くすりのしおり

Internal
Revised: 8/2016

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 100mg "DSEP"
 Active ingredient:
Imatinib mesilate
 Dosage form:
smoky yellowish red to dark yellowish red tablet, diameter 7.6 mm, thick 3.3 mm
 Print on wrapping:
(front) イマチニブ100mg「DSEP」, 第一三共エスファ, イマチニブ, 100mg, ITN, (back) IMATINIB 100mg「DSEP」, イマチニブ100mg「DSEP」, ITN

Effects of this medicine

This medicine inhibits abnormal action of tyrosine kinases that is involved in cell growth, and suppresses the growth of cancer cells.
It is usually used to treat chronic myelogenous leukemia or Philadelphia chromosome-positive acute lymphocytic 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 have currently infected with hepatitis B virus or previously experienced hepatitis B virus infection.
  • 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 myelogenous leukemia (chronic phase): In general, for adults, take 4 tablets (400 mg of imatinib) at a time, once a day after meals. The dosage should be adjusted according to your blood test result, age or symptoms. However, the maximum doses are 6 tablets (600 mg of imatinib) at a time, once a day.
    Chronic myelogenous leukemia (accelerated or acute phase): In general, for adults, take 6 tablets (600 mg of imatinib) at a time, once a day after meals. The dosage should be adjusted according to your blood test result, age or symptoms. However, the maximum doses are 4 tablets (400 mg of imatinib) at a time, twice a day.
    Philadelphia chromosome-positive acute lymphocytic leukemia: In general, for adults, take 6 tablets (600 mg of imatinib) at a time, once a day after meals. The dose may be adjusted according to your blood test result, age or symptoms.
    Strictly follow the instructions in any case.
  • When taking the medicine, take it with a glass of water or lukewarm water (about 200 cc) after meals.
  • If you miss a 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

  • Strictly follow the date of schedule of inspection indicated. Measure your weight periodically, and consult with your doctor if you experience abnormal weight gain.
  • Avoid taking grapefruit juice with this medicine, since it may intensify the therapeutic effects of this medicine.
  • Avoid taking health food that contains hypericum perforatum (St. John's wort) with this medicine, since it may weaken the therapeutic effects of this medicine.
  • Dizziness, drowsiness or foggy vision may occur. Take care in working at heights, driving a car or operating dangerous machinery.
  • If you have a chance of becoming pregnant, you should use birth control while taking this medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea/vomiting, diarrhea, loss of appetite, rash, superficial edema (face, eyelid, lower limbs, etc.), headache, 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 [bone marrow suppression]
  • headache, disturbance of consciousness, abdominal pain [cerebral/subdural/gastrointestinal bleeding]
  • melena/vomiting of blood, stomachache, abdomen enlarged feeling [gastrointestinal perforation, tumor bleeding]
  • body weight gain, chest pain, respiratory distress [serious fluid retention]
  • fever, dry cough, respiratory distress [interstitial pneumonia, pulmonary fibrosis]
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. Ask the pharmacy or medical institution how to discard.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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