APO-OLMESARTAN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

OLMESARTAN MEDOXOMIL

Available from:

APOTEX INC

ATC code:

C09CA08

INN (International Name):

OLMESARTAN MEDOXOMIL

Dosage:

20MG

Pharmaceutical form:

TABLET

Composition:

OLMESARTAN MEDOXOMIL 20MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2017-05-01

Summary of Product characteristics

_APO-OL MESARTAN _
_ _
_Page 1 of 33 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-OLMESARTAN
Olmesartan Medoxomil Tablets
20 mg and 40 mg, Oral
USP
Angiotensin II AT
1
Receptor Blocker
Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
May 01, 2017
Date of Revision:
August 3, 2022
Submission Control Number: 261965
_APO-OL MESARTAN _
_ _
_Page 2 of 33 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS, Pregnancy and Breastfeeding
08/2022
7 Warnings and Precautions, 7.1 Special Populations, 7.1.1 Pregnant
women
08/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
..............................................................................................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
..........................................................................................................6
4.4
Administration
.....