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CINACALCET HYDROCHLORIDE tablet, film coated


  1. Patient Information
  2. Upper Gastrointestinal Bleeding:
  3. Heart Failure:
  4. Hypocalcemia:
  5. Upper Gastrointestinal Bleeding:
  6. Manufactured By:
  7. Distributed By:
  8. Heart Failure:

Patient Information 

  • Hypocalcemia: Advise patients to report symptoms of hypocalcemia, including paresthesias, myalgias, muscle spasms, and seizures, to their healthcare provider[see Warnings and Precautions (5.1)].

Upper Gastrointestinal Bleeding: 

Advise patients to report any symptoms of upper gastrointestinal bleeding to their health care provider[see Warnings and Precautions (5.2)].

Heart Failure: 

Advise patients with heart failure that use of cinacalcet hydrochloride tablets may worsen their heart failure[see Warnings and Precautions (5.3)].
  • Advise patients to report nausea and vomiting to their health care provider[see Adverse Reactions (6.1)].
  • Advise patients to take cinacalcet hydrochloride tablets with food or shortly after a meal and to take the tablets whole and not divide them[see Dosage and Administration (2.1)].
  • Inform patients of the importance of regular blood tests, in order to monitor the safety and efficacy of cinacalcet hydrochloride tablets therapy.
  • Manufactured by:

    Strides Pharma Science Limited

    Puducherry - 605 014, India.

    PON/DRUGS/16 13 4193

    Hypocalcemia: 

    Advise patients to report symptoms of hypocalcemia, including paresthesias, myalgias, muscle spasms, and seizures, to their healthcare provider[see Warnings and Precautions(5.1)]

    Upper Gastrointestinal Bleeding: 

    Advise patients to report any symptoms of upper gastrointestinal bleeding to their health care provider[see Warnings and Precautions(5.2)]

    Manufactured By: 


    Piramal Enterprises Limited,
    Plot No. 67-70 Sector 2,
    Pithampur-454775, Dist. Dhar, Madhya Pradesh, INDIA
    Mfg Lic. No.: 25/10/92

    Distributed By: 

    Slate Run Pharmaceuticals, LLC.
    Columbus, Ohio 43215

    Heart Failure: 

    Advise patients with heart failure that use of cinacalcet may worsen their heart failure[see Warnings and Precautions (5.3)].
  • Advise patients to report nausea and vomiting to their health care provider[see Adverse Reactions (6.1)].
  • Advise patients to take cinacalcet with food or shortly after a meal and to take the tablets whole and not divide them[see Dosage and Administration (2.1)].
  • Inform patients of the importance of regular blood tests, in order to monitor the safety and efficacy of cinacalcet therapy.
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.

    Manufactured In India By:
    Watson Pharma Private Limited
    Verna, Salcette Goa 403 722 India

    Manufactured For:
    Actavis Pharma, Inc.
    Parsippany, NJ 07054 USA

    Revised: August 2018





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