ALERTEC TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MODAFINIL

Available from:

TEVA CANADA LIMITED

ATC code:

N06BA07

INN (International Name):

MODAFINIL

Dosage:

100MG

Pharmaceutical form:

TABLET

Composition:

MODAFINIL 100MG

Administration route:

ORAL

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

Wakefulness-Promoting Agents

Product summary:

Active ingredient group (AIG) number: 0136083001; AHFS:

Authorization status:

APPROVED

Authorization date:

2012-01-03

Summary of Product characteristics

_ _
_Product Monograph _
_ _
_ALERTEC modafinil _
_Page 1 of 45 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ALERTEC
®*
modafinil
Tablets, 100 mg, Oral
Mfr. Std.
Central Nervous System Stimulant
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
Marketed by:
Teva Canada Innovation
Montréal, Quebec
H2Z 1S8
Date of Initial Authorization:
February 26, 1999
Date of Revision:
July 4, 2023
Submission Control Number: 272079
*
ALERTEC is a registered trademark of Cephalon, Inc. Used under license
by Teva Canada Innovation.
_ _
_Product Monograph _
_ _
_ALERTEC modafinil _
_Page 2 of 45 _
RECENT MAJOR LABEL CHANGES
4 Dosage and Administration
11/2021
7 Warnings and Precautions, Alcohol Consumption, Risk of
stroke
11/2021
7 Warnings and Precautions, Dependence/Tolerance
07/2023
9 Drug-Behavioural Interactions – Alcohol Consumption
07/2023
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
............................................................... 4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
.............................................................................................................
4
1.2
Geriatrics
.............................................................................................................
5
2
CONTRAINDICATIONS
................................................................................................
5
4
DOSAGE AND ADMINISTRATION
..............................................................................
5
4.1
Dosing Considerations
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