FrancophonIA/ELRC3.0 huggingface dataset:
English: Efficacy of Sycrest was not demonstrated in an 8-week, placebo-controlled, double-blind, randomized, fixed-dose trial in 306 adolescent patients aged 12-17 years with schizophrenia at doses of 2.5 and 5 mg twice daily.
Croatian: Djelotvornost lijeka Sycrest nije dokazana u osmotjednom, placebom kontroliranom, dvostruko slijepom, randomiziranom ispitivanju s primjenom fiksne doze lijeka, provedenom u 306 bolesnika adolescentske dobi (12 do 17 godina) sa shizofrenijom uz primjenu doza od 2,5 mg i 5 mg dvaput na dan.
English: Following oral administration to pregnant rabbits during the period of organogenesis, asenapine adversely affected body weight at the high dose of 15 mg.kg twice daily.
Croatian: Nakon peroralne primjene skotnim ženkama kunića tijekom organogeneze, asenapin je imao štetne učinke na tjelesnu masu pri visokoj dozi od 15 mg/kg dvaput na dan.
English: - Do not eat or drink for 10 minutes after taking the tablet.
Croatian: - Nemojte jesti niti piti 10 minuta nakon uzimanja tablete.
English: Peelable aluminium/aluminium blisters in cartons of 20, 60 or 100 sublingual tablets per carton.
Croatian: 20, 60 ili 100 sublingvalnih tableta u aluminij/aluminij blisteru s odvojivom folijom, u kutiji.
English: Sycrest contains the active substance asenapine.
Croatian: Sycrest sadrži djelatnu tvar asenapin.
English: Caution should be exercised when Sycrest is prescribed in patients with known cardiovascular disease or family history of QT prolongation, and in concomitant use with other medicinal products thought to prolong the QT interval.
Croatian: Potreban je oprez kad se Sycrest propisuje bolesnicima koji imaju bolest srca i krvnih žila ili produljenje QT-intervala u obiteljskoj anamnezi, kao i kod istodobne primjene lijekova koji produljuju QT-interval.
English: Do not crush the tablet.
Croatian: Tabletu nemojte drobiti.
English: Blood and lymphatic disorders
Croatian: Poremećaji krvi i limfnog sustava neutropenija
English: The clinically relevant adverse reactions identified in the paediatric trials were generally similar to those observed in the adult trials.
Croatian: Klinički značajne nuspojave identificirane u pedijatrijskim ispitivanjima bile su općenito slične onima opaženima u ispitivanjima u odraslih bolesnika.
English: The recommended starting dose of Sycrest as monotherapy is 5 mg twice daily.
Croatian: Preporučena početna doza lijeka Sycrest u monoterapiji je 5 mg dvaput na dan.
English: The incidence of dystonia in paediatric clinical trials using a gradual up-titration was similar to that seen in adult trials.
Croatian: Incidencija distonije u kliničkim ispitivanjima u pedijatrijskih bolesnika prilikom primjene postupnog povećanja doze bila je slična onoj primjećenoj u ispitivanjima u odraslih bolesnika.
English: Maternal and embryo toxic effects were found in animal studies (see section5.3).
Croatian: Međutim, u ispitivanjimana životinjama ustanovljeni su toksični učinci za majku i plod (vidjeti dio5.3).
English: Asenapine has some affinity to melanin-containing tissues.
Croatian: Asenapin pokazuje afinitet prema tkivima koja sadrže melanin.
English: - Do not remove a sublingual tablet from the blister until ready to take it. - Use dry hands when touching the tablet.
Croatian: - Nemojte vaditi sublingvalnu tabletu iz blistera dok je niste spremni uzeti.
English: Eating and drinking should be avoided for 10 minutes after administration.
Croatian: Mora se izbjegavati jelo i piće 10 minuta nakon primjene lijeka.
English: In a second PK study using flavoured sublingual tablets, the 10 mg twice daily dose in a paediatric population (10 to 17 years of age, inclusive) resulted in an approximate dose-proportional increase in asenapine exposure compared to 5 mg twice daily.
Croatian: U drugom ispitivanju farmakokinetike uz primjenu sublingvalnih tableta s okusom, primjena doze od 10 mg dvaput na dan u pedijatrijskoj populaciji (10 do uključivo 17 godina) rezultirala je povećanjem izloženosti asenapinu u odnosu na dozu od 5 mg dvaput na dan, koje je bilo približno proporcionalno dozi.
