Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Azathioprine
Dowelhurst Ltd
L04AX01
Azathioprine
25mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08020100
PATIENT INFORMATION LEAFLET IMURAN ® 25MG TABLETS (azathioprine) The name of your medicine is Imuran 25mg Tablets, but will be referred to as Imuran throughout the remainder of the leaflet. Imuran is also available in a 50mg strength. 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, nurse or pharmacist. • This medicine has been prescribed for you. 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Imuran is and what it is used for 2. What you need to know before you take Imuran 3. How to take Imuran 4. Possible side effects 5. How to store Imuran 6. Contents of the pack and other information 1. WHAT IMURAN IS AND WHAT IT IS USED FOR Imuran tablets contain a medicine called azathioprine. This belongs to a group of medicines called immunosuppressants. These medicines reduce the activity of your body’s immune system. Imuran is used to: • stop your body rejecting an organ transplant • treat diseases where your immune system reacts against your own body (called autoimmune diseases, such as rheumatoid arthritis). Ask your doctor, nurse or pharmacist if you would like any further explanation about these uses. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IMURAN DO NOT TAKE IMURAN IF: • you are allergic (hypersensitive) to azathioprine, mercaptopurine or any of the other ingredients of Imuran (listed in section 6). Do not take Imuran if any of the above apply to you. If you are not sure, talk to your doctor, nurse or pharmacist before taking Imuran. WARNINGS AND PRECAUTIONS Talk to your doctor, nurse or pharmacist before taking Imuran if: • you have liver or kidney disease • you have ‘Lesch- Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Imuran 25 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Azathioprine Each tablet contains 25 mg of the active substance azathioprine. Excipient(s) with known effect Each 25 mg tablet contains 37 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Orange, round, biconvex, film-coated tablets, unscored, branded ‘IM 2’ 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Azathioprine is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and procedures which influence the immune response. Therapeutic effect may be evident only after weeks or months and can include a steroid-sparing effect, thereby reducing the toxicity associated with high dosage and prolonged usage of corticosteroids. Azathioprine, in combination with corticosteroids and/or other immunosuppressive agents and procedures, is indicated to enhance the survival of organ transplants, such as renal transplants, cardiac transplants, and hepatic transplants. It also reduces the corticosteroid requirements of renal transplant recipients. Azathioprine is indicated for the treatment of moderate to severe inflammatory bowel disease (IBD) (Crohn’s disease or ulcerative colitis) in patients in whom corticosteroid therapy is required, in patients who cannot tolerate corticosteroid therapy, or in patients whose disease is refractory to other standard first line therapy. Azathioprine, either alone or more usually in combination with corticosteroids and/or other medicinal products and procedures, has been used with clinical benefit (which may include reduction of dosage or discontinuation of corticosteroids) in a proportion of patients suffering from the following: • severe rheumatoid arthritis; • systemic lupus erythematosus; • dermatomyositis and polymyositis; • auto-immune chronic active hepatitis; • pemphigus vulgaris; • polyarte Lugege kogu dokumenti