PERINDOPRIL ERBUMINE/INDAPAMIDE LD TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
19-01-2023
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Active ingredient:
INDAPAMIDE; PERINDOPRIL ERBUMINE
Available from:
PRO DOC LIMITEE
ATC code:
C09BA04
INN (International Name):
PERINDOPRIL AND DIURETICS
Dosage:
0.625MG; 2MG
Pharmaceutical form:
TABLET
Composition:
INDAPAMIDE 0.625MG; PERINDOPRIL ERBUMINE 2MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Product summary:
Active ingredient group (AIG) number: 0248401002; AHFS:
Authorization status:
APPROVED
Authorization date:
2023-01-20
Summary of Product characteristics
_ _
_PERINDOPRIL ERBUMINE/INDAPAMIDE LD, _
_PERINDOPRIL ERBUMINE/INDAPAMIDE, PERINDOPRIL ERBUMINE/INDAPAMIDE HD _
_(perindopril erbumine / indapamide) Product Monograph _
_Page 1 of 68_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
PERINDOPRIL ERBUMINE/INDAPAMIDE LD
Tablets, 2 mg / 0.625 mg Oral
Pr
PERINDOPRIL ERBUMINE/INDAPAMIDE
Tablets, 4 mg / 1.25 mg Oral
Pr
PERINDOPRIL ERBUMINE/INDAPAMIDE HD
Tablets, 8 mg / 2.5 mg Oral
Perindopril Erbumine / Indapamide Tablets
Angiotensin Converting Enzyme Inhibitor / Diuretic
Pro Doc Ltée
2925, boul. Industriel
Laval, Quebec
H7L 3W9
Date of Initial Authorization:
DEC 7, 2021
Date of Revision:
JAN 19, 2023
Submission Control Number: 270493
_ _
_PERINDOPRIL ERBUMINE/INDAPAMIDE LD, _
_PERINDOPRIL ERBUMINE/INDAPAMIDE, PERINDOPRIL ERBUMINE/INDAPAMIDE HD _
_(perindopril erbumine / indapamide) Product Monograph _
_Page 2 of 68_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
01/2023
7 WARNING AND PRECAUTIONS
01/2023
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
................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................... 5
4
DOSAGE A
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