FrancophonIA/ELRC3.0 huggingface dataset:
English: Very common symptoms in overdose (> 10 % incidence) include tachycardia, agitation/ aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
Croatian: Vrlo česti simptomi predoziranja (incidencija >10%) obuhvaćaju tahikardiju, agitaciju/agresivnost, dizartriju, različite ekstrapiramidalne simptome te smanjenu razinu svijesti u rasponu od sedacije do kome.
English: • Increases in the levels of prolactin in the blood.
Croatian: • povišene razine prolaktina u krvi
English: • Sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males.
Croatian: • bol u zglobovima te seksualne poremećaje kao što su smanjeni libido u muškaraca i žena ili erektilna disfunkcija u muškaraca
English: • Increases in the level of sugars in the blood and urine.
Croatian: • povišene razine šećera u krvi i mokraći
English: Olanzapine Glenmark Europe 5 mg, 10 mg, 15 mg and 20 mg are available in aluminium foil blisters of 28, 56, and 70 orodispersible tablets
Croatian: Olanzapin Glenmark Europe od 5 mg, 10 mg, 15 mg i 20 mg dostupan je u blisterima od aluminijske folije s 28, 56 i 70 raspadljivih tableta za usta.
English: If this happens after you have been given Olanzapine Glenmark Europe, tell your doctor.
Croatian: Ako Vam se ovo pojavi nakon uzimanja lijeka Olanzapin Glenmark Europe, obratite se svom liječniku.
English: • Serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
Croatian: • ozbiljne alergijske reakcije poput reakcije na lijek s eozinofilijom i sistemskim simptomima (engl.
English: You should not be given this medicine when breast-feeding, as small amounts of Olanzapine Glenmark Europe can pass into breast milk.
Croatian: Ne smijete uzimati ovaj lijek dok dojite jer Olanzapin Glenmark može u malim količinama prijeći u majčino mlijeko.
English: - Very rarely, medicines of this type cause a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness.
Croatian: - Vrlo rijetko lijekovi ovog tipa uzrokuju kombinaciju vrućice, ubrzanog disanja, znojenja, ukočenosti mišića te omamljenosti ili pospanosti.
English: • Changes in the levels of some blood cells, circulating fats and early in treatment, temporary increases in liver enzymes.
Croatian: • promjene razina nekih krvnih stanica, cirkulirajućih masti u krvi te, u ranim fazama liječenja,
English: In clinical trials in patients with drug-induced (dopamine agonist) psychosis associated with Parkinson's disease, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo.
Croatian: U kliničkim ispitivanjima u bolesnika s psihozom uzrokovanom lijekovima (agonisti dopamina) povezanom s Parkinsonovom bolešću, vrlo često je zabilježeno pogoršanje simptoma parkinsonizma i halucinacija i češće nego s placebom.
English: In addition, a Single Photon Emission Computed Tomography (SPECT) imaging study in schizophrenic patients revealed that olanzapine-responsive patients had lower striatal D2 occupancy than some other antipsychotic and risperidone-responsive patients, while being comparable to clozapine-responsive patients.
Croatian: Osim toga, ispitivanje snimanjem jednofotonskom emisijskom računalnom tomografijom (SPECT, engl. single photon emission computed tomography) u bolesnika sa shizofrenijom otkrilo je da bolesnici koji reagiraju na olanzapin imaju manju zauzetost strijatalnih D2 receptora od bolesnika koji su reagirali na neke druge antipsihotike i risperidon, dok je zauzetost bila usporediva s onom u bolesnika koji su reagirali na klozapin.
English: Weight should be monitored regularly, e.g. at baseline, 4, 8 and 12 weeks after starting olanzapine treatment and quarterly thereafter.
Croatian: Redovito treba pratiti tjelesnu težinu, npr. na početku, nakon 4, 8 i 12 tjedana nakon početka liječenja olanzapinom te svaka 3 mjeseca nakon toga.
English: You should take your Olanzapine Glenmark Europe orodispersible tablets once a day following the advice of your doctor.
