Pantoloc Control

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
18-01-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
18-01-2022

Active ingredient:

pantoprazol

Available from:

Takeda GmbH

ATC code:

A02BC02

INN (International Name):

pantoprazole

Therapeutic group:

Inhibitori protonske pumpe

Therapeutic area:

Gastroezofagealni refluks

Therapeutic indications:

Kratkoročno liječenje simptoma refluksa (npr. žgaravica, regurgitacija kiseline) u odraslih osoba.

Product summary:

Revision: 18

Authorization status:

povučen

Authorization date:

2009-06-11

Patient Information leaflet

                                21
B. UPUTA O LIJEKU
Lijek koji više nije odobren
22
UPUTA O LIJEKU: INFORMACIJE ZA KORISNIKA
PANTOLOC CONTROL 20 MG ŽELUČANOOTPORNE TABLETE
pantoprazol
PAŽLJIVO PROČITAJTE CIJELU UPUTU PRIJE NEGO POČNETE UZIMATI OVAJ
LIJEK JER SADRŽI VAMA VAŽNE
PODATKE.
Uvijek uzmite ovaj lijek točno onako kako je propisano u ovoj uputi
ili kako su Vam rekli Vaš liječnik
ili ljekarnik.
-
Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.
-
Obratite se ljekarniku ako trebate dodatne informacije ili savjet.
-
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.
-
Obavezno se obratite liječniku ako se ne osjećate bolje ili ako se
osjećate lošije nakon 2 tjedna.
-
Ne smijete uzimati PANTOLOC Control tablete dulje od 4 tjedna bez
savjetovanja s liječnikom.
ŠTO SE NALAZI U OVOJ UPUTI:
1.
Što je PANTOLOC Control i za što se koristi
2.
Što morate znati prije nego počnete uzimati PANTOLOC Control
3.
Kako uzimati PANTOLOC Control
4.
Moguće nuspojave
5.
Kako čuvati PANTOLOC Control
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE PANTOLOC CONTROL I ZA ŠTO SE KORISTI
PANTOLOC Control sadrži djelatnu tvar pantoprazol, koja blokira
„pumpu“ koja proizvodi želučanu
kiselinu. Stoga smanjuje sadržaj kiseline u Vašem želucu.
PANTOLOC Control se koristi za kratkotrajno liječenje simptoma
refluksa (npr. žgaravica, vraćanje
kiseline iz želuca u usta) u odraslih.
Refluks je povrat kiseline iz želuca u jednjak („cijev za hranu”)
koji može postati upaljen i bolan. To
može uzrokovati simptome kao što su bolan osjećaj pečenja u prsnom
košu koji se uzdiže do grla
(žgaravica) i kiseli okus u ustima (vraćanje kiseline iz želuca u
usta).
Olakšanje simptoma refluksa kiseline ili žgaravice možete osjetiti
već nakon jednog dana liječenja
lijekom PANTOLOC Control, ali ovaj lijek nije namijenjen trenutnom
olakšanju simptoma. Možda će
biti potrebno uzimati table
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
Lijek koji više nije odobren
2
1.
NAZIV LIJEKA
PANTOLOC Control 20 mg želučanootporne tablete
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Jedna želučanootporna tableta sadrži 20 mg pantoprazola (u obliku
natrijevog seskvihidrata).
Za cjeloviti popis pomoćnih tvari, vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Želučanootporna tableta.
Žute, ovalne, bikonveksne, filmom obložene tablete sa smeđom
oznakom "P20" na jednoj strani.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
PANTOLOC Control je indiciran za kratkotrajno liječenje simptoma
refluksa (npr. žgaravica,
regurgitacija kiseline) u odraslih.
4.2
DOZIRANJE I NAČIN PRIMJENE
Doziranje
Preporučena doza je 20 mg pantoprazola (jedna tableta) na dan.
Tablete je ponekad potrebno uzimati 2-3 uzastopna dana da bi se
postiglo poboljšanje simptoma. Kad
se simptomi potpuno povuku, liječenje se mora prekinuti. Bez savjeta
liječnika liječenje ne smije
trajati dulje od 4 tjedna.
Ukoliko se nakon 2 tjedna kontinuiranog liječenja simptomi ne povuku,
bolesnika se mora uputiti da
potraži savjet liječnika.
Posebne populacije
Za starije bolesnike i one s oštećenom funkcijom jetre ili bubrega
nije potrebna prilagodba doze.
_Pedijatrijska populacija _
PANTOLOC Control se ne preporučuje za primjenu u djece i adolescenata
u dobi ispod 18 godina jer
nema dovoljno podataka o sigurnosti i djelotvornosti.
Način primjene
PANTOLOC Control 20 mg želučanootporne tablete se ne smiju žvakati
ni lomiti, već ih se mora
progutati cijele s tekućinom prije obroka.
4.3
KONTRAINDIKACIJE
Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih
u dijelu 6.1.
Lijek koji više nije odobren
3
Ne preporučuje se istodobna primjena pantoprazola s inhibitorima HIV
proteaze čija je apsorpcija
ovisna o kiselom intragastričnom pH, kao što su atazanavir i
nelfinavir, zbog značajnog smanjenja
njihove bioraspoloživosti (vidjeti dio 4.5).
4.4
POSEBNA UPOZORENJA I MJERE OPREZA PRI UPORABI
Bolesnika se mora uputiti da se obrati liječni
                                
                                Read the complete document

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Active ingredient pantoprazol

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ATC code A02BC02

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Marketed by Takeda GmbH

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INN (International Name) pantoprazole

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Patient Information leaflet Patient Information leaflet Bulgarian 18-01-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 18-01-2022
Public Assessment Report Public Assessment Report Bulgarian 18-01-2022
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Summary of Product characteristics Summary of Product characteristics Spanish 18-01-2022
Public Assessment Report Public Assessment Report Spanish 18-01-2022
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Public Assessment Report Public Assessment Report Czech 18-01-2022
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Public Assessment Report Public Assessment Report Danish 18-01-2022
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Public Assessment Report Public Assessment Report German 18-01-2022
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Public Assessment Report Public Assessment Report Greek 18-01-2022
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Summary of Product characteristics Summary of Product characteristics Slovak 18-01-2022
Public Assessment Report Public Assessment Report Slovak 18-01-2022
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