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. 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 Azathioprin Actavis is and what it is used for 
2. What you need to know before you use Azathioprin Actavis 
3. How to take Azathioprine Actavis 
4. Possible side effects 
5. How to store Azathioprin Actavis 6. Contents of the pack 
and other information 

What Azathioprine Actavis is and what it is used for

Azathioprine Actavis belongs to a group of medicines called immunosuppressants, which act by inhibiting the body’s immune system and inhibiting cell division. These drugs are used to treat a variety of diseases (such as the skin disease lupus erythematosus) when the immune system needs to be suppressed or after an organ transplant.

Azathioprine contained in Azathioprine Actavis 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 use Azathioprine Actavis

Do not take Azathioprine Actavis

  • if you are allergic to azathioprine or any of the other ingredients of this medicine (listed in section 6), or if you are allergic to the substance that azathioprine is broken down in your body (6-mercaptopurine).
  • if you have a serious infection.
  • if you suffer from severe liver or bone marrow dysfunction.
  • if you have pancreatitis.
  • if you are pregnant (unless the benefits outweigh the risks).
  • if you are breast-feeding.

You should not be vaccinated with live vaccines (especially tuberculosis (BCG), smallpox and yellow fever) while you are being treated with Azathioprine Actavis.

Warnings and cautions

Talk to your doctor or pharmacist before taking Azathioprine Actavis:

  • if you have ulceration of the throat, fever, infection, unexpected bruising, bleeding, or other signs of impaired bone marrow function.
  • if you are deficient in the enzyme thiopurine methyltransferase (TMPT).
  • if you suffer from a disease called Lesch-Nyhan syndrome.
  • if you are taking immunosuppressive therapy and taking Azathioprine Actavis, this may increase your risk of:
    • tumor er, including skin cancer. Therefore, when taking Azathioprine Actavis, you should avoid excessive sunbathing and wear protective clothing, and use a sunscreen with a high protection factor.
    • lymphoproliferative disorders
      • Treatment with Azathioprine Actavis increases your risk of developing a type of cancer called a 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 )).

Taking Azathioprine Actavis may increase your risk of:

  • 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.

The treatment is only given by doctors who are specialists in the field of immunological diseases and by doctors with specialist expertise in your disease.

During the first 8 weeks of treatment, a complete check of the number of blood cells in the blood should be done at least once a week:

  • if you are given a high dose
  • if you are older
  • if you have mild to the moderate liver or bone marrow function
  • if you have impaired kidney function
  • if you have abnormal blood composition

Thereafter, the number of blood cell tests can be done less frequently, approximately once a month or at least once every 3 months. You should be checked regularly if you have severe hepatic impairment.

Careful monitoring of the number of blood cells in the blood is necessary if you are being treated with any of the following medicines at the same time:

  • allopurinol, oxypurinol, or thiopurines (medicines used to treat gout )
  • mesalazine, olsalazine, or sulfasalazine (medicines used to treat intestinal diseases and gout )
  • ACE inhibitors (medicines used to treat high blood pressure )
  • trimethoprim/sulfamethoxazole (medicines used to treat urinary tract infections)
  • cimetidine (a medicine used to treat stomach ulcers )
  • indomethacin (a medicine used to treat gout )
  • drugs with cytotoxic / bone marrow inhibiting effect

If you are going to have surgery, tell your anesthetist that you are using Azathioprin Actavis as it may affect some muscle relaxants used during anesthesia.

You should be carefully monitored if you are also being treated with coumarin-type blood thinners.

Treatment with azathioprine may increase the risk of developing skin cancer. This is especially true of skin areas that are exposed to the sun. You should refrain from sunbathing or using a solarium. Wear protective clothing and a high sun protection factor and check the skin regularly.

You should not leave acute infections untreated. Consult your doctor.

You should be carefully monitored by a doctor if you are being treated with other cancer medicines at the same time.