Croatian: Olanzapin Glenmark Europe raspadljive tablete za usta morate uzimati jednom dnevno pridržavajući se savjeta svog liječnika.
English: • Medicines for Parkinson's disease
Croatian: • lijekove protiv Parkinsonove bolesti,
English: Transient, asymptomatic elevations of hepatic aminotransferases, alanine transferase (ALT), aspartate transferase (AST) have been seen commonly, especially in early treatment.
Croatian: Često su uočeni prolazni asimptomatski porasti vrijednosti jetrenih aminotransferaza, alanin transferaze (ALT) i aspartat transferaze (AST), osobito u ranoj fazi liječenja.
English: What Olanzapine Glenmark Europe is and what it is used for
Croatian: Što je Olanzapin Glenmark Europe i za što se koristi
English: In one clinical trial in patients with bipolar mania, valproate combination therapy with olanzapine resulted in an incidence of neutropenia of 4.1 %; a potential contributing factor could be high plasma valproate levels.
Croatian: U jednom kliničkom ispitivanju u bolesnika s bipolarnom manijom, kombinacijska terapija valproatom i olanzapinom uzrokovala je incidenciju neutropenije od 4,1%; faktor koji je tome pridonio mogle su biti visoke razine valproata u plazmi.
English: Olanzapine Glenmark Europe with alcohol
Croatian: Olanzapin Glenmark Europe s alkoholom
English: Amnesia 9
Croatian: amnezija9
English: 6.5 Nature and contents of container Aluminium/aluminium blisters in cartons of 28, 56, 70 tablets per carton.
Croatian: 6.5 Vrsta i sadržaj spremnika Aluminij/aluminij blisteri u kutijama s 28, 56, 70 tableta.
English: How to store Olanzapine Glenmark Europe Contents of the pack and other information
Croatian: Kako čuvati Olanzapin Glenmark Europe Sadržaj pakiranja i druge informacije
English: Aluminium/aluminium blisters in cartons of 28, 56, 70 tablets per carton.
Croatian: Aluminij/aluminij blisteri u kutijama s 28, 56, 70 tableta.
English: Caution should be exercised and follow-up organised in patients with elevated ALT and/or AST, in patients with signs and symptoms of hepatic impairment, in patients with pre-existing conditions associated with limited hepatic functional reserve, and in patients who are being treated with potentially hepatotoxic medicines.
Croatian: Potreban je oprez i kontrola u bolesnika s povišenim ALT-om i/ili AST-om, u bolesnika sa znakovima i simptomima oštećenja jetre, u bolesnika s prethodno postojećim stanjima povezanima s ograničenom funkcionalnom rezervom jetre te u bolesnika koji se liječe potencijalno hepatotoksičnim lijekovima.
English: In renally impaired patients (creatinine clearance < 10 ml/min) versus healthy subjects, there was no significant difference in mean elimination half-life (37.7 versus 32.4 hr) or clearance (21.2 versus 25.0 l/hr).
Croatian: U bolesnika s oštećenjem bubrega (klirens kreatinina <10 ml/min) nije bilo značajne razlike u odnosu na zdrave ispitanike u srednjoj vrijednosti poluvremena eliminacije (37,7 naspram 32,4 sata) ili klirensu (21,2 naspram 25,0 l/h).
English: Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines, e.g. measuring of blood glucose at baseline, 12 weeks after starting olanzapine treatment and annually thereafter.
Croatian: Savjetuje se odgovarajuće kliničko praćenje bolesnika u skladu s važećim smjernicama za primjenu antipsihotika, na primjer redovito mjerenje glukoze u krvi na početku liječenja, 12 tjedana nakon početka liječenja olanzapinom te jednom godišnje nakon toga.
English: Clinical signs included sedation, ataxia, tremors, increased heart rate, labored respiration, miosis, and anorexia.
Croatian: Klinički znakovi uključivali su sedaciju, ataksiju, tremore, ubrzani srčani ritam, otežano disanje, miozu i anoreksiju.
