natgillin/translations-raw huggingface dataset:
However, since patients with schizophrenia often present with acquired risk factors for venous thromboembolism all possible risk factors of VTE, e.g. immobilisation of patients, should be identified and preventive measures undertaken.
Međutim, budući da bolesnici sa shizofrenijom često imaju stečene čimbenike rizika za vensku tromboemboliju, sve moguće čimbenike rizika za VTE npr. imobilizacija bolesnika,
≥25% was common (2.5%).
(7,1%), a ≥25% bio je čest (2,5%).
Elevated cholesterol levels2,3
Povišene razine kolesterola2,3
Merckle GmbH Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Germany
Merckle GmbH Ludwig-Merckle-Strasse 3, 89143 Blaubeuren,
8 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 U kliničkim ispitivanjima u trajanju do 12 tjedana, koncentracije prolaktina u plazmi prelazile su gornju granicu normalnog raspona u približno 30% bolesnika liječenih olanzapinom s normalnom početnom vrijednosti prolaktina.
Mean infant exposure (mg/kg) at steady state was estimated to be 1.8% of the maternal olanzapine dose (mg/kg).
Prosječna izloženost novorođenčeta (mg/kg) u stanju dinamičke ravnoteže procijenjena je na 1,8% majčine doze olanzapina
Hypothermia12
Hipotermija12
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12.
DATUM PRVOG ODOBRENJA / DATUM OBNOVE ODOBRENJA
The mean increase in olanzapine Cmax following fluvoxamine was 54% in female non-smokers and 77% in male smokers.
Srednja vrijednost porasta Cmax olanzapina, nakon primjene fluvoksamina, iznosila je 54% u žena nepušača i 77% u muškaraca pušača.
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Parkinsonism6 Dyskinesia6
Parkinsonizam6 Diskinezija6
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).
Niža početna doza (5 mg/dan) nije rutinski indicirana, no treba ju razmotriti u osoba u dobi od 65
5HT2A/2C, 5HT3, 5HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1 M5; α1 adrenergic; and histamine H1 receptors.
serotonina 5HT2A/2C, 5HT3, 5HT6; dopamina D1, D2, D3, D4, D5; kolinergičke muskarinske receptore
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).
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 u odnosu na 32,4 sata) ili klirensu (21,2 u odnosu na 25,0 l/sat).
During treatment with olanzapine in combination with lithium or divalproex, an increase of ≥7% from baseline body weight occurred in 17.4% of patients during acute treatment (up to 6 weeks).
Tijekom liječenja olanzapinom u kombinaciji s litijem ili divalproeksom, porast tjelesne težine ≥7% od početne pojavio se u 17,4% bolesnika tijekom akutnog liječenja (do 6 tjedana).
You should swallow the Olanzapine Teva tablets whole with water.
Olanzapin Teva tablete trebate progutati cijele s vodom.
In placebocontrolled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementiarelated 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% vs. 1.5%, respectively).
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% u odnosu na 1,5%).
It may be harmful for patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Može biti štetno za bolesnike s fenilketonurijom, rijetkim genetskim poremećajem kod kojeg dolazi do nakupljanja fenilalanina jer ga tijelo ne može ukloniti na odgovarajući način.
Increased alkaline phosphatase10
Povišena alkalna fosfataza10
Olanzapine Teva tablets break easily, so you should handle the tablets carefully.
Olanzapin Teva tablete lako se lome te s njima treba pažljivo rukovati.
High creatine phosphokinase11
Visoka kreatin fosfokinaza11
Olanzapine demonstrated a greater in vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater 5HT than D activity in vivo models.
Olanzapin je in vitro pokazao veći afinitet za serotoninske 5HT2 nego dopaminske D2 receptore te veće djelovanje na 5HT nego
In a single oral dose (10 mg) Positron Emission Tomography (PET) study in healthy volunteers, olanzapine produced a higher 5HT2A than dopamine D2 receptor occupancy.
