Twynsta Tablet 40mg10mg

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

Amlodipine Besilate 13.870mg eqv Amlodipine; telmisartan

Διαθέσιμο από:

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

Φαρμακολογική κατηγορία (ATC):

C09DB04

Δοσολογία:

10mg

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

Amlodipine Besilate 13.870mg eqv Amlodipine 10mg; telmisartan 40mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

Boehringer Ingelheim Pharma GmbH & Co.KG

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

2011-09-09

Φύλλο οδηγιών χρήσης

 
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

Αρχείο Π.Χ.Π.

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