English: What Olanzapine Glenmark Europe is and what it is used for What you need to know before you take Olanzapine Glenmark Europe How to take Olanzapine Glenmark Europe Possible side effects
Croatian: Što je Olanzapin Glenmark Europe i za što se koristi Što morate znati prije nego počnete uzimati Olanzapin Glenmark Europe
English: The mean increase in olanzapine Cmax following fluvoxamine was 54 % in female non smokers and 77 % in male smokers.
Croatian: Srednja vrijednost porasta Cmax olanzapina nakon primjene fluvoksamina iznosila je 54% u žena nepušača i 77% u muškaraca pušača.
English: The frequency terms listed are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to <
Croatian: Navedene učestalosti definirane su kako slijedi: vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10).
English: Patients treated with any antipsychotic medicines, including olanzapine, should be monitored regularly for lipids in accordance with utilised antipsychotic guidelines e.g. at baseline, 12 weeks after starting olanzapine treatment and every 5 years thereafter.
Croatian: U bolesnika liječenih bilo kojim antipsihotikom, uključujući olanzapin, potrebno je redovito pratiti razinu lipida prema smjernicama za primjenu antipsihotika, na primjer, na početku liječenja, 12 tjedana nakon početka liječenja olanzapinom te svakih 5 godina nakon toga.
English: 2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline.
Croatian: 2 Srednji porast vrijednosti lipida natašte (ukupni kolesterol, LDL kolesterol i trigliceridi) bio je veći u bolesnika bez dokazane disregulacije lipida na početku.
English: In cytopenic dogs, there were no adverse effects on progenitor and proliferating cells in the bone marrow.
Croatian: U pasa s citopenijom nije bilo štetnih događaja za matične i proliferacijske stanice koštane srži.
English: Controlled efficacy data in adolescents (ages 13 to 17 years) are limited to short term studies in schizophrenia (6 weeks) and mania associated with bipolar I disorder (3 weeks), involving less than 200 adolescents.
Croatian: Pedijatrijska populacija Podaci o djelotvornosti iz kontroliranih ispitivanja u adolescenata (u dobi od 13 do 17 godina) su ograničeni na kratkotrajna ispitivanja u shizofreniji (6 tjedana) i maniji povezanim s bipolarnim poremećajem I (3 tjedna), a obuhvatilo je manje od 200 adolescenata.
English: Patients treated with any antipsychotic medicines, including olanzapine, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control.
Croatian: U bolesnika liječenih bilo kojim antipsihotikom, uključujući olanzapin, treba pratiti pojavu znakova i simptoma hiperglikemije (kao što su polidipsija, poliurija, polifagija i slabost), a bolesnike s dijabetesom mellitusom ili čimbenicima rizika za razvoj dijabetesa melitusa treba redovito pratiti zbog mogućeg pogoršanja glikemije.
English: - Weight gain has been seen in patients taking Olanzapine Glenmark Europe.
Croatian: Zapaženo je povećanje tjelesne težine u bolesnika koji uzimaju Olanzapin Glenmark Europe.
English: Temporal association of olanzapine treatment and venous thromboembolism has been reported uncommonly (≥ 0.1% and < 1%).
Croatian: Vremenska povezanost liječenja olanzapinom i venske tromboembolije (VTE) prijavljivana je manje često (<0,01% i < 1%).
English: What you need to know before you take Olanzapine Glenmark Europe
Croatian: Što morate znati prije nego počnete uzimati Olanzapin Glenmark Europe
English: In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki< 100 nM) for serotonin 5 HT2A/2C, 5 HT3, 5 HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; α 1 adrenergic; and histamine H1 receptors.
Croatian: U pretkliničkim ispitivanjima olanzapin je pokazao raspon afiniteta za receptore (Ki < 100 nM) serotonina 5HT2A/2C, 5HT3, 5HT6; dopamina D1, D2, D3, D4, D5; kolinergičke muskarinske receptore M1-M5; α1 adrenergičke; i histaminske H1 receptore.
English: • Slow heart rate.
Croatian: • usporeni rad srca
English: Do not take Olanzapine Glenmark Europe - if you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6).
