国家: 马耳他
语言: 英文
来源: Medicines Authority
BUDESONIDE
Ferring Pharmaceuticals Limited
A07EA06
BUDESONIDE
PROLONGED-RELEASE TABLET
BUDESONIDE 9 milligram(s)
POM
ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
Authorised
2015-01-22
Page 1 of 5 PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CORTIMENT MMX 9MG PROLONGED RELEASE TABLETS Budesonide 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. - 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Cortiment MMX is and it is used for? 2. What you need to know before you take Cortiment MMX 3. How to take Cortiment MMX 4. Possible side effects 5. How to store Cortiment MMX 6. Contents of the pack and other information 1. WHAT CORTIMENT MMX IS AND WHAT IT IS USED FOR Cortiment MMX tablets contain a medicinal product called budesonide. This belongs to a category of medicinal products called 'corticosteroids'. These are used to reduce inflammation. Cortiment MMX tablets are used for adults for the treatment of inflammation of the large intestine (colon) and the rectum. This is called ulcerative colitis. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CORTIMENT MMX DO NOT TAKE CORTIMENT MMX If you are allergic to budesonide or one of the other ingredients of this medicine (listed in section 6). Cortiment MMX 9 mg tablets contain lecithin which is a derivate from soya oil. If you are allergic to peanut or soya, do not use this medicinal product. WARNINGS AND PRECAUTIONS Talk to your doctor before taking Cortiment MMX : - if you have an infection, such as a virus infection, a bacterial infection or a fungal infection; - if you have ever had tuberculosis (TBC); - if you have ever had high blood pressure; - if you have diabetes; - if you ever had brittle bones; Page 2 of 5 - if you ever had a stomach ulcer; - if you ever had elevated eyeball pressure (glaucoma 阅读完整的文件
Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cortiment MMX 9 mg, prolonged release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 9 mg of budesonide. Excipients with known effect: Lactose monohydrate 50 mg Contains lecithin, derived from soya oil. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged release tablet. _ _ White to off-white, round, biconvex, film-coated, gastro-resistant tablet, approximately 9.5 mm diameter, approximately 4.7 mm thickness, debossed on one side with “MX9”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cortiment is indicated in adults for induction of remission in patients with mild to moderate active ulcerative colitis (UC) where 5-ASA treatment is not sufficient. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ The recommended daily dose for induction of remission is one 9 mg tablet in the morning, for up to 8 weeks. When treatment is discontinued, it may be useful to gradually reduce the dose (for more details on treatment discontinuation, see section 4.4). _Paediatric population _ The safety and efficacy of Cortiment tablets in children aged 0-18 years have not yet been established. No data are available, therefore the use in paediatric population is not recommended until further data become available. Page 2 of 10 _Elderly _ No special dose adjustment is recommended. However, experience of the use of Cortiment in the elderly is limited. _Hepatic and renal impairment population _ _ _ Cortiment 9 mg was not studied in patients with hepatic and renal impairment, therefore caution should be exercised in the administration and monitoring of the product in these patients. _ _ Method of administration One tablet of Cortiment 9 mg is taken orally in the morning, with or without food. The tablet should be swallowed with a glass of water and must not be broken, crushed or chewed as the film coating is intended to ensure a prolonged release. 4.3 CONTRAINDICATIONS Hypersensit 阅读完整的文件