PMS-BUSPIRONE TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

BUSPIRONE HYDROCHLORIDE

MAH:

PHARMASCIENCE INC

ATC_code:

N05BE01

INN:

BUSPIRONE

dosage:

10MG

pharmaceutical_form:

TABLET

composition:

BUSPIRONE HYDROCHLORIDE 10MG

administration_route:

ORAL

units_in_package:

100

prescription_type:

Prescription

therapeutic_area:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

leaflet_short:

Active ingredient group (AIG) number: 0116263001; AHFS:

authorization_status:

APPROVED

authorization_date:

1997-03-18

SPC

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-BUSPIRONE
Buspirone Hydrochloride Tablets
Tablets, 5 mg and 10 mg, Oral
USP
Anxiolytic
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Date of Initial Authorization:
MAR 18, 1997
Date of Revision:
AUG 28, 2023
Submission Control Number: 274314
_pms-BUSPIRONE page 2 of 41 _
RECENT MAJOR LABEL CHANGES
1 Indications, 1.2 Geriatrics
08/2023
2 Contraindications
08/2023
3 Serious warnings and precautions box
08/2023
4 Dosage and administration, 4.1 Dosing Considerations
08/2023
7 Warnings and Precautions, General
08/2023
7 Warnings and Precautions, Serotonin Toxicity/Serotonin Syndrome
08/2023
7 Warnings and precautions, Dependence/Tolerance
08/2023
7 Warnings and precautions, Withdrawal
08/2023
7 Warnings and precautions, Falls and Fractures
08/2023
7 Warnings and precautions, 7.1.4 Geriatrics
08/2023
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics......................................................................................................................
4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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