Valsartan Actavis 40 mg film-coated tablets

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Valsartan

Disponible des:

Actavis Group PTC ehf

Codi ATC:

C09CA; C09CA03

Designació comuna internacional (DCI):

Valsartan

Dosis:

40 milligram(s)

formulario farmacéutico:

Film-coated tablet

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

Angiotensin II antagonists, plain; valsartan

Estat d'Autorització:

Marketed

Data d'autorització:

2009-01-30

Informació per a l'usuari

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VALSARTAN ACTAVIS 40 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 Actavis is and what it is used for
2.
What you need to know before you take Valsartan Actavis
3.
How to take Valsartan Actavis
4.
Possible side effects
5.
How to store Valsartan Actavis
6.
Contents of the pack and other information
1.
WHAT VALSARTAN ACTAVIS IS AND WHAT IT IS USED FOR
Valsartan Actavis 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 Actavis works by
blocking the effect of angiotensin II. As
a result, blood vessels relax and blood pressure is lowered.
Valsartan Actavis 40 mg film-coated tablets CAN BE USED FOR THREE
DIFFERENT CONDITIONS:
•
TO TREAT HIGH BLOOD PRESSURE IN 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 SYMP

Fitxa tècnica

HealthProductsRegulatoryAuthority
07May2019
CRN008Y57
Page1of14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valsartan40mgfilm-coatedtablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Onefilm-coatedtabletcontains40mgofvalsartan
Excipients with known effect:
Each
Valsartan40mgfilm-coatedtabletcontains21.11mglactosemonohydrateand0.126mglecithin(containssoyaoil)
For thefulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
Film-coatedtablet
Valsartan40mgtablets:Yellow,oval,biconvex,film-coatedtablets,9x4.5mm,withascorelineononesideandmarkedwitha
Vontheother.
Thetabletcanbedividedintoequaldoses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
Treatmentof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_
Recent myocardial infarction
Inclinicallystablepatients,therapymaybeinitiatedasearlyas12
hoursafteramyocardialinfarction.Afteraninitialdoseof
20 mgtwicedaily,valsartanshouldbetitratedto40
mg,80 mg,and160
mgtwicedailyo