Patient leaflet - AZATHIOPRINE TABLETS 50 MG, AZAPRESS TABLETS 50 MG
2. What you need to know before you take Azathioprine Tablets
3. How to take Azathioprine Tablets
4. Possible side effects
5. How to store Azathioprine Tablets
6. Contents of the pack and other information
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1. WHAT AZATHIOPRINE TABLETS ARE AND WHAT THEY ARE USED FOR
2. what you need to know before you take azathioprine tablets
Do not take this medicine if:
! You are allergic (hypersensitive) to azathioprine or any of the other ingredients of this medicine (listed in section 6)
! You have had an allergic reaction before to 6-mercaptopurine (6-MP) as you are more likely to be hypersensitive to Azathioprine.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Azathioprine Tablets 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.
! You have the inherited deficiency of the enzyme thiopurine methyltransferase (TPMT) or Lesch-Nyhan Syndrome (hypoxanthine-guanine-phosphoribosyltransferase deficiency)
! You have kidney or liver disease
! 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 Azathioprine Tablets. You should inform your anaesthesiologist of your treatment with Azathioprine Tablets prior to surgery.
nogen Pharma
NUDT15-gene mutation
If you have an inherited mutation in the NUDT15-gene (a gene which is not involved in the breakdown 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 Tablets could put you at greater risk of:
! Tumours, including skin cancer. Therefore, when taking Azathioprine Tablets, avoid excessive exposure to sunlight, wear protective clothing and use protective sunscreen with a high protection factor
! Lymphoproliferative disorders
, Treatment with Azathioprine Tablets 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 Sundrome (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 Azathioprine 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 (see section 4 “Possible side effects”).
Other medicines and Azathioprine Tablets Tell your doctor or pharmacist if you are taking, have taken recently or might take any other medicines.
In particular tell your doctor if you are taking any of the following:
! ribavirin (used to treat viral infections)
! methotrexate (mainly used to treat cancers)
! allopurinol, oxipurinol, thiopurinol or other xanthine oxidase inhibitors, such as febuxostat (mainly used to treat gout)
! penicillamine (mainly used in the treatment of rheumatoid arthritis)
! ACE inhibitor (mainly used to treat high blood pressure – hypertension)
! anticoagulants such as Warfarin or acenocoumarol (used to prevent blood clots)
! cimetidine (used to treat stomach ulcers and indigestion)
! indomethacin (used as a pain killer and antiinflammatory)
! cytostatic drugs (drugs used to treat various types of cancer)
! aminosalicylates e.g. olsalazine, mesalazine or sulfasalazine (mainly used in the treatment of ulcerative colitis and Chron's disease)
! co-trimoxazole (an antibiotic, used to treat infections caused by bacteria)
! infliximab (mainly used in the treatment of ulcerative colitis and Crohn's disease)
! muscle relaxants e.g. tubocurarine or succinylcholine (used during operations) as they may interact with Azathioprine Tablets. You should inform your anaesthesiologist of your treatment with Azathioprine Tablets prior to surgery.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Azathioprine Tablets.
Having vaccines whilst taking Azathioprine Tablets
Speak to your doctor or nurse before you have it. This is because vaccines may not work properly while you are taking Azathioprine Tablets.
Azathioprine Tablets with food and drink
You should take you 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
Reliable contraceptive precautions must be taken to avoid pregnancy whilst you or your partner is taking Azathioprine 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 Azathioprine Tablets may pass into the breast milk. It is recommended that women receiving Azathioprine Tablets should avoid breastfeeding unless the benefits outweigh 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
Azathioprine Tablets are not known to affect your ability to drive or use machinery. If you experience any side effect from this medicine, you may not be able to drive or operate machinery.
Azathioprine Tablets contain lactose
This medicine contains lactose (a type of sugar), if you have been told by your doctor that you have an intolerance to some sugars talk to your doctor before taking this medicine.
Sodium content
This medicine contains less than 1mmol sodium (23mg) per tablet, this is to say essentially ‚sodium free‘.
3. how to take azathioprine tablets
Always take Azathioprine Tablets exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
The dose of Azathioprine you take depends on your illness and how bad it is.
You can take Azathioprine 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 given Azathioprine Tablets, this may be relieved by taking the tablets after food.
! When you take Azathioprine 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. Uric acid is a natural substance made in your body and levels of uric acid can rise while you are taking Azathioprine Tablets. High levels of uric acid may damage your kidneys.
Your doctor may sometimes change your dose of Azathioprine Tablets as a result of these tests. Swallow your tablets whole. Do not chew the tablets. The tablets should not be broken or crushed.
It is important that carers are aware of the need for safe handling of this medicine. If you or your caregiver does handle broken tablets, wash your hands immediately. Please consult your doctor or pharmacist for advice.
