Country: Canada
Language: English
Source: Health Canada
NAPROXEN SODIUM
DOMINION PHARMACAL
M01AE02
NAPROXEN
220MG
TABLET
NAPROXEN SODIUM 220MG
ORAL
24/100/125
OTC
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0113934003; AHFS:
CANCELLED POST MARKET
2020-05-06
PRODUCT MONOGRAPH NAPROXEN Naproxen Sodium Tablets USP 220 mg Non-steroidal anti-inflammatory drug Analgesic, Antipyretic DOMINION PHARMACAL 6111 Royalmount Ave., Suite 100, Montréal, Québec H4P 2T4 www.pharmascience.com DATE OF REVISION: May 10, 2019 Submission Control no.: 227094 _ _ _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 .................. Read the complete document