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PATIENT INFORMATION LEAFLET

Azathioprine 25mg and 50mg Film-Coated Tablets

H What Azathioprine is and what it is used for

Azathioprine belongs to a group of medicines called immunosuppressants. These work by reducing the strength of the body's immune system. Azathioprine may be taken long-term as it can take weeks or months before an effect is seen.

Azathioprine is used to treat the following:

•    To prevent the body from rejecting kidney, liver, heart, lung or pancreas transplants

If you are intolerant to or are dependent on steroids and (despite treatment with high doses of steroids) treatment has been ineffective, Azathioprine is used to treat severe cases of the following:

•    Severe inflammatory disease of the joints (rheumatoid arthritis) that cannot be kept under control by less toxic medicines (Disease-Modifying Anti-Rheumatic Drugs [DMARDs] e.g. ciclosporin

•    Moderate to severe inflammatory intestinal diseases (Crohn's disease, ulcerative colitis)

•    Long-term inflammation of skin and/or intestines (systemic lupus erythematosus)

•    Inflammation of the skin and muscles (dermatomyositis, polymyositis)

•    Inflammation of the liver (hepatitis)

•    Inflammation of the walls of the arteries (polyarteritis nodosa)

•    Increased breakdown of red blood cells due to the presence of auto-antibodies active at body temperature (warm) causing anaemia (looking pale and feeling tired)

•    Autoimmune disorder where the number of platelets circulating is reduced by the immune system destroying them, causing a rash and an increased tendency to bleed, persisting longer than 6 months without a specific cause and is not responsive to conventional treatment (chronic refractory idiopathic thrombocytopenic purpura)

•    Blistering of the skin (pemphigus vulgaris)

K What you need to know before ^ you take Azathioprine

Do not take Azathioprine if:

•    You are allergic (hypersensitive) to Azathioprine, Immunosuppressants, 6-mercaptopurine (a derivative of Azathioprine) or any of the other ingredients of this medicine (see section 6 "Contents of the pack and other information")

•    You are suffering from a severe infection

•    You suffer from severe liver disorders

•    You suffer from severely impaired liver or bone-marrow function

•    You suffer from inflammation of the pancreas (pancreatitis)

•    You are due to be given a vaccination for BCG, smallpox, yellow fever (see "Other medicines and Azathioprine" section)

•    You are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby (see "Pregnancy, breastfeeding and fertility" section)

Warnings and precautions

Talk to your doctor before taking Azathioprine:

•    If you are currently taking ribavirin, used to treat chronic hepatitis C (see "Other medicines and Azathioprine" section)

•    If you suffer from kidney or liver problems

•    If you suffer from Lesch-Nyhan Syndrome, a rare hereditary disorder caused by a deficiency of the enzyme HPRT (hypoxanthine-guanine-phosphoribosyl transferase)

•    If you are taking multiple immunosuppressant medicines (see "Other medicines and Azathioprine" section) as treatment should be maintained at the lowest possible dose

•    You should be careful about exposure to the sun or UV light and you should examine your skin at regular intervals. Exposure to sunlight and UV light should be limited and you should wear protective clothing and use a sunscreen with a high protection factor to minimise the risk of skin cancer and abnormal sensitivity of the skin to sunlight (photosensitivity)

•    If you have an untreated severe infection

•    If you are taking a cytostatic medicine (see "Other medicines and Azathioprine" section)

•    If you have, have been exposed to or have ever suffered from chickenpox or shingles (varicella zoster virus infection) as the infection can become severe if you are taking immunosuppressants

•    If you have or are showing signs or symptoms (headache, loss of co-ordination, clumsiness, loss of speech, memory loss, vision problems, weakness of the legs and arms that gets worse) of having Progressive Multifocal Leukoencephalopathy [PML] (a rare infection caused by a virus that damages the material covering and protecting nerves in the brain) as treatment with Azathioprine should be withheld (see section 4 "Possible side effects, Very rare side effects...")

Other medicines and Azathioprine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.

