Duloxetine Boehringer Ingelheim

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
28-01-2010
Summary of Product characteristics Summary of Product characteristics (SPC)
28-01-2010
Public Assessment Report Public Assessment Report (PAR)
17-08-2009

Active ingredient:

duloksetin

Available from:

Boehringer Ingelheim International GmbH

ATC code:

N06AX21

INN (International Name):

duloxetine

Therapeutic group:

Psychoanaleptics,

Therapeutic area:

Diabetične nevropatije

Therapeutic indications:

Zdravljenje diabetične periferne nevropatske bolečine pri odraslih.

Product summary:

Revision: 2

Authorization status:

Umaknjeno

Authorization date:

2008-10-08

Patient Information leaflet

                                Zdravilo nima veā dovoljenja za promet
33
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
Boehringer Ingelheim International GmbH, Binger Str. 173 D-55216
Ingelheim am Rhein, Nemčija
12.
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET
EU/1/08/471/003
EU/1/08/471/004
EU/1/08/471/005
13.
ŠTEVILKA SERIJE
Lot
14.
NAČIN IZDAJANJA ZDRAVILA
Izdaja zdravila je le na recept.
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
DULOKSETIN BOEHRINGER INGELHEIM 30 mg
Zdravilo nima veā dovoljenja za promet
34
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI
DVOJNEM TRAKU
30 MG TRDE GASTROREZISTENTNE KAPSULE
1.
IME ZDRAVILA
DULOKSETIN BOEHRINGER INGELHEIM 30 mg trde gastrorezistentne kapsule
duloksetin
2.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Boehringer Ingelheim
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
4.
ŠTEVILKA SERIJE
Lot
5.
DRUGI PODATKI
Zdravilo nima veā dovoljenja za promet
35
PODATKI NA ZUNANJI OVOJNINI
ŠKATLE ZA 60 MG TRDE GASTROREZISTENTNE KAPSULE
1.
IME ZDRAVILA
DULOKSETIN BOEHRINGER INGELHEIM 60 mg trde gastrorezistentne kapsule
duloksetin
2.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN
Ena kapsula vsebuje 60 mg duloksetina (v obliki klorida).
3.
SEZNAM POMOŽNIH SNOVI
Vsebuje saharozo.
Za nadaljnje informacije glejte navodilo.
4.
FARMACEVTSKA OBLIKA IN VSEBINA
28 trdih gastrorezistentnih kapsul
98 trdih gastrorezistentnih kapsul
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
Za peroralno uporabo.
Pred uporabo preberite priloženo navodilo.
6.
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN
POGLEDA OTROK
Zdravilo shranjujte nedosegljivo otrokom!
7.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
8.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Shranjujte v originalni ovojnini. Shranjujte pri temperaturi do 30
°C.
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
Zdravilo nima veā dovoljenja za promet
36
ZDR
                                
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Summary of Product characteristics

                                Zdravilo nima veā dovoljenja za promet
1
DODATEK I
POVZETEK GLAVNIH ZNAČI
L
NOSTI ZDRAVILA
Zdravilo nima veā dovoljenja za promet
2
1.
IME ZDRAVILA
DULOKSETIN BOEHRINGER INGELHEIM 30 mg trde gastrorezistentne kapsule
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Ena kapsula vsebuje 30 mg duloksetina (v obliki klorida).
Pomožne snovi: saharoza 8,6 mg.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
trde gastrorezistentne kapsule
Neprozorno belo telo z vtisnjenim napisom ‘30 mg’ ter neprozoren
moder pokrovček z vtisnjeno
oznako ‘9543’.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravljenje bolečine diabetične periferne nevropatije pri odraslih.
4.2
ODMERJANJE IN NAČIN UPORABE
Za peroralno uporabo.
_Odrasli _
Začetni in priporočeni vzdrževalni odmerek je 60 mg enkrat na dan s
hrano ali brez nje. V kliničnih
preskušanjih so z vidika varnosti vrednotili odmerjanja prek 60 mg
enkrat na dan, do najvišjega
odmerka 120 mg na dan, dajanega razdeljeno na enake odmerke. Plazemska
koncentracija duloksetina
izkazuje veliko različnost med posamezniki (glejte poglavje 5.2).
Zato lahko nekaterim bolnikom, ki
se na 60 mg odmerek ne odzovejo zadostno, koristi višji odmerek.
Odziv na zdravljenje je treba ovrednotiti po 2 mesecih. Pri bolnikih,
ki imajo nezadosten uvodni odziv,
dodatni odziv po preteku tega obdobja ni verjeten.
Terapevtsko korist je treba redno ponovno ocenjevati (vsaj enkrat na
vsake tri mesece) (glejte
poglavje 5.1).
_Starejši _
Samo na podlagi starosti pri starejših bolnikih prilagajanje odmerka
ni potrebno. Vendar pa je pri
zdravljenju starejših potrebna previdnost (glejte poglavje 5.2).
_Otroci in mladostniki _
Izkušenj pri otrocih in mladostnikih ni (glejte poglavje 4.4).
_Okvarjeno delovanje jeter_
Zdravila DULOKSETIN BOEHRINGER INGELHEIM pri bolnikih z obolenjem
jeter, ki ima za
posledico okvarjeno delovanje jeter, ne smemo uporabljati (glejte
poglavji 4.3 in 5.2).
Zdravilo nima veā dovoljenja za promet
3
_Okvarjeno delovanje ledvic _
Pri bolnikih z blago
                                
