BUPROPION HCL SR TABLET (EXTENDED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BUPROPION HYDROCHLORIDE

Available from:

BAUSCH HEALTH, CANADA INC.

ATC code:

N06AX12

INN (International Name):

BUPROPION

Dosage:

150MG

Pharmaceutical form:

TABLET (EXTENDED-RELEASE)

Composition:

BUPROPION HYDROCHLORIDE 150MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS ANTIDEPRESSANTS

Product summary:

Active ingredient group (AIG) number: 0131140003; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-06-14

Summary of Product characteristics

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
BUPROPION HCL SR
Bupropion Hydrochloride Sustained-Release Tablets
Tablets (sustained-Released), 150mg, for oral use
Mfr. Std.
ANTIDEPRESSANT
DATE
OF
INITIAL
AUTHORIZATION:
JUN
14,
2021
DATE
OF
REVISION:
JUN 01,
2023
BAUSCH
HEALTH,
CANADA
INC.
2150 St-Elzear
Blvd.
West
Laval,
Quebec
H7L 4A8
Control
No.: 273964
_Pr_
_BUPROPION HCL SR Product Monograph _
_Page 2 of 44 _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
7 WARNING AND PRECAUTIONS, Immune
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
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 WARNINGS AND PRECAUTIONS
BOX........................................................ 5
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.1
Dosing Considerations
...........................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment....................................................... 5
4.4
Administration
........................................................................................................
6
4.5
Missed
Dose.........................................................................................