ALTACE HCT TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

RAMIPRIL; HYDROCHLOROTHIAZIDE

Dostupné z:

BAUSCH HEALTH, CANADA INC.

ATC kód:

C09BA05

INN (Medzinárodný Name):

RAMIPRIL AND DIURETICS

Dávkovanie:

10MG; 25MG

Forma lieku:

TABLET

Zloženie:

RAMIPRIL 10MG; HYDROCHLOROTHIAZIDE 25MG

Spôsob podávania:

ORAL

Počet v balení:

15G/50G

Typ predpisu:

Prescription

Terapeutické oblasti:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Prehľad produktov:

Active ingredient group (AIG) number: 0251649005; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2021-03-03

Súhrn charakteristických

_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