Maa: Indonesia
Kieli: indonesia
Lähde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
TELMISARTAN, AMLODIPINE BESILATE
BOEHRINGER INGELHEIM INDONESIA - Indonesia
TELMISARTAN, AMLODIPINE BESILATE
80 Mg /13.870 MG
TABLET
DUS, 4 ALUBLISTER @ 7 TABLET
ROTTENDORF PHARMA GMBH - Federal Republic of Germany
2021-01-27
Page 1 TWYNSTA® Telmisartan and Amlodipine COMPOSITION 1 tablet contains: [1,1’-biphenyl]-2-carboxylic acid, 4’-[(1,4’dimethyl-2’-propyl[2,6 -bi-1H-benzimidazole]-1’-yl)methyl] (= telmisartan) 40 or 80 mg 3-ethyl-5-methyl (4RS)-2-[-(2-aminoethoxy)methyl]-4- (2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3.5-dicarboxylate (= amlodipine) 5 or 10 mg, as besilate Excipients: colloidal anhydrous silica, FD&C blue No 1 aluminium lake (E 133), ferric oxide black (E172), ferric oxide yellow (E172), magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone K25, pregelatinized starch, sodium hydroxide, sorbitol TWYNSTA tablets 40/5 mg, 40/10 mg, 80/5 mg, 80/10 mg contain less than1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. INDICATIONS Treatment of essential hypertension. Replacement Therapy Patients receiving telmisartan and amlodipine from separate tablets may instead receive TWYNSTA containing the same component doses. Add on therapy TWYNSTA is indicated in patients whose blood pressure is not adequately controlled on amlodipine monotherapy. DOSAGE AND ADMINISTRATION DOSAGE Adults TWYNSTA should be taken once daily. The maximum recommended dose is TWYNSTA 80mg/10mg, one tablet per day. TWYNSTA is indicated for long term treatment. Replacement therapy Patients receiving telmisartan and amlodipine from separate tablets can instead receive TWYNSTA containing the same component doses in one tablet once daily, e.g. to enhance convenience or compliance. Add on therapy TWYNSTA 40/5mg tablets may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg alone. Individual dose titration with the components (i.e. amlodipine and telmisartan) is recommended before changing to the fixed dose combination. When clinically appropriate, direct change from monotherapy to the fixed combination may be considered. Patients treated with 10 mg amlodipine who experience any dose limiting adverse reactions such as oedema, may be switche Lue koko asiakirja