25 mg and 50 mg film-coated tablets
azathioprine
1. What Imurel is and what it is used for
Imurel contains the active substance azathioprine. It belongs to a group of medicines called immunosuppressants. Drugs belonging to this group suppress the immune system.
Imurel can be used to help the body accept a transplanted organ, such as a new kidney or liver or a new heart. Imurel can also be used to treat certain diseases that are caused by the immune system attacking the body’s own tissues (autoimmune diseases).
Autoimmune diseases can be:
- severe rheumatoid arthritis (a disease in which the immune system attacks cells surrounding joints and causes swelling, pain and stiffness in the joints)
- systemic lupus erythematosus (a disease in which the immune system attacks several organs and tissues in the body, such as skin, joints, kidneys, brain and other organs and causes severe fatigue, fever, stiffness and joint pain)
- dermatomyositis and polymyositis (a group of diseases that cause inflammation in the muscles, muscle weakness and rash)
- autoimmune chronic active hepatitis (a disease in which the immune system attacks liver cells and causes hepatitis, fatigue, muscle aches, yellowing skin and fever)
- pemphigus (a disease in which the immune system attacks skin cells and causes severe blistering of the skin, mouth, nose, throat and genitals)
- polyarteritis nodosa (a rare disease that causes inflammation of the blood vessels)
- autoimmune hemolytic anemia (a serious blood disorder in which the body destroys red blood cells faster than they are formed, with symptoms such as weakness and shortness of breath)
- chronic refractory idiopathic thrombocytopenic purpura (a disease with low platelet counts that can cause mild or excessive bruising or bleeding).
Imurel can also be used to treat inflammatory bowel disease ( Crohn’s disease or ulcerative colitis ).
Your doctor has chosen this medicine because it is suitable for you and your illness.
Imurel can be used alone but is more often used with other medicines.
Azatioprine contained in Imurel may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before you take Imurel
Do not take Imurel:
- if you are allergic to azathioprine or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to mercaptopurine (a medicine similar to azathioprine which is the active substance in Imurel).
Warnings and cautions
Talk to your doctor or pharmacist before taking Imurel:
- if you have recently received or will receive a vaccination. If you are taking Imurel, you should not receive a live vaccine (eg flu , measles, BCG vaccine, etc.) until your doctor thinks it is safe for you. This is because some vaccines can cause infection if you get them while you are taking Imurel.
- if you have a genetic disorder called Lesch-Nyhan syndrome. This is a rare inherited disease caused by a lack of HPRT, ie hypoxantinguanin phosphoribosyltransferase.
- if you have liver or kidney problems
- if you have a genetic disease called TPMT deficiency (where the body produces too little of an enzyme called thiopurine methyltransferase)
- if you have 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 surgery can affect or be affected by Imurel). Before the operation, tell your anesthetist that you are being treated with Imurel.
NUDT15 gene mutation
If you have a hereditary mutation in the NUDT15 gene (a gene that is involved in the breakdown of Imurel in the body), then the risk is higher for you to get infection and hair loss and in this case, the doctor can give you a lower dose.
If you are not sure if any of the above applies to you, talk to your doctor, nurse, or pharmacist before taking Imurel.
Your doctor will ask you to take regular blood tests while you are taking Imurel to check for any changes (see section 3 “How to take Imurel”). If treatment with Imurel is continued for a long time, blood samples are generally taken less frequently.
If you are receiving immunosuppressive therapy and taking Imurel, this may increase your risk of:
- tumor er, including skin cancer. When taking Imurel, you should therefore avoid excessive sunbathing as well as wear protective clothing and use sunscreen with a high protection factor.
- lymphoproliferative disorders
- Treatment with Imurel increases your risk of developing a type of cancer called lymphoproliferative disorder. During treatment regimens that contain several immunosuppressive drugs (including thiopurines), this can lead to death.
- A combination of several concomitant immunosuppressive drugs increases the risk of disorders of the lymphatic system due to a viral infection (lymphoproliferative disorders associated with Epstein-Barr virus ( EBV )).
- development of a serious condition called macrophage activation syndrome (excessive activation of white blood cells associated with inflammation ), which usually occurs in people with certain types of arthritis .
- severe chickenpox or shingles infection. Therefore, when taking Imurel, avoid contact with people who have chickenpox or shingles .
- previous hepatitis B infection that becomes active again.
- other infections such as PML ( progressive multifocal leukoencephalopathy) which is an opportunistic infection . If you experience any signs of infection , consult a doctor (see section 4 “Possible side effects”).
Other medicines and Imurel
Tell your doctor if you are taking, have recently taken, or might take any other medicines. This is because Imurel may affect the way some medicines work.