Croatian: - Ako ste alergični (preosjetljivi) na olanzapin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: • Increases in levels of uric acid and creatine phosphokinase in the blood
Croatian: • povećanje razine mokraćne kiseline i kreatin fosfokinaze u krvi; pojačan apetit; omaglicu
English: OTHER COMDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: In placebo-controlled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementia-related psychosis and/or disturbed behaviours, there was a 2-fold increase in the incidence of death in olanzapine-treated patients compared to patients treated with placebo (3.5 % versus 1.5 %, respectively).
Croatian: U placebom kontroliranim kliničkim ispitivanjima (trajanja od 6 do 12 tjedana) starijih bolesnika (srednja vrijednost dobi 78 godina) s psihozom i/ili poremećajima ponašanja uzrokovanih demencijom zabilježeno je dvostruko povećanje incidencije smrtnosti u bolesnika liječenih olanzapinom u usporedbi s bolesnicima koji su primali placebo (3,5% naspram 1,5%).
English: Olanzapine Glenmark Europe 5 mg orodispersible tablets Olanzapine Glenmark Europe 10 mg orodispersible tablets Olanzapine Glenmark Europe 15 mg orodispersible tablets Olanzapine Glenmark Europe 20 mg orodispersible tablets
Croatian: Olanzapin Glenmark Europe 5 mg raspadljive tablete za usta Olanzapin Glenmark Europe 10 mg raspadljive tablete za usta Olanzapin Glenmark Europe 15 mg raspadljive tablete za usta Olanzapin Glenmark Europe 20 mg raspadljive tablete za usta olanzapin
English: Olanzapine Glenmark Europe contains aspartame Olanzapine Glenmark Europe contains a source of phenylalanine.
Croatian: Olanzapin Glenmark Europe sadrži aspartam Olanzapin Glenmark Europe sadrži izvor fenilalanina.
English: - The active substance is olanzapine - Each Olanzapine Glenmark Europe orodispersible tablet contains, 5 mg, 10 mg, 15 mg, or
Croatian: - Svaka Olanzapin Glenmark Europe raspadljiva tableta za usta sadrži 5 mg, 10 mg, 15 mg ili
English: Very common: Weight gain 13, elevated triglyceride levels 14, increased appetite.
Croatian: Vrlo često: povećanje tjelesne težine13, povišene razine triglicerida14, povećan apetit Često: povišene razine kolesterola15
English: Seizures have been reported to occur uncommonly in patients when treated with olanzapine.
Croatian: Prijavljeno je da se napadaji rijetko pojavljuju u bolesnika liječenih olanzapinom.
English: Elevated glucose levels4
Croatian: povišene razine glukoze4
English: 70 orodispersible tablets
Croatian: 70 raspadljivih tableta za usta
English: What Olanzapine Glenmark Europe looks like and contents of the pack
Croatian: Kako Olanzapin Glenmark Europe izgleda i sadržaj pakiranja
English: 56 orodispersible tablets
Croatian: 56 raspadljivih tableta za usta
English: 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.
Croatian: U ispitivanju istodobne terapije u bolesnika liječenih litijem ili valproatom tijekom najmanje 2 tjedna, dodavanje 10 mg olanzapina (istodobna terapija litijem ili valproatom), rezultiralo je većim smanjenjem simptoma manije nego monoterapija litijem ili valproatom nakon 6 tjedana.
English: In a single oral dose (10 mg) Positron Emission Tomography (PET) study in healthy volunteers, olanzapine produced a higher 5 HT2A than dopamine D2 receptor occupancy.
Croatian: U ispitivanju pozitronskom emisijskom tomografijom (PET), jedna peroralna doza (10 mg) olanzapina u zdravih dobrovoljaca dovela je do većeg zauzimanja 5HT2A nego dopaminskih D2 receptora.
English: What Olanzapine Glenmark Europe contains
Croatian: Što Olanzapin Glenmark Europe sadrži
English: 28 orodispersible tablets
Croatian: 28 raspadljivih tableta za usta
English: Olanzapine Glenmark Europe orodispersible tablet contains aspartame, which is a source of phenylalanine.
