Olanzapine Cipla (previously Olanzapine Neopharma)

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
24-07-2014
Summary of Product characteristics Summary of Product characteristics (SPC)
24-07-2014
Public Assessment Report Public Assessment Report (PAR)
24-07-2014

Active ingredient:

olanzapine

Available from:

Cipla (EU) Limited

ATC code:

N05AH03

INN (International Name):

olanzapine

Therapeutic group:

Psikolettiċi

Therapeutic area:

Schizophrenia; Bipolar Disorder

Therapeutic indications:

AdultsOlanzapine huwa indikat għall-kura ta ' skizofrenja. Olanzapine hija effettiva biex iżżomm it-titjib kliniku waqt terapija kontinwa f'pazjenti li wrew rispons inizjali għat-trattament. Olanzapine hu indikat għall-kura moderata għal severa ta ' episodju ta'manija. F'pazjenti li l-episodju ta'manija għandu rrispondew għat-trattament b'olanzapine, olanzapine hija indikata għall-prevenzjoni ta'rikorrenza f'pazjenti b'diżordni bipolari.

Product summary:

Revision: 12

Authorization status:

Irtirat

Authorization date:

2007-11-14

Patient Information leaflet

                                Prodott mediċinali li m’għadux awtorizzat
101
B. FULJETT TA' TAGĦRIF
Prodott mediċinali li m’għadux awtorizzat
102
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-UTENT
OLANZAPINE CIPLA 2.5 MG PILLOLI MIKSIJA
OLANZAPINE CIPLA 5 MG PILLOLI MIKSIJA
OLANZAPINE CIPLA 7.5 MG PILLOLI MIKSIJA
OLANZAPINE CIPLA 10 MG PILLOLI MIKSIJA
OLANZAPINE CIPLA 15 MG PILLOLI MIKSIJA
olanzapine
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. M'għandekx tgħaddiha
lill-persuni oħra. Tista' tagħmlilhom
il-ħsara, anki jekk ikollhom l-istess sintomi bħall tiegħek.
-
Jekk ikollok xi effett sekondarju kellem lit-tabib jew lill-ispiżjar
tiegħek. Dan jinkludi xi effett
sekondarju possibbli li m’huwiex elenkat f’dan il-fuljett.
F'DAN IL-FULJETT:
1.
X’inhi OLANZAPINE CIPLA u għalxiex tintuża
2.
X’għandek tkun taf qabel ma tieħu OLANZAPINE CIPLA.
3.
Kif għandek tieħu OLANZAPINE CIPLA.
4.
Effetti sekondarji possibbli
5.
Kif taħżen OLANZAPINE CIPLA.
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU OLANZAPINE CIPLA U GЋALXIEX JINTUŻA
OLANZAPINE CIPLA tappartjeni għall-grupp ta' mediċini msejħa
antipsikotiċi antipsikotiċi u hija
użata fil-kura ta’ dawn il-kondizzjonijiet li ġejjin:

Skizofrenija, marda b'sintomi bħal li tisma', li tara jew li tħoss
affarijiet li mhux qegħdin hemm,
twemmin żbaljat, suspetti mhux tas-soltu, u li tingħalaq fik
innifsek. Nies b'din il-marda jistgħu
wkoll iħossuhom imdejjqin, anzjużi jew taħt tensjoni.

Episodji ta’ manija moderati għal severi, kondizzjoni b’sintomi
ta’ eċċitament jew ewforija.
Ġie muri li OLANZAPINE CIPLA jippreveni li dawn is-sintomi jerġgħu
jseħħu f’pazjenti bipolari,
fejn l-episodju ta’ manija rrisponda għall-kura b’olanzapine.
2.
X'GĦANDEK TKUN TAF QABEL MA TIEĦU OLANZ
                                
