qanastek/EMEA-V3 huggingface dataset:
EU/ 1/ 07/ 415/ 016 (7 tablets) EU/ 1/ 07/ 415/ 017 (14 tablets) EU/ 1/ 07/ 415/ 018 (28 tablets) EU/ 1/ 07/ 415/ 019 (35 tablets) EU/ 1/ 07/ 415/ 020 (56 tablets) EU/ 1/ 07/ 415/ 021 (70 tablets)
Olanzapine naqqas rispons magħ bħ conditioned avoidance, test li juri l- preż
13.
ruf ala
BATCH NUMBER
baxxi minn dawk
Batch:
li jipproduċ l- katalessija, effett li juri l- preż
14.
u
GENERAL CLASSIFICATION FOR SUPPLY
enza ta 'effetti sekondarji li għ andhom
Medicinal product subject to medical prescription.
Għ “ tat- tnaqqis tat- tensjoni ”.
INSTRUCTIONS ON USE
all- kuntrarju ta 'xi aġ
INFORMATION IN BRAILLE
antipsikotiċoħ enti
Zalasta 10 mg tablets
danija (10 mg) f' voluntiera
170 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
f' saħithom, olanzapine pproduċ okkupazzjoni tar- riċ
BLISTER FOR ZALASTA 10 mg TABLETS
ofreniċli wrew li l- pazjenti li i
NAME OF THE MEDICINAL PRODUCT
ofreniku b' sintomi kemm poż
Zalasta 10 mg tablets Olanzapine
ġimgħ Olanzapine wera wkoll riż
2.
at.
NAME OF THE MARKETING AUTHORISATION HOLDER
proporzjon ta 'pazjenti f' remissjoni sintomatika mill- manija għ
KRKA
imgħ
3.
al
EXPIRY DATE
imagħ
EXP:
ebo,
4.
ad
BATCH NUMBER
al- litju fuq
Batch:
allta
OTHER
imgħ
171 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Waqt il- kura b' olanzapine, l- adolexxenti ż aktar fil- piż mg/ ġ
CARTON FOR ZALASTA 15 mg TABLETS
b' mod sinifikanti meta mqabbel
1.
ix
NAME OF THE MEDICINAL PRODUCT
Is -
Zalasta 15 mg tablets Olanzapine
mg kuljum ma kinux assoċ ma ’ xi profil partikolari ta 'avvenimenti sekondarji ħiena. jati
2.
ż
STATEMENT OF ACTIVE SUBSTANCE(S)
litru fis- siegħ rispettivament).
Each tablet contains 15 mg olanzapine.
Sar studju tal- bilanċ
LIST OF EXCIPIENTS
entrazzjoni
Contains lactose monohydrate.
ta 'bejn madwar 7 u madwar 1000 ng/ ml.
See package leaflet for further information.
ġ isem u anqas adolexxenti kienu jpejpu.
PHARMACEUTICAL FORM AND CONTENTS
Effett tossiku akut (minn doż waħ
14 tablets 28 tablets 35 tablets 56 tablets 70 tablets
dożletali medjani kienu bejn wieħ u ieħ 210 mg/ kg (fil- ġ
METHOD AND ROUTE(S) OF ADMINISTRATION
Il- klieb
Read the package leaflet before use.
danin anke sa 100 mg/ kg mingħ ma mietu.
Oral use.
konoxxenza.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
danin sa 100 mg/ kg wasslu għ prostrazzjoni u, f' dożikbar, al
Keep out of the reach and sight of children.
inali u fil- glandoli tas- sider.
7.
i,
OTHER SPECIAL WARNING(S), IF NECESSARY
Kien hemm anemija, tromboċ
8.
ż
EXPIRY DATE
ammir ta 'firien
EXP:
iel. i
9.
a
SPECIAL STORAGE CONDITIONS
vilupp fetali u deher tnaqqis
172 10.
iħ
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Riskju ta ’ kanċ er rieden u fil- firien, ġ konkluż olanzapine ma jż ir- riskju ta ’ Skond ir- riż ultati ta 'l- istudji fil- ġ kanċ er.
11.
ina
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
In- natura tal- kontenitur u ta ’ dak li hemm ġ fih 6. 5 o
12.
jali
EU/ 1/ 07/ 415/ 022 EU/ 1/ 07/ 415/ 023 EU/ 1/ 07/ 415/ 024 EU/ 1/ 07/ 415/ 025 EU/ 1/ 07/ 415/ 026
EU/ 1/ 07/ 415/ 052- 056
(14 tablets) (28 tablets) (35 tablets) (56 tablets) (70 tablets)
14- il pillola 28 pillola 35 pillola 56 pillola 70 pillola
13.
rif
Batch:
JIS:
GENERAL CLASSIFICATION FOR SUPPLY
KUNDIZZJONIJIET SPEĊJALI TA 'KIF JINĦ EN AŻ
Medicinal product subject to medical prescription.
KRKA, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Slovenja ka
16.
ATA
INFORMATION IN BRAILLE
Prodott mediċ jingħ bir- riċ tat- tabib.
Zalasta 15 mg tablets
STRUZZJONIJIET DWAR L- UŻU
173 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
172 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BLISTER FOR ZALASTA 15 mg TABLETS
FOLJA GĦ ZALASTA 2. 5 mg PILLOLI AL
Zalasta 15 mg tablets Olanzapine
Zalasta 2. 5 mg pilloli Olanzapine
174 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
173 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON FOR ZALASTA 20 mg TABLETS
KARTUNA GĦAL ZALASTA 5 mg PILLOLI
Zalasta 20 mg tablets Olanzapine
Zalasta 5 mg pilloli Olanzapine
Each tablet contains 20 mg olanzapine.
Kull pillola fiha 5 mg olanzapine.
See package leaflet for further information.
Fih lactose monohydrate ara l- fuljett ta 'tagħ għ aktar informazzjoni. rif al
14 tablets 28 tablets 35 tablets 56 tablets 70 tablets
14- il pillola 28 pillola 35 pillola 56 pillola 70 pillola
Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħ qabel l- uż Uż orali. u
Oral use.
u.
Keep out of the reach and sight of children.
Żomm fejn ma jintlaħ u ma jidhirx mit- tfal. aqx
SPECIAL STORAGE CONDITIONS
KUNDIZZJONIJIET SPEĊJALI TA 'KIF JINĦ EN AŻ
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊ JALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊ INALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊ INALI, JEKK HEMM BŻONN
175 11.
