OLMETEC PLUS TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE

Prieinama:

ORGANON CANADA INC.

ATC kodas:

C09DA08

INN (Tarptautinis Pavadinimas):

OLMESARTAN MEDOXOMIL AND DIURETICS

Dozė:

40MG; 25MG

Vaisto forma:

TABLET

Sudėtis:

OLMESARTAN MEDOXOMIL 40MG; HYDROCHLOROTHIAZIDE 25MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

15G/50G

Recepto tipas:

Prescription

Gydymo sritis:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2011-02-15

Prekės savybės

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