INHIBACE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
02-06-2020
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Active ingredient:
CILAZAPRIL (CILAZAPRIL MONOHYDRATE)
Available from:
CHEPLAPHARM ARZNEIMITTEL GMBH
ATC code:
C09AA08
INN (International Name):
CILAZAPRIL
Dosage:
5MG
Pharmaceutical form:
TABLET
Composition:
CILAZAPRIL (CILAZAPRIL MONOHYDRATE) 5MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0122806002; AHFS:
Authorization status:
APPROVED
Authorization date:
2019-07-29
Summary of Product characteristics
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_Page 1 of 51_
PRODUCT MONOGRAPH
PR
INHIBACE
®
cilazapril tablets
2.5 mg and 5.0 mg
Angiotensin-converting enzyme inhibitor
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
www.cheplapharm.com
Imported By:
MSD Inc.,
8449 Lawson Road, Unit 102
Milton ON, L9T 9L1
Date of Preparation:
March 22, 1993
Date of Revision:
June 2, 2020
Copyright 1993 - 2020 CHEPLAPHARM Arzneimittel GmbH
Submission Control No: 235666
INHIBACE
is a registered trademark of CHEPLAPHARM Arzneimittel GmbH, used under
license.
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_Page 2 of 51_
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
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................20
DOSAGE AND ADMINISTRATION
..............................................................................26
OVERDOSAGE
................................................................................................................28
ACTION AND CLINICAL PHARMACOLOGY
............................................................29
STORAGE AND STABILITY
..........................................................................................32
SPECIAL HANDLING INSTRUCTIONS
.......................................................................32
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................33
PART II: SCIENTIFIC INFORMATION
...........................
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