Ebixa

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
05-01-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
05-01-2022

Active ingredient:

memantin hidroklorid

Available from:

H. Lundbeck A/S

ATC code:

N06DX01

INN (International Name):

memantine

Therapeutic group:

Ostali lijekovi protiv demencije

Therapeutic area:

Alzheimerova bolest

Therapeutic indications:

Liječenje bolesnika s umjerenom ili teškom Alzheimerovom bolesti.

Product summary:

Revision: 26

Authorization status:

odobren

Authorization date:

2002-05-15

Patient Information leaflet

                                60
B. UPUTA O LIJEKU
61
UPUTA O LIJEKU: INFORMACIJA ZA KORISNIKA
EBIXA 10 MG FILMOM OBLOŽENE TABLETE
memantinklorid
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 Ebixa i za što se koristi
2.
Što morate znati prije nego počnete uzimati Ebixu
3.
Kako uzimati Ebixu
4.
Moguće nuspojave
5.
Kako čuvati Ebixu
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE EBIXA I ZA ŠTO SE KORISTI
KAKO DJELUJE EBIXA
Ebixa sadrži djelatnu tvar memantinklorid. Ona pripada skupini
lijekova poznatih kao lijekovi protiv
demencije.
Gubitak pamćenja u Alzheimerovoj bolesti pripisuje se poremećaju
prijenosa signala u mozgu. Mozak
sadržava takozvane N-metil-D-aspartat (NMDA) receptore koji su
uključeni u prijenos živčanih signala
važnih u učenju i pamćenju. Ebixa spada u skupinu lijekova poznatih
kao antagonisti NMDA receptora.
Ebixa djeluje na navedene NMDA receptore poboljšavajući prijenos
živčanih signala i pamćenje.
Ebixa se koristi za liječenje bolesnika s umjerenom do teškom
Alzheimerovom bolešću.
2.
ŠTO MORATE ZNATI PRIJE NEGO POČNETE UZIMATI EBIXU
NEMOJTE UZIMATI EBIXU
-
ako ste alergični na memantin ili neki drugi sastojak ovog lijeka
(naveden u dijelu 6.).
UPOZORENJA I MJERE OPREZA
Obratite se svom liječniku ili ljekarniku prije nego uzmete Ebixu:
-
ako u anamnezi imate epileptičke napadaje,
-
ako ste nedavno imali infarkt miokarda (srčani udar), ili ako
bolujete od kongestivnog zatajenja
srca ili nekontrolirane hipertenzije (povišeni krvni tla
                                
                                Read the complete document

Summary of Product characteristics

                                1
DODATAK I
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
Ebixa 10 mg filmom obložene tablete
Ebixa 20 mg filmom obložene tablete
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Svaka filmom obložena tableta sadrži 10 mg memantinklorida, što
odgovara 8,31 mg memantina.
Svaka filmom obložena tableta sadrži 20 mg memantinklorida, što
odgovara 16,62 mg memantina.
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Filmom obložena tableta
Ebixa 10 mg filmom obložena tablete
Blijedožuta do žuta filmom obložena tableta ovalnog oblika, s
razdjelnom crtom i ugraviranim
oznakama “1 0” na jednoj strani i “M M” na drugoj strani.
Tableta se može razdijeliti na jednake doze.
Ebixa 20 mg filmom obložena tablete
Blijedocrvene do sivo crvene duguljaste ovalne filmom obložene
tablete s ugraviranim oznakama “20”
na jednoj strani i “MEM” na drugoj strani.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Liječenje odraslih bolesnika s umjerenom do teškom Alzheimerovom
bolešću.
4.2
DOZIRANJE I NAČIN PRIMJENE
Liječenje mora započeti i nadzirati liječnik koji ima iskustva u
dijagnosticiranju i liječenju
Alzheimerove demencije.
Doziranje
Terapiju treba započeti samo ako je dostupan njegovatelj koji će
redovito nadzirati bolesnikovo
uzimanje lijeka. Dijagnozu treba postaviti prema važećim
smjernicama.
Podnošljivost i doziranje memantina treba redovito ponovno
procjenjivati, po mogućnosti unutar tri
mjeseca od početka liječenja. Nakon toga, klinička korist memantina
i podnošljivost liječenja trebaju
biti redovito ponovno procjenjivane u skladu s kliničkim smjernicama.
Terapija održavanja može se
nastaviti toliko dugo dok je terapijska korist povoljna, i dok
bolesnik dobro podnosi liječenje
memantinom. Kada više ne postoji dokaz terapijskog učinka ili ako
bolesnik ne podnosi liječenje,
treba razmotriti prekid liječenja memantinom.
_Odrasli_
_Titriranje doze _
Maksimalna dnevna doza je 20 mg na dan. Radi smanjenja rizika od
nuspojava, doza održavanja se
postiže pove
                                
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Active ingredient memantin hidroklorid

memantin hidroklorid

ATC code N06DX01

N06DX01

Marketed by H. Lundbeck A/S

H. Lundbeck A/S

INN (International Name) memantine

memantine

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