TARO-CANDESARTAN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
05-03-2020
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Active ingredient:
CANDESARTAN CILEXETIL
Available from:
SUN PHARMA CANADA INC
ATC code:
C09CA06
INN (International Name):
CANDESARTAN
Dosage:
32MG
Pharmaceutical form:
TABLET
Composition:
CANDESARTAN CILEXETIL 32MG
Administration route:
ORAL
Units in package:
30
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Product summary:
Active ingredient group (AIG) number: 0135220004; AHFS:
Authorization status:
APPROVED
Authorization date:
2020-03-04
Summary of Product characteristics
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_PR_
_TARO-CANDESARTAN (CANDESARTAN CILEXETIL) TABLETS_
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_Page 1 of 39_
PRODUCT MONOGRAPH
PR
TARO–CANDESARTAN
candesartan cilexetil tablets
4 mg, 8 mg, 16 mg and 32 mg
Angiotensin II AT
1
Receptor Blocker
Sun Pharma Canada Inc.
126 East Drive
Brampton, Ontario
L6T 1C1
Date of Revision:
March 2, 2020
Submission Control Number: 236155
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_PR_
_TARO-CANDESARTAN (CANDESARTAN CILEXETIL) TABLETS_
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_Page 2 of 39_
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
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................19
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................24
PART II: SCIENTIFIC INFORMATION
....................................................................................26
PHARMACEUTICAL INFORMATION
..........................................................................26
CLINICAL TRIALS
......................................................
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