qanastek/EMEA-V3 huggingface dataset:
The recommended starting dose for olanzapine is 10 mg/ day.
Id- do a tal- bidu rakkomandata g al olanzapine hija 10 mg / urnata.
30 appropriate clinical reassessment and should generally occur at intervals of not less than 24 hours.
ting ata fuq l- ikel jew fuq stonku vojt g ax l -
Elderly patients A lower starting dose (5 mg/ day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant (see section 4.4).
Anzjani Do a anqas tal- bidu (5 mg / urnata) mhux indikata normalment imma g andha ti i kkunsidrata g al dawk li g andhom 65 jew fuqhom meta fatturi klini i jindikaw hekk (ara wkoll sezzjoni 4. 4).
31 Dementia-related psychosis and/ or behavioural disturbances Olanzapine is not approved for the treatment of dementia-related psychosis and/ or behavioural disturbances and is not recommended for use in this particular group of patients because of an increase in mortality and the risk of cerebrovascular accident.
33 Psiko i relatata mad- demenzja u/ jew disturbi fil- komportament Olanzapine mhux approvat g at- trattament tal- psiko i relatata mad- demenzja u/ jew disturbi fil - komportament, u mhux irrakkomandat g all- u u f’ dan il- grupp partikolari ta ’ pazjenti, dovut g al ieda fil- mortalità u r- riskju ta ’ in ident erebro- vaskulari.
Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.
34 b’ mod klinikamet xieraq spe jalment f’ pazjenti b’ ammonti mhux normali ta ’ xa mijiet fid- demm u f’ pazjenti li g andhom fatturi ta ’ riskju g all- i vilupp ta ’ disturbi fix- xa mijiet.
32 Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Attività antikoliner ika Waqt li olanzapine wera attività antikoliner ika in vitro, ersperjenza waqt il- provi klini i uriet in idenza baxxa ta 'rajjiet relatati.
33 Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
Diskajne ja Tardiva Fi studji komparattivi li damu sena jew anqas, olanzapine kien asso jat ma 'idenza mnaqqsa ta' in diskajne ja f 'ultat tat- trattament b'
4.5 Interaction with other medicaments and other forms of interaction
Potenzjal t' interazzjonijiet ma 'olanzapine Min abba li olanzapine hija metaboli ata b'
Inhibition of CYP1A2 Fluvoxamine, a specific CYP1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine.
36 Inibizzjoni ta 'CYP1A2 Fluvoxamine, inibitur spe ifiku ta' CYP1A2, deher li jinibixxi sinifikatament il- metaboli mu ta 'olanzapine.
34 Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
Fluvoxetine (inibitur CYP2D6), do i b’ wa diet t 'anta idi (aluminium, magnesium) jew cimetidine ma nstabux li jaffettwaw sinifikatament il- komportament farmakokinetiku ta' olanzapine.
Because olanzapine may cause somnolence and dizziness, patients should be cautioned about operating machinery, including motor vehicles.
37 Ma sarux studji dwar l- effetti fuq il - ila biex issuq jew t addem magni. Min abba li olanzapine jista 'jikkaw a sonnolenza u sturdament, il- pazjenti g andhom ji u av ati dwar l- u u ta' magni, inklu i l - karozzi.
35 transient asymptomatic elevations of hepatic transaminases (see section 4.4), rash, asthenia, fatigue and oedema.
l- olanzapine kienu sonnolenza, ieda fil- pi, eosinofilja,
Vascular disorders
38 Disturbi fil- qalb Disturbi vaskulari
36 Hepato-biliary disorders
Disturbi fil- fwied u fil- marrara
4 Observed for fasting normal levels at baseline (< 5.56 mmol/ l) which increased to high (7 mmol/ l).
39 4 Innotat g al livelli normali waqt is- sawm fil- linja ba i (< 5. 56 mmol/ l) li diedu g al g oljin (7 mmol/ l).
37 7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
7 ew irrapportati sintomi akuti b al g araq, insomnja, rog da, ansjetà, tqallig u rimettar meta olanzapine jitwaqqaf f' daqqa.
Clinically significant weight gain (7%) appears to occur more frequently in the adolescent population compared to adults with comparable exposures.
40 (7%) tidher li sse aktar frekwentement fil- popolazzjoni ta '
Olanzapine also showed a statistically significant advantage over placebo in terms of preventing either recurrence into mania or recurrence into depression.
42 olanzapine wera superjorita sinifikanti u statistikament superjuri fuq il- pla ebo fuq l- g an ewlieni tar - rikorrenza bipolari. olanzapine uriet ukoll vanta statistiku u sinifikanti fuq il- pla ebo fil - prevenzjoni, kemm f 'attakki odda ta' manija kif ukoll f' attakki odda ta 'depressjoni.
40 In an 18-month co-therapy study in manic or mixed episode patients stabilised with olanzapine plus a mood stabiliser (lithium or valproate), long-term olanzapine co-therapy with lithium or valproate was not statistically significantly superior to lithium or valproate alone in delaying bipolar recurrence, defined according to syndromic (diagnostic) criteria.
Fi studju ta '18- il xhar f' pazjenti b 'manija jew b' episodji m allta stabilizzati fuq olanzapine flimkien ma 'stabilizzatur tal- burdata (lithium jew valproate), l- u u fit- tul ta' olanzapine flimkien ma ’ lithium jew l- valproate ma kienx statistikament sinifikanti superjuri g all- lithium jew g all- valproate wa du biex jittardja r- rikorrenza bipolari, kif definit skond il- kriterji (dijanjosti i) tas- sindromu.
In non-smoking versus smoking subjects (males and females) the mean elimination half-life was prolonged (38.6 versus 30.4 hr) and the clearance was reduced (18.6 versus 27.7 l/ hr).
43 F' pazjenti li ma jpejpux f 'paragun ma' dawk li jpejpu (ir iel u nisa) il- medja tal- half life ta' l - eliminazzjoni kien imtawwal (38. 6 kontra 30. 4 sieg a) u l- clearance tnaqqset (18. 6 kontra 27. 7 l/ hr).
