Country: Canada
Language: English
Source: Health Canada
PROPAFENONE HYDROCHLORIDE
PRO DOC LIMITEE
C01BC03
PROPAFENONE
300MG
TABLET
PROPAFENONE HYDROCHLORIDE 300MG
ORAL
100
Prescription
CLASS IC ANTIARRYTHMICS
Active ingredient group (AIG) number: 0116258002; AHFS:
CANCELLED POST MARKET
2016-07-18
Page 1 of 38 PRODUCT MONOGRAPH Pr PROPAFENONE – 150 Pr PROPAFENONE – 300 PROPAFENONE HYDROCHLORIDE TABLETS FILM COATED 150 MG AND 300 MG ANTIARRHYTHMIC AGENT PRO DOC LTÉE DATE OF REVISION: 2925, boul. Industriel September 4, 2013 Laval, Québec H7L 3W9 Control Number: 166802 Page 2 of 38 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ....................................................... 3 SUMMARY PRODUCT INFORMATION ............................................................................. 3 INDICATIONS AND CLINICAL USE ................................................................................... 3 CONTRAINDICATIONS ........................................................................................................ 4 WARNINGS AND PRECAUTIONS ....................................................................................... 5 ADVERSE REACTIONS ......................................................................................................... 5 DRUG INTERACTIONS ....................................................................................................... 13 DOSAGE AND ADMINISTRATION ................................................................................... 16 OVERDOSAGE ...................................................................................................................... 17 ACTION AND CLINICAL PHARMACOLOGY.................................................................. 17 STORAGE AND STABILITY ............................................................................................... 19 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................. 20 PART II: SCIENTIFIC INFORMATION ............................................................................. 21 PHARMACEUTICAL INFORMATION ............................................................................... 21 CLINICAL TRIALS ............................................................................................................... 21 DETAILE Read the complete document