FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical trials and use in accordance with the SPC, quetiapine was not associated with a persistent increase in absolute QT intervals.
Slovenian: V kliničnih preskušanjih in pri uporabi v skladu z SmPC, kvetiapin ni bil povezan s stalnim povečevanjem absolutnih intervalov QT.
English: (For cataracts/lens opacities see section 5.1).
Slovenian: (Za katarakte/zamotnitev očesne leče glejte poglavje 5.1).
English: • Worsening of pre-existing diabetes.
Slovenian: • poslabšanje obstoječe sladkorne bolezni.
English: Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorbcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: It also blocks the action of dopamine agonists, measured either behaviourally or electrophysiologically, and elevates dopamine metabolite concentrations, a neurochemical index of D2-receptor blockade.
Slovenian: Blokira tudi delovanje agonistov dopamina (merjeno vedenjsko ali elektrofiziološko) in zvišuje koncentracijo presnovkov dopamina, ki so nevrokemični kazalci blokade receptorjev D2.
English: Approximately 73% of a radiolabelled drug was excreted in the urine and 21% in the faeces with less than 5% of the total radioactivity representing unchanged drug-related material.
Slovenian: Približno 73 % radioaktivno označenega zdravila se izloči v urinu in 21 % v blatu z manj kot 5 % skupne radioaktivnosti, ki predstavlja nespremenjeno snov povezano z zdravilom.
English: • Allergic reactions that may include raised lumps (weals), swelling of the skin and swelling around the mouth.
Slovenian: • alergijske reakcije, ki lahko vključujejo izbočene otekline (modrice), otekanje kože in predela okoli ust,
English: The elimination half lives of quetiapine and norquetiapine are approximately 7 and 12 hours, respectively.
Slovenian: Izločanje Razpolovni čas izločanja kvetiapina in norkvetiapina je približno 7 oziroma 12 ur.
English: Doses greater than 300 mg should be initiated by physicians experienced in treating bipolar disorder.
Slovenian: Odmerke višje od 300 mg lahko uvede zdravnik, ki ima izkušnje z zdravljenjem bipolarne motnje.
English: during their pregnancy
Slovenian: Motnje v času nosečnosti,
English: These may be increased when first starting treatment, since these medicines all take time to work, usually about two weeks but sometimes longer.
Slovenian: Po prvi uvedbi zdravljenja z antidepresivi lahko te misli postanejo še hujše, saj ta zdravila začnejo delovati šele čez nekaj časa, običajno čez dva tedna, nekatera pa tudi kasneje.
English: The symptoms of tardive dyskinesia can worsen or even arise after discontinuation of treatment (see Section 4.8).
Slovenian: Simptomi zapoznele diskinezije se lahko poslabšajo ali celo pojavijo po prenehanju zdravljenja (glejte poglavje 4.8).
English: Shifts in total T4, free T4, total T3 and free T3 are defined as <0.8 x LLN (pmol/L) and shift in TSH is > 5 mIU/L at any time.
Slovenian: Spremembe celotnega T4, prostega T4, celotnega T3 in prostega T3 so opredeljene kot < 0,8-kratna spodnja normalna meja (pmol/l) in sprememba TSH kot > 5 mIU/l kadarkoli.
English: During post-marketing experience, some cases were fatal.
Slovenian: V obdobju po prihodu zdravila na trg so se nekateri primeri končali s smrtjo.
English: Elderly people If you are elderly your doctor may change your dose.
Slovenian: Starejši bolniki Če ste starejši, vam zdravnik lahko spremeni vaš odmerek.
English: Exacerbation of preexisting diabetes
Slovenian: poslabšanje obstoječe sladkorne bolezni
English: • Breakdown of muscle fibers and pain in muscles (rhabdomyolysis).
Slovenian: • propad mišičnih vlaken in bolečine v mišicah (rabdomioliza),
English: (18) Incidence of patients who have a QTc shift from <450 msec to ≥450 msec with a ≥30 msec increase.
Slovenian: (18) Pojav bolnikov, ki imajo spremembo QTc iz < 450 msek na ≥ 450 msek z ≥30 msek povečanjem.
