Rivastigmine Sandoz

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
25-09-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
25-09-2023

Active ingredient:

rivastigmin

Available from:

Sandoz GmbH

ATC code:

N06DA03

INN (International Name):

rivastigmine

Therapeutic group:

Psychoanaleptics,

Therapeutic area:

Dementia; Alzheimer Disease; Parkinson Disease

Therapeutic indications:

Simptomatsko liječenje blage do umjereno teške Alzheimerove demencije. Simptomatsko liječenje blage do umjereno teške demencije kod pacijenata sa idiopatskom parkinsonovom bolešću.

Product summary:

Revision: 14

Authorization status:

odobren

Authorization date:

2009-12-10

Patient Information leaflet

                                50
B. UPUTA O LIJEKU
51
UPUTA O LIJEKU: INFORMACIJE ZA BOLESNIKA
RIVASTIGMIN SANDOZ 1,5
MG TVRDE KAPSULE
RIVASTIGMIN SANDOZ 3
MG TVRDE KAPSULE
RIVASTIGMIN SANDOZ 4,5
MG TVRDE KAPSULE
RIVASTIGMIN SANDOZ 6
MG TVRDE KAPSULE
rivastigmin
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 ili ljekarnika. To
uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi.
Pogledajte dio 4.
ŠTO SE NALAZI U OVOJ UPUTI
:
1.
Što je Rivastigmin Sandoz i za što se koristi
2.
Što morate znati prije nego počnete uzimati Rivastigmin Sandoz
3.
Kako uzimati Rivastigmin Sandoz
4.
Moguće nuspojave
5.
Kako čuvati Rivastigmin Sandoz
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE RIVASTIGMINE SANDOZ I ZA ŠTO SE KORISTI
Djelatna tvar Rivastigmina Sandoz je rivastigmin.
Rivastigmin pripada skupini tvari koje se nazivaju inhibitori
kolinesteraze. U bolesnika s
Alzheimerovom demencijom ili demencijom uslijed Parkinsove bolesti,
određene živčane stanice
odumiru u mozgu, što dovodi do niskih razina neurotransmitera
acetilkolina (tvari koja živčanim
stanicama omogućava međusobnu komunikaciju). Rivastigmin djeluje
blokiranjem enzima koji
razgrađuju acetilkolinesterazu i butirilkolinesterazu. Blokirajući
te enzime, Rivastigmin Sandoz
omogućava povećanje razina acetilkolina u mozgu, što pomaže u
smanjivanju simptoma Alzheimerove
bolesti i demencije povezane s Parkinsovom bolešću.
Rivastigmin Sandoz se primjenjuje za liječenje odraslih bolesnika s
blago do umjereno teškom
Alzheimerovom demencijom, progresivnim poremećajem mozga koji
postupno utječe na pamćenje,
intelektualnu sposobnost i ponašanje. Kapsule 
                                
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Summary of Product characteristics

                                PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
Rivastigmin Sandoz 1,5 mg tvrde kapsule
Rivastigmin Sandoz 3 mg tvrde kapsule
Rivastigmin Sandoz 4,5 mg tvrde kapsule
Rivastigmin Sandoz 6 mg tvrde kapsule
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Svaka kapsula sadrži rivastigmin hidrogentartarat koji odgovara 1,5
mg rivastigmina.
Svaka kapsula sadrži rivastigmin hidrogentartarat koji odgovara 3 mg
rivastigmina.
Svaka kapsula sadrži rivastigmin hidrogentartarat koji odgovara 4,5
mg rivastigmina.
Svaka kapsula sadrži rivastigmin hidrogentartarat koji odgovara 6 mg
rivastigmina.
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Tvrda kapsula
Bjelkasti do žućkasti prašak u kapsuli sa žutom kapicom i žutim
tijelom s crvenom oznakom
„RIV 1,5 mg“ na tijelu.
Bjelkasti do žućkasti prašak u kapsuli s narančastom kapicom i
narančastim tijelom s crvenom
oznakom „RIV 3 mg“ na tijelu.
Bjelkasti do žućkasti prašak u kapsuli s crvenom kapicom i crvenim
tijelom s bijelom oznakom
„RIV 4,5 mg“ na tijelu.
Bjelkasti do žućkasti prašak u kapsuli s crvenom kapicom i
narančastim tijelom s crvenom oznakom
„RIV 6 mg“ na tijelu.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Simptomatsko liječenje blage do umjereno teške Alzheimerove
demencije.
Simptomatsko liječenje blage do umjereno teške demencije u bolesnika
s idiopatskom Parkinsonovom
bolešću.
4.2
DOZIRANJE I NAČIN PRIMJENE
Liječenje treba započeti i nadgledati liječnik s iskustvom u
dijagnosticiranju i liječenju Alzheimerove
demencije ili demencije povezane s Parkinsonovom bolešću. Dijagnozu
treba postaviti u skladu s
trenutnim smjernicama. Liječenje rivastigminom treba započeti jedino
ako postoji njegovatelj koji će
redovito nadzirati uzima li bolesnik lijek.
Doziranje
Rivastigmin treba primjenjivati dva puta dnevno, uz jutarnji i
večernji obrok. Kapsule treba cijele
progutati.
Početna doza
1,5 mg dva puta na dan.
3
Titriranje doze
Početna doza je 1,5 mg dva puta na dan. Ako se ova doza nakon
najm
                                
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Active ingredient rivastigmin

rivastigmin

ATC code N06DA03

N06DA03

Marketed by Sandoz GmbH

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INN (International Name) rivastigmine

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