APO-PERINDOPRIL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PERINDOPRIL ERBUMINE

Available from:

APOTEX INC

ATC code:

C09AA04

INN (International Name):

PERINDOPRIL

Dosage:

2MG

Pharmaceutical form:

TABLET

Composition:

PERINDOPRIL ERBUMINE 2MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0127178001; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-03-07

Summary of Product characteristics

_APO-PERINDOPRIL (Perindopril erbumine tablets) _
_Page 1 of 75_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
APO-PERINDOPRIL
Perindopril erbumine tablets
Tablets, 2 mg, 4 mg and 8 mg, Oral
Apotex Standard
Angiotensin Converting Enzyme Inhibitor
Submission Control Number: 272361
APOTEX INC.
150 Signet Drive
Weston, Ontario
M9L 1T9
Date of Initial Authorization:
MAR 07, 2018
Date of Revision:
AUG 01, 2023
_APO-PERINDOPRIL (Perindopril erbumine tablets) _
_Page 2 of 75_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
08/2023
7 WARNING AND PRECAUTIONS
08/2023
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
...............................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.......................................................... 5
4
DOSAGE AND
ADMINISTRATION...............................................................................
5
4.1
Dosing Considerations
........................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
................................................... 6
4.4
Administration
................................................................................