Exforge HCT
Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Indlægsseddel
(PIL)
10-06-2024
Produktets egenskaber
(SPC)
10-06-2024
Aktiv bestanddel:
Amlodipine besylate; Hydrochlorothiazide; Valsartan
Tilgængelig fra:
Novartis Pharmaceuticals Australia Pty Ltd
Klasse:
Medicine Registered
Indlægsseddel
EXFORGE HCT
®
_5/160/12.5, 5/160/25, 10/160/12.5, 10/160/25, 10/320/25_
_amlodipine besylate / valsartan/hydrochlorothiazide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Exforge HCT.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT EXFORGE HCT IS
USED FOR
Exforge HCT is used to control high
blood pressure, also called
hypertension.
Everybody has blood pressure. This
pressure helps get your blood all
around your body. Your blood
pressure may be different at different
times of the day, depending on how
busy or worried you are. You have
hypertension (high blood pressure)
when your blood pressure stays
higher than is needed, even when you
are calm and relaxed.
High blood pressure increases the
workload of the heart and blood
vessels. If it continues for a long
time, it can damage the blood vessels
in the brain, heart and kidneys. This
can lead to stroke, heart failure or
kidney failure. High blood pressure
increases the risk of heart attacks.
Lowering your blood pressure
reduces the chance of these disorders
happening.
Exforge HCT contains amlodipine
besylate, valsartan and
hydrochlorothiazide. These
medicines reduce blood p
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Produktets egenskaber
1
EXFORGE HCT 5/160/12.5
EXFORGE HCT 5/160/25
EXFORGE HCT 10/160/25
EXFORGE HCT 10/160/12.5
EXFORGE HCT 10/320/25
(AMLODIPINE BESYLATE/VALSARTAN/HYDROCHLOROTHIAZIDE)
NAME OF THE MEDICINE
Active ingredients (INN): amlodipine besylate, valsartan and
hydrochlorothiazide
Structural formula:
N
H
O
NH
2
O
O
CH
3
C
H
3
O
O
C
H
3
Cl
H
SO
3
H
.
*
and enantiomer
AMLODIPINE (AS THE BESYLATE SALT)
(3-ethyl 5-methyl (4RS)-2-[(2-aminoethoxy)
methyl]-4-(2-chlorophenyl)-6-methyl-1,4-
dihydropyridine-3,5-dicarboxylate
benzenesulphonate)
CAS: 111470-99-6
Molecular formula: C
20
H
25
CIN
2
O
5
,C
6
H
6
O
3
S
Molecular weight: 567.06
N
O
N
N
N
NH
COOH
(S)
VALSARTAN
(N-Pentanoyl-N-[2’-(1H-tetrazol-5-yl)biphenyl-
4ylmethyl]-L-valine)
CAS : 137862-53-4
Molecular formula: C
24
H
29
N
5
O
3
Molecular weight: 435.5
SO
2
NH
N
H
H
2
NO
2
S
Cl
HYDROCHLOROTHIAZIDE
(6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-
7-sulfonamide-1,1-dioxide)
CAS : 58-93-5
Molecular formula: C
7
H
8
CIN
3
O
4
S
2
Molecular weight: 297.72
DESCRIPTION
Amlodipine besylate is a white or almost white powder that is
slightly soluble in water and
sparingly soluble in ethanol. Valsartan is a white to practically
white microcrystalline and slightly
bitter tasting powder. It is soluble in ethanol and methanol and
slightly soluble in water.
2
Hydrochlorothiazide is a white or almost white powder, very
slightly soluble in water and freely
soluble in dimethylsulfoxide.
Exforge HCT 5/160/12.5
®
, Exforge HCT 5/160/25
®
, Exforge HCT 10/160/12.5
®
, Exforge HCT
10/160/25
®
, and Exforge HCT 10/320/25
®
are available as film-coated tablets in five strengths
containing amlodipine besylate (5 or 10 mg), valsartan(160 or
320 mg) and hydrochlorothiazide
(12.5 or 25 mg) as: 5/160/12.5 mg, 5/160/25 mg, 10/160/12.5 mg,
10/160/25mg and 10/320/25 mg.
Excipi
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