Medicines which may interact with or be affected by Azathioprine:

•    If you are due to have surgery, you should make sure that the anaesthetist is aware you are taking Azathioprine

•    Medicines used to treat gout such as allopurinol, oxypurinol, thiopurinol. If these medicines are given concomitantly with Azathioprine, the dose of Azathioprine must be reduced to a quarter of the original dose

•    Muscle relaxants such as curare, pancuronium, tubocurarine, succinylcholine (neuromuscular blocking agents)

•    Medicines used to reduce the body's immunity when receiving organ transplant such as ciclosporin, tacrolimus (immunosuppressants)

•    Medicines used to treat chronic inflammatory bowel diseases such as olsalazine, mesalazine, sulfasalazine (aminosalicylic acid derivatives) as lower doses of Azathioprine may need to be considered when given concomitantly with aminosalicylate derivatives

•    Medicines used to thin the blood such as warfarin, acenocoumarol (anti-coagulants)

•    Medicines used to treat high blood pressure or heart failure e.g. captopril (Angiotensin-Converting Enzyme [ACE] Inhibitors)

•    Medicines used to treat infections such as trimethoprim, sulphamethoxazole (antibiotics)

•    Medicines used to treat stomach ulcers such as cimetidine (H2-receptor antagonist)

•    Medicines used to treat certain rheumatic disorders such as indomethacin (Non Steroidal Anti-Inflammatory Drugs [NSAIDs])

•    Cytostatic medicines used to treat cancer by inhibiting cell growth and multiplication e.g. cyclophosphamide, ifosfamide

•    Medicines which may have a myelosuppressive effect (decrease in bone marrow activity resulting in fewer red and white blood cells and platelets) such as penicillamine

•    Medicines used to increase frequency of urination such as furosemide (diuretics)

•    Live vaccines such as BCG, smallpox, yellow fever (see section 2 "What you need to know before you take Azathioprine, Do not take...")

•    Inactive vaccines such as hepatitis B (especially when used in combination with Azathioprine and corticosteroids (medicines used to relieve inflammation e.g. prednisolone)

•    Ribavirin, used to treat chronic hepatitis C

•    Methotrexate, used to treat auto-immune conditions such as rheumatoid/psoriatic arthritis and vasculitis as the dose of Azathioprine may need to be adjusted

Taking Azathioprine with food and drink

•    Azathioprine should be taken with sufficient fluid (200mls liquid).

•    Azathioprine should be taken at least 1 hour before or 3 hours after food or milk.

Pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Do not take Azathioprine if you are pregnant, trying to become pregnant or think you may be pregnant.

Contraception

•    Additional contraceptive measures should be taken (by both male and female patients of reproductive age) during and for at least 3 months after the end of treatment with Azathioprine.

•    This also applies if you suffer from impaired fertility due to chronic uraemia (excess urea in the blood).

•    Azathioprine is known to interfere with the effectiveness of intrauterine contraceptive devices (e.g. coil).

Breast-feeding

Do not take Azathioprine if you are breast-feeding as 6-Mercaptopurine, a derivative of Azathioprine is passed into breast milk.

Fertility

Kidney transplant involving treatment with Azathioprine has been accompanied by increased fertility in both male and female transplant patients.

Azathioprine contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Azathioprine

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

•    These tablets are to be taken orally and should be swallowed whole with sufficient fluid (200mls liquid).

•    These tablets should be taken at least 1 hour before or 3 hours after food or milk.

Adults

You should be adequately monitored for toxic effects throughout the duration of treatment. Particular care should be taken to monitor your response and to reduce the maintenance dose to the lowest dose possible.

Although adverse effects on blood cell formation (haematopoiesis) occur most commonly at the beginning of treatment with Azathioprine, late occurrence has been reported. Therefore, careful monitoring of the blood cell counts is recommended even if you are on stable long-term treatment with Azathioprine.

It is recommended that a complete blood count, including platelet count, should be performed at least once a week for the first 8 weeks of treatment. After 8 weeks, the frequency may be reduced to once a month or intervals of not longer than 3 months. At the first signs of an abnormal fall in blood counts, treatment should be interrupted immediately as white blood cells and platelets may continue to fall after treatment is stopped.

This count should be performed more frequently if:

•    Higher doses are used

•    You are elderly

•    Kidney function is impaired or in severe kidney disorders

•    Liver function is mildly to moderately impaired or in liver disorders

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