175 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
14- il pillola 28 pillola 35 pillola 56 pillola 70 pillola
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL
EU/ 1/ 07/ 415/ 027 (14 tablets) EU/ 1/ 07/ 415/ 028 (28 tablets) EU/ 1/ 07/ 415/ 029 (35 tablets) EU/ 1/ 07/ 415/ 030 (56 tablets) EU/ 1/ 07/ 415/ 031 (70 tablets)
EU/ 1/ 07/ 415/ 011 (14- il pillola) EU/ 1/ 07/ 415/ 012 (28 pillola) EU/ 1/ 07/ 415/ 013 (35 pillola) EU/ 1/ 07/ 415/ 014 (56 pillola) EU/ 1/ 07/ 415/ 015 (70 pillola)
14.
ATA
Medicinal product subject to medical prescription.
Prodott mediċ jingħ bir- riċ tat- tabib.
Zalasta 20 mg tablets
Zalasta 7. 5 mg pilloli
176 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
178 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BLISTER FOR ZALASTA 20 mg TABLETS
FOLJA GĦ ZALASTA 7. 5 mg PILLOLI AL
Zalasta 20 mg tablets Olanzapine
Zalasta 7. 5 mg pilloli Olanzapine
177 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA
CARTON FOR ZALASTA 5 mg ORODISPERSIBLE TABLETS
MOD TA ’ KIF U MNEJN JINGĦATA
Zalasta 5 mg orodispersible tablets Olanzapine
OĦRAJN
Each orodispersible tablet contains 5 mg olanzapine.
MOD TA ’ KIF U MNEJN JINGĦATA
LIST OF EXCIPIENTS
DATA TA ’ META JISKADI
Contains aspartame.
183 11.
See package leaflet for further information.
KRKA, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Slovenja ka
PHARMACEUTICAL FORM AND CONTENTS
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
14 orodispersible tablets 28 orodispersible tablets 35 orodispersible tablets 56 orodispersible tablets 70 orodispersible tablets
EU/ 1/ 07/ 415/ 022 (14- il pillola) EU/ 1/ 07/ 415/ 023 (28 pillola) EU/ 1/ 07/ 415/ 024 (35 pillola) EU/ 1/ 07/ 415/ 025 (56 pillola) EU/ 1/ 07/ 415/ 026 (70 pillola)
METHOD AND ROUTE(S) OF ADMINISTRATION
ATA
Read the package leaflet before use.
Prodott mediċ jingħ bir- riċ tat- tabib.
Oral use.
16.
Do not handle the tablets with wet hands as the tablets may break up.
184 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Hold the blister strip at the edges and separate one blister cell from the rest of the strip by gently tearing along the perforations around it.
ISEM TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Pull up the edge of the foil and peel foil off completely.
185 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Tip the tablet out onto your hand.
Kull pillola fiha 20 mg olanzapine.
Put the tablet on the tongue as soon as it is removed from the packaging.
Fih lactose monohydrate ara l- fuljett ta 'tagħ għ aktar informazzjoni. rif al
Swallow the tablet with or without water.
GĦAMLA FARMAĊEWTIKA U KONTENUT
You can also place the tablet in a full glass or cup of water and drink it straight away.
Aqra l- fuljett ta ’ tagħ qabel l- uż Uż orali. u
178 6.
rif
EU/ 1/ 07/ 415/ 032 EU/ 1/ 07/ 415/ 033 EU/ 1/ 07/ 415/ 034 EU/ 1/ 07/ 415/ 035 EU/ 1/ 07/ 415/ 036
EU/ 1/ 07/ 415/ 027 (14- il pillola) EU/ 1/ 07/ 415/ 028 (28 pillola) EU/ 1/ 07/ 415/ 029 (35 pillola) EU/ 1/ 07/ 415/ 030 (56 pillola) EU/ 1/ 07/ 415/ 031 (70 pillola)
Zalasta 5 mg orodispersible tablets
OĦRAJN
179 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
KARTUNA GĦAL ZALASTA 5 mg PILLOLI LI JINĦALLU FIL- ĦALQ
BLISTER FOR ZALASTA 5 mg ORODISPERSIBLE TABLETS
MOD TA ’ KIF U MNEJN JINGĦATA
Zalasta 5 mg orodispersible tablets Olanzapine
Zalasta 5 mg pilloli li jinħ fil- ħ Olanzapine
2.
Ċarrat. ħ 2.
Peel.
Neħi.
180 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
191 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON FOR ZALASTA 7.5 mg ORODISPERSIBLE TABLETS
KARTUNA GĦAL ZALASTA 7. 5 mg PILLOLI LI JINĦALLU FIL- ĦALQ
Zalasta 7.5 mg orodispersible tablets Olanzapine
Zalasta 7. 5 mg pilloli li jinħ fil- ħ allu alq Olanzapine
Each orodispersible tablet contains 7.5 mg olanzapine.
Kull pillola li tinħ fil- ħ fiha 7. 5 mg olanzapine.
See package leaflet for further information.
Fih aspartame ara l- fuljett ta 'tagħ għ aktar informazzjoni. rif al
14 orodispersible tablets 28 orodispersible tablets 35 orodispersible tablets 56 orodispersible tablets 70 orodispersible tablets
28 pillola li tinħ fil- ħ 35 pillola li tinħ 56 pillola li tinħ 70 pillola li tinħ
Do not handle the tablets with wet hands as the tablets may break up.
Taqbadx il- pilloli b’ idejn imxarrbin għ il- pilloli jistgħ jinkisru.
1.
ax
Hold the blister strip at the edges and separate one blister cell from the rest of the strip by gently tearing along the perforations around it.
Żomm l- istrixxa ta ’ folji mit- truf tagħ u neħi ċ ħ ellula waħ ta ’ folja mill- bqija billi ċarrat ċ
2.
da
Pull up the edge of the foil and peel foil off completely.
matul il- perforazzjonijiet ta ’ madwarha. ħ 2.
3.
Iġ it- tarf tal- fojl u neħiha kompletament. bed 3.
Tip the tablet out onto your hand.
Aqleb il- pillola għ fuq idek. al
4.
ħ
Put the tablet on the tongue as soon as it is removed from the packaging.
Poġi l- pillola fuq ilsienek malli tneħiha mill- pakkett.
You can also place the tablet in a full glass or cup of water and drink it straight away.
Ibla ’ l- pillola bl- ilma jew waħedha. ġ Tista ’ wkoll tpoġi l- pillola f’ tazza jew kikkra mimlija bl- ilma u tixrobha mill- ewwel.
Keep out of the reach and sight of children.
