Imuran 50 mg, 100 tabs

Trade Name:

Imuran 50 mg

100 film coated tablets

Composition:

Azathioprine 50 mg

Inactive ingredients:

lactose, pregelatinized starch, maize starch, stearic acid, magnesium stearate, methylhydroxypropyl cellulose, propylene glycol 400.

• There is no colouring in the yellow tablets.
• The colouring in the orange tablets contains titanium dioxide (E171), iron oxide yellow (E172) and iron oxide red (E172).

Properties:

Imuran tablets contain the active substance azathioprine. They belong to a group of medicines called  immunosuppressives. This means that they reduce the strength of your immune system.

Indications:

Imuran 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 

‒ systemic lupus erythematosus 

‒ dermatomyositis and polymyositis 

‒ auto-immune chronic active hepatitis 

‒ pemphigus vulgaris 

‒ polyarteritis nodosa  

‒ auto-immune haemolytic anaemia 

‒ chronic refractory idiopathic thrombocytopenic purpura

Dosage and administration:

Always take this medicine exactly as your doctor  has told you. Check with your doctor if you are not sure.The dose depends on the condition for which you are being treated. 

You should take your medicine at least 1 hour before or 2 hours after having milk or dairy products.

You can take Imuran Tablets with food or on an empty stomach but the choice of method should be consistent from day to day. Some patients feel nausea (sick) when first given Imuran Tablets, this may  be relieved by taking the tablets after food.

• When you take Imuran Tablets, your doctor will take regular blood tests. This is to check the number and type of cells in your blood, and to ensure your liver is working correctly.
• Your doctor may also ask for other blood and urine tests to monitor how your kidneys are working and to measure uric acid levels. Your doctor may sometimes change your dose of Imuran Tablets as a result of these tests.
• Swallow your tablets whole. Do not chew the tablets. The tablets should not be broken or crushed.

The recommended dose is:

• Adults who have had an organ transplant: On the first day of treatment, the usual dose is up to 5 mg per kilogram of body weight, then a usual daily dose of 1 mg to 4 mg per kilogram of body weight. During treatment your doctor will adjust the dose depending on your reaction to the medicine.
• Adults with other conditions: The usual starting dose is 1 mg to 3 mg per kilogram of body weight, then a usual daily dose of less than 1 mg to 3 mg per kilogram of body weight. During treatment your  doctor will adjust the dose depending on your reaction to the medicine.

• Elderly patients may need a reduced dose.
• Patients with kidney or liver problems may need a reduced dose.
• Use in children 

-Children who have had organ transplant: The dosing for children who have had an organ transplant is the same as adults.

-Children with other conditions: 

The dosing for children with other conditions is the same as adults.

-Children who are considered overweight may require a higher dose.

• If you take more Imuran Tablets than you should contact your doctor immediately.
• If you forget to take Imuran Tablets

Do not take a double dose to make up for the dose that you missed. Inform your doctor if you do miss a dose.

• Before you stop taking Imuran Tablets, consult with your doctor or pharmacist. Do not stop taking Imuran Tablets until your doctor tells you it is safe to do so.

Side effects:

-allergic reactions;

-general tiredness, dizziness, feeling sick (nausea), being sick (vomiting), diarrhoea or abdominal pain;

-swelling of the eyelids, face or lips;

-redness of the skin, skin nodules or a skin rash;

-pain in the muscles or joints;

-sudden wheezing, coughing or difficulty breathing.

In severe cases these reactions may be life-threatening.

• Skin rashes or redness, which may develop into life-threatening skin reactions including widespread rash with blisters and peeling skin, particularly occurring around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), extensive peeling of the skin (toxic epidermal necrolysis); 
• Reversible pneumonitis;
• Problems with your blood and bone marrow, signs include weakness, tiredness, paleness, bruising easily, unusual bleeding or infections.

If you get any of the following serious side effects, talk to your doctor or specialist doctor immediately, you may need urgent medical treatment:

• you have a high temperature (fever) or other signs of an infection such as sore throat, sore mouth, urinary problems, or chest infection causing breathlessness and cough;
• problems with your liver, signs include your skin or the whites of your eyes turn yellow (jaundice);
• various types of cancers including blood, lymph and skin cancers ;
• Sweet’s syndrome;
• a certain type of lymphomas (hepatosplenic T-cell lymphoma). 

Very Common:

• low white blood cell level in your blood tests, which may cause an infection

Common: 

• nausea 

Uncommon: 

• anaemia 
• pancreatitis   

Rare:

• hair loss 

Very rare:

• problems with your bowels leading to diarrhoea, abdominal pain, constipation, feeling or being sick

Contraindications:

Do not take Imuran Tablets:

• if you are allergic to azathioprine or any of the other ingredients of this medicine
• if you are allergic to mercaptopurine (a medicine which is similar to azathioprine)

Warnings and precautions:

Talk to your doctor or pharmacist before taking Imuran Tablets:

• if you have recently received, or are due to receive, a vaccination (vaccine). If you take Imuran 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 Imuran Tablets;
• if you have a genetic condition known as Lesch-Nyhan Syndrome. This is a rare condition that runs in families caused by a lack of something called HPRT or ‘hypoxanthine-guanine- phosphoribosyltransferase;

• if you have liver or kidney problems;
• if you have a genetic condition called TPMT deficiency (where your body produces too little of an enzyme called thiopurine methyltransferase);
• if you have ever had chickenpox or shingles;
• if you have had hepatitis B (a liver disease caused by a virus);
• if you are going to have an operation (this is because medicines including tubocurarine, or succinylcholine used as muscle relaxants during operations may interact with Imuran Tablets. You should inform your anaesthesiologist of your treatment with Imuran Tablets prior to surgery.

If you are receiving immunosuppressive therapy, taking Imuran could put you at greater risk of:

• tumours, including skin cancer. (Therefore, when taking Imuran, avoid excessive exposure to sunlight, wear protective clothing and use protective sunscreen with a high protection factor);
• lymphoproliferative disorders;
• treatment with Imuran 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);

• 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, when taking Imuran Tablets}, avoid contact with people who have 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.

Tell your doctor if you are taking, or are planning to take: 

• ribavirin • methotrexate • allopurinol, oxipurinol, thiopurinol or other xanthine oxidase inhibitors, such as febuxostat 
• penicillamine • ACE inhibitors •anticoagulants such as warfarin or acenocoumarol • cimetidine •indomethacin • cytostatic drugs • aminosalicylates e.g. olsalazine, mesalazine or sulfasalazine •Trimethoprim/sulfamethoxazole •infliximab • Muscle relaxants e.g. tubocurarine or succinylcholine. 
• Before a surgical procedure, tell the anesthesiologist that you are taking azathioprine because muscle relaxants used during anesthesia may interact with azathioprine.
• Pregnancy:

Reliable contraceptive precautions must be taken to avoid pregnancy whilst you or your partner are taking Imuran Tablets. 

If you are pregnant your doctor will carefully consider whether you should take this medicine, based on the risks and benefits of treatment. 

• Breast-feeding:

Small amounts of Imuran may pass into the breast milk. It is recommended that women receiving Imuran should avoid breastfeeding unless the benefits outweigh the potential risks to the child. Ask your doctor for advice before breastfeeding.

Storage:

Store at a temperature not exceeding 25°C

Package:

Carton box contains 100 film coated tablets and paper instructions.