FLUANXOL 3MG - TAB TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
12-12-2017
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Active ingredient:
FLUPENTIXOL (FLUPENTIXOL DIHYDROCHLORIDE)
Available from:
LUNDBECK CANADA INC
ATC code:
N05AF01
INN (International Name):
FLUPENTIXOL
Dosage:
3MG
Pharmaceutical form:
TABLET
Composition:
FLUPENTIXOL (FLUPENTIXOL DIHYDROCHLORIDE) 3MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
THIOXANTHENES
Product summary:
Active ingredient group (AIG) number: 0131297002; AHFS:
Authorization status:
MARKETED
Authorization date:
1995-12-31
Summary of Product characteristics
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_Page 1 of 35 _
November 17, 2017
PRODUCT MONOGRAPH
Pr
FLUANXOL
®
Flupentixol Tablets
(as flupentixol dihydrochloride)
0.5 mg, 3 mg, and 5 mg
Pr
FLUANXOL
®
DEPOT
Flupentixol Decanoate Intramuscular Injection
2% and 10% flupentixol decanoate
ANTIPSYCHOTIC AGENT
Lundbeck Canada Inc.
2600 Alfred-Nobel
Suite 400
St-Laurent, QC
H4S 0A9
Date of Revision:
December 12, 2017
Submission Control No : 209135
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_Page 2 of 35_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................15
OVERDOSAGE
................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................22
PART II: SCIENTIFIC INFORMATION
...............................................................................23
PHARMACEUTICAL INFORMATION
..........................................................................23
DETAILED PHARMACOLOGY
.................................................
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