Ebixa

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
05-01-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
05-01-2022
Public Assessment Report Public Assessment Report (PAR)
05-01-2012

Active ingredient:

memantina idrokloridu

Available from:

H. Lundbeck A/S

ATC code:

N06DX01

INN (International Name):

memantine

Therapeutic group:

Mediċini oħra kontra d-demenzja

Therapeutic area:

Marda ta 'Alzheimer

Therapeutic indications:

Trattament ta 'pazjenti b'mard ta' Alzheimer moderat għal sever.

Product summary:

Revision: 26

Authorization status:

Awtorizzat

Authorization date:

2002-05-15

Patient Information leaflet

                                60
B. FULJETT TA’ TAGĦRIF
61
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-UTENT
EBIXA 10 MG PILLOLI MIKSIJIN B’RITA
Memantine hydrochloride
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 biss. M’għandekx tgħaddiha
lil persuni oħra. Tista’
tagħmlilhom il-ħsara, anki jekk ikollhom 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 Ebixa u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tieħu Ebixa
3.
Kif għandek tieħu Ebixa
4.
Effetti sekondarji possibbli
5.
Kif taħżen Ebixa
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU EBIXA U GĦALXIEX JINTUŻA
Ebixa fih is-sustanza attiva memantine hydrochloride. Jagħmel parti
minn grupp ta’ mediċini
magħrufa bħala mediċini kontra d-dimenzja.
It-telf tal-memorja fil-marda ta’ Alzheimer jiġi minħabba disturbi
fis-sinjali tal-messaġġi fil-moħħ.
Il-moħħ fih l-hekk imsejjħa riċetturi-N-methyl-D-aspartate (NMDA)
li jieħdu sehem fit-trasmissjoni
tas-sinjali fin-nervituri importanti għat-tagħlim u l-memorja. Ebixa
jagħmel parti minn grupp ta’
mediċini li jissejħu antagonisti tar-riċettur-NMDA. Ebixa jaħdem
fuq dawn ir-riċetturi-NMDA u
jtejjeb it-trasmissjoni tas-sinjali fin-nervituri u l-memorja.
Ebixa jintuża għall-kura ta’ pazjenti bil-marda ta’ Alzheimer
minn moderata għal severa.
2.
X'GĦANDEK TKUN TAF QABEL MA TIEĦU EBIXA
TIĦUX EBIXA
-
jekk inti allerġiku/a għal memantine jew għal xi sustanza oħra
ta’ din il-mediċina (elenkati fis-
sezzjoni 6).
TWISSIJIET U PREKAWZJONIJIET
Kellem lit-tabib jew l-ispiżjar tiegħek qabel tieħu Ebixa:
-
jekk fil-pass
                                
                                Read the complete document

Summary of Product characteristics

                                1
_ _
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
1.
ISEM IL-PRODOTT MEDIĊINALI
Ebixa 10 mg pilloli miksijin b’rita.
Ebixa 20 mg pilloli miksijin b’rita.
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
_ _
Kull pillola miksija b’rita fiha 10 mg memantine hydrochloride
ekwivalenti għal 8.31 mg memantine.
Kull pillola miksija b’rita fiha 20 mg memantine hydrochloride
ekwivalenti għal 16.62 mg memantine.
Għal-lista kompluta ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Pillola miksija b’rita.
Ebixa 10 mg pillola miksija b’rita.
Pilloli sofor ċari għal sofor, miksijin b’rita u b’forma ovali,
b’xaqq minn fejn jistgħu jinqasmu u
b’intaljar ta’ “1 0” fuq naħa waħda u “M M” fuq in-naħa
l-oħra. Il-pillola tista’ tinqasam f’dożi
ugwali.
Ebixa 20 mg pilloli miksijin b’rita.
Pilloli ħomor ċari għal ħomor griżi, miksijin b’rita b’forma
ovali-oblong u b’intaljar ta’ “20” fuq naħa
waħda u “MEM” fuq in-naħa l-oħra.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Kura ta’ pazjenti adulti bil-marda ta’ Alzheimer moderata għal
severa.
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
Il-kura għandha tibda tingħata u tibqa taħt superviżjoni ta’
tabib li jkollu esperjenza bid-dijanjożi u l-
kura tad-dimenzja ta’ Alzheimer.
Pożoloġija
_ _
It-terapija għandha tinbeda biss jekk ikun hemm persuna li
timmoniterja t-teħid tal-prodott mediċinali
mill-pazjent. Id-dijanjożi għandha ssir skond il-linji gwida li hemm
bħalissa. It-tolleranza u d-dożaġġ
ta’ memantine għandhom jerġgħu jiġu vvalutati fuq bażi
regolari, preferibbilment fi żmien tliet xhur
mill-bidu tal-kura. Wara dan, il-benefiċċju kliniku ta’ memantine
u t-tolleranza tal-pazjent għall-kura
għandhom jerġgħu jiġu vvalutati fuq bażi regolari skond il-linji
gwida li hemm bħalissa. Il-kura ta’
manteniment tista’ tkompli sakemm ikun hemm benefiċċju terapewtiku
favorevoli u sakemm il-
pazjent jibqa’ jittollera l-kura b’memantine. It-twaq
                                
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Similar products

Active ingredient memantina idrokloridu

memantina idrokloridu

ATC code N06DX01

N06DX01

Marketed by H. Lundbeck A/S

H. Lundbeck A/S

INN (International Name) memantine

memantine

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