Irbesartan Zentiva (previously Irbesartan Winthrop)

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

Buy It Now

Patient Information leaflet Patient Information leaflet (PIL)
28-09-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
28-09-2022
Public Assessment Report Public Assessment Report (PAR)
23-09-2013

Active ingredient:

irbesartana

Available from:

Zentiva k.s.

ATC code:

C09CA04

INN (International Name):

irbesartan

Therapeutic group:

Sredstva koja djeluju na sustav renin-angiotenzina

Therapeutic area:

Hipertenzija

Therapeutic indications:

Liječenje esencijalne hipertenzije. Liječenje zatajenja bubrega u bolesnika s hipertenzijom i tip-2 dijabetesa kao dio antihipertenzivnih lijekova proizvoda shema.

Product summary:

Revision: 28

Authorization status:

odobren

Authorization date:

2007-01-19

Patient Information leaflet

                                103
B. UPUTA O LIJEKU
104
UPUTA O LIJEKU: INFORMACIJA ZA KORISNIKA
IRBESARTAN ZENTIVA 75 MG TABLETE
irbesartan
PAŽLJIVO PROČITAJTE CIJELU UPUTU PRIJE NEGO POČNETE UZIMATI OVAJ
LIJEK JER SADRŽI VAMA VAŽNE
PODATKE.
▪
Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.
▪
Ako imate dodatnih pitanja, obratite se svom liječniku ili
ljekarniku.
▪
Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im
naškoditi, čak i ako su
njihovi znakovi bolesti jednaki Vašima.
▪
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti
liječnika ili ljekarnika. To uključuje
i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte
dio 4.
ŠTO SE NALAZI U OVOJ UPUTI
1.
Što je Irbesartan Zentiva i za što se koristi
2.
Što morate znati prije nego počnete uzimati Irbesartan Zentiva
3.
Kako uzimati Irbesartan Zentiva
4.
Moguće nuspojave
5.
Kako čuvati Irbesartan Zentiva
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE IRBESARTAN ZENTIVA I ZA ŠTO SE KORISTI
Irbesartan Zentiva pripada skupini lijekova koja se naziva antagonisti
receptora angiotenzina II.
Angiotenzin II je tvar koja se stvara u tijelu i koja se veže na
receptore u krvnim žilama te uzrokuje
njihovo sužavanje. To dovodi do povišenja krvnog tlaka. Irbesartan
Zentiva sprječava vezanje
angiotenzina II na te receptore uzrokujući opuštanje krvnih žila i
sniženje krvnog tlaka. Irbesartan
Zentiva usporava slabljenje bubrežne funkcije u bolesnika koji imaju
povišen krvni tlak i boluju od
šećerne bolesti tipa 2.
Irbesartan Zentiva se primjenjuje u odraslih bolesnika za
▪
liječenje visokog krvnog tlaka (_esencijalne hipertenzije_)
▪
zaštitu bubrega u bolesnika sa šećernom bolešću tipa 2 koji imaju
povišeni krvni tlak i
laboratorijski dokazanu oslabljenu bubrežnu funkciju.
2.
ŠTO MORATE ZNATI PRIJE NEGO POČNETE UZIMATI IRBESARTAN ZENTIVA
NEMOJTE UZIMATI IRBESARTAN ZENTIVA
▪
ako ste ALERGIČNI na irbesartan ili neki drugi sastojak ovog lijeka
(naveden u dijelu 6.)
▪
ako ste TRUDNI VI
                                
                                Read the complete document

Summary of Product characteristics

                                1
_ _
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
Irbesartan Zentiva 75 mg tablete
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Jedna tableta sadrži 75 mg irbesartana.
Pomoćna tvar s poznatim učinkom: 15,37 mg laktoze hidrata po
tableti.
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Tableta.
Bijela do gotovo bijela, bikonveksna, ovalna tableta, s utisnutom
oznakom srca na jednoj i brojem
2771 na drugoj strani.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Irbesartan Zentiva je indiciran za liječenje esencijalne hipertenzije
u odraslih.
Također je indiciran za liječenje bubrežne bolesti u odraslih
bolesnika s hipertenzijom i šećernom
bolešću tipa 2 u sklopu antihipertenzivne terapije (vidjeti dijelove
4.3, 4.4, 4.5 i 5.1).
4.2
DOZIRANJE I NAČIN PRIMJENE
Doziranje
Uobičajena preporučena početna doza i doza održavanja iznosi 150
mg jedanput na dan, s hranom ili
bez nje. Doza od 150 mg lijeka Irbesartan Zentiva jedanput na dan
općenito osigurava bolju kontrolu
krvnog tlaka u razdoblju od 24 sata nego doza od 75 mg. Međutim, u
bolesnika na hemodijalizi i u
bolesnika starijih od 75 godina može se razmotriti započinjanje
terapije dozom od 75 mg.
U bolesnika u kojih se bolest ne može dostatno kontrolirati dozom od
150 mg jedanput na dan, doza
lijeka Irbesartan Zentiva može se povećati na 300 mg ili se mogu
dodati drugi antihipertenzivi (vidjeti
dijelove 4.3, 4.4, 4.5 i 5.1) . Pokazalo se da dodavanje diuretika
poput hidroklorotiazida ostvaruje
aditivan učinak s lijekom Irbesartan Zentiva (vidjeti dio 4.5).
U hipertenzivnih bolesnika sa šećernom bolešću tipa 2 liječenje
treba započeti sa 150 mg irbesartana
jedanput na dan i dozu titrirati do 300 mg jedanput na dan, što je
doza održavanja koja se preporučuje
za liječenje bubrežne bolesti.
Dokaz koristi lijeka Irbesartan Zentiva na bubrežnu funkciju u
hipertenzivnih bolesnika sa šećernom
bolešću tipa 2 zasniva se na ispitivanjima u kojima se irbesartan
prema potrebi uzimao kao dopuna
ostaloj antih
                                
                                Read the complete document

Similar products

Active ingredient irbesartana

irbesartana

ATC code C09CA04

C09CA04

Marketed by Zentiva k.s.

