TEVA-PAROXETINE TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

PAROXETINE (PAROXETINE HYDROCHLORIDE ACETONE SOLVATE)

Beschikbaar vanaf:

TEVA CANADA LIMITED

ATC-code:

N06AB05

INN (Algemene Internationale Benaming):

PAROXETINE

Dosering:

10MG

farmaceutische vorm:

TABLET

Samenstelling:

PAROXETINE (PAROXETINE HYDROCHLORIDE ACETONE SOLVATE) 10MG

Toedieningsweg:

ORAL

Eenheden in pakket:

30/100

Prescription-type:

Prescription

Therapeutisch gebied:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Product samenvatting:

Active ingredient group (AIG) number: 0123131003; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2010-06-01

Productkenmerken

Teva-Paroxetine
_Page 1 of 63_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-PAROXETINE
Paroxetine Tablets
Tablets, 10 mg, 20 mg and 30 mg paroxetine (as paroxetine
hydrochloride), Oral
Teva Standard
Selective Serotonin Reuptake Inhibitor
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Canada
www.tevacanada.com
Submission Control No: 267886
Date of Initial Authorization:
December 9, 2003
Date of Revision:
February 12, 2024
Teva-Paroxetine
_Page 2 of 63_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE 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
............................................................................................................
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
............................................................. 7
4.4 Administration
.............................................................................................................
9
4.5 Missed Dose
................................................................