APO-SIBUTRAMINE CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
12-10-2016
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Active ingredient:
SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE
Available from:
APOTEX INC
ATC code:
A08AA10
INN (International Name):
SIBUTRAMINE
Dosage:
15MG
Pharmaceutical form:
CAPSULE
Composition:
SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE 15MG
Administration route:
ORAL
Units in package:
30
Prescription type:
Prescription
Therapeutic area:
ANOREXIGENIC AGENTS & RESPIRATORY AND CEREBRAL STIMULANTS, MISCELLANEOUS
Product summary:
Active ingredient group (AIG) number: 0142562002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2010-10-12
Summary of Product characteristics
Page 1 of 49
PRODUCT MONOGRAPH
PR
APO-SIBUTRAMINE
(SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE)
CAPSULES 10 MG AND 15 MG
ANOREXIANT/ANTIOBESITY AGENT
APOTEX INC.
DATE OF PREPARATION:
150 SIGNET DRIVE
NOVEMBER 13, 2009
WESTON, ONTARIO
M9L 1T9
CONTROL NUMBER: 123475
Page 2 of 49
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................. 3
SUMMARY PRODUCT INFORMATION
.....................................................................
3
INDICATIONS AND CLINICAL USE
..........................................................................
3
CONTRAINDICATIONS
.............................................................................................
5
WARNINGS AND PRECAUTIONS
.............................................................................
6
ADVERSE REACTIONS
...........................................................................................
10
DRUG INTERACTIONS
............................................................................................
18
DOSAGE AND ADMINISTRATION
..........................................................................
21
OVERDOSAGE
.........................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 23
STORAGE AND STABILITY
....................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 26
PART II: SCIENTIFIC INFORMATION
....................................................................
28
PHARMACEUTICAL INFORMATION
......................................................................
28
CLINICAL TRIALS
...................................................................................................
29
DETAILED PHARMACOLOGY
................................................................................
32
TOXICOLOGY
.......................................................
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