ALTACE HCT TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

RAMIPRIL; HYDROCHLOROTHIAZIDE

Available from:

BAUSCH HEALTH, CANADA INC.

ATC code:

C09BA05

INN (International Name):

RAMIPRIL AND DIURETICS

Dosage:

10MG; 25MG

Pharmaceutical form:

TABLET

Composition:

RAMIPRIL 10MG; 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: 0251649005; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-03-03

Summary of Product characteristics

_Pr_
_ALTACE _
_®_
_ HCT (Ramipril and Hydrochlorothiazide Tablets) Product Monograph
Page 1 of 65_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ALTACE
® HCT
Ramipril and hydrochlorothiazide Tablets
Tablets, 2.5/12.5 mg, 5/12.5 mg, 10/12.5 mg, 5/25 mg, 10/25 mg, Oral
Angiotensin Converting Enzyme Inhibitor Plus Diuretic
Bausch Health, Canada Inc.
2150 St-Elzear Blvd. West
Laval, Quebec
H7L 4A8
Date of Initial Authorization:
April 23, 2015
Date of Revision:
January 6, 2023
Submission Control Number: 265837
_ _
_Pr_
_ALTACE _
_®_
_ HCT (Ramipril and Hydrochlorothiazide Tablets) Product Monograph
Page 2 of 65_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Ophthalmologic
06/2021
7 WARNINGS AND PRECAUTIONS, Respiratory
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
..........................................................................................................
4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
..............................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX..................................................... 5
4
DOSAGE AND ADMINISTRATION
.............................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and