Esmya

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
03-02-2021
Summary of Product characteristics Summary of Product characteristics (SPC)
03-02-2021
Public Assessment Report Public Assessment Report (PAR)
03-02-2021

Active ingredient:

ulipristal acetat

Available from:

Gedeon Richter Ltd 

ATC code:

G03XB02

INN (International Name):

ulipristal

Therapeutic group:

Spolni hormoni i modulatori genitalnog sustava,

Therapeutic area:

uterusa

Therapeutic indications:

Ulipristal acetat je indicirana preoperativna liječenja umjerene do jake simptome mioma u odraslih žena reproduktivne dobi. Ulipristal acetat je indiciran za prekidima liječenje umjerene do teške simptome uterine fibroids kod odraslih žena reproduktivne dobi.

Product summary:

Revision: 16

Authorization status:

odobren

Authorization date:

2012-02-22

Patient Information leaflet

                                26
B. UPUTA O LIJEKU
27
UPUTA O LIJEKU: INFORMACIJE ZA KORISNIKA
_ _
ESMYA 5 MG TABLETE
ulipristalacetat
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 Esmya i za što se koristi
2.
Što morate znati prije nego počnete uzimati Esmyu
3.
Kako uzimati Esmyu
4.
Moguće nuspojave
5.
Kako čuvati Esmyu
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE ESMYA I ZA ŠTO SE KORISTI
Esmya sadrži djelatnu tvar ulipristalacetat. Koristi se za liječenje
umjerenih do teških simptoma
fibroida maternice (poznatih pod nazivom miomi) koji su nekancerozni
tumori uterusa (maternice).
Esmya se koristi u odraslih žena (starijih od 18 godina) prije nego
uđu u menopauzu.
U nekih žena fibroidi maternice mogu uzrokovati obilno menstrualno
krvarenje („mjesečnicu“), bol u
zdjelici (nelagodu u trbuhu) te stvarati pritisak na druge organe.
Ovaj lijek djeluje mijenjajući aktivnost progesterona, hormona koji
se inače stvara u organizmu.
Koristi se za dugotrajno liječenje fibroida kako bi se smanjila
njihova veličina, zaustavilo ili smanjilo
krvarenje te povećao broj crvenih krvnih stanica.
2.
ŠTO MORATE ZNATI PRIJE NEGO POČNETE UZIMATI ESMYU
_ _
Trebate znati da većina žena nema menstrualno krvarenje
(mjesečnicu) tijekom liječenja ovim lijekom
te nekoliko tjedana nakon toga.
_ _
NEMOJTE UZIMATI ESMYU
-
ako ste alergični na djelatnu(e) tvar(i) ili neki drugi sastojak
lijeka Esmya (naveden u dijelu 6).
-
ako imate poremećaj jetre kao podležeću bolest.
-
ako ste trudn
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
_ _
Esmya 5 mg tablete
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Jedna tableta sadrži 5 mg ulipristalacetata.
Za cjeloviti popis pomoćnih tvari, vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Tableta.
Bijela do bjelkasta, okrugla bikonveksna tableta promjera 7 mm s
utisnutim znakom “ES5” na jednoj
strani.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Ulipristalacetat je indiciran za intermitentno liječenje umjerenih do
teških simptoma fibroida
maternice u odraslih žena koje nisu u menopauzi, kada embolizacija
fibroida maternice i/ili kirurško
liječenje nisu prikladni ili nisu bili uspješni.
4.2
DOZIRANJE I NAČIN PRIMJENE
Liječenje lijekom Esmya trebaju započeti i nadzirati liječnici s
iskustvom u dijagnosticiranju i
liječenju fibroida maternice.
Doziranje
Liječenje se sastoji od primjene jedne tablete od 5 mg jednom dnevno
za cikluse liječenja od po
najviše 3 mjeseca. Tablete se mogu uzeti s hranom ili bez nje.
Liječenje treba početi tek kada nastupi menstruacija:
- Prvi ciklus liječenja treba početi tijekom prvog tjedna
menstruacije.
- Ponovne cikluse liječenja treba početi najranije tijekom prvog
tjedna druge menstruacije koja nastupi
nakon završetka prethodnog ciklusa liječenja.
Liječnik bolesnicu mora upozoriti na potrebu razdoblja bez
liječenja.
Ponovljeno intermitentno liječenje ispitivano je u trajanju do 4
intermitentna ciklusa.
Ako bolesnica propusti dozu, treba uzeti ulipristalacetat što je
prije moguće. Ako je doza propuštena
za više od 12 sati, bolesnica ne smije uzeti propuštenu dozu već
jednostavno nastaviti primjenjivati
uobičajeni raspored doziranja.
_Posebne populacije _
_Oštećenje bubrežne funkcije _
Nije potrebna prilagodba doze u bolesnica s blagim ili umjerenim
oštećenjem bubrežne funkcije. U
nedostatku specifičnih ispitivanja ulipristalacetat ne preporučuje
se u liječenju bolesnica s teškim
oštećenjem bubrežne funkcije osim ako bolesnica nije pod strogim
nadzorom (vidjeti dijelove 4.4 i
5.2)
                                
                                Read the complete document

Similar products

Active ingredient ulipristal acetat

ulipristal acetat

ATC code G03XB02

G03XB02

Marketed by Gedeon Richter Ltd 

Gedeon Richter Ltd 

INN (International Name) ulipristal

ulipristal

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