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, pharmacist, or nurse.
  • 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, pharmacist or nurse. This also applies to any side effects not mentioned in this information. See section 4.

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

What Azathioprine Orifarm is and what it is used for

Azathioprine Orifarm belongs to a group of medicines called immunosuppressants. This means that the medicine weakens your immune system.

Immunosuppressive drugs may sometimes be needed to make it easier for the body to accept a transplanted organ, such as a new kidney or liver or a new heart, or to treat some diseases in which the immune system reacts to its own body (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).

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

Azathioprine contained in Azathioprine Orifarm may also be approved for the treatment of other conditions not mentioned in this product information. 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 Orifarm

Do not take Azathioprine Orifarm

  • if you are allergic to azathioprine or any of the other ingredients of this medicine (listed in section 6).
  • if you are allergic to 6-mercaptopurine (6-MP) as azathioprine is converted in your body.

Warnings and cautions

Talk to your doctor, pharmacist or nurse before taking Azathioprine Orifarm.

  • if you have recently received or will receive a vaccination. If you are taking Azathioprine Orifarm, 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 Orifarm.
  • 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 disease
  • if you have a specific hereditary enzyme deficiency – thiopurine methyltransferase (TPMT) deficiency
  • 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 azathioprine). Before the operation, tell your anesthetist that you are being treated with Azathioprine Orifarm.

NUDT15 gene mutation

If you have a hereditary mutation in the NUDT15 gene (a gene that is involved in the breakdown of Azathioprine Orifarm in your body), the risk of getting infection and hair loss is higher and your doctor may 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 Azathioprine Orifarm.

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

Contact a doctor immediately if you:

  • get infection , sore throat, fever, unexpected bruising or bleeding (may be symptoms of bone marrow infection).

Taking immunosuppressive therapy with Azathioprine Orifarm may increase your risk of:

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

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Azathioprine Orifarm may affect the way some medicines work and some other medicines may affect the way Azathioprine Orifarm works.


It is especially important that you tell your doctor if you are taking or are planning to take the following medicines:

  • ribavirin (for viral infections)
  • methotrexate (mainly for cancer)
  • penicillamine (mainly used to treat rheumatoid arthritis )
  • allopurinol, oxipurinol, thiopurinol or other xanthine oxidase inhibitors (mainly used to treat gout in the feet)
  • anticoagulants , such as warfarin (blood thinners)
  • other chemotherapy drugs (medicines used to treat different types of cancer)
  • aminosalicylates, such as mesalazine, olsalazine and sulfasalazine (medicines for certain intestinal diseases)
  • ACE inhibitors (for high blood pressure )
  • cimetidine (for stomach ulcers / stomach acid)
  • indomethacin (used as an analgesic and anti-inflammatory)
  • 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 Azathioprine Orifarm. Before the operation, tell your anesthetist that you are being treated with Azathioprine Orifarm.

Getting vaccinated during treatment with Azathioprine Orifarm

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

Azathioprine Orifarm with food and drink

You should take the medicine 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.


ravidity

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

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

Breast-feeding

Small amounts of azathioprine pass into breast milk.

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

Fertility

The effects of Azathioprine Orifarm on fertility are unknown.

Driving and using machines

The effect of Azathioprine on your ability to drive and use machines is unknown. You must be aware of how the medicine affects you.


You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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.

How to take Azathioprine Orifarm

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 Orifarm 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 Orifarm 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 Orifarm. The nausea can be relieved if the tablets are taken after a meal. You should take the medicine at least 1 hour before or 2 hours after drinking milk or eating dairy products.

The tablet should be swallowed whole. Do not chew the tablets. Do not split or crush the tablet. The notch is not intended for splitting the tablet.

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. When you take Azathioprine Orifarm, 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 Azathioprine Orifarm. High levels of uric acid can damage the kidneys. Sometimes your doctor may change the dose of Azathioprine Orifarm based on the test results.

The recommended dose is:

Adults:

Transplantation:

The first day of treatment is the usual dose up to 5 mg / kg body weight, then a daily dose is 1-4 mg / kg body weight. During treatment, your doctor will adjust the dosedepending on how you react to the medicine.

Other diseases:

The usual starting dose is 1-3 mg / kg body weight, after which the daily dose is less than 1-3 mg / kg body weight. During treatment, your doctor will adjust the dosedepending on how you react to the medicine.

Use for children:

Transplantation:

The dose for children who have had an organ transplant is the same as for adults.

Other diseases:

Dose one for children with other diseases is the same as for adults.

Children who are considered overweight may need a higher dose .

