くすりのしおり

Internal
Revised: 3/2020

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 :
Prograf Capsules 5mg [for autoimmune disease]
 Active ingredient:
Tacrolimus hydrate
 Dosage form:
grayish red capsule (length: 14.5 mm)
 Print on wrapping:
(Face) プログラフ5mg, house-mark, f657, プログラフ5, (Back) 5mg Prograf, 5mg プログラフ, プログラフ5, Prograf 5, タクロリムス(Tacrolimus), house-mark, アステラス製薬

Effects of this medicine

This medicine acts on immune-related T cells and suppresses inflammation by inhibiting the production of cytokines associated with inflammation. It will improve symptoms of refractory ulcerative colitis.
It is usually used to treat 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 you have: infections, renal disorder or liver disorder.
  • If you are 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, take initially 0.025 mg/kg of tacrolimus at a time twice a day after meal in the morning/evening. For subsequent 2 weeks, the dosage may be adjusted according to the patient's blood concentration. The maximum daily dose is 0.3 mg/kg in principle.
    This preparation contains 5 mg of tacrolimus in a capsule. Strictly follow the instructions.
  • If you miss a dose, take a dose as soon as possible. However, the next dose should be at least 5 hours apart. You should never take two doses at one time or change the dosing schedule.
  • 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

  • Since you are likely to become infected, wash hands and gargle and regulate your daily life.
  • Avoid taking grapefruit (juice) with this medicine, since it may intensify the therapeutic effects of this medicine.
  • Avoid taking any food containing St. John's wort with this medicine, since it may diminish medicinal effects.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include renal disorder, elevation of blood pressure, tremor (shivering of hands/fingers/feet), infections and diabetes mellitus. 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, see your doctor immediately.
  • decreased urinary output, general edema, thirst [acute renal disorder, nephrotic syndrome]
  • palpitations, shortness of breath, chest distress, general edema, chest pain [heart failure, arrhythmia, myocardial infarction, angina pectoris, pericardial effusion, myocardial disorder]
  • convulsion, consciousness disorder, speech difficulties [central nervous system disorders including reversible posterior leukoencephalopathy syndrome, hypertensive encephalopathy, progressive multifocal leukoencephalopathy]
  • headache, temporary consciousness disorder, paralysis of limbs on one side [cerebrovascular disorder]
  • respiratory distress, breathing difficulty [respiratory distress, acute respiratory distress syndrome]
  • fever, general malaise, cold-like symptoms [infections]
  • dry mouth, excessive fluid intake/urination, getting tired easily [diabetes mellitus or aggravation of diabetes mellitus, hyperglycemia]
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 reach of children. Store away from direct sunlight, heat and moisture.
  • Discard the remainder. Do not store them. Ask the pharmacist or medical facility how to discard them.
  • Do not receive vaccination without an approval of your doctor.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.