NIASPAN FCT TABLET (EXTENDED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
23-10-2015
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Active ingredient:
NICOTINIC ACID
Available from:
SUNOVION PHARMACEUTICALS CANADA INC
ATC code:
C10AD02
INN (International Name):
NICOTINIC ACID
Dosage:
750MG
Pharmaceutical form:
TABLET (EXTENDED-RELEASE)
Composition:
NICOTINIC ACID 750MG
Administration route:
ORAL
Units in package:
90
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS ANTILIPEMIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0108396016; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2017-05-31
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
NIASPAN FCT
®
Extended-Release Niacin
500 mg, 750 mg, 1000 mg Extended-Release Film Coated Tablets
Lipid Metabolism Regulator
Manufacturer:
Sunovion Pharmaceuticals Canada Inc.
6790 Century Ave., Suite 100
Mississauga, Ontario
Canada
DATE OF REVISION:
October 23, 2015
SUBMISSION CONTROL NUMBER: 185767
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
...........................................................................................................
7
DRUG INTERACTIONS
..........................................................................................................
11
DOSAGE AND ADMINISTRATION
......................................................................................
12
OVERDOSAGE
........................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
14
STORAGE AND STABILITY
.................................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 17
PART II: SCIENTIFIC INFORMATION
..............................................................................
18
PHARMACEUTICAL INFORMATION
.................................................................................
18
CLINICAL
TRIALS............................................................
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