Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
SUCRALFATE
Chugai Pharma UK Ltd
A02BX02
SUCRALFATE
1 g/5ml
Oral Suspension
Product subject to prescription which may be renewed (B)
sucralfate
Not marketed
2000-03-31
PACKAGE LEAFLET: INFORMATION FOR THE USER ANTEPSIN 1 G / 5 ML ORAL SUSPENSION sucralfate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Antepsin Suspension is and what it is used for 2. What you need to know before you take Antepsin Suspension 3. How to take Antepsin Suspension 4. Possible side effects 5. How to store Antepsin Suspension 6. Contents of the pack and other information 1. WHAT ANTEPSIN SUSPENSION IS AND WHAT IT IS USED FOR The name of your medicine is Antepsin 1 g/ 5 mL Oral Suspension (called Antepsin Suspension in this leaflet). Antepsin Suspension contains a medicine called sucralfate. This belongs to a group of medicines called “Ulcer-healing” medicines. It works by forming a protective barrier over a stomach ulcer and helps stop further irritation caused by stomach acid. Antepsin Suspension is used to treat: • Stomach ulcers • Ulcers in your bowel • Inflammation of your stomach lining Antepsin can also be used to prevent bleeding ulcers in seriously ill patients in hospital. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANTEPSIN SUSPENSION DO NOT TAKE ANTEPSIN SUSPENSION: • If you are allergic (hypersensitive) to sucralfate or any of the other ingredients of Antepsin Suspension (listed in Section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue • If you are on dialysis for kidney problems Do not take this medicine if any of the above apply to you. If you are not sure talk to your Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Antepsin 1g/5ml Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml dose contains 1 gram sucralfate. Each 5ml dose also contains sodium propyl hydroxybenzoate (E217) 2.0mg and sodium methyl hydroxybenzoate (E219) 3.75mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral suspension White to off-white viscous suspension with an odour of aniseed/caramel. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Antepsin is indicated in adults and adolescents over 14 years old for the treatment of duodenal ulcer, gastric ulcer, chronic gastritis, and the prophylaxis of gastrointestinal haemorrhage from stress ulceration in seriously ill patients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. Antepsin must not be administered intravenously. _Duodenal ulcer, gastric ulcer, chronic gastritis:_ Adults: The usual dose is 2 grams twice daily to be taken on rising and at bedtime, or 1 gram 4 times a day to be taken 1 hour before meals and at bedtime. Maximum daily dose: 8 grams. Four to six weeks treatment is usually needed for ulcer healing, but up to twelve weeks may be necessary in resistant cases. Antacids may be used as required for relief of pain, but should not be taken half an hour before or after Antepsin. Paediatric population: The safety and efficacy of Antepsin in children under 14 years of age has not been established. Currently available data are described in section 5.1 but no recommendation on posology can be made. Elderly: see below _Prophylaxis of gastrointestinal haemorrhage from stress ulceration:_ Adults: The usual dose is 1 gram six times a day. A maximum dose of 8 grams daily should not be exceeded. Antacids may be used as required for relief of pain, but should not be taken half an hour before or after Antepsin. Paediatric population The safety and efficacy of Antepsin in children under 14 years of age has not been established. Currently available data are described in section 5 Прочитајте комплетан документ