natgillin/translations-raw huggingface dataset:
The most frequently (seen in ≥ 1% of patients) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness, akathisia, parkinsonism, leukopenia, neutropenia (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic aminotransferases (see section 4.4), rash, asthenia, fatigue, pyrexia, arthralgia, increased alkaline phosphatase, high gamma glutamyltransferase, high uric acid, high creatine phosphokinase and oedema. 
Najpogosteje poročani (opaženi pri  1 % bolnikov) neželeni učinki, povezani z uporabo olanzapina v kliničnih preskušanjih, so bili zaspanost, povečanje telesne mase, eozinofilija, zvišane ravni prolaktina, holesterola, glukoze in trigliceridov (glejte poglavje 4.4), glikozurija, povečan apetit, omotica, akatizija, parkinsonizem, levkopenija, nevtropenija (glejte poglavje 4.4), diskinezija, ortostatska hipotenzija, antiholinergični učinki, prehodna asimptomatska zvišanja jetrnih aminotransferaz (glejte poglave 4.4), izpuščaj, astenija, utrujenost, pireksija, artralgija, zvišana alkalna fosfataza, visoka raven gama-glutamiltransferaze, visoka raven sečne kisline, visoka raven kreatinfosfokinaze in edem.
Transient, asymptomatic elevations of hepatic aminotransferases, alanine transferase (ALT), aspartate transferase (AST) have been seen commonly, especially in early treatment. 
Pogosto so opažali prehodna, asimptomatska zvišanja jetrnih aminotransferaz, alanin transferaze (ALT), aspartat transferaze (AST), posebno na začetku zdravljenja.
Clinical signs included sedation, ataxia, tremors, increased heart rate, labored respiration, miosis, and anorexia. 
Klinični znaki so vključevali sedacijo, ataksijo, tresenje, zvišano srčno frekvenco, težko dihanje, miozo in izgubo apetita.
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 %). 
S kratkoročnim zdravljenjem (srednje trajanje 47 dni) povezano zvečanje telesne mase za ≥ 7 % od osnovne telesne mase je bilo zelo pogosto (22,2 %), ≥ 15 % pogosto (4,2 %) in ≥ 25 % občasno (0,8 %).
Excipient with known effect: Each film-coated tablet contains 189.50 mg lactose. 
Pomožna snov z znanim učinkom: Vsaka filmsko obložena tableta vsebuje 189,50 mg laktoze.
PHARMACEUTICAL FORM AND CONTENTS 28 orodispersible tablets 
FARMACEVTSKA OBLIKA IN VSEBINA 28 orodisperzibilnih tablet
Rare side effects (may affect up to 1 in 1000 people) include lowering of normal body temperature; abnormal rhythms of the heart; sudden unexplained death; inflammation of the pancreas causing severe stomach pain, fever and sickness; liver disease appearing as yellowing of the skin and white parts of the eyes; muscle disease presenting as unexplained aches and pains; and prolonged and/or painful erection. 
Redki neželeni učinki (lahko prizadenejo do 1 od 1.000 bolnikov) vključujejo znižanje normalne telesne temperature, motnje srčnega ritma, nenadno nerazložljivo smrt, vnetje trebušne slinavke, ki povzroča hude bolečine v predelu želodca, zvišano telesno temperaturo in slabost, obolenje jeter, ki se kaže kot obarvanje kože in beločnic na rumeno, mišične bolezni, ki se kažejo kot nerazložljive bolečinske težave in bolečine, podaljšano in/ali bolečo erekcijo.
Olanzapine Apotex 5 mg orodispersible tablets Olanzapine Apotex 10 mg orodispersible tablets Olanzapine Apotex 15 mg orodispersible tablets Olanzapine Apotex 20 mg orodispersible tablets 
Olanzapin Apotex 5 mg orodisperzibilne tablete Olanzapin Apotex 10 mg orodisperzibilne tablete Olanzapin Apotex 15 mg orodisperzibilne tablete Olanzapin Apotex 20 mg orodisperzibilne tablete olanzapin
You should swallow the Olanzapine Apotex tablets whole with water. 
Olanzapin Apotex tablete pogoltnite cele z vodo.
