Faktu 100 mg 2 5 mg čepići

Glavna informacija

  • Trgovački naziv:
  • Faktu 100 mg/2,5 mg čepići
  • Doziranje:
  • 100 mg + 2,5 mg
  • Farmaceutski oblik:
  • čepić
  • Sastav:
  • Urbroj: 1 čepić sadrži 100 mg polikrezulena i 2,5 mg cinhokainklorida
  • Tip recepta:
  • na recept, u ljekarni neponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Takeda GmbH Singen, Singen, Njemačka

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Faktu 100 mg/2,5 mg čepići
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 10 čepića u stripu, u kutiji [HR-H-179313303-01] Urbroj: 381-12-01/70-16-12

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-179313303
  • Datum autorizacije:
  • 30-06-2016
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacija za bolesnika

Faktu 100 mg/2,5 mg čepići

polikrezulen, cinhokain

Pažljivo pročitajte cijelu uputu prije nego počnete primjenjivati ovaj lijek jer sadrži Vama važne

podatke.

Sačuvajte 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, vidjeti dio 4.

Što se nalazi u ovoj uputi:

Što su Faktu čepići i za što se koriste?

Što morate znati prije nego počnete primjenjivati Faktu čepiće?

Kako primjenjivati Faktu čepiće?

Moguće nuspojave

Kako čuvati Faktu čepiće?

Sadržaj pakiranja i druge informacije

1.

Što su Faktu čepići i za što se koriste?

Faktu čepići sadrže djelatne tvari polikrezulen i cinhokain.

Faktu čepići su lijek namijenjen liječenju simptoma hemoroida kod odraslih, naročito ako ih prate krvarenje

i upala, rascjepa kože i sluznice u području čmara te svrbeža i ekcema izazvanih oboljenjem završnog dijela

debelog crijeva i čmara. Također se koristi za liječenje rana nakon operacije čmara ili završnog dijela

crijeva.

Polikrezulen

djeluje

hemoroida

bolesno

tkivo,

zdravo

tkivo

nema

utjecaja.

Njegovim

djelovanjem se zaustavlja krvarenje, sprječava vlaženje, potiče cijeljenje i sprječava sekundarna infekcija.

Cinhokain je lokalni anestetik koji smanjuje osjetljivost osjetilnih živaca i olakšava bol i svrbež.

2.

Što morate znati prije nego počnete primjenjivati Faktu čepiće?

Nemojte primjenjivati Faktu čepiće

ako ste alergični na polikrezulen, cinhokain ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6)

ako ste alergični na srodne lokalne anestetike

ako ste alergični na soju ili kikiriki, jer Faktu čepići sadrže spojeve (lecitin) dobivene iz soje.

Upozorenja i mjere opreza

Obratite se svom liječniku prije nego primijenite Faktu:

ako se liječite zbog nepravilnih otkucaja srca (aritmija).

Drugi lijekovi i Faktu čepići

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

lijekove. Nije poznato stupa li lijek Faktu u međudjelovanje s drugim lijekovima.

H A L M E D

30-06-2016

O D O B R E N O

Trudnoća i dojenje

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

ljekarniku za savjet prije nego uzmete ovaj lijek.

Primjena u trudnoći kod ljudi nije ispitana. Faktu čepići se tijekom trudnoće smiju koristiti samo nakon

pažljive procjene liječnika.

Nije poznato izlučuju li se aktivni sastojci u majčino mlijeko. Razgovarajte s liječnikom prije primjene

lijeka Faktu tijekom dojenja. Faktu se tijekom dojenja smije koristiti samo uz pažljivu procjenu liječnika.

Upravljanje vozilima i strojevima

Ne očekuje se utjecaj na sposobnost upravljanja vozilima i strojevima.

3.

Kako primjenjivati Faktu čepiće?

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

liječnikom ili ljekarnikom ako niste sigurni.

Koliko Faktu čepića trebam koristiti i koliko često?

Odrasli

Umetnite 1 čepić u rektum 2-3 puta dnevno. Nakon poboljšanja simptoma, liječenje se može nastaviti s

jednim čepićem dnevno.

Kako i kada koristiti Faktu čepiće?

Faktu čepiće treba umetnuti u rektum ujutro i navečer, te prema potrebi tijekom dana, nakon pražnjenja

crijeva.

Nakon primjene u rektum, moguće je prljanje odjeće jer se čepići na tjelesnoj temperaturi otapaju.

Preporučuje se nošenje uloška ili podloženog donjeg rublja.

Koliko dugo koristiti Faktu čepiće?

Lijek je namijenjen za kratkotrajno ublažavanje simptoma te je primjenu potrebno ograničiti na najviše 2

tjedna. Ukoliko su i dalje prisutni simptomi, obratite se Vašem liječniku.

Primjena u djece i adolescenata

Nema podataka o primjeni u djece i adolescenata u dobi ispod 18 godina.

Ako primijenite više Faktu čepića nego što ste trebali

Ukoliko ste upotrijebili previše Faktu čepića, obavijestite svog liječnika. U slučaju nenamjernog gutanja,

odmah se javite liječniku.

Ako ste zaboravili primijeniti Faktu čepiće

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu. Nastavite liječenje u propisanim

intervalima.