192 Żomm fejn ma jintlaħ u ma jidhirx mit- tfal. aqx
EU/ 1/ 07/ 415/ 037 EU/ 1/ 07/ 415/ 038 EU/ 1/ 07/ 415/ 039 EU/ 1/ 07/ 415/ 040 EU/ 1/ 07/ 415/ 041
EU/ 1/ 07/ 415/ 037 (14- il pillola li jinħ fil- ħ
(14 orodispersible tablets) (28 orodispersible tablets) (35 orodispersible tablets) (56 orodispersible tablets) (70 orodispersible tablets)
EU/ 1/ 07/ 415/ 038 (28 pillola li tinħ fil- ħ EU/ 1/ 07/ 415/ 039 (35 pillola li tinħ EU/ 1/ 07/ 415/ 040 (56 pillola li tinħ EU/ 1/ 07/ 415/ 041 (70 pillola li tinħ
Zalasta 7.5 mg orodispersible tablets
Zalasta 7. 5 mg pilloli li jinħ fil- ħ allu alq
182 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
193 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BLISTER FOR ZALASTA 7.5 mg ORODISPERSIBLE TABLETS
FOLJA GĦ ZALASTA 7. 5 mg PILLOLI LI JINĦALLU FIL- ĦALQ AL
183 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
194 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON FOR ZALASTA 10 mg ORODISPERSIBLE TABLETS
KARTUNA GĦAL ZALASTA 10 mg PILLOLI LI JINĦALLU FIL- ĦALQ
Zalasta 10 mg orodispersible tablets Olanzapine
Zalasta 10 mg pilloli li jinħ fil- ħ allu alq Olanzapine
Each orodispersible tablet contains 10 mg olanzapine.
Kull pillola li tinħ fil- ħ fiha 10 mg olanzapine.
Contains aspartame.
Fih aspartame.
Keep out of the reach and sight of children.
195 Żomm fejn ma jintlaħ u ma jidhirx mit- tfal. aqx
EU/ 1/ 07/ 415/ 042 EU/ 1/ 07/ 415/ 043 EU/ 1/ 07/ 415/ 044 EU/ 1/ 07/ 415/ 045 EU/ 1/ 07/ 415/ 046
EU/ 1/ 07/ 415/ 042 (14- il pillola li jinħ fil- ħ
(14 orodispersible tablets) (28 orodispersible tablets) (35 orodispersible tablets) (56 orodispersible tablets) (70 orodispersible tablets)
EU/ 1/ 07/ 415/ 043 (28 pillola li tinħ fil- ħ EU/ 1/ 07/ 415/ 044 (35 pillola li tinħ EU/ 1/ 07/ 415/ 045 (56 pillola li tinħ EU/ 1/ 07/ 415/ 046 (70 pillola li tinħ
Zalasta 10 mg orodispersible tablets
Zalasta 10 mg pilloli li jinħ fil- ħ allu alq
185 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
196 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BLISTER FOR ZALASTA 10 mg ORODISPERSIBLE TABLETS
FOLJA GĦ ZALASTA 10 mg PILLOLI LI JINĦ
186 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
197 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON FOR ZALASTA 15 mg ORODISPERSIBLE TABLETS
KARTUNA GĦAL ZALASTA 15 mg PILLOLI LI JINĦALLU FIL- ĦALQ
Zalasta 15 mg orodispersible tablets Olanzapine
Zalasta 15 mg pilloli li jinħ fil- ħ allu alq Olanzapine
Each orodispersible tablet contains 15 mg olanzapine.
Kull pillola li tinħ fil- ħ fiha 15 mg olanzapine.
Keep out of the reach and sight of children.
198 Żomm fejn ma jintlaħ u ma jidhirx mit- tfal. aqx
EU/ 1/ 07/ 415/ 047 EU/ 1/ 07/ 415/ 048 EU/ 1/ 07/ 415/ 049 EU/ 1/ 07/ 415/ 050 EU/ 1/ 07/ 415/ 051
EU/ 1/ 07/ 415/ 047 (14- il pillola li jinħ fil- ħ
(14 orodispersible tablets) (28 orodispersible tablets) (35 orodispersible tablets) (56 orodispersible tablets) (70 orodispersible tablets)
EU/ 1/ 07/ 415/ 048 (28 pillola li tinħ fil- ħ EU/ 1/ 07/ 415/ 049 (35 pillola li tinħ EU/ 1/ 07/ 415/ 050 (56 pillola li tinħ EU/ 1/ 07/ 415/ 051 (70 pillola li tinħ
Zalasta 15 mg orodispersible tablets
Zalasta 15 mg pilloli li jinħ fil- ħ allu alq
188 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
199 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BLISTER FOR ZALASTA 15 mg ORODISPERSIBLE TABLETS
FOLJA GĦ ZALASTA 15 mg PILLOLI LI JINĦ
189 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
200 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON FOR ZALASTA 20 mg ORODISPERSIBLE TABLETS
KARTUNA GĦAL ZALASTA 20 mg PILLOLI LI JINĦALLU FIL- ĦALQ
Zalasta 20 mg orodispersible tablets Olanzapine
Zalasta 20 mg pilloli li jinħ fil- ħ allu alq Olanzapine
Each orodispersible tablet contains 20 mg olanzapine.
Kull pillola li tinħ fil- ħ fiha 20 mg olanzapine.
Keep out of the reach and sight of children.
201 Żomm fejn ma jintlaħ u ma jidhirx mit- tfal. aqx
EU/ 1/ 07/ 415/ 052 EU/ 1/ 07/ 415/ 053 EU/ 1/ 07/ 415/ 054 EU/ 1/ 07/ 415/ 055 EU/ 1/ 07/ 415/ 056
EU/ 1/ 07/ 415/ 052 (14- il pillola li jinħ fil- ħ
(14 orodispersible tablets) (28 orodispersible tablets) (35 orodispersible tablets) (56 orodispersible tablets) (70 orodispersible tablets)
EU/ 1/ 07/ 415/ 053 (28 pillola li tinħ fil- ħ EU/ 1/ 07/ 415/ 054 (35 pillola li tinħ EU/ 1/ 07/ 415/ 055 (56 pillola li tinħ EU/ 1/ 07/ 415/ 056 (70 pillola li tinħ
Zalasta 20 mg orodispersible tablets
Zalasta 20 mg pilloli li jinħ fil- ħ allu alq
191 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
202 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BLISTER FOR ZALASTA ORODISPERSIBLE TABLETS
FOLJA GĦ ZALASTA 20 mg PILLOLI LI JINĦ
193 PACKAGE LEAFLET:
204 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER
INFORMAZZJONI GĦ MIN QED JAGĦMEL UŻ MINNU
Zalasta 2.5 mg tablets Zalasta 5 mg tablets Zalasta 7.5 mg tablets Zalasta 10 mg tablets Zalasta 15 mg tablets Zalasta 20 mg tablets Olanzapine
Zalasta 2. 5 mg pilloli Zalasta 5 mg pilloli Zalasta 7. 5 mg pilloli Zalasta 10 mg pilloli Zalasta 15 mg pilloli Zalasta 20 mg pilloli Olanzapine
Read all of this leaflet carefully before you start taking this medicine.
Aqra sew dan il- fuljett kollu qabel tibda tieħ din il- mediċ
- Keep this leaflet.
omm dan il- fuljett.
