SERTRALINE CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

Available from:

SANIS HEALTH INC

ATC code:

N06AB06

INN (International Name):

SERTRALINE

Dosage:

25MG

Pharmaceutical form:

CAPSULE

Composition:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 25MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0123417003; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2010-06-08

Summary of Product characteristics

_Page 1 of 62_
_SERTRALINE Product Monograph_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SERTRALINE
Sertraline Hydrochloride Capsules
Capsules, 25 mg, 50 mg and 100 mg sertraline (as sertraline
hydrochloride), Oral
Antidepressant / Antipanic / Antiobsessional Agent
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Submission Control Number: 274293
Date of Initial Authorization:
JUL 27, 2010
Date of Revision:
MAY 03, 2023
_SERTRALINE Product Monograph _
_Page 2 of 62_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
07/2022
7.1.1 Pregnant Women
07/2022
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
1
INDICATIONS
...................................................................................................................
4
1.1
Pediatrics
.......................................................................................................................
5
1.2
Geriatrics
.......................................................................................................................
5
2
CONTRAINDICATIONS
......................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.................................................................. 6
4
DOSAGE AND ADMINISTRATION
......................................................................................
6
4.1
Dosing Considerations
..................................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
............................................................. 6
4.4
Administration
.........................................................................