Ivel 1 mg filmom obložene

Glavna informacija

  • Trgovački naziv:
  • Ivel 1 mg filmom obložene tablete
  • Doziranje:
  • 1 mg
  • Farmaceutski oblik:
  • filmom obložena tableta
  • Sastav:
  • Urbroj: jedna filmom obložena tableta sadrži 1 mg anastrozola
  • Tip recepta:
  • na recept, u ljekarni ograničeni recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Genera d.d., Rakov Potok, Republika Hrvatska

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Ivel 1 mg filmom obložene tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 28 tableta u blisteru, u kutiji [HR-H-428240035-01] Urbroj: 381-12-01/70-17-26

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-428240035
  • Datum autorizacije:
  • 02-11-2017
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

UPUTA O LIJEKU

Ivel 1 mg filmom obložene tablete

anastrozol

Prije uzimanja lijeka pažljivo pročitajte uputu!

Čuvajte ovu uputu jer Vam može ponovno zatrebati.

Ako imate dodatna pitanja, obratite se svom liječniku ili ljekarniku.

Ovaj je lijek propisan Vama osobno i ne smijete ga davati drugima jer im može

štetiti čak i ako imaju simptome jednake Vašima.

Ukoliko primijetite bilo koju nuspojavu, obavijestite o tome svog liječnika ili

ljekarnika. To uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi.

U ovoj uputi možete pronaći sljedeće odgovore:

Što su Ivel tablete i za što se koriste

Što morate znati prije početka uzimanja Ivel tableta

Kako uzimati Ivel tablete

Moguće nuspojave

Kako čuvati Ivel tablete

Dodatne informacije

1.

Što su Ivel tablete i za što se koriste

Ivel tablete sadržavaju djelatnu tvar anastrozol koja pripada skupini inhibitora aromataze.

Anastrozol je namijenjen za liječenje uznapredovanog raka dojke žena u postmenopauzi.

Djeluje na snižavanje količine hormona koji se zove estrogen, a stvara se u tijelu. Čini to na

način da blokira enzim koji se zove aromataza.

2.

Što morate znati prije početka uzimanja Ivel tableta

Nemojte uzimati Ivel tablete:

ako ste alergični (preosjetljivi) na anastrozol ili bilo koji sastojak lijeka (vidjeti dio 6.)

ako ste trudnica ili dojilja (vidjeti dijelove „Trudnoća“ i „Dojenje“)

Nemojte uzimati Ivel tablete ako se bilo što od navedenog odnosi na Vas. Ako niste

sigurni, pitajte svog liječnika ili ljekarnika prije nego počnete uzimati Ivel tablete.

Budite oprezni s uzimanjem Ivel tableta:

ako još uvijek imate redoviti menstrualni ciklus i niste ušli u menopauzu

ako uzimate lijekove koji sadrže tamoksifen ili lijekove koji sadrže estrogen (vidjeti

dio „Uzimanje drugih lijekova“)

ako ste ikada bolovali od bolesti koje utječu na čvrstoću Vaših kostiju (osteoporoza)

ako imate problema s jetrom ili bubrezima

Ukoliko niste sigurni da se bilo što od navedenog odnosi na Vas, pitajte svog liječnika ili

ljekarnika prije nego počnete uzimati Ivel tablete.

Pri odlasku u bolnicu ili drugi medicinsku ustanovu, kažite medicinskom osoblju da

uzimate Ivel tablete.

Uzimanje drugih lijekova

Obavijestite svog liječnika ako uzimate ili ste nedavno uzimali bilo kakve lijekove,

uključujući one koje kupujete bez recepta i biljne lijekove. Neki lijekovi mogu utjecati na

djelotvornost anastrozola kao što i anastrozol može utjecati na njihovu djelotvornost.

Budite pažljivi tijekom istodobne primjene Ivel tableta i sljedećih lijekova:

H A L M E D

02 - 11 - 2017

O D O B R E N O

tamoksifen, zato što tamoksifen može zaustaviti pravilno djelovanje anastrozola

pripravci koji sadržavaju estrogen kao što je hormonska nadomjesna terapija

Obavijestite

svog

liječnika

ljekarnika

uzimate

LHRH

agoniste

(gonadorelin,

buserelin, goserelin, leuprorelin i triptorelin). To su lijekovi za liječenje raka dojke i nekih

ginekoloških bolesti žena i neplodnosti.

