PMS-ESOMEPRAZOLE DR CAPSULE (DELAYED RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM DIHYDRATE)

Available from:

PHARMASCIENCE INC

ATC code:

A02BC05

INN (International Name):

ESOMEPRAZOLE

Dosage:

40MG

Pharmaceutical form:

CAPSULE (DELAYED RELEASE)

Composition:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM DIHYDRATE) 40MG

Administration route:

ORAL

Units in package:

30/100

Prescription type:

Prescription

Therapeutic area:

PROTON-PUMP INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0145162002; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-05-26

Summary of Product characteristics

_pms-ESOMEPRAZOLE DR Product Monograph _
_Page 1 of 55_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-ESOMEPRAZOLE DR
Esomeprazole Magnesium Delayed Release Capsules
Delayed-Release Capsules, 20 mg, 40 mg esomeprazole (as esomeprazole
magnesium
dihydrate), Oral
H
+
, K
+
-ATPase Inhibitor
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
Submission Control Number: 258544
Date of Initial Authorization:
MAY 26, 2014
Date of Revision:
MAR 16, 2022
_pms-ESOMEPRAZOLE DR Product Monograph _
_Page 2 of 55_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, General
03/2022
7 WARNINGS AND PRECAUTIONS, Gastrointestinal
03/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
03/2022
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
2
CONTRAINDICATIONS........................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.......................................................................................
5
4.1
Dosing Considerations
............................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment.......................................................... 5
4.4
Administration..................................................................