TEVA-OLMESARTAN / HCTZ TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE

Available from:

TEVA CANADA LIMITED

ATC code:

C09DA08

INN (International Name):

OLMESARTAN MEDOXOMIL AND DIURETICS

Dosage:

40MG; 25MG

Pharmaceutical form:

TABLET

Composition:

OLMESARTAN MEDOXOMIL 40MG; HYDROCHLOROTHIAZIDE 25MG

Administration route:

ORAL

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0252502003; AHFS:

Authorization status:

APPROVED

Authorization date:

2023-12-01

Summary of Product characteristics

ACT OLMESARTAN HCT Page 1 of 39
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ACT OLMESARTAN HCT
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
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Initial Approval:
May 1, 2017
Date of Revision:
December 2, 2021
Submission Control No: 256058
ACT OLMESARTAN HCT Page 2 of 39
RECENT MAJOR LABEL CHANGES
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 ............................................................. 5
4.3
RECONSTITUTION .......................................................................................................................
7
4.4
ADMINISTRATION .......................................................................................................................
7
4.5
MISSED DOSE ..............................................................................................................