English: Therefore, Sycrest should be used with caution in patients who have a history of seizure disorder or have conditions associated with seizures.
Croatian: Stoga se Sycrest mora primjenjivati uz oprez u bolesnika koji u anamnezi imaju napadaje ili bolesti povezane s napadajima.
English: Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic medicines.
Croatian: Antipsihoticima se pripisuje svojstvo ometanja sposobnosti organizma da snizi bazalnu tjelesnu temperaturu.
English: There is no experience with asenapine in patients with severe renal impairment who have a creatinine clearance less than 15 mL/min.
Croatian: Nema iskustva o primjeni asenapina u bolesnika s teškim oštećenjem funkcije bubrega u kojih je klirens kreatinina manji od 15 ml/min.
English: Peelable blister.
Croatian: Blister s odvojivom folijom.
English: However, when tested in vitro it was devoid of phototoxicity.
Croatian: Međutim, nije se pokazao fototoksičnim u ispitivanjima in vitro.
English: Neuroleptic malignant syndrome (NMS), characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatine phosphokinase levels, has been reported to occur with antipsychotics, including asenapine.
Croatian: Kod primjene antipsihotika, uključujući asenapin, prijavljen je neuroleptički maligni sindrom (NMS) obilježen hipertermijom, rigiditetom mišića, nestabilnošću autonomnog živčanog sustava, promjenama svijesti i povišenim razinama kreatin fosfokinaze u serumu.
English: Asenapine caused mild maternal toxicity and slight retardation of foetal skeletal development.
Croatian: Asenapin je bio blago toksičan za majku te je uzrokovao blagi zastoj u razvoju kostura ploda.
English: Few cases of overdose were reported in the asenapine program.
Croatian: U programu ispitivanja asenapina prijavljen je mali broj slučajeva predoziranja.
English: Sycrest is indicated for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults.
Croatian: Sycrest je indiciran za liječenje umjerenih do teških maničnih epizoda povezanih s bipolarnim poremećajem tipa
English: The proportion of subjects with clinically significant weight gain (≥ 7 % weight gain from baseline at endpoint) in the short-term schizophrenia trials was 5.3 % for asenapine compared to 2.3 % for placebo.
Croatian: Udio ispitanika s klinički značajnim porastom tjelesne težine (≥ 7% porasta od početne vrijednosti na kraju ispitivanja) u kratkoročnim ispitivanjima u bolesnika sa shizofrenijom bio je 5,3% za asenapin u usporedbi s 2,3% za placebo.
English: From the clinical trials, it is concluded that clinically relevant body temperature dysregulation does not appear to be associated with asenapine.
Croatian: Na temelju kliničkih ispitivanja zaključeno je da asenapin nije povezan s klinički značajnim poremećajem regulacije tjelesne temperature.
English: Do not eat or drink for 10 minutes after taking the tablet.
Croatian: Nemojte jesti niti piti 10 minuta nakon uzimanja tablete.
English: if you have ever been diagnosed with a condition whose symptoms include high body temperature and muscle stiffness (also known as neuroleptic malignant syndrome).
Croatian: - ako Vam je ikada ustanovljena bolest čiji simptomi uključuju visoku temperaturu i ukočenost mišića (poznata i pod nazivom neuroleptički maligni sindrom), - ako ste ikada imali nekontrolirane pokrete jezika ili lica (tardivna diskinezija).
English: The proportion of subjects with clinically significant weight gain (≥ 7 % weight gain from baseline at endpoint) in the short-term, flexible-dose bipolar mania trials was 6.5 % for asenapine compared to 0.6 % for placebo.
Croatian: Udio ispitanika s klinički značajnim porastom tjelesne težine (≥ 7% porasta od početne vrijednosti na kraju ispitivanja) u kratkoročnim ispitivanjima s promjenjivom dozom u bolesnika s manijom u bipolarnom poremećaju bio je 6,5% za asenapin u odnosu na 0,6% za placebo.
English: Sycrest is used to treat moderate to severe manic episodes associated with bipolar I disorder in adults.
Croatian: Sycrest se koristi za liječenje umjerenih do teških maničnih epizoda povezanih s bipolarnim poremećajem tipa
English: There is no experience with asenapine in severe renal impairment patients with a creatinine clearance less than 15 mL/min.
Croatian: Nema iskustva s primjenom asenapina u bolesnika s teškim oštećenjem funkcije bubrega s klirensom kreatinina manjim od 15 ml/min.
