APO-NAPRO-NA TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

NAPROXEN SODIUM

Available from:

APOTEX INC

ATC code:

M01AE02

INN (International Name):

NAPROXEN

Dosage:

275MG

Pharmaceutical form:

TABLET

Composition:

NAPROXEN SODIUM 275MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0113934001; AHFS:

Authorization status:

MARKETED

Authorization date:

1989-12-31

Summary of Product characteristics

_APO-NAPRO-NA/APO-NAPRO-NA DS (naproxen sodium)_
Page 1 of 48
_ _
PRODUCT
MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-NAPRO-NA
PR
APO-NAPRO-NA
DS
Naproxen Sodium Tablets
Tablets, 275 mg and 550 mg, Oral
USP
Non-Steroidal Anti-Inflammatory Drug (NSAID)
APOTEX INC.
150 Signet Drive,
Toronto, Ontario
M9L 1T9
Submission Control No: 260918
Date of Initial Authorization:
DEC 31, 1989
Date of Revision:
August 17, 2022
_APO-NAPRO-NA/APO-NAPRO-NA DS (naproxen sodium)_
Page 2 of 48
_ _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
[08/2022]
3 SERIOUS WARNING AND PRECAUTIONS BOX
[08/2022]
7 WARNINGS AND PRECAUTIONS, Monitoring and
Laboratory Tests, _Pregnancy _
[08/2022]
7 WARNINGS AND PRECAUTIONS, Psychiatric
[08/2022]
7 WARNINGS AND PRECAUTIONS, Skin
[08/2022]
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
[08/2022]
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
1.2
Geriatrics...................................................................................................................
4
2
CONTRAINDICATIONS
......................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................. 5
4
DOSAGE AND ADMINISTRATION
..............................................................................