País: Indonèsia
Idioma: indonesi
Font: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
VALSARTAN, AMLODIPINE BESILATE
NOVARTIS INDONESIA - Indonesia
VALSARTAN, AMLODIPINE BESILATE
160.0 MG /6.94 MG
TABLET SALUT SELAPUT
DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT
SIEGFRIED BARBERA, S.L. - Spain
2021-09-09
EXFORGE ® (AMLODIPINE/VALSARTAN) FILM-COATED TABLETS 5 MG/80 MG, 5 MG/160 MG, AND 10 MG/160 MG LEAFLET DISETUJUI OLEH BPOM: 10/08/2021 EREG100005VR12100109 EREG100005VR12100110 EREG100005VR12100111 TRADE NAME EXFORGE ® 5 mg/80 mg, 5 mg/160 mg and 10 mg/160 mg film-coated tablets. DESCRIPTION AND COMPOSITION Active substances: Amlodipine besylate: 3-Ethyl-5-methyl (±)-2-[(2-minoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro- 6-methyl-3,5-pyridinedicarboxylate, mono-benzenesulphonate. Valsartan: ( _S_ )-N-valeryl-N-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-valine. Three strengths are available. One tablet of Exforge contains: • 5 mg of amlodipine (as amlodipine besylate) and 80 mg of valsartan, dark yellow, round shaped film-coated tablet with bevelled edges, debossed with “NVR” on one side and “NV” on the reverse side. _ _ • 5 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan, dark yellow, ovaloid shaped film-coated tablet with bevelled edges, debossed with “NVR” on one side and “ECE” on the reverse side. _ _ • 10 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan, light yellow, ovaloid shaped film-coated tablet with bevelled edges, debossed with “NVR” on one side and “UIC” on the reverse side. EXCIPIENTS Exforge 5/80 mg: Cellulose microcrystalline; crospovidone; silica, colloidal anhydrous; magnesium stearate; hypromellose, macrogol 4000, talc, titanium dioxide (E171), iron oxide, yellow (E172 ) Exforge 5/160 mg: Cellulose microcrystalline; crospovidone; silica, colloidal anhydrous; magnesium stearate; hypromellose, macrogol 4000, talc, titanium dioxide (E171), iron oxide, yellow (E172) Exforge 10/160 mg: Cellulose microcrystalline; crospovidone; silica, colloidal anhydrous, magnesium stearate, hypromellose, macrogol 4000, talc, titanium dioxide (E171), iron oxide, yellow (E172), iron oxide, red (E172 ) PHARMACEUTICAL FORM Film-coated tablets. DISETUJUI OLEH BPOM: 10/08/2021 EREG100005VR12100109 EREG100005VR12100110 EREG100005VR12100111 INDICATIONS Llegiu el document complet