Country: Canada
Language: English
Source: Health Canada
CANDESARTAN CILEXETIL
MYLAN PHARMACEUTICALS ULC
C09CA06
CANDESARTAN
8MG
TABLET
CANDESARTAN CILEXETIL 8MG
ORAL
30/100
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0135220002; AHFS:
CANCELLED POST MARKET
2018-08-15
_MYLAN-CANDESARTAN Product Monograph_ _Page 1 of 38 _ PRODUCT MONOGRAPH PR MYLAN-CANDESARTAN (candesartan cilexetil tablets) 4 mg, 8 mg, 16 mg and 32 mg Angiotensin II AT 1 Receptor Blocker Mylan Pharmaceuticals ULC 85 Advance Road Toronto, ON M8Z 2S6 Submission Control Number: 193792 Date of Preparation: December 4, 2009 Date of Revision: April 14, 2016 _MYLAN-CANDESARTAN Product Monograph_ _Page 2 of 38 _ TABLE OF CONTENTS PART 1: HEALTH PROFESSIONAL INFORMATION .................................................... 3 SUMMARY PRODUCT INFORMATION ............................................................................. 3 INDICATIONS AND CLINICAL USE ................................................................................... 3 CONTRAINDICATIONS .......................................................................................................... 4 WARNINGS AND PRECAUTIONS ........................................................................................ 4 ADVERSE REACTIONS .......................................................................................................... 8 DRUG INTERACTIONS ......................................................................................................... 14 DOSAGE AND ADMINISTRATION .................................................................................... 17 OVERDOSAGE ......................................................................................................................... 19 ACTION AND CLINICAL PHARMACOLOGY ..................................................................... 20 STORAGE AND STABILITY ................................................................................................ 22 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................................. 22 PART II: SCIENTIFIC INFORMATION ............................................................................. 24 PHARMACEUTICAL INFORMATION ............................................................................... 24 CLINICAL T Read the complete document