English: • Abnormal dreams and nightmares
Slovenian: • nenavadne sanje in nočna mora,
English: Seroquel with food, drink and alcohol
Slovenian: Zdravilo Seroquel skupaj s hrano, pijačo in alkoholom
English: Cardiomyopathy and Myocarditis
Slovenian: Kardiomiopatija in miokarditis
English: The data showed an additive effect at week 3.
Slovenian: Podatki so v 3. tednu pokazali aditivni učinek.
English: Seroquel can be used to treat several illnesses, such as:
Slovenian: Zdravilo Seroquel se lahko uporablja za zdravljenje več bolezni, npr.:
English: • A severe allergic reaction (called anaphylaxis) which may cause difficulty in breathing or shock.
Slovenian: • huda alergijska reakcija (imenovana anafilaksija), ki lahko povzroči težave pri dihanju ali šok,
English: • Blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing.
Slovenian: • krvni strdki v žilah, zlasti v nogah (simptomi so oteklina, bolečina in rdečina na nogi), ki lahko potujejo skozi krvne žile v pljuča in povzročajo bolečine v prsih ter težave z dihanjem.
English: • add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy (see Section 5.1).
Slovenian: • kot dodatno zdravljenje velikih depresivnih epizod pri bolnikih z veliko depresivno motnjo (MDD - Major Depressive Disorder), ki so imeli suboptimalni odziv na antidepresivno monoterapijo (glejte poglavje 5.1).
English: Clinical efficacy:
Slovenian: Klinična učinkovitost:
English: (32) May occur at or near initiation of treatment and be associated with hypotension and/or syncope.
Slovenian: (32) Lahko se pojavi ob uvedbi zdravljenja ali kmalu po njej in jo lahko spremljata hipotenzija in/ali sinkopa.
English: Neutropenia should be considered in patients presenting with infection or fever, particularly in the absence of obvious predisposing factor(s), and should be managed as clinically appropriate.
Slovenian: Na nevtropenijo je treba pomisliti pri bolnikih, ki imajo okužbo ali zvišano telesno temperaturo, zlasti če nimajo očitnih predispozicijskih dejavnikov; nevtropenijo je treba obravnavati, kot je klinično primerno.
English: These data do not establish a causal relationship between quetiapine treatment and death in elderly patients with dementia.
Slovenian: Ti podatki ne dokazujejo vzročne povezanosti med zdravljenjem s kvetiapinom in smrtjo pri starejših bolnikih z demenco.
English: In comparison, a light meal had no significant effect on the Cmax or AUC of quetiapine.
Slovenian: V primerjavi s tem lahek obrok ni značilno vplival ne na Cmax ne na AUC kvetiapina.
English: Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Slovenian: Bolnike (in skrbnike bolnikov) je treba opozoriti, da morajo biti pozorni na kakršnokoli klinično poslabšanje, samomorilno vedenje ali razmišljanje in na neobičajne vedenjske spremembe.
English: A second study did not demonstrate an additive effect at week 6.
Slovenian: Druga študija ni pokazala aditivnega učinka po 6 tednih.
English: Epinephrine and dopamine should be avoided, since beta stimulation may worsen hypotension in the setting of quetiapine-induced alpha blockade.
Slovenian: Adrenalinu in dopaminu se je treba izogniti, ker lahko beta-stimulacija v primeru alfa-blokade s kvetiapinom poslabša hipotenzijo.
English: • Sexual dysfunction.
Slovenian: • spolne motnje,
English: • You know that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines).
Slovenian: • veste, da ste v preteklosti imeli nizko število belih krvnih celic, ki bi ga lahko ali pa tudi ne,
English: The average molar dose fraction of free quetiapine and the active human plasma metabolite norquetiapine is <5% excreted in the urine.
Slovenian: Povprečni molarni delež odmerka prostega kvetiapina in norkvetiapina, aktivnega presnovka v človeški plazmi, je < 5 % izločen v urinu.
English: Somnambulism and related reactions such as sleep talking and sleep related eating disorder
Slovenian: somnambuliz em in podobne reakcije, npr. govorjenje med spanjem ali s spanjem povezana motnja hranjenja
English: In the continuation phase in two of these studies, it was demonstrated that long-term treatment, of patients who responded on Seroquel IR 300 or 600 mg, was efficacious compared to placebo treatment with respect to depressive symptoms, but not with regard to manic symptoms.
