OLMETEC PLUS TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
27-04-2021
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Active ingredient:
OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE
Available from:
ORGANON CANADA 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:
15G/50G
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Product summary:
Active ingredient group (AIG) number: 0252502002; AHFS:
Authorization status:
APPROVED
Authorization date:
2011-02-15
Summary of Product characteristics
Page 1 of 39
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
OLMETEC PLUS
®
Olmesartan Medoxomil and Hydrochlorothiazide Tablets
20 mg/12.5 mg, 40 mg/12.5 mg,
and 40 mg/25 mg Tablets
Oral
Angiotensin II AT
1
Receptor Blocker – Diuretic
ORGANON CANADA INC.
16766 route Transcanadienne
Kirkland, Quebec
H9H 4M7
www.organon.ca
Date of Initial Approval:
October 18, 2010
Date of Revision:
April 27, 2021
Submission Control No: 250557
Page 2 of 39
_OLMETEC PLUS_
®
_(olmesartan medoxomil and hydrochlorothiazide)_
RECENT MAJOR LABEL CHANGES
Contraindications, Pregnancy and Breastfeeding, November 2020
Warning and Precautions, Special Populations, Pregnant Women, May 2020
Warning and Precautions, Carcinogenesis and Mutagenesis, Non-melanoma
Skin-Cancer number,
May 2019
Warning and Precautions, Sensitivity/Resistance, Photosensitivity, May
2019
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........................................................ 4
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.1
Dosing Considerations
.........................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
..................................................... 5
4.3
Reconstitution
......................................................................................................
7
4.4
Admin
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