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What is AZIMUNE 50 mg?
- AZIMUNE 50 mg contains Azathioprine which belongs to a group of medicines called immunosuppressants. This means that they reduce the strength of your immune system
CONSUMER MEDICINE INFORMATION
THERAPEUTIC USES
WARNING & PRECAUTIONS
INTERACTIONS
DIRECTIONS FOR USE
SIDE EFFECTS
MORE INFORMATION
What AZIMUNE 50 mg is used for?
It is used to:
- treat severe rheumatoid arthritis
- treat severe inflammation of the gut (Crohns disease or ulcerative colitis)
- treat some diseases where your immune system is reacting against your own body (autoimmune diseases) including severe inflammatory diseases of the skin, liver, arteries and some blood disorders
- prevent our body from graft rejection
Talk to your doctor before taking AZIMUNE 50 mg, If you
- have or have ever had any liver or kidney problems
- have a condition where your body produces too little of a natural chemical called Thiopurine methyltransferase (TPMT)
- have an infection for which you have not yet received treatment
- are going to have an operation
- have a rare genetic disorder called Lesch-Nyhan syndrome
- are receiving immunosuppressive therapy
- have any risk of getting a type of cancer called lymphoproliferative disorder
- have any risk of disorders of the lymph system due to viral infection (Epstein-Barr virus (EBV)-associated lymphoproliferative disorders)
- 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
- Women of childbearing potential and men must use effective contraception during treatment with AZIMUNE 50 mg and for at least 3 months after the treatment is discontinued AZIMUNE 50 mg has been reported to interfere with the effectiveness of intrauterine contraceptive devices (IUCD) therefore additional contraceptive measures are recommended
- Do not take the tablets if you are breast-feeding
Tell your doctor if you are taking, have recently taken or might take any other medicines. The following medicines may interact with AZIMUNE 50 mg Tablets:
- allopurinol, oxipurinol or thiopurinol (used mainly to treat gout)
- ciclosporin or tacrolimus (also used as immunosuppressant medicines)
- infliximab (used to treat inflammation of the bowels [Crohns disease])
- olsalazine, mesalazine or sulfasalazine (used mainly to treat ulcers or chronic inflammation of the colon and anal passage)
- warfarin or phenprocoumon (used to prevent blood clots)
- ACE-inhibitors or Furosemide (used to treat high blood pressure and heart failure)
- trimethoprim/sulfamethoxazole (used to treat bacterial infections)
- cimetidine (used to treat stomach ulcers and indigestion)
- indometacin (used as a painkiller and to treat inflammation)
- cytotoxic medicines - also called chemotherapy (used to treat cancer)
- vaccines (such as hepatitis B vaccine)
- curare, d-tubocurarine, pancuronium or succinylcholine (used as muscle relaxants during operations)
- Always take this medicine exactly as your doctor has told you
- The tablets should be swallowed whole with one full glass of water (about 200ml)
- Take your tablets during meals
- You should take care to avoid too much sun (including sunbeds) whilst taking AZIMUNE 50 mg Tablets
- Your doctor will monitor how you respond to your medicine and may change your dose if required
- Whilst you are taking AZIMUNE 50 mg Tablets your doctor will want you to have a complete blood test performed, at least once a week, during the first 8 weeks of treatment. In certain situations, your doctor may decide to carry out blood tests more frequently
- After 8 weeks the frequency of the testing may be reduced, and your doctor may ask you to repeat the complete blood test every month or at least at intervals of no longer than 3 months
After organ transplant
- A dose of 5mg per kilogram of your bodyweight per day may be given on the 1st day of your treatment. However, the usual maintenance dose is between 1 and 4mg per kilogram of your bodyweight per day. Your doctor may adjust this dose according to your bodys response to your medicine
Patients with chronic active hepatitis
- The usual dose is between 1 and 1.5mg per kilogram of your bodyweight per day
If you have taken more AZIMUNE 50 mg
- If you have taken too many tablets, contact your doctor or go the nearest hospital casualty department immediately
If you forget to take your AZIMUNE 50 mg
- Do not take a double dose to make up for a forgotten tablet. Wait and take your next dose at the usual time. If you have missed more than one dose, contact your doctor for advice
If you stop taking AZIMUNE 50 mg
- Do not stop taking your medicine unless the doctor tells you because stopping your medicine can make your condition worse
Like all this medicine can cause side effects, although not everybody gets them.
SERIOUS
COMMON
UNCOMMON
RARE
VERY RARE
- any ulcers in the throat, fever, bruises or bleeding
- any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting the whole body)
- increased infections in patients with bowel inflammation
- reduction in blood platelets which increases risk of bleeding or bruisingdecrease in red blood cells in the blood (anaemia)
- decrease in white blood cells in patients with rheumatoid arthritis
- certain types of cancer (lymphomas, cancer of the cervix, vulva and skin (especially on areas of the skin exposed to the sun)) are common in patients after kidney transplant
- inflammation of the pancreas, which causes severe pain in the abdomen and back
- nausea and vomiting
- loss of appetite (anorexia)
- increased infections in patients suffering from rheumatoid arthritis
- blood disorder after transplant surgery
- foul smelling stools which are bulky, loose and greasy
- hair loss (alopecia)
- liver problems in patients with rheumatoid arthritis
- paleness, fatigue or shortness of breath caused when the bodys bone marrow is not producing enough blood cells (aplastic anaemia)
- cough and fever caused by pneumonia or inflammation of the lung
- following transplantation, stomach ulcers (which can bleed) and disease which may cause heartburn, vomiting, general discomfort in the stomach
- following transplantation, bowel problems leading to diarrhoea, abdominal pain and constipation
- blood and bone marrow disorders (including granulocytopenia, pancytopenia, megaloblastic anaemia, erythroid hypoplasia and agranulocytosis)
- sensitivity to sunlight which can cause skin discolouration or a rash
- various types of cancers including blood, lymph and skin cancers
