Memantine Accord

Country: European Union

Language: Estonian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
13-01-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
13-01-2022
Public Assessment Report Public Assessment Report (PAR)
16-12-2013

Active ingredient:

memantiinvesinikkloriid

Available from:

Accord Healthcare S.L.U.

ATC code:

N06DX01

INN (International Name):

memantine

Therapeutic group:

Muud dementsusevastased ravimid

Therapeutic area:

Alzheimeri tõbi

Therapeutic indications:

Mõõduka kuni raske Alzheimeri tõvega patsientide ravi.

Product summary:

Revision: 7

Authorization status:

Volitatud

Authorization date:

2013-12-03

Patient Information leaflet

                                51
B. PAKENDI INFOLEHT
52
PAKENDI INFOLEHT: INFORMATSIOON KASUTAJALE
MEMANTINE ACCORD 10 MG, ÕHUKESE POLÜMEERIKATTEGA TABLETID
memantiinvesinikkloriid
ENNE RAVIMI KASUTAMIST LUGEGE HOOLIKALT INFOLEHTE, SEST SEE SISALDAB
TEIE JAOKS VAJALIKKU TEAVET.
-
Hoidke infoleht alles, et seda vajadusel uuesti lugeda.
-
Kui teil on lisaküsimusi, pidage palun nõu arsti või apteekriga.
-
Ravim on välja kirjutatud ainult teile ja seda ei tohi anda kellelegi
teisele. Ravim võib olla neile
kahjulik isegi kui haigusnähud on sarnased.
-
Kui Teil esineb ükskõik milline kõrvaltoimetest palun rääkige
sellest oma arstile või apteekrile.
Kaasa arvatud ükskõik milline kõrvaltoime, mida selles infolehes ei
ole nimetatud. Vt lõik 4.
MILLE KOHTA ANTAKSE ÜLEVAADE SELLES INFOLEHES
1.
Mis ravim on Memantine Accord ja milleks seda kasutatakse
2.
Mida on vaja teada enne Memantine Accord’i kasutamist
3.
Kuidas Memantine Accord’i kasutada
4.
Võimalikud kõrvaltoimed
5
Kuidas Memantine Accord’i säilitada
6.
Pakendi sisu ja lisainfo
1.
MIS RAVIM ON MEMANTINE ACCORD JA MILLEKS SEDA KASUTATAKSE
KUIDAS MEMANTINE ACCORD TOIMIB
Memantine Accord sisaldab toimeainena memantiinvesinikkloriidi.
Memantine Accord kuulub dementsusevastaste ravimite gruppi.
Alzheimeri tõve korral esinev mälukaotus on tingitud
närviimpulsside häirunud ülekandest ajus. Ajus
on niinimetatud N-metüül-D-aspartaadi (NMDA) retseptorid, mis
osalevad õppimise ja mäluga seotud
närviimpulsside ülekandes. Memantine Accord kuulub ravimite gruppi,
mida nimetatakse
NMDA-retseptorite antagonistideks. Memantine Accord toimib nendele
NMDA-retseptoritele,
parandades närviimpulsside ülekannet ja mälu.
MILLEKS MEMANTINE ACCORD’I KASUTATAKSE
Memantine Accord’i kasutatakse mõõduka kuni raske Alzheimeri tõve
raviks.
2.
MIDA ON VAJA TEADA ENNE MEMANTINE ACCORD’I KASUTAMIST
ÄRGE VÕTKE MEMANTINE ACCORD’I:
-
kui te olete allergiline memantiinvesinikkloriidi või selle ravimi
mõne eespool loetletud
koostisosa suhtes (loetletud lõigus 6).
HOIATUSED JA ET
                                
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Summary of Product characteristics

                                1
_ _
I LISA
RAVIMI OMADUSTE KOKKUVÕTE
2
1.
RAVIMPREPARAADI NIMETUS
Memantine Accord 10 mg õhukese polümeerikattega tabletid.
2.
KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS
Üks õhukese polümeerikattega tablett sisaldab 10 mg
memantiinvesinikkloriidi, mis vastab 8,31 mg
memantiinile.
Teadaolevat toimet omavad abiained: iga õhukese polümeerikattega
tablett sisaldab 183,13 mg
laktoosi (monohüdraadina).
Abiainete täielik loetelu vt lõik 6.1.
3.
RAVIMVORM
Õhukese polümeerkattega tablett.
Valge, piklik, kaetud ja poolitusjoonega tablett, mille ühele
küljele on sisse pressitud ,,MT“ ja
poolitusjoon ning teisele küljele ,,10“ ja poolitusjoon.
Tableti saab jagada võrdseteks annusteks.
4.
KLIINILISED ANDMED
4.1
NÄIDUSTUSED
Mõõduka kuni raske Alzheimeri tõve ravi.
4.2
ANNUSTAMINE JA MANUSTAMISVIIS
Annustamine
Ravi peab alustama ja juhendama Alzheimeri dementsuse diagnoosimisele
ja ravile spetsialiseerunud
arst. Ravi tohib alustada vaid juhul, kui patsiendil on olemas
hooldaja, kes kontrollib regulaarselt
ravimi võtmist. Diagnoos tuleb panna vastavalt kehtivatele juhistele.
Memantiini taluvust ja
annustamist tuleb regulaarselt uuesti hinnata, soovitavalt kolme kuu
jooksul pärast ravi algust. Seejärel
tuleb memantiini kliinilist kasu ja patsiendi taluvust ravile uuesti
hinnata regulaarselt vastavalt
kehtivatele ravijuhenditele. Säilitusravi võib jätkata seni, kuni
ravist saadav kasu on soodne ja patsient
talub ravi memantiiniga. Memantiinravi katkestamist tuleks kaaluda
siis, kui terapeutilist efekti enam
ei esine või kui patsient ei talu ravi.
_Täiskasvanud _
Doosi tiitrimine
Maksimaalne ööpäevane annus on 20 mg. Et vähendada kõrvaltoimete
riski, tuleb säilitusannuse
saavutamiseks annust järk-järgult suurendada 5 mg kaupa nädalas
esimese 3 nädala jooksul järgmiselt.
1. nädal (1….7. päev):
Patsient peab võtma pool 10 mg õhukese polümeerikattega tabletti (5
mg) ööpäevas 7 päeva.
2. nädal (8….14. päev):
Patsient peab võtma ühe 10 mg õhukese polümeerikattega tableti (10

