TARO-CANDESARTAN TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
05-03-2020
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Werkstoffen:
CANDESARTAN CILEXETIL
Beschikbaar vanaf:
SUN PHARMA CANADA INC
ATC-code:
C09CA06
INN (Algemene Internationale Benaming):
CANDESARTAN
Dosering:
4MG
farmaceutische vorm:
TABLET
Samenstelling:
CANDESARTAN CILEXETIL 4MG
Toedieningsweg:
ORAL
Eenheden in pakket:
100
Prescription-type:
Prescription
Therapeutisch gebied:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Product samenvatting:
Active ingredient group (AIG) number: 0135220001; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2020-03-04
Productkenmerken
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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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