ARCOSYL PLUS LD TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PERINDOPRIL ARGININE; INDAPAMIDE

Available from:

SERVIER CANADA INC

ATC code:

C09BA04

INN (International Name):

PERINDOPRIL AND DIURETICS

Dosage:

2.5MG; 0.625MG

Pharmaceutical form:

TABLET

Composition:

PERINDOPRIL ARGININE 2.5MG; INDAPAMIDE 0.625MG

Administration route:

ORAL

Units in package:

14/20/28/30/50

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0252492002; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2019-06-26

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
ARCOSYL
® PLUS LD
2.5 MG / 0.625 MG
film-coated tablets
PR
ARCOSYL
® PLUS
5 MG / 1.25 MG
film-coated tablets
10 MG / 2.5 MG
film-coated tablets
(perindopril arginine / indapamide)
Angiotensin converting enzyme inhibitor / Diuretic
SERVIER CANADA INC.
235, Boulevard Armand Frappier
Laval, Québec H7V 4A7
Submission Control No.:
213434
Date of Revision:
June 5, 2018
_Product Monograph - ARCOSYL_
_®_
_ PLUS LD / ARCOSYL_
_® _
_PLUS _
_Page 2 of 65_
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
.................................................................. 28
OVERDOSAGE
....................................................................................................
29
ACTION AND CLINICAL PHARMACOLOGY
................................................ 30
STORAGE AND STABILITY
.............................................................................
35
SPECIAL HANDLING INSTRUCTIONS
........................................................... 35
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................. 35
PART II: SCIENTIFIC INFORMATION ............................................................... 37
PHARMACEUTICAL INFORMATION
............................................................. 37
CLINICAL TRIALS
...........................................................................................