RIVA-PAROXETINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE)

Available from:

LABORATOIRE RIVA INC.

ATC code:

N06AB05

INN (International Name):

PAROXETINE

Dosage:

10MG

Pharmaceutical form:

TABLET

Composition:

PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) 10MG

Administration route:

ORAL

Units in package:

30/100/250

Prescription type:

Prescription

Therapeutic area:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2004-01-09

Summary of Product characteristics

_Page 1 of 56_
_RIVA-PAROXETINE – Product Monograph_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RIVA-PAROXETINE
Paroxetine Tablets
Tablets, 10 mg, 20 mg and 30 mg paroxetine (as paroxetine
hydrochloride hemihydrate), Oral
USP
Selective Serotonin Reuptake Inhibitor
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Quebec
J7C 3V4
www.labriva.com
Submission Control No.: 276263
Date of Initial Authorization:
JAN
9, 2004
Date of Revision:
JUL 10, 2023
_RIVA-PAROXETINE – Product Monograph _
_Page 2 of 56_
RECENT MAJOR LABEL CHANGES
SECTION
DATE
7 WARNINGS AND PRECAUTIONS, Cardiovascular
7 WARNINGS AND PRECAUTIONS, Hematologic
07/2022
7 WARNINGS AND PRECAUTIONS, Immune
05/2021
7 WARNINGS AND PRECAUTIONS, Neurologic
07/2022
7 WARNINGS AND PRECAUTIONS, Psychiatric
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and
Male Potential
05/2021
7 WARNINGS AND PRECAUTIONS, 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
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
2
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATI