OLMETEC TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

OLMESARTAN MEDOXOMIL

Available from:

ORGANON 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:

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:

2011-02-15

Summary of Product characteristics

_OLMETEC_
_®_
_ _
_(olmesartan medoxomil)_
_ _
_Page 1 of 28_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
OLMETEC
®
Olmesartan Medoxomil Tablets
5 mg
_*_
, 20 mg, and 40 mg Tablets
Oral
Angiotensin II AT
1
Receptor Blocker
ORGANON CANADA INC.
16766 route Transcanadienne
Kirkland, Quebec
H9H 4M7
www.organon.ca
Date of Initial Approval:
October 28, 2008
Date of Revision:
April 28, 2021
Submission Control No.: 250401
_*5 mg tablet not marketed_
_OLMETEC_
_®_
_ _
_(olmesartan medoxomil)_
_ _
_Page 2 of 28_
RECENT MAJOR LABEL CHANGES
Contraindications, Pregnancy and Breastfeeding, November 2020
Warnings and Precautions, Special Populations, Pregnant women,
November 2020
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................ 4
1
INDICATIONS
................................................................................................................
4
Pediatrics
........................................................................................................................
4
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
......