NUDT15 gene mutation

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

Other medicines and Azathioprine Actavis

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

It is especially important that you tell your doctor if you are being treated with the following medicines:

  • allopurinol, oxypurinol, thiopurine, or other xanthine oxidase inhibitors, such as febuxostat (used mainly to treat gout ).
  • ciclosporin or tacrolimus (used to inhibit the immune system).
  • olsalazine, mesalazine, and sulfasalazine (medicines used to treat intestinal diseases and gout ).
  • warfarin and phenprocoumon (blood thinners).
  • ACE inhibitor (used to treat high blood pressure ).
  • trimethoprim/sulfamethoxazole (used to treat urinary tract infections).
  • cimetidine (used to treat stomach ulcers ).
  • indomethacin (used to treat gout.
  • anticancer drugs or other medicines with bone marrow-inhibiting effect.
  • vaccination with the live vaccine (especially for tuberculosis (BCG), smallpox and yellow fever).
  • killed (weakened) vaccines ( hepatitis B; jaundice that is transmitted through the blood).
  • infliximab (a medicine used to treat 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.

Inform your doctor. Dose one may need to be adjusted.

Talk to your doctor before starting treatment as there are risks associated with Azathioprine Actavis. You may need regular check-ups for side effects and side effects throughout treatment with Azathioprine Actavis.

Azathioprine Actavis with food and drink

Take Azathioprine Actavis with a meal.

Pregnancy and breastfeeding

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

Do not use Azathioprine Actavis if you are pregnant unless your doctor considers it absolutely necessary.

Breast-feeding

You should not use Azathioprine Actavis if you are breast-feeding because azathioprine is excreted in human milk.

Fertility

Women of childbearing potential and men must use reliable contraception during treatment with azathioprine and for at least 3 months after stopping treatment.

Azathioprine has been reported to inhibit intrauterine contraceptives (eg plastic coil, metal ring, copper coil, hormone coil).

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

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

Azathioprine Actavis contains sodium

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

How to use Azathioprine Actavis

Dosage

Always take Azathioprine Actavis exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Transplantation

Adults

The recommended dose is between 1-5 mg/kg/day, the highest dose given at the beginning of treatment. Your doctor may decide to add treatment with adrenal cortex hormone to prevent rejection. If treatment is stopped after several years of treatment, there is a risk of rejection reaction.

Use for children and adolescents

Dose one is determined by the doctor who adjusts it individually for you. Dosage one is the same as for adults (see above).

Skin disease (Lupus erythematosus)

Adults: Dose one is determined by the doctor who adjusts it individually for you. The usual dose is between 1-3 mg / kg / day. If you tolerate the treatment, it can continue as a long-term treatment.

Use for children and adolescents

Azathioprine is not recommended for the treatment of skin disease (Lupus erythematosus) in children and adolescents under 18 years of age.

Use in patients with renal and hepatic impairment

The doctor reduces the dose one (in case of renal impairment and moderate hepatic impairment).

You must not take azathioprine if you have severe hepatic impairment.

Use for the elderly

The doctor decides on a reduced dose.

Always follow a doctor’s prescription. Dose one varies between patients.

Change or discontinuation of treatment should always be done according to the doctor’s instructions as it should be done gradually and checked carefully.

How to take the tablets

The tablets are film-coated and should be swallowed whole with a large glass of water. If you need to divide the tablet into two parts, avoid skin contact with the broken side or with the tablet dust. Also, do not inhale the tablet dust when swallowing half the tablet.

Healthcare professionals, especially pregnant women, should also take safety precautions to avoid skin contact with the tablet dust.

Symptoms of overdose include infection, fever, and ulceration of the throat. There may also be bruising, bleeding, and a feeling of tiredness.

If you forget to use Azathioprine Actavis

Take the next dose as planned if you forget to take a dose of Azathioprine Actavis. Do not take a double dose to make up for a forgotten dose.

If you stop using Azathioprin Actavis

If you are going to stop treatment with Azathioprine Actavis, this should be done slowly and under close medical supervision.

