ZINDA-CANDESARTAN/HYDROCHLOROTHIAZIDE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
25-11-2014
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Active ingredient:
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Available from:
ZINDA PHARMA LIMITED
ATC code:
C09DA06
INN (International Name):
CANDERSARTAN AND DIURETICS
Dosage:
32MG; 12.5MG
Pharmaceutical form:
TABLET
Composition:
CANDESARTAN CILEXETIL 32MG; HYDROCHLOROTHIAZIDE 12.5MG
Administration route:
ORAL
Units in package:
30/1000/8X10
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Product summary:
Active ingredient group (AIG) number: 0244181002; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2021-10-04
Summary of Product characteristics
_ZINDA-CANDESARTAN/HYDROCHLOROTHIAZIDE – Product Monograph _
Page 1 of 38
PRODUCT
MONOGRAPH
PR
ZINDA-CANDESARTAN/ HYDROCHLOROTHIAZIDE
CANDESARTAN CILEXETIL/HYDROCHLOROTHIAZIDE TABLETS
32 MG / 12.5 MG,
32 MG / 25 MG
ANGIOTENSIN II AT1 RECEPTOR BLOCKER + DIURETIC
Zinda Pharma Limited
Date of Preparation:
8250 Décarie – suite 110
November 25, 2014
Montreal, Quebec
H4P 2P5
Submission Control No: 166748
_ZINDA-CANDESARTAN/HYDROCHLOROTHIAZIDE – Product Monograph _
Page 2 of 38
TABLE OF CONTENTS
CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................................
3
CONTRAINDICATIONS
.................................................................................................................
4
WARNINGS AND PRECAUTIONS
...............................................................................................
4
ADVERSE REACTIONS
.................................................................................................................
9
DRUG INTERACTIONS
...............................................................................................................
13
DOSAGE AND ADMINISTRATION
...........................................................................................
18
OVERDOSAGE
..............................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
..........................................................................
20
STORAGE AND STABILITY
.......................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................... 24
PART II: SCIENTIFIC INFORMATION
..................................................................................................................
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