Plicet 500 mg tablete

Glavna informacija

  • Trgovački naziv:
  • Plicet 500 mg tablete
  • Doziranje:
  • 500 mg
  • Farmaceutski oblik:
  • tableta
  • Sastav:
  • Urbroj: jedna tableta sadrži 500 mg paracetamola
  • Tip recepta:
  • bez recepta, u ljekarni i specijaliziranim prodavaonicama za promet na malo lijekovima
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Pliva Hrvatska d.o.o., Zagreb, Republika Hrvatska

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Plicet 500 mg tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 10 tableta u blisteru, u kutiji [HR-H-379575746-01]; 20 tableta u blisteru, u kutiji [HR-H-379575746-02] Urbroj: 381-12-01/30-15-04

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-379575746
  • Datum autorizacije:
  • 28-05-2015
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

UPUTA O LIJEKU: Informacija za korisnika

Plicet 500 mg tablete

paracetamol

Pažljivo pročitajte cijelu uputu prije nego što počnete uzimati ovaj lijek jer sadrži Vama

važne podatke.

Ovaj je lijek dostupan bez liječničkog recepta. Ipak, morate ga uzimati oprezno kako biste

postigli najbolji učinak.

- Sačuvajte ovu uputu., Možda ćete je trebati ponovno pročitati.

- Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku.

- Ovaj lijek je 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.

- Obavezno se obratite liječniku ako se ne osjećate bolje ili ako se osjećate lošije nakon 3

dana.

Što se nalazi u ovoj uputi:

1.

Što su Plicet 500 mg tablete i za što se koriste

2.

Što morate znati prije nego počnete uzimati Plicet

500 mg tablete

3.

Kako uzimati Plicet 500 mg tablete

4.

Moguće nuspojave

5.

Kako čuvati Plicet 500 mg tablete

6.

Sadržaj pakiranja i druge informacije

1. ŠTO SU PLICET 500 mg TABLETE I ZA ŠTO SE KORISTE

Plicet 500 mg tablete sadrže paracetamol koji ima izraženo djelovanje protiv boli i povišene

tjelesne temperature te vrlo blago protuupalno djelovanje.

Plicet

tablete

namijenjene

uklanjanje

boli

različitog

uzroka

(glavobolja,

zubobolja, bol zbog upale živca, ishijalgija, mišićna bol, boli nakon operacija i povreda, bolne

menstruacije). Plicet 500 mg tablete su također namijenjene za snižavanje povišene tjelesne

temperature.

H A L M E D

28 - 05 - 2015

O D O B R E N O

Djelovanje protiv boli i povišene tjelesne temperature započinje oko pola sata nakon primjene

i traje tri do četiri sata.

Plicet 500 mg tablete su osobito pogodne u liječenju bolesnika preosjetljivih na salicilate.

2. ŠTO MORATE ZNATI PRIJE NEGO POČNETE UZIMATI PLICET 500 mg

TABLETE

Za vrijeme uzimanja Plicet 500 mg tableta nemojte uzimati neke druge lijekove koji

sadrže paracetamol.

Nemojte uzimati Plicet 500 mg tablete ako:

ste alergični na paracetamol ili neki drugi sastojak Plicet 500 mg tableta (naveden u

dijelu 6)

bolujete od akutne upale jetre (akutnog hepatitisa)

imate aktivnu kroničnu bolest jetre (aktivni kronični hepatitis)

imate genetski nedostatak enzima glukoza 6 fosfat dehidrogenaze u eritrocitima

Budite oprezni s Plicet 500 mg tabletama ako:

imate problema s jetrom /bubrezima

ste trudni ili dojite dijete

imate problema s alkoholom jer kod prekomjernog konzumiranja alkohola postoji

povećani rizik od predoziranja

Uzimanje drugih lijekova s Plicet 500 mg tabletama

Obavijestite svog liječnika ako:

uzimate lijekove protiv žgaravice (antacide), lijekove za liječenje Parkinsonove bolesti

(antikolinergike)

jake

lijekove

protiv

bolova

(narkotičke

analgetike)

mogu

usporiti djelovanje

Plicet 500 mg tableta

uzimate lijek za regulaciju probave metoklopramid, lijekove za liječenje AIDS-a

(zidovudin) antibiotik kloramfenikol ili lijek za liječenje gihta (probenecid) jer mogu

H A L M E D

28 - 05 - 2015

O D O B R E N O

ubrzati djelovanje

Plicet 500 mg tableta ili povećati štetno djelovanje nekog od

navedenih lijekova

uzimate lijekove za depresiju (tricikličke antidepresive), barbiturate, izoniazid ili

alkohol jer u kombinaciji s Plicet 500 mg tabletama mogu štetno djelovati na jetru

uzimate kolestiramin (lijek za snižavanje masnoća u krvi) ili varfarin (lijek protiv

zgrušavanja krvi).

Prije uzimanja ovog lijeka obavijestite svog liječnika ili ljekarnika ako uzimate, ili ste

nedavno uzimali, bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.

Uzimanje hrane i pića s Plicet 500 mg tabletama

Tijekom uzimanja ovog lijeka nemojte piti alkoholna pića.

Trudnoća i dojenje

Posavjetujte se s liječnikom ili ljekarnikom prije uzimanja bilo kojeg lijeka.

Prije nego što počnete uzimati Plicet 500 mg tablete, obavijestite svog liječnika ako ste

trudni, ako pokušavate zatrudnjeti ili ako dojite.

