TEVA-ENALAPRIL/HCTZ TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
28-07-2015
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Active ingredient:
ENALAPRIL SODIUM; HYDROCHLOROTHIAZIDE
Available from:
TEVA CANADA LIMITED
ATC code:
C09BA02
INN (International Name):
ENALAPRIL AND DIURETICS
Dosage:
8MG; 25MG
Pharmaceutical form:
TABLET
Composition:
ENALAPRIL SODIUM 8MG; HYDROCHLOROTHIAZIDE 25MG
Administration route:
ORAL
Units in package:
30/100
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0252326001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2018-06-15
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
TEVA-ENALAPRIL/HCTZ
Enalapril / Hydrochlorothiazide Tablets
5 mg/12.5 mg and 10 mg/25 mg
Professed Standard
Each tablet is made with 5 or 10 mg of enalapril maleate that appears
as 4 or 8 mg of
enalapril sodium, and 12.5 mg or 25 mg of hydrochlorothiazide,
respectively
Angiotensin Converting Enzyme Inhibitor / Diuretic
Teva Canada Limited
Date of Revision:
30 Novopharm Court
July 23, 2015
Toronto ON M1B 2K9
CANADA
www.tevacanada.com
Submission Control No: 185425
2
PART I: HEALTH PROFESSIONAL
INFORMATION................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................... 3
INDICATIONS AND CLINICAL USE
.........................................................................
3
CONTRAINDICATIONS
..............................................................................................
3
WARNINGS AND PRECAUTIONS
.............................................................................
4
ADVERSE REACTIONS
...............................................................................................
9
DRUG INTERACTIONS
.............................................................................................
13
DOSAGE AND ADMINISTRATION
.........................................................................
15
OVERDOSAGE
...........................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 16
STORAGE AND STABILITY
.....................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................ 19
PART II: SCIENTIFIC INFORMATION
........................................................................
21
PHARMACEUTICAL INFORMATION
.....................................................................
21
CLINICAL TRIALS
...........................................................................
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