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.

Stop taking Azathioprine Actavis immediately and contact your doctor immediately if you notice any of the following serious side effects. You may need emergency medical care.

  • allergic reaction. Signs of this can be:
    • a general feeling of tiredness, dizziness, nausea, vomiting, or diarrhea
    • high body temperature (fever), tremors, and chills
    • redness or rash
    • joint or muscle pain
    • changes in the amount and color of urine (kidney problems) 
      dizziness, confusion, feeling dizzy or weak due to low blood pressure
  • you are more likely to get bruises or detect unusual bleeding
  • you have a high body temperature (fever) or other signs of infection
  • you feel extremely tired
  • you discover lumps in one or more places on the body
  • you notice skin changes, such as blisters or flaking of the skin
  • your health suddenly deteriorates
  • you come in contact with someone who has chickenpox or shingles
  • 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 may 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).

If you experience any of the above, stop taking Azathioprine Actavis immediately and contact your doctor.

Other side effects can be the following:

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

  • infection is (in kidney transplant patients)
  • reduction in the number of white blood cells which makes infection more likely
  • nausea and vomiting
  • loss of appetite.

Common (may affect up to 1 in 10 people):

  • increased susceptibility to infection in patients with inflammatory bowel disease
  • decreased platelet count, which increases the risk of bleeding and bruising
  • the decrease in the number of red blood cells in the blood ( anemia ), which can mean that you get tired, have a headache, become short of breath, feel dizzy and pale
  • reduction in white blood cell counts in patients with rheumatoid arthritis
  • liver disease
  • Certain types of cancer ( lymphoma, cancer of the cervix, labia, and skin (especially in areas exposed to the sun)) are common in patients after kidney transplantation
  • inflammation of the pancreas, which can cause severe pain in the abdomen and back.

Uncommon (may affect up to 1 in 100 people):

  • infection is in patients with rheumatoid arthritis
  • blood disorders after transplant surgery
  • foul-smelling stools that are abundant, loose, and oily
  • hair loss ( alopecia )
  • liver problems in patients with rheumatoid arthritis
  • liver problems, which may include light stools, dark urine, itching, and yellowing of the skin and whites of the eyes.

Rare (may affect up to 1 in 1,000 people):

  • a condition in which bone marrow can not produce blood cells in sufficient numbers ( aplastic anemia ) which can lead to pallor, fatigue, or shortness of breath
  • inflammation in your lungs which causes shortness of breath, cough, and fever
  • after transplantation: gastric ulcer (which may be bleeding), and diseases that may cause heartburn, vomiting, general discomfort in the stomach
  • after transplantation: stomach problems leading to diarrhea, abdominal pain, and constipation
  • blood and bone marrow diseases (including granulocytopenia, pancytopenia, megaloblastic anemia , erythrohypoplasia, and agranulocytosis )
  • severe liver damage which can be life-threatening
  • different types of cancers such as blood, lymph, or skin cancer
  • sensitivity to sunlight which may cause discoloration or rash on the skin

Very rare (may affect up to 1 in 10,000 people):

  • blood disorders (including acute myeloid leukemia and myelodysplastic syndrome).

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. 

5. How to store Azathioprine Actavis

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

Store in the original package. Sensitive to light.

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.

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. Each film-coated tablet contains 50 mg of azathioprine.
  • The other ingredients are microcrystalline cellulose, mannitol, corn starch, povidone, croscarmellose sodium, sodium stearyl fumarate, hypromellose, and macrogol 400.

What the medicine looks like and the contents of the pack

Azathioprine Actavis are light yellow, round film-coated tablets with a notch and marked with “AZA” and “50” on each side of the notch. The tablets are smooth on the other side.

Pack sizes:

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78

220 Hafnarfjörður

Iceland

Manufacturer

Actavis Group PTC ehf

Reykjavíkurvegur 76-78

IS-220 Hafnarfjörður

Muhammad Nadeem

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