Upravljanje vozilima i strojevima

Plicet 500 mg tablete ne utječu na sposobnost upravljanja vozilima i rada na strojevima.

3. KAKO UZIMATI PLICET 500 mg TABLETE

Plicet 500 mg tablete treba progutati s vodom.

Odrasli i djeca starija od 12 godina

Uobičajena doza je 1 do 2 Plicet 500 mg tablete 3 do 4 puta na dan.

Dnevna doza ne smije biti veća od 8 tableta (4 g paracetamola).

Djeca

Tablete nisu predviđene za djecu do 12 godina.

ublažavanje boli

Plicet 500 mg tablete ne smijete uzimati dulje od 10 dana. Djeci starijoj

od 12 godina lijek nemojte davati dulje od 5 dana. Nakon tog razoblja posavjetujte se s

liječnikom, koji će odrediti daljnje liječenje.

H A L M E D

28 - 05 - 2015

O D O B R E N O

snižavanje povišene tjelesne temperature

Plicet 500 mg tablete nemojte uzimati

dulje od

3 dana. Ni djetetu ga ne smijete davati dulje od 3 dana.

Ako se stanje nakon 3 dana ne poboljša ili se čak pogorša, posavjetujte se s liječnikom, koji će

odrediti daljnje liječenje.

U slučaju da imate problema s radom bubrega

liječnik mora odrediti dozu Plicet 500 mg

tableta (vremenski razmak između pojedinih primjena treba biti najmanje 8 sati).

Ako uzmete više Plicet 500 mg tableta nego što ste trebali

U slučaju prekoračenja doze potrebno je hitno se javiti liječniku, čak i ako nema

simptoma jer se znaci oštećenja jetre mogu javiti 24 do 48 sati nakon uzimanja lijeka, a

teško predoziranje može dovesti i do smrtnog ishoda.

Može se javiti bljedilo, opća slabost, mučnina, povraćanje i bol u trbuhu, a može nastati i

akutno oštećenje bubrega te poremećaji srčanog ritma.

U slučaju bilo kakvih nejasnoća ili pitanja u vezi s primjenom Plicet 500 mg tableta

obratite

se svom liječniku ili ljekarniku.

4. MOGUĆE NUSPOJAVE

Kao i svi drugi lijekovi Plicet 500 mg tablete mogu uzrokovati nuspojave, iako se one neće

pojaviti kod svakoga.

Mogu se javiti promjene na koži (kožni osip – egzantem, dok su vrlo rijetko zabilježeni

slučajevi ozbiljnih kožnih reakcija - jaki osip, koprivnjača, crvenilo kože cijelog tijela, jaki

svrbež, mjehuriće na usnama, očima i ustima, lještenje i oticanje kože, upalu sluznice

Nuspojave nepoznate učestalosti:

poteškoće s disanjem, znojenje, omaglica pad krvnog tlaka koji može napredovati do stanja

šoka, gubitak svijesti

poremećaji

krvi

(trombocitopenija,

agranulocitoza,

hemolitička

anemija)

koji

mogu

očitovati

groznicom

tresavicom,

grloboljom,

neobjašnjivim

umorom

slabošću

neobjašnjivim krvarenjima ili podljevima. Moguće je i oštećenje jetre te poremećaji bubrega i

mokraćnog sustava (tubularna nekroza, intersticijski nefritis – upala bubrega, nefropatija).

H A L M E D

28 - 05 - 2015

O D O B R E N O

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

.

Prijavljivanjem

nuspojava

možete

pridonijeti

u

procjeni

sigurnosti ovog lijeka.

5. KAKO ČUVATI PLICET 500 mg TABLETE

PLICET 500 mg TABLETE ČUVAJTE IZVAN POGLEDA I DOHVATA DJECE.

Čuvati na temperaturi ispod 25 °C.

Plicet 500 mg tablete

se ne smiju upotrijebiti nakon isteka roka valjanosti navedenog na

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

6. SADRŽAJ PAKIRANJA I DRUGE INFORMACIJE

Što Plicet 500 mg tablete sadrže

Svaka Plicet tableta sadrži 500 mg paracetamola.

Plicet 500 mg tablete također sadrže i sljedeće pomoćne tvari: kukuruzni škrob, silicijev

dioksid, koloidni, bezvodni, povidon, kalijev sorbat, glicerol, celuloza, mikrokristalična,

talk, magnezijev stearat, natrijev škroboglikolat (tip A).

Kako Plicet 500 mg tablete izgledaju i sadržaj pakiranja

Tableta

Plicet 500 mg tablete su bijele, okrugle tablete s natpisom PLIVA na jednoj strani i

razdjelnim urezom na drugoj strani.

Plicet 500 mg tablete

dostupne su u pakiranju od 10 (1x10) i 20 (2x10) tableta u blisteru, u

kutiji.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač:

PLIVA Hrvatska d.o.o.

Prilaz baruna Filipovića 25

10 000 Zagreb, Hrvatska

H A L M E D

28 - 05 - 2015

O D O B R E N O

Način i mjesto izdavanja lijeka

Lijek se izdaje bez recepta, u ljekarni i specijaliziranim prodavaonicama za promet na malo

lijekovima.

Ova uputa je zadnji puta revidirana u svibnju

2015.

H A L M E D

28 - 05 - 2015

O D O B R E N O

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