TWYNSTA

Land: Indonesien

Sprache: Indonesisch

Quelle: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Wirkstoff:

TELMISARTAN, AMLODIPINE BESILATE

Verfügbar ab:

BOEHRINGER INGELHEIM INDONESIA - Indonesia

INN (Internationale Bezeichnung):

TELMISARTAN, AMLODIPINE BESILATE

Dosierung:

80 Mg /6.935 MG

Darreichungsform:

TABLET

Einheiten im Paket:

DUS, 4 ALUBLISTER @ 7 TABLET

Hergestellt von:

ROTTENDORF PHARMA GMBH - Federal Republic of Germany

Berechtigungsdatum:

2021-01-27

Fachinformation

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