Slovenian: V nadaljevalni fazi dveh od teh študij je bilo dokazano, da je dolgotrajno zdravljenje bolnikov, ki so se odzvali na zdravilo Seroquel 300 mg ali 600 mg, učinkovito v primerjavi s placebom, kar zadeva simptome depresije, ne pa, kar zadeva simptome manije.
English: Less than 1% of patients had an increase to a prolactin level >100 ug/L.
Slovenian: Pri manj kot 1 % bolnikov se je koncentracija prolaktina zvišala na > 100 ug/l.
English: • Seroquel XR can be affected by food and you should therefore take your tablets at least one hour before a meal or prior to bedtime.
Slovenian: • Hrana lahko vpliva na zdravilo Seroquel SR, zato morate vzeti tableto s podaljšanim sproščanjem vsaj eno uro pred obrokom ali pred spanjem.
English: Given its primary central nervous system effects, quetiapine may interfere with activities requiring mental alertness.
Slovenian: Zaradi svojih primarnih učinkov na osrednji živčni sistem lahko kvetiapin vpliva na dejavnosti, ki zahtevajo pozornost.
English: The following studies were conducted with Seroquel XR as monotherapy treatment, however Seroquel XR is only indicated for use as add-on therapy:
Slovenian: Naslednje študije so bile izvedene z zdravilom Seroquel SR kot monoterapijo, vendar je zdravilo Seroquel SR indicirano le za uporabo kot dodatno zdravilo:
English: Weight should be monitored regularly.
Slovenian: Redno je treba kontrolirati telesno maso.
English: Patients should be observed for signs and symptoms of infection and neutrophil counts followed (until they exceed 1.5 X 109/L) (see section 5.1).
Slovenian: Bolnike je potrebno spremljati glede znakov in simptomov okužbe ter jim kontrolirati število nevtrofilcev (dokler ne preseže 1,5 x 109/l) (glejte poglavje 5.1).
English: QT Prolongation:
Slovenian: Podaljšanje intervala QT:
English: Severe Neutropenia and agranulocytosis:
Slovenian: Huda nevtropenija in agranulocitoza:
English: This could increase the occurrence of accidental injury (fall), especially in the elderly population.
Slovenian: To lahko poveča pojavljanje naključnih poškodb (padci), zlasti pri starejših bolnikih.
English: This effect occurred in the presence of overt maternal effects such as reduced body weight gain.
Slovenian: Ta učinek se je pojavil v prisotnosti manifestnih učinkov pri samicah-materah, npr. zmanjšanega pridobivanja telesne mase.
English: Whilst the prevention of absorption in overdose has not been investigated, gastric lavage can be indicated in severe poisonings and if possible to perform within one hour of ingestion.
Slovenian: Čeprav možnosti preprečevanja absorpcije prevelikih odmerkov niso preučevali, lahko razmislimo tudi o možnosti uporabe praznjenja želodca pri hudih zastupitvah in ga izvesti, če je mogoče, v eni uri po zaužitju.
English: This increase in clearance reduced systemic quetiapine exposure (as measured by AUC) to an average of 13% of the exposure during administration of quetiapine alone; although a greater effect was seen in some patients.
Slovenian: To povečanje očistka je zmanjšalo sistemsko izpostavljenost kvetiapinu (izmerjeno z AUC) v povprečju na 13-% izpostavljenost glede na uporabo samega kvetiapina; pri nekaterih bolnikih so opazili še večji učinek.
English: Quetiapine and norquetiapine have no appreciable affinity at benzodiazepine receptors but high affinity at histaminergic and adrenergic alpha1 receptors, moderate affinity at adrenergic alpha2 receptors and moderate to high affinity at several muscarinic receptors.
Slovenian: Kvetiapin in norkvetiapin nimata upoštevanja vredne afinitete za benzodiazepinske receptorje, imata pa veliko afiniteto za histaminergične receptorje in adrenergične receptorje alfa 1, zmerno afiniteto za adrenergične receptorje alfa 2 ter zmerno do veliko afiniteto za več muskarinskih receptorjev.
English: An increase in LDL cholesterol of ≥30 mg/dL (≥0.769 mmol/L) has been very commonly observed.
Slovenian: Povečanje LDL holesterola ≥ 30 mg/dl (≥ 0,769 mmol/l) je bilo opisano v zelo pogostih primerih.
English: Toxic Epidermal Necrolysis, Erythema Multiforme
Slovenian: toksična epidermalna nekroliza, multiformni eritem
English: When Seroquel XR is being taken to treat major depressive episodes in major depressive disorder, it will be taken in addition to another drug being used to treat this illness.
Slovenian: Če je zdravilo Seroquel SR uporabljeno za zdravljenje velikih depresivnih epizod pri veliki depresivni motnji, ga je treba jemati kot dodatek k nekemu drugemu zdravilu, namenjenemu zdravljenju te bolezni.
English: • You will take your tablets once a day.
Slovenian: • Tablete s podaljšanim sproščanjem boste jemali enkrat na dan.
English: Furthermore, the long-term safety implications of treatment with quetiapine on growth and maturation have not been studied beyond 26 weeks.
Slovenian: Poleg tega, dolgoročne varnostne posledice zdravljenja s kvetiapinom za rast in dozorevanje niso raziskane, če zdravljenje traja več kot 26 tednov.
English: Quetiapine should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or other conditions predisposing to hypotension.
Slovenian: Kvetiapin je treba uporabljati previdno pri bolnikih z znanimi srčno-žilnimi boleznimi, možganskožilnimi boleznimi in drugimi stanji, ki povzročajo nagnjenost k hipotenziji.
English: The incidences of ADRs associated with quetiapine therapy, are tabulated below (Table 1) according to the format recommended by the Council for International Organizations of Medical Sciences (CIOMS III Working Group; 1995).
Slovenian: Pogostnost pojavljanja neželenih učinkov, povezanih z uporabo kvetiapina, je navedena v spodnji preglednici (Preglednica 1) v skladu z obliko, ki jo priporoča Council for International Organizations of Medical Sciences (Delovna skupina CIOMS III 1995).
English: Effects related to elevated prolactin levels were seen in rats, although these are not directly relevant to humans (see section 5.3 preclinical data).
Slovenian: Pri podganah so ugotovili učinke, povezane z zvišanjem prolaktina, vendar ti niso neposredno relevantni za človeka (glejte poglavje 5.3, Predklinični podatki).
English: dizziness, and irritability.
Slovenian: bruhanje, omotico in razdražljivost.
English: There have been reports of false positive results in enzyme immunoassays for methadone and tricyclic antidepressants in patients who have taken quetiapine.
Slovenian: Poročajo o lažno pozitivnih rezultatih encimskih preiskav (EIA) za določanje metadona in tricikličnih antidepresivov pri bolnikih, ki so prejemali kvetiapin.
English: The usual effective dose is in the range of 400 to 800 mg/day.
Slovenian: Običajno učinkovit odmerek je med 400 do 800 mg na dan.
English: The use of quetiapine has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still.
Slovenian: Uporabo kvetiapina je spremljal pojav akatizije, za katero sta značilna subjektivno neprijeten ali zoprn nemir ter potreba po gibanju, pogosto hkrati z bolnikovo nezmožnostjo, da bi stal ali sedel pri miru.
English: Agranulocytosis26
Slovenian: agranulocitoz a26
English: Do not use physostigmine in case of dysrhythmias, any degree of heart block or QRS-widening.
Slovenian: Fizostigmin se ne sme uporabljati v primeru disaritmij, katerih koli stopenj srčnega bloka ali razširitve
English: In a third short-term placebo-controlled monotherapy trial with Seroquel XR in children and adolescent patients (10-17 years of age) with bipolar depression, efficacy was not demonstrated.
Slovenian: Tretje kratkotrajno, s placebom kontrolirano preskušanje monoterapije z zdravilom Seroquel SR pri otrocih in mladostnikih (starih od 10 do 17 let) z bipolarno depresijo ni dokazalo učinkovitosti.
