Plenadren

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
06-12-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
06-12-2022
Public Assessment Report Public Assessment Report (PAR)
05-01-2017

Active ingredient:

hidrokortizon

Available from:

Takeda Pharmaceuticals International AG Ireland Branch

ATC code:

H02AB09

INN (International Name):

hydrocortisone

Therapeutic group:

Kortikosteroidi za sistemsku upotrebu

Therapeutic area:

Nedostatak nadbubrežne žlijezde

Therapeutic indications:

Liječenje adrenalne insuficijencije kod odraslih.

Product summary:

Revision: 14

Authorization status:

odobren

Authorization date:

2011-11-03

Patient Information leaflet

                                22
B. UPUTA O LIJEKU
23
UPUTA O LIJEKU: INFORMACIJE ZA BOLESNIKA
PLENADREN 5 MG TABLETE S PRILAGOĐENIM OSLOBAĐANJEM
PLENADREN 20 MG TABLETE S PRILAGOĐENIM OSLOBAĐANJEM
hidrokortizon
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 Plenadren i za što se koristi
2.
Što morate znati prije nego počnete uzimati Plenadren
3.
Kako uzimati Plenadren
4.
Moguće nuspojave
5.
Kako čuvati Plenadren
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE PLENADREN I ZA ŠTO SE KORISTI
Plenadren sadrži tvar koja se naziva hidrokortizon (ponekad se naziva
kortizol). Hidrokortizon je
glukokortikoid. Pripada skupini lijekova koji se nazivaju
kortikosteroidi. Glukokortikoidi se u tijelu
javljaju prirodno, a pomažu u održavanju Vašeg općeg zdravlja i
dobrobiti.
Plenadren se upotrebljava u odraslih za liječenje stanja poznatog kao
adrenalna insuficijencija ili
nedostatak kortizola. Adrenalna insuficijencija nastupa kada
nadbubrežne žlijezde (smještene
neposredno iznad bubrega) ne proizvode dovoljno hormona kortizola.
Bolesnicima koji pate od
dugotrajne (kronične) adrenalne insuficijencije potrebna je
nadomjesna terapija kako bi preživjeli.
Plenadren zamjenjuje prirodni kortizol koji u nedostaje u adrenalnoj
insuficijenciji. Lijek dostavlja
hidrokortizon u Vaše tijelo tijekom cijeloga dana. Razina kortizola u
krvi brzo se poveća do najviše
razine otprilike 1 sat otkako ste ujutro uzeli tabletu, a zatim se
postupno smanjuje tijekom dana s tim
da kasno navečer i noću, ka
                                
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Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
Plenadren 5 mg tablete s prilagođenim oslobađanjem
Plenadren 20 mg tablete s prilagođenim oslobađanjem
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Plenadren 5 mg tablete s prilagođenim oslobađanjem
Jedna tableta s prilagođenim oslobađanjem sadrži 5 mg
hidrokortizona.
Plenadren 20 mg tablete s prilagođenim oslobađanjem
Jedna tableta s prilagođenim oslobađanjem sadrži 20 mg
hidrokortizona.
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Tableta s prilagođenim oslobađanjem.
Plenadren 5 mg tablete s prilagođenim oslobađanjem
Tablete su okrugle (promjera 8 mm), ispupčene i ružičaste boje.
Plenadren 20 mg tablete s prilagođenim oslobađanjem
Tablete su okrugle (promjera 8 mm) ispupčene i bijele boje.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Liječenje adrenalne insuficijencije u odraslih.
4.2
DOZIRANJE I NAČIN PRIMJENE
Doziranje
Plenadren se daje kao terapija održavanja. Peroralne nadomjesne doze
treba odrediti za svakog
bolesnika pojedinačno prema kliničkom odgovoru. Uobičajena doza
održavanja iznosi 20-30 mg na
dan, a daje se jedanput na dan i to ujutro. U bolesnika u kojih još
donekle postoji proizvodnja
endogenog kortizola, može biti dovoljna niža doza. Doza od 40 mg
najviša je ispitana doza
održavanja. Primjenjivati valja najnižu moguću dozu održavanja. U
situacijama u kojima je tijelo
izloženo prekomjernom fizičkom i/ili psihičkom stresu, bolesnicima
može biti potrebna dodatna
zamjenska tableta hidrokortizona s neposrednim/trenutnim oslobađanjem
osobito poslije
podne/uvečer, vidjeti također dio 'Primjena u slučaju istovremene
bolesti' gdje su opisani drugi načini
privremenog povećanja doze hidrokortizona.
_Prijelaz s konvencionalnog peroralnog liječenja glukokortikoidima na
liječenje Plenadrenom_
Pri prijelazu bolesnika s konvencionalne peroralne nadomjesne terapije
hidrokortizonom uzimane tri
puta na dan na Plenadren, može se davati jednaka ukupna dnevna doza.
Zbog manje biolo
                                
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Similar products

Active ingredient hidrokortizon

hidrokortizon

ATC code H02AB09

H02AB09

Marketed by Takeda Pharmaceuticals International AG Ireland Branch

Takeda Pharmaceuticals International AG Ireland Branch

INN (International Name) hydrocortisone

hydrocortisone

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Plenadren