VASERETIC TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ENALAPRIL SODIUM (ENALAPRIL MALEATE); HYDROCHLOROTHIAZIDE

Available from:

ORGANON CANADA INC.

ATC code:

C09BA02

INN (International Name):

ENALAPRIL AND DIURETICS

Dosage:

8MG; 25MG

Pharmaceutical form:

TABLET

Composition:

ENALAPRIL SODIUM (ENALAPRIL MALEATE) 8MG; HYDROCHLOROTHIAZIDE 25MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0252326001; AHFS:

Authorization status:

APPROVED

Authorization date:

2005-08-09

Summary of Product characteristics

_VASERETIC® (enalapril and hydrochlorothiazide tablets) _
_Page 1 of 60 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
VASERETIC®
(enalapril and hydrochlorothiazide)
Tablets 10 mg/25 mg oral
Each tablet is made with 10 mg of enalapril maleate that appears as 8
mg of enalapril sodium in
the tablet and 25 mg of hydrochlorothiazide.
Angiotensin Converting Enzyme Inhibitor / Diuretic
ORGANON CANADA INC.
16766 route Transcanadienne
Kirkland, QC Canada
H9H 4M7
www.organon.ca
Date of Initial Authorization:
Jul 4, 1990
Date of Revision:
November 4, 2022
Submission Control Number: 265020
_VASERETIC® (enalapril and hydrochlorothiazide tablets) _
_Page 2 of 60 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.1 Pediatrics
06/2021
1 INDICATIONS, 1.2 Geriatrics
06/2021
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
06/2021
4 DOSAGE AND ADMINISTRATION, 4.5 Missed dose
06/2021
7 WARNINGS AND PRECAUTIONS
11/2022
TABLE OF CONTENTS
RECENT MAJOR LABEL
CHANGES..............................................................................................2
TABLE OF CONTENTS
................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................4
1
INDICATIONS
................................................................................................................4
1.1
Pediatrics
............................................................................................................4
1.2
Geriatrics.............................................................................................................4
2
CONTRAINDICATIONS
...................................................................................................4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
..............................................................5
4
DOSAGE AND
ADMINISTRATION...................................................................................5
4.1
Dosing Considerations