LISINOPRIL TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
04-03-2014
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Active ingredient:
LISINOPRIL (LISINOPRIL DIHYDRATE)
Available from:
COBALT PHARMACEUTICALS COMPANY
ATC code:
C09AA03
INN (International Name):
LISINOPRIL
Dosage:
5MG
Pharmaceutical form:
TABLET
Composition:
LISINOPRIL (LISINOPRIL DIHYDRATE) 5MG
Administration route:
ORAL
Units in package:
30/100/500
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0121550003; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2017-09-01
Summary of Product characteristics
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_LISINOPRIL (Lisinopril Tablets, USP) 5 mg, 10 mg and 20 mg _
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PRODUCT MONOGRAPH
PR
LISINOPRIL
Lisinopril Tablets, USP
5 mg, 10 mg and 20 mg
(of Lisinopril as Lisinopril Dihydrate)
Angiotensin Converting Enzyme Inhibitor
Cobalt Pharmaceuticals Company
6500 Kitimat Road
Mississauga, Ontario
Canada, L5N 2B8
CONTROL NUMBER: 172480
Date of Revision:
March 4, 2014
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_LISINOPRIL (Lisinopril Tablets, USP) 5 mg, 10 mg and 20 mg _
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
5
WARNINGS AND PRECAUTIONS
.........................................................................................
5
ADVERSE REACTIONS
.........................................................................................................
11
DRUG INTERACTIONS
.........................................................................................................
17
DOSAGE AND ADMINISTRATION
.....................................................................................
20
OVERDOSAGE
.......................................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 23
STORAGE AND STABILITY
.................................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
.........................
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