41 The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, and in non-smokers versus smokers.
Il- clearance ta 'olanzapine mill- pla ma huwa anqas f' nisa f' paragun ma 'iel, u f'
However, the magnitude of the impact of age, gender, or smoking on olanzapine clearance and half-life is small in comparison to the overall variability between individuals.
ta' l- età, is- sess, jew tat- tipjip fuq il- clearance ta' olanzapine u fuq il- half life huwa g ir f 'paragun mal- varjabilità totali ta' bejn individwi.
Carcinogenicity Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Kan ero eni ità Ibba at fuq ri ultati ta' studji fuq il - rieden u l- firien, kien konklu li olanzapine mhuwiex kan ero eniku.
ZYPREXA VELOTAB 20 mg orodispersible tablets
ZYPREXA VELOTAB 20 mg pilloli li jin allu fil - alq
Each orodispersible tablet contains 20 mg olanzapine.
Kull pillola li tin all fil - alq g andha 20 mg olanzapine.
Each orodispersible tablet contains 1.60 mg aspartame, 0.30 mg sodium methyl parahydroxybenzoate, 0.10 mg sodium propyl parahydroxybenzoate.
Kull pillola li tin all fil - alq 1. 6 mg aspartame 0. 3 mg sodium methyl parahydroxybenzoate 0. 1 mg sodium propyl parahydroxybenzoate.
The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see section 5.1).
Id- do a tal- bidu hija ta 'mg b ala do a wa da kuljum bil- monoterapija jew 15 10 mg kuljum f' terapija flimkien ma 'sustanza o ra (Ara sezzjoni 5. 1). xi
44 appropriate clinical reassessment and should generally occur at intervals of not less than 24 hours.
ting ata fuq l- ikel jew fuq stonku vojt g ax l -
45 Dementia-related psychosis and/ or behavioural disturbances Olanzapine is not approved for the treatment of dementia-related psychosis and/ or behavioural disturbances and is not recommended for use in this particular group of patients because of an increase in mortality and the risk of cerebrovascular accident.
48 Psiko i relatata mad- demenzja u/ jew disturbi fil- komportament Olanzapine mhux approvat g at- trattament tal- psiko i relatata mad- demenzja u/ jew disturbi fil - komportament, u mhux irrakkomandat g all- u u f’ dan il- grupp partikolari ta ’ pazjenti, dovut g al ieda fil- mortalità u r- riskju ta ’ in ident erebro- vaskulari.
46 Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
49 Attività antikoliner ika Waqt li olanzapine wera attività antikoliner ika in vitro, ersperjenza waqt il- provi klini i uriet in idenza baxxa ta 'rajjiet relatati.
47 Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
Diskajne ja Tardiva Fi studji komparattivi li damu sena jew anqas, olanzapine kien asso jat ma 'idenza mnaqqsa ta' in diskajne ja f 'ultat tat- trattament b'
A lower starting dose of olanzapine should be considered in patients who are using fluvoxamine or any other CYP1A2 inhibitors, such as ciprofloxacin.
51 ju aw fluvoxamine jew xi inibituri o ra ta' CYP1A2, b al ciprofloxacin.
48 Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
Fluvoxetine (inibitur CYP2D6), do i b’ wa diet t 'anta idi (aluminium, magnesium) jew cimetidine ma nstabux li jaffettwaw sinifikatament il- komportament farmakokinetiku ta' olanzapine.
4.8 Undesirable effects
52 4. 8 Effetti mhux mixtieqa
49 transient asymptomatic elevations of hepatic transaminases (see section 4.4), rash, asthenia, fatigue and oedema.
l- olanzapine kienu sonnolenza, ieda fil- pi, eosinofilja,
Ventricular tachycardia/ fibrillation, sudden death (see section 4.4)
53 Disturbi vaskulari
50 Hepato-biliary disorders
Disturbi fil- fwied u fil- marrara
5 Observed for fasting normal levels at baseline (< 1.69 mmol/ l) which increased to high (2.26 mmol/ l).
54 5 Innotat g al livelli normali waqt is- sawm fil- linja ba i (< 1. 69 mmol/ l) li diedu g al g oljin (2. 26 mmol/ l).
51 7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
7 ew irrapportati sintomi akuti b al g araq, insomnja, rog da, ansjetà, tqallig u rimettar meta olanzapine jitwaqqaf f' daqqa.
Cardiovascular monitoring is necessary to detect possible arrhythmias.
56 biex tinduna b’ ta bit irregolari tal- qalb li jista ’ jse.
Pharmacotherapeutic group: antipsychotic, ATC code:
Grupp farmako- terapewtiku: antipsikotiku, kodi i ATC N05A H03.
N05A.
ta '
Olanzapine is an antipsychotic, antimanic and mood stabilising agent that demonstrates a broad pharmacologic profile across a number of receptor systems.
ri
In a 12-month recurrence prevention study in manic episode patients who achieved remission on olanzapine and were then randomised to olanzapine or placebo, olanzapine demonstrated statistically significant superiority over placebo on the primary endpoint of bipolar recurrence.
tnaqqis akbar tas- sintomi tal- manija milli b '
Olanzapine also showed a statistically significant advantage over placebo in terms of preventing either recurrence into mania or recurrence into depression.
Fi studju ta' 12- il xahar ta' prevenzjoni ta' rikorrenza f 'pazjenti b' episodju ta' manija, li kienu di à ikkontrollati b’ olanzapine, imbag ad kienu mog tija ming ajr g a la olanzapine jew il- pla ebo, olanzapine wera superjorita sinifikanti u statistikament superjuri fuq il- pla ebo fuq l- g an ewlieni tar - rikorrenza bipolari. olanzapine uriet ukoll vanta statistiku u sinifikanti fuq il- pla ebo fil - prevenzjoni, kemm f 'attakki odda ta' manija kif ukoll f' attakki odda ta 'depressjoni.
In a second 12-month recurrence prevention study in manic episode patients who achieved remission with a combination of olanzapine and lithium and were then randomised to olanzapine or lithium alone, olanzapine was statistically non-inferior to lithium on the primary endpoint of bipolar recurrence (olanzapine 30.0%, lithium 38.3%; p = 0.055).
57 Fit- tieni studju ta' 12- il xhar dwar ir- rikorrenza preventiva f 'pazjenti b' episodju ta' manija li kienu ikkontrollati b’ olanzapine u l- lithium flimkien, kienu mbag ad mqassmin ming ajr g a la u mog tija olanzapine jew il- lithium wa du. olanzapine kien statistikament mhux inferjuri g all- lithium fuq l - g an ewlieni ta 'rikorrenza bipolari (olanzapine 30. 0%, lithium 38. 3%; p = 0. 055).
