Product Details

Product Information of Azathioprine

What you need to know before you take Azathioprine

Do not take Azathioprine if you • are allergic to azathioprine, to mercaptopurine (a medicine used to treat leukaemia, a cancer of the white blood cells) or any of the other ingredients of this medicine (listed in section 6). • are pregnant or intend to become pregnant • are breast-feeding. Page 2 of 7 Warnings and precautions Talk to your doctor or pharmacist before taking this medicine if you: • know you have a metabolic abnormality called Lesch-Nyhan syndrome. Azathioprine is not recommended if you have this condition. • know you have a shortage of a liver enzyme called thiopurine methyltransferase (TPMT). TPMT breaks down azathioprine and other medicines. • have liver or kidney disease. You may have to take a lower dose and your doctor will closely monitor you. • have ever suffered from chickenpox or shingles. • if you have had hepatitis B (a liver disease caused by a virus) NUDT15-gene mutation If you have an inherited mutation in the NUDT15-gene (a gene which is involved in the break-down of Azathioprine in the body), you have a higher risk of infections and hair loss and your doctor may in this case give you a lower dose. If you are receiving immunosuppressive therapy, taking Azathioprine could put you at greater risk of: • tumours, including skin cancer. Therefore, when taking Azathioprine, avoid excessive exposure to sunlight, wear protective clothing and use protective sunscreen with a high protection factor. • lymphoproliferative disorders • treatment with Azathioprine increases your risk of getting a type of cancer called lymphoproliferative disorder. With treatment regimen containing multiple immunosuppressants (including thiopurines), this may lead to death. • A combination of multiple immunosuppressants, given concomitantly increases the risk of disorders of the lymph system due to a viral infection (Epstein-Barr virus (EBV)-associated lymphoproliferative disorders). Taking Azathioprine could put you at greater risk of: • developing a serious condition called Macrophage Activation Syndrome (excessive activation of white blood cells associated with inflammation), which usually occurs in people who have certain types of arthritis. • developing a serious condition called Macrophage Activation Syndrome (excessive activation of white blood cells associated with inflammation), which usually occurs in people who have certain types of arthritis, severe chickenpox or shingles infection. Therefore, you should avoid contact with anyone suffering from chickenpox or shingles. • a previous hepatitis B infection becoming active again • other infections such as PML (Progressive Multifocal Leukoencephalopathy) which is an opportunistic infection If you experience any signs of infection please contact your doctor (see section 4 “Possible side effects”). Your doctor will need to monitor you closely throughout your treatment. You should therefore visit your doctor regularly whilst taking Azathioprine so your condition can be checked. You will need to have your blood count checked at least once a week for the first two months of treatment and then monthly. Other medicines and Azathioprine Tell your doctor if you are taking, have recently taken or might take any other medicines. This is because Azathioprine tablets can affect the way some medicines work. Also some other medicines can affect the way Azathioprine works. In particular tell your doctor if you are taking, or are planning to take: • ribavirin (used to treat viral infections) • other immunosuppressants e.g. ciclosporin, methotrexate, tacrolimus • medicines to treat cancer e.g. doxorubicin • allopurinol, oxipurinol or thiopurinol or other xanthine oxidase inhibitors, such as febuxostat (for gout or kidney stones) Page 3 of 7 • cimetidine (for gut or stomach ulcers) • furosemide (‘water tablets’) • penicillamine (for rheumatoid arthritis) • anticoagulants such as warfarin or acenocoumarol (to ‘thin’ the blood) • ACE inhibitors such as captopril (for blood pressure or heart failure) • indomethacin (an anti-inflammatory) • co-trimoxazole (an antibiotic) • infliximab, mesalazine, olsalazine, sulfasalazine or balsalazide (mainly used to treat ulcerative colitis and Crohn’s disease) • before a surgical procedure tell the anesthesiologist that you are taking azathioprine because muscle relaxants such as tubocurarine or succinylcholine (used during anesthesia) may interact with azathioprine If you are going to have an operation, tell your doctor or the hospital staff as Azathioprine can interact with medicines called muscle relaxants (e.g. succinylcholine or tubocurarine), which you might be given during your operation. if you have recently received, or are due to receive, a vaccination (vaccine). If you take Azathioprine tablets, you should not have a live organism vaccine (for example; flu vaccine, measles vaccine, BCG vaccine, etc.) until advised it is safe to do so by your doctor. This is because some vaccines may give you an infection if you receive them while you are taking Azathioprine tablets Azathioprine with food and drink You should take your medicine at least 1 hour before or 2 hours after having milk or dairy products. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine. Pregnancy Do not take Azathioprine if you are pregnant, become pregnant, or suspect you may already be pregnant as the product could harm your baby (see section 2 “Do not take Azathioprine” above). Contact your doctor as soon as possible for advice. Do not take Azathioprine if you are planning to have a baby. This applies to both men and women. You and your partner must use a reliable method of contraception whilst taking Azathioprine. Breast-feeding Small amounts of Azathioprine may pass into the breast milk. It is recommended that women receiving Azathioprine should avoid breastfeeding unless the benefits outweighs the potential risks to the child. Ask your doctor for advice before breastfeeding. Fertility The effects of Azathioprine tablets on fertility are not known. Driving and using machines Do not drive or operate machinery if you feel dizzy while taking this medicine. Information on sodium content This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free’.