Nixar 20 mg tablete

Glavna informacija

  • Trgovački naziv:
  • Nixar 20 mg tablete
  • Doziranje:
  • 20 mg
  • Farmaceutski oblik:
  • tableta
  • Sastav:
  • Urbroj: jedna tableta sadrži 20 mg bilastina
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Faes Farma S.A., Leioa (Vizcaya), Španjolska; Menarini-Von Heyden GmbH, Dresden, Njemačka; A. Menarini Manufacturing Logistics

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Nixar 20 mg tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 10 tableta u blisteru, u kutiji [HR-H-535007756-01]; 20 tableta u blisteru, u kutiji [HR-H-535007756-02] Urbroj: 381-12-01/30-18-04

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-535007756
  • Datum autorizacije:
  • 12-01-2018
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

Nixar 20 mg tablete

bilastin

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 Vašem 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 Vašeg liječnika ili ljekarnika. To

uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte dio 4.

Što se nalazi u ovoj uputi:

Što je Nixar

i za što se koristi?

Što morate znati prije nego počnete uzimati Nixar?

Kako uzimati Nixar?

Moguće nuspojave

Kako čuvati Nixar

Sadržaj pakiranja i druge informacije

1.

Što je Nixar i za što se koristi?

Nixar

sadrži djelatnu tvar bilastin, koji je antihistaminik. Nixar

se koristi za ublažavanje simptoma

peludne hunjavice (kihanje, svrbež nosa, curenje iz nosa i začepljen nos, crvene i suzne oči) i ostalih

oblika alergijskog rinitisa. Može se koristiti i za liječenje kožnog osipa koji svrbi (koprivnjača ili

urtikarija).

2.

Što morate znati prije nego počnete uzimati Nixar?

Nemojte uzimati Nixar

ako ste alergični na bilastin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).

Upozorenja i mjere opreza

Obratite se Vašem liječniku ili ljekarniku prije nego uzmete Nixar ako imate umjereno ili teško

oštećenje funkcije bubrega, a još dodatno uzimate druge lijekove (vidjeti„ Drugi lijekovi i Nixar“).

Djeca

Nemojte davati lijek djeci mlađoj od 12 godina.

Nemojte prekoračivati preporučenu dozu. Ako simptomi potraju, posavjetujte se s liječnikom.

Drugi lijekovi i Nixar

Obavijestite Vašeg liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje

druge lijekove, uključujući i one koje ste nabavili bez recepta

Osobito se posavjetujte s liječnikom ako uzimate neki od sljedećih lijekova:

ketokonazol (lijek protiv gljivica)

eritromicin (antibiotik)

diltiazem (za liječenje angine pektoris)

H A L M E D

12 - 01 - 2018

O D O B R E N O

ciklosporin

smanjenje

aktivnosti

imunološkog

sustava

radi

sprječavanja

odbacivanja

presađenog organa ili radi smanjenja aktivnosti bolesti kod autoimunih i alergijskih poremećaja,

poput psorijaze, atopijskog dermatitisa i reumatoidnog artritisa)

ritonavir (za liječenje HIV infekcije)

rifampicin (antibiotik).

Nixar s hranom, pićem i alkoholom

Ove tablete ne smiju se uzimati s hranom, sokom od grejpa ni s drugim voćnim sokovima jer će se

time smanjiti učinak bilastina. Kako biste to izbjegli, možete:

uzeti tabletu i pričekati jedan sat prije nego što uzmete hranu ili voćni sok, ili

ako ste uzeli hranu ili voćni sok, pričekati dva sata prije nego što uzmete tabletu.

Bilastin u preporučenoj dnevnoj dozi (20 mg) ne pojačava

omamljenost nastao konzumacijom

alkohola.

Trudnoća, dojenje i plodnost

Ne postoje ili su ograničeni podaci o primjeni bilastina kod trudnica i tijekom dojenja i utjecaja na

plodnost.

Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate trudnoću, obratite se Vašem

liječniku za savjet prije nego uzmete ovaj lijek.

Obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek.

Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po doznoj jedinici, tj. zanemarive količine natrija.

Upravljanje vozilima i strojevima

Ispitivanje utjecaja na sposobnost upravljanja vozilima pokazalo je da uzimanje Nixara u dozi od 20

mg ne utječe na tu sposobnost. No, vrlo rijetko se u nekih ljudi javi omamljenost, što može utjecati na

njihovu sposobnost upravljanja vozilima i rada sa strojevima.

3.

Kako uzimati Nixar?

Uvijek uzmite ovaj lijek točno onako kako Vam je rekao Vaš liječnik ili ljekarnik. Provjerite s Vašim

liječnikom ili ljekarnikom ako niste sigurni.

Preporučena doza za odrasle, uključujući starije osobe i adolescente u dobi od 12 godina i

starije je jedna tableta (20 mg) dnevno.

Tableta se uzima kroz usta.

Tableta se mora uzeti na prazan želudac, primjerice ujutro prije doručka. Ne smijete jesti jedan

sat nakon uzimanja Nixara (vidjeti dio 2, Nixar s hranom, pićem i alkoholom)

Tabletu progutajte uz čašu vode.

Urez služi samo da Vam pomogne prelomiti tabletu, ako je ne možete progutati cijelu.

Što se tiče trajanja liječenja, liječnik će utvrditi od koje bolesti patite i odrediti koliko dugo trebate

uzimati Nixar.

Primjena u djece

Nemojte davati ovaj lijek djeci mlađoj od 12 godina.

Ako uzmete više Nixara nego što ste trebali

Uzmete li Vi ili netko drugi previše Nixara treba se odmah javiti liječniku ili ljekarniku.

Ako ste zaboravili uzeti Nixar

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.

Zaboravite li uzeti dozu lijeka na vrijeme, uzmite je čim bude moguće, a zatim lijek nastavite uzimati

po uobičajenom rasporedu.

H A L M E D

12 - 01 - 2018

O D O B R E N O

Ako imate bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se Vašem liječniku ili

ljekarniku.

4.

Moguće nuspojave

Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće pojaviti kod svakoga.

Nuspojave koje se javljaju mogu biti:

Česte: mogu se javiti u manje od 1 na 10 osoba

glavobolja

omamljenost

Manje česte: mogu se javiti u manje od 1 na 100 osoba

abnormalni nalaz EKG-a

krvne pretrage koje pokazuju promjene u radu jetre

omaglica

bol u želucu

umor

pojačan apetit

nepravilni otkucaji srca

povećana tjelesna težina

mučnina

tjeskoba

suh nos ili neugodan osjećaj u nosu

bol u trbuhu

proljev

gastritis (upala želučane stijenke)

vrtoglavica

osjećaj slabosti

žeđ

dispneja (otežano disanje)

suha usta

otežana probava

svrbež

groznica (oralni herpes)

vrućica

tinitus (zvonjava u ušima)

teškoće sa spavanjem

krvne pretrage koje pokazuju promjene u radu bubrega

povišene masnoće u krvi.

Nepoznata učestalost: ne može se procijeniti iz dostupnih podataka:

palpitacije (osjećaj lupanja srca)

tahikardija (ubrzan rad srca)

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti

Vašeg liječnika ili ljekarnika. To

uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Nuspojave možete prijaviti

izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

H A L M E D

12 - 01 - 2018

O D O B R E N O

5.

Kako čuvati Nixar?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake

EXP. Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.

Lijek ne zahtijeva posebne uvjete čuvanja.

Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad. Pitajte Vašeg ljekarnika kako

baciti lijekove koje više ne koristite. Ove će mjere pomoći u očuvanju okoliša.

6.

Sadržaj pakiranja i druge informacije

Što Nixar

sadrži?

Djelatna tvar je bilastin. Jedna tableta sadrži 20 mg bilastina.

