ACCEL-CANDESARTAN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
11-05-2017
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Active ingredient:
CANDESARTAN CILEXETIL
Available from:
ACCEL PHARMA INC
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:
CANCELLED POST MARKET
Authorization date:
2020-03-05
Summary of Product characteristics
______________________________________________________________________________
_Accel-Candesartan Product Monograph_
_ Page 1 of 34_
PRODUCT MONOGRAPH
PR
ACCEL-CANDESARTAN
Candesartan Cilexetil Tablets
4 mg, 8 mg, 16 mg and 32 mg tablets
Angiotensin II AT
1
Receptor Blocker
Accel Pharma Inc.
99 Place Frontenac,
Point-Claire, Quebec
H9R 4Z7
_www.accelpharma.com _
Submission Control Number: 204353
Date of Preparation:
May 8, 2017
Product Monograph
Pg. 1
______________________________________________________________________________
_Accel-Candesartan Product Monograph_
_ Page 2 of 34_
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
.............................................................................................................
13
DOSAGE AND ADMINISTRATION
.........................................................................................
15
OVERDOSAGE
...........................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
18
STORAGE AND STABILITY
.....................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................ 20
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