Olanzapine Apotex 2.5 mg film-coated tablets Olanzapine Apotex 5 mg film-coated tablets Olanzapine Apotex 7.5 mg film-coated tablets Olanzapine Apotex 10 mg film-coated tablets 
Olanzapin Apotex 2,5 mg filmsko obložene tablete Olanzapin Apotex 5 mg filmsko obložene tablete Olanzapin Apotex 7,5 mg filmsko obložene tablete Olanzapin Apotex 10 mg filmsko obložene tablete olanzapin
Olanzapine Apotex film-coated tablets contain lactose. 
Olanzapin Apotex filmsko obložene tablete vsebujejo laktozo.
Elevated cholesterol levels Elevated glucose levels4 
zvišane ravni holesterola2,3 zvišane ravni glukoze4
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. 
Pri bolnikih s zvišano ALT in/ali AST, bolnikih z znaki in simptomi okvarjenega delovanja jeter, bolnikih s prej obstoječimi stanji, povezanimi z omejeno jetrno funkcionalno rezervo, in pri bolnikih, ki se zdravijo s potencialno hepatotoksičnimi zdravili, sta potrebna previdnost in nadaljnje spremljanje.
Investigations Elevated plasma prolactin levels8 
Preiskave zvišane plazemske koncentracije prolaktina8
and 98 tablets. 
98 filmsko obloženih tablet
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 %). 
13 S kratkotrajnim zdravljenjem (srednje trajanje 22 dni) povezano povečanje telesne mase za ≥ 7 % od osnovne telesne mase (kg) je bilo zelo pogosto (40,6 %), ≥ 15 % pogosto (7,1 %) in za ≥ 25 % občasno (2,5 %).
Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (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; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome problems with speech; stuttering; slow heart rate; sensitivity to sunlight; bleeding from the nose; abdominal distension; memory loss or forgetfulness; urinary incontinence; lack of ability to urinate; hair loss; absence or decrease in menstrual periods; and changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth. 
Občasni neželeni učinki (lahko prizadenejo do 1 od 100 bolnikov) vključujejo preobčutljivost (npr. otekanje v ustih in grlu, srbenje, izpuščaj), sladkorno bolezen ali poslabšanje sladkorne bolezni, občasno povezano s ketoacidozo (ketoni v krvi in urinu) ali komo, krče, običajno povezane s krči (epileptičnimi napadi) v preteklosti, mišično okorelost ali krče (vključno z obračanjem zrkel), sindrom nemirnih nog, težave pri govoru, jecljanje, upočasnjen srčni utrip, občutljivost za sončno svetlobo, krvavitev iz nosa, trebušno distenzijo, izgubo spomina ali pozabljivost, urinsko inkontinenco, težave pri mokrenju, izgubo las, odsotnost ali zmanjšanje menstruacij ter spremembe na prsih pri moških in ženskah, kot na primer nenormalno nastajanje mleka v prsih ali nenormalna rast.
Excipient with known effect: Each film-coated tablet contains 252.70 mg lactose. 
Pomožna snov z znanim učinkom: Vsaka filmsko obložena tableta vsebuje 252,70 mg laktoze.
28 orodispersible tablets 56 orodispersible tablets 98 orodispersible tablets 
FARMACEVTSKA OBLIKA IN VSEBINA 28 orodisperzibilnih tablet 56 orodisperzibilnih tablet 98 orodisperzibilnih tablet
High creatine phosphokinase11 
Visoka raven kreatinfosfokinaze11
METHOD AND ROUTE(S) OF ADMINISTRATION Oral use 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Peroralna uporaba.
Excipient with known effect: Each film-coated tablet contains 63.17 mg lactose. 
Pomožna snov z znanim učinkom: Vsaka filmsko obložena tableta vsebuje 63,17 mg laktoze.
There is a risk of feeling drowsy when you are given Olanzapine Apotex. 
Vpliv na sposobnost upravljanja vozil in strojev Obstaja tveganje, da se boste po tem, ko ste dobili zdravilo Olanzapin Apotex, počutili zaspane.
