Valsartan Actavis 80 mg film-coated tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Valsartan

Dostępny od:

Actavis Group PTC ehf

Kod ATC:

C09CA; C09CA03

INN (International Nazwa):

Valsartan

Dawkowanie:

80 milligram(s)

Forma farmaceutyczna:

Film-coated tablet

Typ recepty:

Product subject to prescription which may be renewed (B)

Dziedzina terapeutyczna:

Angiotensin II antagonists, plain; valsartan

Status autoryzacji:

Marketed

Data autoryzacji:

2009-01-30

Ulotka dla pacjenta

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VALSARTAN 80 MG FILM-COATED TABLETS
VALSARTAN 160MG 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 is and what it is used for
2.
What you need to know before you take Valsartan
3.
How to take Valsartan
4.
Possible side effects
5.
How to store Valsartan
6.
Contents of the pack and other information
1.
WHAT VALSARTAN IS AND WHAT IT IS USED FOR
Valsartan 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. Valsartan works by blocking the
effect of angiotensin II. As a result, blood
vessels relax and blood pressure is lowered.
Valsartan 80 mg film-coated tablets
CAN BE USED FOR THREE DIFFERENT CONDITIONS:
•
TO TREAT HIGH BLOOD PRESSURE IN ADULT AND CHILDREN AND ADOLESCENTS 6
TO 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.
•
TO TREAT ADULT PATIENTS AFTER A RECENT HEART ATTACK
(myocardial infarction)
.
“Recent” here means
between 12 hours and 10 days.
•
TO TREAT SYMPTOMATIC HEART FAILURE IN

Charakterystyka produktu

HealthProductsRegulatoryAuthority
07May2019
CRN008Y57
Page1of14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valsartan80mgfilm-coatedtablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coatedtabletcontains80mg of valsartan
Excipients with known effect:
EachValsartan80mgfilm-coatedtabletcontains42.22mglactosemonohydrateand0.252mglecithin(containssoyaoil)
For thefulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
Film-coatedtablet
Valsartan80mgtablets:
Pink,round,biconvex,film-coatedtablets,8mmindiameter,withascorelineonbothsidesand
markedwithaV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18
yearsofage.
Recent myocardial infarction
Treatmentofclinicallystableadultpatientswithsymptomaticheartfailureorasymptomaticleftventricularsystolicdysfunction
afterarecent(12 hours-to10
days)myocardialinfarction(seesections4.4and5.1).
Heart failure
TreatmentofadultpatientswithsymptomaticheartfailurewhenACEinhibitorsarenottoleratedorinbeta‑blockerintolerant
patientsasadd‑ontherapytoACE‑inhibitorswhenmineralcorticoidreceptorantagonistcannotbeused(seesections4.2,4.4,
4.5and5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
Hypertension
TherecommendedstartingdoseofValsartanis80
mgoncedaily.Theantihypertensiveeffectissubstantiallypresentwithin
2 weeks,andmaximaleffectsareattainedwithin4
weeks.Insomepatient