ESOMEPRAZOLE TABLET (DELAYED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
24-02-2023
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Active ingredient:
ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM)
Available from:
JAMP PHARMA CORPORATION
ATC code:
A02BC05
INN (International Name):
ESOMEPRAZOLE
Dosage:
40MG
Pharmaceutical form:
TABLET (DELAYED-RELEASE)
Composition:
ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM) 40MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Therapeutic area:
PROTON-PUMP INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0145162002; AHFS:
Authorization status:
APPROVED
Authorization date:
2021-09-23
Summary of Product characteristics
_ESOMEPRAZOLE (Esomeprazole Magnesium Delayed Release Tablets) Product
Monograph _
_Page 1 of 54_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ESOMEPRAZOLE
Esomeprazole Magnesium Delayed Release Tablets
Delayed release tablets, 20 mg and 40 mg esomeprazole (as esomeprazole
magnesium amorphous)
, Oral use
H
+
, K
+
-ATPase Inhibitor
JAMP Pharma Corporation
1310, rue Nobel
Boucherville, Québec
J4B 5H3
Date of Initial Authorization:
September 23, 2021
Date of Revision:
February 24, 2023
Submission Control No. 267724
_ESOMEPRAZOLE (Esomeprazole Magnesium Delayed Release Tablets) Product
Monograph _
_Page 2 of 54_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, General
02-2023
7 WARNINGS AND PRECAUTIONS, Gastrointestinal
02-2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant
Women
02-2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES.............................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS........................................................................................................................
4
1.1 Pediatrics
......................................................................................................................
4
2 CONTRAINDICATIONS
..........................................................................................................
4
4 DOSAGE AND ADMINISTRATION
..........................................................................................
5
4.1 Dosing Considerations
...................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
................................................................ 5
4.4 Administration
...........................................................................................................
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