PMS-NIFEDIPINE ER TABLET (EXTENDED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
05-01-2017
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Active ingredient:
NIFEDIPINE
Available from:
PHARMASCIENCE INC
ATC code:
C08CA05
INN (International Name):
NIFEDIPINE
Dosage:
30MG
Pharmaceutical form:
TABLET (EXTENDED-RELEASE)
Composition:
NIFEDIPINE 30MG
Administration route:
ORAL
Units in package:
30/100
Prescription type:
Prescription
Therapeutic area:
DIHYDROPYRIDINES
Product summary:
Active ingredient group (AIG) number: 0115253004; AHFS:
Authorization status:
APPROVED
Authorization date:
2014-01-08
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
PMS-NIFEDIPINE ER
Nifedipine Extended-Release Tablets, House Standard
20 mg, 30 mg and 60 mg Nifedipine
Antianginal/Antihypertensive Agent
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
Date of Revision:
December 14, 2016
Submission Control No: 200335
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_pms-NIFEDIPINE ER Product Monograph _
_Page 2 of 43_
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
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................19
OVERDOSAGE
................................................................................................................20
ACTION AND CLINICAL PHARMACOLOGY
............................................................21
STORAGE AND STABILITY
..........................................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................24
PART II: SCIENTIFIC INFORMATION
...............................................................................25
PHARMACEUTICAL INFORMATION
..........................................................................25
CLINICAL TRIALS
........................................................................................................
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