IPG-CANDESARTAN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
22-08-2016
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Active ingredient:
CANDESARTAN CILEXETIL
Available from:
MARCAN PHARMACEUTICALS INC
ATC code:
C09CA06
INN (International Name):
CANDESARTAN
Dosage:
32MG
Pharmaceutical form:
TABLET
Composition:
CANDESARTAN CILEXETIL 32MG
Administration route:
ORAL
Units in package:
30/1000
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Product summary:
Active ingredient group (AIG) number: 0135220004; AHFS:
Authorization status:
APPROVED
Authorization date:
2016-08-19
Summary of Product characteristics
1
PRODUCT MONOGRAPH
PR
IPG-CANDESARTAN
Candesartan Cilexetil Tablets
4 mg, 8 mg, 16 mg and 32 mg
Angiotensin II AT
1
Receptor Blocker
Date of Preparation:
August 19, 2016
Marcan Pharmaceuticals Inc.
77 Auriga Drive, Suite #4
Ottawa, Ontario
K2E 7Z7
CONTROL# 196962
2
TABLE OF CONTENTS
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
.....................
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