NAPROXEN - 250 TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

NAPROXEN

Available from:

PRO DOC LIMITEE

ATC code:

M01AE02

INN (International Name):

NAPROXEN

Dosage:

250MG

Pharmaceutical form:

TABLET

Composition:

NAPROXEN 250MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0109634001; AHFS:

Authorization status:

APPROVED

Authorization date:

2022-04-13

Summary of Product characteristics

_NAPROXEN (Naproxen Tablets) _
_Page 1 of 47_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
NAPROXEN – 250
PR
NAPROXEN – 375
PR
NAPROXEN – 500
Naproxen Tablets
Tablets, 250 mg, 375 mg and 500 mg, Oral
USP
ATC Code: M01AE02
Non-Steroidal Anti-Inflammatory Drug (NSAID)
PRO DOC LTÉE
2925, Boul. Industriel
Laval, Québec
H7L 3W9
Date of Initial Authorization:
March 11, 1983
Date of Revision
November 14, 2023
_ _
Submission Control Number: 278690
_NAPROXEN (Naproxen Tablets) _
_Page 2 of 47_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
11/2023
3 SERIOUS WARNING AND PRECAUTIONS BOX
11/2023
7 WARNINGS AND PRECAUTIONS
11/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
11/2023
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
.......................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.................................................................. 6
4
DOSAGE AND ADMINISTRATION
.......................................................................................
7
4.1
Dosing Considerations
..................................................................................