EFFEXOR TABLETS, 37.5MG
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
22-11-2004
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Active ingredient:
VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)
Available from:
WYETH CANADA
ATC code:
N06AX16
INN (International Name):
VENLAFAXINE
Dosage:
37.5MG
Pharmaceutical form:
TABLET
Composition:
VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 37.5MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0131294002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2004-08-19
Summary of Product characteristics
PRODUCT MONOGRAPH
Pr
EFFEXOR
®
(Venlafaxine Hydrochloride)
Tablets
Pr
EFFEXOR
®
XR
(Venlafaxine Hydrochloride)
Extended Release Capsules
ANTIDEPRESSANT/ANXIOLYTIC
WYETH CANADA
DATE OF PREPARATION:
MONTREAL, CANADA
July 18, 1994
Control Number:
DATE OF REVISION:
094122
November 16, 2004
THIS PRODUCT MONOGRAPH IS THE EXCLUSIVE PROPERTY OF WYETH
CANADA AND CANNOT BE REFERENCED, PUBLISHED OR COPIED WITHOUT
THE WRITTEN APPROVAL OF WYETH CANADA.
©Wyeth Canada
2
EFFEXOR/EFFEXOR XR
(Venlafaxine HCl)
PRODUCT MONOGRAPH
TABLE OF CONTENTS
PAGE
ACTIONS AND CLINICAL PHARMACOLOGY . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . 4
INDICATIONS AND CLINICAL USE . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . 16
CONTRAINDICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
18
WARNINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
PRECAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Discontinuation Symptoms
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . 28
Use in Pregnancy, Labour and Delivery, and in Nursing Mothers
. . . . . . . . . . . . . . . . . 36
Paediatric Use
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . 38
Use in the Elderly
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . 38
Drug Interactions . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Drug Abuse and Dependence . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . 47
ADVERSE
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