MYLAN-NAPROXEN/ESOMEPRAZOLE MR TABLET (IMMEDIATE AND DELAYED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

NAPROXEN; ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM)

Available from:

MYLAN PHARMACEUTICALS ULC

ATC code:

M01AE52

INN (International Name):

NAPROXEN AND ESOMEPRAZOLE

Dosage:

375MG; 20MG

Pharmaceutical form:

TABLET (IMMEDIATE AND DELAYED-RELEASE)

Composition:

NAPROXEN 375MG; ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM) 20MG

Administration route:

ORAL

Units in package:

60/100/500

Prescription type:

Prescription

Therapeutic area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0252870001; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-02-10

Summary of Product characteristics

_ _
_MYLAN-NAPROXEN / ESOMEPRAZOLE MR (Naproxen / Esomeprazole Modified
Release Tablets) _
_Page 1 of 65_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MYLAN-NAPROXEN / ESOMEPRAZOLE MR
Naproxen / Esomeprazole (as esomeprazole magnesium)
Modified release tablets, 375 mg naproxen / 20 mg esomeprazole and 500
mg naproxen / 20 mg
esomeprazole, Oral
NSAID and H
+
, K
+
-ATPase Inhibitor
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
FEB 08, 2017
Date of Revision:
JUL 04, 2023
Submission Control Number: 273201
_ _
_MYLAN-NAPROXEN / ESOMEPRAZOLE MR (Naproxen / Esomeprazole Modified
Release Tablets) _
_Page 2 of 65_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
07/2023
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests
07/2023
7 WARNINGS AND PRECAUTIONS, Skin
07/2023
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations
07/2023
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
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4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.