RAN-QUINAPRIL TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
30-06-2017
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Active ingredient:
QUINAPRIL (QUINAPRIL HYDROCHLORIDE)
Available from:
RANBAXY PHARMACEUTICALS CANADA INC.
ATC code:
C09AA06
INN (International Name):
QUINAPRIL
Dosage:
40MG
Pharmaceutical form:
TABLET
Composition:
QUINAPRIL (QUINAPRIL HYDROCHLORIDE) 40MG
Administration route:
ORAL
Units in package:
30/1000
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0123206004; AHFS:
Authorization status:
APPROVED
Authorization date:
2014-10-17
Summary of Product characteristics
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_RAN™-QUINAPRIL (Quinapril Tablets USP) Product Monograph_
_Page 1 of 39_
PRODUCT MONOGRAPH
PR
RAN
™
-QUINAPRIL
QUINAPRIL TABLETS USP
(5 MG, 10 MG, 20 MG AND 40 MG OF QUINAPRIL AS QUINAPRIL HYDROCHLORIDE)
ANGIOTENSIN CONVERTING ENZYME INHIBITOR
Ranbaxy Pharmaceuticals Canada Inc.
126 East Drive
Brampton, ON
L6T 1C1
Date of Revision:
June 22, 2017
CONTROL NO. 206533
RAN trademark owned by Sun Pharmaceutical Industries Ltd.
_Pr_
_RAN™-QUINAPRIL (Quinapril Tablets USP) Product Monograph_
_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
....................................................................................................
11
DRUG INTERACTIONS
....................................................................................................
15
DOSAGE AND ADMINISTRATION
................................................................................
18
OVERDOSAGE
...................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 20
STORAGE AND STABILITY
............................................................................................
23
DOSAGE FORMS, COMPOSITION ANDPACKAGING
................................................. 23
PART II: SCIENTIFIC INFORMATION
..................................................................................
24
PHARMACEUTICAL INFORMATION
......................
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