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 Azathioprine Tablets than you should
If you take too many tablets, contact your doctor or pharmacist immediately.
If you stop taking Azathioprine Tablets Before you stop taking Azathioprine Tablets, consult with your doctor or pharmacist. Do not stop taking Azathioprine Tablets until your doctor tells you it is safe to do so.
If you forget to take Azathioprine 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.
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, then go back to taking it as you would normally.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Azathioprine Tablets and see a doctor straight away, if you notice any of the following serious side effects, you may need urgent medical treatment:
! Allergic reactions (these are uncommon side effects which may affect up to 1 in 100 people) these signs may include:
, 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 (including blisters itching, or peeling skin)
, pain in the muscles or joints
, sudden wheeziness, coughing or difficulty breathing
In severe cases these reactions may be lifethreatening (this is rare which may affect up to 1 in 10,000 people).
! 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 ) (these may be very rare side effects which may affect up to 1 in 10,000 people).
! Reversible pneumonitis (inflammation of your lungs causing breathlessness, cough and fever) (these may be very rare side effects which may affect up to 1 in 10,000 people)
! Problems with your blood and bone marrow, signs include weakness, tiredness, paleness, bruising easily, unusual bleeding or infections (these may be very common side effects which may affect more than 1 in 10 people)
! When Azathioprine Tablets is used in combination with other immunosuppressives you may get a virus which causes damage to your brain. This may cause headaches, changes in behaviour, impaired speech, worsening of abilities such as memory, attention and decision making (cognitive decline) and may be fatal (condition known as JC virus associated Progressive Multifocal Leukoencephalopathy ) (these may be very rare side effects which may affect more than 1 in 10,000 people)
If you get any of the following serious side effects, talk to your doctor or specialist doctor immediately, you may need 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 (these may be very common side effects which may affect more than 1 in 10 people)
! Problems with your liver, signs include your skin, or the whites of your eyes turn yellow (jaundice) (these may be uncommon side effects which may affect up to 1 in 100 people)
! Various types of cancers including blood, lymph and skin cancers (see section 2 Warnings and precautions) (these may be rare side effects which may affect up to 1 in 1000 people)
! Sweet's syndrome (also known as acute febrile neutrophilic dermatosis). You may develop a rash (raised red, pink or purple lumps which are sore to touch), particularly on your arms, hands, fingers, face and neck, which may also be accompanied by a fever (high temperature) (the rate at which these side effects occur is not known – cannot be estimated from available data)
! a certain type of lymphomas (hepatosplenic T-cell lymphoma). You may develop nose bleeds, fatigue, significant night sweats, weight loss and unexplained fevers (high temperature) (the rate at which these side effects occur is not known – cannot be estimated from available data)
If you notice any of the above, stop taking Azathioprine Tablets and see a doctor straight away.
Other side effects include:
Very common (may affect more than 1 in 10 people)
! Low white blood cell level in your blood tests, which may cause an infection
Common (may affect up to 1 in 10 people)
! Nausea (feeling sick)
Uncommon (may affect up to 1 in 100 people)
! Anaemia (low red blood cell level)
! Pancreatitis (inflammation of the pancreas), which may cause severe upper stomach pain
Rare (may affect up to 1 in 1,000 people)
! You might notice some hair loss while taking Azathioprine Tablets. Often hair does grow again, even if you carry on taking Azathioprine Tablets. If you are worried ask your doctor.
Very Rare (may affect up to 1 in 10,000 people
! Problems with your bowels leading to diarrhoea, abdominal pain, constipation, feeling or being sick (bowel perforation)
! Inflammation of your lungs causing breathlessness, cough, and a fever
Not known (frequency cannot be estimated from the available data)
! Photosensitivity (sensitivity to light or sunlight)
Reporting or side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. how to store azathioprine tablets
Check the expiry date printed on the label or side of the box. Do not use after the expiry date stated on the label. Store in a dry place, below 25°C. Store in the original package to protect from light. In case of any visible signs of deterioration you should discard the package.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment.
Keep out of the sight and reach of children
6. contents of the pack and other information
What Azathioprine Tablets contain :
Each tablet contains 50mg azathioprine.
The other ingredients are: lactose, starch maize, microcrystalline cellulose, magnesium stearate, purified talc, and sodium starch glycollate.
What Azathioprine Tablets look like and contents of the pack
Azathioprine Tablets are pale yellow biconvex tablets scored on one side and engraved with ‚A10‘ on the other side. The score line is not intended for breaking the tablet.
These tablets are supplied in packs of 28, 50, 56, 100 or 250 tablets or in securitainers of 50 or 100 tablets. Not all pack sizes may be marketed.
Manufacturing and Marketing Authorisation Holder:
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK
This leaflet was last revised in June 2021.
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