Exforge Tablet 10mg160mg

Država: Singapur

Jezik: angleščina

Source: HSA (Health Sciences Authority)

Aktivna sestavina:

Amlodipine besylate 13.87mg (corresponds to amlodipine base); Valsartan

Dostopno od:

NOVARTIS (SINGAPORE) PTE LTD

Odmerek:

10.0mg

Farmacevtska oblika:

TABLET, FILM COATED

Sestava:

Amlodipine besylate 13.87mg (corresponds to amlodipine base) 10.0mg; Valsartan 160.0mg

Pot uporabe:

ORAL

Tip zastaranja:

Prescription Only

Izdeluje:

Siegfried Barbera S.L.

Status dovoljenje:

ACTIVE

Datum dovoljenje:

2008-02-28

Navodilo za uporabo



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

Lastnosti izdelka

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