Valsacor tablets film-coated

Krajina: Arménsko

Jazyk: angličtina

Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktívna zložka:

valsartan

Dostupné z:

KRKA d.d.

ATC kód:

C09CA03

INN (Medzinárodný Name):

valsartan

Dávkovanie:

160mg

Forma lieku:

tablets film-coated

Počet v balení:

(28/4x7/) in blister

Typ predpisu:

Prescription

Stav Autorizácia:

Registered

Dátum Autorizácia:

2020-10-21

Súhrn charakteristických

1
1.
NAME OF THE MEDICINAL PRODUCT
Valsacor 80 mg film-coated tablets
Valsacor 160 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 80 mg or 160 mg valsartan.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
80 mg tablets: pink, round, biconvex, scored on one side. The tablet
can be divided into equal doses.
160 mg tablets: yellow-brown, oval, biconvex, scored on one side. The
tablet can be divided 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 not treated
with ACE inhibitors. In these
patients, valsartan reduces mortality and morbidity and the number of
hospital days due to heart
failure. Valsartan also slows the progression of heart failure,
improves left ventricular ejection fraction
and left ventricular internal diastolic diameter and compared to
placebo improves the signs and
symptoms of heart failure (see section 5.1).
Recent myocardial infarction
Valsartan is indicated to improve survival following myocardial
infarction in clinically stable patients
with signs, symptoms or radiological evidence of left ventricular
failure and/or left ventricular systolic
dysfunction (see section 5.1).
POSOLOGY AND METHOD OF ADMINISTRATION
Hypertension
The recommended dose of valsartan is 80 mg once daily regardless of
age, sex or race of the patient.
The antihypertensive effect occurs in two weeks and the maximum
antihypertensive effect after four
weeks. In patients whose blood pressure is not adequately controlled,
the daily dose can be increased
to 160 mg or a diuretic can be added. The maximum daily dose is 320
mg.
Dosage adjustment is not required in patients with impaired renal
function or impaired hepatic
function of non-biliary origin and without cholestasis.
Valsartan may also be administered concomitantly with other
antihypertensive drugs.
_Heart failure_
The recommended initial dose of