English: The tablet should not be removed from the blister until ready to take it. Dry hands should be used when touching the tablet.
Croatian: Tableta se ne smije izvaditi iz blistera dok je bolesnik nije spreman uzeti.
English: In subjects with severe hepatic impairment (Child-Pugh C), a 7-fold increase in asenapine exposure was observed.
Croatian: U bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C) opažen je sedmerostruki porast ekspozicije asenapinu.
English: - Each Sycrest 10 mg sublingual tablet contains 10 mg asenapine.
Croatian: - Jedna Sycrest 10 mg sublingvalna tableta sadrži 10 mg asenapina.
English: In a 3-week, placebo-controlled, randomized, fixed-dose efficacy and safety trial in paediatric patients 10 to 17 years of age with bipolar I disorder, the mean change from baseline to endpoint in weight for placebo and asenapine 2.5 mg, 5 mg, and 10 mg twice daily, was 0.48, 1.72, 1.62, and 1.44 kg, respectively.
Croatian: U trotjednom, placebom kontroliranom, randomiziranom ispitivanju djelotvornosti i sigurnosti primjene s primjenom fiksne doze lijeka u pedijatrijskih bolesnika u dobi od 10 do 17 godina s bipolarnim poremećajem tipa I, prosječna promjena tjelesne težine od početne vrijednosti do kraja ispitivanja za placebo te asenapin od 2,5 mg, 5 mg odnosno 10 mg dvaput na dan iznosila je 0,48, 1,72, 1,62, odnosno 1,44 kg.
English: The incidences of the ADRs associated with asenapine therapy are tabulated below.
Croatian: Incidencije nuspojava povezanih s liječenjem asenapinom prikazane su u tablici.
English: In one double-blind, fixed-dose, parallel-group, 3-week placebo controlled trial in subjects with bipolar I disorder experiencing an acute manic or mixed episode involving 367 patients of which 126 received placebo, 122 received asenapine 5 mg twice daily (BID), and 119 received asenapine 10 mg BID, the primary efficacy hypothesis was met.
Croatian: I koji su imali akutnu maničnu ili miješanu epizodu i koje je uključivalo 367 bolesnika od kojih je 126 bolesnika primalo placebo, 122 bolesnika je primalo asenapin u dozi od 5 mg dvaput na dan, a 119 bolesnika je primalo asenapin u dozi od 10 mg dvaput na dan, primarna hipoteza djelotvornosti je zadovoljena.
English: - Each Sycrest 5 mg sublingual tablet contains 5 mg asenapine.
Croatian: - Jedna Sycrest 5 mg sublingvalna tableta sadrži 5 mg asenapina.
English: The clinically relevant adverse experiences identified in the paediatric bipolar and schizophrenia trials were similar to those observed in adult bipolar and schizophrenia trials.
Croatian: Klinički značajne nuspojave utvrđene u ispitivanjima u pedijatrijskih bolesnika s bipolarnim poremećajem i shizofrenijom bile su slične onima opaženima u ispitivanjima u odraslih bolesnika s bipolarnim poremećajem i shizofrenijom.
English: There was a statistically significant higher incidence of patients with ≥ 7 % weight gain (from baseline to endpoint) compared to placebo (3.1 %) for Sycrest 2.5 mg twice daily (9.5 %) and Sycrest 5 mg twice daily (13.1 %).
Croatian: Zabilježena je statistički značajno veća incidencija bolesnika s povećanjem tjelesne težine za ≥ 7% (od početne vrijednosti do kraja ispitivanja) kod primjene lijeka Sycrest u dozi od 2,5 mg dvaput na dan (9,5%) i lijeka Sycrest u dozi od 5 mg dvaput na dan (13,1%) u odnosu na placebo
English: For combination therapy a starting dose of 5 mg twice daily is recommended.
Croatian: Vidjeti dio 5.1. Za kombinirano liječenje preporučuje se početna doza od 5 mg dvaput na dan.
English: Asenapine does not cause induction of CYP1A2 or CYP3A4 activities in cultured human hepatocytes.
Croatian: U kulturi ljudskih hepatocita asenapin ne inducira djelovanje CYP1A2 niti CYP3A4.
English: Based upon a LOCF analysis including all patients treated, the difference in least squares (LS) mean change from baseline to Day 21 in the Y-MRS total score between asenapine 5 mg BID and placebo was -3.1 points (95 % CI [-5.7, -0.5]; p-value = 0.0183).
