くすりのしおり

Internal
Revised: 11/2019

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 :
REMITCH CAPSULES 2.5 mcg
 Active ingredient:
Nalfurafine hydrochloride
 Dosage form:
slightly pale yellow to pale yellow capsule (major axis: approx. 9.7 mm, minor axis: approx. 6.6 mm)
 Print on wrapping:
(face) REMITCH, レミッチ, 2.5μg, TR11
(back) レミッチ カプセル 2.5μg, レミッチ

Effects of this medicine

This medicine is a selective κ (kappa) opioid receptor agonist to suppress itch. It controls itch when other existing antihistamine or antiallergic medicines are ineffectual.
It is usually used for improvement of itch in dialysis and/or chronic liver disease when other existing treatment is insufficient.

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 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 1 capsule (2.5 mcg of the active ingredient) at a time, once daily, after supper or before bedtime. The dosage may be increased according to the symptoms, however, the dosage is limited to 2 capsules (5 mcg) once daily. Strictly follow the instructions.
  • If you are taking this medicine for improvement of pruritus caused by hemodialysis, leave a sufficient interval between taking this medicine and receiving hemodialysis.
  • If you are taking this medicine for improvement of pruritus caused by peritoneal dialysis, leave a sufficient interval between taking this medicine and exchanging dialysate.
  • If you miss a dose, in case you are instructed to take the medicine after supper and remember it before bedtime on the same day, take a dose as soon as possible. In other cases, 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

  • The medicine may cause drowsiness or dizziness. Do not drive a car or operate dangerous machinery.
  • Grapefruit juice may raise the plasma concentration and enhance the effect of the medicine. Never take the medicine with grapefruit juice.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include sleeplessness, constipation and drowsiness in hemodialysis; sleeplessness, drowsiness and vomiting in peritoneal dialysis; sleeplessness, drowsiness, constipation, pollakiuria and nocturia in chronic liver disease. 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.
  • generalized fatigability, loss of appetite, yellowness of the skin or conjunctiva [liver dysfunction, jaundice]
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 light, heat and moisture. Remove from press-through package (PTP) sheet just before taking.
  • Discard the remainder. Do not store them. Ask your pharmacist or medical institution how to discard them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.