U ispitivanju pomoću pozitronske emisijske tomografije (PET), jednostruka oralna doza (10 mg) olanzapina u zdravih dobrovoljaca dovela je do većeg zauzimanja 5HT2A nego dopaminskih D2 receptora.
SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from light.
POSEBNE MJERE ČUVANJA Čuvajte u originalnom pakiranju radi zaštite od svjetlosti.
Olanzapine Teva film-coated tablets contain lactose.
Olanzapin Teva filmom obložene tablete sadrže laktozu.
Gastrointestinal disorders Mild, transient anticholinergic effects including constipation and dry mouth
Blagi, prolazni antikolinergički učinci uključujući konstipaciju i suha usta
There were more smokers among subjects with cirrhosis (4/6; 67%) than among subjects with no hepatic dysfunction (0/3; 0%).
(4/6, 67%) nego među ispitanicima koji nisu imali disfunkciju jetre (0/3, 0%).
With long-term exposure (at least 24 weeks), 89.4% gained ≥7%, 55.3%gained ≥15% and 29.1% gained ≥25% of their baseline body weight.
Tijekom dugotrajne izloženosti (najmanje 24 tjedna), u 89,4% bolesnika povećala se tjelesna težina ≥7%, u 55,3% ≥15%, a u 29,1% bolesnika tjelesna težina se povećala ≥25% od njihove tjelesne težine na početku liječenja.
In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥500 milliseconds [msec] at any time post baseline in patients with baseline QTcF <500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
U kliničkim ispitivanjima, klinički značajna produljenja QTc (Fridericia QT korekcija [QTcF] ≥500 milisekundi [msek] bilo kada nakon početne vrijednosti u bolesnika s početnom vrijednošću QTcF<500 milisekundi) bila su manje česta (0,1% do 1%) u bolesnika liječenih olanzapinom, bez značajnih razlika u povezanim kardijalnim događajima u usporedbi s placebom.
If this happens after you have been given Olanzapine Teva tell your doctor.
Ako Vam se ovo pojavi nakon uzimanja Olanzapina Teva, obratite se svom liječniku.
A greater magnitude of weight gain, lipid and prolactin alterations has been reported in short term studies of adolescent patients than in studies of adult patients (see sections 4.4, 4.8, 5.1 and 5.2).
Kratkotrajna ispitivanja provedena na adolescentima zabilježila su veće povećanje tjelesne težine i veće promjene vrijednosti lipida i prolaktina nego ispitivanja provedena na odraslim bolesnicima (vidjeti dijelove 4.4, 4.8, 5.1 i 5.2).
Olanzapine orodispersible tablet is bioequivalent to olanzapine coated tablets, with a similar rate and extent of absorption.
Olanzapin raspadljiva tableta za usta je bioekvivalent tabletama olanzapina, sa sličnom brzinom i opsegom apsorpcije.
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).
U drugom 12-mjesečnom ispitivanju prevencije relapsa epizode manije, bolesnici koji su postigli remisiju kombinacijom olanzapina i litija te su potom bili randomizirani u skupinu koja je primala samo olanzapin ili samo litij, olanzapin nije bio statistički inferioran litiju u pogledu primarnog ishoda relapsa bipolarnog poremećaja (olanzapin 30,0%, litij 38,3%; p=0,055).
Very common: Weight gain13, elevated triglyceride levels14, increased appetite.
Poremećaji metabolizma i prehrane Vrlo često: Povećanje tjelesne težine13, povišene razine triglicerida14, povećani apetit.
Bradycardia QTc prolongation (see section 4.4)
Bradikardija produljenje QTc intervala (vidjeti dio 4.4)
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 antipsychoticand risperidone-responsive patients, while being comparable to clozapine-responsive patients.
engl. single photon emission computed tomography) snimanja u bolesnika sa shizofrenijom otkrila su 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.
Thromboembolism Temporal association of olanzapine treatment and venous thromboembolism has been reported uncommonly (≥0.1% and <1%).
Vremenska povezanost liječenja olanzapinom i venske tromboembolije (VTE) zabilježena je manje često (<0,01% i <1%).
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.
