ACH-TELMISARTAN HCTZ TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TELMISARTAN; HYDROCHLOROTHIAZIDE

Available from:

ACCORD HEALTHCARE INC

ATC code:

C09DA07

INN (International Name):

TELMISARTAN AND DIURETICS

Dosage:

80MG; 12.5MG

Pharmaceutical form:

TABLET

Composition:

TELMISARTAN 80MG; HYDROCHLOROTHIAZIDE 12.5MG

Administration route:

ORAL

Units in package:

28/30/100

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0244783001; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-01-13

Summary of Product characteristics

_ACH-TELMISARTAN HCTZ (Telmisartan/Hydrochlorothiazide Tablets) _
_Page 1 of 63 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ACH-TELMISARTAN HCTZ
Telmisartan/Hydrochlorothiazide Tablets
Tablet, 80 mg/12.5 mg, and 80 mg/25 mg, Oral
Manufacturer’s Standard
Angiotensin II AT
1
Receptor Blocker/Diuretic
Accord Healthcare Inc.
3535 Boul. St. Charles, Suite 704
Kirkland, QC, H9H 5B9
Canada
Date of Initial Authorization:
JAN 13, 2014
Date of Revision:
NOVEMBER 14, 2022
Submission Control Number: 264676
_ACH-TELMISARTAN HCTZ (Telmisartan/Hydrochlorothiazide Tablets) _
_Page 2 of 63 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
11/2022
4 DOSAGE AND ADMINISTRATION
11/2022
7 WARNINGS AND PRECAUTIONS
11/2022
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 Dosage Adjustment
..........................