くすりのしおり

Internal
Published: 6/2015

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 12.5mg[hypercalcemia]
 Active ingredient:
Cinacalcet hydrochloride
 Dosage form:
light yellow-red tablet, diameter: 6 mm, thickness: 3.4 mm
 Print on wrapping:
レグパラ12.5, KR05

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 hypercalcemia in patients with parathyroid carcinoma, and hypercalcemia in patients with primary hyperparathyroidism who are unable to undergo parathyroidectomy or who experience recurrent primary hyperparathyroidism.

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 2 tablets (25 mg of cinacalcet) at a time, twice daily. Then the dosage may be adjusted to take 2 to 6 tablets (25 to 75 mg) at a time, twice daily, by observing serum calcium level. Dose should be increased by 2 tablets (25 mg) at a time, at intervals of at least two weeks. The dosage may be increased up to a maximum dose of 6 tablets (75 mg) at a time, 3 or 4 times a day. Strictly follow the instructions.
  • This medicine contains 12.5 mg of cinacalcet in each tablet. According to the patient's condition, this medicine may be taken as one tablet or may be taken with tablet(s) which contains different amount (25mg/75mg) of same ingredients.
  • 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

  • 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, gastroesophageal reflux disease, paresthesia, decreased body weight and decreased appetite. 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.

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