Champix

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
31-10-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
31-10-2023
Public Assessment Report Public Assessment Report (PAR)
03-04-2014

Active ingredient:

varenicline

Available from:

Pfizer Europe MA EEIG

ATC code:

N07BA03

INN (International Name):

varenicline

Therapeutic group:

Ostali lijekovi protiv živčanog sustava

Therapeutic area:

Ukidanje uporabe duhana

Therapeutic indications:

Champix je indiciran za prestanak pušenja kod odraslih osoba.

Product summary:

Revision: 38

Authorization status:

odobren

Authorization date:

2006-09-25

Patient Information leaflet

                                118
B. UPUTA O LIJEKU
119
UPUTA O LIJEKU: INFORMACIJE ZA KORISNIKA
CHAMPIX 0,5 MG FILMOM OBLOŽENE TABLETE
CHAMPIX 1 MG FILMOM OBLOŽENE TABLETE
vareniklin
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 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 CHAMPIX i za što se koristi
2.
Što morate znati prije nego počnete uzimati CHAMPIX
3.
Kako uzimati CHAMPIX
4.
Moguće nuspojave
5.
Kako čuvati CHAMPIX
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE CHAMPIX I ZA ŠTO SE KORISTI
CHAMPIX sadrži djelatnu tvar vareniklin. CHAMPIX je lijek koji se
koristi u odraslih kao pomoć
kod prestanka pušenja.
CHAMPIX može pomoći ublažiti žudnju i simptome ustezanja povezane
s prestankom pušenja.
CHAMPIX može umanjiti užitak pušenja cigareta ako ipak pušite
tijekom liječenja.
2.
ŠTO MORATE ZNATI PRIJE NEGO ŠTO POČNETE UZIMATI CHAMPIX
NEMOJTE UZIMATI CHAMPIX:
-
ako ste alergični na vareniklin ili neki drugi sastojak ovog lijeka
(naveden u dijelu 6.)
UPOZORENJA I MJERE OPREZA
Obratite se svom liječniku ili ljekarniku prije nego uzmete CHAMPIX.
U bolesnika koji su uzimali CHAMPIX zabilježeni su slučajevi
depresije, razmišljanja o
samoubojstvu, samoubilačkog ponašanja i pokušaja samoubojstva. Ako
uzimate CHAMPIX i
postanete uznemireni ili depresivni, ako primijetite promjene u
ponašanju koje zabrinjavaju Vas, Vašu
obitelj ili liječnika, odnosno ako Vam se jave misli o samoubojstvu
ili samoubilačko ponašanje,
odmah prestanite uzimati CHAMPIX i obratite se svom liječniku zbog
procjene liječenja.
_Uč
                                
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Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
CHAMPIX 0,5 mg filmom obložene tablete
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Jedna filmom obložena tableta sadrži 0,5 mg vareniklina (u obliku
vareniklintartarata).
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Filmom obložena tableta dimenzija 4 mm x 8 mm
Bijele, bikonveksne tablete oblika kapsule, s utisnutom oznakom
"_Pfizer_" na jednoj i "CHX 0.5" na
drugoj strani.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
CHAMPIX je indiciran za odvikavanje od pušenja u odraslih.
4.2
DOZIRANJE I NAČIN PRIMJENE
Doziranje
Preporučena doza je 1 mg vareniklina dvaput na dan nakon jednotjedne
titracije prema sljedećem
rasporedu:
1. – 3. dan:
0,5 mg jedanput na dan
4. – 7. dan:
0,5 mg dvaput na dan
8. dan – kraj liječenja:
1 mg dvaput na dan
Bolesnik treba odrediti datum kada će prestati pušiti. S uzimanjem
lijeka CHAMPIX obično treba
započeti 1-2 tjedna prije toga datuma (vidjeti dio 5.1). Bolesnike
treba liječiti lijekom CHAMPIX 12
tjedana.
U bolesnika koji su uspješno prestali pušiti na kraju 12 tjedana,
može se razmotriti dodatni 12-tjedni
ciklus liječenja lijekom CHAMPIX u dozi od 1 mg dvaput na dan za
održavanje apstinencije (vidjeti
dio 5.1).
U bolesnika koji ne mogu ili ne žele naglo prestati pušiti, treba
razmotriti pristup postepenog prestanka
pušenja uz lijek CHAMPIX. Bolesnici moraju smanjiti pušenje tijekom
prvih 12 tjedana liječenja i
prestati do kraja razdoblja liječenja. Bolesnici zatim trebaju
nastaviti uzimati CHAMPIX tijekom
dodatnih 12 tjedana do ukupno 24 tjedna liječenja (vidjeti dio 5.1).
Bolesnici koji su motivirani prestati pušiti, ali nisu u tome uspjeli
tijekom prethodne terapije lijekom
CHAMPIX, ili koji su ponovno počeli pušiti nakon liječenja, mogu
imati koristi od još jednog
pokušaja prestanka pušenja s lijekom CHAMPIX (vidjeti dio 5.1).
U bolesnika koji ne mogu podnijeti nuspojave lijeka CHAMPIX, doza se
može privremeno ili trajno
smanjiti na 0,5 mg dvaput na dan.
3

                                
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Active ingredient varenicline

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ATC code N07BA03

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Marketed by Pfizer Europe MA EEIG

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INN (International Name) varenicline

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