くすりのしおり

Internal
Revised: 5/2018

The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name :
AZANIN Tablets 50mg [Crohn's disease and ulcerative colitis]
 Active ingredient:
Azathioprine
 Dosage form:
light yellow tablet, diameter:8.0mm, thickness: 3.0mm
 Print on wrapping:
(Face) アザニン50mg, Azanin, TA101 (Back) アザニン50mg

Effects of this medicine

This medicine suppresses an overactive immune system by interfering with nucleic acid (DNA) production. By preventing flare-ups of Crohn's disease, it reduces the need for steroids. If steroids have brought the disease under control, this medicine helps to maintain that symptom-free period (remission).
It is usually used to bring about remission or to maintain it in steroid-dependent Crohn's disease or steroid-dependent ulcerative colitis.

Before using this medicine, be sure to tell your doctor and pharmacist

  • If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
    If white blood cell counts are 3,000/mm3 or lower.
    If you have myelosuppression, infections, suspected hemorrhagic disorders, hepatic dysfunction, renal failure or varicella.
  • If you are pregnant, possibly pregnant or breastfeeding.
  • If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

Dosing schedule (How to take this medicine)

  • Your dosing schedule prescribed by your doctor is ((        to be written by a healthcare professional))
  • In general, for adults and children, take a daily dose of 1 to 2 mg of the active ingredient per kg of body weight (Usually 50 mg to 100 mg in adults).
    This preparation contains 50 mg of the active ingredient in 1 tablet. Strictly follow the instructions.
  • If you miss a dose, take a dose as soon as possible. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. You should never take two doses at one time.
  • If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop taking this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • To avoid the risk of skin cancer caused by exposure to harmful UV rays of the sun, wear sun (UV) protection clothing or use a very high-protection sunscreen.
  • This medicine may cause serious adverse reactions such as marrow depression and hepatic function disorder, etc. Your blood, liver, and kidney function may need to be checked once every 1 to 2 weeks initially, and fairly frequently thereafter. You may be asked to come in at a specific date and time for these tests.
  • You should avoid getting pregnant while you or your partner is taking this medicine. If you do become pregnant during treatment, consult your doctor immediately. Also, if you wish to become pregnant, consult your doctor.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include rash, vasculitis, renal dysfunction, general malaise, muscle pain, joint pain, fever, chills, dizziness, diarrhea, pancreatitis and alopecia. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
  • symptoms of anemia, haemorrhage symptom, fever [blood disorder such as aplastic anaemia, pancytopenia, etc.]
  • chills, tremor, dizziness on standing up [shock-like symptom]
  • general malaise, loss of appetite, yellowing of the skin and whites of the eyes [hepatic dysfunction, jaundice]
  • fever, dry cough, respiratory distress [interstitial pneumonia]
  • consciousness disorder, paralysis symptoms, language disorder [progressive multifocal leukoencephalopathy]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.

Storage conditions and other information

  • Keep out of the reach of children. Store away from light, heat and moisture.
  • Discard the remainder. Do not store them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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