Druge pomoćne tvari su mikrokristalična celuloza, natrijev škroboglikolat vrste A (dobiven iz

krumpira), silicijev dioksid, koloidni, bezvodni, magnezijev stearat.

Kako Nixar

izgleda i sadržaj pakiranja?

Nixar

tablete su bijele, ovalne, dvostruko ispupčene, s urezom (duljina 10 mm, širina 5 mm).

Tablete su dostupne u blister pakiranjima od 10 ili 20 tableta.

U prometu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet i proizvoĎač

Nositelj odobrenja

Menarini International Operations Luxembourg S.A.

1, Avenue de la Gare

L-1611 Luksemburg

Luksemburg

ProizvoĎači

Faes Farma S.A.

Máximo Aguirre, 14

48940 Leioa (Vizcaya)

Španjolska

A. Menarini Manufacturing Logistics and Services S.r.l.

Via Campo di Pile

67100 L'Aquila

Italija

Menarini – Von Heyden GmbH

Leipziger Strasse 7-13

01097 Dresden

Njemačka

Predstavnik nositelja odobrenja za Republiku Hrvatsku

Berlin-Chemie Menarini Hrvatska d.o.o., Horvatova 80/A, 10 020 Zagreb

Tel: 01/4821361

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u siječnju 2018.

H A L M E D

12 - 01 - 2018

O D O B R E N O

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Otezla (Celgene Europe B.V.)

Otezla (Celgene Europe B.V.)

Otezla (Active substance: apremilast) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5391 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3746/T/20

Europe -DG Health and Food Safety

30-7-2018

Esmya (Gedeon Richter Plc.)

Esmya (Gedeon Richter Plc.)

Esmya (Active substance: ulipristal) - Referral - Commission Decision (2018)5101 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2041/A-20

Europe -DG Health and Food Safety

22-7-2018

Even when Essure is no longer sold, the #FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events and publicly communicate any new safety findings on this - and any other device. ht

Even when Essure is no longer sold, the #FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events and publicly communicate any new safety findings on this - and any other device. ht

Even when Essure is no longer sold, the #FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events and publicly communicate any new safety findings on this - and any other device. https://www.bloomberg.com/news/articles/2018-07-20/bayer-to-stop-selling-contraceptive-implant-after-threats-by-fda …

FDA - U.S. Food and Drug Administration

20-7-2018

Agenda:  Agenda - CAT agenda of the 18-20 July 2018 meeting

Agenda: Agenda - CAT agenda of the 18-20 July 2018 meeting

Committee for Advanced Therapies (CAT) agenda for the meeting on 18-20 July 2018

Europe - EMA - European Medicines Agency

4-7-2018

Lemtrada (Genzyme Therapeutics Ltd)

Lemtrada (Genzyme Therapeutics Ltd)

Lemtrada (Active substance: Alemtuzumab) - Centralised - Renewal - Commission Decision (2018) 4348 of Wed, 04 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3718/R/20

Europe -DG Health and Food Safety

29-6-2018

A past diagnosis of asthma is also associated with #COPD in 20% of the cases. Visit  https://bit.ly/1xErH2t  to learn more. #FactFridaypic.twitter.com/JWK672XtdI

A past diagnosis of asthma is also associated with #COPD in 20% of the cases. Visit https://bit.ly/1xErH2t  to learn more. #FactFridaypic.twitter.com/JWK672XtdI

A past diagnosis of asthma is also associated with #COPD in 20% of the cases. Visit https://bit.ly/1xErH2t  to learn more. #FactFriday pic.twitter.com/JWK672XtdI

FDA - U.S. Food and Drug Administration

29-6-2018

EU/3/18/2030 (Biophytis)

EU/3/18/2030 (Biophytis)

EU/3/18/2030 (Active substance: 20-hydroxyecdysone) - Orphan designation - Commission Decision (2018)4175 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/18

Europe -DG Health and Food Safety