natgillin/translations-raw huggingface dataset:
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.
Cu toate acestea, importan a impactului vârstei, sexului sau fumatului asupra clearance- ului i timpului de înjum t ire plasmatic este mic în compara ie cu variabilitatea interindividual general.
Reversible neutropenia, thrombocytopenia, or anemia developed in a few dogs treated with 8 or 10 mg/ kg/ day (total olanzapine exposure [area under the curve] is 12- to 15-fold greater than that of a man given a 12-mg dose).
44 10 mg/ kg i zi (expunere total la olanzapin [ASC] de 12- 15 ori mai mare decât pentru doza de 12 mg/ zi la om) s- au dezvoltat neutropenie, trombocitopenie sau anemie reversibile.
Aluminium blister strips in cartons of 28, 35, 56 or 70 orodispersible tablets per carton.
Benzi de blistere de aluminiu, în cutii de carton a 28, 35, 56 sau 70 comprimate orodispersabile per cutie.
Each orodispersible tablet contains 20 mg olanzapine.
Fiecare comprimat orodispersabil con ine 20 mg olanzapin.
Each orodispersible tablet contains 1.60 mg aspartame, 0.30 mg sodium methyl parahydroxybenzoate, 0.10 mg sodium propyl parahydroxybenzoate.
Fiecare comprimat orodispersabil con ine aspartam 1, 60 mg, metil parahidroxibenzoat de sodiu 0, 30 mg, propil parahidroxibenzoat de sodiu 0, 10 mg.
44 appropriate clinical reassessment and should generally occur at intervals of not less than 24 hours.
47 reevaluarea clinic adecvat i nu trebuie realizat, în general, la intervale mai mici de 24 ore.
4.4 Special warnings and precautions for use
48 4. 4 Aten ion ri i precau ii speciale pentru utilizare
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.
Psihoza asociat demen ei i/ sau alte tulbur ri de comportament Olanzapina nu este autorizat pentru a fi utilizat în tratamentul psihozelor asociate demen ei i/ sau tulbur rilor de comportament asociate demen ei i nu se recomandat la acest grup particular de pacien i din cauza cre terii mortalit ii i a riscului de accident cerebrovascular.
Lipid alterations Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo- controlled clinical trials (see section 4.8).
49 Alter ri ale lipidelor În studiile clinice controlate placebo s- au observat alter ri nedorite ale lipidelor în rândul pacien ilor trata i cu olanzapin (vezi pct.
46 Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Activitate anticolinergic Cu toate c olanzapina a demonstrat activitate anticolinergic in vitro, experien a din studiile clinice a eviden iat o frecven mic a evenimentelor legate de aceast ac iune.
Seizures Olanzapine should be used cautiously in patients who have a history of seizures or are subject to factors which may lower the seizure threshold.
50 Convulsii Olanzapina trebuie utilizat cu pruden la pacien ii cu antecedente convulsive sau la cei expu i unor factori care pot s scad pragul convulsivant.
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.
Diskinezie tardiv În studiile comparative cu durat de un an sau mai pu in, olanzapina s- a asociat cu o frecven mai mic, semnificativ statistic, a diskineziei iatrogene.
48 Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
S- a constatat c fluoxetina (un inhibitor al CYP2D6), dozele unice de antiacide (aluminiu, magneziu) sau cimetidina nu afecteaz semnificativ farmacocinetica olanzapinei.
4.8 Undesirable effects
52 4. 8 Reac ii adverse
49 transient asymptomatic elevations of hepatic transaminases (see section 4.4), rash, asthenia, fatigue and oedema.
4. 4), glucozuria, cre terea apetitului alimentar, ame eala, akatizia, parkinsonismul (vezi pct.
Orthostatic hypotension
53 Tulbur ri vasculare
50 Hepato-biliary disorders
Cre teri tranzitorii, asimptomatice ale transaminazelor hepatice (ALAT, ASAT), în special la ini ierea tratamentului (vezi pct.
5 Observed for fasting normal levels at baseline (< 1.69 mmol/ l) which increased to high (2.26 mmol/ l).
54 5 Observat pentru valori ini iale normale à jeun (< 1, 69 mmol/ l) care au atins valori crescute (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 Simptome acute precum transpira ii, insomnie, tremor, anxietate, grea atunci când olanzapina a fost întrerupt brusc.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
55 fost mai mari în cazul expunerii îndelungate (cel pu in 24 s pt mâni) decât în cazul expunerilor de scurt durat.
