LOSEC CAPSULE (DELAYED RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
17-10-2023
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Active ingredient:
OMEPRAZOLE
Available from:
CHEPLAPHARM ARZNEIMITTEL GMBH
ATC code:
A02BC01
INN (International Name):
OMEPRAZOLE
Dosage:
20MG
Pharmaceutical form:
CAPSULE (DELAYED RELEASE)
Composition:
OMEPRAZOLE 20MG
Administration route:
ORAL
Units in package:
28
Prescription type:
Prescription
Therapeutic area:
PROTON-PUMP INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0121643001; AHFS:
Authorization status:
APPROVED
Authorization date:
2020-11-02
Summary of Product characteristics
_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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
...........................................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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4
4.1
Dosing Conside
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