EXFORGE 5/80 amlodipine 5mg (as besilate)/valsartan 80mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

valsartan, Quantity: 80 mg; amlodipine besilate, Quantity: 6.94 mg (Equivalent: amlodipine, Qty 5 mg)

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

INN (International Name):

amlodipine besilate,Valsartan

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

30 tablets, 28 tablets, 7 tablets, 56 tablets, 14 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of hypertension. Treatment should not be initiated with this fixed dose combination.

Product summary:

Visual Identification: Dark yellow, round film-coated tablet with bevelled edge, debossed with NVR on one side and NV on the other.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2008-02-05

Patient Information leaflet

EXFORGE
®
_5/80; 5/160; 10/160; 5/320; 10/320_
_Amlodipine besylate/Valsartan_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about EXFORGE.
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 IS
USED FOR
EXFORGE 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 contains valsartan and
amlodipine besylate. These
medicines reduce blood pressure in
two different ways.
1.
Valsartan blocks the effect of
angiotensin II, which is a
substanc

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
EXFORGE
 5/80
EXFORGE
 5/160
EXFORGE
 10/160
EXFORGE
 5/320
EXFORGE
 10/320
(amlodipine besylate and valsartan) film-coated tablets
1
NAME OF THE MEDICINE
amlodipine besylate/valsartan
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Exforge 5/80, Exforge 5/160, Exforge 10/160, Exforge 5/320 and Exforge
10/320 are available as
film-coated tablets in three strengths containing amlodipine besylate
(5 or 10 mg) and valsartan
(80,160 mg or 320mg) as: 5/80 mg, 5/160 mg,10/160 mg, 5/320 mg and
10/320 mg.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Exforge 5/80 (5mg amlodipine and 80mg valsartan): Dark yellow, round
film-coated tablet with bevelled
edge, debossed with NVR on one side and NV on the other.
Exforge 5/160 (5mg amlodipine and 160mg valsartan): Dark yellow,
ovaloid film-coated tablet with
bevelled edge, debossed with NVR on one side and ECE on the other.
Exforge 10/160 (10mg amlodipine and 160mg valsartan): Light yellow,
ovaloid film-coated tablet with
bevelled edge, debossed with NVR on one side and UIC on the other.
Exforge 5/320 (5mg amlodipine and 320mg valsartan): Very dark yellow,
ovaloid film-coated tablet
with bevelled edge, debossed with NVR on one side and CSF on the
other.
Exforge 10/320 (10mg amlodipine and 320mg valsartan): Dark yellow,
ovaloid film-coated tablet
with bevelled edge, debossed with NVR on one side and LUF on the
other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Exforge is indicated for the treatment of hypertension. Treatment
should not be initiated with this
fixed dose combination.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Exforge 5/80, Exforge 5/160, Exforge 10/160, Exforge 5/320 and Exforge
10/320 are available as
film-coated tablets in five strengths containing amlodipine besylate
(5 or 10 mg) and valsartan (80,
160 or 320 mg) as: 5/80 mg, 5/160 mg , 10/160 mg, 5/320 mg and 10/320
mg.
The recommended dose is one tablet per day of either Exforge 5/80 mg,
5/160 mg, 10/160 mg, 5/320
mg o