APO-OLMESARTAN/HCTZ TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE

Διαθέσιμο από:

APOTEX INC

Φαρμακολογική κατηγορία (ATC):

C09DA08

INN (Διεθνής Όνομα):

OLMESARTAN MEDOXOMIL AND DIURETICS

Δοσολογία:

40MG; 25MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

OLMESARTAN MEDOXOMIL 40MG; HYDROCHLOROTHIAZIDE 25MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

30/100/500

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2017-05-01

Αρχείο Π.Χ.Π.

_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