Valsartan Krka 320mg film-coated Tablets

Negara: Malta

Bahasa: Inggris

Sumber: Medicines Authority

Bahan aktif:

VALSARTAN

Tersedia dari:

KRKA DD Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Kode ATC:

C09CA03

INN (Nama Internasional):

VALSARTAN 320 mg

Bentuk farmasi:

FILM-COATED TABLET

Komposisi:

VALSARTAN 320 mg

Jenis Resep:

POM

Area terapi:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Status otorisasi:

Authorised

Tanggal Otorisasi:

2011-05-09

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE USER
VALSARTAN KRKA 320 MG FILM-COATED TABLETS
valsartan
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Valsartan Krka is and what it is used for
2.
What you need to know before you take Valsartan Krka
3.
How to take Valsartan Krka
4.
Possible side effects
5.
How to store Valsartan Krka
6.
Contents of the pack and other information
1.
WHAT VALSARTAN KRKA IS AND WHAT IT IS USED FOR
Valsartan Krka belongs to a class of medicines known as angiotensin II
receptor antagonist, which
help to control high blood pressure. Angiotensin II is a substance in
the body that causes vessels to
tighten, thus causing your blood pressure to increase. It works by
blocking the effect of angiotensin II.
As a result, blood vessels relax and blood pressure is lowered.
Valsartan Krka 320 mg film-coated tablets can be used
-
TO TREAT HIGH BLOOD PRESSURE IN ADULTS AND IN CHILDREN AND ADOLESCENTS
6 TO LESS THAN 18
YEARS OF AGE.
High blood pressure increases the workload on the heart and arteries.
If not treated it can
damage the blood vessels of the brain, heart, and kidneys, and may
result in a stroke, heart
failure, or kidney failure. High blood pressure increases the risk of
heart attacks. Lowering your
blood pressure to normal reduces the risk of developing these
disorders.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALSARTAN KRKA
DO NOT TAKE VALSARTAN KRKA
-
if you are
ALLERGIC
to valsartan or any of the other ingredients of this medicine (listed
in section
6).
-
if you have
SEVERE L

Karakteristik produk

1.
NAME OF THE MEDICINAL PRODUCT
Valsartan Krka 320 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 320 mg valsartan.
Excipient with known effect:
-
lactose: 114 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Appearance of 320 mg film-coated tablets: light brown, capsule shaped,
biconvex film-coated tablets
scored on one side. The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension
Treatment of essential hypertension in adults, and hypertension in
children and adolescents 6 to less
than 18 years of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
Hypertension
The recommended starting dose of Valsartan Krka is 80 mg once daily.
The antihypertensive effect is
substantially present within 2 weeks, and maximal effects are attained
within 4 weeks. In some
patients whose blood pressure is not adequately controlled, the dose
can be increased to 160 mg and to
a maximum of 320 mg.
Valsartan Krka may also be administered with other antihypertensive
agents (see sections 4.3, 4.4, 4.5
and 5.1). The addition of a diuretic such as hydrochlorothiazide will
decrease blood pressure even
further in these patients.
_Additional information on special populations_
Elderly
No dose adjustment is required in elderly patients.
Renal impairment
No dose adjustment is required for adult patients with a creatinine
clearance >10 ml/min (see sections
4.4 and 5.2).
Hepatic impairment
Valsartan is contraindicated in patients with severe hepatic
impairment, biliary cirrhosis and in
patients with cholestasis (see sections 4.3, 4.4 and 5.2). In patients
with mild to moderate hepatic
impairment without cholestasis, the dose of valsartan should not
exceed 80 mg.
_Paediatric population_
Paediatric hypertension
_Children and adolescents 6 to less than 18 years of age _
The initial dose is 40 mg once daily for children weighing below 35 kg
and 80 mg once daily for those
weighing 35 kg or more