                                Read the complete document

Summary of Product characteristics

                                Prodott mediċinali li m’għadux awtorizzat
1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
_ _
Prodott mediċinali li m’għadux awtorizzat
2
1.
ISEM IL-PRODOTT MEDIĊINALI_ _
Olanzapine Cipla 2.5 mg pilloli miksija
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Kull pillola miksija fiha 2.5 mg ta’ olanzapine.
Eċċipjent b’effett magħruf: Kull pillola miksija fiha 80.7 mg
lactose monohydrate
Għal-lista kompluta ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Pillola miksija
Pilloli bojod, tondi, bikonvessi, miksija b’ ’2.5’ imnaqqxa fuq
naħa waħda u ‘OLZ’ fuq in-naħa
l-oħra.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
_Adulti _
Olanzapine hija indikata għat-trattament tal-iskiżofrenja.
Olanzapine hija effettiva biex iżomm it-titjib kliniku waqt terapija
kontinwa f'pazjenti li wrew
reazzjoni għat-trattament tal-bidu.
Olanzapine hija indikata għat-trattament ta' episodju ta' manija
moderat jew serju.
F'pazjenti li l-episodju ta' manija tagħhom irreaġixxa
għat-trattament ta’ olanzapine, olanzapine hija
indikata għall-prevenzjoni ta' rikorrenza f'pazjenti b'diżordni
bipolari (ara sezzjoni 5.1).
4.2
POŻOLOĠIJA U METODU TA' KIF GĦANDU JINGĦATA
_Adulti _
Skiżofrenja: Id-doża tal-bidu rakkomandata għal olanzapine hija 10
mg/ġurnata.
Episodju ta' manija: Id-doża tal-bidu hija ta' 15 mg bħala doża
waħda kuljum bil-monoterapija jew
10 mg kuljum f'terapija flimkien ma' xi sustanza oħra (ara sezzjoni
5.1).
Il-prevenzjoni tar-rikorrenza fid-diżordni bipolari: Id-doża
rakkomandata tal-bidu hija 10 mg/ġurnata.
Għall-pazjenti li diġà qegħdin jieħdu olanzapine biex ikun
trattat episodju ta' manija, kompli t-terapija
bl-istess doża għall-prevenzjoni tar-rikorrenza. Jekk ikun hemm
episodju ġdid ta' manija, imħallat, jew
ta' depressjoni, it-trattament b’ olanzapine għandu jitkompla
(bl-aħjar użu tad-doża skond il-bżonn),
b'terapija supplimentari biex ikunu trattati s-sintomi tal-burdata,
kif indikat klinikament.
Waqt it-trattament għas-skiżof
                                
