EXFORGE HCT 5/160/12.5 amlodipine/valsartan/hydrochlorothiazide combination tablet blister pack

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

amlodipine besilate, Quantity: 6.94 mg (Equivalent: amlodipine, Qty 5 mg); valsartan, Quantity: 160 mg; hydrochlorothiazide, Quantity: 12.5 mg

Disponibil de la:

Novartis Pharmaceuticals Australia Pty Ltd

INN (nume internaţional):

amlodipine besilate,Hydrochlorothiazide,Valsartan

Forma farmaceutică:

Tablet, film coated

Compoziție:

Excipient Ingredients: colloidal anhydrous silica; microcrystalline cellulose; crospovidone; magnesium stearate; titanium dioxide; hypromellose; purified talc; macrogol 4000

Calea de administrare:

Oral

Unități în pachet:

7, 14, 28, 30, 56

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

Exforge HCT is indicated ONLY as substitution therapy for the treatment of hypertension in patients whose blood pressure is already adequately controlled on the triple combination of amlodipine, valsartan and hydrochlorothiazide taken either as three single component formulations or as dual-component formulation with a single component formulation, all components at the same dose level. Treatment should not be initiated with these fixed-dose combinations (see DOSAGE AND ADMINISTRATION).

Rezumat produs:

Visual Identification: White film coated tablet, ovaloid, biconvex with bevelled edge with "NVR" on one side and "VCL" on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Statutul autorizaţiei:

Licence status A

Data de autorizare:

2010-04-09

Prospect

EXFORGE HCT
®
_5/160/12.5, 5/160/25, 10/160/12.5, 10/160/25, 10/320/25_
_amlodipine besilate/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
besilate, valsartan and
hydrochlorothiazide. These
medicines reduce blood pressure in
three d

Caracteristicilor produsului

1
AUSTRALIAN PRODUCT INFORMATION
EXFORGE HCT 5/160/12.5

(AMLODIPINE BESILATE/VALSARTAN/HYDROCHLOROTHIAZIDE)
FILM-COATED TABLET
EXFORGE HCT 5/160/25

(AMLODIPINE BESILATE/VALSARTAN/HYDROCHLOROTHIAZIDE)
FILM-COATED TABLET
EXFORGE HCT 10/160/25

(AMLODIPINE BESILATE/VALSARTAN/HYDROCHLOROTHIAZIDE)
FILM-COATED TABLET
EXFORGE HCT 10/160/12.5

(AMLODIPINE BESILATE/VALSARTAN/HYDROCHLOROTHIAZIDE)
FILM-COATED TABLET
EXFORGE HCT 10/320/25

(AMLODIPINE BESILATE/VALSARTAN/HYDROCHLOROTHIAZIDE)
FILM-COATED TABLET
1
NAME OF THE MEDICINE
Amlodipine besilate/valsartan/hydrochlorothiazide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amlodipine besilate 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. 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 besilate (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.
For the full list of excipients, see Section 6.1 List of excipients.
2
3
PHARMACEUTICAL FORM
Exforge HCT 5/160/12.5
®
(5mg amlodipine, 160mg valsartan and 12.5mg hydrochlorothiazide):
white, ovaloid, biconvex film-coated tablet with bevelled edge,
debossed with “NVR” on one side
and “VCL” on the other.
Exforge HCT 10/160/12.5
®
(10mg amlodipine, 160mg valsartan and 12.5mg hydrochlorothiazide):
pale yellow, ovaloid, biconvex film-coated tablet with bevelled edge,
debossed with “NVR” on one
side and “VDL” on the other.
Exforge HCT 5/160/25
®
(5mg amlodipine, 160mg valsartan and 25mg hydrochlo