MYLAN-LISINOPRIL TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
19-12-2016
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Active ingredient:
LISINOPRIL (LISINOPRIL DIHYDRATE)
Available from:
MYLAN PHARMACEUTICALS ULC
ATC code:
C09AA03
INN (International Name):
LISINOPRIL
Dosage:
5MG
Pharmaceutical form:
TABLET
Composition:
LISINOPRIL (LISINOPRIL DIHYDRATE) 5MG
Administration route:
ORAL
Units in package:
100/500
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0121550003; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2017-08-02
Summary of Product characteristics
Page 1 of 46
PRODUCT MONOGRAPH
PR
MYLAN-LISINOPRIL
(Lisinopril Tablets, USP)
Tablets 5 mg, 10 mg and 20 mg
(Lisinopril as lisinopril dihydrate)
Angiotensin Converting Enzyme Inhibitor
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control number: 192608
Date of Revision:
December 19, 2016
Page 2 of 46
_ _
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
.........................................................................................................
11
DRUG
INTERACTIONS
.........................................................................................................
17
DOSAGE
AND
ADMINISTRATION
.....................................................................................
19
OVERDOSAGE
.......................................................................................................................
22
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
23
STORAGE
AND
STABILITY
.................................................................................................
26
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 26
PART II: SCIENTIFIC INFORMATION
...............................................................................
27
PHARMACEUTICAL
INFORMATION
.................................................................................
27
CLINICAL
TRIALS
....................................................
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