Trudnoća

Ivel tablete nemojte uzimati tijekom trudnoće. Prije uzimanja bilo kojeg lijeka tijekom

trudnoće upitajte za savjet svog liječnika ili ljekarnika.

Dojenje

Ivel tablete nemojte uzimati tijekom dojenja. Prije uzimanja bilo kojeg lijeka tijekom dojenja

pitajte za savjet svog liječnika ili ljekarnika.

Upravljanje vozilima i strojevima

Nije vjerojatno da bi Ivel tablete umanjile sposobnost upravljanja motornim vozilima ili

strojevima. Ipak, pri uzimanju anastrozola opisane su pojave slabosti i pospanosti, stoga se

preporučuje oprez pri upravljanju motornim vozilima ili strojevima.

Važne informacije vezane uz učinak nekih pomoćnih tvari

Ivel tablete sadržavaju laktozu. Ako Vam je liječnik rekao da imate bolest nepodnošenja

nekih šećera, prije nego što počnete uzimati ovaj lijek posavjetujte se sa svojim liječnikom.

3.

Kako uzimati Ivel tablete

Uvijek uzimajte Ivel tablete točno prema uputi liječnika. Raspitajte se kod svog liječnika ili

ljekarnika ako niste posve sigurni kako trebate uzimati Ivel tablete.

Ivel tablete se uzimaju jednom dnevno.

Pokušajte uzimati tabletu uvijek u isto vrijeme u danu.

Progutajte je cijelu s vodom.

Nije važno uzmete li Ivel tablete prije, za vrijeme ili poslije jela.

Nastavite s uzimanjem Ivel tableta onoliko dugo koliko Vam je odredio liječnik. Liječenje je

dugotrajno i možda ćete trebati uzimati Ivel tablete i nekoliko godina.

Upotreba u djece i adolescenata

Ivel tablete se ne smiju primjenjivati u djece i adolescenata.

Što ako ste uzeli veću dozu Ivel tableta nego što ste trebali

Ako uzmete više Ivel tableta nego što smijete, odmah o tome obavijestite svog liječnika.

Što ako ste zaboravili uzeti Ivel tablete

Ako ste zaboravili uzeti svoju dozu, uzmite je čim ste u mogućnosti, osim ako je vrijeme za

sljedeću dozu. Ne uzimajte dvostruku dozu da biste nadoknadili zaboravljenu tabletu.

Što ako prestanete uzimati Ivel tablete

Ne prekidajte uzimanje lijeka osim ako Vam to nije savjetovao liječnik.

U slučaju bilo kakvih nejasnoća ili pitanja u vezi s uzimanjem Ivel tableta obratite se svom

liječniku ili ljekarniku.

H A L M E D

02 - 11 - 2017

O D O B R E N O

4.

Moguće nuspojave

Kao i svi drugi lijekovi i ovaj lijek može izazvati nuspojave, iako se one ne moraju pojaviti

u svih.

Vrlo česte nuspojave (više od 1 od 10 osoba):

glavobolja

navale vrućine (valunzi)

osjećaj slabosti (mučnina)

kožni osip

bol ili ukočenost u zglobovima

upala zglobova (artritis)

osjećaj slabosti

gubitak gustoće kostiju (osteoporoza)

Česte nuspojave (1 do 10 od 100 osoba):

gubitak apetita

povišene ili visoke razine masnih tvari poznate kao kolesterol u krvi, vidljiv u

krvnim pretragama

osjećaj pospanosti

sindrom karpalnog kanala (trnci, bol, hladnoća, slabost u nekim dijelovima ruke)

proljev

osjećaj slabosti (povraćanje)

promjene u krvnim testovima koji pokazuju koliko dobro radi Vaša jetra

stanjivanje kose (gubitak kose)

alergijske reakcije lica, usana ili jezika

bol u kostima

suhoća rodnice

krvarenje iz vagine (obično u prvih nekoliko tjedana liječenja - ako se krvarenje

nastavi, razgovarajte sa svojim liječnikom)

bol u mišićima

Manje česte nuspojave (1 do 10 od 1000 osoba):

promjene u jetrenim krvnim testovima koji pokazuju kako radi Vaša jetra (gama-GT i

bilirubin)

upala jetre (hepatitis)

osip ili urtikarija

„škljocavi“ (eng. trigger) prst (stanje u kojem se prst ili palac nalaze u zakrivljenom

položaju)

povećanje količine kalcija u krvi. Ako osjetite mučninu, povraćanje i žeĎ, trebali biste

obavijestiti svog liječnika, ljekarnika ili medicinsku sestru jer ćete možda morati ići

na krvnu pretragu.

