Nchi: Armenia
Lugha: Kiingereza
Chanzo: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
trandolapril, verapamil (verapamil hydrochloride)
AbbVie Deutschland GmbH & Co. KG
C09BB10
trandolapril, verapamil (verapamil hydrochloride)
4mg+ 240mg
tablets modified-release film-coated
(28/2x14/) in blister
Prescription
Registered
2020-07-17
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 Soma hati kamili