Azoran 75mg Tablet contains Azathioprine, an immunosuppressant (purine antimetabolite) that lowers the activity of the immune system. It is made by RPG Life Sciences and is supplied as a strip of 10 tablets, each containing 75 mg of azathioprine.

Azathioprine is used, usually with other medicines, to prevent rejection of a transplanted organ and to treat certain immune-mediated conditions such as rheumatoid arthritis and inflammatory bowel disease. It is a slow-acting medicine, and treatment needs regular blood tests and specialist supervision.

Azoran 75mg Tablet is used to:

• Prevent organ transplant rejection: Along with corticosteroids and other immunosuppressants, in people who have had a kidney, heart or liver transplant, as advised by the transplant team.

• Treat rheumatoid arthritis: To reduce the signs and symptoms of active, severe rheumatoid arthritis.

• Treat inflammatory bowel disease: In moderate to severe Crohn’s disease or ulcerative colitis when steroids are needed, not tolerated or not enough, as prescribed by a specialist.

• Treat other immune-mediated conditions: These include systemic lupus erythematosus, autoimmune hepatitis, dermatomyositis, polymyositis, pemphigus vulgaris, polyarteritis nodosa, autoimmune haemolytic anaemia and chronic refractory immune thrombocytopenia, when prescribed by a specialist.

Azoran controls these conditions but does not cure them. Your doctor decides which use applies to you.

Azoran 75mg Tablet contains azathioprine, which the body converts to 6-mercaptopurine and then to active thiopurine nucleotides. These are built into the DNA of rapidly dividing cells such as immune cells (lymphocytes) and interfere with their multiplication.

By lowering immune activity, azathioprine helps protect a transplanted organ from attack and reduces inflammation in autoimmune conditions. It is slow-acting. Benefit may take several weeks to months to appear, and its effects can last for a while after the medicine is stopped.

Tell your doctor about all prescription medicines, over-the-counter medicines, supplements and herbal products you take before starting Azoran.

• Allopurinol and febuxostat: Allopurinol slows the breakdown of azathioprine, so the azathioprine dose must be reduced to about one-third to one-quarter of the usual dose. Febuxostat is not recommended with azathioprine.

• Aminosalicylates: Sulfasalazine, mesalazine and olsalazine can reduce the activity of an enzyme (TPMT) that breaks down azathioprine. Use together only with caution and blood count monitoring.

• Medicines that affect blood counts: Co-trimoxazole, ACE inhibitors (such as enalapril, ramipril and lisinopril) and ribavirin can lower blood counts further. Combining ribavirin with azathioprine is not advised.

• Warfarin: Azathioprine may reduce the blood-thinning effect of warfarin, so your INR needs closer monitoring.

• Vaccines: Do not have any vaccine during or after treatment without talking to your doctor. Live vaccines should be avoided.

• Store Azoran 75mg Tablet at room temperature, between 20°C and 25°C, in a dry place.

• Protect from light, heat and moisture. Do not store in the bathroom.

• Keep the strip in its outer carton until you are ready to use the tablet.

• Keep out of the reach of children and pets.

• Dispose of unused or expired tablets safely, as advised by your pharmacist. Do not flush them down the toilet.

Take Azoran 75mg Tablet exactly as prescribed by your doctor. The dose depends on your condition, your body weight and your blood counts, and your doctor may adjust it over time. It is usually taken once or twice a day at about the same time each day. Swallow the tablet whole with water. Do not crush, chew or break it. Taking it after meals can ease nausea. Follow the same routine every day.

• Blood counts are checked weekly in the first month, twice a month in the second and third months, and then monthly or as your doctor advises.

• Your doctor may test for TPMT and NUDT15 enzyme activity, which affects how safely you can take azathioprine.

• If you miss a dose, take it as soon as you remember unless it is almost time for the next dose. Do not take a double dose.

• Do not stop treatment without talking to your doctor, even if you feel well.

• If you start allopurinol, your azathioprine dose must be reduced.

Common side effects of Azoran 75mg Tablet may include:

• Nausea

• Vomiting

• Diarrhoea

• Loss of appetite

• Skin rash

• Hair loss

• Fever

• Low white blood cell count

• Joint or muscle aches

Nausea and vomiting are most common in the first few weeks and may ease when the tablet is taken after meals.

Serious side effects

Seek medical attention if you develop:

• Signs of infection, such as fever, chills or sore throat. New confusion, weakness or difficulty walking can be signs of a rare serious brain infection.

• Unusual bruising or bleeding, pale skin or extreme tiredness, which can be signs of bone marrow suppression.

• Severe nausea, vomiting or diarrhoea with fever, rash, muscle pain or low blood pressure, usually in the first few weeks.

• Severe upper abdominal pain with vomiting, which can be a sign of pancreatitis.

• Yellowing of the skin or eyes, dark urine or abdominal swelling, which can be signs of liver problems.

• New skin changes, lumps, swollen glands, night sweats or unexplained weight loss, because azathioprine increases the risk of skin cancer and lymphoma.

• New cough or shortness of breath.

• Keep all appointments for blood tests so that your blood counts can be monitored.

• Report any sign of infection straight away.

• Ask your doctor whether TPMT and NUDT15 testing has been done before you start.

• Protect your skin from the sun with protective clothing and sunscreen, and report new skin changes or lumps.

• Avoid live vaccines and ask your doctor before any vaccination.

• Tell all your doctors that you take azathioprine, and check with your doctor before starting allopurinol, febuxostat, warfarin or any new medicine.

• Tell your doctor or dentist before any surgery or dental procedure.

• Do not stop suddenly. Take the tablet at the same times each day and with food if it upsets your stomach.

• Discuss family planning and contraception with your doctor before starting and during treatment.