BUPROPION HCL XL TABLET (EXTENDED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
03-02-2023
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Active ingredient:
BUPROPION HYDROCHLORIDE
Available from:
BAUSCH HEALTH, CANADA INC.
ATC code:
N06AX12
INN (International Name):
BUPROPION
Dosage:
300MG
Pharmaceutical form:
TABLET (EXTENDED-RELEASE)
Composition:
BUPROPION HYDROCHLORIDE 300MG
Administration route:
ORAL
Units in package:
7/90
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS ANTIDEPRESSANTS
Product summary:
Active ingredient group (AIG) number: 0131140004; AHFS:
Authorization status:
APPROVED
Authorization date:
2021-09-16
Summary of Product characteristics
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
BUPROPION HCL
XL
Bupropion Hydrochloride Extended-Release Tablets
Tablet (extended-release), 150 mg, 300 mg, For oral use
USP
Antidepressant
Bausch Health, Canada Inc.
2150 St-Elzear Blvd. West
Laval, Quebec
H7L 4A8
Submission Control Number: 270781
Date
of Initial Authorization:
SEP 16, 2021
Date of Revision:
FEB 3, 2023
_ _
_Pr_
_BUPROPION HCL XL Product Monograph Page 2 of 59_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS
01/2023
7 WARNING AND PRECAUTIONS
, Immune
01/2023
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
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX………………………………………………………..…5
2
CONTRAINDICATIONS
................................................................................................
5
4
DOSAGE AND ADMINISTRATION
..............................................................................
5
4.1
Dosing Considerations
.........................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
..................................................... 5
4.4
Administration
............................................................................
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