OLMETEC PLUS TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE

Saadav alates:

ORGANON CANADA INC.

ATC kood:

C09DA08

INN (Rahvusvaheline Nimetus):

OLMESARTAN MEDOXOMIL AND DIURETICS

Annus:

40MG; 12.5MG

Ravimvorm:

TABLET

Koostis:

OLMESARTAN MEDOXOMIL 40MG; HYDROCHLOROTHIAZIDE 12.5MG

Manustamisviis:

ORAL

Ühikuid pakis:

15G/50G

Retsepti tüüp:

Prescription

Terapeutiline ala:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2011-02-15

Toote omadused

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