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 :
Imatinib Tablets 200mg "Nichiiko"
 Active ingredient:
Imatinib mesilate
 Dosage form:
smoky yellow-red to deep yellow red oval tablet with split line, major axis:16.0 mm, minor axis: 7.4 mm, thickness:4.7 mm
 Print on wrapping:
イマチニブ錠200mg「日医工」, イマチニブ, 食後に多めの水で服用, n255, 200mg, Imatinib 200mg, イマチニブ「日医工」

Effects of this medicine

This medicine inhibits the abnormal action of tyrosine kinase which relates with cell proliferation to show the effect to suppress cancer cell proliferation.
It is usually used to treat chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia.

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 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))
  • Chronic myeloid leukemia(chronic phase) : In general, for adults, take 2 tablets (400 mg of imatinib) at a time, once a day, after a meal. The dosage may be adjusted according to hematological finding, age and symptoms of the patient. DO NOT exceed the daily maximum dosage, 3 tablets (600 mg) at a time.
    Chronic myeloid leukemia(transition or acute phase) : In general, for adults, take 3 tablets (600 mg of imatinib) at a time, once a day, after a meal. The dosage may be adjusted according to hematological finding, age and symptoms of the patient. DO NOT exceed the daily maximum dosage, 2 tablets (400 mg) at a time, twice a day.
    Philadelphia chromosome-positive acute lymophcytic leukemia : In general, for adults, take 3 tablets (600 mg of imatinib) at a time, once a day, after a meal. The dosage may be decreased according to hematological finding, age and symptoms of the patient.
    Strictly follow the instructions in any case.
  • Take this medicine with a glass of water or lukewarm water (about 200 cc) after a meal.
  • If you miss a dose, do not take a dose as soon as you remember, skip the missed dose and follow 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

  • Strictly follow the instructed inspection date. Check your body weight regularly. If you gain weight abnormally, consult with your doctor.
  • Do not take foods containing St. John's wort as it may weaken the effect of this medicine.
  • Do not drink grapefruit juice while taking this medicine as the components of it may intensify the effect of this medicine.
  • This medicine may cause dizziness, sleepiness, foggy vision etc. Pay close attention to operate in potentially hazardous activities such as driving a car and working at heights.
  • If you have a possibility of being pregnant, make sure to avoid pregnancy during medication.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea, vomiting, diarrhea, loss of appetite, abdominal pain, rash, superficial edema (on face, eyelid, etc.) , muscle spasm, malaise and fever. 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.
  • anemia, fever, bleeding tendency [myelosuppression]
  • headache, nausea, vomiting [bleeding (cerebral bleeding, subdural hemorrhage)]
  • abdominal pain, vomiting of blood/melena, anemia [gastrointestinal bleeding, gastric antral vascular ectasia]
  • severe abdominal pain, nausea, vomiting [gastrointestinal perforation, tumor hemorrhage]
  • general malaise, loss of appetite, yellowing of the skin and the white of eyes [liver dysfunction, jaundice, liver failure]
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 direct sunlight, 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.