AMLODIPINE/VALSARTAN/HCT NOVARTIS 10/320/25 amlodipine/valsartan/hydrochlorothiazide tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

valsartan, Quantity: 320 mg; hydrochlorothiazide, Quantity: 25 mg; amlodipine besilate, Quantity: 13.87 mg (Equivalent: amlodipine, Qty 10 mg)

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

INN (International Name):

amlodipine besilate,Hydrochlorothiazide,Valsartan

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; colloidal anhydrous silica; crospovidone; microcrystalline cellulose; hypromellose; purified talc; iron oxide yellow; macrogol 4000

Administration route:

Oral

Units in package:

30, 14, 56, 7, 28

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

AMLODIPINE/VALSARTAN/HCT NOVARTIS 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).

Product summary:

Visual Identification: brown-yellow, non-scored, ovaloid, biconvex film-coated tablet with bevelled edge, debossed with "NVR" on one side and "VFL" on the other.; 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; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2010-04-09

Patient Information leaflet

AMLODIPINE/
VALSARTAN/ HCT
NOVARTIS
®
_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 AMLODIPINE/
VALSARTAN/HCT NOVARTIS.
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 AMLODIPINE/
VALSARTAN/HCT
NOVARTIS IS USED FOR
AMLODIPINE/VALSARTAN/HCT
NOVARTIS 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.
AMLODIPINE/VALSARTAN/HCT
NOVARTIS

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
AMLODIPINE/VALSARTAN/HCT NOVARTIS 5/160/12.5

(AMLODIPINE /VALSARTAN/HYDROCHLOROTHIAZIDE) FILM-COATED TABLET
AMLODIPINE/VALSARTAN/HCT NOVARTIS 5/160/25

(AMLODIPINE /VALSARTAN/HYDROCHLOROTHIAZIDE) FILM-COATED TABLET
AMLODIPINE/VALSARTAN/HCT NOVARTIS 10/160/25

(AMLODIPINE /VALSARTAN/HYDROCHLOROTHIAZIDE) FILM-COATED TABLET
AMLODIPINE/VALSARTAN/HCT NOVARTIS 10/160/12.5

(AMLODIPINE /VALSARTAN/HYDROCHLOROTHIAZIDE) FILM-COATED TABLET
AMLODIPINE/VALSARTAN/HCT NOVARTIS 10/320/25

(AMLODIPINE /VALSARTAN/HYDROCHLOROTHIAZIDE) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Amlodipine /valsartan/hydrochlorothiazide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
AMLODIPINE/VALSARTAN/HCT NOVARTIS 5/160/12.5
®
, AMLODIPINE/VALSARTAN/HCT NOVARTIS
5/160/25
®
, AMLODIPINE/VALSARTAN/HCT NOVARTIS 10/160/12.5
®
, AMLODIPINE/VALSARTAN/HCT
NOVARTIS 10/160/25
®
, and AMLODIPINE/VALSARTAN/HCT NOVARTIS 10/320/25
®
are available as
film-coated tablets in five strengths containing amlodipine (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.
3
PHARMACEUTICAL FORM
AMLODIPINE/VALSARTAN/HCT NOVARTIS 5/160/12.5
®
(5 mg amlodipine, 160 mg valsartan and 12.5
mg hydrochlorothiazide): white, non-scored, ovaloid, biconvex
film-coated tablet with bevelled
edge, debossed with “NVR” on one side and “VCL” on the other.
AMLODIPINE/VALSARTAN/HCT NOVARTIS 10/160/12.5
®
(10 mg amlodipine, 160 mg valsartan and
12.5 mg hydrochlorothiazide): pale yellow, non-scored, ovaloid,
biconvex film-coated tablet with
bevelled edge, debossed with “NVR” on one side and “VDL” on
the other.
AMLODIPINE/VALSARTAN/HCT NOVARTIS 5/160/25
®
(5 mg amlodipine, 160 mg valsartan and 25 mg
hydrochlorothiazide): yellow, non-scored, ovaloid, biconvex
film-coated tablet with bevelled edge,
debossed with “NVR” on one side and “VEL” on the other.