54 In an 18-month co-therapy study in manic or mixed episode patients stabilised with olanzapine plus a mood stabiliser (lithium or valproate), long-term olanzapine co-therapy with lithium or valproate was not statistically significantly superior to lithium or valproate alone in delaying bipolar recurrence, defined according to syndromic (diagnostic) criteria.
Fi studju ta '18- il xhar f' pazjenti b 'manija jew b' episodji m allta stabilizzati fuq olanzapine flimkien ma 'stabilizzatur tal- burdata (lithium jew valproate), l- u u fit- tul ta' olanzapine flimkien ma ’ lithium jew l- valproate ma kienx statistikament sinifikanti superjuri g all- lithium jew g all- valproate wa du biex jittardja r- rikorrenza bipolari, kif definit skond il- kriterji (dijanjosti i) tas- sindromu.
The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, and in non-smokers versus smokers.
58 Il- clearance ta 'olanzapine mill- pla ma huwa anqas f' nisa f' paragun ma 'iel, u f'
55 smoking on olanzapine clearance and half-life is small in comparison to the overall variability between individuals.
ta' l- età, is- sess, jew tat- tipjip fuq il- clearance ta' olanzapine u fuq il- half life huwa g ir f 'paragun mal- varjabilità totali ta' bejn individwi.
Carcinogenicity Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
59 Kan ero eni ità Ibba at fuq ri ultati ta' studji fuq il - rieden u l- firien, kien konklu li olanzapine mhuwiex kan ero eniku.
57 ANNEX II
61 ANNESS II
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI G ALL - RU TAL - LOTT
Name and address of the manufacturers responsible for batch release in the EEA
Isem u indirizz tal- manifatturi responsabbli g all - ru tal- lott fl- EEA
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Fuq il- fuljett ta 'rif tal- prodott medi inali g andu jkun hemm l- isem u l- indirizz tal- manifattur tag responsabbli g all - ru tal- lott kon ernat
The Marketing Authorisation Holder will provide the PSUR annually.
Id- Detentur ta ’ l- Awtorizzazzjoni g at- Tqeg id fis- Suq se jipprovdi l- PSUR kull sena.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.1, of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Id- Detentur ta ’ l- Awtorizzazzjoni g at- Tqeg id fis- Suq jikkommetti ru u li jag mel l- istudji u attivitajiet ta ’ farmakovi ilanza addizzjonali dettaljati fil- Pjan ta ’ Farmakovi ilanza, kif miftiehem f - ver joni 1. 1 tal - Pjan g all- Immani jar tar- Riskju (RMP) ippre entat f’ Modulu 1. 8. 2 ta ’ l - Awtorizzazzjoni g at- Tqeg id fis- Suq u f’ a ornamenti sussegwenti tal- RMP kif miftiehem mal - CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Kif dettaljat fil- Linji Gwida tal- CHMP fuq i- Sistemi g all- Immani jar tar- Riskju g all- prodotti medi inali g all- u u fil- bniedem, l- RMP a ornat g andu ji i sottomess mar- Rapport Perjodiku ta ’ A ornament Dwar Sigurta ’ (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Minn barra hekk, RMP a ornat g andu g andu ji i sottomess • Meta ti i mi bura xi informazzjoni dida li tista taffetwa l- ispe ifikazzjoni attwali dwar is - Sigurta ’, il- Pjan ta ’ Farmakovi ilanza jew attivitajiet ta ’ tnaqqis ta ’ Riskji • Fi mien 60 urnata minn meta tkun intla qet xi rajja importanti (ta ’ farmakovi ilanza jew tnaqqis ta ’ riskju) • Meta jkun mitlub mill- EMEA
59 ANNEX III
63 ANNESS III
LABELLING AND PACKAGE LEAFLET
TIKKETTA U FULJETT TA 'TAG RIF
61 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
65 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
CARTON OF ZYPREXA VELOTAB 5 mg ORODISPERSIBLE TABLETS
KARTUN TA ’ ZYPREXA VELOTAB 5 mg PILLOLI LI JIN ALLU FIL - ALQ
ZYPREXA VELOTAB 5 mg orodispersible tablets Olanzapine
ZYPREXA VELOTAB 5 mg, pilloli li jin allu fil - alq Olanzapine
Each orodispersible tablet contains 5 mg olanzapine
Kull pillola li tin all fil - alq fiha 5 mg ta ’ olanzapine
Other ingredients: gelatin, mannitol (E421), aspartame (E951), sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217).
Ingredjenti o ra: gelatin, mannitol (E421), aspartame (E951), sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217).
28 orodispersible tablets 35 orodispersible tablets 56 orodispersible tablets 70 orodispersible tablets
28 pillola li jin 35 pillola li jin 56 pillola li jin 70 pillola li jin
METHOD AND ROUTE(S) OF ADMINISTRATION
MOD TA 'KIF U MNEJN JING ATA
Read the package leaflet before use
Aqra l- fuljett ta ’ tag rif qabel l- u u.
Oral use
Jittie ed mill - alq
2.
Issepara ellola wa da tal- folja mill- istrixxa 2.
Carefully peel off the backing.
Qaxxar il- bi a ta '
4.
Imbotta il- pillola ’ l barra bil- mod 4.
Put the tablet in your mouth
Po i l- pillola o alqek
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
TWISSIJA SPE JALI LI L- PRODOTT G ANDU JIN AMM FEJN MA JINTLA AQX U MA JIDHIRX MIT- TFAL
Keep out of the reach and sight of children
omm fejn ma jintla aqx u ma jidhirx mit- tfal.
Store in the original package in order to protect from light and moisture.
A en fil- pakkett ori inali sabiex tilqa' mid- dawl u mill- umdità
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPE JALI G AR- RIMI TA 'PRODOTTI MEDI INALI MHUX U ATI JEW SKART MINN DAWN IL- PRODOTTI MEDI INALI, JEKK HEMM B ONN.
