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:

10MG

Pharmaceutical form:

TABLET

Composition:

OLMESARTAN MEDOXOMIL 10MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0152496004; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-05-01

Summary of Product characteristics

_APO-OLMESARTAN (Olmesartan medoxomil) _
_ _
_Page 1 of 33 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-OLMESARTAN
Olmesartan Medoxomil Tablets
Tablets, 10 mg, Oral
Angiotensin II AT
1
Receptor Blocker
Apotex Standard
APOTEX INC.
150 Signet Drive Toronto,
Ontario
M9L 1T9
Date of Initial Approval:
MAY 01, 2017
Date of Revision:
APR 28, 2023
Submission Control No: 269929
_APO-OLMESARTAN (Olmesartan medoxomil) _
_ _
_Page 2 of 33 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS, Pregnancy and Breastfeeding
04/2023
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations,
7.1.1 Pregnant women
04/2023
TABLE OF CONTENTS
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
....................................................................................