English: When Seroquel XR is compared to Seroquel immediate release, the norquetiapine metabolite AUC is 18% lower.
Slovenian: Ko primerjamo zdravilo Seroquel SR z zdravilom Seroquel je AUC za norkvetiapinijev metabolit 18 % nižji.
English: About 45% of the patient population had an additional diagnosis of ADHD.
Slovenian: Približno 45 % te populacije bolnikov je imelo dodatno diagnozo ADHD (motnje s pomanjkanjem pozornosti in hiperaktivnostjo).
English: In pre-clinical tests predictive of EPS, quetiapine is unlike typical antipsychotics and has an atypical profile.
Slovenian: V predkliničnih testih, ki napovedujejo EPU (ekstrapiramidne neželene učinke), se kvetiapin razlikuje od tipičnih antipsihotikov in ima atipičen profil.
English: • Feeling sleepy (this may go away with time, as you keep taking Seroquel) (may lead to falls).
Slovenian: • občutek zaspanosti (ta lahko sčasoma mine, ko nadaljujete jemanje zdravila Seroquel ) (lahko povzroči padce),
English: Both in mania and schizophrenia higher doses resulted in numerically lower response rates.
Slovenian: Tako pri maniji kot pri shizofreniji so večji odmerki dosegli številsko manjše deleže odziva.
English: Concomitant use of quetiapine with a strong hepatic enzyme inducer such as carbamazepine or phenytoin substantially decreases quetiapine plasma concentrations, which could affect the efficacy of quetiapine therapy.
Slovenian: Sočasna uporaba kvetiapina in močnih induktorjev jetrnih encimov, kot sta karbamazepin ali fenitoin, bistveno zmanjša plazemske koncentracije kvetiapina, kar lahko vpliva na učinkovitost zdravljenja s kvetiapinom.
English: The rate of dose titration of Seroquel XR may need to be slower, and the daily therapeutic dose lower, than that used in younger patients.
Slovenian: Potrebno utegne biti počasnejše titriranje zdravila Seroquel SR, dnevni terapevtski odmerek pa je lahko nižji kot pri mlajših bolnikih.
English: • Severe rash, blisters, or red patches on the skin.
Slovenian: • hud izpuščaj, mehurji ali rdeče lise po koži,
English: Quetiapine and norquetiapine exhibit affinity for brain serotonin (5HT2) and dopamine D1- and D2- receptors.
Slovenian: Kvetiapin in norkvetiapin imata afiniteto za možganske receptorje za serotonin (5HT2) in dopamin (D1 in D2).
English: The primary outcome variable in the placebo-controlled trial was change from baseline to final assessment in the PANSS total score.
Slovenian: Primarna spremenljivka izida v preskušanju, kontroliranem s placebom, je bila sprememba celotnega seštevka po PANSS od izhodišča do končne ocene.
English: A placebo-controlled trial evaluating fixed doses of quetiapine across the range of 75 to 750 mg/day showed no evidence of an increase in EPS or the use of concomitant anticholinergics.
Slovenian: V nadzorovanem preskušanju s placebom z ustaljenimi odmerki kvetiapina v območju od 75 do 750 mg/dan niso dokazali povečanja EPS ali sočasne uporabe antiholinergikov.
English: You should not take Seroquel during pregnancy unless this has been discussed with your doctor.
Slovenian: Ne jemljite zdravila Seroquel med nosečnostjo, razen če se o tem niste pogovorili s svojim zdravnikom.
English: Seroquel XR achieves peak quetiapine and norquetiapine plasma concentrations at approximately 6 hours after administration (Tmax).
Slovenian: Zdravilo Seroquel SR doseže vrh koncentracije kvetiapina in norkvetiapina v plazmi približno 6 ur po uporabi (tmax).
English: Clinical manifestations include hyperthermia, altered mental status, muscular rigidity, autonomic instability, and increased creatine phosphokinase.
Slovenian: Klinični znaki sindroma so hipertermija, spremembe psihičnega statusa, mišična togost, avtonomna nestabilnost in povečane vrednosti kreatin-fosfokinaze.
English: (31) See Section 4.6.
Slovenian: (31) Glejte poglavje 4.6.
