IPG-DULOXETINE CAPSULE (DELAYED RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
28-04-2017
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Active ingredient:
DULOXETINE (DULOXETINE HYDROCHLORIDE)
Available from:
MARCAN PHARMACEUTICALS INC
ATC code:
N06AX21
INN (International Name):
DULOXETINE
Dosage:
60MG
Pharmaceutical form:
CAPSULE (DELAYED RELEASE)
Composition:
DULOXETINE (DULOXETINE HYDROCHLORIDE) 60MG
Administration route:
ORAL
Units in package:
8/30/1000
Prescription type:
Prescription
Therapeutic area:
SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0152350002; AHFS:
Authorization status:
APPROVED
Authorization date:
2016-05-02
Summary of Product characteristics
Page 1 of 77
PRODUCT MONOGRAPH
PR
IPG-DULOXETINE
Duloxetine Delayed - Release Capsules, Mfr. Std.
Duloxetine (as duloxetine hydrochloride)
30 mg and 60 mg
ANALGESIC/ANTIDEPRESSANT/ANXIOLYTIC
MARCAN PHARMACEUTICALS INC. DATE OF REVISION:
77 AURIGA DRIVE, UNIT# 4 APRIL 25, 2017
OTTAWA, ON
CANADA K2E 7Z7
Control # 204721
Page 2 of 77
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
.......................................................................................................................
17
DRUG INTERACTIONS
.......................................................................................................................
35
DOSAGE AND ADMINISTRATION
...................................................................................................
38
OVERDOSAGE
......................................................................................................................................
41
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
42
STORAGE AND STABILITY
...............................................................................................................
45
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................... 46
PART II: SCIENTIFIC INFORMATION
.........................................................................................
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