TARKA TABLET (EXTENDED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE

Available from:

BGP PHARMA ULC

ATC code:

C09BB10

INN (International Name):

TRANDOLAPRIL AND VERAPAMIL

Dosage:

4MG; 240MG

Pharmaceutical form:

TABLET (EXTENDED-RELEASE)

Composition:

TRANDOLAPRIL 4MG; VERAPAMIL HYDROCHLORIDE 240MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS CALCIUM-CHANNEL BLOCKING AGENTS

Product summary:

Active ingredient group (AIG) number: 0233661003; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2019-11-19

Summary of Product characteristics

_TARKA_
_®_
_ Product Monograph _
_Page 1 of 59 _
_Date of Revision: January 29, 2018 and Control No. 211228 _
PRODUCT MONOGRAPH
PR
TARKA
®

trandolapril/verapamil hydrochloride sustained-release tablets
2 mg/240 mg, 4 mg/240 mg
_ _
_ _
Antihypertensive Agent
BGP Pharma ULC
Date of Preparation:
85 Advance Road
January 7, 2015
Etobicoke, Ontario
M8Z 2S6
Date of Previous Revision:
January 29, 2018
Date of Revision:
February 13, 2018
Submission Control No: 211228
_TARKA_
_®_
_ Product Monograph _
_Page 2 of 59 _
_Date of Revision: January 29, 2018 and Control No. 211228 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................15
DRUG INTERACTIONS
..................................................................................................20
DOSAGE AND ADMINISTRATION
..............................................................................33
OVERDOSAGE
................................................................................................................35
ACTION AND CLINICAL PHARMACOLOGY
............................................................37
STORAGE AND STABILITY
..........................................................................................41
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................42
PART II: SCIENTIFIC INFORMATION
................................................................................43
PHARMACEUTICAL INFORMATI