Memantine Accord

Country: European Union

Language: Slovenian

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:

memantinijev klorid

Available from:

Accord Healthcare S.L.U.

ATC code:

N06DX01

INN (International Name):

memantine

Therapeutic group:

Druga zdravila proti demenciji

Therapeutic area:

Alzheimerjeva bolezen

Therapeutic indications:

Zdravljenje bolnikov z zmerno do hudo Alzheimerjevo boleznijo.

Product summary:

Revision: 7

Authorization status:

Pooblaščeni

Authorization date:

2013-12-03

Patient Information leaflet

                                32
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Španija
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/13/880/001 28 filmsko obloženih tablet.
EU/1/13/880/002 30 filmsko obloženih tablet.
EU/1/13/880/003 42 filmsko obloženih tablet
EU/1/13/880/004 50 filmsko obloženih tablet.
EU/1/13/880/005 56 filmsko obloženih tablet.
EU/1/13/880/006 98 filmsko obloženih tablet
EU/1/13/880/007 100 filmsko obloženih tablet.
EU/1/13/880/008 112 filmsko obloženih tablet.
EU/1/13/880/014 14 filmsko obloženih tablet.
13.
ŠTEVILKA SERIJE
Lot:
14.
NAČIN IZDAJANJA ZDRAVILA
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Memantin Accord 10 mg
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA_ _
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI_ _
PC:
SN:
NN:
33
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI
DVOJNEM TRAKU
PRETISNI OMOT ZA TABLETE
1.
IME ZDRAVILA
Memantin Accord 10 mg filmsko obložene tablete
memantinijev klorid
2.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Accord
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP:
4.
ŠTEVILKA SERIJE
Lot:
5.
DRUGI PODATKI
34
PODATKI NA ZUNANJI OVOJNINI
ŠKATLA ZA PRETISNI OMOT
1.
IME ZDRAVILA
Memantin Accord 10 mg filmsko obložene tablete
memantinijev klorid
2.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN
Ena filmsko obložena tableta vsebuje 10 mg memantinijevega klorida,
kar ustreza 8,31 mg
memantina.
3.
SEZNAM POMOŽNIH SNOVI
Vsebuje laktozo.
Za podrobnejše informacije glejte navodilo za uporabo.
4.
FARMACEVTSKA OBLIKA IN VSEBINA
filmsko obložene tablete
14 x 1 filmsko obložena tableta
28 x 1 filmsko obložena tableta
56 x 1 filmsko obložena tableta
98 x 1 filmsko obložena tableta
5.
POSTOPEK IN POT(I)
                                
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Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA
Memantin Accord 10 mg filmsko obložene tablete
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Ena filmsko obložena tableta vsebuje 10 mg memantinijevega klorida,
kar ustreza 8,31 mg
memantina.
Pomožna snov z znanim učinkom: ena filmsko obložena tableta vsebuje
183,13 mg laktoze (v obliki
monohidrata).
_ _
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
filmsko obložena tableta
Bele, podolgovate filmsko obložene tablete, z razdelilno zarezo in
vtisnjeno oznako "MT" na eni strani
zareze in številko "10" na drugi strani zareze.
Tableta se lahko deli na dva enaka odmerka.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravljenje bolnikov z zmerno do hudo Alzheimerjevo boleznijo.
4.2
ODMERJANJE IN NAČIN UPORABE
Odmerjanje
Zdravljenje naj prične in nadzoruje zdravnik, ki ima izkušnje z
diagnozo in zdravljenjem
Alzheimerjeve demence. Zdravljenje naj se začne le v primeru, če je
na voljo ustrezna oseba, ki za
bolnika skrbi in ki lahko nadzoruje redno jemanje zdravila. Diagnozo
je potrebno postaviti v skladu z
veljavnimi smernicami. Prenašanje in odmerjanje memantina je treba
redno ocenjevati, najbolje v
prvih treh mesecih po začetku zdravljenja. Potem je treba ocenjevati
klinično korist in prenašanje
zdravljenja z memantinom v skladu s trenutno veljavnimi kliničnimi
smernicami. Z vzdrževalnim
zdravljenjem lahko nadaljujemo, dokler obstaja korist za bolnika in
dokler bolnik zdravljenje prenaša.
O prekinitvi zdravljenja z memantinom je treba razmisliti, ko ni več
dokazov o zdravilnem učinku ali
če bolnik zdravljenja ne prenaša.
_Odrasli_
Prilagajanje odmerka
Najvišji dnevni odmerek je 20 mg. Da bi zmanjšali pojavnost
neželenih učinkov, je potrebno postopno
zviševanje odmerka po 5 mg na teden v prvih treh tednih zdravljenja,
dokler ni dosežen vzdrževalni
odmerek, in sicer:
1. teden (1.–7. dan):
Bolnik naj sedem dni jemlje polovico 10 mg filmsko obložene tablete
(5 mg) na dan.
2. teden (8.–14. dan):

                                
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Similar products

Active ingredient memantinijev klorid

memantinijev klorid

ATC code N06DX01

N06DX01

Marketed by Accord Healthcare S.L.U.

Accord Healthcare S.L.U.

INN (International Name) memantine

memantine

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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
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Summary of Product characteristics Summary of Product characteristics Spanish 13-01-2022
Public Assessment Report Public Assessment Report Spanish 16-12-2013
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Public Assessment Report Public Assessment Report Czech 16-12-2013
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Public Assessment Report Public Assessment Report Danish 16-12-2013
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Public Assessment Report Public Assessment Report German 16-12-2013
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Public Assessment Report Public Assessment Report Estonian 16-12-2013
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Public Assessment Report Public Assessment Report English 16-12-2013
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