Croatian: Olanzapin Glenmark Europe raspadljiva tableta za usta sadrži aspartam, koji je izvor fenilalanina.
English: Following short term treatment (median duration 47 days), weight gain ≥ 7 % of baseline body weight was very common (22.2%), ≥ 15% was common (4.2%) and ≥25% was uncommon (0.8%).
Croatian: Nakon kratkotrajnog liječenja (medijan trajanja 47 dana), povećanje tjelesne težine ≥ 7% od početne tjelesne težine bilo je vrlo često (22,2%), povećanje ≥ 15% bilo je često (4,2%), a ≥ 25% bilo je manje često (0,8%).
English: In healthy elderly (65 and over) versus non-elderly subjects, the mean elimination half-life was prolonged (51.8 versus 33.8 hr) and the clearance was reduced (17.5 versus 18.2 l/hr).
Croatian: U zdravih starijih ispitanika (65 godina i starijih) u odnosu na mlađe ispitanike srednja vrijednost poluvremena eliminacije bila je produljena (51,8 naspram 33,8 sati), a klirens je bio smanjen (17,5 naspram 18,2 l/h).
English: The frequency terms listed are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the data available).
Croatian: Učestalost je definirana kako slijedi: vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10), manje često (≥ 1/1000 do < 1/100), rijetko (≥ 1/10 000 do < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Hyperglycaemia and/or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported uncommonly, including some fatal cases (see section 4.8).
Croatian: Rijetko su prijavljivane hiperglikemija i/ili razvoj ili egzacerbacija dijabetesa ponekad povezani s ketoacidozom ili komom, uključujući neke smrtne slučajeve (vidjeti dio 4.8).
English: In female versus male subjects the mean elimination half life was somewhat prolonged (36.7 versus 32.3 hrs) and the clearance was reduced (18.9 versus 27.3 l/hr).
Croatian: U žena je srednja vrijednost poluvremena eliminacije nešto dulja u odnosu na muškarce (36,7 naspram 32,3 sata), a klirens je smanjen (18,9 naspram 27,3 l/h).
English: 20 mg olanzapine - The other ingredients are mannitol (E 421), microcrystalline cellulose, aspartame (E 951),
Croatian: - Drugi sastojci su: manitol (E421), mikrokristalična celuloza, aspartam (E951), krospovidon,
English: METHOD AND ROUTE(S) OF ADMINISTRATION The tablet should be dissolved in the mouth or in a drink.
Croatian: Tabletu treba otopiti u ustima ili nekom napitku.
English: • Urinary incontinence, lack of ability to urinate.
Croatian: • nemogućnost zadržavanja mokraće (inkontinencija); nemogućnost mokrenja
English: Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported very rarely (≥ 0.01% and < 0.1%) when olanzapine is stopped abruptly.
Croatian: Akutni simptomi kao što su znojenje, nesanica, tremor, anksioznost, mučnina ili povraćanje vrlo su prijavljivani (≥ 0,01% i < 0,1%) nakon naglog prekida uzimanja olanzapina.
English: 13 Following short term treatment (median duration 22 days), weight gain ≥ 7 % of baseline body weight (kg) was very common (40.6 %), ≥ 15 % of baseline body weight was common (7.1 %) and ≥ 25 % was common (2.5 %).
Croatian: 13 Nakon kratkotrajnog liječenja (medijan trajanja 22 dana), povećanje tjelesne težine ≥ 7% od početne tjelesne težine (kg) bilo je vrlo često (40,6%), porast ≥ 15% od početne tjelesne težine bio je čest (7,1%), a ≥ 25% bio je čest (2,5%).
English: • Restless legs syndrome
Croatian: • sindrom nemirnih nogu
English: Urinary incontinence, urinary retention
Croatian: Poremećaji bubrega i mokraćnog sustava urinarna inkontinencija, urinarna retencija otežano mokrenje11
English: • Fever
Croatian: • vrućicu
English: Patients gaining ≥7%, ≥15% and ≥25% of their baseline body weight with long-term-exposure (at least 48 weeks) were very common (64.4 %, 31.7 % and 12.3 % respectively).
