COVERSYL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PERINDOPRIL ERBUMINE

Available from:

SERVIER CANADA INC

ATC code:

C09AA04

INN (International Name):

PERINDOPRIL

Dosage:

4MG

Pharmaceutical form:

TABLET

Composition:

PERINDOPRIL ERBUMINE 4MG

Administration route:

ORAL

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0127178002; AHFS:

Authorization status:

MARKETED

Authorization date:

1994-12-31

Summary of Product characteristics

_ _
_COVERSYL_
_®_
_ (perindopril erbumine) Product Monograph _
_Page 1 of 63_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
COVERSYL®
Perindopril erbumine Tablets
Tablets, 2 mg, 4 mg and 8 mg, Oral
Angiotensin Converting Enzyme Inhibitor
Servier Canada Inc.
3224 Avenue Jean-Béraud #270
Laval, Quebec H7T 2S4
Canada
Date of Initial Authorization:
June 6, 1994
Date of Revision:
October 21, 2022
Submission Control Number: 264109
_ _
_COVERSYL_
_®_
_ (perindopril erbumine) Product Monograph _
_Page 2 of 63_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
[10/2022]
7 WARNING AND PRECAUTIONS
[10/2022]
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL
CHANGES..............................................................................................2
TABLE OF CONTENTS
................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................4
1
INDICATIONS
................................................................................................................4
1.1
Pediatrics (< 18 years of
age)................................................................................4
1.2
Geriatrics (>65 years of
age).................................................................................4
2
CONTRAINDICATIONS
...................................................................................................4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
..............................................................5
4
DOSAGE AND
ADMINISTRATION...................................................................................5
4.1
Dosing Considerations
.........................................................................................5
4.2
Recommended Dose and Dosage
Adjustment.......................................................5
4.4
Administration.................