Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
enalapril (enalapril maleate)
KRKA d.d.
C09AA02
enalapril (enalapril maleate)
20mg
tablets
(20/2x10/) in blister
Prescription
Registered
2017-02-10
VOL: I; P: 99/456 SPC, Labelin 1.3.1 JIHCTOK-BKll!l)J;hIW (O.llHOBpeMeHHo Cpe.llCTBa) '3HAN* 2,5 MR TAOJJETKH '3RAN* 5 MR TAOJLETKR '3HAN· 10 MR TAOJJETKH '3HAN· 20 MR TAOJLETKH HHCTPYKUJoUIno Me.llHU'HHCKOMY np'HMeHeH'H1OneKapCTBeHHoro TOPROBOE H31BAHHC '3Han (Enap) EX r E R T _I_ J !. T A - _d/2/ll._ _01_ _1/_ ~-LI~ .~ ... T _P//YrO/r/Y_ MELK,LLYHAP0.LLHOE HEN3TEHTOBAHHOE HA3BAHHE Enalapril JIEKAPCTBEUHASI TOPM3 Ta6J1eTKH 2,5 Mf, Ta6neTKH 5 Mf, Ta6neTKH 10 Mf; Ta6neTKH 20 Mf EOCTAB Ka)l(JlaR Ta6J1eTKa CO.llep)l(lfT 2,5 Mf, 5 Mf, 10 Mr Hmf 20 MT 3HananpwJa ManeaTa. Ta6neTKH 2,5 Mr _BcnoMOZameJ7bHble_ _6l!U1ecm6a:_ HaTpHli rHJlpoKap6oHaT, naKT03a MOHOrHJlpaT, MaHCOBLI" KpaXMan, rHJlPOKcHIlpOITHJ1IleJ1J1lOn03a, TanLK, MafHHlI CTeapaT. T a611eTKH 5 Mr _BcnoMozame,7bHble_ _6el/.leCm6a:_ HaTpHli rHJlpoKap6oHaT, naKT03a MOHOnfJlpaT, MaHcoBblR KpaxMan, rIof.llpOKCnnpOmVIlleJUDOn03a, Tan'bIC,MarHHJI cTeapaT. Ta6neTKlf 10 Mf _BcnOiWOZameJlbHble_ _6l!U1ecm6a:_ HaTpHli rHJlpOKap6oHaT, naKT03a MOHOrHJlpaT, MaHCOBLI" KpaxMan, :lKene3a OKCH,llKpacHblH E 172, TanI.K, MarHJ.fJICTeapaT. Ta6neTKH 20 Mr _BcnOlWOZameJ7bHble 6eulecm6a:_ HaTpJ.fJl nf.llpOKap6oHaT, _naKT03a_ MOHofHJlpaT, MaHCOBhI" KpaXMan, :lKene3a OKCHJlKpacHbIH E 172, )Kene3a OKCH,ll)KenTbIH E 172, TanbK, MafHJ.fJI cTeapaT. ONHCAHRE Ta6neTKH 2,5 Mr: KpyrJlble, .llBOliKOBblnyKJIble, co CKoweHHI.IM KpaeM Ta6neTKH, 6eJIoro useTa. Ta6neTKlf 5 Mf: KpyrJ1'bIe, IUIOCKlfe Ta6neTKlf, 6eJIoro Hnlf nO'lTH 6eJIOfO UBeTa, co CKomeHHLIMH KpallMH H HaCe'IICOHRa O.llHOHcTopoHe. Ta6neTKa MO)KeT 6LTTI. nO.lleneHa Ha paBHLTeqaCTH. Ta6J1eTKH 10 Mr: KpyrnLle, rulOcKlfe Ta6neTKH KpacHoBaTo - Kop",,"eBOfO UBeTa, co CKOlUeHHLIM KpaeM H HaCeqKOMHa OJlHOHcTopoHe, C OT)lenLHLlMH BKpanneHHJJMH 6enofo UBen Ha nOBepxHocTH H B Macce Ta6neTKH. HaCe'lKa He npe.llHa3HaqeHa .ll11l1pa3nOMa Ta6neTKH. Ta6neTKH 20 Mf: KpyrJl'ble, nJlOCKHe Ta6neTKH CBeTno - OpaH)KeBOrO UBeTa co CKOlUeHHblM KpaeM J.I Hace'! Kon Ha O)lHOMcTopoHe, C OT)lenbHbIMH BKpalTJleHHlIMH 6enofo UBen Ha nOBepxHocTH H B Macce Ta6neTKl Прочитать полный документ
1.3.1 Enalapril maleate SPC, Labeling and Package Leaflet AM SmPCPIL164228_1 01.04.2021 – Updated: 01.04.2021 Page 1 of 15 1. NAME OF THE MEDICINAL PRODUCT Enap ® 2.5 mg tablets Enap ® 5 mg tablets Enap ® 10 mg tablets Enap ® 20 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg, 5 mg, 10 mg or 20 mg enalapril maleate, which is equivalent to 1.9 mg, 3.8 mg, 7.6 mg or 15.3 mg enalapril. Excipient with known effect: 2.5 mg tablets 5 mg tablets 10 mg tablets 20 mg tablets lactose 61.7 mg 123.3 mg 118.4 mg 111.9 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. 2.5 mg: white, round, biconvex, bevel-edged tablets. 5 mg: white to almost white, round, flat, bevel-edged tablets scored on one side. The tablet can be divided into equal doses. 10 mg: round, flat, red-brown, one side scored tablets with bevel edge and individual white spots on the surface and within the mass of tablets. The scoreline is not intended to facilitate breaking of the tablet for ease of swallowing or to divide it into equal halves. 20 mg: round, flat, light-orange, one-side scored tablets with bevel edge, and individual white spots on the surface and within the mass of tablets. The scoreline is not intended to facilitate breaking of the tablet for ease of swallowing or to divide it into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Treatment of hypertension - Treatment of symptomatic heart failure - Prevention of symptomatic heart failure in patients with asymptomatic left ventricular dysfunction (ejection fraction ≤ 35%) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Hypertension_ The initial dose is 5 mg to 20 mg, depending on the degree of hypertension and the condition of the patient. The drug should be taken once daily. In mild hypertension, the recommended initial dose is 5 mg to 10 mg daily. Patients with a strongly activated renin-angiotensin-aldosterone system, (e.g. renovascular hypertension, salt and/or volume depletion, cardiac decompensation or Прочитать полный документ