COVERSYL PLUS LD TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PERINDOPRIL ERBUMINE; INDAPAMIDE

Available from:

SERVIER CANADA INC

ATC code:

C09BA04

INN (International Name):

PERINDOPRIL AND DIURETICS

Dosage:

2MG; 0.625MG

Pharmaceutical form:

TABLET

Composition:

PERINDOPRIL ERBUMINE 2MG; INDAPAMIDE 0.625MG

Administration route:

ORAL

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0248401002; AHFS:

Authorization status:

APPROVED

Authorization date:

2002-10-18

Summary of Product characteristics

_ _
_COVERSYL_
_®_
_ PLUS LD / COVERSYL_
_®_
_ PLUS / COVERSYL_
_®_
_ PLUS HD _
_(perindopril erbumine / indapamide) Product Monograph _
_Page 1 of 65_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
COVERSYL® PLUS LD
Tablets, 2 mg / 0.625 mg Oral
Pr
COVERSYL® PLUS
Tablets, 4 mg / 1.25 mg Oral
Pr
COVERSYL® PLUS HD
Tablets, 8 mg / 2.5 mg Oral
perindopril erbumine / indapamide
Angiotensin Converting Enzyme Inhibitor / Diuretic
Servier Canada Inc.
3224 Avenue Jean-Béraud #270
Laval, Quebec, H7V 2S4
Date of Initial Authorization:
October 4, 2002
Date of Revision:
October 21, 2022
Submission Control Number: 264225
_ _
_COVERSYL_
_®_
_ PLUS LD / COVERSYL_
_®_
_ PLUS / COVERSYL_
_®_
_ PLUS HD _
_(perindopril erbumine / indapamide) Product Monograph _
_Page 2 of 65_
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................................................ Error!
Bookmark not defined.
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 Consi