You may need to read it again.
taqrah. a ’
- If you have any further questions, ask your doctor or pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiż tiegħ
- This medicine has been prescribed for you.
M' għ
Do not pass it on to others.
andekx tgħ addiha lil persuni oħ
It may harm them, even
Tista ’ tagħ ra. mlilhom il -
if their symptoms are the same as yours.
ħ sara, anki jekk ikollhom l- istess sintomi bħ tiegħ
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Jekk xi wieħ mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
please tell your doctor or pharmacist.
ed ġ imsemmijin f’ dan il- fuljett, jekk jogħbok, għ lit- tabib jew lill- ispiż tiegħ
What Zalasta is and what it is used for 2.
X’ inhu Zalasta u għ 2.
Before you take Zalasta 3.
Qabel ma tieħ Zalasta u
How to take Zalasta 4.
Kif għ andek tieħ Zalasta u 4.
Possible side effects 5.
Effetti sekondarji li jista ’ jkollu ż 5.
How to store Zalasta 6.
Kif taħen Zalasta 6.
Further information
Aktar tagħ
WHAT ZALASTA IS AND WHAT IT IS USED FOR
X’ INHU ZALASTA U GĦALXIEX JINTUŻA
Zalasta belongs to a group of medicines called antipsychotics.
Zalasta jappartieni għ grupp ta 'mediċ msejħ antipsikotiċ
Zalasta is used to treat a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.
Zalasta jintuż biex jittratta marda b' sintomi bħ tara, tisma 'jew tħ affarijiet li m' humiex hemm,
People with this disease may also feel depressed, anxious or tense.
ossuhom depressi, ansjużjew b' tensjoni. i
Zalasta is used to treat a condition with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.
Zalasta jintuż biex jittratta kundizzjoni b' sintomi bħ tħ
It is also a mood stabiliser that prevents further occurrences of the disabling high and low (depressed) extremes of mood associated with this condition.
Huwa wkoll stabbilizzatur tal- burdata li jimpedixxi aktar okkorrenzi ta 'l- estremitajiet diżabilitanti għ jew baxxi (depressi) assoċ ma ’ din il - kundizzjoni.
BEFORE YOU TAKE ZALASTA
QABEL MA TIEĦU ZALASTA
Do not take Zalasta
Tiħ Zalasta: ux ċ
- if you are allergic (hypersensitive) to olanzapine or any of the other ingredients of Zalasta.
- jekk int allerġ iku/ a (tbati minn sensittività eċessiva) għ olanzapine jew sustanzi oħ ta 'Zalasta.
An
ra
allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath.
Reazzjoni allerġ tista ’ tingħ minn raxx, ħ wiċ minfuħxufftejn minfuħ jew qtugħta 'ċ
If this has happened to you, tell your doctor.
Jekk ġ ralek hekk, għ lit- tabib tiegħ
- if you have been previously diagnosed with eye problems such as certain kinds of glaucoma
ajnejn bħ xi tipi ta 'glawkoma (ż fil- pressjoni ġ -
(increased pressure in the eye).
jekk kont issofri qabel bi problemi fl- għ l- għajn).
Take special care with Zalasta ─ Medicines of this type may cause unusual movements mainly of the face or tongue.
Jekk ċ
If this happens after you have been given Zalasta tell your doctor. ─ Very rarely, medicines of this type cause a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness.
─ Rari ħ afna, mediċ ta 'dan it- tip jikkawż taħ ta' deni, nifs aktar mgħ ġ tagħ ebusija fil -
If this happens, contact your doctor at once. ─ The use of Zalasta in elderly patients with dementia is not recommended as it may have serious side effects.
Jekk inti tbati minn xi waħ mill- mardiet li ġ għ lit- tabib tiegħ mill- aktar fis possibbli. ─ Dijabete ─ Mard tal- qalb
194 If you suffer from any of the following illnesses tell your doctor as soon as possible: ─ Diabetes ─ Heart disease ─ Liver or kidney disease ─ Parkinson’ s disease ─ Epilepsy ─ Prostate problems ─ A blocked intestine (paralytic ileus) ─ Blood disorders ─ Stroke or “ mini” stroke (temporary symptoms of stroke).
─ Mard tal- kliewi jew tal- fwied ─ Il- marda ta ’ Parkinson ─ Epilessija ─ Problemi bil- prostata ─ Imblokk intestinali (ileus paralitiku) ─ Disturbi tad- demm ─ Puplesija jew puplesija “ ħ afifa ” (sintomi temporanji ta 'puplesija)
If you suffer from dementia, you or your carer/ relative should tell your doctor if you have ever had a stroke or “ mini” stroke.
ek/ min jieħ ħ Jekk tbati mid- dimenzja, int jew qarib tiegħ kellek puplesija jew puplesija “ ħafifa ”.
As a routine precaution, if you are over 65 years your blood pressure may be monitored by your doctor.
ala andek aktar minn 65 sena, il- pressjoni tiegħ tista ’ tiġ mmonitorjata mit- tabib tiegħ ek.
Zalasta is not for patients who are under 18 years.
Zalasta mhux għ pazjenti li għ al andhom anqas minn 18- il sena.
Taking other medicines Please inform your doctor if you are taking or have recently taken any other medicines, even those not prescribed.
Jekk jogħbok għ lit- tabib tiegħ jekk qed tieħ jew ħ dan l- aħar xi mediċ oħ anki dawk
Tell your doctor if:  you are taking medicines for Parkinson’ s disease,  you are taking antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).
Għ lit- tabib tiegħ jekk: id ek qed tieħ mediċ kontra l- marda ta ’ Parkinson
You might feel drowsy if Zalasta is taken in combination with these medicines,  if you are taking fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic), as it may be necessary to change your Zalasta dose.
qed tieħ fluvoxamine (anti- dipressant), jew ciprofloxacin (antibijotiku), għ jista 'jkun hemm
Taking Zalasta with food and drink Zalasta may be taken with or without food.
bż li tinbidel id- doż tiegħ ta 'Zalasta.
Do not drink any alcohol if you have been given Zalasta as Zalasta and alcohol together may make you feel drowsy.
Meta tieħ Zalasta ma 'l- ikel u max- xorb u Zalasta jista' jittieħ kemm ma 'l- ikel jew fuq stonku vojt. ed
Pregnancy Tell your doctor as soon as possible if you are pregnant or think you may be pregnant.
Tixrobx alkoħ jekk ingħ Zalasta għ Zalasta u l- alkoħ flimkien jistgħ jqabbduk ħ kbira.
You should not take this medicine when pregnant unless you have discussed this with your doctor.
M’ għ
Breast-feeding You should not be given this medicine when breast-feeding, as small amounts of Zalasta can pass into breast milk.
Treddigħ andekx tingħ din il- mediċ meta tkun qed tredda ’ għ ammonti ż ar ta 'Zalasta jistgħ M' għ
Driving and using machines There is a risk of feeling drowsy when you are given Zalasta.
