国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
SUCRALFATE
Chugai Pharma UK Ltd
A02BX02
SUCRALFATE
1 Grams
Tablets
Product subject to prescription which may be renewed (B)
sucralfate
Not marketed
2000-03-31
PACKAGE LEAFLET: INFORMATION FOR THE USER ANTEPSIN 1G TABLETS 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 Tablets are and what they are used for 2. What you need to know before you take Antepsin Tablets 3. How to take Antepsin Tablets 4. Possible side effects 5. How to store Antepsin Tablets 6. Contents of the pack and other information 1. WHAT ANTEPSIN TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Antepsin 1g Tablets (called Antepsin Tablets in this leaflet). Antepsin Tablets contain 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 Tablets are used to treat: • Stomach ulcers • Ulcers in your bowel • Inflammation of your stomach lining 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANTEPSIN TABLETS DO NOT TAKE ANTEPSIN TABLETS: • If you are allergic (hypersensitive) to sucralfate or any of the other ingredients of Antepsin Tablets (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 doctor or pharmacist before taking Antepsin. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Antepsin Tablets if: • You 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Antepsin 1g Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 gram of sucralfate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Biconvex, oblong, white tablets with a dividing score on one side. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. _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. For ease of administration, Antepsin Tablets may be dispersed in 10-15 ml of water. 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. Elderly: There are no special dosage requirements for elderly patients but, as with all medicines, the lowest effective dose should be used. 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. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ 完全なドキュメントを読む