AG-TOPIRAMATE TABLETS

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TOPIRAMATE

Available from:

ANGITA PHARMA INC.

ATC code:

N03AX11

INN (International Name):

TOPIRAMATE

Dosage:

100MG

Pharmaceutical form:

TABLET

Composition:

TOPIRAMATE 100MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2023-03-30

Summary of Product characteristics

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_AG-Topiramate Tablets_
_Page 1 of 73_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AG-TOPIRAMATE TABLETS
Topiramate Tablets
Tablets, 25 mg, 100 mg and 200 mg, oral
USP
Antiepileptic/Migraine Prophylaxis
Angita Pharma Inc.
1310 Nobel Street
Boucherville, Québec
J4B 5H3
Date of Initial Authorization:
MAR 30, 2023
Submission Control Number: 272943
_ _
_AG-Topiramate Tablets_
_Page 2 of 73_
RECENT MAJOR LABEL CHANGES
N/A
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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1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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4
4.1
Dosing Considerations
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5
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.4
Administration
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7
4.5
Missed Dose
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7
5
OVE