Sewqan u tħ addim ta 'magni Hemm riskju li tħ ossok imħeddel meta tingħ Zalasta.
If this happens do not drive or operate any tools or machines.
Għ lit- tabib tiegħ
Tell your doctor.
ek.
Important information about some of the ingredients of Zalasta Zalasta contains lactose.
Jekk it- tabib tiegħ qallek li għ
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
andek intolleranza għ xi tipi ta ’ zokkor, ikkuntattja lit- tabib tiegħ al ek
195 3.
inali.
HOW TO TAKE ZALASTA
KIF GĦANDEK TIEĦ ZALASTA U
Always take Zalasta exactly as your doctor has told you.
Dejjem għ
You should check with your doctor or pharmacists if you are not sure.
ispiż tiegħ jekk ikollok xi dubju.
Your doctor will tell you how many Zalasta tablets to take and how long you should continue to take them.
andek tieħ pilloli Zalasta u għ kemm ż
The daily dose of Zalasta is between 5 – 20 mg.
doż ta ’ kuljum ta ’ Zalasta hija bejn 5- 20 mg. a
Consult your doctor if your symptoms return but do not stop taking Zalasta unless your doctor tells you to.
Ikkonsulta lit- tabib tiegħ jekk is- sintomi tiegħ jerġ u jidhru iż tiqafx tuż Zalasta jekk ma jgħidlekx it- tabib.
You should take your Zalasta tablets once a day following the advice of your doctor.
Ipprova ħ l- pilloli tiegħ fl- istess Għ
Try to take your tablets at the same time each day.
Mhux importanti jekk teħ in odhomx ma ’ l- ikel jew fuq stonku vojt.
It does not matter whether you take them with or without food.
Inti għandek tibla ’ l- pilloli sħ bl- ilma. aħ
You should swallow the tablets whole with water.
ilsien) u tnaqqis fil- livell ta ’ koxjenza.
If you take more Zalasta than you should Patients who have taken more Zalasta than they should, have experienced the following symptoms: rapid beating of the heart, agitation/ aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
(epilessija), koma, taħ ta ’ dawn is- sintomi, deni, nifs aktar mgħ ġ għ
Other symptoms may be: acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness, slowing of the breathing rate, aspiration, high blood pressure or low blood pressure, abnormal rhythms of the heart.
ħ jew ngħ tnaqqis fil- frekwenza ta ’ nifsijiet, aspirazzjoni, pressjoni tad- demm għ jew baxxa,
Contact your doctor or hospital straight away.
Ikkuntattja lit- tabib jew l- isptar minnufih.
Show the doctor your pack of tablets.
Uri lit- tabib il- pakkett tal- pilloli tiegħ ek.
If you forget to take Zalasta Take your tablets as soon as you remember.
M’ għ u andekx tieħ doż doppja f’ ġ
Do not take two doses in one day.
urnata.
If you stop taking Zalasta Do not stop taking your tablets just because you feel better.
Jekk tieqaf tieħ Zalasta u Tieqafx tieħ l- pilloli tiegħ sempliċ
It is important that you carry on taking Zalasta for as long as your doctor tells you.
ement għ aliex tħ ossok aħ Huwa importanti li tibqa 'tieħ Zalasta jar. u
If you suddenly stop taking Zalasta, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur.
ċ Jekk twaqqaf Zalasta f' daqqa, jistgħ jitfaċaw sintomi bħ tagħ nuqqas ta 'rqad, rogħ ansjetà,
Your doctor may suggest you to reduce the dose gradually before stopping treatment.
It- tabib tiegħ jista 'jissuġerixxi li tnaqqas id- doż bil- mod qabel ma twaqqaf it - trattament.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
andek aktar mistoqsijiet dwar l- uż ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiż tiegħ
Like all medicines, Zalasta can cause side effects, although not everybody gets them.
Bħ kull mediċ oħ Zalasta jista ’ jkollu effetti sekondarji, għ al
Very common side effects: affect 1 user in 10  Weight gain.  Sleepiness.  Increases in the levels of prolactin in the blood.
afna: jaffettwaw 1 minn kull 10 pazjenti
Common side effects: affect 1 to 10 users in 100  Changes in the levels of some blood cells and circulating fats.  Increases in the level of sugars in the blood and urine.  Feeling more hungry.  Dizziness.  Restlessness.  Tremor.
207 Effetti sekondarji komuni: jaffettwaw 1 sa 10 minn kull 100 pazjent
196  Muscle stiffness or spasm (including eye movements).  Problems with speech.  Unusual movement (especially of the face or tongue).  Constipation.  Dry mouth.  Rash.  Loss of strength.  Extreme tiredness.  Water retention leading to swelling of the hands, ankles or feet.  In the early stages of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position.
jalment tal- wiċ jew ta ’ l- ilsien).  Stitikezza.  Ħ xott. alq  Raxx.  Titlef il- forzi.
This will usually pass on its own but if it does not, tell your doctor.
Fl- ewwel stadji tal- kura, xi persuni jistgħ jħ
Uncommon side effects: affect 1 to 10 users in 1,000  Slow heart rate.  Make you sensitive to sunlight.  Hair loss.
Effetti sekondarji mhux komuni: jaffettwaw 1 sa 10 minn kull 1, 000 pazjent  Il- qalb tħ abbat bil- mod.  Issir sensittiv għ ad- dawl tax- xemx.
Rare side effects: affect 1 to 10 users in 10,000  Male or female breast enlargement.
Effetti sekondarji rari: jaffettwaw 1 sa 10 minn kull 10, 000 pazjent  Jikber is- sider fl- irġ jew fin- nisa. iel
Other possible side effects: frequency cannot be estimated from the available data.  Allergic reaction (e. g. swelling in the mouth and throat, itching, rash).  Diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma.  Lowering of normal body temperature.  Seizures, usually associated with a history of seizures (epilepsy).  Combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness.  Spasms of the muscle of the eye causing rolling movement of the eye.  Abnormal rhythms of the heart.  Sudden unexplained death.  Blood clots such as deep venous thrombosis of the leg or blood clot on the lung.  Inflammation of the pancreas causing severe stomach pain, fever and sickness.  Liver disease appearing as yellowing of the skin and white parts of the eyes.  Muscle disease presenting as unexplained aches and pains.  Difficulty in passing urine.  Prolonged and/ or painful erection.
igħ
While taking olanzapine, elderly patients with dementia may suffer from stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, a rise in body temperature, redness of the skin and have trouble walking.
Waqt li jkunu qed jieħ olanzapine, pazjenti anzjani bid- dimenzja jistgħ jsofru minn puplesija,
Some fatal cases have been reported in this particular group of patients.
