 YEARS OF AGE: Not recommended. 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 11 November 2021 CRN00CND3 Page 2 of 4 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 ethyl parahydroxybenzoate (E214), propyl parahydroxybenzoate (E216) and butyl parahydroxybenzoate (see section 4.4). 4.4 SPECIAL WARNINGS A 전체 문서 읽기