Plenadren

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

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:

hydrocortisone

Available from:

Takeda Pharmaceuticals International AG Ireland Branch

ATC code:

H02AB09

INN (International Name):

hydrocortisone

Therapeutic group:

Kortikosterojdi għal użu sistemiku

Therapeutic area:

Insuffiċjenza Adrenali

Therapeutic indications:

Trattament ta 'insuffiċjenza adrenali fl-adulti.

Product summary:

Revision: 14

Authorization status:

Awtorizzat

Authorization date:

2011-11-03

Patient Information leaflet

                                22
B. FULJETT TA’ TAGĦRIF
23
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-PAZJENT
PLENADREN 5 MG PILLOLI LI JERĦU L-MEDIĊINA B’MOD MODIFIKAT
PLENADREN 20 MG PILLOLI LI JERĦU L-MEDIĊINA B’MOD MODIFIKAT
hydrocortisone
AQRA SEW DAN IL-FULJETT KOLLU QABEL TIBDA TIEĦU DIN IL-MEDIĊINA
PERESS LI FIH INFORMAZZJONI
IMPORTANTI GĦALIK.
-
Żomm dan il-fuljett. Jista’ jkollok bżonn terġa’ taqrah.
-
Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib jew lill-ispiżjar
tiegħek.
-
Din il-mediċina ġiet mogħtija lilek. M’għandekx tgħaddiha lil
persuni oħra. Tista’ tagħmlilhom
il-ħsara anke jekk għandhom l-istess sinjali ta’ mard bħal
tiegħek.
-
Jekk ikollok xi effett sekondarju kellem lit-tabib jew lill-ispiżjar
tiegħek. Dan jinkludi xi effett
sekondarju possibbli li mhuwiex elenkat f’dan il-fuljett. Ara
sezzjoni 4.
F’DAN IL-FULJETT
1.
X’inhu Plenadren u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tieħu Plenadren
3.
Kif għandek tieħu Plenadren
4.
Effetti sekondarji possibbli
5.
Kif taħżen Plenadren
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU PLENADREN U GЋALXIEX JINTUŻA
Plenadren fih sustanza msejħa hydrocortisone (xi drabi msejħa
kortisol). Hydrocortisone huwa
glukokortikojde. Jagħmel parti minn grupp ta’ mediċini li
jissejħu kortikosterojdi. Il-glukokortikojdi
huma preżenti b’mod naturali fil-ġisem, u jgħinu għaż-żamma
tas-saħħa ġenerali u l-benesseri tiegħek.
Plenadren jintuża fl-adulti fil-kura ta’ kundizzjoni magħrufa
bħala insuffiċjenza adrenali, jew
defiċjenza ta’ kortisol. L-insuffiċjenza adrenali sseħħ meta
l-glandoli adrenali tiegħek (ftit ’il fuq mill-
kliewi) ma jipproduċux biżżejjed ammont tal-ormon kortisol.
Il-pazjenti li jbatu minn insuffiċjenza
adrenali fit-tul (kronika) jeħtieġu terapija ta’ sostituzzjoni
biex jgħixu.
Plenadren jieħu post il-kortisol naturali li huwa nieqes
fl-insuffiċjenza adrenali. Il-mediċina twassal il-
hydrocortisone fil-ġisem tiegħek matul il-ġurnata. Il-livelli ta’

                                
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Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
1.
ISEM IL-PRODOTT MEDIĊINALI
Plenadren 5 mg pilloli li jerħu l-mediċina b’mod modifikat
Plenadren 20 mg pilloli li jerħu l-mediċina b’mod modifikat
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Plenadren 5 mg pilloli li jerħu l-mediċina b’mod modifikat
Kull pillola li terħi l-mediċina b’mod modifikat fiha 5 mg ta’
hydrocortisone.
Plenadren 20 mg pilloli li jerħu l-mediċina b’mod modifikat
Kull pillola li terħi l-mediċina b’mod modifikat fiha 20 mg ta’
hydrocortisone.
Għal-lista sħiħa ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Pillola li terħi l-mediċina b’mod modifikat.
Plenadren 5 mg pilloli li jerħu l-mediċina b’mod modifikat
Il-pilloli huma tondi (dijametru ta’ 8 mm), konvessi u roża.
Plenadren 20 mg pilloli li jerħu l-mediċina b’mod modifikat
Il-pilloli huma tondi (dijametru ta’ 8 mm), konvessi u bojod.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Kura tal-insuffiċjenza renali fl-adulti.
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
Pożoloġija
Plenadren jingħata bħala terapija ta’ manteniment. Id-dożi ta’
sostituzzjoni li jittieħdu b’mod orali
għandhom jiġu individwalizzati skont ir-rispons kliniku. Doża
komuni ta’ manteniment hija ta’ 20–
30 mg kuljum, li tingħata darba filgħodu. F’pazjenti li għad
fadlilhom xi ftit produzzjoni ta’ kortisol
endoġenu tista’ tkun biżżejjed doża aktar baxxa. L-ogħla doża
ta’ manteniment li ġiet studjata hija ta’
40 mg. Għandha tintuża l-aktar doża baxxa ta’ manteniment
possibbli. F’sitwazzjonijiet fejn il-ġisem
jiġi espost għal stress fiżiku u /jew mentali eċċessiv,
il-pazjenti jistgħu jeħtieġu sostituzzjoni
addizzjonali permezz ta’ pilloli ta’ hydrocortisone li jerħu
l-mediċina b’mod immedjat speċjalment
wara nofsinhar/filgħaxija, ara aktar fis-sezzjoni ‘Użu f’mard
interkorrenti’ fejn hemm deskrizzjoni ta’
modi oħra ta’ kif iżżid id-doża ta’ hydrocortisone b’
                                
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Active ingredient hydrocortisone

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ATC code H02AB09

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Marketed by Takeda Pharmaceuticals International AG Ireland Branch

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INN (International Name) hydrocortisone

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