PMS-ENALAPRIL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ENALAPRIL SODIUM

Available from:

PHARMASCIENCE INC

ATC code:

C09AA02

INN (International Name):

ENALAPRIL

Dosage:

4MG

Pharmaceutical form:

TABLET

Composition:

ENALAPRIL SODIUM 4MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0152325004; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2016-12-31

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
PMS-ENALAPRIL
Enalapril Maleate Tablets, House Standard
2.5 mg, 5 mg, 10 mg and 20 mg
Each tablet is made with 2.5 mg, 5 mg, 10 mg or 20 mg of enalapril
maleate that appears as
2 mg, 4 mg, 8 mg or 16 mg of enalapril sodium in the tablets
Angiotensin Converting Enzyme Inhibitor
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, QC, Canada
H4P 2T4
www.pharmascience.com
Date of Revision:
April 7, 2016
SUBMISSION CONTROL NO.: 193659
_pms-ENALAPRIL Product Monograph _
_Page 2 of 40_
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
...................................................................................................
13
DOSAGE
AND
ADMINISTRATION
...............................................................................
14
OVERDOSAGE
.................................................................................................................
16
ACTION
AND
CLINICAL
PHARMACOLOGY
.............................................................17
STORAGE
AND
STABILITY
...........................................................................................
19
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING............................................... 19
PART II: SCIENTIFIC INFORMATION
.................................................................................
20
PHARMACEUTICAL
INFORMATION
........................................