Sycrest

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
07-12-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
07-12-2022
Public Assessment Report Public Assessment Report (PAR)
26-01-2016

Active ingredient:

asenapine (as maleate) 

Available from:

N.V. Organon

ATC code:

N05AH05

INN (International Name):

asenapine

Therapeutic group:

Psycholeptics

Therapeutic area:

Bipolarni poremećaj

Therapeutic indications:

Sycrest je indiciran za liječenje umjerenih do teških maničnih epizoda povezanih s bipolarnim poremećajem u odraslih osoba.

Product summary:

Revision: 21

Authorization status:

odobren

Authorization date:

2010-09-01

Patient Information leaflet

                                38
B. UPUTA O LIJEKU
39
UPUTA O LIJEKU: INFORMACIJE ZA BOLESNIKA
SYCREST 5 MG SUBLINGVALNE TABLETE
SYCREST 10 MG SUBLINGVALNE TABLETE
asenapin
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, ljekarniku ili
medicinskoj sestri.
-
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, ljekarnika ili medicinsku
sestru. To uključuje i svaku moguću nuspojavu koja nije navedena u
ovoj uputi. Pogledajte
dio 4.
ŠTO SE NALAZI U OVOJ UPUTI:
1.
Što je Sycrest i za što se koristi
2.
Što morate znati prije nego počnete uzimati Sycrest
3.
Kako uzimati Sycrest
4.
Moguće nuspojave
5.
Kako čuvati Sycrest
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE SYCREST I ZA ŠTO SE KORISTI
Sycrest sadrži djelatnu tvar asenapin. Ovaj lijek pripada skupini
lijekova koji se zovu antipsihotici.
Sycrest se koristi za liječenje umjerenih do teških maničnih
epizoda povezanih s bipolarnim
poremećajem tipa I u odraslih. Antipsihotici djeluju na spojeve koji
omogućuju komunikaciju između
živčanih stanica (neurotransmitere). Bolesti koje zahvaćaju mozak,
poput bipolarnog poremećaja
tipa I, mogu nastati zbog poremećaja ravnoteže nekih tvari u mozgu,
primjerice dopamina i serotonina,
a ta neravnoteža može izazvati neke simptome koje možda osjećate.
Nije točno poznato na koji način
djeluje ovaj lijek, ali se smatra da popravlja ravnotežu tih tvari.
Manične epizode povezane s bipolarnim poremećajem tipa I su bolest
koju prate simptomi poput
osjećaja ushićenja, prekomjerne količine energije, puno manje
potrebe za snom nego je uobičajeno,
vrlo brzog govora s ubrzanim tijekom misli te ponekad jake
razdražljivosti.
2.
ŠTO MORATE ZNATI PRIJE NEGO POČNETE UZIMATI SYCREST
NEMOJTE UZIMATI
                                
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Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
Sycrest 5 mg sublingvalne tablete
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Jedna sublingvalna tableta sadrži 5 mg asenapina (u obliku
asenapinmaleata).
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Sublingvalna tableta
Bijele do gotovo bijele okrugle sublingvalne tablete, s utisnutom
oznakom "5" na jednoj strani.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Sycrest je indiciran za liječenje umjerenih do teških maničnih
epizoda povezanih s bipolarnim
poremećajem tipa I u odraslih.
4.2
DOZIRANJE I NAČIN PRIMJENE
Doziranje
_ _
Preporučena početna doza lijeka Sycrest u monoterapiji je 5 mg
dvaput na dan. Jedna doza se mora
uzeti ujutro, a jedna navečer. Na temelju individualnog kliničkog
odgovora i podnošljivosti, doza se
može povećati na 10 mg dvaput na dan. Vidjeti dio 5.1. Za
kombinirano liječenje preporučuje se
početna doza od 5 mg dvaput na dan. Ovisno o kliničkom odgovoru i
podnošljivosti u pojedinog
bolesnika, doza se može povećati na 10 mg dvaput na dan.
Posebne populacije
_ _
_Starije osobe_
Sycrest se u starijih osoba mora primjenjivati uz oprez. Podaci o
djelotvornosti u bolesnika starijih od
65 godina su ograničeni. Dostupni farmakokinetički podaci opisani su
u dijelu 5.2.
_Oštećenje funkcije bubrega _
Nije potrebno prilagođavati dozu u bolesnika s oštećenjem funkcije
bubrega. Nema iskustva o
primjeni asenapina u bolesnika s teškim oštećenjem funkcije bubrega
u kojih je klirens kreatinina
manji od 15 ml/min.
_Oštećenje funkcije jetre _
Nije potrebno prilagođavati dozu u bolesnika s blagim oštećenjem
funkcije jetre. Ne može se isključiti
mogućnost povišenja razine asenapina u plazmi u nekih bolesnika s
umjereno oštećenom funkcijom
jetre (Child-Pugh stadij B) te se preporučuje oprez. U bolesnika s
teškim oštećenjem funkcije jetre
(Child-Pugh stadij C) opažen je sedmerostruki porast ekspozicije
asenapinu. Stoga se Sycrest ne
preporučuje u bolesnika s teškim oštećenjem fun
                                
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Similar products

Active ingredient asenapine (as maleate) 

asenapine (as maleate) 

ATC code N05AH05

N05AH05

Marketed by N.V. Organon

N.V. Organon

INN (International Name) asenapine

asenapine

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Summary of Product characteristics Summary of Product characteristics Bulgarian 07-12-2022
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