国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
MESALAZINE
Tillotts Pharma Limited
MESALAZINE
800 Milligram
Tablets Gastro-Resistant
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ASACOLON 400 MG AND 800 MG GASTRO-RESISTANT TABLETS Active substance: mesalazine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, please ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Asacolon is and what it is used for 2. Before you take Asacolon 3. How to take Asacolon 4. Possible side-effects 5. How to store Asacolon 6. Further Information 1. WHAT ASACOLON IS AND WHAT IT IS USED FOR The name of your medicine is Asacolon 400 mg Gastro-resistant Tablets / Asacolon 800 mg Gastro-resistant Tablets. The tablets are called gastro-resistant tablets because they are covered with a coating which allows the tablets to pass through the stomach without dissolving. The tablet coating will break down in the bowel where the active mesalazine is released. Asacolon Gastro-resistant Tablets contain the active substance mesalazine. This is an anti- inflammatory medicine used to treat ulcerative colitis and to prevent further episodes of Crohn’s disease. Ulcerative colitis is a disease in which the lining of the large bowel (colon) or back passage (rectum) becomes inflamed (red and swollen). Asacolon acts locally at the inflamed sites to reduce the inflammation. It can also be used to prevent further attacks of ulcerative colitis. Crohn’s disease is a disease in which the lining of the small and large bowel is affected and 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Asacolon 800mg Gastro-resistant Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: mesalazine 800mg Excipients: contains 152.8mg of lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet. The tablets are reddish to brownish and oblong-shaped. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of mild acute ulcerative colitis. For the maintenance of remission of ulcerative colitis. For the maintenance of surgically-induced remission of Crohn’s Disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults: _Ulcerative colitis:_ Induction of remission: 2.4 g (3 tablets) per day in divided doses. If required the dose may be increased to 4.8 g (6 tablets) daily. The dosage can be adjusted in accordance with the response to the treatment. Maintenance of remission: 1.6 to 2.4 g per day once daily or in divided doses. _Crohn’s disease:_ Maintenance of remission: 2.4 g (3 tablets) per day once daily or in divided doses. Elderly population The normal adult dose can be taken unless liver or renal function is severely impaired (see section 4.3 and 4.4). No studies have been carried out in the elderly population. Paediatric population There is only limited documentation for an effect in children (age 6-18 years). Children 6 years of age and older IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 14/01/2014_ _CRN 2140986_ _page number: 1_ • _Active disease_: To be determined individually, starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day in divided doses. The total dose should not exceed 4.0 g/day. • _Maintenance 阅读完整的文件