Xi każfatali ġ irrappurtati f’ dan il- grupp partikolari
In patients with Parkinson's disease Zalasta may worsen the symptoms.
208 F’ pazjenti bil- marda ta ’ Parkinson Zalasta jista ’ jiggrava s- sintomi.
Rarely women taking medicines of this type for a long time have started to secrete milk and have missed periods or had irregular periods.
Rarament, nisa li jieħ mediċ ta ’ dan it- tip għ ż
If this persists tell your doctor.
jew kellhom pirjids irregolari.
Very rarely babies born to mothers who have taken Zalasta in the last stage of pregnancy (3rd trimester) may have tremors, be sleepy or drowsy.
nisa li ħ Zalasta fl- aħar stadju tat- tqala (it- 3 trimestru) jista ’ jkollhom rogħ ikunu bi ngħ jew ħ
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħ mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m' humiex ed ġ imsemmijin f’ dan il- fuljett, jekk jogħbok, għ lit- tabib jew lill- ispiż tiegħ
HOW TO STORE ZALASTA
KIF TAĦŻ ZALASTA EN
197 Keep out of the reach and sight of children.
Żommu fejn ma jintlaħ u ma jidhirx mit- tfal. aqx
Do not use Zalasta after the expiry date which is stated on the packaging.
ħ Tuż Zalasta wara d- data ta ’ skadenza li tidher fuq il- pakkett.
The expiry date refers to the last day of that month.
ġurnata ta ’ dak ix- xahar.
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċ ma jeħ x kundizzjonijiet ta ’ ħin speċ ż
Medicines should not be disposed of via wastewater or household waste.
ini andhomx jintremew ma ’ l- ilma tad- dranaġ jew ma ’ l- iskart domestiku.
Ask your pharmacist how to dispose of medicines no longer required.
andekx bż Dawn il- miż jgħ onn.
These measures will help to protect the environment.
ta ’ l- ambjent.
What Zalasta contains
X’ fih Zalasta
Each tablet contains 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg or
Kull pillola fiha 2. 5 mg, 5 mg, 7. 5 mg, 10 mg, 15 mg jew 20 mg -
20 mg olanzapine.
olanzapine
- The other ingredients are alpha-lactose monohydrate, powdered cellulose, pregelatinised maize
- Is- sustanzi l- oħ huma alpha- lactose monohydrate, powdered cellulose, pregelatinised starch
starch, maize starch, colloidal anhydrous silica, magnesium stearate.
ra (vegetable origin), maize starch, colloidal anhydrous silica, magnesium stearate.
What Zalasta looks like and contents of the pack Zalasta 2.5 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots.
Id- dehra ta ’ Zalasta u l- kontenuti tal- pakkett Zalasta 2. 5 mg pilloli huma: tondi, daqsxejn konvessi, jagħ fl- isfar possibbilment b’ tikek sofor tu individwali.
Zalasta 5 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription 5.
Zalasta 5 mg pilloli huma: tondi, daqsxejn konvessi, jagħ fl- isfar possibbilment b’ tikek sofor tu individwali bl- iskrizzjoni 5.
Zalasta 7.5 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription 7.5.
Zalasta 7. 5 mg pilloli huma: tondi, daqsxejn konvessi, jagħ fl- isfar possibbilment b’ tikek sofor tu individwali bl- iskrizzjoni 7. 5.
Zalasta 10 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription 10.
Zalasta 10 mg pilloli huma: tondi, daqsxejn konvessi, jagħ fl- isfar possibbilment b’ tikek sofor tu individwali bl- iskrizzjoni 10.
Zalasta 15 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription 15.
Zalasta 15 mg pilloli huma: tondi, daqsxejn konvessi, jagħ fl- isfar possibbilment b’ tikek sofor tu individwali bl- iskrizzjoni 15.
Zalasta 20 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription 20.
Zalasta 20 mg pilloli huma: tondi, daqsxejn konvessi, jagħ fl- isfar possibbilment b’ tikek sofor tu individwali bl- iskrizzjoni 20.
Zalasta 2.5 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blister packs.
Zalasta 2. 5 mg pilloli: disponibbli f’ kaxxi ta’ 14, 28, 35, 56 u 70 pillola f’ pakketti ta ’ folji.
Zalasta 5 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blister packs.
Zalasta 5 mg pilloli: disponibbli f’ kaxxi ta’ 14, 28, 35, 56 u 70 pillola f’ pakketti ta ’ folji.
Zalasta 7.5 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blister packs.
Zalasta 7. 5 mg pilloli: disponibbli f’ kaxxi ta’ 14, 28, 35, 56 u 70 pillola f’ pakketti ta ’ folji.
Zalasta 10 mg tablets: available in boxes of 7, 14, 28, 35, 56 and 70 tablets in blister packs.
Zalasta 10 mg pilloli: disponibbli f’ kaxxi ta ’ 7, 14, 28, 35, 56 u 70 pillola f’ pakketti ta ’ folji.
Zalasta 15 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blister packs.
209 Zalasta 15 mg pilloli: disponibbli f’ kaxxi ta’ 14, 28, 35, 56 u 70 pillola f’ pakketti ta ’ folji.
Zalasta 20 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blister packs.
Zalasta 20 mg pilloli: disponibbli f’ kaxxi ta’ 14, 28, 35, 56 u 70 pillola f’ pakketti ta ’ folji.
Marketing Authorisation Holder KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħ fis- Suq: id KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenja ka
Manufacturer 1.
Il- Manifattur 1.
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka 2.
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenja ka 2.
Równoległ 5, 02-235 Warsaw, Poland a
Równoległ5, 02- 235 Warsaw, Il- Polonja a
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
inali, jekk jogħbok ikkuntattja lir- rappreż entant lokali tad -
Tel.: + 353 (0)86 3838 282 Ísland KRKA Sverige AB Tel: + 46 8 643 67 66 Italia KRKA, d. d., Novo mesto Tel.: +39 069448827 Κ πο
Tel.: + 353 (0) 86 3838 282 Ísland KRKA Sverige AB Tel: + 46 8 643 67 66
Tel: +421 (0)257104504 Suomi/ Finland KRKA Sverige AB Tel: + 46 8 643 67 66
Tel: +421 (0) 257104504
ύρς KRKA, d. d., Novo mesto Tel: +30 (0)210 9581143 (EL) Latvija KRKA, d. d., Novo mesto Tel.: +371 (0)733 8610 Lietuva KRKA, d. d., Novo mesto Tel.: +370 (0)2 362 742
210 Suomi/ Finland Italia KRKA Sverige AB KRKA, d. d., Novo mesto Tel: + 46 8 643 67 66 Tel.: +39 069448827 Κ πο ύρς Sverige KRKA, d. d., Novo mesto Tel: +30 (0) 210 9581143 (EL) Latvija KRKA, d. d., Novo mesto Tel.: +371 (0) 733 8610 Lietuva KRKA, d. d., Novo mesto Tel.: +370 (0) 2 362 742
This leaflet was last approved in
Dan il- fuljett kien approvat l- aħ ar f ’
199 PACKAGE LEAFLET:
211 FULJETT TA 'TAGĦRIF:
INFORMATION FOR THE USER
Zalasta 5 mg pillola li tinħ fil- ħ
Zalasta 5 mg orodispersible tablets Zalasta 7.5 mg orodispersible tablets Zalasta 10 mg orodispersible tablets Zalasta 15 mg orodispersible tablets Zalasta 20 mg orodispersible tablets Olanzapine
Zalasta 15 mg pillola li tinħ Zalasta 20 mg pillola li tinħ Olanzapine
If this happens after you have been given Zalasta tell your doctor. ─ Very rarely, medicines of this type cause a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness.
