LACOSAMIDE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LACOSAMIDE

Available from:

SANIS HEALTH INC

ATC code:

N03AX18

INN (International Name):

LACOSAMIDE

Dosage:

50MG

Pharmaceutical form:

TABLET

Composition:

LACOSAMIDE 50MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS ANTICONVULSANTS

Product summary:

Active ingredient group (AIG) number: 0152810001; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-02-25

Summary of Product characteristics

_LACOSAMIDE Product Monograph _Page 1 of 42
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LACOSAMIDE
Lacosamide Tablets
Film-coated tablets, 50 mg, 100 mg, 150 mg and 200 mg, Oral
House standard
Antiepileptic
ATC Code: N03AX18
SANIS HEALTH INC.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Initial Authorization:
February 25, 2021
Date of Revision:
August 24, 2023
Submission Control Number: 274418
_LACOSAMIDE Product Monograph _Page 2 of 42
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, 7.1.1 Pregnant Women
08/2023
7 Warnings and Precautions, 7.1.2 Breast-feeding
08/2023
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
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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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4
4.2 Recommended Dose and Dosage Adjustment
........................................................... 4
4.4 Administration
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