Some other medicines may also affect the way Imurel works. In particular, tell your doctor if you are taking or plan to take:
- ribavirin (used to treat viral infections)
- methotrexate (mainly used to treat cancer)
- allopurinol, oxipurinol, thiopurinol or other xanthine oxidase inhibitors, such as febuxostat (used mainly to treat gout )
- penicillamine (mainly used to treat rheumatoid arthritis )
- ACE inhibitor (mainly used to treat high blood pressure )
- anticoagulants , such as warfarin or acenocoumarin (used to prevent blood clots)
- cimetidine (used to treat stomach ulcers and digestive problems)
- indomethacin (used as an analgesic and anti-inflammatory)
- cytostatics (drugs used to treat various types of cancer)
- aminosalicylates, e.g. olsalazine, mesalazine or sulfasalazine (used mainly to treat ulcerative colitis and Crohn’s disease )
- trimethoprim sulfa ( antibiotics used to treat bacterial infections)
- infliximab (mainly used to treat ulcerative colitis and Crohn’s disease )
- muscle relaxants, e.g. tubocurarine or succinylcholine (used in surgery) as they may affect or be affected by Imurel. Before undergoing surgery, tell your anesthetist that you are being treated with azathioprine, as the muscle relaxants used in anesthesia may affect or be affected by azathioprine.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Imurel.
Getting vaccinated during treatment with Imurel
If you will receive a vaccination, talk to a doctor or nurse before receiving the vaccination. If you are taking Imurel, you should not receive a live vaccine (eg influenza, measles, BCG vaccine, etc.) until your doctor thinks it is safe for you. This is because some vaccines can cause infection if you get them while you are taking Imurel.
Imurel with food and drink
You should take Imurel at least 1 hour before or 2 hours after drinking milk or eating dairy products.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy
A reliable contraceptive must be used to avoid pregnancy while you or your partner are taking Imurel.
If you are pregnant, your doctor will carefully consider whether to take this medicine on the basis of the risks and benefits of treatment.
Breast-feeding
Small amounts of Imurel may pass into breast milk. It is recommended that women receiving Imurel avoid breastfeeding unless the benefits outweigh the potential risks to the baby. Consult a doctor before breastfeeding.
Fertility
The effects of Imurel on fertility are unknown.
Driving and using machines
It is not known that Imurel would have any effect on the ability to drive or use machines. If you get any side effects from this medicine, you may not be able to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Imurel contains lactose
Imurel contains lactose monohydrates. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Imurel
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The amount of Imurel to take varies from patient to patient. The number of tablets to be taken is determined by the doctor. Dose one depends on the disease being treated.
You can take Imurel with a meal or on an empty stomach, but you should take the tablet, in the same way, every day. Some patients may experience nausea at the beginning of treatment with Imurel. Nausea can be relieved if the tablets are taken after a meal.
- When you take Imurel, your doctor will take regular blood tests. This is done to control the number and type of blood cells in your blood and to ensure that your liver is functioning properly.
- Your doctor may also ask for other blood and urine tests to check how your kidneys are working and to measure the level of uric acid . Uric acid is a natural substance that is formed in the body and the level of uric acid can rise when you take Imurel. High levels of uric acid can damage the kidneys.
Sometimes your doctor may change the dose of Imurel based on test results.
Swallow the tablets whole. Do not chew the tablets. The tablets should not be split or crushed.
It is important that carers know how to handle this medicine safely. If you or your caregiver handle broken tablets, wash your hands immediately. Consult a doctor or pharmacist.
The recommended dose is:
Adults who have had an organ transplant: The first day of treatment is the usual dose up to 5 mg/kg body weight, then the usual daily dose is 1-4 mg/kg body weight. During treatment, your doctor will adjust the dose depending on how you react to the medicine.
Adults with other diseases: The usual starting dose is 1-3 mg/kg body weight, after which the usual daily dose is less than 1-3 mg/kg body weight. During treatment, your doctor will adjust the dose depending on how you react to the medicine.
Elderly patients may need a lower dose.
Patients with kidney or liver problems may need a lower dose.
Use for children
Children who have had an organ transplant: The dose for children who have had an organ transplant is the same as for adults.
Children with other diseases: The dose for children with other diseases is the same as for adults.
Children who are considered overweight may need a higher dose.
If you take more Imurel than you should:
If you have taken too many tablets, contact your doctor or pharmacist immediately.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to take Imurel:
Do not take a double dose to make up for a forgotten dose . If you forget to take a dose , tell your doctor.
If it is almost time for your next dose , skip the missed dose and take your next dose as usual. Otherwise, take a dose as soon as you remember and then return to taking the dose as usual.