212 ─ Rari ħ afna, mediċ ta 'dan it- tip jikkawż taħ ta' deni, nifs aktar mgħ ġ tagħ ebusija fil -
200 If you suffer from any of the following illnesses tell your doctor as soon as possible: ─ Diabetes ─ Heart disease ─ Liver or kidney disease ─ Parkinson’ s disease ─ Epilepsy ─ Prostate problems ─ A blocked intestine (paralytic ileus) ─ Blood disorders ─ Stroke or “ mini” stroke (temporary symptoms of stroke).
─ Mard tal- kliewi jew tal- fwied ─ Il- marda ta ’ Parkinson ─ Epilessija ─ Problemi bil- prostata ─ Imblokk intestinali (ileus paralitiku) ─ Disturbi tad- demm ─ Puplesija jew puplesija “ ħ afifa ” (sintomi temporanji ta 'puplesija)
Taking Zalasta with food and drink Zalasta may be taken with or without food.
Ħ ed alqek għ
Your mouth should be empty before placing the tablet on the tongue.
andu jkun vojt qabel ma tpoġi l - pillola fuq l- ilsien.
Do not drink any alcohol if you have been given Zalasta as Zalasta and alcohol together may make you feel drowsy.
Tixrobx alkoħ jekk ingħ Zalasta għ Zalasta u l- alkoħ flimkien jistgħ jqabbduk ħ kbira.
Pregnancy Tell your doctor as soon as possible if you are pregnant or think you may be pregnant.
M’ għ
You should not take this medicine when pregnant unless you have discussed this with your doctor.
mediċ meta tkun tqila jekk ma tkunx iddiskutejt dan mat- tabib tiegħ
Important information about some of the ingredients of Zalasta Zalasta contains a source of phenylalanine.
Jista 'jkun ta' ħ għ nies li għ
May be harmful for people with phenylketonuria.
andhom phenylketonuria.
HOW TO TAKE ZALASTA
KIF GĦANDEK TIEĦU ZALASTA
201 Your doctor will tell you how many Zalasta tablets to take and how long you should continue to take them.
andek tieħ pilloli Zalasta u għ kemm ż
You should take your Zalasta tablets once a day following the advice of your doctor.
andek tieħ l- pilloli Zalasta darba kuljum skond il- parir tat- tabib.
Try to take your tablets at the same time each day.
Ipprova ħ l- pilloli tiegħ fl- istess Għ
It does not matter whether you take them with or without food.
Mhux importanti jekk teħ in odhomx ma ’ l- ikel jew fuq stonku vojt.
How to take Zalasta Zalasta tablets break easily, so you should handle the tablets carefully.
Kif għ andek tieħ Zalasta u Il- pilloli Zalasta jinkisru malajr, għalhekk għ andek toqgħ attent kif tmiss il- pilloli.
Do not handle the tablets with wet hands as the tablets may break up.
Biex toħ
To take a tablet out of the packaging:
roġpillola mill- pakkett:
The tablet begins breaking up in the mouth within seconds and can then be swallowed with or without water.
Ħ
Your mouth should be empty before placing the tablet on the tongue.
għ andu jkun vojt qabel ma tpoġi l- pillola fuq l- ilsien.
You can also place the tablet in a full glass or cup of water.
Tista 'wkoll tpoġi l- pillola ġ tazza jew kikkra mimlija bl- ilma.
Drink it straight away.
Ixrobha mill- ewwel.
If you take more Zalasta than you should Patients who have taken more Zalasta than they should, have experienced the following symptoms: rapid beating of the heart, agitation/ aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
Sintomi oħ jistgħ jkunu: konfuż akuta, aċessjonijiet
Other symptoms may be: acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness, slowing of the breathing rate, aspiration, high blood pressure or low blood pressure, abnormal rhythms of the heart.
(epilessija), koma, taħ ta ’ dawn is- sintomi, deni, nifs aktar mgħ ġ għ
If you stop taking Zalasta Do not stop taking your tablets just because you feel better.
214 Jekk tieqaf tieħ Zalasta u Tieqafx tieħ l- pilloli tiegħ sempliċ
202 Like all medicines, Zalasta can cause side effects, although not everybody gets them.
Bħ kull mediċ oħ Zalasta jista ’ jkollu effetti sekondarji, għ al
Common side effects: affect 1 to 10 users in 100  Changes in the levels of some blood cells and circulating fats.  Increases in the level of sugars in the blood and urine.  Feeling more hungry.  Dizziness.  Restlessness.  Tremor.  Muscle stiffness or spasm (including eye movements).  Problems with speech.  Unusual movement (especially of the face or tongue).  Constipation.  Dry mouth.  Rash.  Loss of strength.  Extreme tiredness.  Water retention leading to swelling of the hands, ankles or feet.  In the early stages of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position.
Effetti sekondarji komuni: jaffettwaw 1 sa 10 minn kull 100 pazjent
This will usually pass on its own but if it does not, tell your doctor.
idiet fil- livelli ta 'zokkor fid- demm u fl- awrina. ossok aktar bil- ġ. uħ
Uncommon side effects: affect 1 to 10 users in 1,000  Slow heart rate.  Make you sensitive to sunlight.  Hair loss.
 Sturdament.  Irrekwjetezza.
Other possible side effects: frequency cannot be estimated from the available data.  Allergic reaction (e. g. swelling in the mouth and throat, itching, rash).  Diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma.  Lowering of normal body temperature.  Seizures, usually associated with a history of seizures (epilepsy).  Combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness.  Spasms of the muscle of the eye causing rolling movement of the eye.  Abnormal rhythms of the heart.  Sudden unexplained death.  Blood clots such as deep venous thrombosis of the leg or blood clot on the lung.  Inflammation of the pancreas causing severe stomach pain, fever and sickness.  Liver disease appearing as yellowing of the skin and white parts of the eyes.  Muscle disease presenting as unexplained aches and pains.  Difficulty in passing urine.  Prolonged and/ or painful erection.
