PROZAC CAPSULES 10MG

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FLUOXETINE (FLUOXETINE HYDROCHLORIDE)

Available from:

ELI LILLY 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:

MARKETED

Authorization date:

1993-12-31

Summary of Product characteristics

_PROZAC_ _(fluoxetine hydrochloride) _
_Page 1 of 53_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
PROZAC
®
fluoxetine hydrochloride
Capsules, 10 mg and 20 mg (equivalent to Fluoxetine), Oral
Antidepressant / Antiobsessional / Antibulimic
© Eli Lilly Canada Inc.
Exchange Tower
130 King Street West, Suite 900
PO Box 73
Toronto, Ontario
M5X 1B1
1-888-545-5972
www.lilly.ca
Date of Initial Authorization:
DEC 31,1989
Date of Revision:
JAN 12, 2024
Submission Control Number: 277882
_PROZAC (fluoxetine hydrochloride) _
_Page 2 of 53_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Neurologic
01/2024
7 Warnings and Precautions, Reproductive Health: Female and
Male Potential
01/2024
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
.................................................................................................
4
3
SERIOUS WARNING AND PRECAUTIONS BOX
.............................................................. 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
6
4.1
Dosing Considerations
............................................................................................
6
4.2
Recommended Do