CANDESARTAN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CANDESARTAN CILEXETIL

Available from:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC code:

C09CA06

INN (International Name):

CANDESARTAN

Dosage:

16MG

Pharmaceutical form:

TABLET

Composition:

CANDESARTAN CILEXETIL 16MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2013-08-21

Summary of Product characteristics

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_CANDESARTAN (CANDESARTAN CILEXETIL) TABLETS_
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_Page 1 of 28_
PRODUCT MONOGRAPH
PR
CANDESARTAN
candesartan cilexetil tablets
4 mg, 8 mg, 16 mg, and 32 mg
Angiotensin II AT
1
Receptor Blocker
Ranbaxy Pharmaceuticals Canada Inc.,
2680 Matheson Blvd. E., Suite 200
Mississauga, Ontario L4W 0A5
Submission Control No: 166986
DATE OF PREPARATION:
August 15, 2013
_ _
_CANDESARTAN (CANDESARTAN CILEXETIL) TABLETS_
_ _
_Page 2 of 28_
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
....................................................................................................6
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................13
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND STABILITY
..........................................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................17
PART II: SCIENTIFIC INFORMATION
...............................................................................18
PHARMACEUTICAL INFORMATION
..........................................................................18
CLINICAL TRIALS
.....................................................