 Mard tal- muskoli li jimmanifesta ruħ bħ wġ inspjegabbli. u ala igħ  Diffikultà biex tgħ l- awrina. addi  Erezzjoni mtawwla u/ jew bl- uġ. igħ
203 While taking olanzapine, elderly patients with dementia may suffer from stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, a rise in body temperature, redness of the skin and have trouble walking.
Waqt li jkunu qed jieħ olanzapine, pazjenti anzjani bid- dimenzja jistgħ jsofru minn puplesija,
In patients with Parkinson's disease Zalasta may worsen the symptoms.
F’ pazjenti bil- marda ta ’ Parkinson Zalasta jista ’ jiggrava s- sintomi.
Keep out of the reach and sight of children.
Żommu fejn ma jintlaħ u ma jidhirx mit- tfal. aqx
This medicinal product does not require any special storage conditions.
tieġebda kundizzjoni ta ’ ħin speċ ż Dan il- prodott mediċ ma jeħ
Each orodispersible tablet contains 5 mg, 7.5 mg, 10 mg,
Kull pillola li tinħ fil- ħ fiha 5 mg, 7. 5 mg, 10 mg, 15 mg jew
15 mg or 20 mg olanzapine.
20 mg olanzapine
- The other ingredients are mannitol, microcrystalline cellulose, crospovidone, low-substituted
- Is- sustanzi l- oħ huma mannitol, microcrystalline cellulose, crospovidone, low- substituted
hydroxypropylcellulose, aspartame, calcium silicate, magnesium stearate.
ra hydroxypropylcellulose, aspartame, calcium silicate, magnesium stearate.
What Zalasta looks like and contents of the pack Zalasta 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg orodispersible tablets are: round, slightly biconvex, yellow marbled tablets with possible individual spots.
Zalasta 5 mg, 7. 5 mg, 10 mg, 15 mg jew 20 mg pilloli li jinħ fil- ħ huma tondi, kemxejn konvessi, sofor irħamati bil- possibbiltà ta 'tikek individwali.
Zalasta 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg orodispersible tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blister packs.
Zalasta 5 mg pilloli li jinħ fil- ħ disponibbli f’ kaxxi ta’ 14, 28, 35, 56 u 70 pillola f’ pakketti ta ’ folji.
Marketing Authorisation Holder KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħ fis- Suq id KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, is- Slovenja ka
Manufacturer 1.
Il- Manufattur 1.
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka 2.
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, is- Slovenja ka 2.
Równoległ 5, 02-235 Warsaw, Poland a
Równoległ5, 02- 235 Warsaw, il- Polonja a
λά α KRKA, d. d., Novo mesto Tel.: +30 (0)210 9581143 España KRKA, d. d., Novo mesto Tel.: +34 615 089809 France KRKA, d. d., Novo mesto Tel.: +33 557 021 923 Ireland KRKA Pharma Dublin, Ltd.
217 España KRKA, d. d., Novo mesto Tel.: +34 615 089809 France KRKA, d. d., Novo mesto Tel.: +33 557 021 923 Ireland KRKA Pharma Dublin, Ltd.
Tel.: +48 (0)22 573 7503 Portugal KRKA Farmacêutica, Unipessoal Lda.
Portugal KRKA Farmacêutica, Unipessoal Lda.
This leaflet was last approved in
Dan il- fuljett ġ approvat l- aħ ar f ’ ħ ie
What is Zarzio?
X’ inhu Zarzio?
Zarzio is a solution for injection or infusion (drip into a vein) in a pre-filled syringe.
Zarzio huwa soluzzjoni għal injezzjoni jew infużjoni (dripp fil- vina) f’ siringa mimlija minn qabel.
Zarzio is a ‘ biosimilar’ medicine.
Zarzio hija mediċina ‘ bijosimili ’.
This means that Zarzio is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘ reference medicine’).
Dan ifisser li Zarzio huwa simili għal mediċina bijoloġika li hija diġà awtorizzata fl- Unjoni Ewropea (UE) u li tinkludi fiha l- istess sustanza attiva (magħrufa bħala ‘ mediċina ta ’ referenza ’).
The reference medicine for Zarzio is Neupogen.
Il- mediċina ta ’ referenza għal Zarzio hija Neupogen.
What is Zarzio used for?
Għalxiex jintuża Zarzio?
Zarzio is used to stimulate the production of white blood cells in the following situations:  to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving chemotherapy (cancer treatment) that is cytotoxic (cell-killing);  to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at a risk of long-term, severe neutropenia;  to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections;  to treat persistent neutropenia in patients with advanced human immunodeficiency virus (HIV) infection, to reduce the risk of bacterial infections when other treatments are not appropriate.
Zarzio huwa użat sabiex jistimula l- produzzjoni ta ’ ċelloli bojod fid- demm fis- sitwazzjonijiet li ġejjin:  Inaqqas iż- żmien ta ’ newtropenija (livelli baxxi ta ’ newtrofili, tip ta ’ ċellola bajda tad- demm) u l - każ li jkun hemm newtropenija febbrili (newtropenija fil- fwied) f’ pazjenti li jirċievu l - kemoterapija (trattament tal- kanċer) li huwa ċitotossiku (joqtol iċ- ċelloli);  Inaqqas iż- żmien ta ’ newtropenija f’ pazjenti li għaddejjin bi trattament li jkisser iċ- ċelloli tal - mudullum qabel mal- mudullum jiġi trapjantat (bħal f’ xi pazjenti bil- lewkimja) jekk ikunu f’ riskju ta ’ newtropenija severa fuq żmien twil;  Iżid il- livelli ta ’ newtrofili u jnaqqas ir- riskju ta ’ infezzjonijiet f’ pazjenti bin- newtropenija li għandhom storja ta ’ infezzjonijiet severi u repetuti;  Jittratta newtropenija persistenti f’ pazjenti bil- vajrus uman tal- immunodefiċjenza fi stat avvanzat [HIV]).
Zarzio can also be used in people who are about to donate blood stem cells for transplant, to help release these cells from the bone marrow.
Zarzio jista ’ jintuża wkoll f’ pazjenti li ser jagħtu ċ- ċelloli staminali tad- demm għal trapjant, sabiex dan jgħin fir- rilaxx taċ- ċelloli mill- mudullum.
How is Zarzio used?
Kif jintuża Zarzio?
Zarzio is given by injection under the skin or infusion into a vein.
Zarzio jingħata b’ injezzjoni taħt il- ġilda jew infużjoni fil- vina.
How it is given, the dose and the duration of treatment depend on why it is being used, the patient’ s body weight and the response to treatment.
Il- mod ta ’ kif jingħata, id- doża u ż - żmien tat- trattament jiddependu fuq ir- raġuni tal- użu, il- massa korporja tal- pazjent u r- rispons għat - trattament.