Exforge HCT 10/320/25 mg Film-coated Tablet

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

AMLODIPINE BESILATE; VALSARTAN; HYDROCHLOROTHIAZIDE

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

AMLODIPINE BESILATE; VALSARTAN; HYDROCHLOROTHIAZIDE

Unit dalam pakej:

2 x 7tablet Tablets; 1 X 70 mL; 1 x 7tablet Tablets; 4 x 7tablet Tablets; 2x7tablet Tablets; 1x7tablet Tablets; 2x7tablet Tablet

Dikeluarkan oleh:

Novartis Farmaceutica S.A.

Risalah maklumat

EXFORGE HCT
®
AMLODIPINE BESYLATE/VALSARTAN/HYDROCHLOROTHIAZIDE
5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg,
10/320/25 mg Film-coated tablets
_Consumer Medication Information Leaflet (RiMUP) _
1
WHAT IS IN THIS LEAFLET
1.
WHAT EXFORGE HCT IS USED FOR
2.
HOW EXFORGE HCT WORKS
3.
BEFORE YOU TAKE EXFORGE HCT
4.
HOW TO USE EXFORGE HCT
5.
WHILE USING EXFORGE HCT
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF EXFORGE
HCT
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
WHAT EXFORGE HCT IS USED FOR
Your medicine is called Exforge HCT
and is available as a film-coated tablet.
Exforge HCT contains three
medicines: Amlodipine, a medicine
that belongs to the class of calcium
antagonists, valsartan, which belongs
to the class of so-called angiotensin-II
receptor antagonists and
hydrochlorothiazide, a diuretic which
belongs to the sulfonamides. All three
medicines help in different ways to
control high blood pressure.
Exforge HCT is used to treat high
blood pressure in patients whose blood
pressure is not adequately controlled
with a dual combination of blood
pressure lowering drugs, or for patients
on separate antihypertensive drugs who
wish to take one tablet with all three
components. If high blood pressure
persists for a long time, it can damage
the blood vessels of the brain, heart,
and kidneys, and may result in a stroke,
heart failure, kidney failure or damage
to the retina of the eye. High blood
pressure increases the risk of heart
attacks. Lowering your blood pressure
to normal levels reduces the risk of
developing these disorders.
HOW EXFORGE HCT WORKS
Exforge HCT contains three
medicines: Amlodipine blocks calcium
channels at the blood vessels level.
This has a relaxant effect on the blood
vessels. Valsartan works by blocking
the effect of angiotensin II.
Angiotensin II is a substance produced
by the body that causes blood vessels
to tighten, thus increasing the blood
pressure. Hydrochlorothiazide reduces
the amount of salt and water in the
body by increasing the

Ciri produk

Novartis
Page 2
International Package Leaflet
10-Sep-2018
Exforge HCT
EXFORGE HCT

Angiotensin II antagonists combinations plain (valsartan) with
dihydropyridine derivatives
(amlodipine) and thiazide diuretics (HCTZ)
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Film-coated tablets (FCT).
Five strengths are available.

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.

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.

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.

10 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.

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.
Exforge HCT FCT are non-divisible and cannot be divided into equal
doses.
ACTIVE SUBSTANCES
Amlodipine besylate
Valsartan
Hydrochlorothiazide
EXCIPIENTS
5/160/12.5
mg:
cellulose
microcrystalline;
crospovidone;
silica,
colloidal
anhydrous;
magnesium stearate; hypromellose, macrogol 4000, talc, titanium
dioxide (E171).
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