AURO-PERINDOPRIL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PERINDOPRIL ERBUMINE

Available from:

AURO PHARMA INC

ATC code:

C09AA04

INN (International Name):

PERINDOPRIL

Dosage:

8MG

Pharmaceutical form:

TABLET

Composition:

PERINDOPRIL ERBUMINE 8MG

Administration route:

ORAL

Units in package:

30/100/500

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0127178003; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-03-07

Summary of Product characteristics

AURO-PERINDOPRIL PRODUCT MONOGRAPH Page 1 of 67
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-PERINDOPRIL
Perindopril Erbumine Tablets
Tablets, 2 mg, 4 mg and 8 mg, Oral
House Standard
Angiotensin Converting Enzyme Inhibitor
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Initial Authorization:
January 11, 2018
Date of Revision:
June 6, 2023
Submission Control Number: 270817
AURO-PERINDOPRIL PRODUCT MONOGRAPH Page 2 of 67
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
06/2023
7 WARNING AND PRECAUTIONS
06/2023
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
...............................................................................................
6
4.2 Recommended Dose and Dosage Adjustment
............................................................ 6
4.4 Administration