APO-FLUOXETINE CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FLUOXETINE (FLUOXETINE HYDROCHLORIDE)

Available from:

APOTEX INC

ATC code:

N06AB03

INN (International Name):

FLUOXETINE

Dosage:

20MG

Pharmaceutical form:

CAPSULE

Composition:

FLUOXETINE (FLUOXETINE HYDROCHLORIDE) 20MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0116847001; AHFS:

Authorization status:

APPROVED

Authorization date:

2022-01-14

Summary of Product characteristics

_PR_
_APO-FLUOXETINE_
_ _
_(fluoxetine hydrochloride)_
_Page 1 of 56 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-FLUOXETINE
Fluoxetine Capsules
Capsules, 10 mg and 20 mg fluoxetine (as fluoxetine hydrochloride),
Oral
USP
PR
APO-FLUOXETINE
Fluoxetine Oral Solution
Solution, 20 mg/5 mL fluoxetine (as fluoxetine hydrochloride), Oral
USP
Antidepressant/ Antiobsessional/ Antibulimic
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
March 21, 1996
Date of Revision:
June 27, 2022
Submission Control Number: 264854
_PR_
_APO-FLUOXETINE_
_ _
_(fluoxetine hydrochloride)_
_Page 2 of 56 _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions
06/2022
7 Warnings and Precautions, 7.1.1 Pregnant Women
06/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
..................................................................................................................
4
1.1
Pediatrics
...............................................................................................................................
4
1.2
Geriatrics
...............................................................................................................................
4
2
CONTRAINDICATIONS
.....................................................................................................
5
4
DOSAGE AND ADMINISTRATION
.....................................................................................
6
4.1
Dosing Considerations
...........................................................................................................
6
4.2
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