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:

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:

APPROVED

Authorization date:

2021-01-19

Summary of Product characteristics

_PR_
_FLUOXETINE (fluoxetine hydrochloride)_
_Page 1 of 56 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
FLUOXETINE
Fluoxetine Hydrochloride Capsules
10 mg and 20 mg fluoxetine (as fluoxetine hydrochloride), Oral
USP
PR
FLUOXETINE
Fluoxetine Oral Solution
20 mg/5 mL fluoxetine (as fluoxetine
hydrochloride)
USP
Antidepressant/ Antiobsessional/ Antibulimic
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
January 19, 2021
Date of Revision:
March 18, 2022
Submission Control number:
257282
_PR_
_FLUOXETINE (fluoxetine hydrochloride)_
_Page 2 of 56 _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions
03/2022
7 Warnings and Precautions, 7.1.1 Pregnant Women
03/2022
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
Recommended Dose and Dosage Adjustment
..............................................