NAPROXEN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
26-03-2020
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Active ingredient:
NAPROXEN SODIUM
Available from:
PHARMASCIENCE INC
ATC code:
M01AE02
INN (International Name):
NAPROXEN
Dosage:
220MG
Pharmaceutical form:
TABLET
Composition:
NAPROXEN SODIUM 220MG
Administration route:
ORAL
Units in package:
24/100
Prescription type:
OTC
Therapeutic area:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Product summary:
Active ingredient group (AIG) number: 0113934003; AHFS:
Authorization status:
APPROVED
Authorization date:
2012-02-02
Summary of Product characteristics
PRODUCT MONOGRAPH
NAPROXEN
Naproxen Sodium Tablets USP
220 mg
Non-steroidal anti-inflammatory drug
Analgesic, Antipyretic
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
DATE OF REVISION:
March 26, 2020
Submission Control no.: 235589
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_NAPROXEN Product Monograph _
_Page 2 of 39_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
..........................................................................
3
INDICATIONS AND CLINICAL USE
................................................................................
3
CONTRAINDICATIONS
.....................................................................................................
4
WARNINGS AND PRECAUTIONS
....................................................................................
4
ADVERSE REACTIONS
......................................................................................................
6
DRUG INTERACTIONS
......................................................................................................
9
DOSAGE AND ADMINISTRATION
................................................................................
11
OVERDOSAGE
...................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 12
STORAGE AND STABILITY
............................................................................................
14
SPECIAL HANDLING INSTRUCTIONS
.........................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 14
PART II: SCIENTIFIC INFORMATION
..............................................................................
15
PHARMACEUTICAL INFORMATION
............................................................................
15
CLINICAL TRIALS
......
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