Country: Canada
Language: English
Source: Health Canada
FLUOXETINE (FLUOXETINE HYDROCHLORIDE)
ELI LILLY CANADA INC
N06AB03
FLUOXETINE
20MG
CAPSULE
FLUOXETINE (FLUOXETINE HYDROCHLORIDE) 20MG
ORAL
100CAP
Prescription
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0116847001; AHFS:
MARKETED
1989-12-31
_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 Read the complete document