PMS-AMITRIPTYLINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

AMITRIPTYLINE HYDROCHLORIDE

Available from:

PHARMASCIENCE INC

ATC code:

N06AA09

INN (International Name):

AMITRIPTYLINE

Dosage:

25MG

Pharmaceutical form:

TABLET

Composition:

AMITRIPTYLINE HYDROCHLORIDE 25MG

Administration route:

ORAL

Units in package:

100/1000

Prescription type:

Prescription

Therapeutic area:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0101524002; AHFS:

Authorization status:

APPROVED

Authorization date:

1998-12-11

Summary of Product characteristics

_pms-AMITRIPTYLINE (amitriptyline chlorhydrate) _
_Page 1 of 44 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-AMITRIPTYLINE
Amitriptyline Hydrochloride Tablets
Tablets, 10 mg, 25 mg, 50 mg, 75 mg and 100 mg, Oral
USP
Antidepressant
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada H4P 2T4
www.pharmascience.com
Submission Control Number: 277374
Date of Initial Authorization:
December 11, 1998
Date of Revision:
January 5, 2024
_pms-AMITRIPTYLINE (amitriptyline chlorhydrate) _
_Page 2 of 44 _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
01/2024
7 WARNINGS AND PRECAUTIONS
01/2024
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
01/2024
7 WARNINGS AND PRECAUTIONS, Neurologic
02/2023
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
.............................................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
................................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
...........................................................................
5
4
DOSAGE AND ADMINISTRATION
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