Rijetke nuspojave (1 do 10 na 10000 osoba):

rijetka upala kože koja može uključivati crvene mrlje ili plikove

kožni osip uzrokovan preosjetljivošću (to može biti od alergijske reakcije ili

anafilaktoidne reakcije)

upala malih krvnih žila koja uzrokuju nastanak crvene ili ljubičaste boje kože. Vrlo

rijetko se mogu pojaviti bol u zglobovima, želucu i bubrezima poznat kao

„Henoch-Schönleinova purpura“ .

H A L M E D

02 - 11 - 2017

O D O B R E N O

Vrlo rijetke nuspojave (manje od 1 na 10000 osoba):

izuzetno teška reakcija kože s defektima ili plikovima na koži. Ova reakcija poznata je

kao „Stevens-Johnsonov sindrom“.

alergijske reakcije (preosjetljivost) koje rezultiraju oticanjem grla koje može

uzrokovati poteškoće u gutanju ili disanju (angioedem)

Ako Vam se dogodi bilo što od navedenog odmah pozovite hitnu pomoć ili posjetite liječnika

jer će Vam možda biti potrebno hitno liječenje.

Učinci na kosti

Anastrozol smanjuje količinu hormona estrogena u tijelu, što može smanjiti mineralni sadržaj

kostiju. Kosti mogu postati manje čvrste i sklonije puknuću.

Vaš liječnik će procijeniti rizike i utjecaj na zdravlje Vaših kostiju.

Razgovarajte sa svojim liječnikom o rizicima i mogućnostima liječenja.

Ako bilo koja od nuspojava postane ozbiljna ili ako primijetite bilo koju nuspojavu koja nije

navedena u ovoj uputi, obavijestite svog liječnika ili ljekarnika.

5.

Kako čuvati Ivel tablete

Čuvati izvan pogleda i dohvata djece.

Lijek ne zahtijeva posebne uvjete čuvanja.

Tablete se ne smiju upotrebljavati nakon isteka roka valjanosti navedenog na pakovanju.

Lijekovi se ne smiju odbacivati u odvod ili kućno smeće. Pitajte Vašeg ljekarnika kako

odložiti lijek koji više ne trebate. Ove mjere pridonose zaštiti okoliša.

6.

Dodatne informacije

Što sadržavaju Ivel tablete

Djelatna tvar u Ivel tabletama je anastrozol.

Pomoćne tvari:

Jezgra tablete: laktoza hidrat; povidon; natrijev škroboglikolat, vrsta A; magnezijev stearat

Ovojnica tablete: hipromeloza, makrogol 300, titanijev dioksid (E171)

Kako izgledaju Ivel tablete i sadržaj pakovanja

Filmom obložena tableta.

Ivel 1 mg filmom obložene tablete su bijele do skoro bijele, okrugle, bikonveksne, filmom

obložene tablete s utisnutom oznakom „AHI“ na jednoj strani tablete.

28 (2x14) tableta u PVC/PVdC//Al blister pakovanju, u kutiji.

Ime i adresa nositelja odobrenja za stavljanje lijeka u promet i proizvoĎača lijeka

Nositelj odobrenja:

Mylan Hrvatska d.o.o.,

Koranska 2

10000 Zagreb

ProizvoĎač:

Genera d.d

Svetonedeljska 2

Kalinovica, 10436 Rakov Potok

Način i mjesto izdavanja lijeka

Na recept, u ljekarni.

H A L M E D

02 - 11 - 2017

O D O B R E N O

Datum revizije upute

Studeni, 2017.

H A L M E D

02 - 11 - 2017

O D O B R E N O

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