RAN-FLUOXETINE CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
07-05-2013
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Active ingredient:
FLUOXETINE (FLUOXETINE HYDROCHLORIDE)
Available from:
RANBAXY PHARMACEUTICALS CANADA INC.
ATC code:
N06AB03
INN (International Name):
FLUOXETINE
Dosage:
10MG
Pharmaceutical form:
CAPSULE
Composition:
FLUOXETINE (FLUOXETINE HYDROCHLORIDE) 10MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0116847003; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2022-09-07
Summary of Product characteristics
RAN-Fluoxetine Capsules BP 10 mg & 20 mg Product Monograph
Page 1 of 51
PRODUC T MONOGRAP H
PR
RAN-FLUOXETINE
FLUOXETINE CAPSULES BP
10 mg and 20 mg fluoxetine (as fluoxetine hydrochloride)
Antidepressant / Antiobsessional / Antibulimic
Ranbaxy Pharmaceuticals Canada Inc.
2680 Matheson Blvd. E., Suite 200
Mississauga, ON
L4W 0A5
Date of Preparation:
April 24, 2013
Submission Control No: 163892
RAN-Fluoxetine Capsules BP 10 mg & 20 mg Product Monograph
Page 2 of 51
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
...............................................................................................
14
DRUG INTERACTIONS
...............................................................................................
23
DOSAGE AND ADMINISTRATION
..........................................................................
27
OVERDOSAGE
..............................................................................................................
29
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 31
STORAGE AND
STABILITY.......................................................................................
33
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................... 33
PART II: SCIENTIFIC INFORMATION
...............................................................................
34
PHARMACEUTICAL INFORMATION
.....................................................................
34
CLINICAL TRIALS
...................................................
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