Exforge HCT Tablet 10mg160mg25mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Amlodipine besylate 13.87mg eqv amlodipine; Hydrochlorothiazide; Valsartan

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

C09DX01

Dosage:

10.00mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Amlodipine besylate 13.87mg eqv amlodipine 10.00mg; Hydrochlorothiazide 25.00mg; Valsartan 160.00mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Novartis Pharma Stein AG

Authorization status:

ACTIVE

Authorization date:

2010-12-24

Patient Information leaflet

EXFORGE HCT


Angiotensin  II  antagonists  combinations  plain  (valsartan)  with  dihydropyridine  derivatives 
(amlodipine) and thiazide diuretics (HCTZ) 
DESCRIPTION AND COMPOSITION 
PHARMACEUTICAL FORM 
Film-coated tablets 
Five strengths are available  
-Exforge HCT tablet 5/160/12.5
mg containing 5 mg of amlodipine (as amlodipine besylate), 
160 mg of valsartan and 12.5 mg hydrochlorothiazide : White
film-coated tablet, ovaloid, 
biconvex with beveled edge with debossing “NVR” on one side
and “VCL” on the other side. 
-Exforge HCT tablet 10/160/12.5 mg containing_ _10
mg of amlodipine (as amlodipine 
besylate),160 mg of valsartan and 12.5
mg hydrochlorothiazide : Pale yellow film-coated 
tablet, ovaloid, biconvex with beveled edge with
debossing “NVR” on one side and “VDL” 
on the other side. 
- Exforge HCT tablet 5/160/25 mg containing_ _5
mg of amlodipine (as amlodipine besylate), 
160 mg of valsartan and 25 mg hydrochlorothiazide :Yellow
film-coated tablet, ovaloid, 
biconvex with beveled edge with debossing “NVR” on
one side and “VEL” on the other side. 
-Exforge HCT tablet 10/160/25
mg containing10 mg of amlodipine (as amlodipine besylate) 
and 160 mg of valsartan and 25
mg hydrochlorothiazide :Brown-yellow film-coated tablet, 
ovaloid, biconvex with beveled edge with debossing “NVR” on
one side and “VHL” on the 
other side. 
- Exforge HCT tablet 10/320/25
mg containing_ _10 mg of amlodipine (as amlodipine besylate) 
and 320 mg of valsartan and 25
mg hydrochlorothiazide : Brown-yellow film-coated tablet, 
ovaloid, biconvex with beveled edge with debossing “NVR” on
one side and “VFL” on the 
other side. 

ACTIVE SUBSTANCES:  
Amlodipine  besylate:  3-Ethyl-5-methyl  (±)-2-[(2-minoethoxy)methyl]-4-(2-chlorophenyl)-
1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, mono-benzenesulphona

Summary of Product characteristics

TRADE NAME
EXFORGE HCT
®
5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg and 10/160/25 mg
Film-coated
tablets.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Film-coated tablets (FCT)
Four strengths are available
-Exforge HCT tablet 5/160/12.5 mg containing 5 mg of amlodipine (as
amlodipine besylate), 160
mg of valsartan and 12.5 mg hydrochlorothiazide : White film-coated
tablet, ovaloid, biconvex
with beveled edge with debossing “NVR” on one side and “VCL”
on the other side.
-Exforge
HCT
tablet
10/160/12.5
mg
containing
10
mg
of
amlodipine
(as
amlodipine
besylate),160 mg of valsartan and 12.5 mg hydrochlorothiazide : Pale
yellow film-coated tablet,
ovaloid, biconvex with beveled edge with debossing “NVR” on one
side and “VDL” on the other
side.
-Exforge HCT tablet 5/160/25 mg containing 5 mg of amlodipine (as
amlodipine besylate), 160
mg of valsartan and 25 mg hydrochlorothiazide :Yellow film-coated
tablet, ovaloid, biconvex with
beveled edge with debossing “NVR” on one side and “VEL” on the
other side.
-Exforge HCT tablet 10/160/25 mg containing10 mg of amlodipine (as
amlodipine besylate) and
160 mg of valsartan and 25 mg hydrochlorothiazide :Brown-yellow
film-coated tablet, ovaloid,
biconvex with beveled edge with debossing “NVR” on one side and
“VHL” on the other side.
Exforge HCT FCT are non-divisible and cannot be divided into equal
doses.
ACTIVE SUBSTANCES
Amlodipine besylate
Valsartan
Hydrochlorothiazide
Certain dosage strengths may not be available in all countries.
EXCIPIENTS
Exforge HCT tablet 5/160/12.5 mg: cellulose microcrystalline;
crospovidone; silica, colloidal
anhydrous; magnesium stearate; hypromellose, macrogol 4000, talc,
titanium dioxide (E171).
Exforge HCT tablet 10/160/12.5 mg: cellulose microcrystalline;
crospovidone; silica,
colloidal anhydrous; magnesium stearate; hypromellose, macrogol 4000,
talc, titanium
dioxide (E171), iron oxide, yellow (E172), iron oxide, red (E 172).
Exforge HCT tablet 5/160/25 mg: cellulose microcrystalline;
crospovidone; silica, col