GLN-TOPIRAMATE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TOPIRAMATE

Available from:

GLENMARK PHARMACEUTICALS CANADA INC.

ATC code:

N03AX11

INN (International Name):

TOPIRAMATE

Dosage:

100MG

Pharmaceutical form:

TABLET

Composition:

TOPIRAMATE 100MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS ANTICONVULSANTS

Product summary:

Active ingredient group (AIG) number: 0132938002; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-09-02

Summary of Product characteristics

_Pr_
_GLN-TOPIRAMATE (Topiramate Tablets) _
_ _
_Page 1 of 76 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
GLN-TOPIRAMATE
Topiramate Tablets
Tablets, 25 mg, 100 mg, and 200 mg, Oral
USP
Antiepileptic / Migraine Prophylaxis
Glenmark Pharmaceuticals Canada Inc.
1600 Steeles Ave. West, Suite 407
Concord, Ontario
L4K 4M2
Date of Initial Authorization:
November 03, 2006
Date of Revision:
January 23, 2024
Submission Control Number: 278404
_Pr_
_GLN-TOPIRAMATE (Topiramate Tablets) _
_ _
_Page 2 of 76 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, OPHTHALMOLOGIC
01/2023
7 WARNINGS AND PRECAUTIONS, REPRODUCTIVE HEALTH: FEMALE AND
MALE POTENTIAL, TERATOGENIC RISK
01/2024
7 WARNINGS AND PRECAUTIONS, INFORMATION FOR PATIENTS, FETAL
TOXICITY
01/2024
7.1.1 PREGNANT WOMEN
01/2024
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
................................................................. 4
1 INDICATIONS
...........................................................................................................................
4
1.1 Pediatrics
...........................................................................................................................
4
1.2 Geriatrics
...........................................................................................................................
4
2 CONTRAINDICATIONS
............................................................................................................
4
4 DOSAGE AND ADMINISTRATION
..........................................................................................
5
4.1 Dosing Considerations
.....................................................................