RAN-DULOXETINE CAPSULE (DELAYED RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
11-06-2021
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Active ingredient:
DULOXETINE (DULOXETINE HYDROCHLORIDE)
Available from:
RANBAXY PHARMACEUTICALS CANADA INC.
ATC code:
N06AX21
INN (International Name):
DULOXETINE
Dosage:
30MG
Pharmaceutical form:
CAPSULE (DELAYED RELEASE)
Composition:
DULOXETINE (DULOXETINE HYDROCHLORIDE) 30MG
Administration route:
ORAL
Units in package:
30/80/100/1000
Prescription type:
Prescription
Therapeutic area:
SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0152350001; AHFS:
Authorization status:
APPROVED
Authorization date:
2016-05-02
Summary of Product characteristics
_Pr_
_RAN™_
_-DULOXETINE (Duloxetine Delayed-Release Capsules, Mfr. Std.) Product
Monograph _
_Page 1 _
PRODUCT MONOGRAPH
PR
RAN™
-DULOXETINE
Duloxetine Delayed-Release Capsules, Mfr. Std.
Duloxetine (as duloxetine hydrochloride)
30 mg and 60 mg
ANALGESIC/ANTIDEPRESSANT/ANXIOLYTIC
Ranbaxy Pharmaceuticals Canada Inc.,
126 East Drive
Brampton, ON
L6T 1C1
Date of Revision:
June 11, 2021
Control No: 252828
RAN trademark owned by Sun Pharmaceutical Industries Ltd.
_Pr_
_RAN™_
_-DULOXETINE (Duloxetine Delayed-Release Capsules, Mfr. Std.) Product
Monograph _
_Page 2 _
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
...................................................................................................
18
DRUG INTERACTIONS
....................................................................................................
35
DOSAGE AND ADMINISTRATION
.................................................................................
39
OVERDOSAGE
.................................................................................................................
42
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 43
STORAGE AND STABILITY
............................................................................................
46
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 46
PART II: SCIENTIFIC
INFORMATION.............................................................................
47
PH
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