LOSEC CAPSULE (DELAYED RELEASE)

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

OMEPRAZOLE

Disponible desde:

CHEPLAPHARM ARZNEIMITTEL GMBH

Código ATC:

A02BC01

Designación común internacional (DCI):

OMEPRAZOLE

Dosis:

20MG

formulario farmacéutico:

CAPSULE (DELAYED RELEASE)

Composición:

OMEPRAZOLE 20MG

Vía de administración:

ORAL

Unidades en paquete:

28

tipo de receta:

Prescription

Área terapéutica:

PROTON-PUMP INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0121643001; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2020-11-02

Ficha técnica

_Product Monograph _
_Date: September 2023 _
_LOSEC (omeprazole delayed release capsules) _
_Page 1 of 43_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
LOSEC®
Omeprazole delayed release capsules
Capsules (delayed release), 20 mg omeprazole, oral
Proton Pump Inhibitor
MANUFACTURER:
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
IMPORTER / DISTRIBUTOR:
Xediton Pharmaceuticals Inc.
2020 Winston Park Drive, Suite 402
Oakville, Ontario L6H 6X7
Tel: 1-888-XEDITON (933-4866)
DATE OF INITIAL AUTHORIZATION:
JAN 13, 1989
DATE OF REVISION:
OCT 17, 2023
Submission Control Number: 275360
LOSEC
®
is a registered trademark.
_Product Monograph _
_Date: September 2023 _
_LOSEC (omeprazole delayed release capsules) _
_Page 2 of 43_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
10/2023
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
............................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................................................
4
1
INDICATIONS
...........................................................................................................................
4
1.1
Pediatrics
...............................................................................................................................
4
1.2
Geriatrics
...............................................................................................................................
4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
..............................................................................................
4
4.1
Dosing Conside