MARKETING AUTHORISATION NUMBER (S)
NUMRU( I) TA 'L- AWTORIZZAZZJONI G AT- TQEG ID FIS- SUQ
EU/ 1/ 99/ 125/ 001 28 orodispersible tablets EU/ 1/ 99/ 125/ 009 35 orodispersible tablets EU/ 1/ 99/ 125/ 005 56 orodispersible tablets EU/ 1/ 99/ 125/ 013 70 orodispersible tablets
EU/ 1/ 99/ 125/ 001 EU/ 1/ 99/ 125/ 009 EU/ 1/ 99/ 125/ 005 EU/ 1/ 99/ 125/ 013
GENERAL CLASSIFICATION FOR SUPPLY
ENERALI TA 'KIF JING ATA
63 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
67 TAG RIF MINIMU LI G ANDU JIDHER FUQ IL- FOLJI JEW FUQ L - ISTRIXXI
ZYPREXA VELOTAB 5 mg ORODISPERSIBLE TABLETS:
ZYPREXA VELOTAB 5 mg PILLOLI LI JIN ALLU FIL - ALQ:
BLISTER FOIL LABEL
TIKKETTA TAL- FOJL TAL- FOLJA
ZYPREXA VELOTAB 5 mg orodispersible tablets Olanzapine
ZYPREXA VELOTAB 5 mg pilloli li jin allu fil - alq Olanzapine
64 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
68 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
CARTON OF ZYPREXA VELOTAB 10 mg ORODISPERSIBLE TABLETS
KARTUN TA ’ ZYPREXA VELOTAB 10 mg PILLOLI LI JIN ALLU FIL - ALQ
ZYPREXA VELOTAB 10 mg orodispersible tablets Olanzapine
ZYPREXA VELOTAB 10 mg, pilloli li jin allu fil - alq Olanzapine
Each orodispersible tablet contains 10 mg olanzapine
Kull pillola li tin all fil - alq fiha 10 mg ta ’ olanzapine
EU/ 1/ 99/ 125/ 002 28 orodispersible tablets EU/ 1/ 99/ 125/ 010 35 orodispersible tablets EU/ 1/ 99/ 125/ 006 56 orodispersible tablets EU/ 1/ 99/ 125/ 014 70 orodispersible tablets
EU/ 1/ 99/ 125/ 002 EU/ 1/ 99/ 125/ 010 EU/ 1/ 99/ 125/ 006 EU/ 1/ 99/ 125/ 014
66 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
70 TAG RIF MINIMU LI G ANDU JIDHER FUQ IL- FOLJI JEW FUQ L - ISTRIXXI
ZYPREXA VELOTAB 10 mg ORODISPERSIBLE TABLETS:
ZYPREXA VELOTAB 10 mg PILLOLI LI JIN ALLU FIL - ALQ:
ZYPREXA VELOTAB 10 mg orodispersible tablets Olanzapine
ZYPREXA VELOTAB 10 mg pilloli li jin allu fil - alq Olanzapine
67 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
71 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
CARTON OF ZYPREXA VELOTAB 15 mg ORODISPERSIBLE TABLETS
KARTUN TA ’ ZYPREXA VELOTAB 15 mg PILLOLI LI JIN ALLU FIL - ALQ
ZYPREXA VELOTAB 15 mg orodispersible tablets Olanzapine
ZYPREXA VELOTAB 15 mg, pilloli li jin allu fil - alq Olanzapine
Each tablet contains 15 mg olanzapine
Kull pillola li tin all fil - alq fiha15 mg ta ’ olanzapine
EU/ 1/ 99/ 125/ 003 28 orodispersible tablets EU/ 1/ 99/ 125/ 011 35 orodispersible tablets EU/ 1/ 99/ 125/ 007 56 orodispersible tablets EU/ 1/ 99/ 125/ 015 70 orodispersible tablets
EU/ 1/ 99/ 125/ 003 EU/ 1/ 99/ 125/ 011 EU/ 1/ 99/ 125/ 007 EU/ 1/ 99/ 125/ 015
69 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
73 TAG RIF MINIMU LI G ANDU JIDHER FUQ IL- FOLJI JEW FUQ L - ISTRIXXI
ZYPREXA VELOTAB 15 mg ORODISPERSIBLE TABLETS:
ZYPREXA VELOTAB 15 mg PILLOLI LI JIN ALLU FIL - ALQ:
ZYPREXA VELOTAB 15 mg orodispersible tablets Olanzapine
ZYPREXA VELOTAB 15 mg pilloli li jin allu fil - alq Olanzapine
70 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
74 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
CARTON OF ZYPREXA VELOTAB 20 mg ORODISPERSIBLE TABLETS
KARTUN TA ’ ZYPREXA VELOTAB 20 mg PILLOLI LI JIN ALLU FIL - ALQ
ZYPREXA VELOTAB 20 mg orodispersible tablets Olanzapine
ZYPREXA VELOTAB 20 mg, pilloli li jin allu fil - alq Olanzapine
Each orodispersible tablet contains 20 mg olanzapine
Kull pillola li tin all fil - alq fiha 20 mg ta ’ olanzapine
Store in the original package in order to protect from light and moisture
A en fil- pakkett ori inali sabiex tilqa' mid- dawl u mill- umdità
EU/ 1/ 99/ 125/ 004 28 orodispersible tablets EU/ 1/ 99/ 125/ 012 35 orodispersible tablets EU/ 1/ 99/ 125/ 008 56 orodispersible tablets EU/ 1/ 99/ 125/ 016 70 orodispersible tablets
EU/ 1/ 99/ 125/ 004 EU/ 1/ 99/ 125/ 012 EU/ 1/ 99/ 125/ 008 EU/ 1/ 99/ 125/ 016
72 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
76 TAG RIF MINIMU LI G ANDU JIDHER FUQ IL- FOLJI JEW FUQ L - ISTRIXXI
ZYPREXA VELOTAB 20 mg ORODISPERSIBLE TABLETS:
ZYPREXA VELOTAB 20 mg PILLOLI LI JIN ALLU FIL - ALQ:
ZYPREXA VELOTAB 20 mg orodispersible tablets Olanzapine
ZYPREXA VELOTAB 20 mg pilloli li jin allu fil - alq Olanzapine
PACKAGE LEAFLET
FULJETT TA 'TAG RIF
74 PACKAGE LEAFLET:
78 FULJETT TA ’ TAG RIF:
ZYPREXA VELOTAB 5 mg orodispersible tablets ZYPREXA VELOTAB 10 mg orodispersible tablets ZYPREXA VELOTAB 15 mg orodispersible tablets ZYPREXA VELOTAB 20 mg orodispersible tablets olanzapine
ZYPREXA VELOTAB 5 mg, pilloli li jin allu fil - alq ZYPREXA VELOTAB 10 mg, pilloli li jin allu fil - alq ZYPREXA VELOTAB 15 mg, pilloli li jin allu fil - alq ZYPREXA VELOTAB 20 mg, pilloli li jin allu fil - alq olanzapine
Read all of this leaflet carefully before you start taking this medicine. • Keep this leaflet.
