Riik: Singapur
keel: inglise
Allikas: HSA (Health Sciences Authority)
Amlodipine besylate 13.87mg (corresponds to amlodipine base); Valsartan
NOVARTIS (SINGAPORE) PTE LTD
10.0mg
TABLET, FILM COATED
Amlodipine besylate 13.87mg (corresponds to amlodipine base) 10.0mg; Valsartan 160.0mg
ORAL
Prescription Only
Siegfried Barbera S.L.
ACTIVE
2008-02-28
EXFORGE Angiotensin II antagonists (valsartan) combination with dihydropyridine derivatives (amlodipine) DESCRIPTION AND COMPOSITION ACTIVE SUBSTANCES: Amlodipine besylate: 3-ethyl 5-methyl (4RS)-2[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6- methyl-1,4-dihydropyridine-3-,5-dicarboxylate benzenesulphonate. Valsartan: (_S_)-N-valeryl-N-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-valine. Three strengths are available. One film-coated tablet of Exforge contains: - 5 mg of amlodipine (as amlodipine besylate) and 80 mg of valsartan, - 5 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan, - 10 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan, For a full list of excipients, see section EXCIPIENTS. PHARMACEUTICAL FORM Film-coated tablet Exforge Tablet 5mg/80mg: Dark yellow, round film-coated tablet with bevelled edges, imprinted with “NVR” on one side and “NV” on the other side. Exforge Tablet 5mg/160mg: Dark yellow, ovaloid film-coated tablet with bevelled edges, imprinted with “NVR” on one side and “ECE” on the other side. Exforge Tablet 10mg/160mg: Light yellow, ovaloid film-coated tablet with bevelled edges, imprinted with “NVR” on one side and “UIC” on the other side. EXCIPIENTS 5/80 mg: Cellulose microcrystalline; crospovidone; silica, colloidal anhydrous; magnesium stearate; hypromellose, macrogol 4000, talc, titanium dioxide (E171), iron oxide, yellow (E172 ) 5/160 mg: Cellulose microcrystalline; crospovidone; silica, colloidal anhydrous; magnesium stearate; hypromellose, macrogol 4000, talc, titanium dioxide (E171), iron oxide, yellow (E172) 10/160 mg: Cellulose microcrystalline; crospovidone; silica, colloidal anhydrous Lugege kogu dokumenti
Exforge Feb2021.SIN Page 1 of 20 TRADE NAME EXFORGE ® 5 mg/80 mg, 5 mg/160 mg and 10 mg/160 mg film-coated tablets DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Film-coated tablet ACTIVE SUBSTANCES: Amlodipine besylate Valsartan Three strengths are available. One film-coated tablet of Exforge contains: - 5 mg of amlodipine (as amlodipine besylate) and 80 mg of valsartan, dark yellow, round film- coated tablet with bevelled edges, imprinted with “NVR” on one side and “NV” on the other side. - 5 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan, dark yellow, ovaloid film- coated tablet with bevelled edges, imprinted with “NVR” on one side and “ECE” on the other side. - 10 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan, light yellow, ovaloid film- coated tablet with bevelled edges, imprinted with “NVR” on one side and “UIC” on the other side. For a full list of excipients, see section Excipients. Exforge FCT are non-divisible and cannot be divided into equal doses. EXCIPIENTS 5/80 mg: Cellulose microcrystalline; crospovidone; silica, colloidal anhydrous; magnesium stearate; hypromellose, macrogol 4000, talc, titanium dioxide (E171), iron oxide, yellow (E172) 5/160 mg: Cellulose microcrystalline; crospovidone; silica, colloidal anhydrous; magnesium stearate; hypromellose, macrogol 4000, talc, titanium dioxide (E171), iron oxide, yellow (E172) 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) INDICATIONS Treatment of essential hypertension Exforge is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy. Exforge Feb2021.SIN Page 2 of 20 DOSAGE REGIMEN AND ADMINISTRATION DOSAGE REGIMEN GENERAL TARGET POPULATION The recommended dose of Exforge is one tablet per day. A patient whose blood pressure is not adequately controlled on monotherapy may Lugege kogu dokumenti