Libertek

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
08-02-2018
Summary of Product characteristics Summary of Product characteristics (SPC)
08-02-2018
Public Assessment Report Public Assessment Report (PAR)
08-02-2018

Active ingredient:

roflumilast

Available from:

AstraZeneca AB

ATC code:

R03DX08

INN (International Name):

roflumilast

Therapeutic group:

Lijekovi za opstruktivne plućne bolesti dišnih putova,

Therapeutic area:

Plućna bolest, kronična opstruktivna

Therapeutic indications:

Libertek je indiciran za terapiju održavanja teške kronične opstruktivne plućne bolesti (KOPB) (FEV1 manji od 50% predvidjeti) povezane s kroničnim bronhitisom kod odraslih bolesnika s učestalim egzacerbacijama kao dodatak bronhodilatatorima.

Product summary:

Revision: 11

Authorization status:

povučen

Authorization date:

2011-02-28

Patient Information leaflet

                                23
B. UPUTA O LIJEKU
Lijek koji više nije odobren
24
UPUTA O LIJEKU: INFORMACIJA ZA BOLESNIKA
LIBERTEK 500 MIKROGRAMA FILMOM OBLOŽENE TABLETE
roflumilast
Ovaj je lijek pod dodatnim praćenjem.Time se omogućuje brzo
otkrivanje novih sigurnosnih
informacija. Prijavom svih sumnji na nuspojavu i Vi možete pomoći.
Za postupak prijavljivanja
nuspojava, pogledajte dio 4.
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
štetiti, 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 Libertek i za što se koristi
2.
Što morate znati prije nego počnete uzimati Libertek
3.
Kako uzimati Libertek
4.
Moguće nuspojave
5.
Kako čuvati Libertek
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE LIBERTEK I ZA ŠTO SE KORISTI
Libertek sadrži djelatnu tvar roflumilast, a to je protuupalni lijek
koji zovemo inhibitorom
fosfodiesteraze-4. Roflumilast smanjuje aktivnost fosfodiesteraze-4,
proteina koji se prirodno javlja u
tjelesnim stanicama. Pri smanjenoj aktivnosti tog proteina smanjuje se
upala u plućima. Time se
zaustavlja sužavanje dišnih puteva koje se javlja u KRONIČNOJ
OPSTRUKTIVNOJ PLUĆNOJ BOLESTI (KOPB).
Libertek stoga ublažava teškoće s disanjem.
Libertek se koristi za terapiju održavanja teškog KOPB-a kod
odraslih koji su u prošlosti imali često
pogoršanje simptoma KOPB-a (takozvane egzacerbacije) i koji imaju
kronični bronhitis. KOPB je
kronična plućna bolest čije su posljedice stezanje dišnih putova
(opstrukcija), te oticanje i nadražaj
stijenki malih dišnih puteva (upala). To dovodi do simptoma poput
ka
                                
                                Read the complete document

Summary of Product characteristics

                                1
DODATAK I
SAŽETAK OPISA SVOJSTAVA LIJEKA
Lijek koji više nije odobren
2
Ovaj je lijek pod dodatnim praćenjem.Time se omogućuje brzo
otkrivanje novih sigurnosnih
informacija. Od zdravstvenih djelatnika se traži da prijave svaku
sumnju na nuspojavu za ovaj lijek. Za
postupak prijavljivanja nuspojava vidjeti dio 4.8.
1.
NAZIV LIJEKA
Libertek 500 mikrograma filmom obložene tablete
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Jedna tableta sadrži 500 mikrograma roflumilasta.
Pomoćna tvar s poznatim učinkom:
Jedna filmom obložena tableta sadrži 188,72 mg laktoze (u obliku
hidrata).
Za cjeloviti popis pomoćnih tvari, vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Filmom obložena tableta (tableta).
Žuta, filmom obložena tableta u obliku slova D od 9 mm, s utisnutim
„D“ s jedne strane.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Libertek je indiciran za terapiju održavanja teške kronične
opstruktivne plućne bolesti (KOPB)
(postbronhodilatacijski FEV
1
manji od 50% predviđenog) povezane s kroničnim bronhitisom kod
odraslih bolesnika s učestalim egzacerbacijama u anamnezi, kao
dodatak liječenju bronhodilatatorima.
4.2
DOZIRANJE I NAČIN PRIMJENE
Doziranje
Preporučena doza je 500 mikrograma (jedna tableta) roflumilasta
jedanput na dan.
Libertek je ponekad potrebno uzimati više tjedana da bi se postigao
učinak (vidjeti dio 5.1). U kliničkim
ispitivanjima ispitana je primjena Liberteka u trajanju do godine
dana.
Posebne populacije bolesnika
_Stariji _
Nije potrebna prilagodba doze.
_Oštećenje funkcije bubrega_
Nije potrebna prilagodba doze.
_Oštećenje funkcije jetre_
Klinički podaci o primjeni Liberteka kod bolesnika s blagim
oštećenjem jetre klasificiranim kao
Child-Pugh A nisu dovoljni da bi se preporučilo smanjenje doze
(vidjeti dio 5.2), stoga Libertek kod tih
bolesnika treba koristiti uz oprez.
Lijek koji više nije odobren
3
Bolesnici s umjerenim i teškim oštećenjem jetre klasificiranim kao
Child-Pugh B ili C ne smiju uzimati
Libertek (vidjeti dio 4.3).
_Pedijatrijski bolesnici_
Nema relev
                                
                                Read the complete document

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Active ingredient roflumilast

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ATC code R03DX08

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INN (International Name) roflumilast

roflumilast

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