25 mg 50 mg film-coated tablets 
azathioprine

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Azatioprine Mylan is and what it is used for 
1. What you need to know before taking Azatioprine Mylan 
3. How to take Azatioprine Mylan 
4. Possible side effects 
5. How to store Azathioprine Mylan 
6. Package contents and other information 

1. What Azatioprine Mylan is and what it is used for

Azathioprine Mylan contains the active substance azathioprine. The

belongs to a group of medicines called immunosuppressants. Drugs belonging to this group suppress the immune system.

Azathioprine Mylan can be used to help the body accept a transplanted organ, such as a new kidney or liver or a new heart. Azathioprine Mylan 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 the 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).

Azathioprine Mylan 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.

Azathioprine Mylan can be used alone, but is more often used with other medicines.

Azathioprine contained in Azathioprine Mylan may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Azathioprine Mylan

Do not take Azathioprine Mylan

  • 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 Azathioprine Mylan).

Warnings and cautions

Talk to your doctor before taking Azathioprine Mylan:

  • if you have recently received or will receive a vaccination. If you are taking Azathioprine Mylan, 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 Azathioprine Mylan.
  • 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 a muscle relaxant during surgery may affect or be affected by Azathioprine Mylan.) Before surgery, tell your anesthetist that you are being treated with Azathioprine Mylan.

NUDT15 gene mutation

If you have a hereditary mutation in the NUDT15 gene (a gene that is involved in the breakdown of azathioprine in the body), the risk is higher that you will get an infection and hair loss and the doctor can give you a lower dose in this case .

If you are unsure if any of the above apply to you, speak up

with a doctor, nurse or

pharmacy staff before taking Azathioprine Mylan.

Your doctor will ask you to take regular blood tests while you are taking Azathioprine Mylan to check for any changes (see section 3 “How to take Azathioprine Mylan”). If treatment with Azathioprine Mylan is continued for a long time, blood tests are generally taken less frequently.

Taking immunosuppressive therapy and taking Azathioprine Mylan may increase your risk of:

  • tumor er, including skin cancer. Therefore, when taking Azathioprine Mylan, you should avoid excessive sunbathing as well as wear protective clothing and use sunscreen with a high protection factor.
  • lymphoproliferative disorders
    • Treatment with Azathioprine Mylan 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 the 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. When you take Azathioprine Mylan

are you

  • therefore 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 Azathioprine Mylan

Tell your doctor if you are taking, have recently taken, or might take any other medicines. This is because Azathioprine Mylan may affect the way some medicines work. Some other medicines may also affect the way Azathioprine Mylan works. Tell your doctor specifically and you are taking or plan to take:

  • ribavirin (used to treat viral infections)
  • methotrexate (mainly used to treat cancer)
  • allopurinol, oxypurinol, thiopurine, or other xanthine oxidase inhibitors, such as febuxostat (used mainly to treat gout)
  • penicillamine (mainly used to treat rheumatoid arthritis )
  • ACE inhibitors (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 )
  • 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 Azathioprine Mylan.

Getting vaccinated during treatment with Azathioprine Mylan

If you will be vaccinated, talk to a doctor or nurse before receiving the vaccination. If you are taking Azathioprine Mylan, 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 Azathioprine Mylan.

Azathioprine Mylan with food and drink

You should take Azathioprine Mylan at least 1 hour before or 2 hours after drinking milk or eating dairy products.

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 or pharmacist for advice before taking this medicine.

Pregnancy

A reliable contraceptive must be used to avoid pregnancy while you or your partner are taking Azathioprine Mylan.

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 Azathioprine Mylan may pass into breast milk. It is recommended that women receiving Azathioprine Mylan avoid breast-feeding unless the benefits outweigh the potential risks to the baby. Consult a doctor before breastfeeding.

Fertility

The effects of Azathioprine Mylan on fertility are unknown.

Driving and using machines

It is not known that Azathioprine Mylan 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.

Azathioprine Mylan is almost sodium-free

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

How to take Azathioprine Mylan

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 Azathioprine Mylan to be taken 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 Azathioprine Mylan 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 Azathioprine Mylan. Nausea can be relieved if the tablets are taken after a meal.

  • When you take Azathioprine Mylan, your doctor will take regular blood tests. This is done to check the number and type of blood cells in your blood and make sure your liver is working 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 Azathioprine Mylan. High levels of uric acid can damage the kidneys.

Sometimes your doctor may change the dose of Azathioprine Mylan based on the 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 Azathioprine Mylan than you should

If you forget to take Azathioprine Mylan

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 the next dose usually. Otherwise, take a dose as soon as you remember and then return to taking the dose as usual.

If you stop taking Azathioprine Mylan

Talk to your doctor or pharmacist before stopping taking Azathioprine Mylan. Do not stop taking Azathioprine Mylan until your doctor tells you it is safe to do so.

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 Azathioprine Mylan 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 may 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 occur in up to 1 in 10,000 users).

  • 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 occur in up to 1 in 10,000 users)
  • transient pneumonia ( pneumonia causing shortness of breath, cough and fever) (these can be very rare side effects that can occur in up to 1 in 10,000 users)
  • problems with the blood and bone marrow , the signs include weakness, fatigue, paleness, bruising, unusual bleeding or infection (these can be very common side effects that can occur in more than 1 in 10 users)
  • When Azathioprine Mylan is used in combination with other immunosuppressive agents, you may be exposed to 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 J C virus associated with progressive multifocal leukoencephalopathy ) (these can be very rare side effects such as may affect up to 1 in 10,000 users)

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

  • fever or other signs of infection such as sore throat, mouth pain, urination problems or infection of the chest that causes shortness of breath and cough (these can be very common side effects that can occur in more than 1 in 10 users)
  • 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 occur in up to 1 in 1,000 users)
  • 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 neutrophildermatosis ). 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 (has been reported – occurs in an unknown number of users).

If you get any of the above, stop taking Azathioprine Mylan and see a doctor immediately.

Other side effects include:

Very common (may affect more than 1 user in 10 )

  • 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 Azathioprine Mylan can cause hair loss, but hair often grows back even if you continue treatment with Azathioprine Mylan. 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).

Has been reported (occurs in an unknown number of users)

  • photosensitivity (sensitivity to light or sunlight).

Reporting of 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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

5. How to store Azathioprine Mylan

Store in the original package. 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.

If your doctor has told you to stop taking the tablets, leave the remaining tablets to the pharmacist. Keep them only if your doctor tells you to.

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 per tablet respectively.
  • The other ingredients are microcrystalline cellulose, mannitol, corn starch, povidone, croscarmellose sodium, sodium stearyl fumarate, hypromellose, macrogol.

What the medicine looks like and the contents of the pack

The tablets are yellow and round. 25 mg tablet is labeled “AE 25” on one side and “G” on the other. The 50 mg tablet is marked “AE 50” on one side and has a notch on the other side.

Pack sizes:

25 mg: 50 pcs in a plastic jar,

50 mg: 50 and 100 pcs in a plastic jar

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Mylan AB, Box 23033, 104 35 Stockholm

Manufacturer

McDermott Laboratories to Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

Generics UK Limited, Station Close, Potters bar, Hertfordshire, EN6 1T, UK Delpharm Lille SAS, Roubaix-Est Activity Park, 22 Rue de Toufflers CS 50070, Lys lez Lannoy, 59452, France

Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1, Hungary

Muhammad Nadeem

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