מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Budesonide
Ferring Ireland Ltd
A07EA; A07EA06
Budesonide
9 milligram(s)
Prolonged-release tablet
Product subject to prescription which may be renewed (B)
Corticosteroids acting locally; budesonide
Marketed
2014-12-05
Package leaflet: Information for the patient Cortiment ® 9 mg 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 is and what it is used for 2. What you need to know before you take Cortiment 3. How to take Cortiment 4. Possible side effects 5. How to store Cortiment 6. Contents of the pack and other information 1. What Cortiment is and what it is used for Cortiment tablets contain a medicinal substance called budesonide. Budesonide belongs to a category of medicinal products called 'corticosteroids', which are used to reduce inflammation. Cortiment tablets are used in adults to treat: • ulcerative colitis which is an inflammation of the large intestine (colon) and the rectum. • acute episodes of microscopic colitis which is a disease with chronic inflammation of the large intestine (colon) typically with chronic watery diarrhea. 2. What you need to know before you take Cortiment Do not take Cortiment If you are allergic to budesonide or one of the other ingredients of this medicine (listed in section 6). If you are allergic to peanut or soya since Cortiment contains lecithin, which is a derivative from soya oil. Warnings and precautions Contact your doctor if you experience blurred vision or other visual disturbances. Talk to your doctor before taking Cortiment: • if you have an infection, such as a virus infection, a bacterial infection or a fungal infection; • if you have ever had high blood pressure; • if you have diabetes; • if you ever had brittle bones; קרא את המסמך השלם
Health Products Regulatory Authority 06 November 2020 CRN009N2T Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cortiment 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 induction of remission in patients with active microscopic colitis (MC) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ Ulcerative colitis and microscopic colitis: 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. _Elderly_ No special dose adjustment is recommended. However, experience of the use of Cortiment in the elderly is limited. _Hepatic and renal impairment population_ _ _ Health Products Regulatory Authority 06 November 2020 CRN009N2T Page 2 of 9 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 t קרא את המסמך השלם