Tarka tablets modified-release film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

trandolapril, verapamil (verapamil hydrochloride)

Available from:

AbbVie Deutschland GmbH & Co. KG

ATC code:

C09BB10

INN (International Name):

trandolapril, verapamil (verapamil hydrochloride)

Dosage:

4mg+ 240mg

Pharmaceutical form:

tablets modified-release film-coated

Units in package:

(28/2x14/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-07-17

Summary of Product characteristics

Trandolapril - Verapamil
SOLID 1000311530
v9.0
COMPANY CORE DATA
SHEET
TRANDOLAPRIL/VERAPAMIL
Date of approval: 24-Sep-2014
Date of previous approval: 14-Jan-2014
Abbott
Confidential information
1/28
This information is confidential
_NAME OF THE MEDICINAL PRODUCT_
Tarka 180 mg / 2 mg, modify-released, film-coated tablets.
Tarka 240 mg / 4 mg, modify-released, film-coated tablets.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tarka is supplied as tablets or capsules containing immediate release
trandolapril and
sustained release verapamil.
Tarka 180 mg / 2 mg, bilayer tablet:
Each bilayer tablet contains 180 mg verapamil hydrochloride and 2 mg
trandolapril.
Excipient: Each 2 mg/180 mg bilayer tablet contains up to 108.625 mg
lactose (as lactose
monohydrate).
Tarka 240 mg / 4 mg, bilayer tablet:
Each bilayer tablet contains 240 mg verapamil hydrochloride and 4 mg
trandolapril.
Excipient: Each 4 mg/240 mg bilayer tablet contains 110.37 mg lactose
(as lactose
monohydrate).
For the full list of excipients, see List of excipients section.
PHARMACEUTICAL FORM
Tarka 180 mg / 2 mg, bilayer tablet:
Please see local registration
Tarka 240 mg / 4 mg, bilayer tablet:
Please see local registration
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Tarka is indicated for the treatment of essential hypertension in
patients whose blood pressure
has been normalized with the individual components in the same
proportion of doses or in
patients whose blood pressure is not adequately controlled on
trandolapril or verapamil alone.
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use
Posology
_Adults:_
The usual dosage is one tablet or capsule daily.
SPECIAL POPULATIONS
_Pediatric population:_
The safety and efficacy of Tarka in children and adolescents have not
yet been established.
Trandolapril - Verapamil
SOLID 1000311530
v9.0
COMPANY CORE DATA
SHEET
TRANDOLAPRIL/VERAPAMIL
Date of approval: 24-Sep-2014
Date of previous approval: 14-Jan-2014
Abbott
Confidential information
2/28
This information is confidential
Therefore use in this age group is no