52 Metabolism and nutrition disorders Very common:
Tulbur ri metabolice i de nutri ie Foarte frecvente:
Symptomatic treatment and monitoring of vital organ function should be instituted according to clinical presentation, including treatment of hypotension and circulatory collapse and support of respiratory function.
56 Trebuie instituit tratament simptomatic i monitorizarea func iilor vitale în func ie de starea clinic, incluzând tratamentul hipotensiunii arteriale i a colapsului circulator i sus inerea func iei respiratorii.
N05A.
N05A H03.
In a co-therapy study of patients treated with lithium or valproate for a minimum of 2 weeks, the addition of olanzapine 10 mg (co-therapy with lithium or valproate) resulted in a greater reduction in symptoms of mania than lithium or valproate monotherapy after 6 weeks.
57 valproat) a determinat, dup 6 s pt mâni, o reducere mai mare a simptomelor maniacale decât în cazul monoterapiei cu litiu sau cu valproat.
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.
Într- un studiu de tratament asociat, cu durata de 18 luni, la pacien i cu episoade maniacale sau mixte stabiliza i cu olanzapin i un stabilizator de dispozi ie (litiu sau valproat), asocierea de lung durat dintre olanzapin i litiu sau valproat nu a fost semnificativ statistic superioar monoterapiei cu litiu sau valproat în întârzierea recuren ei tulbur rii bipolare, definit conform criteriilor diagnostice.
55 smoking on olanzapine clearance and half-life is small in comparison to the overall variability between individuals.
Cu toate acestea, importan a impactului vârstei, sexului sau fumatului asupra clearance- ului i timpului de înjum t ire plasmatic este mic în compara ie cu variabilitatea interindividual general.
Reversible neutropenia, thrombocytopenia, or anemia developed in a few dogs treated with 8 or 10 mg/ kg/ day (total olanzapine exposure [area under the curve] is 12- to 15-fold greater than that of a man given a 12-mg dose).
59 10 mg/ kg i zi (expunere total la olanzapin [ASC] de 12- 15 ori mai mare decât pentru doza de 12 mg/ zi la om) s- au dezvoltat neutropenie, trombocitopenie sau anemie reversibile.
57 ANNEX II
61 ANEXA II
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
DE IN TORUL( II) AUTORIZA IEI DE FABRICA IE RESPONSABIL( I) PENTRU ELIBERAREA SERIEI
Name and address of the manufacturers responsible for batch release in the EEA
Numele i adresa produc torului( ilor) responsabil( i) pentru eliberarea seriei
The Marketing Authorisation Holder will provide the PSUR annually.
De in torul autoriza iei de punere pe pia va depune anual RPAS.
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.
Plan de Management al Riscului DAPP se angajeaz s realizeze studiile i activit ile suplimentare de farmacovigilen detaliate în Planul de Farmacovigilen, a a cum s- a stabilit în versiunea 1. 1 a Planului de Management al Riscului (PMR) prezentat în Modulul 1. 8. 2. al Autoriza iei de punere pe pia i în orice actualiz ri consecutive ale PMR aprobate de c tre 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).
În conformitate cu Ghidul CHMP cu privire la Sisteme de Management al Riscului pentru medicamentele de uz uman, PMR actualizat trebuie depus la acela i moment cu urm torul Raport Periodic Actualizat referitor la Siguran (RPAS).
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
Suplimentar, va fi depus un PMR actualizat: • Când se primesc noi informa ii ce pot avea impact asupra specifica iilor curente referitoare la siguran, planul de farmacovigilen sau activit ile de sc dere a riscului • În decurs de 60 zile de la atingerea unei inte importante (farmacovigilen sau sc dere a riscului) • La cererea EMEA
59 ANNEX III
63 ANEXA III
61 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
65 INFORMA II CARE TREBUIE S APAR PE AMBALAJUL SECUNDAR
ZYPREXA VELOTAB 5 mg orodispersible tablets Olanzapine
ZYPREXA VELOTAB 5 mg comprimate orodispersabile olanzapin
Each orodispersible tablet contains 5 mg olanzapine
Fiecare comprimat orodispersabil con ine olanzapin 5 mg
Other ingredients: gelatin, mannitol (E421), aspartame (E951), sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217).
