PRIVA-PERINDOPRIL ERBUMINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PERINDOPRIL ERBUMINE

Available from:

NORA PHARMA INC

ATC code:

C09AA04

INN (International Name):

PERINDOPRIL

Dosage:

2MG

Pharmaceutical form:

TABLET

Composition:

PERINDOPRIL ERBUMINE 2MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2022-07-25

Summary of Product characteristics

_Priva-PERINDOPRIL ERBUMINE _
_Page 1 of 55 _
PRODUCT MONOGRAPH
PR PRIVA-PERINDOPRIL ERBUMINE
PERINDOPRIL ERBUMINE TABLETS, USP
2 MG, 4 MG AND 8 MG ANGIOTENSIN CONVERTING ENZYME INHIBITOR
NORA PHARMA INC.
1565, Lionel-Boulet Boul.
Varennes, Québec
J3X 1P7
CONTROL NUMBER: 264075
DATE OF PREPARATION:
May 31, 2022
_Priva-PERINDOPRIL ERBUMINE _
_Page 2 of 55 _
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
......................................................................................................
13
DRUG INTERACTIONS
......................................................................................................
20
DOSAGE AND ADMINISTRATION
..................................................................................
22
OVERDOSAGE
.....................................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 25
STORAGE AND STABILITY
..............................................................................................
28
SPECIAL HANDLING INSTRUCTIONS
............................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 29
PART II: SCIENTIFIC INFORMATION ...................................................................................
30
PHARMACEUTICAL INFORMATION
.........................................