                                Read the complete document

Similar products

Active ingredient olanzapine

olanzapine

ATC code N05AH03

N05AH03

Marketed by Cipla (EU) Limited

Cipla (EU) Limited

INN (International Name) olanzapine

olanzapine

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 24-07-2014
Summary of Product characteristics Summary of Product characteristics Bulgarian 24-07-2014
Public Assessment Report Public Assessment Report Bulgarian 24-07-2014
Patient Information leaflet Patient Information leaflet Spanish 24-07-2014
Summary of Product characteristics Summary of Product characteristics Spanish 24-07-2014
Public Assessment Report Public Assessment Report Spanish 24-07-2014
Patient Information leaflet Patient Information leaflet Czech 24-07-2014
Summary of Product characteristics Summary of Product characteristics Czech 24-07-2014
Public Assessment Report Public Assessment Report Czech 24-07-2014
Patient Information leaflet Patient Information leaflet Danish 24-07-2014
Summary of Product characteristics Summary of Product characteristics Danish 24-07-2014
Public Assessment Report Public Assessment Report Danish 24-07-2014
Patient Information leaflet Patient Information leaflet German 24-07-2014
Summary of Product characteristics Summary of Product characteristics German 24-07-2014
Public Assessment Report Public Assessment Report German 24-07-2014
Patient Information leaflet Patient Information leaflet Estonian 24-07-2014
Summary of Product characteristics Summary of Product characteristics Estonian 24-07-2014
Public Assessment Report Public Assessment Report Estonian 24-07-2014
Patient Information leaflet Patient Information leaflet Greek 24-07-2014
Summary of Product characteristics Summary of Product characteristics Greek 24-07-2014
Public Assessment Report Public Assessment Report Greek 24-07-2014
Patient Information leaflet Patient Information leaflet English 24-07-2014
Summary of Product characteristics Summary of Product characteristics English 24-07-2014
Public Assessment Report Public Assessment Report English 24-07-2014
Patient Information leaflet Patient Information leaflet French 24-07-2014
Summary of Product characteristics Summary of Product characteristics French 24-07-2014
Public Assessment Report Public Assessment Report French 24-07-2014
Patient Information leaflet Patient Information leaflet Italian 24-07-2014
Summary of Product characteristics Summary of Product characteristics Italian 24-07-2014
Public Assessment Report Public Assessment Report Italian 24-07-2014
Patient Information leaflet Patient Information leaflet Latvian 24-07-2014
Summary of Product characteristics Summary of Product characteristics Latvian 24-07-2014
Public Assessment Report Public Assessment Report Latvian 24-07-2014
Patient Information leaflet Patient Information leaflet Lithuanian 24-07-2014
Summary of Product characteristics Summary of Product characteristics Lithuanian 24-07-2014
Public Assessment Report Public Assessment Report Lithuanian 24-07-2014
Patient Information leaflet Patient Information leaflet Hungarian 24-07-2014
Summary of Product characteristics Summary of Product characteristics Hungarian 24-07-2014
Public Assessment Report Public Assessment Report Hungarian 24-07-2014
Patient Information leaflet Patient Information leaflet Dutch 24-07-2014
Summary of Product characteristics Summary of Product characteristics Dutch 24-07-2014
Public Assessment Report Public Assessment Report Dutch 24-07-2014
Patient Information leaflet Patient Information leaflet Polish 24-07-2014
Summary of Product characteristics Summary of Product characteristics Polish 24-07-2014
Public Assessment Report Public Assessment Report Polish 24-07-2014
Patient Information leaflet Patient Information leaflet Portuguese 24-07-2014
Summary of Product characteristics Summary of Product characteristics Portuguese 24-07-2014
Public Assessment Report Public Assessment Report Portuguese 24-07-2014
Patient Information leaflet Patient Information leaflet Romanian 24-07-2014
Summary of Product characteristics Summary of Product characteristics Romanian 24-07-2014
Public Assessment Report Public Assessment Report Romanian 24-07-2014
Patient Information leaflet Patient Information leaflet Slovak 24-07-2014
Summary of Product characteristics Summary of Product characteristics Slovak 24-07-2014
Public Assessment Report Public Assessment Report Slovak 24-07-2014
Patient Information leaflet Patient Information leaflet Slovenian 24-07-2014
Summary of Product characteristics Summary of Product characteristics Slovenian 24-07-2014
Public Assessment Report Public Assessment Report Slovenian 24-07-2014
Patient Information leaflet Patient Information leaflet Finnish 24-07-2014
Summary of Product characteristics Summary of Product characteristics Finnish 24-07-2014
Public Assessment Report Public Assessment Report Finnish 24-07-2014
Patient Information leaflet Patient Information leaflet Swedish 24-07-2014
Summary of Product characteristics Summary of Product characteristics Swedish 24-07-2014
Public Assessment Report Public Assessment Report Swedish 24-07-2014
Patient Information leaflet Patient Information leaflet Norwegian 24-07-2014
Summary of Product characteristics Summary of Product characteristics Norwegian 24-07-2014
Patient Information leaflet Patient Information leaflet Icelandic 24-07-2014
Summary of Product characteristics Summary of Product characteristics Icelandic 24-07-2014
Patient Information leaflet Patient Information leaflet Croatian 24-07-2014
Summary of Product characteristics Summary of Product characteristics Croatian 24-07-2014
Public Assessment Report Public Assessment Report Croatian 24-07-2014

Search alerts related to this product

Alerts Olanzapine Cipla

Olanzapine Cipla

View documents history

Documents history Documents history

Olanzapine Cipla (previously Olanzapine Neopharma)