APO-TELMISARTAN-AMLODIPINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TELMISARTAN; AMLODIPINE (AMLODIPINE BESYLATE)

Available from:

APOTEX INC

ATC code:

C09DB04

INN (International Name):

TELMISARTAN AND AMLODIPINE

Dosage:

80MG; 5MG

Pharmaceutical form:

TABLET

Composition:

TELMISARTAN 80MG; AMLODIPINE (AMLODIPINE BESYLATE) 5MG

Administration route:

ORAL

Units in package:

30/100/500

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0252947003; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-09-04

Summary of Product characteristics

_Product Monograph _
_APO-TELMISARTAN-AMLODIPINE (telmisartan/amlodipine) _
_Page 1 of 59 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-TELMISARTAN-AMLODIPINE
Telmisartan / Amlodipine Tablets
Tablets, 40/5 mg, 40/10 mg, 80/5 mg and 80/10 mg telmisartan /
amlodipine (as amlodipine
besylate), Oral
House Standard
Angiotensin II AT1 Receptor Blocker / Calcium Channel Blocker
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization
FEB 27, 2018
Date of Revision:
OCT 16, 2023
Submission Control Number: 274810
_Product Monograph _
_APO-TELMISARTAN-AMLODIPINE (telmisartan/amlodipine) _
_Page 2 of 59 _
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION
10/2023
7 WARNINGS AND PRECAUTIONS
10/2023
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
......................