Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Azathioprine
Relon Chem Limited
L04AX; L04AX01
Azathioprine
50 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Other immunosuppressants; azathioprine
Not marketed
2007-11-23
AZATHIOPRINE 50MG FILM-COATED TABLETS (Azathioprine) PACKAGE LEAFLET: INFORMATION FOR THE USER 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 or pharmacist or nurse. 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 or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Azathioprine 50mg Tablets are and what they are used for 2. What you need to know before you take Azathioprine 50mg Tablets 3. How to take Azathioprine 50mg Tablets 4. Possible side effects 5. How to store Azathioprine 50mg Tablets 6. Contents of the pack and other information 1. WHAT AZATHIOPRINE 50MG TABLETS ARE AND WHAT THEY ARE USED FOR Azathioprine 50mg Tablets belong to a group of medicines called immunosuppressants. These medicines reduce the activity of your body’s immune system. Azathioprine 50mg Tablets are 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 AZATHIOPRINE 50MG TABLETS DO NOT TAKE AZATHIOPRINE IF: You are allergic to azathioprine, mercaptopurine or any of the other ingredients of Azathioprine (listed in section 6). You are pregnant or likely to become pregnant (see Pregnancy, breast- feeding and fertility). Do not take Azathioprine if any of the above apply to you. If you are not sure, talk to your doctor, nurse or pharmacist before taking Azathioprine. WARNINGS AND PRECAUTIONS Talk to your doctor, nurse or pharmacist befor Les hele dokumentet
Health Products Regulatory Authority 22 June 2020 CRN008L7T Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Azathioprine 50mg film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50mg Azathioprine. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets Azathioprine 50mg Tablets are pale, yellow, circular, film-coated biconvex tablets engraved with “AZA”, score-lined and “50” on one face. The other face is plain. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Azathioprine 50mg Tablets are 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 50mg Tablets, 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; and to reduce the corticosteroid requirements of renal transplant recipients. Azathioprine 50mg Tablets, either alone or more usually in combination with corticosteroids and/or other drugs 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 Polyarteritis nodosa Auto-immune haemolytic anaemia Chronic refractory idiopathic thrombocytopenic purpura 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral Transplantation - adults and children Depending on the immunosuppressive regimen employed, a do Les hele dokumentet