English: Increased appetite, blood glucose increased to hyperglycaemic levels 6, 30
Slovenian: povečanje telesne mase povečan apetit, zvišanje glukoze v krvi do hiperglikemične ravni 6, 30
English: In addition, these conditions may be co-morbid with major depressive episodes.
Slovenian: Ta stanja so lahko dodatno prisotna poleg velikih depresivnih epizod.
English: Bipolar Disorder
Slovenian: Bipolarna motnja
English: • Feeling weak.
Slovenian: • občutek šibkosti,
English: This may make you feel dizzy or faint (may lead to falls).
Slovenian: Posledici sta lahko omotica ali omedlevica (lahko povzroči padce).
English: • Unpleasant sensations in the legs (also called restless legs syndrome).
Slovenian: • neprijeten občutek v nogah (tako imenovan sindrom nemirnih nog),
English: 9/L.
Slovenian: celic/l.
English: If signs and symptoms of tardive dyskinesia appear, dose reduction or discontinuation of quetiapine should be considered.
Slovenian: Če se pojavijo znaki in simptomi zapoznele diskinezije, je treba razmisliti o zmanjšanju odmerka ali prekinitvi uporabe kvetiapina.
English: For about 2/3 of all cases, cessation of quetiapine treatment was associated with a reversal of the effects on total and free T4, irrespective of the duration of treatment.
Slovenian: V približno 2/3 vseh primerov je učinek na celotni in prosti T4 po prenehanju zdravljenja s kvetiapinom izginil, ne glede na trajanje zdravljenja.
English: Possible risk factors for neutropenia include pre-existing low white blood cell count (WBC) and history of drug induced neutropenia.
Slovenian: Med možnimi dejavniki tveganja za nevtropenijo sta že prisotno manjše število belih krvnih celic in predhodna, z zdravili povzročena nevtropenija.
English: Effect on Urine Drug Screens
Slovenian: Vpliv na urinske teste
English: The mean dose of Seroquel XR during the randomised phase was 177 mg/day.
Slovenian: Povprečni odmerek zdravila Seroquel SR med randomizirano fazo je bil 177 mg/dan.
English: Based on shifts above clinically significant thresholds (adapted from the National Institutes of Health criteria) or increases >20 mmHg for systolic or >10 mmHg for diastolic blood pressure at any time in two acute (3-6 weeks) placebo-controlled trials in children and adolescents.
Slovenian: Na podlagi sprememb nad klinično pomembnimi pragi (prirejeno po merilih National Institutes of Health) ali zvišanja sistoličnega tlaka > 20 mmHg ali diastoličnega tlaka > 10 mmHg kadarkoli v dveh akutnih (3- do 6-tedenskih) s placebom kontroliranih preskušanjih pri otrocih in mladostnikih.
English: The same side effects that may occur in adults may also occur in children and adolescents.
Slovenian: Enaki neželeni učinki, ki se lahko pojavijo pri odraslih, se lahko pojavijo tudi pri otrocih in mladostnikih.
English: During an extended post-treatment follow-up phase of the bipolar depression trial, there were two additional suicide related events in two patients; one of these patients was on quetiapine at the time of the event.
Slovenian: V fazi podaljšanega spremljanja po zdravljenju v preskušanju pri bipolarni depresiji so zabeležili dva dodatna s samomorom povezana dogodka pri dveh bolnikih; eden od obeh bolnikov je v času dogodka prejemal kvetiapin.
English: • The active substance is quetiapine.
Slovenian: • Zdravilna učinkovina je kvetiapin.
English: Anaphylactic reaction5
Slovenian: anafilaktična reakcija5
English: What Seroquel is and what it is used for
Slovenian: Kaj je zdravilo Seroquel in za kaj ga uporabljamo
English: Tablet coating: hypromellose, macrogol, titanium dioxide (E171).
Slovenian: Obloga tablete: hipromeloza, makrogol, titanov dioksid (E171).
English: As with other antipsychotics, caution is recommended when treating patients with a history of seizures (see Section 4.8).
Slovenian: Tako kot pri drugih antipsihotičnih zdravilih je priporočljiva previdnost pri zdravljenju bolnikov z anamnezo konvulzij (glejte poglavje 4.8).