In clinical trials of up to 12 weeks, plasma prolactin concentrations exceeded the upper limit of normal range in approximately 30% of olanzapine treated patients with normal baseline prolactin value. 
8 V kliničnih preskušanjih, ki so trajala do 12 tednov, so pri 30 % bolnikov z normalno začetno vrednostjo prolaktina, ki so se zdravili z olanzapinom, ugotovili zvišanje plazemske koncentracije prolaktina nad zgornjo mejo normalne vrednosti.
Olanzapine Apotex orodispersible tablets are for oral use. 
Olanzapin Apotex orodisperzibilne tablete so za peroralno uporabo.
3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high 
3 Opazovano pri osnovnih normalnih ravneh na tešče (< 5,17 mmol/l), ki so se povišale na visoke
Common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating fats and early in treatment, temporary increases in liver enzymes; increases in the level of sugars in the blood and urine; increases in levels of uric acid and creatine phosphokinase in the blood; feeling more hungry; dizziness; restlessness; tremor; unusual movements(dyskinesias); constipation; dry mouth; rash; loss of strength; extreme tiredness; water retention leading to swelling of the hands, ankles or feet; fever; joint pain; and sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males. 
Pogosti neželeni učinki (lahko prizadenejo do 1 od 10 bolnikov) vključujejo spremembe v ravneh nekaterih krvnih celic, v krvnem obtoku in v začetnih obdobjih zdravljenja, začasno povišanje jetrnih encimov, zvišanja v ravni sladkorjev v krvi in urinu, zvišanja v ravni sečne kisline in kreatinfosfokinaze v krvi, večji občutek lakote, omotico, nemirnost, tresenje, nenavadne gibe (diskinezijo), zaprtje, suha usta, izpuščaj, izgubo moči, hudo utrujenost, zadrževanje vode, ki vodi v otekanje rok, gležnjev ali nog, vročino, bolečine v sklepih ter spolne disfunkcije, kot na primer zmanjšan libido pri moških in ženskah ter erektilna disfunkcija pri moških.
Do not take Olanzapine Apotex 
Ne jemljite zdravila Olanzapin Apotex
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON BOX 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA
Titanium dioxide (E171) 
Obloga tablete hipromeloza hidroksipropilceluloza makrogol 8000 titanov dioksid (E171)
In non-smoking versus smoking subjects (males and females), the mean elimination half-life was prolonged (38.6 versus 30.4 hrs) and the clearance was reduced (18.6 versus 27.7 l/hr). 
KadilciV primerjavi nekadilcev s kadilci (moškimi in ženskami) je bil srednji razpolovni čas izločanja podaljšan (38,6 v primerjavi s 30,4 ure) in očistek zmanjšan (18,6 l/h v primerjavi s 27,7 l/h).
What Olanzapine Apotex looks like and contents of the pack 
Izgled zdravila Olanzapin Apotex in vsebina pakiranja
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). 
Pri ženskah v primerjavi z moškimi je bil srednji razpolovni čas izločanja nekoliko podaljšan (36,7 v primerjavi z 32,3 ure) in očistek zmanjšan (18,9 v primerjavi s 27,3 l/h).
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. 
AST, bolnikih z znaki in simptomi okvarjenega delovanja jeter, bolnikih s prej obstoječimi stanji, povezanimi z omejeno jetrno funkcionalno rezervo, in pri bolnikih, ki se zdravijo s potencialno hepatotoksičnimi zdravili, sta potrebna previdnost in nadaljnje spremljanje.
How to store Olanzapine Apotex Contents of the pack and other information 
5 Shranjevanje zdravila Olanzapin Apotex Vsebina pakiranja in dodatne informacije
Dysarthria 
Amenoreja
Changes in fasting triglycerides from borderline at baseline (≥ 1.69 mmol/l< 2.26 mmol/l) to high (≥ 2.26 mmol/l) were very common. 
Zelo pogoste so bile spremembe v ravneh trigliceridov na tešče z mejnih osnovnih vrednosti (≥ 1,69 mmol/l - < 2,26 mmol/l) na visoke (≥ 2,26 mmol/l).
2D barcode carrying the unique identifier included. 