Najčešće zabilježene nuspojave (uočene u ≥1% bolesnika) povezane s primjenom olanzapina u kliničkim ispitivanjima bile su somnolencija, povećanje tjelesne težine, eozinofilija, povišene vrijednosti prolaktina, kolesterola, glukoze i triglicerida (vidjeti dio 4.4), glukozurija, povećan apetit, omaglica, akatizija, parkinsonizam, leukopenija, neutropenija (vidjeti dio 4.4), diskinezija, ortostatska hipotenzija, antikolinergički učinci, prolazni asimptomatski porast razina jetrenih aminotransferaza
There was a 3-fold increase in CVAE in patients treated with olanzapine compared to patients treated with placebo (1.3% vs. 0.4%, respectively).
U bolesnika liječenim olanzapinom zabilježen je trostruki porast CV štetnih događaja u usporedbi s bolesnicima koji su liječeni placebom (1,3% u odnosu na 0,4%).
Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4)11
Razvoj ili egzacerbacija dijabetesa ponekad povezana s ketoacidozom ili komom, uključujući i neke slučajeve sa smrtnim ishodom (vidjeti dio 4.4)11
Brampton Road, Hampden Park Eastbourne, East Sussex, BN22 9AG United Kingdom
Brampton Road, Hampden Park Eastbourne, East Sussex, BN22 9AG Ujedinjeno Kraljevstvo
Seizures where in most cases a history of seizures or risk factors for seizures were reported11
Napadaji u većini slučajeva kada su zabilježeni napadaji u anamnezi ili čimbenici rizika za nastanak napadaja11 Distonija
Olanzapine Teva contains the active substance olanzapine.
Olanzapin Teva sadrži djelatnu tvar olanzapin.
Glucosuria Increased appetite
Povećani apetit
In female versus male subjects the mean elimination half-life was somewhat prolonged (36.7 versus 32.3 hr) and the clearance was reduced (18.9 versus 27.3 l/hr).
U žena je srednja vrijednost poluvremena eliminacije nešto duža u odnosu na muškarce (36,7 u odnosu na 32,3 sata), a klirens je smanjen (18,9 u odnosu na 27,3 l/sat).
Priapism12
Prijapizam12
Olanzapine Teva 2.5 mg/5 mg/7.5 mg/10 mg film-coated tablets Colour mixture white (polydextrose, hypromellose, glycerol triacetate, macrogol 8000, titanium dioxide E171)
Olanzapin Teva 2,5 mg/5 mg/7,5 mg/10 mg filmom obložene tablete smjesa bijele boje (polidekstroza, hipromeloza, gliceroltriacetat, makrogol 8000, titanijev dioksid (E171))
- Weight gain has been seen in patients taking Olanzapine Teva.
- Opaženo je povećanje tjelesne težine u bolesnika koji uzimaju Olanzapin Teva.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom Lapp laktaze ili glukoza-galaktoza malapsorpcijom ne bi trebali uzimati ovaj lijek.
(See sections 4.5 and 5.2)
(vidjeti dijelove 4.4 i 4.8).
How to take Olanzapine Teva
Kako uzimati Olanzapin Teva
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%).
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%).
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Bolesnici s rijetkim nasljednim poremećajem nepodnošenja fruktoze, glukoza-galaktoza malapsorpcijom ili saharoza-izomaltaza insuficijencijom ne smiju uzimati ovaj lijek.
Elevated glucose levels4
Povišene razine glukoze4
Rhabdomyolysis11
Rabdomioliza11
Keep this medicine out of the sight and reach of children.
Kako čuvati Olanzapin Teva Lijek čuvajte izvan pogleda i dohvata djece.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu<, and on the website of {name of MS Agency (link)}>.
{MM/GGGG} Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu<, kao i na internetskoj stranici {naziv nadležnog tijela države članice
See package leaflet for further information.
Vidjeti uputi o lijeku za više informacija.
Poligono Industrial Malpica, c/C, no. 4, 50.016 Zaragoza,
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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.
