NAPROXEN SODIUM TABLETS
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
31-01-2012
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Active ingredient:
NAPROXEN SODIUM
Available from:
VITA HEALTH PRODUCTS INC
ATC code:
M01AE02
INN (International Name):
NAPROXEN
Dosage:
220MG
Pharmaceutical form:
TABLET
Composition:
NAPROXEN SODIUM 220MG
Administration route:
ORAL
Units in package:
24/100/250/500
Prescription type:
OTC
Therapeutic area:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Product summary:
Active ingredient group (AIG) number: 0113934003; AHFS:
Authorization status:
APPROVED
Authorization date:
2012-01-30
Summary of Product characteristics
_Page 1 of 35_
PRODUCT MONOGRAPH
NAPROXEN SODIUM TABLETS
NAPROXEN SODIUM CAPLETS
NAPROXEN SODIUM TABLETS USP, 220 MG
Non-steroidal anti-inflammatory drug
Analgesic, Antipyretic
Vita Health Products Inc.
150 Beghin Avenue, Winnipeg
Manitoba, Canada R2J 3W2
Date of Preparation:
January 26, 2012
Control No.: 134246
_Page 2 of 35_
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
...............................................................................................................13
SPECIAL HANDLING INSTRUCTIONS
............................................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................................14
PART II:
Read the complete document
