Страна: Сінгапур
мова: англійська
Джерело: HSA (Health Sciences Authority)
Amlodipine Besilate 6.935mg eqv Amlodipine; telmisartan
BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
C09DB04
5 mg
TABLET
Amlodipine Besilate 6.935mg eqv Amlodipine 5 mg; telmisartan 80.000 mg
ORAL
Prescription Only
Boehringer Ingelheim Pharma GmbH & Co.KG
ACTIVE
2011-09-09
0275-03 (SG) 20130322 1 TWYNSTA ® Abcd 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 DESCRIPTION Telmisartan / amlodipine layered tablets 40/5 mg are layered tablets of oval, biconvex shape. The two layers have different colours with the telmisartan layer being white to off- white, the amlodipine layer is blue. The white layer is debossed with the Boehringer Ingelheim company symbol and the code A1. The tablets are for oral administration. Telmisartan / amlodipine layered tablets 40/10 mg are layered tablets of oval, biconvex shape. The two layers have different colours with the telmisartan layer being white to off- white, the amlodipine layer is blue. The white layer is debossed with the Boehringer Ingelheim company symbol and the code A2. The tablets are for oral administration. Telmisartan / amlodipine layered tablets 80/5 mg are layered tablets of oval, biconvex shape. The two layers have different colours with the telmisartan layer being white to off- white, the amlodipin Прочитайте повний документ
TWYNSTA ® Abcd 1. NAME OF THE MEDICINAL PRODUCT TWYNSTA 40 mg/5 mg tablets TWYNSTA 40 mg/10 mg tablets TWYNSTA 80 mg/5 mg tablets TWYNSTA 80 mg/10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40 mg or 80 mg telmisartan and 5 mg or 10 mg amlodipine (as amlodipine besilate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Telmisartan / amlodipine layered tablets 40/5 mg are layered tablets of oval, biconvex shape. The two layers have different colours with the telmisartan layer being white to off- white, the amlodipine layer is blue. The white layer is debossed with the Boehringer Ingelheim company symbol and the code A1. The tablets are for oral administration. Telmisartan / amlodipine layered tablets 40/10 mg are layered tablets of oval, biconvex shape. The two layers have different colours with the telmisartan layer being white to off- white, the amlodipine layer is blue. The white layer is debossed with the Boehringer Ingelheim company symbol and the code A2. The tablets are for oral administration. Telmisartan / amlodipine layered tablets 80/5 mg are layered tablets of oval, biconvex shape. The two layers have different colours with the telmisartan layer being white to off- white, the amlodipine layer is blue. The white layer is debossed with the Boehringer Ingelheim company symbol and the code A3. The tablets are for oral administration. Telmisartan / amlodipine layered tablets 80/10 mg are layered tablets of oval, biconvex shape. The two layers have different colours with the telmisartan layer being white to off- white, the amlodipine layer is blue. The white layer is debossed with the Boehringer Ingelheim company symbol and the code A4. The tablets are for oral administration. 4. CLINICAL PARTICULARS 4.1 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 w Прочитайте повний документ