MYLAN-PERINDOPRIL/INDAPAMIDE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
05-07-2022
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Active ingredient:
INDAPAMIDE; PERINDOPRIL ERBUMINE
Available from:
MYLAN PHARMACEUTICALS ULC
ATC code:
C09BA04
INN (International Name):
PERINDOPRIL AND DIURETICS
Dosage:
1.25MG; 4MG
Pharmaceutical form:
TABLET
Composition:
INDAPAMIDE 1.25MG; PERINDOPRIL ERBUMINE 4MG
Administration route:
ORAL
Units in package:
30/100
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0248401001; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2023-06-07
Summary of Product characteristics
_Product Monograph _
_–_
_ Mylan-Perindopril/Indapamide _
_ Page 1 of 63_
PRODUCT MONOGRAPH
Pr
MYLAN-PERINDOPRIL/INDAPAMIDE
(2 mg/0.625 mg) tablets
Pr
MYLAN-PERINDOPRIL/INDAPAMIDE
(4 mg/1.25 mg) tablets
Pr
MYLAN-PERINDOPRIL/INDAPAMIDE
(8 mg/2.5 mg) tablets
(perindopril erbumine/indapamide)
Angiotensin Converting Enzyme Inhibitor / Diuretic
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Initial Approval:
March 07, 2018
Date of Revision:
July 5, 2022
Submission Control No.: 265136
_Product Monograph _
_–_
_ Mylan-Perindopril/Indapamide _
_ Page 2 of 63_
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
...........................................................................................................
16
DRUG INTERACTIONS
...........................................................................................................
23
DOSAGE AND ADMINISTRATION
..........................................................................................
29
OVERDOSAGE
........................................................................................................................
30
ACTION AND CLINICAL PHARMACOLOGY
...........................................................................
31
STORAGE AND STABILITY
....................................................................................................
36
SPECIAL HANDLING INSTRUCTIONS
.............................................................
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