CANDESARTAN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
10-11-2021
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Active ingredient:
CANDESARTAN CILEXETIL
Available from:
PRO DOC LIMITEE
ATC code:
C09CA06
INN (International Name):
CANDESARTAN
Dosage:
32MG
Pharmaceutical form:
TABLET
Composition:
CANDESARTAN CILEXETIL 32MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Product summary:
Active ingredient group (AIG) number: 0135220004; AHFS:
Authorization status:
APPROVED
Authorization date:
2014-04-14
Summary of Product characteristics
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_Candesartan _
_Page 1 of 35_
PRODUCT MONOGRAPH
PR
CANDESARTAN
Candesartan Cilexetil Tablets
8 mg, 16 mg and 32 mg
Manufacturer's Standard
Angiotensin II AT
1
Receptor Blocker
Pro Doc Ltée
Date of Revision:
2925, boul. Industriel November 10, 2021
Laval, Quebec
H7L 3W9
Submission Control No.: 257568
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_Candesartan _
_Page 2 of 35_
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
...........................................................................................................
12
DOSAGE
AND
ADMINISTRATION
.......................................................................................
14
OVERDOSAGE
.........................................................................................................................
17
ACTION
AND
CLINICAL
PHARMACOLOGY
.....................................................................
17
STORAGE
AND
STABILITY...................................................................................................
19
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ...................................................... 19
PART II: SCIENTIFIC INFORMATION
................................................................................
21
PHARMACEUTICAL
INFORMATION
..................................................................................
21
CLINICAL
TRIALS
...........................
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