ATACAND TAB 8MG TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
23-02-2016
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Active ingredient:
CANDESARTAN CILEXETIL
Available from:
ASTRAZENECA CANADA INC
ATC code:
C09CA06
INN (International Name):
CANDESARTAN
Dosage:
8MG
Pharmaceutical form:
TABLET
Composition:
CANDESARTAN CILEXETIL 8MG
Administration route:
ORAL
Units in package:
30/100
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Product summary:
Active ingredient group (AIG) number: 0135220002; AHFS:
Authorization status:
APPROVED
Authorization date:
2000-01-18
Summary of Product characteristics
COPYRIGHT 1998-2016 ASTRAZENECA CANADA INC.
Page 1 of 39
PRODUCT MONOGRAPH
ATACAND
®
candesartan cilexetil tablets
4 mg, 8 mg, 16 mg and 32 mg
Angiotensin II AT
1
Receptor Blocker
AstraZeneca Canada Inc.
1004 Middlegate Road
Mississauga, Ontario
L4Y 1M4
www.astrazeneca.ca
Date of Revision:
February 19, 2016
Submission Control Number: 187873
ATACAND
®
is a registered trademark of the AstraZeneca group of companies.
Manufactured
under license from Takeda Pharmaceutical Company Ltd.
COPYRIGHT 1998-2016 ASTRAZENECA CANADA INC.
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
...............................................................................
5
ADVERSE REACTIONS
.................................................................................................
9
DRUG INTERACTIONS
...............................................................................................
15
DOSAGE AND ADMINISTRATION
...........................................................................
19
OVERDOSAGE
..............................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 22
STORAGE AND STABILITY
.......................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 25
PART II: SCIENTIFIC INFORMATION
.............................................................................
26
PHARMACEUTICAL INFORMATION
.......................................................
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