ADDERALL XR CAPSULE (EXTENDED RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MIXED SALTS AMPHETAMINE

Available from:

TAKEDA CANADA INC

ATC code:

N06BA01

INN (International Name):

AMFETAMINE

Dosage:

20MG

Pharmaceutical form:

CAPSULE (EXTENDED RELEASE)

Composition:

MIXED SALTS AMPHETAMINE 20MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Schedule G (CDSA I)

Therapeutic area:

AMPHETAMINES

Product summary:

Active ingredient group (AIG) number: 0161310004; AHFS:

Authorization status:

APPROVED

Authorization date:

2007-10-04

Summary of Product characteristics

_ADDERALL XR_
_®_
_ (mixed salts amphetamine extended-release capsules) _
_Page 1 of 43 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ADDERALL XR®
mixed salts amphetamine
extended-release capsule
5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg
Oral
Central Nervous System Stimulant
Takeda Canada Inc.
22 Adelaide Street West, Suite 3800
Toronto, Ontario
M5H 4E3
Date of Initial Authorization:
JAN 23, 2004
Date of Revision:
MAR 09, 2023
Submission Control Number: 269618
ADDERALL XR
_®_
and ADDERALL
_®_
are registered trademarks of Takeda Pharmaceuticals U.S.A., Inc.
TAKEDA® and the TAKEDA Logo
_®_
are registered trademarks of Takeda Pharmaceutical Company Limited,
used under license.
_ _
_ADDERALL XR_
_®_
_ (mixed salts amphetamine extended-release capsules) _
_Page 2 of 43_
RECENT MAJOR LABEL CHANGES
No major label changes during the past 24 months.
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
...................................................................................................................
5
1.2
Geriatrics
...................................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.........................................................