Reagila

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
07-06-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
07-06-2022
Public Assessment Report Public Assessment Report (PAR)
18-09-2017

Active ingredient:

kariprazin hidroklorid

Available from:

Gedeon Richter

ATC code:

N05AX15

INN (International Name):

cariprazine

Therapeutic group:

Psycholeptics

Therapeutic area:

Shizofrenija

Therapeutic indications:

Reagila je indicirana za liječenje shizofrenije kod odraslih bolesnika.

Product summary:

Revision: 7

Authorization status:

odobren

Authorization date:

2017-07-13

Patient Information leaflet

                                41
B. UPUTA O LIJEKU
42
UPUTA O LIJEKU: INFORMACIJE ZA KORISNIKA
REAGILA 1,5 MG TVRDE KAPSULE
REAGILA 3 MG TVRDE KAPSULE
REAGILA 4,5 MG TVRDE KAPSULE
REAGILA 6 MG TVRDE KAPSULE
kariprazin
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 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
liječnika. To uključuje i svaku
moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte dio 4.
ŠTO SE NALAZI U OVOJ UPUTI
1.
Što je Reagila i za što se koristi
2.
Što morate znati prije nego počnete uzimati lijek Reagila
3.
Kako uzimati lijek Reagila
4.
Moguće nuspojave
5.
Kako čuvati lijek Reagila
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE REAGILA I ZA ŠTO SE KORISTI
Reagila sadrži djelatnu tvar kariprazin i pripada skupini lijekova
koji se nazivaju antipsihotici. Koristi
se za liječenje odraslih sa shizofrenijom.
Shizofrenija je bolest koju karakteriziraju simptomi kao što su da
bolesnik čuje, vidi ili osjeća stvari
kojih nema (halucinacija), sumnjičavost, pogrešno vjerovanje,
nepovezan govor i ponašanje te
emocionalna tupost. Osobe s ovom bolešću također mogu osjećati
depresiju, krivnju, tjeskobu,
napetost ili nedostatak sposobnosti za započinjanje i održavanje
planiranih aktivnosti, nespremnost da
govore te nedostatak emocionalnog odgovora na situaciju koja
uobičajeno izaziva emocije kod drugih.
2.
ŠTO MORATE ZNATI PRIJE NEGO POČNETE UZIMATI LIJEK REAGILA
NEMOJTE UZIMATI LIJEK REAGILA
-
ako ste alergični na kariprazin ili neki drugi sastojak ovog lijeka
(naveden u dijelu 6.).
-
ako uzimate lijekove koji se koriste za liječenje:
-
hepatitisa C (lijekovi koji sadrže boceprevir i telaprevir)
-
bakterijskih infekcija (lijekovi koji sadrže klari
                                
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Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
Reagila 1,5 mg tvrde kapsule
Reagila 3 mg tvrde kapsule
Reagila 4,5 mg tvrde kapsule
Reagila 6 mg tvrde kapsule
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Reagila 1,5 mg tvrde kapsule
Jedna tvrda kapsula sadrži 1,5 mg kariprazina u obliku
kariprazinklorida.
Reagila 3 mg tvrde kapsule
Jedna tvrda kapsula sadrži 3 mg kariprazina u obliku
kariprazinklorida.
Pomoćna tvar s poznatim učinkom
Jedna tvrda kapsula sadrži 0,0003 mg boje
_Allura red AC_
(E 129).
Reagila 4,5 mg tvrde kapsule
Jedna tvrda kapsula sadrži 4,5 mg kariprazina u obliku
kariprazinklorida.
Pomoćna tvar s poznatim učinkom
Jedna tvrda kapsula sadrži 0,0008 mg boje
_Allura red AC_
(E 129).
Reagila 6 mg tvrde kapsule
Jedna tvrda kapsula sadrži 6 mg kariprazina u obliku
kariprazinklorida.
Pomoćna tvar s poznatim učinkom
Jedna tvrda kapsula sadrži 0,0096 mg boje
_Allura red AC_
(E 129).
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Tvrda kapsula
Reagila 1,5 mg tvrde kapsule
Tvrda želatinska kapsula veličine 4 (približne duljine 14,3 mm) s
neprozirnom bijelom kapicom i
neprozirnim bijelim tijelom te oznakom „GR 1.5“ otisnutom crnom
tintom na tijelu kapsule. Kapsule
sadrže bijelu do žućkastobijelu mješavinu praška.
Reagila 3 mg tvrde kapsule
Tvrda želatinska kapsula veličine 4 (približne duljine 14,3 mm) s
neprozirnom zelenom kapicom i
neprozirnim bijelim tijelom te oznakom „GR 3“ otisnutom crnom
tintom na tijelu kapsule. Kapsule
sadrže bijelu do žućkastobijelu mješavinu praška.
3
Reagila 4,5 mg tvrde kapsule
Tvrda želatinska kapsula veličine 4 (približne duljine 14,3 mm) s
neprozirnom zelenom kapicom i
neprozirnim zelenim tijelom te oznakom „GR 4.5“ otisnutom bijelom
tintom na tijelu kapsule.
Kapsule sadrže bijelu do žućkastobijelu mješavinu praška.
Reagila 6 mg tvrde kapsule
Tvrda želatinska kapsula veličine 3 (približne duljine 15,9 mm) s
neprozirnom ljubičastom kapicom i
neprozirnim bijelim tijelom te oznakom „GR 6
                                
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Similar products

Active ingredient kariprazin hidroklorid

kariprazin hidroklorid

ATC code N05AX15

N05AX15

Marketed by Gedeon Richter

Gedeon Richter

INN (International Name) cariprazine

cariprazine

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Patient Information leaflet Patient Information leaflet Bulgarian 07-06-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 07-06-2022
Public Assessment Report Public Assessment Report Bulgarian 18-09-2017
Patient Information leaflet Patient Information leaflet Spanish 07-06-2022
Summary of Product characteristics Summary of Product characteristics Spanish 07-06-2022
Public Assessment Report Public Assessment Report Spanish 18-09-2017
Patient Information leaflet Patient Information leaflet Czech 07-06-2022
Summary of Product characteristics Summary of Product characteristics Czech 07-06-2022
Public Assessment Report Public Assessment Report Czech 18-09-2017
Patient Information leaflet Patient Information leaflet Danish 07-06-2022
Summary of Product characteristics Summary of Product characteristics Danish 07-06-2022
Public Assessment Report Public Assessment Report Danish 18-09-2017
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Summary of Product characteristics Summary of Product characteristics German 07-06-2022
Public Assessment Report Public Assessment Report German 18-09-2017
Patient Information leaflet Patient Information leaflet Estonian 07-06-2022
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Public Assessment Report Public Assessment Report Estonian 18-09-2017
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Summary of Product characteristics Summary of Product characteristics Greek 07-06-2022
Public Assessment Report Public Assessment Report Greek 18-09-2017
Patient Information leaflet Patient Information leaflet English 07-06-2022
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Public Assessment Report Public Assessment Report English 18-09-2017
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Public Assessment Report Public Assessment Report French 18-09-2017
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Public Assessment Report Public Assessment Report Hungarian 18-09-2017
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Public Assessment Report Public Assessment Report Romanian 18-09-2017
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Public Assessment Report Public Assessment Report Slovak 18-09-2017
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Public Assessment Report Public Assessment Report Slovenian 18-09-2017
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Reagila