MINT-CANDESARTAN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
29-11-2022
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Active ingredient:
CANDESARTAN CILEXETIL
Available from:
MINT PHARMACEUTICALS INC
ATC code:
C09CA06
INN (International Name):
CANDESARTAN
Dosage:
32MG
Pharmaceutical form:
TABLET
Composition:
CANDESARTAN CILEXETIL 32MG
Administration route:
ORAL
Units in package:
30/100/1000
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Product summary:
Active ingredient group (AIG) number: 0135220004; AHFS:
Authorization status:
APPROVED
Authorization date:
2018-06-05
Summary of Product characteristics
MINT-CANDESARTAN Product Monograph
Page 1 of 34
PRODUCT MONOGRAPH
PR
MINT-CANDESARTAN
Candesartan Cilexetil Tablets
4 mg, 8 mg, 16 mg and 32 mg
Angiotensin II AT
1
Receptor Blocker
Mint Pharmaceuticals Inc., DATE OF REVISION:
6575 Davand Drive
November 29, 2022
Mississauga, Ontario
L5T 2M3
Submission
Control No: 265629
MINT-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
....................................................................................................
3
WARNINGS AND PRECAUTIONS
...................................................................................
4
ADVERSE REACTIONS
....................................................................................................
8
DRUG
INTERACTIONS....................................................................................................13
DOSAGE AND
ADMINISTRATION.................................................................................14
OVERDOSAGE
.................................................................................................................17
ACTION AND CLINICAL PHARMACOLOGY
................................................................17
STORAGE AND
STABILITY............................................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................20
PART II: SCIENTIFIC
INFORMATION................................................................................21
PHARMACEUTICAL
INFORMATION.............................................................................21
CLINICAL TRIALS
..........................................................................................
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