Country: Canada
Language: English
Source: Health Canada
PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE)
LABORATOIRE RIVA INC.
N06AB05
PAROXETINE
30MG
TABLET
PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) 30MG
ORAL
30/100/250
Prescription
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0123131001; AHFS:
APPROVED
2004-01-09
_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 Read the complete document