くすりのしおり

Internal
Revised: 8/2017

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: 14.5mm)
 Print on wrapping:
(Face) house-mark, f657, プログラフ5, (Back) 5mg プログラフ, プログラフ5, タクロリムス(Tacrolimus), house-mark

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 hepatic disorder, renal disorder, or infections.
  • 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, take initially 0.025 mg/kg of tacrolimus at a time twice daily 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 0.3mg/kg in principle.
    One capsule of this preparation contains 5 mg of tacrolimus. 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.
  • Grapefruit (juice) may enhance this medicine's effect, resulting in renal disorder. Avoid intake of grapefruit (juice) together with the medicine.
  • Foods/drinks containing Hypericum perforatum (St. John's wort) may reduce this medicine's effect. Avoid intake of these foods/drinks together with the medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include tremor (tremble of hands/feet), hot flush, paraesthesia, nausea, renal dysfunction, hepatic dysfunction and headache. 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.
  • decrease in 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, language disorder [central nervous system disorders including reversible posterior leukoencephalopathy syndrome, hypertensive encephalopathy, progressive multifocal leukoencephalopathy]
  • headache, temporary conscious disorder, paralyzation on either side of the body [cerebrovascular disorder]
  • respiratory distress, breathing difficulty [respiratory distress]
  • fever, general malaise, cold-like symptoms  [infections]
  • dry mouth, excessive drinking/urination, getting tired easily  [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 the reach of infants and 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.