TEVA-OLMESARTAN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

OLMESARTAN MEDOXOMIL

Available from:

TEVA CANADA LIMITED

ATC code:

C09CA08

INN (International Name):

OLMESARTAN MEDOXOMIL

Dosage:

40MG

Pharmaceutical form:

TABLET

Composition:

OLMESARTAN MEDOXOMIL 40MG

Administration route:

ORAL

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0152496003; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-05-01

Summary of Product characteristics

TEVA-OLMESARTAN Page 1 of 28
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-OLMESARTAN
Olmesartan Medoxomil Tablets
Tablets, 20 mg, and 40 mg, Oral
Teva Standard
Angiotensin II AT
1
Receptor Blocker
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Initial Authorization:
May 5, 2017
Date of Revision:
March 10, 2023
Submission Control No: 265873
TEVA-OLMESARTAN Page 2 of 28
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
03/2023
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.1 Pregnant
Women
03/2023
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 Dosage
Adjustment.................................................................
6
4.3
Reconstitution..................