ATACAND TAB 16 MG TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

CANDESARTAN CILEXETIL

MAH:

ASTRAZENECA CANADA INC

ATC_code:

C09CA06

INN:

CANDESARTAN

dosage:

16MG

pharmaceutical_form:

TABLET

composition:

CANDESARTAN CILEXETIL 16MG

administration_route:

ORAL

units_in_package:

30/100

prescription_type:

Prescription

therapeutic_area:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

leaflet_short:

Active ingredient group (AIG) number: 0135220003; AHFS:

authorization_status:

APPROVED

authorization_date:

2000-01-18

SPC

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
.......................................................