Al i excipien i: gelatin, manitol (E421), aspartam (E951), metil parahidroxibenzoat de sodiu (E219), propil parahidroxibenzoat de sodiu (E217).
28 orodispersible tablets 35 orodispersible tablets 56 orodispersible tablets 70 orodispersible tablets
28 comprimate orodispersabile 35 comprimate orodispersabile 56 comprimate orodispersabile 70 comprimate orodispersabile
Separate one blister cell from the strip.
Separa i o celul din blister de restul benzii.
Carefully peel off the backing.
Îndep rta i cu grij folia din partea de jos a celulei.
Gently push the tablet out.
Scoate i comprimatul din blister f r s for a i.
Put the tablet in your mouth
Pune i comprimatul în gur.
Keep out of the reach and sight of children
A nu se l sa la îndemâna i vederea copiilor.
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 28 comprimate orodispersabile EU/ 1/ 99/ 125/ 009 35 comprimate orodispersabile EU/ 1/ 99/ 125/ 005 56 comprimate orodispersabile EU/ 1/ 99/ 125/ 013 70 comprimate orodispersabile
63 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
67 MINIMUM DE INFORMA II CARE TREBUIE S APAR PE BLISTER SAU PE FOLIE TERMOSUDAT
ZYPREXA VELOTAB 5 mg ORODISPERSIBLE TABLETS:
ZYPREXA VELOTAB 5 mg COMPRIMATE ORODISPERSABILE:
ZYPREXA VELOTAB 5 mg orodispersible tablets Olanzapine
ZYPREXA VELOTAB 5 mg comprimate orodispersabile Olanzapin
64 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
68 INFORMA II CARE TREBUIE S APAR PE AMBALAJUL SECUNDAR
ZYPREXA VELOTAB 10 mg orodispersible tablets Olanzapine
ZYPREXA VELOTAB 10 mg comprimate orodispersabile olanzapin
Each orodispersible tablet contains 10 mg olanzapine
Fiecare comprimat orodispersabil con ine olanzapin 10 mg
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 28 comprimate orodispersabile EU/ 1/ 99/ 125/ 010 35 comprimate orodispersabile EU/ 1/ 99/ 125/ 006 56 comprimate orodispersabile EU/ 1/ 99/ 125/ 014 70 comprimate orodispersabile
66 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
70 MINIMUM DE INFORMA II CARE TREBUIE S APAR PE BLISTER SAU PE FOLIE TERMOSUDAT
ZYPREXA VELOTAB 10 mg ORODISPERSIBLE TABLETS:
ZYPREXA VELOTAB 10 mg COMPRIMATE ORODISPERSABILE:
ZYPREXA VELOTAB 10 mg orodispersible tablets Olanzapine
ZYPREXA VELOTAB 10 mg comprimate orodispersabile Olanzapin
67 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
71 INFORMA II CARE TREBUIE S APAR PE AMBALAJUL SECUNDAR
ZYPREXA VELOTAB 15 mg orodispersible tablets Olanzapine
ZYPREXA VELOTAB 15 mg comprimate orodispersabile olanzapin
Each tablet contains 15 mg olanzapine
Fiecare comprimat orodispersabil con ine olanzapin 15 mg
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 28 comprimate orodispersabile EU/ 1/ 99/ 125/ 011 35 comprimate orodispersabile EU/ 1/ 99/ 125/ 007 56 comprimate orodispersabile EU/ 1/ 99/ 125/ 015 70 comprimate orodispersabile
ZYPREXA VELOTAB 15 mg
INSTRUC IUNI DE UTILIZARE
69 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
73 MINIMUM DE INFORMA II CARE TREBUIE S APAR PE BLISTER SAU PE FOLIE TERMOSUDAT
ZYPREXA VELOTAB 15 mg ORODISPERSIBLE TABLETS:
ZYPREXA VELOTAB 15 mg COMPRIMATE ORODISPERSABILE:
ZYPREXA VELOTAB 15 mg orodispersible tablets Olanzapine
ZYPREXA VELOTAB 15 mg comprimate orodispersabile Olanzapin
70 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
74 INFORMA II CARE TREBUIE S APAR PE AMBALAJUL SECUNDAR
ZYPREXA VELOTAB 20 mg orodispersible tablets Olanzapine
ZYPREXA VELOTAB 20 mg comprimate orodispersabile olanzapin
Each orodispersible tablet contains 20 mg olanzapine
Fiecare comprimat orodispersabil con ine olanzapin 20 mg
Store in the original package in order to protect from light and moisture
A se p stra în ambalajul original pentru a fi protejat de lumin
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 28 comprimate orodispersabile EU/ 1/ 99/ 125/ 012 35 comprimate orodispersabile EU/ 1/ 99/ 125/ 008 56 comprimate orodispersabile EU/ 1/ 99/ 125/ 016 70 comprimate orodispersabile
72 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
76 MINIMUM DE INFORMA II CARE TREBUIE S APAR PE BLISTER SAU PE FOLIE TERMOSUDAT
ZYPREXA VELOTAB 20 mg ORODISPERSIBLE TABLETS:
ZYPREXA VELOTAB 20 mg COMPRIMATE ORODISPERSABILE:
ZYPREXA VELOTAB 20 mg orodispersible tablets Olanzapine
ZYPREXA VELOTAB 20 mg comprimate orodispersabile Olanzapin
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 comprimate orodispersabile ZYPREXA VELOTAB 10 mg comprimate orodispersabile ZYPREXA VELOTAB 15 mg comprimate orodispersabile ZYPREXA VELOTAB 20 mg comprimate orodispersabile olanzapin
Read all of this leaflet carefully before you start taking this medicine. • Keep this leaflet.