If you stop taking Imurel
Talk to your doctor or pharmacist before stopping taking Imurel. Do not stop taking Imurel until your doctor tells you it is safe to do so.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them. The following side effects may occur with this medicine:
Stop taking Imurel and see a doctor immediately if you notice any of the following serious side effects , you may need urgent medical attention.
- allergic reactions (these are less common side effects that can affect up to 1 in 100 people), symptoms include:
- general fatigue, dizziness, nausea, vomiting, diarrhea or abdominal pain
- swelling of eyelids, face or lips
- reddening of the skin or rash (including blisters, itching or flaky skin)
- pain in muscles or joints
- sudden wheezing, coughing or difficulty breathing
In severe cases, these reactions can be life-threatening (this is very rare and can affect up to 1 in 10,000 people).
- rash or redness that can develop into life-threatening skin reactions including widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome ), extensive peeling skin ( toxic epidermal necrolysis ) (these can be very rare side effect s which can affect up to 1 in 10,000 people)
- transient pneumonia ( pneumonia that causes shortness of breath, cough and fever) (these can be very rare side effects that can affect up to 1 in 10,000 people)
- problems with the blood and bone marrow , the signs include weakness, fatigue, pallor, bruising, unusual bleeding or infection (these can be very common side effects that can affect more than 1 in 10 people)
- When Imurel is used in combination with other immunosuppressive agents, you may be infected with a virus that damages the brain. This can cause headaches, behavioral changes, impaired speech, impaired abilities such as memory, attention and decision making ( cognitive impairment) and can be fatal (a condition called JC virus associated with progressive multifocal leukoencephalopathy ) (these can be very rare side effects that can affect up to 1 in 10,000 people).
If you get any of the following serious side effects , talk to a doctor or specialist immediately, you may need urgent medical attention:
- fever or other signs of infection such as sore throat, sore mouth, urination problems or infection of the chest that causes shortness of breath and cough (these can be very common side effects that can affect more than 1 in 10 people)
- liver problems, signs include yellowing of the skin or whites of the eyes (jaundice) (these may be less common side effects that may affect up to 1 in 100 people)
- different cancers including blood, lymph and skin cancers (see section 2 “Warnings and precautions”) (these can be rare side effects that can affect up to 1 in 1,000 people)
- You may get rashes (red, light red or purple rashes that are sore when you touch them), especially on the arms, hands, fingers, face and neck and which can also be accompanied by fever (Sweet’s syndrome, also called acute febrile neutrophil dermatosis ). It is not known how common these side effects are (it is not possible to calculate from the available data).
- a specific type of lymphoma ( hepatosplenic T-cell lymphoma ). You may get nosebleeds, fatigue, heavy sweating at night, weight loss and unexplained fever (no known frequency – can not be calculated from the available data).
If you get any of the above, stop taking Imurel and see a doctor immediately.
Other side effects include:
Very common (may affect more than 1 in 10 people)
- low number of white blood cells in blood samples, which can cause infection .
Common (may affect up to 1 in 10 people)
- nausea.
Uncommon (may affect up to 1 in 100 people)
- anemia (low red blood cell count )
- pancreatitis ( pancreatitis ) which can cause severe pain in the upper abdomen.
Rare (may affect up to 1 in 1,000 people)
- treatment with Imurel can cause hair loss, but hair often grows back even if you continue treatment with Imurel. If you have any further questions, ask your doctor.
Very rare (may affect up to 1 in 10,000 people)
- intestinal problems that cause diarrhea, abdominal pain, constipation, nausea or vomiting (intestinal perforation).
No known frequency (can not be calculated from the available data)
- photosensitivity (sensitivity to light or sunlight).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Imurel
Store in the outer carton. Sensitive to light.
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton.
The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is azathioprine 25 mg and 50 mg respectively per tablet.
- The other ingredients are lactose monohydrate 37 mg (25 mg tablet) or 74 mg (50 mg tablet), magnesium stearate, stearic acid, hypromellose, maize starch , pregelatinised starch , macrogol 400. The 25 mg tablet also contains the dyes titanium dioxide E171 and iron oxide E172.
What the medicine looks like and contents of the pack
Imurel 25 mg film-coated tablet is orange, round, biconvex, marked IM 2.
Imurel 50 mg film-coated tablet is yellow, round, biconvex, scored, marked IM 5.
Imurel 25 mg is supplied in a blister pack containing 50 tablets.
Imurel 50 mg is supplied in pressure packs containing 50 or 100 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder :
Aspen Pharma Trading Limited
3016 Lake Drive,
Citywest Business Campus,
Dublin 24, Ireland
Tel: +46 856 642 572
Manufacturer:
Excella GmbH & Co. KG
Nürnberger Strasse 12
90537, Feucht, Germany
Aspen Bad Oldesloe GmbH
Industriestrasse 32-36
23843 Bad Oldesloe
Germany