Nchi: Uingereza
Lugha: Kiingereza
Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)
Azathioprine
Ennogen Pharma Ltd
L04AX01
Azathioprine
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08020100; GTIN: 05060313370363
AZATHIOPRINE TABLETS 50MG [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 TABLETS ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AZATHIOPRINE TABLETS 3. HOW TO TAKE AZATHIOPRINE TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE AZATHIOPRINE TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT AZATHIOPRINE TABLETS ARE AND WHAT THEY ARE USED FOR Azathioprine Tablets contain the active ingredient Azathioprine which belongs to a group of medicines called immunosuppressants. Azathioprine Tablets may be used to help your body accept an organ transplant, such as a new kidney, heart or liver, or to treat some diseases where your immune system is reacting against your own body (autoimmune diseases). Autoimmune diseases may include: ! severe rheumatoid arthritis (a disease where the immune system attacks cells lining the joints causing swelling, pain, stiffness of the joints), ! systemic lupus erythematosus (a disease where the immune system attacks many of the body's organs and tissues, including skin, joints, kidneys, brain, and other organs causing severe fatigue, fever, stiffness and joint pain), ! dermatomyositis and polymyositis (a group of diseases causing inflammation of the muscles, muscle weakness and skin rash), ! auto-immune chronic active hepatitis (a disease in which the immune system attacks liver cells causing liver inflammation, fatigue, muscle aches, yellowing of the Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Azapress Tablets 50 mg Azathioprine Tablets 50 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg of the active substance Azathioprine BP Excipient(s) with known effect: Lactose BP 3 PHARMACEUTICAL FORM Pale yellow, biconvex tablets, scored on one side and engraved with ‘A10’ on the other side. The score line is not for breaking the tablet. 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 (SLE) • dermatomyositis and polymyositis • auto-immune chronic active hepatitis • pemphigus vulgaris • polyarteritis nodosa • auto-im Soma hati kamili