Croatian: Na temelju LOCF analize koja je uključivala sve liječene bolesnike, razlika u srednjoj vrijednosti promjene dobivenoj metodom najmanjih kvadrata (engl. least squares, LS) rezultata na ljestvici Y-MRS od početka ispitivanja do 21. dana između asenapina u dozi od 5 mg dvaput na dan i placeba iznosila je -3,1 boda (95% CI [-5,7; -0,5]; p-vrijednost=0,0183).
English: Merck Sharp & Dohme, inovativna zdravila d.o.o.
Croatian: Slovenská republika Merck Sharp & Dohme, s. r. o.
English: (EPS) which may include one or more of the following: abnormal movements of muscles,
Croatian: - abnormalni pokreti mišića: skup simptoma koje nazivamo ekstrapiramidalni simptomi, a koji obuhvaćaju jedan ili više od sljedećih simptoma: neuobičajene pokrete mišića,
English: EU/1/10/640/001 20 sublingual tablets EU/1/10/640/002 60 sublingual tablets EU/1/10/640/003 100 sublingual tablets
Croatian: EU/1/10/640/001 20 sublingvalnih tableta EU/1/10/640/002 60 sublingvalnih tableta EU/1/10/640/003 100 sublingvalnih tableta
English: Actions at other receptors e.g., 5-HT1A, 5-HT1B, 5-HT2C, 5-HT6, 5-HT7, D3, and α2-adrenergic receptors, may also contribute to the clinical effects of asenapine.
Croatian: Kliničkim učincima asenapina može pridonijeti i djelovanje na drugim receptorima, npr. 5-HT1A, 5-HT1B, 5-HT2C, 5-HT6, 5-HT7, D3 i α2-adrenergičkim receptorima.
English: Indicative of CYP2D6 inhibition, treatment with asenapine 5 mg twice daily resulted in a fractional decrease in DX/DM ratio to 0.43.
Croatian: Liječenje asenapinom u dozi od 5 mg dvaput na dan dovelo je do djelomičnog smanjenja omjera DX/DM na 0,43, što ukazuje na inhibiciju CYP2D6.
English: EU/1/10/640/004 20 sublingual tablets EU/1/10/640/005 60 sublingual tablets EU/1/10/640/006 100 sublingual tablets
Croatian: EU/1/10/640/004 20 sublingvalnih tableta EU/1/10/640/005 60 sublingvalnih tableta EU/1/10/640/006 100 sublingvalnih tableta
English: Marketing Authorisation Holder N.V. Organon
Croatian: Nositelj odobrenja za stavljanje lijeka u promet N.V.
English: Hyperglycaemia or exacerbation of pre-existing diabetes has occasionally been reported during treatment with asenapine.
Croatian: Tijekom liječenja asenapinom povremeno su prijavljeni hiperglikemija ili pogoršanje postojeće šećerne bolesti.
English: Manifestation of this increased sensitivity can include confusion, obtundation, postural instability with frequent falls, in addition to extrapyramidal symptoms.
Croatian: Navedena povećana osjetljivost može se, uz ekstrapiramidalne simptome, očitovati konfuzijom, stanjem smanjene svijesti i nestabilnošću pri stajanju praćenom čestim padovima.
English: Each sublingual tablet contains 5 mg asenapine (as maleate).
Croatian: Jedna sublingvalna tableta sadrži 5 mg asenapina (u obliku asenapinmaleata).
English: In clinical trials, there were few adverse reactions related to abnormal prolactin levels reported.
Croatian: U kliničkim ispitivanjima prijavljen je mali broj nuspojava povezanih s patološkim razinama prolaktina.
English: Rhabdomyolysis
Croatian: Disfagija
English: In vitro studies indicate that asenapine weakly inhibits CYP2D6.
Croatian: Ispitivanja in vitro ukazuju da je asenapin slab inhibitor CYP2D6.
English: Each sublingual tablet contains 10 mg asenapine (as maleate).
Croatian: Jedna sublingvalna tableta sadrži 10 mg asenapina (u obliku asenapinmaleata).
English: Overall, steady-state asenapine pharmacokinetics are similar to single-dose pharmacokinetics.
Croatian: Farmakokinetika asenapina u stanju dinamičke ravnoteže općenito je slična farmakokinetici nakon uzimanja jedne doze.