Aqra sew dan il- fuljett kollu qabel tibda tie u din il- medi ina.
You may need to read it again. • If you have any further questions, ask your doctor or your pharmacist. • This medicine has been prescribed for you.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispi jar tieg ek.
Do not pass it on to others.
Tista 'mlilhom
It may harm them, even if their symptoms are the same as yours. • 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.
imsemmijin f’ dan il- fuljett, jekk jog bok, g id lit- tabib jew lill- ispi jar tieg ek.
What ZYPREXA VELOTAB is and what it is used for 2.
X’ inhi ZYPREXA VELOTAB u g alxiex tintu a 2.
Before you take ZYPREXA VELOTAB 3.
Qabel ma 'u ZYPREXA VELOTAB. tie 3.
Possible side effects 5.
X 'effetti o ra jista' jkollha 5.
How to store ZYPREXA VELOTAB 6.
Kif ta en ZYPREXA VELOTAB.
WHAT ZYPREXA VELOTAB IS AND WHAT IT IS USED FOR
X’ INHI ZYPREXA VELOTAB U G ALXIEX TINTU A
ZYPREXA VELOTAB belongs to a group of medicines called antipsychotics.
ZYPREXA VELOTAB tappartjeni g all- grupp ta' medi ini msej a antipsikoti i.
ZYPREXA VELOTAB 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.
affarijiet li mhux qeg din hemm, twemmin baljat, suspetti mhux tas- soltu, u li ting alaq fik innifsek.
People with this disease may also feel depressed, anxious or tense.
Nies b 'il- marda jistg u wkoll i ossuhom imdejjqin, anzju i jew ta t tensjoni. din
ZYPREXA VELOTAB 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.
e essiv, li jkollok ammonti ta 'ener ija e essiva, li jkollok b onn afna anqas irqg ad mis- soltu, li titkellem mg a el b' afna sibijiet ji ru f'
It is also a mood stabiliser that prevents further occurrences of the disabling high and low (depressed) extremes of mood associated with this condition.
stabbili atur tal- burdata li jipprevjeni li jer a jkun hemm l- inkapa ità asso jata mat- taqlib tal- burdata bejn stat ta' fer jew dwejjaq e essiv asso jat ma 'il- kundizzjoni. din
BEFORE YOU TAKE ZYPREXA VELOTAB
QABEL MA TIE U ZYPREXA VELOTAB
Do not take ZYPREXA VELOTAB • If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of ZYPREXA VELOTAB.
- Jekk inti aller iku/ a (tbati minn sensittività e essiva) g al olanzapine jew g al xi sustanzi o ra
An allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath.
tidher b ala raxx, akk, wi minfu,
If this has happened to you, tell your doctor. • If you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).
- Jekk kont issofri bi problemi fl- g ajnejn b al xi tipi ta' glawkoma (ieda fil- pressjoni ewwa l -
Take special care with ZYPREXA VELOTAB • Medicines of this type may cause unusual movements mainly of the face or tongue.
- Medi ini ta 'it- tip jistg u jikkaw aw moviment tal- wi jew ta'
If this happens after you have been given ZYPREXA VELOTAB tell your doctor. • Very rarely, medicines of this type cause a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness.
- Rari afna, medi ini ta 'it- tip jikkaw aw ta lita ta'
If this happens, contact your doctor at once.
Jekk ji rilek hekk g id lit tabib tieg ek minnufih.
75 • The use of ZYPREXA VELOTAB in elderly patients with dementia is not recommended as it may have serious side effects.
- L- u u ta ’ ZYPREXA VELOTAB f’ pazjenti anzjani bid- demenzja mhux irrakkomandat g ax
If you suffer from any of the following illnesses tell your doctor as soon as possible:
79 Jekk issoffri minn xi mard elenkat hawn ta t g id lit- tabib tieg ek mill- aktar fis possibli:
• 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)
• Dijabete • Mard tal- qalb • Mard tal- fwied jew tal- kliewi • Mard ta 'Parkinson • Epilessija • Problemi tal- prostata • Intestin ibblokkat (Ileus paralitiku) • Disturbi tad- demm • Puplesija jew puplesija “ 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.
Jekk tbati mid- demenzja, int jew min jie u siebek jew xi qarib g andu jg id lit- tabib tieg ek jekk qatt kellek xi puplesija jew puplesija “ g ira ”.
As a routine precaution, if you are over 65 years your blood pressure may be monitored by your doctor.
B ala prekawzjoni ta' rutina, jekk g andek 'fuq minn 65 sena l- pressjoni tieg ek tista' i e aminata mit- tabib tieg ek.
ZYPREXA VELOTAB is not for patients who are under 18 years.
ZYPREXA VELOTAB mhux g al pazjenti li g andhom anqas minn 18- il sena.
Taking other medicines Only take other medicines while you are on ZYPREXA VELOTAB if your doctor tells you that you can.
Meta tie u medi ini o ra: u biss medi ini o ra waqt li qed tie u ZYPREXA VELOTAB jekk it- tabib tieg ek jg idlek li tista ’.
You might feel drowsy if ZYPREXA VELOTAB is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).
Jista' jkun li t ossok im eddel jekk tie u ZYPREXA VELOTAB flimkien ma 'medi ini g all- ansjetà jew biex jg inuk torqod (kalmanti).
You should tell your doctor if you are taking fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic), as it may be necessary to change your ZYPREXA VELOTAB dose.
G andek tg arraf lit- tabib tieg ek jekk qed tie u fluvoxamine (anti- dipressant), jew ciprofloxacin (antibijotiku), g ax jista' jkun hemm b onn li tbiddel id- do a tieg ek ta' ZYPREXA VELOTAB.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jog bok g id lit- tabib tieg ek jekk qieg ed tie u jew adt dan l- a ar xi medi ini o ra, anki dawk ming ajr ri etta.
