PROPAFENONE-150 TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
04-09-2013
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Active ingredient:
PROPAFENONE HYDROCHLORIDE
Available from:
PRO DOC LIMITEE
ATC code:
C01BC03
INN (International Name):
PROPAFENONE
Dosage:
150MG
Pharmaceutical form:
TABLET
Composition:
PROPAFENONE HYDROCHLORIDE 150MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
CLASS IC ANTIARRYTHMICS
Product summary:
Active ingredient group (AIG) number: 0116258001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2016-07-18
Summary of Product characteristics
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
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