Citi i cu aten ie i în întregime acest prospect înainte de a începe s lua i acest medicament.
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.
poate face r u, chiar dac au acelea i simptome cu ale dumneavoastr.
Do not pass it on to others.
- Dac vreuna dintre reac iile adverse devine grav sau dac observa i orice reac ie advers
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.
nemen ionat în acest prospect, v rug m s - i spune i medicului dumneavoastr sau farmacistului.
What ZYPREXA VELOTAB is and what it is used for 2.
Ce este ZYPREXA VELOTAB i pentru ce se utilizeaz 2.
Before you take ZYPREXA VELOTAB 3.
Înainte s lua i ZYPREXA VELOTAB 3.
How to take ZYPREXA VELOTAB 4.
Cum s lua i ZYPREXA VELOTAB 4.
How to store ZYPREXA VELOTAB 6.
Cum se p streaz ZYPREXA VELOTAB 6.
WHAT ZYPREXA VELOTAB IS AND WHAT IT IS USED FOR
CE ESTE ZYPREXA VELOTAB I PENTRU CE SE UTILIZEAZ
ZYPREXA VELOTAB belongs to a group of medicines called antipsychotics.
ZYPREXA VELOTAB apar ine grupului de medicamente denumit antipsihotice.
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.
ZYPREXA VELOTAB se folose te pentru tratamentul unei boli cu simptome cum ar fi: vederea, auzirea sau sim irea unor lucruri care nu sunt prezente, convingerile eronate, suspiciunea neobi nuit i tendin a la izolare.
People with this disease may also feel depressed, anxious or tense.
Persoanele cu aceast boal pot, de asemenea, s se simt deprima i, anxio i sau tensiona i.
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.
ZYPREXA VELOTAB se folose te pentru tratamentul unei afec iuni cu simptome cum ar fi senza ia de a fi „ în form ”, faptul de a avea excesiv de mult energie, de a avea nevoie de mult mai pu in somn decât de obicei, de a vorbi foarte repede cu idei care fug i, uneori, cu iritabilitate sever.
It is also a mood stabiliser that prevents further occurrences of the disabling high and low (depressed) extremes of mood associated with this condition.
Este de asemenea, un stabilizator al dispozi iei care previne apari ia ulterioar a varia iilor extreme ale dispozi iei, în sens pozitiv i negativ (deprimare) asociate cu aceast afec iune.
BEFORE YOU TAKE ZYPREXA VELOTAB
ÎNAINTE S LUA I ZYPREXA VELOTAB
Do not take ZYPREXA VELOTAB • If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of ZYPREXA VELOTAB.
Nu lua i ZYPREXA VELOTAB
An allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath.
Reac ia alergic este caracterizat prin erup ii la nivelul pielii, mânc rime, umflarea fe ei, buze umflate sau dificult i în respira ie.
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).
Dac vi s- a întâmplat a a ceva, spune i- i medicului dumneavoastr.
Take special care with ZYPREXA VELOTAB • Medicines of this type may cause unusual movements mainly of the face or tongue.
79 Ave i grij deosebit cu ZYPREXA VELOTAB
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.
