APO-ATOMOXETINE CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
13-01-2016
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Active ingredient:
ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)
Available from:
APOTEX INC
ATC code:
N06BA09
INN (International Name):
ATOMOXETINE
Dosage:
10MG
Pharmaceutical form:
CAPSULE
Composition:
ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 10MG
Administration route:
ORAL
Units in package:
30/100/1000
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS
Product summary:
Active ingredient group (AIG) number: 0150434001; AHFS:
Authorization status:
APPROVED
Authorization date:
2010-09-21
Summary of Product characteristics
Page 1 of 60
PRODUCT MONOGRAPH
PR
APO-ATOMOXETINE
ATOMOXETINE HYDROCHLORIDE CAPSULES
10 MG, 18 MG, 25 MG, 40 MG, 60 MG, 80 MG AND 100 MG*
*ATOMOXETINE AS ATOMOXETINE HYDROCHLORIDE
SELECTIVE NOREPINEPHRINE REUPTAKE INHIBITOR
FOR ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
DATE OF REVISION:
January 8, 2016
SUBMISSION CONTROL NO: 190898
Page 2 of 60
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................... 3
SUMMARY PRODUCT INFORMATION
.................................................................. 3
INDICATIONS AND CLINICAL USE
.......................................................................
3
CONTRAINDICATIONS
.............................................................................................
4
WARNINGS AND PRECAUTIONS
...........................................................................
5
ADVERSE REACTIONS
.............................................................................................
13
DRUG ABUSE AND DEPENDENCE
.........................................................................
23
DRUG INTERACTIONS
............................................................................................
24
DOSAGE AND ADMINISTRATION
........................................................................
26
OVERDOSAGE
............................................................................................................
30
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 30
STORAGE AND STABILITY
.....................................................................................
35
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................... 35
PART II: SCIENTIFIC INFORMATION
............................................................... 37
PHARMACEUTICAL INFORMATION
.....................................................................
37
CLINICAL TRIALS
...............................................................
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