Rijetke nuspojave (mogu se pojaviti u do 1 na 1000 osoba) uključuju sniženje normalne tjelesne temperature; poremećaj srčanog ritma; naglu neobjašnjivu smrt; upalu gušterače koja uzrokuje jaku bol u trbuhu, vrućicu i mučninu; bolest jetre koja se očituje žutilom kože i bjeloočnica; bolest mišića koja se manifestira neobjašnjivim bolovima; te produžena i/ili bolna erekcija.
Manic episode: The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see section 5.1).
Epizoda manije: početna doza je 15 mg primjenjena kao jednokratna dnevna doza u monoterapiji ili 10
In cases where dose increments of 2.5 mg are considered necessary, Olanzapine Teva film-coated tablets should be used.
U slučajevima kada je potrebno povećavati dozu u koracima od 2,5 mg treba primijeniti Olanzapin
Lemon flavour [flavouring preparation(s), maltodextrin, sucrose, gum arabic (E414), glyceryl triacetate (E1518) and alpha-Tocopherol (E307)]
guma arabika (E414), gliceriltriacetat (E1518) i α-tokoferol (E307)].
Olanzapine Teva contains lactose, sucrose and aspartame This medicine contains lactose and sucrose.
Olanzapin Teva sadrži laktozu, saharozu i aspartam
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).
U zdravih starijih ispitanika (65 godina i stariji) u odnosu na mlađe ispitanike srednja vrijednost poluvremena eliminacije bila je produžena (51,8 u odnosu na 33,8 sati), a klirens je bio smanjen (17,5
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).
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%).
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.
kombinacija vrućice, ubrzanog disanja, znojenja, ukočenosti mišića i omamljenosti ili pospanosti, usporavanje disanja, aspiracija, visoki krvni tlak ili niski krvni tlak, poremećaj srčanog ritma.
If you notice any of these symptoms seek medical advice immediately; - a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness (the frequency of this side effect cannot be estimated from the available data).
• kombinaciju vrućice, ubrzanog disanja, znojenja, ukočenosti mišića i omamljenosti ili pospanosti (učestalost ove nuspojave ne može se procijeniti iz dostupnih podataka).
Glutamyltransfera se10
Visoka gama glutamiltransferaza10
Changes in fasting glucose from borderline at baseline (≥5.56-<7 mmol/l) to high (≥7 mmol/l) were very common.
Promjene vrijednosti glukoze natašte od početnih graničnih vrijednosti (≥5,56-<7 mmol/l) do visokih vrijednosti (≥7 mmol/l) bile su vrlo česte.
Tablet coating: hypromellose, polydextrose, glycerol triacetate, macrogol 8000, titanium dioxide (E171).
Ovojnica tablete: hipromeloza, polidekstroza, gliceroltriacetat, makrogol 8000, titanijev dioksid (E171).
Only take other medicines while you are on Olanzapine Teva if your doctor tells you that you can. You might feel drowsy if Olanzapine Teva is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).
Ako uzimate Olanzapin Teva u kombinaciji s antidepresivima ili lijekovima za tjeskobu ili lijekovima koji Vam pomažu zaspati (trankvilizeri), možete se osjećati pospano.
Hepatitis (including hepatocellular, cholestatic or mixed liver injury)
hepatocelularno, kolestatsko ili mješovito oštećenje jetre)11
Excipient with known effect Each film-coated tablet contains 68.9 mg lactose.
Svaka filmom obložena tableta sadrži 68,9 mg laktoze.
Each orodispersible tablet contains 142.5 mg lactose, 0.7875 mg sucrose and 6.75 mg aspartame (E951).
Svaka raspadljiva tableta za usta sadrži 142,5 mg laktoze, 0,7875 mg saharoze i 6,75 mg aspartama (E951).
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.
Vrlo česte su bile promjene ukupnih razina kolesterola natašte od graničnih početnih vrijednosti (≥4,39-<5,17 mmol/l) do visokih (≥5,17 mmol/l).
Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olanzapine Teva and regularly during treatment.