U slučaju bilo kakvih nejasnoća ili pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku ili

ljekarniku.

4.

Moguće nuspojave

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

H A L M E D

30-06-2016

O D O B R E N O

Ako primijetite sljedeće nuspojave, odmah prestanite primjenjivati lijek:

ozbiljne alergijske reakcije (vrlo rijetke, mogu se javiti u manje od 1 na 10 000 osoba):

npr. bolno oticanje kože i potkožnog tkiva, oticanje grkljana,koprivnjača. Takve reakcije mogu

zahvatiti cijelo tijelo i napredovati sve do anafilaktičkog šoka.

Savjetujte se sa svojim liječnikom ili

se javite u hitnu službu najbliže zdravstvene ustanove.

kontaktne alergijske reakcije (vrlo rijetke, mogu se javiti u manje od 1 na 10000 osoba)

upalno crvenilo kože sa stvaranjem mjehurića uz stalan svrbež.

Savjetujte sa sa svojim liječnikom.

Ostale nuspojave su:

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

nelagoda (npr. svrbež ili žarenje) na mjestu upotrebe. U većini slučajeva brzo nestaju.

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika. Ovo 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.

5.

Kako čuvati Faktu čepiće?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i strip pakiranju iza Rok

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

Moguća je promjena boje, kao i pojava svijetlih mrlja na čepićima (izlučena masnoća), ali te promjene ne

utječu na djelotvornost lijeka.

Ne čuvati na temperaturi višoj od 25ºC.

6.

Sadržaj pakiranja i druge informacije

Što Faktu čepići sadrže?

Djelatne tvari su polikrezulen i cinhokainklorid. 1 čepić sadrži 100 mg polikrezulena i 2,5 mg cinho-

kainklorida.

Drugi sastojci su natrijev hidroksid, koloidni bezvodni silicijev dioksid, mikrokristalična celuloza, sojin

lecitin, tvrda mast, edetatna kiselina.

Kako Faktu čepići izgledaju i sadržaj pakiranja?

Čepići su čunjasti, krem do crvenkastosmeđe boje, jednolikog izgleda i glatke površine

duljine 32 mm i

maksimalnog promjera 11,6 mm. U kutiji je 10 (2 x 5) čepića u strip pakiranju.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

Nositelj odobrenja:

Takeda Pharmaceuticals Croatia d.o.o.

Zadarska 80

10 000 Zagreb

Proizvođač:

Takeda GmbH

Proizvodno mjesto Singen

Robert-Bosch-Str. 8

Singen

H A L M E D

30-06-2016

O D O B R E N O

Njemačka

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji put revidirana u lipnju 2016.

H A L M E D

30-06-2016

O D O B R E N O

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The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Agency advertises two vacancies for experts in its Quality Assessment Team. The Agency is looking for strong candidates who are willing to work on challenging and interesting tasks. Each vacancy is a full position (100%). Application deadline is up to and including 16 July 2017.

IMA - Icelandic Medicines Agency

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

2-10-2018

NexoBrid (MediWound Germany GmbH)

NexoBrid (MediWound Germany GmbH)

NexoBrid (Active substance: Concentrate of proteolytic enzymes enriched in bromelain) - PSUSA - Modification - Commission Decision (2018)6460 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10028/201712

Europe -DG Health and Food Safety

19-9-2018

Kadcyla (Roche Registration GmbH)

Kadcyla (Roche Registration GmbH)

Kadcyla (Active substance: Trastuzumab emtansine) - Centralised - Renewal - Commission Decision (2018)6100 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2389/R/39

Europe -DG Health and Food Safety

23-8-2018

 Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Europe - EMA - European Medicines Agency

27-7-2018

EU/3/12/1003 (bluebird bio (Germany) GmbH)

EU/3/12/1003 (bluebird bio (Germany) GmbH)

EU/3/12/1003 (Active substance: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA) - Transfer of orphan designation - Commission Decision (2018)5033 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/009/12/T/01

Europe -DG Health and Food Safety

27-6-2018

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Active substance: pantoprazole) - PSUSA - Modification - Commission Decision (2018)4105 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1100/PSUSA/2285/201708

Europe -DG Health and Food Safety

6-6-2018

Agenda:  Agenda for the 100th meeting of the Management Board

Agenda: Agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

5-6-2018

Agenda:  Draft agenda for the 100th meeting of the Management Board

Agenda: Draft agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

24-5-2018

Tybost (Gilead Sciences International Limited)

Tybost (Gilead Sciences International Limited)

Tybost (Active substance: cobicistat) - PSUSA - Modification - Commission Decision (2018)3255 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10081/201708

Europe -DG Health and Food Safety

24-5-2018

Stribild (Gilead Sciences International Limited)

Stribild (Gilead Sciences International Limited)

Stribild (Active substance: elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil (as fumarate)) - PSUSA - Modification - Commission Decision (2018)3277 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2574/PSUSA/10082/201708

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Active substance: 4-{[(2R,3S,4R,5S)-4-(4-chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid) - Transfer of orphan designation - Commission Decision (2018)3149 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/14/T/01

Europe -DG Health and Food Safety