MYLAN-CILAZAPRIL TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
16-11-2021
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Active ingredient:
CILAZAPRIL (CILAZAPRIL MONOHYDRATE)
Available from:
MYLAN PHARMACEUTICALS ULC
ATC code:
C09AA08
INN (International Name):
CILAZAPRIL
Dosage:
1MG
Pharmaceutical form:
TABLET
Composition:
CILAZAPRIL (CILAZAPRIL MONOHYDRATE) 1MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0122806001; AHFS:
Authorization status:
APPROVED
Authorization date:
2009-07-10
Summary of Product characteristics
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_Page 1_
PRODUCT MONOGRAPH
PR MYLAN-CILAZAPRIL
Cilazapril
Monohydrate Tablets
1 mg, 2.5 mg, 5 mg
Angiotensin Converting Enzyme Inhibitor
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission
Control No.: 257402
Date of Revision:
November 16, 2021
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_Page 2_
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............................................................................................12
DRUG INTERACTIONS
............................................................................................19
DOSAGE AND ADMINISTRATION
.........................................................................23
OVERDOSAGE
.........................................................................................................26
ACTION AND CLINICAL
PHARMACOLOGY.........................................................27
STORAGE AND STABILITY
....................................................................................30
SPECIAL HANDLING INSTRUCTIONS
...................................................................30
DOSAGE FORMS, COMPOSITION AND PACKAGING
..........................................30
PART II: SCIENTIFIC INFORMATION
..........................................................................
32
PHARMACEUTICAL INFORMATION
.....................................................................32
CLINICAL TRIALS
...................................................................................................33
DETAILED
PHARMACOLOGY..........................................
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