GLN-OLMESARTAN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

OLMESARTAN MEDOXOMIL

Available from:

GLENMARK PHARMACEUTICALS CANADA INC.

ATC code:

C09CA08

INN (International Name):

OLMESARTAN MEDOXOMIL

Dosage:

20MG

Pharmaceutical form:

TABLET

Composition:

OLMESARTAN MEDOXOMIL 20MG

Administration route:

ORAL

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0152496002; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-11-15

Summary of Product characteristics

_Pr_
_GLN-Olmesartan (olmesartan medoxomil)_ _ _
_ _
_Page 1 of 31_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
GLN-OLMESARTAN
Olmesartan Medoxomil
20 mg and 40 mg Tablets
Oral
Manufacturer’s Standard
Angiotensin II AT
1
Receptor Blocker
Glenmark Pharmaceuticals Canada Inc.
1600 Steeles Ave. West
Suite 407, Concord, ON
L4K 4M2
Date of Initial Approval:
November 10, 2017
Date of Revision:
February 3, 2022
Submission Control No: 252819
_Pr_
_GLN-Olmesartan (olmesartan medoxomil)_ _ _
_ _
_Page 2 of 31_
RECENT MAJOR LABEL CHANGES
Contraindications, Pregnancy and Breastfeeding, February 2022
Warnings and Precautions, Special Populations, Pregnant women,
February 2022
TABLE OF CONTENTS
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
............................................................................................................
6
4.4 Administration
.............................................................................................................
6
4.5 Missed Dose
...................................