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako
Amenorrhea Breast enlargement Galactorrhea in females 
Povečanje dojk Galaktoreja pri ženskah
The active substance is olanzapine. 
Zdravilna učinkovina je olanzapin.
• High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking Olanzapine Apotex. 
• Pri bolnikih, ki so jemali zdravilo Olanzapin Apotex, so opazili visok nivo sladkorja v krvi in visok nivo maščob (trigliceridov in holesterola).
Manufacturer Apotex Nederland B.V. Archimedesweg 2 
Izdelovalec Apotex Nederland B.V.
Reversible neutropenia, thrombocytopenia, or anaemia developed in a few dogs treated with 8 or 10 mg/kg/day (total olanzapine exposure [AUC] is 12- to 15-fold greater than that of a man given a 12-mg dose). 
Pri nekaj psih, ki so prejemali 8 ali 10 mg/kg/dan (celotno izpostavljanje olanzapinu [AUC] je 12- do 15-krat večje kot pri človeku, ki dobi 12-miligramski odmerek), se je razvila reverzibilna nevtropenija, trombocitopenija ali anemija.
Nervous system disorders Somnolence Dizziness Akathisia6 
Bolezni živčevja zaspanost omotica akatizija6 parkinsonizem6 diskinezije6
Only take other medicines while you are on Olanzapine Apotex if your doctor tells you that you can. You might feel drowsy if Olanzapine Apotex is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers). 
Če jemljete zdravilo Olanzapin Apotex v kombinaciji z zdravili za zdravljenje depresije, zdravili za zdravljenje občutkov tesnobe ali zdravili, ki vam pomagajo spati (pomirjevala), se lahko počutite zaspani.
Gynaecomastia/breast enlargement in males 
Ginekomastija/p ovečanje dojk pri moških
Olanzapine Apotex contains lactose 
Zdravilo Olanzapin Apotex vsebuje laktozo
How to take Olanzapine Apotex 
Kako jemati zdravilo Olanzapin Apotex
• Each Olanzapine Apotex 20 mg orodispersible tablet contains 20 mg olanzapine. 
• Ena orodisperzibilna tableta zdravila Olanzapin Apotex 20 mg vsebuje 20 mg olanzapina.
• Each Olanzapine Apotex 7.5 mg film-coated tablet contains 7.5 mg olanzapine. 
• Ena filmsko obložena tableta zdravila Olanzapin Apotex 7,5 mg vsebuje 7,5 mg olanzapina.
If you get any side effects talk to your doctor or pharmacist. 
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
Changes in fasting glucose from borderline at baseline (≥ 5.56 - < 7 mmol/l) to high (≥ 7 mmol/l) were very common. 
Zelo pogoste so bile spremembe v ravneh glukoze na tešče z mejnih osnovnih vrednosti (≥ 5,56 mmol/l - < 7 mmol/l) na visoke (≥ 7 mmol/l).
• Olanzapine Apotex 20 mg orodispersible tablets are available in blister packs of 28 and 56 tablets. 
• Olanzapin Apotex 20 mg orodisperzibilne tablete so na voljo v škatli s pretisnim omotom po 28 in 56 tablet.
Changes in total fasting cholesterol levels from borderline at baseline (≥ 5.17< 6.2 mmol/l) to high (≥ 6.2 mmol/l) were very common. 
Zelo pogoste so bile spremembe v ravneh celokupnega holesterola na tešče z mejnih osnovnih vrednosti (≥ 5,17 mmol/l - < 6,2 mmol/l) na visoke (≥ 6,2 mmol/l).
Metabolism and nutrition disorders Weight gain1 
Presnovne in prehranske motnje povečanje telesne mase1
Aluminium/aluminium blister strips in cartons of 28, 56 and 98 film-coated tablets per carton. 
Pretisni omoti aluminij/aluminij v škatlah po 28, 56 in 98 filmsko obloženih tablet.
MARKETING AUTHORISATION NUMBER(S) EU/1/10/635/008-009 EU/1/10/635/017 BATCH NUMBER 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/10/635/008-009 EU/1/10/635/017
Olanzapine Apotex film-coated tablets are for oral use. 
Olanzapin Apotex obložene tablete so za peroralno uporabo.
