Country: Canada
Language: English
Source: Health Canada
FLUPENTIXOL (FLUPENTIXOL DIHYDROCHLORIDE)
LUNDBECK CANADA INC
N05AF01
FLUPENTIXOL
0.5MG
TABLET
FLUPENTIXOL (FLUPENTIXOL DIHYDROCHLORIDE) 0.5MG
ORAL
100
Prescription
THIOXANTHENES
Active ingredient group (AIG) number: 0131297001; AHFS:
MARKETED
1995-12-31
_ _ _ _ _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 _ _ _ _ _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 ................................................. Read the complete document