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Calcelar 25

Calcelar 25 Side Effects

Manufacturer:

Unison

Distributor:

Medispec
Full Prescribing Info
Side Effects
Clinically significant adverse reactions: Hypocalcemia/decreased serum calcium (14.7%): Symptoms considered attributable to hypocalcemia (prolonged QT interval, numbness, cramping, feeling unwell, arrhythmia, decreased blood pressure, seizure, etc.) may occur. Therefore, the serum calcium level should be determined once a week at the start of administration and during the dose adjustment period, and at least once every two weeks during the maintenance period. If any abnormalities are observed, the serum calcium level should be confirmed and administration of Calcium or Vitamin D preparations taken into consideration. Moreover, it should also be considered to reduce the dose of CALCELAR 25 mg Film Coated Tablet or discontinue the treatment as needed (see Precautions related to Dosage and Administration under Dosage & Administration).
Prolonged QT interval (5.8%): The QT interval may be prolonged. If any abnormalities are observed, the serum calcium level should be confirmed and administration of Calcium or Vitamin D preparations taken into consideration. Moreover, it should also be considered to reduce the dose of CALCELAR 25 mg Film Coated Tablet or discontinue the treatment as needed.
Gastrointestinal hemorrhage, gastrointestinal ulcer (incidence unknown): Gastrointestinal hemorrhage and/or gastrointestinal ulcer may develop. Patients must therefore be carefully monitored. If any abnormalities are observed, administration should be discontinued and appropriate measures taken.
Decreased level consciousness (0.2%), temporary loss of consciousness (incidence unknown): Decreased level of consciousness, temporary loss of consciousness, etc. may occur. If any abnormalities are observed, appropriate measures including discontinuation of the treatment should be taken.
Sudden death (0.3%): Unexplained sudden death has been reported in patients treated with Cinacalcet.
Other adverse reactions: If any of the following symptoms are observed, appropriate measure such as dosage reduction or discontinuation should be taken. (See Table 2.)

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