BUSPIRONE-10 TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BUSPIRONE HYDROCHLORIDE

Available from:

PRO DOC LIMITEE

ATC code:

N05BE01

INN (International Name):

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

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2022-01-05

Summary of Product characteristics

_BUSPIRONE _
_Page 1 of 38_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
BUSPIRONE-5
PR
BUSPIRONE-10
Buspirone Hydrochloride Tablets
5 mg and 10 mg, Oral
USP
Anxiolytic
PRO DOC LTÉE
2925, boul. Industriel
Laval, Québec
H7L 3W9
Submission Control Number: 259313
Date of Initial Authorization:
January 15, 1997
Date of Revision:
December
31, 2021
Buspirone
Buspirone En PM.pdf
Pg. 1
_ _
_BUSPIRONE _
_Page 2 of 38_
RECENT MAJOR LABEL CHANGES
1 Indications, 1.2 Geriatrics
11/2021
2 Contraindications
04/2021
3 Serious warnings and precautions box
11/2021
4 Dosage and administration, 4.1 Dosing Considerations
11/2021
7 Warnings and precautions, General
11/2021
7 Warnings and Precautions, Serotonin Toxicity/Serotonin Syndrome
04/2021
7 Warnings and precautions, Dependence/Tolerance
11/2021
7 Warnings and precautions, Withdrawal
11/2021
7 Warnings and precautions, Falls and Fractures
11/2021
7 Warnings and precautions, 7.1.4 Geriatrics
11/2021
8 Adverse Reactions, 8.5 Post-Market Adverse Reactions
11/2021
9 Drug Interactions
04/2021
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
................................................................................................................
4
1.1
Pediatrics.................................................................................................................
4
1.2
Geriatrics
.................................................................................................................
4
2
CONTRAINDICATIONS
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