Valsartan Sandoz Film-Coated Tablet 160mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

VALSARTAN

Boleh didapati daripada:

DKSH MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

VALSARTAN

Unit dalam pakej:

28 Tablets; 30 Tablets

Dikeluarkan oleh:

NOVARTIS FARMA S.P.A.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
VALSARTAN SANDOZ FILM-COATED TABLET
VALSARTAN (80MG, 160MG)
1
WHAT IS IN THIS LEAFLET:
1.
What VALSARTAN SANDOZ is
used for
2.
How VALSARTAN SANDOZ
works
3.
Before you use VALSARTAN
SANDOZ
4.
How to use VALSARTAN
SANDOZ
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal of
VALSARTAN SANDOZ
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT VALSARTAN SANDOZ IS USED
FOR
VALSARTAN SANDOZ is used for
treating high blood pressure
(hypertension) in adults. It is also taken
for treating a heart condition known as
heart failure in adults where the heart
does not pump your blood around your
body as well as it should. VALSARTAN
SANDOZ can also be used to treat adults
after a heart attack (myocardial
infarction) to improve survival and
reduce further heart problems.
HOW VALSARTAN SANDOZ WORKS
VALSARTAN SANDOZ is a type of
medicine called an angiotensin II
receptor antagonist, which by blocking
the effects of the hormone angiotensin II
causes the blood vessels to relax and
widen. This results in a lowering of your
blood pressure, and makes it easier for
your heart to pump blood to all parts of
your body.
BEFORE YOU USE VALSARTAN
SANDOZ
Do not take VALSARTAN SANDOZ if
you are pregnant, think you might be
pregnant or considering becoming
pregnant. You must tell your doctor if
you think you are (or might become)
pregnant. VALSARTAN SANDOZ may
cause serious harm or even death to your
baby if used during pregnancy.
-
_When you must not use it_
•
If you are pregnant or planning to
become pregnant.
•
If you are allergic to any of the
ingredients in VALSARTAN
SANDOZ.
•
If you are a Type 2 diabetic
patients taking VALSARTAN
SANDOZ and aliskiren
concomitantly.
-
_Before you start to use it _
Please talk to your doctor or
pharmacist before taking this
medicine:
•
If you have any liver problems.
•
If you have any kidney
problems.
•
If you are suffering from
vomiting or diarrhea or are
taking high doses of a diureti

Ciri produk

1.
NAME OF THE MEDICINAL PRODUCT
Valsartan Sandoz Film-coated Tablet 80 mg
Valsartan Sandoz Film-coated Tablet 160 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Valsartan Sandoz 80 mg: One film-coated tablet contains 80 mg of
valsartan.
Valsartan Sandoz 160 mg: One film-coated tablet contains 160 mg of
valsartan.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Valsartan Sandoz 80 mg: Pale red, round with bevelled edges, scored on
one side; with debossing
“D/V” on the scored side and “NVR” on the other side.
Valsartan Sandoz 160 mg: Grey-orange, ovaloid, scored on one side;
with debossing “DX/DX” on the
scored side and “NVR” on the other side.
The score line on one side of Valsartan Sandoz Film-coated Tablet 80
mg or 160 mg is only to
facilitate breaking for ease of swallowing and not to divide into
equal doses.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
Treatment of hypertension.
Heart failure
Treatment of heart failure (NYHA class II-IV) in patients receiving
usual therapy (such as diuretics,
digitalis) who are intolerant to ACE inhibitors.
Valsartan Sandoz improves morbidity in these patients, primarily via
reduction in hospitalization for
heart failure. Valsartan also slows the progression of heart failure,
improves NYHA functional class,
ejection fraction and signs and symptoms of heart failure and improves
quality of life versus placebo
(see section PHARMACOLOGICAL PROPERTIES).
Post-myocardial infarction
Valsartan Sandoz is indicated to improve survival following myocardial
infarction in clinically stable
patients with signs, symptoms or radiological evidence of left
ventricular failure and/or with left
ventricular systolic dysfunction (see section PHARMACOLOGICAL
PROPERTIES).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE
Hypertension
The recommended dose of Valsartan is 80 mg or 160 mg film-coated
tablet once daily, irrespective of
race, age, or gender. The antihypertensive effect is substantially
present within 2 weeks and