English: The difference in LS mean change from baseline to Day 21 in the Y-MRS total score between asenapine 10 mg BID and placebo was -3.0 points (95 % CI [-5.6, -0.4]; p-value = 0.0244).
Croatian: Razlika u srednjoj vrijednosti promjene LS rezultata na ljestvici Y-MRS od početka ispitivanja do 21. dana između asenapina u dozi od 10 mg dvaput na dan i placeba iznosila je -3,0 boda (95% CI [-5,6;
English: fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called “neuroleptic malignant syndrome”).
Croatian: Sycrest. - vrućicu, tešku ukočenost mišića, znojenje ili smanjenu razinu svijesti (poremećaj koji se naziva
English: In clinical trials, cases of syncope were occasionally reported during treatment with Sycrest.
Croatian: U kliničkim su ispitivanjima tijekom liječenja lijekom Sycrest povremeno prijavljeni slučajevi sinkope.
English: In an in vivo study in humans with radio-labelled asenapine, the predominant drug-related entity in plasma was asenapine +-glucuronide; others included N-desmethylasenapine, N-desmethylasenapine N-carbamoyl glucuronide, and unchanged asenapine in smaller amounts.
Croatian: +-glukuronid, a ostali spojevi bili su N-dezmetilasenapin, N-dezmetilasenapin N-karbamoil glukuronid te u manjim količinama nepromijenjeni asenapin.
English: Common side effects (may affect up to 1 in 10 people) - weight gain - increased appetite - slow or sustained muscle contractions - restlessness - involuntary muscle contractions - slow movements, tremor - sedation - dizziness - nausea - change in taste - numb feeling of the tongue or in the mouth
Croatian: Česte nuspojave (mogu se javiti u najviše 1 na 10 osoba) - porast tjelesne težine - pojačan tek - usporeno ili dugotrajno stezanje mišića - nemir - nevoljno stezanje mišića - usporeni pokreti, drhtanje (tremor) - umirenje (sedacija) - omaglica - mučnina - promjena osjeta okusa - osjećaj utrnulosti jezika ili usta - pojačano lučenje sline (slinjenje) - napetost mišića - umor - povišene razine jetrenih proteina
English: Tel: +386 1 5204 201 msd.slovenia@merck.com
Croatian: Tel: +421 2 58282010 dpoc_czechslovak@merck.com
English: Embryotoxicity was found in reproduction toxicology studies using rats and rabbits.
Croatian: U ispitivanjima reproduktivne toksičnosti na štakorima i kunićima ustanovljena je embriotoksičnost.
English: The possibility of multiple medicinal product involvement should be considered.
Croatian: Mora se uzeti u obzir da je bolesnik možda uzeo više različitih lijekova.
English: Orthostatic hypotension Hypotension
Croatian: Krvožilni poremećaji ortostatska hipotenzija, hipotenzija
English: The sublingual tablets are provided in peelable blisters containing 10 tablets each.
Croatian: Sublingvalne tablete dostupne su u blisterima s odvojivom folijom.
English: However, asenapine may enhance the inhibitory effects of paroxetine on its own metabolism.
Croatian: Čini se da je asenapin in vivo slab inhibitor CYP2D6, ali može pojačati inhibitorni učinak paroksetina na vlastiti metabolizam.
English: The 10 mg sublingual tablets are round white to off-white tablets marked with “10” on one side.
Croatian: Sublingvalne tablete od 10 mg su bijele do gotovo bijele okrugle tablete, s utisnutom oznakom "10" na jednoj strani.
English: Sexual dysfunction Amenorrhoea
Croatian: Poremećaji reproduktivnog sustava i dojki poremećaj spolne funkcije, amenoreja ginekomastija, galaktoreja
English: The safety and efficacy of Sycrest was evaluated in 403 paediatric patients with bipolar I disorder who participated in a single, 3-week, placebo-controlled, double-blind trial, of whom 302 patients received Sycrest at fixed doses ranging from 2.5 mg to 10 mg twice daily.
Croatian: I koji su sudjelovali u jednom trotjednom, placebom kontroliranom, dvostruko slijepom ispitivanju i od kojih je njih 302 primalo Sycrest u fiksnoj dozi u rasponu od 2,5 mg do 10 mg dvaput na dan.
English: In clinical trials, cases of tardive dyskinesia were occasionally reported during treatment with asenapine.
Croatian: U kliničkim su ispitivanjima tijekom liječenja asenapinom povremeno prijavljeni slučajevi tardivne diskinezije.