Zentiva k.s.

INN (International Name) irbesartan

irbesartan

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 28-09-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 28-09-2022
Public Assessment Report Public Assessment Report Bulgarian 23-09-2013
Patient Information leaflet Patient Information leaflet Spanish 28-09-2022
Summary of Product characteristics Summary of Product characteristics Spanish 28-09-2022
Public Assessment Report Public Assessment Report Spanish 23-09-2013
Patient Information leaflet Patient Information leaflet Czech 28-09-2022
Summary of Product characteristics Summary of Product characteristics Czech 28-09-2022
Public Assessment Report Public Assessment Report Czech 23-09-2013
Patient Information leaflet Patient Information leaflet Danish 28-09-2022
Summary of Product characteristics Summary of Product characteristics Danish 28-09-2022
Public Assessment Report Public Assessment Report Danish 23-09-2013
Patient Information leaflet Patient Information leaflet German 28-09-2022
Summary of Product characteristics Summary of Product characteristics German 28-09-2022
Public Assessment Report Public Assessment Report German 23-09-2013
Patient Information leaflet Patient Information leaflet Estonian 28-09-2022
Summary of Product characteristics Summary of Product characteristics Estonian 28-09-2022
Public Assessment Report Public Assessment Report Estonian 23-09-2013
Patient Information leaflet Patient Information leaflet Greek 28-09-2022
Summary of Product characteristics Summary of Product characteristics Greek 28-09-2022
Public Assessment Report Public Assessment Report Greek 23-09-2013
Patient Information leaflet Patient Information leaflet English 28-09-2022
Summary of Product characteristics Summary of Product characteristics English 28-09-2022
Public Assessment Report Public Assessment Report English 23-09-2013
Patient Information leaflet Patient Information leaflet French 28-09-2022
Summary of Product characteristics Summary of Product characteristics French 28-09-2022
Public Assessment Report Public Assessment Report French 23-09-2013
Patient Information leaflet Patient Information leaflet Italian 28-09-2022
Summary of Product characteristics Summary of Product characteristics Italian 28-09-2022
Public Assessment Report Public Assessment Report Italian 23-09-2013
Patient Information leaflet Patient Information leaflet Latvian 28-09-2022
Summary of Product characteristics Summary of Product characteristics Latvian 28-09-2022
Public Assessment Report Public Assessment Report Latvian 23-09-2013
Patient Information leaflet Patient Information leaflet Lithuanian 28-09-2022
Summary of Product characteristics Summary of Product characteristics Lithuanian 28-09-2022
Public Assessment Report Public Assessment Report Lithuanian 23-09-2013
Patient Information leaflet Patient Information leaflet Hungarian 28-09-2022
Summary of Product characteristics Summary of Product characteristics Hungarian 28-09-2022
Public Assessment Report Public Assessment Report Hungarian 23-09-2013
Patient Information leaflet Patient Information leaflet Maltese 28-09-2022
Summary of Product characteristics Summary of Product characteristics Maltese 28-09-2022
Public Assessment Report Public Assessment Report Maltese 23-09-2013
Patient Information leaflet Patient Information leaflet Dutch 28-09-2022
Summary of Product characteristics Summary of Product characteristics Dutch 28-09-2022
Public Assessment Report Public Assessment Report Dutch 23-09-2013
Patient Information leaflet Patient Information leaflet Polish 28-09-2022
Summary of Product characteristics Summary of Product characteristics Polish 28-09-2022
Public Assessment Report Public Assessment Report Polish 23-09-2013
Patient Information leaflet Patient Information leaflet Portuguese 28-09-2022
Summary of Product characteristics Summary of Product characteristics Portuguese 28-09-2022
Public Assessment Report Public Assessment Report Portuguese 23-09-2013
Patient Information leaflet Patient Information leaflet Romanian 28-09-2022
Summary of Product characteristics Summary of Product characteristics Romanian 28-09-2022
Public Assessment Report Public Assessment Report Romanian 23-09-2013
Patient Information leaflet Patient Information leaflet Slovak 28-09-2022
Summary of Product characteristics Summary of Product characteristics Slovak 28-09-2022
Public Assessment Report Public Assessment Report Slovak 23-09-2013
Patient Information leaflet Patient Information leaflet Slovenian 28-09-2022
Summary of Product characteristics Summary of Product characteristics Slovenian 28-09-2022
Public Assessment Report Public Assessment Report Slovenian 23-09-2013
Patient Information leaflet Patient Information leaflet Finnish 28-09-2022
Summary of Product characteristics Summary of Product characteristics Finnish 28-09-2022
Public Assessment Report Public Assessment Report Finnish 23-09-2013
Patient Information leaflet Patient Information leaflet Swedish 28-09-2022
Summary of Product characteristics Summary of Product characteristics Swedish 28-09-2022
Public Assessment Report Public Assessment Report Swedish 23-09-2013
Patient Information leaflet Patient Information leaflet Norwegian 28-09-2022
Summary of Product characteristics Summary of Product characteristics Norwegian 28-09-2022
Patient Information leaflet Patient Information leaflet Icelandic 28-09-2022
Summary of Product characteristics Summary of Product characteristics Icelandic 28-09-2022

Search alerts related to this product

Alerts Irbesartan Zentiva irbesartana

Irbesartan Zentiva irbesartana

View documents history

Documents history Documents history

Irbesartan Zentiva (previously Irbesartan Winthrop)