Aluminium/aluminium blister strips in cartons of 28 film-coated tablets per carton. 
Pretisni omoti aluminij/aluminij v škatlah po 28 filmsko obloženih tablet.
Abdominal distension9 Pancreatitis11 
Trebušna distenzija9
MARKETING AUTHORISATION NUMBER(S) EU/1/10/635/013-014 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/635/013-014
• Olanzapine Apotex 7.5 mg film-coated tablets are available in blisters packs of 28 and 56 tablets. 
• Olanzapin Apotex 7,5 mg filmsko obložene tablete so na voljo v škatli s pretisnim omotom po 28 in 56 tablet.
MARKETING AUTHORISATION NUMBER(S) EU/1/10/635/010-011 EU/1/10/635/018 BATCH NUMBER 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/10/635/010-011 EU/1/10/635/018
• Olanzapine Apotex 15 mg orodispersible tablets are available in blisters packs of 28 tablets. 
• Olanzapin Apotex 15 mg orodisperzibilne tablete so na voljo v škatli s pretisnim omotom po 28 tablet.
High Gamma Glutamyltransferase 
Visoka raven gamaglutamiltransferaze10
EU/1/10/635/006-007 EU/1/10/635/016 
ZDRAVILOM EU/1/10/635/006-007 EU/1/10/635/016
MARKETING AUTHORISATION NUMBER(S) EU/1/10/635/004-005 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/635/004-005
• Olanzapine Apotex 2.5 mg film-coated tablets are available in blisters packs of 28 tablets. 
• Olanzapin Apotex 2,5 mg filmsko obložene tablete so na voljo v škatli s pretisnim omotom po 28 tablet.
Changes in total fasting cholesterol levels from borderline at baseline (≥ 4.39 - < 5.17 mmol/l) to high (≥ 5.17 mmol/l) were very common. 
Zelo pogoste so bile spremembe v ravneh celokupnega holesterola na tešče z mejnih osnovnih vrednosti (≥ 4,39 mmol/l - < 5,17 mmol/l) na visoke (≥ 5,17 mmol/l).
High Gamma Glutamyltransferase High uric acid 10 
Visoka raven gamaglutamiltransferaze10 Visoka raven sečne kisline10
• Each Olanzapine Apotex 2.5 mg film-coated tablet contains 2.5 mg olanzapine. 
• Ena filmsko obložena tableta zdravila Olanzapin Apotex 2,5 mg vsebuje 2,5 mg olanzapina.
2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline. 
2 Povprečna povišanja vrednosti lipidov na tešče (celokupni holesterol, LDL holesterol in trigliceridi)
Talk to your doctor or pharmacist before taking Olanzapine Apotex. 
Pred začetkom jemanja zdravila Olanzapin Apotex se posvetujte z zdravnikom ali farmacevtom.
Elevated triglyceride levels Glucosuria Increased appetite 
zvišane ravni holesterola2,3 zvišane ravni glukoze4 zvišane ravni trigliceridov2,5 glikozurija povečan apetit
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 7.5 mg olanzapine. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 7,5 mg olanzapina.
NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 7.5 mg film-coated tablets 
IME ZDRAVILA Olanzapin Apotex 7,5 mg filmsko obložene tablete
QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 20 mg olanzapine. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena orodisperzibilna tableta vsebuje 20 mg olanzapina.
Renal and/or hepatic impairment 
Okvarjeno ledvično in/ali jetrno delovanje
• Olanzapine Apotex 7.5 mg are white, round biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘7.5' on the other side. 
• Olanzapin Apotex 7,5 mg so bele, okrogle, bikonveksne filmsko obložene tablete z vtisnjenim napisom "APO" na eni strani in "OLA" nad "7.5" na drugi strani
Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/l) to high (≥ 5.17 mmol/l) were observed commonly. 
15 Pogosto so opazovali spremembe v ravneh celokupnega holesterola na tešče z normalnih osnovnih vrednosti (< 4,39 mmol/l), ki so se povišale na visoke (≥ 5,17 mmol/l).
Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials. 
Posturalna hipotenzija V kliničnih preskušanjih olanzapina so pri starejših redko poročali o posturalni hipotenziji.
