くすりのしおり

Internal
Published: 2/2014

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 :
REGPARA TABLETS 75mg[secondary hyperparathyroidism in patients undergoing maintenance dialysis]
 Active ingredient:
Cinacalcet hydrochloride
 Dosage form:
light-yellow tablet, diameter: 8 mm, thickness: 4 mm
 Print on wrapping:
レグパラ75, KR03

Effects of this medicine

This medicine directly acts on calcium receptors on parathyroid cells to suppress synthesis and secretion of parathyroid hormone (PTH), and it consequently decreases serum PTH and serum calcium.
It is usually used in the treatment of secondary hyperparathyroidism in patients undergoing maintenance dialysis.

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: hypocalcaemia or hepatic function disorder, seizure or a history of it.
  • 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, start with taking 25 mg of cinacalcet at a time, once daily, then the dosage may be adjusted to take 25 to 75 mg by observing PTH and serum calcium level. The maximum daily dose is limited to 100 mg. Dose should be increased by 25 mg at a time, at intervals of at least three weeks. This preparation contains 75 mg of cinacalcet in a tablet. Strictly follow the instructions.
  • If you miss a dose, skip the missed dose and continue your regular dosing schedule on the next day. 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

  • Grapefruit and grapefruit juice may intensify the therapeutic effects of the medicine. Do not eat grapefruit or drink grapefruit juice while you are taking the medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea, vomiting, gastric discomfort, loss of appetite and abdominal distention. 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.
  • numbness, seizure, feeling unwell, arrhythmia, decreased blood pressure [hypocalcaemia, decreased serum calcium]
  • palpitation, chest discomfort, chest pain [prolonged QT interval]
  • vomiting of blood, nausea, gastric pain [gastrointestinal hemorrhage, gastrointestinal ulcer]
  • impaired mind, judgment failure, temporary loss of consciousness [decreased level of consciousness, temporary loss of consciousness]
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 the medicine out of the reach of children. Store it 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.