Especially tell your doctor if you are taking medicines for Parkinson’ s disease.
Spe jalment g id lit- tabib tieg ek jekk qed tie u medi ini g all- marda ta 'Parkinson.
Taking ZYPREXA VELOTAB with food and drink Do not drink any alcohol if you have been given ZYPREXA VELOTAB as ZYPREXA VELOTAB and alcohol together may make you feel drowsy.
Tixrobx alko ol jekk qed tie u ZYPREXA VELOTAB g ax ZYPREXA VELOTAB u l- alko ol flimkien jistg u i eddluk.
Pregnancy and breast-feeding Tell your doctor as soon as possible if you are pregnant or think you may be pregnant.
Tqala u Treddig G id lit- tabib tieg ek minnufih jekk inti inqbadt tqila jew jekk ta seb li inti tqila.
You should not take this medicine when pregnant, unless you have discussed this with your doctor.
M 'andekx tie u g din il- medi ina waqt it- tqala sakemm ma tkunx iddiskutejtha mat- tabib tieg ek.
You should not be given this medicine when breast-feeding, as small amounts of ZYPREXA VELOTAB can pass into breast milk.
M 'andekx ting ata g din il- medi ina meta tkun qed tredda ’, g ax ammonti g ar ta ’ ZYPREXA VELOTAB jistg u jg addu fil - alib tas- sider.
Driving and using machines There is a risk of feeling drowsy when you are given ZYPREXA VELOTAB.
Sewqan u t addim ta 'magni Hemm ir- riskju li t ossok im eddel meta ting ata ZYPREXA VELOTAB.
If this happens do not drive or operate any tools or machines.
Jekk ji rilek hekk issuqx u m 'andekx tag mel u u minn g odda jew t addem magni.
Tell your doctor.
G id lit- tabib tieg ek g
Important information about some of the ingredients of ZYPREXA VELOTAB Patients who cannot take phenylalanine should note that ZYPREXA VELOTAB contains aspartame, which is a source of phenylalanine.
Tag rif importanti dwar xi w ud mis- sustanzi ta 'ZYPREXA VELOTAB:
May be harmful for people with phenylketonuria.
Pazjenti li ma jistg ux jie du Phenylalanine g andhom jinnutaw illi ZYPREXA VELOTAB fiha l - aspartame, li huwa mibdul f 'Phenylalanine fil - isem.
Patients who cannot take mannitol should note that ZYPREXA VELOTAB contains mannitol.
Pazjenti li ma jistg ux jie du mannitol g andhom jinnutaw illi ZYPREXA VELOTAB fihag andha mannitol.
76 ZYPREXA VELOTAB contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which may cause an allergic reaction in some people.
ZYPREXA VELOTAB fiha sodium methyl parahydroxybenzoate u sodium propyl parahydroxybenzoate li jistg u jikkaw aw reazzjoni aller ika f 'nies.
An allergic reaction may be recognised as a rash, itching or shortness of breath.
Reazzjoni aller ika tista '
This may occur immediately or some time after you take ZYPREXA VELOTAB.
Dan jista 'ri e att wara jew ftit in wara li tie u ZYPREXA ji VELOTAB.
HOW TO TAKE ZYPREXA VELOTAB
KIF G ANDEK TIE U ZYPREXA VELOTAB
Always take ZYPREXA VELOTAB exactly as your doctor has told you.
Dejjem g andek tie u ZYPREXA skond il- parir tat- tabib.
Your doctor will tell you how many ZYPREXA VELOTAB tablets to take and how long you should continue to take them.
Id- do a ta '
The daily dose of ZYPREXA VELOTAB is between 5 and 20 mg.
Ikkonsulta mat -
Consult your doctor if your symptoms return but do not stop taking ZYPREXA VELOTAB unless your doctor tells you to.
tabib tieg ek jekk jer g u jitfa aw is- sintomi imma tieqafx tie u ZYPREXA VELOTAB sakemm ma jg idlekx it- tabib tieg ek.
You should take your ZYPREXA VELOTAB tablets once a day following the advice of your doctor.
G andek tie u l- pilloli ZYPREXA VELOTAB darba kuljum wara li ting ata parir mit- tabib tieg ek.
Try to take your tablets at the same time each day.
Ipprova u l- pilloli tieg ek kuljum fl- istess in.
It does not matter whether you take them with or without food.
Ma jimpurtax jekk te odhom ma' l- ikel jew fuq stonku vojt.
ZYPREXA VELOTAB orodispersible tablets are for oral use.
ZYPREXA VELOTAB pilloli li jin allu fil - alq huma g all- u u orali.
ZYPREXA VELOTAB tablets break easily, so you should handle the tablets carefully.
Il- pilloli - ZYPREXA VELOTAB jinqasmu malajr, u g alhekk g andek tmiss il- pilloli b 'kawtela.
Do not handle the tablets with wet hands as the tablets may break up.
Tmisx il- pilloli b 'idejk imxarba g ax il- pilloli jistg u jinqasmu.
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.
1. omm l- strixxi tal- folja mit- tarf u ssepara ellola tal- folja wa da mill- bqijja ta 'l- istrixxa billi bil- mod tqatta it- toqob ta' mad- dawra tag ha.
Carefully peel off the backing.
Qaxxar il -- wara tag ha bil- mod.
Put the tablet in your mouth.
Po i l- pillola o alqek.
It will dissolve directly in your mouth, so that it can be easily swallowed.
Hija tin all direttament o alqek, sabiex tkun tista '
You can also place the tablet in a full glass or cup of water, orange juice, apple juice, milk or coffee, and stir.
Tista 'wkoll tpo i l- pillola f' tazza jew kikkra mimlija bl- ilma, meraq tal- larin, meraq tat- tuffie, alib jew kafe, u awwad.
With some drinks, the mixture may change colour and possibly become cloudy.
Huwa importanti li tkompli tie u ZYPREXA VELOTAB sakemm jg idlek it- tabib tieg ek.
Drink it straight away.
ZYPREXA VELOTAB m 'hijiex g all- pazjenti li huma ta t it- 18- il - sena.