Elderly :

Dose one may need to be lowered. Follow your doctor’s instructions.

Renal and hepatic impairment:

Dose one may need to be lowered. Follow your doctor’s instructions.


An overdose can cause nausea, vomiting, diarrhea, infections , sore throats, bruising and bleeding. 

If you forget to take Azathioprine Orifarm

Do not take a double dose to make up for a forgotten tablet.

If it is almost time for your next dose , skip the missed dose and take the next doseas usual. Otherwise, take a dose as soon as you remember and then return to taking the dose as usual.

If you stop taking Azathioprine Orifarm

The treatment should only be changed or stopped in consultation with a doctor.

Discontinuation of treatment may lead to severe deterioration of the treated condition.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

Stop taking Azathioprin Orifarm immediately and contact your doctor immediately if you notice any of the following serious side effects , you may need urgent medical attention:


Very common side effect are
 (can occur in more than 1 in 10):

  • General fatigue, paleness, bleeding from the skin and mucous membranes, bruising and infection due to decreased number of blood cells and impaired bone marrow function.

Common side effects are (may affect up to 1 in 10):

  • Bleeding from skin and mucous membranes and bruising, due to changes in the blood (decreased number of platelets ).

Less common side effects are (may affect up to 1 in 100):

  • Severe abdominal pain and fever due to inflammation of the pancreas.

Rare side effects are (may affect up to 1 in 1000):

  • Jaundice, abdominal pain, bloated stomach, due to life-threatening liver damage.
  • Significantly reduced number of all types of blood cells , which can cause weakness, bruising or increase the risk of infection .

Very rare side effects are (may affect up to 1 in 10 000 users):

  • Bladder-shaped rashes and inflammation of the skin, especially on the hands and feet, and in and around the mouth, together with fever ( Stevens-Johnson syndrome ).
  • Severe skin peeling and rejection ( toxic epidermal necrolysis ).
  • Dry cough due to connective tissue inflammation in the lungs ( reversiblepneumonitis ).
  • Severe abdominal pain and affected general condition due to perforation (holes) in the intestine.
  • Diarrhea, mucus and possible bleeding from the stomach due to colitis. Tendency to constipation, bloating and abdominal pain caused by pockets in the colon.

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

  • A specific type of lymphoma (hepatosplenic T-cell lymphoma). You may experience nosebleeds, fatigue, heavy sweating at night, weight loss and unexplained fever.
  • Sweet’s syndrome (also called acute febrile neutrophil dermatosis ). You may get rashes (red, light red or purple rashes that are sore when touched), especially on the arms, hands, fingers, face and neck and which may also be accompanied by fever.

Other side effects can be the following:

Very common side effect are (can occur in more than 1 in 10):

  • Increased susceptibility to infection in transplant patients.
  • General fatigue, more infection than usual and fever due to changes in your blood picture (decreased number of white blood cells ). Can be serious. Contact a doctor if you get a fever. 

Common side effects are (may affect up to 1 in 10):

  • Nausea. 

Less common side effects are (may affect up to 1 in 100):

  • Paleness and fatigue due to anemia . Can get serious. Contact a doctor.
  • Allergic reactions.
  • Jaundice, nausea, vomiting and itching due to liver problems. Can get serious. Contact a doctor.
  • Increased susceptibility to infection.

Rare side effects are (may affect up to 1 in 1000):

  • Different cancers include blood, lymph ( lymphoma ) and skin cancer ( melanoma).
  • Hair loss. Hair often grows back, even if you continue treatment with Azathioprine Orifarm. Consult a doctor if you are worried.

Very rare side effects are (may affect up to 1 in 10 000 users):

  • Progressive multifocal leukoencephalopathy (PML), an opportunistic infectioncaused by the JC virus .

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

  • Photosensitivity (sensitivity to light or sunlight).

5. How to store Azathioprin Orifarm

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

Store in the original package. Sensitive to light.

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 50 mg.
  • Other ingredients are:
    • Tablet core: Microcrystalline cellulose, mannitol, maize starch, povidone, croscarmellose sodium and sodium stearyl fumarate.
    • Film coating: Hypromellose and macrogol 4000.

What the medicine looks like and the contents of the pack

Light yellow, film-coated, round, biconvex tablet with the inscription ‘A50’, a notch on one side and no marking on the other side.

Pack sizes

14, 20, 28, 30, 50, 56, 98,100 in blister packs.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orifarm Generics A / S

Energivej 15

5260 Odense S

Denmark

Local representative

Orifarm Generics AB

Box 56048

102 17 Stockholm

info@orifarm.com

Muhammad Nadeem

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