English: The tablet pack should not be cut or torn.
Croatian: Blister se ne smije rezati niti trgati.
English: Clinically relevant QT prolongation does not appear to be associated with asenapine.
Croatian: Čini se da primjena asenapina nije povezana s klinički značajnim produljenjem QT-intervala.
English: The tablet should not be pushed through the tablet pack.
Croatian: Tableta se ne smije protiskivati kroz blister.
English: Sycrest 5 mg sublingual tablets Sycrest 10 mg sublingual tablets asenapine
Croatian: Sycrest 5 mg sublingvalne tablete Sycrest 10 mg sublingvalne tablete asenapin
English: Slovenská republika Merck Sharp & Dohme, s. r. o. Tel: +421 2 58282010 dpoc_czechslovak@merck.com
Croatian: Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +386 1 5204 201 msd.slovenia@merck.com
English: Musculoskeleta l and connective tissue disorders
Croatian: Poremećaji mišićnokoštanog sustava i vezivnog tkiva ukočenost mišića rabdomioliza
English: Increases in prolactin levels were observed in some patients with Sycrest.
Croatian: U nekih bolesnika koji su uzimali Sycrest opažen je porast razine prolaktina.
English: Immune system disorders
Croatian: Poremećaji imunološkog sustava alergijske reakcije
English: No dose adjustment is required for patients with renal impairment.
Croatian: Nije potrebno prilagođavati dozu u bolesnika s oštećenjem funkcije bubrega.
English: In clinical trials, cases of seizure were occasionally reported during treatment with asenapine.
Croatian: U kliničkim su ispitivanjima tijekom liječenja asenapinom povremeno prijavljeni napadaji.
English: Other findings
Croatian: Ostali nalazi
English: Sycrest 10 mg sublingual tablets
Croatian: Sycrest 10 mg sublingvalne tablete
English: Direct glucuronidation (mediated by UGT1A4) and cytochrome P450 (primarily CYP1A2, with contributions of 2D6 and 3A4) mediated oxidation and demethylation are the primary metabolic pathways for asenapine.
Croatian: Primarni putevi metabolizma asenapina su neposredna glukuronidacija (pomoću UGT1A4) te oksigenacija i demetilacija posredovana citokromom P450
English: Sycrest 5 mg sublingual tablets
Croatian: Sycrest 5 mg sublingvalne tablete
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja plućna embolija
English: Electrocardiogram QT prolonged Sinus tachycardia
Croatian: Srčani poremećaji sinusna bradikardija, blok provodnog sustava srca, produljenje QT-intervala na EKG-u, sinusna tahikardija
English: Sublingual tablet Round, white to off-white, sublingual tablets debossed with “5” on one side.
Croatian: Sublingvalna tableta Bijele do gotovo bijele okrugle sublingvalne tablete, s utisnutom oznakom "5" na jednoj strani.
English: Seek medical attention immediately if you have any of the following symptoms: - allergic reactions (These usually involve a combination of effects such as difficulty in breathing or swallowing, swollen face, lips, tongue or throat, skin rash, itching and increased heart rate.)
Croatian: Odmah potražite medicinsku pomoć ukoliko imate bilo koji od sljedećih simptoma: - alergijske reakcije (obično obuhvaćaju kombinaciju učinaka kao što su poteškoće pri disanju ili gutanju, oticanje lica, usana, jezika ili grla, kožni osip, svrbež i ubrzani puls) - nagli porast tjelesne temperature uz znojenje, ubrzane otkucaje srca, jaku ukočenost mišića, smetenost i fluktuacije krvnog tlaka koje mogu dovesti do stanja kome - konvulzije, napadaji - nesvjestica - padovi koji mogu nastupiti kao posljedica jednog ili više štetnih događaja kao što su: pospanost, nagli pad krvnog tlaka pri ustajanju, omaglica i promjene Vaše sposobnosti za kretanje i održavanje ravnoteže.
English: Esophageal dysmotility and aspiration have been associated with antipsychotic treatment.
Croatian: Kod liječenja antipsihoticima javljaju se dismotilitet jednjaka i aspiracija.
English: Sublingual tablet Round, white to off-white, sublingual tablets debossed with ”10” on one side.
Croatian: Sublingvalna tableta Bijele do gotovo bijele okrugle sublingvalne tablete, s utisnutom oznakom "10" na jednoj strani.