If you take more ZYPREXA VELOTAB than you should Patients who have taken more ZYPREXA VELOTAB 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.
Jekk tie u ZYPREXA VELOTAB aktar milli suppost Pazjenti li adu i jed ZYPREXA VELOTAB milli suppost kellhom dawn is- sintomi li ejjin: t abbit mg a el tal- qalb, a itazzjoni/ aggressività, problemi biex jitkellmu, movimenti mhux tas- soltu (spe jalment tal - alq u ta ’ l- ilsien) u tnaqqis fil- livell ta ’ koxjenza.
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.
Sintomi o ra jistg u jkunu: konfu joni akuta, a essjonijiet (epilessija), koma, ta lita ta ’ dawn is- sintomi, deni, nifs aktar mg a el, g araq, ebusija tal- muskoli u edla jew ng as, tnaqqis fil- frekwenza ta ’ nifsijiet, aspirazzjoni, pressjoni tad- demm g olja jew baxxa, ritmi mhux normali tal- qalb.
Contact your doctor or hospital straight away.
Ikkuntatja lit- tabib tieg ek jew l- isptar mill- ewwel.
Show the doctor your pack of tablets.
Uri l- pakkett tal- pilloli tieg ek lit- tabib.
If you forget to take ZYPREXA VELOTAB Take your tablets as soon as you remember.
Jekk tinsa tie u ZYPREXA VELOTAB: u l- pilloli tieg ek e att kif tiftakar.
Do not take two doses in one day.
Tie ux ew do i f' urnata wa da.
If you stop taking ZYPREXA VELOTAB Do not stop taking your tablets just because you feel better.
Jekk tieqaf tie u ZYPREXA VELOTAB Tieqafx tie u l- pilloli tieg ek sempli ement g aliex t ossok a jar.
It is important that you carry on taking ZYPREXA VELOTAB for as long as your doctor tells you.
Huwa importanti li tibqa 'u tie ZYPREXA VELOTAB sakemm jg idlek it- tabib tieg ek.
If you suddenly stop taking ZYPREXA VELOTAB, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur.
daqqa, jista 'jkollok sintomi b al g araq, ma tkunx tista'
Your doctor may suggest you to reduce the dose gradually before stopping treatment.
It- tabib tieg ek jista' jissu erilek li tnaqqas id- do a bil- mod qabel ma twaqqaf il- kura.
77 If you have any further questions on the use of this product, ask your doctor or pharmacist.
Jekk g andek aktar mistoqsijiet dwar l- u u ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispi jar tieg ek.
Like all medicines, ZYPREXA VELOTAB can cause side effects, although not everybody gets them.
B al kull medi ina o ra, ZYPREXA VELOTAB jista ’ jkollu effetti sekondarji, g alkemm ma jidhrux fuq kul add.
Very common side effects: affect 1 user in 10 • Weight gain. • Sleepiness. • Increases in the levels of prolactin in the blood.
Effetti sekondarji komuni afna: jaffettwaw 1 minn kull 10 pazjenti • ieda fil- pi. • Ng as. • idiet fil- livelli ta' prolactin fid- demm.
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 • Tibdil fil- livelli ta 'elluli tad- demm u xa mijiet fid- demm. xi • idiet fil- livelli ta' zokkor fid- demm u fl- awrina. • T ossok aktar bil - u. • Sturdament. • Irrekwitezza. • Rog da. • Ebusija tal- muskoli jew spa mi (inklu i movimenti fl- g ajnejn). • Problemi fil- mod kif titkellem. • Moviment mhux tas- soltu (spe jalment tal- wi jew ta ’ l- ilsien). • Stitikezza. • alq xott. • Raxx. • Titlef il- forzi. • G eja esa erata. •
This will usually pass on its own but if it does not, tell your doctor.
Dan normalment jg addi wa du i da jekk le g id lit- tabib tieg ek.
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 t abbat bil- mod. • Issir sensittiv g ad- dawl tax- xemx. • Jaqa 'x- xag ar.
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- ir iel jew fin- nisa.
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.
Effetti sekondarji o ra possibbli: ma tistax ti i stmata frekwenza mill- informazzjoni disponibbli • Reazzjonijiet aller i i (e. nef a fil - alq u l- ger uma, akk, raxx). • Dijabete jew dijabete li tmur g all- ag ar, kultant asso jata ma 'ketoa ido i (ketoni fid- demm u fl- awrina) jew koma. • Titbaxxa t- temperatura normali tal - isem. •
78 • Muscle disease presenting as unexplained aches and pains. • Difficulty in passing urine. • Prolonged and/ or painful erection.
• Ta lita ta' deni, nifs mg a el, g araq, ebusija tal- muskoli u edla jew ng as. • Spa mi tal- muskolu ta 'ajn li jikkaw a taqlib ta' ajn.
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 qed jie du l- olanzapine, il- pazjenti anzjani bid- demenzja jistg u jsofru minn puplesija, il - pnewmonja,, l- inkontinenza ta ’ l- awrina, waqg at, g eja kbira, allu inazzjonijiet vi ivi, jieda fit - temperatura tal - isem, mura fil - ilda u jistg u jkollhom problemi fil- mixi.
Some fatal cases have been reported in this particular group of patients.
Xi ka ijiet fatali kienu rapportati f’ dan il- grupp partikolari ta ’ pazjenti.
In patients with Parkinson's disease ZYPREXA VELOTAB may worsen the symptoms.
F' pazjenti li g andhom il- marda ta' Parkinson, ZYPREXA VELOTABS tista 'mel is- sintomi tag ag ar.
Rarely women taking medicines of this type for a long time have started to secrete milk and have missed periods or had irregular periods.
Rari nisa li kienu qed jie du medi ini ta 'dawn it- tip g al mien twil bdew inixxu l - alib u tilfu xi pirjid jew kellhom pirjid rregolari.
If this persists tell your doctor.
Jekk dawn jippersistu g id lit- tabib tieg ek.
Very rarely babies born to mothers who have taken ZYPREXA VELOTAB in the last stage of pregnancy (3rd trimester) may have tremors, be sleepy or drowsy.
Rarament afna trabi li jitwieldu lil ommijiet li adu ZYPREXA VELOTABS fl- a ar stadju tat- tqala (fl- a ar tlett xhur) jista' jkollhom rog da, ng as u edla.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Jekk xi wie ed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jog bok, g id lit- tabib tieg ek.