Dac vi se întâmpl aceasta dup ce a i luat ZYPREXA VELOTAB, spune i medicului dumneavoastr.
If this happens, contact your doctor at once.
Dac se întâmpl acest lucru, adresa i- v imediat medicului dumneavoastr.
75 • The use of ZYPREXA VELOTAB in elderly patients with dementia is not recommended as it may have serious side effects.
- Utilizarea ZYPREXA VELOTAB la pacien ii vârstnici cu demen nu se recomand deoarece
If you suffer from any of the following illnesses tell your doctor as soon as possible:
Dac suferi i de oricare dintre bolile urm toare, spune i- i medicului dumneavoastr cât mai repede posibil:
• 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)
• Diabet zaharat • Boal de inim • Boal de ficat sau rinichi • Boal Parkinson • Epilepsie • Afec iuni ale prostatei • Intestin blocat (ileus paralitic) • Afec iuni ale sângelui • Accident vascular cerebral sau accident vascular cerebral minor (simptome temporare de accident vascular cerebral)
If you suffer from dementia, you or your carer/ relative should tell your doctor if you have ever had a stroke or “ mini” stroke.
Dac suferi i de demen, dumneavoastr sau apar in torul dumneavoastr, trebuie s anun a i medicul dac a i avut vreodat accident vascular cerebral sau accident vascular cerebral minor.
As a routine precaution, if you are over 65 years your blood pressure may be monitored by your doctor.
Ca m sur de precau ie uzual, dac ave i vârsta peste 65 ani, poate fi necesar ca medicul dumneavoastr s v monitorizeze tensiunea arterial.
ZYPREXA VELOTAB is not for patients who are under 18 years.
ZYPREXA nu este destinat pacien ilor sub 18 ani.
Taking other medicines Only take other medicines while you are on ZYPREXA VELOTAB if your doctor tells you that you can.
Folosirea altor medicamente În timp ce lua i ZYPREXA VELOTAB, nu lua i alte medicamente decât dac medicul dumneavoastr v spune c se poate.
You might feel drowsy if ZYPREXA VELOTAB is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).
Dac lua i ZYPREXA VELOTAB în asociere cu antidepresive sau cu medicamente care se iau pentru anxietate sau care v ajut s dormi i (tranchilizante), s- ar putea s v sim i i somnolent.
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.
Trebuie s - i spune i medicului dumneavoastr dac lua i fluvoxamin (un antidepresiv) sau ciprofloxacin (un antibiotic), deoarece s- ar putea s fie necesar s se modifice doza de ZYPREXA VELOTAB.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
V rug m s spune i medicului dumneavoastr dac lua i sau a i luat recent orice alte medicamente, inclusiv dintre cele eliberate f r prescrip ie medical.
Especially tell your doctor if you are taking medicines for Parkinson’ s disease.
În special, spune i medicului dumneavoastr dac lua i medicamente pentru boal 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.
Folosirea ZYPREXA VELOTAB cu alimente i b uturi Nu consuma i alcool etilic dac utiliza i ZYPREXA VELOTAB deoarece ZYPREXA VELOTAB i alcoolul etilic v pot face s v sim i i somnolent.
Pregnancy and breast-feeding Tell your doctor as soon as possible if you are pregnant or think you may be pregnant.
Sarcina i al ptarea Spune i medicului dumneavoastr cât mai repede posibil dac sunte i sau b nui i c sunte i gravid.
You should not take this medicine when pregnant, unless you have discussed this with your doctor.
Nu trebuie s lua i acest medicament dac sunte i gravid, decât dup ce discuta i cu medicul dumneavoastr.
You should not be given this medicine when breast-feeding, as small amounts of ZYPREXA VELOTAB can pass into breast milk.
Nu trebuie s lua i acest medicament în timp ce al pta i pentru c mici cantit i de ZYPREXA VELOTAB pot trece în lapte.
Driving and using machines There is a risk of feeling drowsy when you are given ZYPREXA VELOTAB.
80 Conducerea vehiculelor i folosirea utilajelor Atunci când lua i ZYPREXA VELOTAB exist riscul s v sim i i somnolent.
If this happens do not drive or operate any tools or machines.
Dac se întâmpl acest lucru, nu conduce i vehicule i nu lucra i cu nici un fel de utilaje.
Tell your doctor.
Discuta i cu medicul dumneavoastr.