Croatian: Tijekom dugotrajne izloženosti lijeku (najmanje 48 tjedana), povećanje tjelesne težine ≥ 7%, ≥ 15% i ≥ 25% od početne bilo je vrlo često (64,4%, 31,7%, odnosno 12,3%).
English: Olanzapine Glenmark Europe contains the active substance olanzapine.
Croatian: Olanzapin Glenmark Europe sadrži djelatnu tvar olanzapin.
English: Very common side effects (may affect more than 1 in 10 people) include:
Croatian: Vrlo česte nuspojave (mogu se pojaviti u više od 1 na 10 osoba) uključuju:
English: phosphokinase11
Croatian: trombocitopenija11
English: How to take Olanzapine Glenmark Europe
Croatian: Kako uzimati Olanzapin Glenmark Europe
English: Rare side effects (may affect up to 1 in 1000 people) include:
Croatian: Rijetke nuspojave (mogu se pojaviti u do 1 na 1000 osoba) uključuju:
English: SmokingIn 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).
Croatian: Srednja vrijednost poluvremena eliminacije u ispitanika nepušača (muškarci i žene) bila je dulja nego u ispitanika pušača (38,6 naspram 30,4 sata), a klirens je bio manji (18,6 naspram 27,7 l/h).
English: How to store Olanzapine Glenmark Europe
Croatian: Kako čuvati Olanzapin Glenmark Europe
English: - High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking Olanzapine Glenmark Europe.
Croatian: - U bolesnika koji uzimaju Olanzapin Glenmark Europe uočena je visoka razina šećera i masnoća u krvi (trigliceridi i kolesterol).
English: Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olanzapine Glenmark Europe and regularly during treatment.
Croatian: Prije početka uzimanja Olanzapin Glenmark Europe te redovito tijekom liječenja, liječnik bi Vam trebao obaviti krvne pretrage kako bi provjerio razinu šećera i određenih masnoća u krvi.
English: • Dizziness.
Croatian: • napadaji.
English: Other medicines and Olanzapine Glenmark Europe Only take other medicines while you are on Olanzapine Glenmark Europe if your doctor tells you that you can. You might feel drowsy if Olanzapine Glenmark Europe is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).
Croatian: Ako uzimate Olanzapin Glenmark Europe u kombinaciji s antidepresivima ili lijekovima za tjeskobu ili lijekovima koji Vam pomažu zaspati (trankvilizeri), možete se osjećati omamljeno.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Glenmark Arzneimittel GmbH
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Glenmark Arzneimittel GmbH
English: Olanzapine Glenmark Europe 5mg is supplied as: yellow coloured circular flat bevelled edge orodispersible tablets with ‘B' debossed on one side.
Croatian: Olanzapin Glenmark Europe 5 mg su dostupne kao: žute, okrugle, plosnate raspadljive tablete za usta kosih rubova, s utisnutom oznakom ‘B' na jednoj strani.
English: If you stop taking Olanzapine Glenmark Europe Do not stop taking your tablets just because you feel better.
Croatian: Nemojte prestati uzimati tablete samo zato jer se osjećate bolje.
English: Mild, transient anticholinergic effects including constipation and dry mouth
Croatian: Poremećaji probavnog sustava blagi, prolazni antikolinergički učinci uključujući konstipaciju i suha usta distenzija abdomena9 pankreatitis11
English: • Sleepiness
Croatian: • pospanost
English: Glucosuria
Croatian: • omaglicu
English: Excipient with known effect: Each orodispersible tablet contains 0.23 mg of aspartame For the full list of excipients, see section 6.1
Croatian: Pomoćna tvar s poznatim učinkom: svaka raspadljiva tableta za usta sadrži 0,23 mg aspartama.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/588/010
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/588/010
English: Glenmark Arzneimittel GmbH Industriestr.
Croatian: Magyarország Glenmark Arzneimittel GmbH, Germany