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Active ingredient duloksetin

duloksetin

ATC code N06AX21

N06AX21

Marketed by Boehringer Ingelheim International GmbH

Boehringer Ingelheim International GmbH

INN (International Name) duloxetine

duloxetine

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 28-01-2010
Summary of Product characteristics Summary of Product characteristics Bulgarian 28-01-2010
Public Assessment Report Public Assessment Report Bulgarian 17-08-2009
Patient Information leaflet Patient Information leaflet Spanish 28-01-2010
Summary of Product characteristics Summary of Product characteristics Spanish 28-01-2010
Public Assessment Report Public Assessment Report Spanish 17-08-2009
Patient Information leaflet Patient Information leaflet Czech 28-01-2010
Summary of Product characteristics Summary of Product characteristics Czech 28-01-2010
Public Assessment Report Public Assessment Report Czech 17-08-2009
Patient Information leaflet Patient Information leaflet Danish 28-01-2010
Summary of Product characteristics Summary of Product characteristics Danish 28-01-2010
Public Assessment Report Public Assessment Report Danish 17-08-2009
Patient Information leaflet Patient Information leaflet German 28-01-2010
Summary of Product characteristics Summary of Product characteristics German 28-01-2010
Public Assessment Report Public Assessment Report German 17-08-2009
Patient Information leaflet Patient Information leaflet Estonian 28-01-2010
Summary of Product characteristics Summary of Product characteristics Estonian 28-01-2010
Public Assessment Report Public Assessment Report Estonian 17-08-2009
Patient Information leaflet Patient Information leaflet Greek 28-01-2010
Summary of Product characteristics Summary of Product characteristics Greek 28-01-2010
Public Assessment Report Public Assessment Report Greek 17-08-2009
Patient Information leaflet Patient Information leaflet English 28-01-2010
Summary of Product characteristics Summary of Product characteristics English 28-01-2010
Public Assessment Report Public Assessment Report English 17-08-2009
Patient Information leaflet Patient Information leaflet French 28-01-2010
Summary of Product characteristics Summary of Product characteristics French 28-01-2010
Public Assessment Report Public Assessment Report French 17-08-2009
Patient Information leaflet Patient Information leaflet Italian 28-01-2010
Summary of Product characteristics Summary of Product characteristics Italian 28-01-2010
Public Assessment Report Public Assessment Report Italian 17-08-2009
Patient Information leaflet Patient Information leaflet Latvian 28-01-2010
Summary of Product characteristics Summary of Product characteristics Latvian 28-01-2010
Public Assessment Report Public Assessment Report Latvian 17-08-2009
Patient Information leaflet Patient Information leaflet Lithuanian 28-01-2010
Summary of Product characteristics Summary of Product characteristics Lithuanian 28-01-2010
Public Assessment Report Public Assessment Report Lithuanian 17-08-2009
Patient Information leaflet Patient Information leaflet Hungarian 28-01-2010
Summary of Product characteristics Summary of Product characteristics Hungarian 28-01-2010
Public Assessment Report Public Assessment Report Hungarian 17-08-2009
Patient Information leaflet Patient Information leaflet Maltese 28-01-2010
Summary of Product characteristics Summary of Product characteristics Maltese 28-01-2010
Public Assessment Report Public Assessment Report Maltese 17-08-2009
Patient Information leaflet Patient Information leaflet Dutch 28-01-2010
Summary of Product characteristics Summary of Product characteristics Dutch 28-01-2010
Public Assessment Report Public Assessment Report Dutch 17-08-2009
Patient Information leaflet Patient Information leaflet Polish 28-01-2010
Summary of Product characteristics Summary of Product characteristics Polish 28-01-2010
Public Assessment Report Public Assessment Report Polish 17-08-2009
Patient Information leaflet Patient Information leaflet Portuguese 28-01-2010
Summary of Product characteristics Summary of Product characteristics Portuguese 28-01-2010
Public Assessment Report Public Assessment Report Portuguese 17-08-2009
Patient Information leaflet Patient Information leaflet Romanian 28-01-2010
Summary of Product characteristics Summary of Product characteristics Romanian 28-01-2010
Public Assessment Report Public Assessment Report Romanian 17-08-2009
Patient Information leaflet Patient Information leaflet Slovak 28-01-2010
Summary of Product characteristics Summary of Product characteristics Slovak 28-01-2010
Public Assessment Report Public Assessment Report Slovak 17-08-2009
Patient Information leaflet Patient Information leaflet Finnish 28-01-2010
Summary of Product characteristics Summary of Product characteristics Finnish 28-01-2010
Public Assessment Report Public Assessment Report Finnish 17-08-2009
Patient Information leaflet Patient Information leaflet Swedish 28-01-2010
Summary of Product characteristics Summary of Product characteristics Swedish 28-01-2010
Public Assessment Report Public Assessment Report Swedish 17-08-2009

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