WELLBUTRIN 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:

250ML

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS ANTIDEPRESSANTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2001-07-04

Summary of Product characteristics

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_WELLBUTRIN_
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_ SR, Bupropion Hydrochloride_ _Page 1 of 44_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
WELLBUTRIN
 SR
Bupropion Hydrochloride
Sustained-Release Tablets, 150 mg, for oral use
Mfr. Std.
ANTIDEPRESSANT
Bausch Health, Canada Inc.
Date of Initial Authorization:
2150 St-Elzear Blvd. West
April 28, 1998
Laval, Quebec
H7L 4A8
Date of Revision:
July 18, 2022
Control #: 261888
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_WELLBUTRIN_
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_ SR, Bupropion Hydrochloride Page 2 of 44 _
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RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
0/2022
7 WARNING AND PRECAUTIONS, Immune
01/2022
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...................................