Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Mesalazine
Tillotts Pharma GmbH
A07EC; A07EC02
Mesalazine
800 milligram(s)
Gastro-resistant tablet
Product subject to prescription which may be renewed (B)
Aminosalicylic acid and similar agents; mesalazine
Marketed
2003-02-07
PACKAGE LEAFLET: INFORMATION FOR THE USER ASACOLON 400 MG AND 800 MG GASTRO-RESISTANT TABLETS Mesalazine 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, please 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Asacolon is and what it is used for 2. What you need to know before you take Asacolon 3. How to take Asacolon 4. Possible side effects 5. How to store Asacolon 6. Contents of the pack and other 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 becomes inflamed. If you have been treated by surgery for Crohn’s disease and it is under control, Asacolon act to prevent further episodes of Crohn’s disease. 2. Belgenin tamamını okuyun
Health Products Regulatory Authority 02 March 2023 CRN00DD7R Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Asacolon 800mg Gastro-resistant Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro resistant tablet contains: 800mg mesalazine Excipient with known effect:152.8mg lactose, see section 4.4. For the 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 Asacolon is indicated in adults, children above 6 years and adolescents: For the treatment of mild to moderate 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 once daily or in divided doses. If required the dose may be increased to 4.8 g (6 tablets) per day in divided doses. Above 2.4 g daily in divided doses only. The dosage can be adjusted in accordance with the response to the treatment. Maintenance of remission: 1.6 to 2.4 g (2 to 3 tablets) 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. Older people 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 older people. Paediatric population There is only limited documentation for an effect in children (age 6-18 years). Children 6 years of age and older Health Products Regulatory Authority 02 March 2023 CRN00DD7R Page 2 of 9 _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 treatment_: To be determined individually, starting with 15-30 mg/kg/day in di Belgenin tamamını okuyun