HOW TO STORE ZYPREXA VELOTAB
EN ZYPREXA VELOTAB
Keep out of the reach and sight of children.
omm fejn ma tintla aqx u ma tidhirx mit- tfal.
Do not use ZYPREXA VELOTAB after the expiry date, which is stated on the carton.
Tu ax ZYPREXA VELOTAB wara d- data ta ’ skadenza li tidher fuq il- kartuna
ZYPREXA VELOTAB should be stored in its original pack in order to protect against light and moisture.
ZYPREXA VELOTAB g andha tin a en fil- pakkett ori inali sabiex tilqa ’ kontra d- dawl u l- umdità.
Please return left over medicine to your pharmacist.
Jekk jog bok ag ti lura l- medi ina li tibqalek lill- ispi jar tieg ek.
These measures will help to protect the environment.
Dawn il- mi uri jg inu g all- protezzjoni ta ’ l- ambjent.
FURTHER INFORMATION
X’ fiha ZYPREXA VELOTAB:
What ZYPREXA VELOTAB contains • The active substance is olanzapine.
Kull pillola li tin all fil - alq ta ’ ZYPREXA VELOTAB
Each ZYPREXA VELOTAB orodispersible tablet contains either 5 mg, 10 mg, 15 mg or 20 mg of the active substance.
g andha 5 mg, 10 mg, 15 mg jew 20 mg tas- sustanza attiva.
The exact amount is shown on your ZYPREXA VELOTAB pack. • The other ingredients are
L- ammont e att jidher fuq il - pakkett tieg ek ta ’ ZYPREXA VELOTAB.
- gelatin, mannitol (E421), aspartame (E951), sodium methyl parahydroxybenzoate (E219) and
- Is- sustanzi l- o ra huma
sodium propyl parahydroxybenzoate (E217).
gelatin, mannitol (E421), aspartame (E951), sodium methyl parahydroxybenzoate (E219) u sodium propyl parahydroxybenzoate (E217).
Orodispersible tablet is the technical name for a tablet which dissolves directly in your mouth, so that it can be easily swallowed.
ZYPREXA VELOTAB 5 mg, 10 mg, 15 mg u 20 mg huma pilloli sofor li jin allu fil - alq. Pillola li tin all fil - alq huwa l- isem tekniku g al pillola li tin all direttament f' alqek, sabiex tkun tista' tinbela 'malajr.
ZYPREXA VELOTAB 5 mg, 10 mg, 15 mg and 20 mg are available in cartons containing 28, 35, 56 or 70 tablets.
ZYPREXA VELOTAB 5 mg, 10 mg, 15 mg u 20 mg huma disponibbli f’ pakketti ta ’ 28, 35, 56 jew 70 pillola.
Not all pack sizes may be marketed.
Jista jkun li mhux il- pakketti tad- daqsijiet kollha jkunu g all- skop kummer jali.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
83 Id- Detentur ta ’ l- Awtorizzazzjoni g at- tqeg id fis- Suq u l- Manifattur:
Eli Lilly Nederland BV, Grootslag 1-5, NL-3991 RA Houten, The Netherlands.
Eli Lilly Nederland BV, Grootslag 1 - 5, NL - 3991 RA, Houten, L- Olanda.
Lilly S. A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.
De la Industria 30, 28108 Alcobendas, Madrid Spanja.
79 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
G al kull tag rif dwar dan il- prodott medi inali, jekk jog bok ikkuntattja lir- rappre entant lokali tad - Detentur ta ’ l- Awtorizzazzjoni g at- tqeg id fis- Suq:
Phadisco Ltd: + 357 22 715000 Latvija Eli Lilly Holdings Limited, p! rst! vniec"ba Latvij!
Phadisco Ltd & '+357 22 715000 (:
Tel: + 371 7364000 Lietuva Eli Lilly Holdings Limited atstovyb# Tel. + 370 (5) 2649600
Latvija Eli Lilly Holdings Limited, p) rst) vniec* ba Latvij) Tel: + 371 7364000
This leaflet was last approved in
Dan il- fuljett kien approvat l' a
EMEA/ 62913/ 2006
EMEA/ 145694/ 2006
Summary of the work programme for the
Ġabra fil- qosor tal- programm ta 'ħidma ta' l -
2006 This document provides a summary of the Agency’ s work programme 2006, adopted by the Management Board on 15 December 2005.
2006 Dan id- dokument jipprovdi ġabra fil- qosor tal- programm ta 'ħidma ta' l- Aġenzija għall- 2006, adottat mill- Bord ta ’ Tmexxija fil- 15 ta 'Diċembru 2005.
The full work programme 2006 in English can be found on the Agency’ s website: www. emea. eu. int
Il- programm ta 'ħidma sħiħ għall- 2006 bl- Ingliż jinstab fuq il- websajt ta' l- Aġenzija: www. emea. eu. int
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non-commercial purposes only provided the EMEA is acknowledged Contents Introduction by the Executive Director
©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non- commercial purposes only provided the EMEA is acknowledged Werrej Introduzzjoni mid- Direttur Eżekuttiv
CHAPTER 1 EMEA IN THE EUROPEAN SYSTEM The European medicines network
KAPITOLU 1
Transparency, communication and provision of information to patients, healthcare professionals and users of medicines Availability of medicines and innovation Small and medium-sized enterprises EU institutions, agencies and European and international partners Managing the Agency
In- netwerk Ewropew tal- mediċini
CHAPTER 2 MEDICINES FOR HUMAN AND VETERINARY USE Orphan medicinal products for human use Scientific advice to enterprises Initial evaluation Establishment of maximum residue limits for veterinary medicines Post-authorisation activities Parallel distribution Safety of medicines Arbitrations and referrals Herbal medicinal products for human use
Trasparenza, komunikazzjoni u l- għoti ta 'informazzjoni lill- pazjenti, lill- professjonisti tal- kura tas- saħħa u lill- utenti tal- mediċini Id- disponibbiltà tal- mediċini u l- innovazzjoni Intrapriżi żgħar u ta' daqs medju L- istituzzjonijiet ta ’ l- UE, l- aġenziji u l- imsieħba Ewropej u internazzjonali Tmexxija ta 'l- Aġenzija