Memantine Accord

Country: European Union

Language: Icelandic

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
13-01-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
13-01-2022

Active ingredient:

memantínhýdróklóríð

Available from:

Accord Healthcare S.L.U.

ATC code:

N06DX01

INN (International Name):

memantine

Therapeutic group:

Önnur lyf gegn vitglöpum

Therapeutic area:

Alzheimer sjúkdómur

Therapeutic indications:

Meðferð sjúklinga með miðlungsmikla til alvarlega Alzheimerssjúkdóma.

Product summary:

Revision: 7

Authorization status:

Leyfilegt

Authorization date:

2013-12-03

Patient Information leaflet

                                51
B. FYLGISEÐILL
52
FYLGISEÐILL: UPPLÝSINGAR FYRIR NOTANDA LYFSINS
MEMANTINE ACCORD 10 MG FILMUHÚÐAÐAR TÖFLUR
memantínhýdróklóríð
LESIÐ ALLAN FYLGISEÐILINN VANDLEGA ÁÐUR EN BYRJAÐ ER AÐ NOTA
LYFIÐ. Í HONUM ERU MIKILVÆGAR
UPPLÝSINGAR.
-
Geymið fylgiseðilinn. Nauðsynlegt getur verið að lesa hann
síðar.
-
Leitið til læknisins eða lyfjafræðings ef þörf er á frekari
upplýsingum.
-
Þessu lyfi hefur verið ávísað til persónulegra nota. Ekki má
gefa það öðrum. Það getur valdið
þeim skaða, jafnvel þótt um sömu sjúkdómseinkenni sé að
ræða.
-
Látið lækninn eða lyfjafræðing vita um allar aukaverkanir.
Þetta gildir einnig um aukaverkanir
sem ekki er minnst á í þessum fylgiseðli. Sjá kafla 4.
Í FYLGISEÐLINUM ERU EFTIRFARANDI KAFLAR
:
1.
Upplýsingar um Memantine Accord og við hverju það er notað
2.
Áður en byrjað er að nota Memantine Accord
3.
Hvernig nota á Memantine Accord
4.
Hugsanlegar aukaverkanir
5.
Hvernig geyma á Memantine Accord
6.
Pakkningar og aðrar upplýsingar
1.
UPPLÝSINGAR UM MEMANTINE ACCORD OG VIÐ HVERJU ÞAÐ ER NOTAÐ
HVERNIG VIRKAR MEMANTINE ACCORD
Memantine Accord inniheldur virka efnið memantínhýdróklóríð.
Memantine Accord tilheyrir flokki lyfja sem kallaður er lyf við
heilabilun.
Minnistap vegna Alzheimers-sjúkdóms stafar af truflun í boðskiptum
heilans. Í heilanum eru
svokallaðir N-meýtl-D-aspartat (NMDA) viðtakar sem bera áfram
taugaboð sem eru mikilvæg þegar
nám og minni er annars vegar. Memantine Accord tilheyrir lyfjahópi
sem nefnist
NMDA-viðtakablokkar. Memantine Accord hefur áhrif á NMDA-viðtakana
og bætir sendingu
taugaboða ásamt minni.
VIÐ HVERJU ER MEMANTINE ACCORD NOTAÐ
Memantine Accord er notað við meðferð sjúklinga sem haldnir eru
miðlungs til alvarlegum
Alzheimers-sjúkdómi.
2.
ÁÐUR EN BYRJAÐ ER AÐ NOTA MEMANTINE ACCORD
EKKI MÁ NOTA MEMANTINE ACCORD
-
ef um er að ræða ofnæmi fyrir memantínhýdróklóríði eða
einhverju öðru innihaldsefni lyfsins
(ta
                                
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Summary of Product characteristics

                                1
VIÐAUKI I
SAMANTEKT Á EIGINLEIKUM LYFS
2
1.
HEITI LYFS
Memantine Accord 10 mg filmuhúðaðar töflur.
2.
INNIHALDSLÝSING
Hver filmuhúðuð tafla inniheldur 10 mg af
memantínhýdróklóríði, samsvarandi 8,31 mg af memantíni.
Hjálparefni með þekkta verkun: hver filmuhúðuð tafla inniheldur
183,13 mg laktósa (sem einhýdrat).
Sjá lista yfir öll hjálparefni í kafla 6.1.
3.
LYFJAFORM
Filmuhúðuð tafla.
Hvít, aflöng, filmuhúðuð tafla með deiliskoru og ígreyptu
„MT“ sem skipt er í tvennt af deiliskorunni
á annarri hliðinni og „10“ sem skipt er í tvennt af
deiliskorunni á hinni hliðinni.
Töflunni má skipta í jafna skammta.
4.
KLÍNÍSKAR UPPLÝSINGAR
4.1
ÁBENDINGAR
Meðferð sjúklinga sem haldnir eru miðlungs til alvarlegum
Alzheimers-sjúkdómi.
4.2
SKAMMTAR OG LYFJAGJÖF
Skammtar
Eingöngu læknir sem hefur reynslu af greiningu og meðferð
Alzheimers-vitglapa skal hefja meðferð
og hafa umsjón með henni. Aðeins skal hefja meðferð ef kostur er
á tilsjónarmanni sem hefur reglulegt
eftirlit með lyfjatöku sjúklingsins. Greiningu skal framkvæma
samkvæmt núgildandi leiðbeiningum.
Endurmeta skal þol fyrir memantíni og skömmtun reglulega, helst
innan þriggja mánaða frá upphafi
meðferðar. Eftir það á að endurmeta klínískan ávinning af
memantíni og hversu vel sjúklingurinn þolir
meðferðina reglulega samkvæmt gildandi klínískum leiðbeiningum.
Halda má viðhaldsmeðferð áfram
meðan ávinningur er af meðferðinni og sjúklingurinn þolir
meðferð með memantíni. Þegar vissa fyrir
lækningalegum áhrifum er ekki lengur til staðar eða ef
sjúklingurinn þolir ekki meðferðina ætti að
íhuga að hætta henni.
_Fullorðnir_
Skammtatítrun
Hámarks dagsskammtur er 20 mg. Til að draga úr líkum á
aukaverkunum er skammtur hækkaður um
5 mg á viku fyrstu þrjár vikurnar upp að viðhaldsskammti sem hér
segir:
Vika 1 (dagur 1-7):
Sjúklingurinn skal taka hálfa 10 mg filmuhúðaða töflu (5 mg) á
dag í 7 daga.
Vika 2 (dagur 8-14
                                
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Active ingredient memantínhýdróklóríð

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ATC code N06DX01

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INN (International Name) memantine

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