ACH-CANDESARTAN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
12-04-2017
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Active ingredient:
CANDESARTAN CILEXETIL
Available from:
ACCORD HEALTHCARE INC
ATC code:
C09CA06
INN (International Name):
CANDESARTAN
Dosage:
8MG
Pharmaceutical form:
TABLET
Composition:
CANDESARTAN CILEXETIL 8MG
Administration route:
ORAL
Units in package:
30/100
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Product summary:
Active ingredient group (AIG) number: 0135220002; AHFS:
Authorization status:
APPROVED
Authorization date:
2012-02-02
Summary of Product characteristics
Page 1 of 38
PRODUCT MONOGRAPH
ACH-CANDESARTAN
Candesartan Cilexetil
4 mg, 8 mg, 16 mg and 32 mg
Angiotensin II AIMIPENEM AND CILASTATIN FOR INJECTION T
1
Receptor Blocker
Accord Healthcare Inc.
3535 boul. St. Charles suite 704
Kirkland, QC, H9H 5B9
Canada
Date of Revision:
March 30, 2017
Submission Control Number: 203995
Page 2 of 38
TABLE OF CONTENTS
PART I: 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
.......................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 20
STORAGE AND STABILITY
................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 23
PART II: SCIENTIFIC INFORMATION
................................................................................
24
PHARMACEUTICAL INFORMATION
..............................................................................
24
CLINICAL TRIALS
.......................................................................
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