                                
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Active ingredient memantiinvesinikkloriid

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Patient Information leaflet Patient Information leaflet Bulgarian 13-01-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 13-01-2022
Public Assessment Report Public Assessment Report Bulgarian 16-12-2013
Patient Information leaflet Patient Information leaflet Spanish 13-01-2022
Summary of Product characteristics Summary of Product characteristics Spanish 13-01-2022
Public Assessment Report Public Assessment Report Spanish 16-12-2013
Patient Information leaflet Patient Information leaflet Czech 13-01-2022
Summary of Product characteristics Summary of Product characteristics Czech 13-01-2022
Public Assessment Report Public Assessment Report Czech 16-12-2013
Patient Information leaflet Patient Information leaflet Danish 13-01-2022
Summary of Product characteristics Summary of Product characteristics Danish 13-01-2022
Public Assessment Report Public Assessment Report Danish 16-12-2013
Patient Information leaflet Patient Information leaflet German 13-01-2022
Summary of Product characteristics Summary of Product characteristics German 13-01-2022
Public Assessment Report Public Assessment Report German 16-12-2013
Patient Information leaflet Patient Information leaflet Greek 13-01-2022
Summary of Product characteristics Summary of Product characteristics Greek 13-01-2022
Public Assessment Report Public Assessment Report Greek 16-12-2013
Patient Information leaflet Patient Information leaflet English 13-01-2022
Summary of Product characteristics Summary of Product characteristics English 13-01-2022
Public Assessment Report Public Assessment Report English 16-12-2013
Patient Information leaflet Patient Information leaflet French 13-01-2022
Summary of Product characteristics Summary of Product characteristics French 13-01-2022
Public Assessment Report Public Assessment Report French 16-12-2013
Patient Information leaflet Patient Information leaflet Italian 13-01-2022
Summary of Product characteristics Summary of Product characteristics Italian 13-01-2022
Public Assessment Report Public Assessment Report Italian 16-12-2013
Patient Information leaflet Patient Information leaflet Latvian 13-01-2022
Summary of Product characteristics Summary of Product characteristics Latvian 13-01-2022
Public Assessment Report Public Assessment Report Latvian 16-12-2013
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Summary of Product characteristics Summary of Product characteristics Lithuanian 13-01-2022
Public Assessment Report Public Assessment Report Lithuanian 16-12-2013
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Public Assessment Report Public Assessment Report Hungarian 16-12-2013
Patient Information leaflet Patient Information leaflet Maltese 13-01-2022
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Public Assessment Report Public Assessment Report Maltese 16-12-2013
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Summary of Product characteristics Summary of Product characteristics Dutch 13-01-2022
Public Assessment Report Public Assessment Report Dutch 16-12-2013
Patient Information leaflet Patient Information leaflet Polish 13-01-2022
Summary of Product characteristics Summary of Product characteristics Polish 13-01-2022
Public Assessment Report Public Assessment Report Polish 16-12-2013
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Summary of Product characteristics Summary of Product characteristics Portuguese 13-01-2022
Public Assessment Report Public Assessment Report Portuguese 16-12-2013
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Summary of Product characteristics Summary of Product characteristics Romanian 13-01-2022
Public Assessment Report Public Assessment Report Romanian 16-12-2013
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Summary of Product characteristics Summary of Product characteristics Slovak 13-01-2022
Public Assessment Report Public Assessment Report Slovak 16-12-2013
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Summary of Product characteristics Summary of Product characteristics Slovenian 13-01-2022
Public Assessment Report Public Assessment Report Slovenian 16-12-2013
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Summary of Product characteristics Summary of Product characteristics Finnish 13-01-2022
Public Assessment Report Public Assessment Report Finnish 16-12-2013
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Summary of Product characteristics Summary of Product characteristics Swedish 13-01-2022
Public Assessment Report Public Assessment Report Swedish 16-12-2013
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Patient Information leaflet Patient Information leaflet Croatian 13-01-2022
Summary of Product characteristics Summary of Product characteristics Croatian 13-01-2022
Public Assessment Report Public Assessment Report Croatian 16-12-2013

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