Prije početka uzimanja Olanzapina Teva te redovito tijekom liječenja, liječnik bi Vam trebao obaviti krvne pretrage kako bi provjerio razinu šećera i određenih masnoća u krvi.
3 Observed for fasting normal levels at baseline (<5.17 mmol/l) which increased to high (≥6.2 mmol/l).
3 Uočeno za početne normalne razine natašte (<5,17 mmol/l) koje su porasle na visoke razine (≥6,2 mmol/l).
Hepatic function
Hepatitis
Children and adolescents Olanzapine Teva is not for patients who are under 18 years.
Olanzapin Teva nije za primjenu u bolesnika mlađih od 18 godina.
Olanzapine Teva contains lactose
Olanzapin Teva sadrži laktozu
Poligono Industrial Malpica, c/C, no. 4 50.016 Zaragoza
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Hepatitis (including hepatocellular, cholestatic or aminotransferases (ALT, AST), especially in early treatment (see section 4.4)
(uključujući hepatocelularno, kolestatsko ili jetre (ALT, AST), osobito na početku liječenja
Each orodispersible tablet contains 190.0 mg lactose, 1.05 mg sucrose and 9.0 mg aspartame (E951).
Svaka raspadljiva tableta za usta sadrži 190,0 mg laktoze, 1,05 mg saharoze i 9,0 mg aspartama (E951).
Excipient with known effect Each film-coated tablet contains 206.7 mg lactose.
Svaka filmom obložena tableta sadrži 206,7 mg laktoze.
If you suddenly stop taking Olanzapine Teva, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur.
Ako naglo prestanete s uzimanjem Olanzapin Teva mogu se pojaviti simptomi poput znojenja,
5 Observed for fasting normal levels at baseline (<1.69 mmol/l) which increased to high
Uočeno za početne normalne razine natašte (<1,69 mmol/l) koje su porasle na visoke razine
(≥ 1.016 mmol/l-<1.467 mmol/l) to high (≥1.467 mmol/l).
14 Uočeno za normalne početne razine triglicerida natašte (<1,016 mmol/l) koje su porasle na visoke razine (≥1,467 mmol/l) i promjene vrijednosti triglicerida natašte od početnih graničnih vrijednosti (≥1,016 mmol/l-<1,467 mmol/l) do visokih vrijednosti (≥1,467 mmol/l).
Other medically significant sequelae of overdose include delirium, convulsion, coma, possible neuroleptic malignant syndrome, respiratory depression, aspiration, hypertension or hypotension,
Druge medicinski značajne posljedice predoziranja obuhvaćaju delirij, konvulzije, komu, mogući neuroleptički maligni sindrom, respiratornu depresiju, aspiraciju, hipertenziju ili hipotenziju, srčane aritmije (<2% slučajeva predoziranja) i kardiopulmonalni arest.
Tablet core: lactose monohydrate, hydroxypropylcellulose, crospovidone (type A), silica colloidal anhydrous, microcrystalline cellulose, magnesium stearate.
Jezgra tablete: laktoza hidrat, hidroksipropilceluloza, krospovidon (vrste A), silicijev dioksid,
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
Česte nuspojave (mogu se pojaviti u manje od 1 na 10 osoba) uključuju promjene razina nekih krvnih stanica i cirkulirajućih masti u krvi te, u ranim fazama liječenja, privremena povećanja razine jetrenih enzima; povišene razine šećera u krvi i mokraći; povećanje razine mokraćne kiseline i kreatin fosfokinaze u krvi; pojačan apetit; omaglicu; nemir; nevoljno drhtanje;neuobičajene pokrete (diskinezije); zatvor; suha usta; osip; slabost; pojačani umor; zadržavanje vode u tijelu koje dovodi do otečenosti ruku, zglobova ili stopala; vrućicu, bol u zglobovima te seksualne poremećaje kao što su smanjeni libido u muškaraca i žena ili erektilna disfunkcija u muškaraca.
Excipient with known effect Each film-coated tablet contains 103.3 mg lactose.
Svaka filmom obložena tableta sadrži 103,3 mg laktoze.