TARO-ENALAPRIL TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
06-12-2018
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
ENALAPRIL SODIUM
Available from:
TARO PHARMACEUTICALS INC
ATC code:
C09AA02
INN (International Name):
ENALAPRIL
Dosage:
2.0MG
Pharmaceutical form:
TABLET
Composition:
ENALAPRIL SODIUM 2.0MG
Administration route:
ORAL
Units in package:
100/500
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0152325001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2022-01-11
Summary of Product characteristics
_ _
_ _
_Page 1 of 39_
PRODUCT MONOGRAPH
PR
TARO-ENALAPRIL
ENALAPRIL TABLETS
2.5, 5, 10 AND 20 MG
EACH TABLET IS MADE WITH 2.5, 5, 10 OR 20 MG OF ENALAPRIL MALEATE THAT
APPEARS AS 2, 4, 8 OR
16 MG OF ENALAPRIL SODIUM IN THE TABLETS
ANGIOTENSIN CONVERTING ENZYME INHIBITOR
ATC C09AA02
TARO PHARMACEUTICALS INC.
DATE OF REVISION:
130 EAST DRIVE
DECEMBER 6, 2018
BRAMPTON, ONTARIO
L6T 1C1
WWW.TARO.CA
SUBMISSION CONTROL NO: 221494
_ _
_ _
_Page 2 of 39_
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
...................................................................................................
9
DRUG INTERACTIONS
.................................................................................................
14
DOSAGE AND ADMINISTRATION
.............................................................................
16
OVERDOSAGE
...............................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 18
STORAGE AND STABILITY
.........................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 21
PART II: SCIENTIFIC INFORMATION
..............................................................................
22
PHARMACEUTICAL INFORMATION
.........................................................................
22
CLINICAL TRIALS
....................................
Read the complete document