MARKETING AUTHORISATION NUMBER(S) EU/1/10/635/012 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/635/012
Olanzapine Apotex contains the active substance olanzapine. 
Zdravilo Olanzapin Apotex vsebuje zdravilno učinkovino olanzapin.
INFORMATION IN BRAILLE Olanzapine Apotex 7.5 mg film-coated tablet 
PODATKI V BRAILLOVI PISAVI Olanzapin Apotex 7,5 mg filmsko obložena tableta
muscle stiffness and drowsiness or sleepiness. 
nespečnost, tresenje, tesnoba, slabost in bruhanje.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Apotex Europe B.V. 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Apotex Europe B.V.
Aluminium/aluminium blister strips in cartons of 28 and 56 film-coated tablets per carton. 
Pretisni omoti aluminij/aluminij v škatlah po 28 in 56 filmsko obloženih tablet.
MARKETING AUTHORISATION NUMBER(S) EU/1/10/635/001 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/635/001
Pancreatitis 
Mutagenost
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2.5 mg olanzapine. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 2,5 mg olanzapina.
• Each Olanzapine Apotex 15 mg orodispersible tablet contains 15 mg olanzapine. 
• Ena orodisperzibilna tableta zdravila Olanzapin Apotex 15 mg vsebuje 15 mg olanzapina.
Marketing Authorisation Holder Apotex Europe B.V. 
Imetnik dovoljenja za promet z zdravilom Apotex Europe B.V.
White, round, biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘2.5' on the other side. 
Bele, okrogle, bikonveksne filmsko obložene tablete z vtisnjenim napisom "APO" na eni strani in "OLA" nad "2.5" na drugi strani.
28 orodispersible tablets 56 orodispersible tablets 
FARMACEVTSKA OBLIKA IN VSEBINA 28 orodisperzibilnih tablet 56 orodisperzibilnih tablet
• Each Olanzapine Apotex 10 mg orodispersible tablet contains 10 mg olanzapine. 
• Ena orodisperzibilna tableta zdravila Olanzapin Apotex 10 mg vsebuje 10 mg olanzapina.
• Olanzapine Apotex 20 mg orodispersible tablets are yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘20' on the other side. 
• Olanzapin Apotex 20 mg orodisperzibilne tablete so rumene, okrogle, ravne tablete s krožnim krožnim robom in vtisnjenim napisom "APO" na eni strani in "OL" nad "20" na drugi strani
• Olanzapine Apotex 5 mg and 10 mg orodispersible tablets are available in blisters packs of 28 , 56 
• Olanzapin Apotex 5 mg in 10 mg orodisperzibilne tablete so na voljo v škatli s pretisnim omotom po 28, 56 in 98 tablet.
• Olanzapine Apotex 10 mg are white, round biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘10' on the other side. 
• Olanzapin Apotex 10 mg so bele, okrogle, bikonveksne filmsko obložene tablete z vtisnjenim napisom "APO" na eni strani in "OLA" nad "10" na drugi strani
NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 10 mg film-coated tablets 
IME ZDRAVILA Olanzapin Apotex 10 mg filmsko obložene tablete
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg olanzapine. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 5 mg olanzapina.
Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported rarely (≥ 0.01% and < 0.1%) when olanzapine is stopped abruptly. 
Redko (≥ 0,01 % in < 0,1 %) so pri nenadni prekinitvi zdravljenja z olanzapinom poročali o akutnih simptomih, kot so znojenje, nespečnost, tresenje, občutek tesnobe, slabost ali bruhanje.
NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 2.5 mg film-coated tablets 
IME ZDRAVILA Olanzapin Apotex 2,5 mg filmsko obložene tablete
INFORMATION IN BRAILLE Olanzapine Apotex 10 mg film-coated tablet 
PODATKI V BRAILLOVI PISAVI Olanzapin Apotex 10 mg filmsko obložena tableta
• Each Olanzapine Apotex 10 mg film-coated tablet contains 10 mg olanzapine. 
• Ena filmsko obložena tableta zdravila Olanzapin Apotex 10 mg vsebuje 10 mg olanzapina.