APO-OLMESARTAN/HCTZ TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE

Available from:

APOTEX INC

ATC code:

C09DA08

INN (International Name):

OLMESARTAN MEDOXOMIL AND DIURETICS

Dosage:

40MG; 12.5MG

Pharmaceutical form:

TABLET

Composition:

OLMESARTAN MEDOXOMIL 40MG; HYDROCHLOROTHIAZIDE 12.5MG

Administration route:

ORAL

Units in package:

30/100/500

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0252502002; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-05-01

Summary of Product characteristics

_APO-OLMESARTAN/HCTZ (Olmesartan medoxomil and Hydrochlorothiazide
Tablets) _
_Page 1 of 49 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-OLMESARTAN/HCTZ
Olmesartan Medoxomil and Hydrochlorothiazide Tablets
Tablets, 20 mg / 12.5 mg, 40 mg / 12.5 mg and 40 mg / 25 mg, Oral
Angiotensin II AT
1
Receptor Blocker – Diuretic
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
MAY 01, 2017
Date of Revision:
JAN 12, 2023
Submission Control Number: 266735
_APO-OLMESARTAN/HCTZ (Olmesartan medoxomil and Hydrochlorothiazide
Tablets) _
_Page 2 of 49 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS, Pregnancy and Breastfeeding
01/2023
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.1 Pregnant
Women
01/2023
7 WARNINGS AND PRECAUTIONS, Carcinogenesis and Mutagenesis, Non-
Melanoma Skin Cancer
02/2020
7 WARNINGS AND PRECUATIONS, Sensitivity/Resistance, Photosensitivity
02/2020
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
5
1
INDICATIONS...................................................................................................................
5
1.1
Pediatrics
.............................................................................................................
5
1.2
Geriatrics..............................................................................................................
5
2
CONTRAINDICATIONS
.....................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................. 6
4
DOSAGE AND ADMIN