Country: Canada
Language: English
Source: Health Canada
CANDESARTAN CILEXETIL
ASTRAZENECA CANADA INC
C09CA06
CANDESARTAN
32MG
TABLET
CANDESARTAN CILEXETIL 32MG
ORAL
30
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0135220004; AHFS:
APPROVED
2008-05-29
COPYRIGHT 1998-2016 ASTRAZENECA CANADA INC. Page 1 of 39 PRODUCT MONOGRAPH ATACAND ® candesartan cilexetil tablets 4 mg, 8 mg, 16 mg and 32 mg Angiotensin II AT 1 Receptor Blocker AstraZeneca Canada Inc. 1004 Middlegate Road Mississauga, Ontario L4Y 1M4 www.astrazeneca.ca Date of Revision: February 19, 2016 Submission Control Number: 187873 ATACAND ® is a registered trademark of the AstraZeneca group of companies. Manufactured under license from Takeda Pharmaceutical Company Ltd. COPYRIGHT 1998-2016 ASTRAZENECA CANADA INC. Page 2 of 39 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ....................................................... 3 SUMMARY PRODUCT INFORMATION ...................................................................... 3 INDICATIONS AND CLINICAL USE ........................................................................... 3 CONTRAINDICATIONS ................................................................................................. 4 WARNINGS AND PRECAUTIONS ............................................................................... 5 ADVERSE REACTIONS ................................................................................................. 9 DRUG INTERACTIONS ............................................................................................... 15 DOSAGE AND ADMINISTRATION ........................................................................... 19 OVERDOSAGE .............................................................................................................. 22 ACTION AND CLINICAL PHARMACOLOGY .......................................................... 22 STORAGE AND STABILITY ....................................................................................... 24 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................... 25 PART II: SCIENTIFIC INFORMATION ............................................................................. 26 PHARMACEUTICAL INFORMATION ....................................................... Read the complete document