natgillin/translations-raw huggingface dataset:
These symptoms could be due to either discontinuation effects or excess serotonergic activity. 
Ti se simptomi mogu javiti ili zbog učinaka prekida liječenja ili zbog povećane serotonergičke aktivnosti.
Vortioxetine must be discontinued for at least 14 days before starting treatment with an irreversible non-selective MAOI (see section 4.3). 
Liječenje vortioksetinom mora se prekinuti najmanje 14 dana prije početka liječenja ireverzibilnim neselektivnim MAOI-ma (vidjeti dio 4.3).
When a single dose of 20 mg vortioxetine was co-administered following 10 days of rifampicin 600 mg/day (a broad inducer of CYP isozymes) in healthy subjects, a 72% decrease in AUC of vortioxetine was observed. 
Kada je jedna doza od 20 mg vortioksetina istodobno primjenjena nakon 10 dana rifampicina 600 mg/dan (induktor širokog spektra CYP izoenzima) u zdravih ispitanika, opaženo je smanjenje od 72% u AUC-u vortioksetina.
No clinically significant changes were observed in hepatic or renal assessments in clinical studies. 
Nisu opažene klinički značajne promjene u pretragama jetre ili bubrega u kliničkim ispitivanjima.
The film-coated tablets can be taken with or without food. 
Filmom obložene tablete se mogu uzeti sa ili bez hrane.
Vortioxetine had no effect on rat fertility, mating performance, reproductive organs, or sperm morphology and motility. 
Vortioksetin nije imao učinka na plodnost štakora, sposobnost parenja, reproduktivne organe ili morfologiju i pokretljivost sperme.
Vortioxetine separated from placebo statistically with results of 8.0 for vortioxetine versus 5.1 points for placebo (p=0.0003). 
Vortioksetin se statistički odvojio od placeba s rezultatima 8,0 bodova za vortioksetin naspram 5,1 bod za placebo (p=0,0003).
Pack sizes of 100 and 200 film-coated tablets. 
Veličine pakiranja od 100 i 200 filmom obloženih tableta.
Most cases were a combination of airway and skin symptoms. 
Većinu su slučajeva sačinjavale kombinacije simptoma vezanih uz dišne puteve i kožu.
Each bottle contains 15 ml Brintellix oral drops, solution. 
Svaka boca sadrži 15 ml Brintellixa oralnih kapi, otopine.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Brintellix treatment taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 
Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja Brintellixom, uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
Ingestion of vortioxetine in clinical trials in the dose range of 40 mg to 75 mg has caused an aggravation of the following adverse reactions: nausea, postural dizziness, diarrhoea, abdominal discomfort, generalised pruritus, somnolence and flushing. 
Primjena vortioksetina u kliničkim ispitivanjima u rasponu doze od 40 mg do 75 mg prouzročila je pogoršanje sljedećih nuspojava: mučnine, posturalne omaglice, proljeva, abdominalne nelagode, generaliziranog pruritusa, somnolencije i navale crvenila.
When adjusting for the change in MADRS the total score in the meta-analysis of the same studies showed that vortioxetine separated from placebo (p<0.05) with a standardised effect size of 0.24. 
Pri prilagodbi za promjenu u MADRS-u, ukupni rezultat u meta analizi istih ispitivanja pokazao je da se vortioksetin odvojio od placeba (p<0,05) sa standardiziranom veličinom učinka od 0,24.
The efficacy of vortioxetine (5-20 mg/day) in patients with MDD has been investigated in 2 adult and 1 elderly short-term, placebo-controlled studies. 
Djelotvornost vortioksetina (5-20 mg/dan) u bolesnika s MDD-om je ispitivana u 2 kratkoročna placebom kontrolirana ispitivanja u odraslih i 1 kratkoročnom placebom kontroliranom ispitivanju u starijih osoba.
Your doctor will make a decision on whether you should stop breast-feeding, or stop using Brintellix taking into account the benefit of breast-feeding for your child, and the benefit of therapy for you. 
Vaš će liječnik odlučiti da li morate prekinuti dojenje ili prekinuti uzimanje Brintellixa uzimajući u obzir korist dojenja za dijete i korist liječenja za Vas.
Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving a medicinal product from related pharmacological classes of antidepressants (SSRIs or TCAs). 
Epidemiološka ispitivanja, uglavnom provedena u bolesnika u dobi od 50 godina i starijih, pokazuju povećan rizik od prijeloma kostiju u bolesnika koji primaju lijekove iz srodne farmakološke skupine antidepresiva (SSRI ili tricikličke antidepresive (TCA)).
This syndrome may be associated with hallucinations, involuntary twitching, accelerated heartbeat, high blood pressure, fever, nausea and diarrhoea. 
Ovaj sindrom može biti povezan s halucinacijama, nevoljnim trzanjem mišića, ubrzanim otkucajima srca, visokim krvnim tlakom, vrućicom, mučninom i proljevom.
Concomitant use with nonselective monoamine oxidase inhibitors (MAOIs) or selective MAO-A inhibitors (see section 4.5). 
Istodobna primjena s neselektivnim inhibitorima monoaminooksidaze (MAOI) ili sa selektivnim MAO-A inhibitorima (vidjeti dio 4.5).
- Based upon the review of a signal for rash, a plausible temporal relationship was concluded in several post-marketing cases reported (74% of reported time to onset was within one week and 93% was within one month), including cases with positive de- or re-challenge (respectively 135 and 8 cases). 
U sklopu ocjene signala osipa, vremenska povezanost nekoliko slučajeva prijavljenih nakon stavljanja lijeka u promet ocijenjena je kao vjerojatna (vremenski okvir do nastupa u 74% slučajeva bio je tjedan dana, a u 93% slučajeva mjesec dana), uključujući i slučajeve s pozitivnim dechallenge-om ili rechallenge-om (135, odnosno 8 slučajeva).
In studies using the Arizona Sexual Experience Scale (ASEX), the incidence of treatment-emergent sexual dysfunction (TESD) and the ASEX total score showed no clinically relevant difference to placebo in symptoms of sexual dysfunction at the 5 to 15 mg/day doses of vortioxetine. 
Arizona Sexual Experience Scale, (ASEX)), incidencija spolne disfunkcije koja se javila tijekom liječenja te ukupni rezultat ASEX-a, nisu pokazali klinički relevantne razlike u odnosu na placebo po pitanju simptoma spolne disfunkcije pri dozama vortioksetina od 15 mg/dan.
Patients in remission after an initial 12-week open-label treatment period with vortioxetine were randomised to vortioxetine 5 or 10 mg/day or placebo and observed for relapse during a double-blind period of at least 24 weeks (24 to 64 weeks). 
Bolesnici koji su bili u remisiji nakon početnog razdoblja otvorenog liječenja vortioksetinom od 12 tjedana bili su randomizirani da prime vortioksetin 5 ili 10 mg/dan ili placebo te su praćeni zbog moguće pojave relapsa tijekom dvostruko slijepog razdoblja od najmanje 24 tjedna (24 do 64 tjedana).
Interactions in CYP2D6 poor metabolisers 
Interakcije u slabih metabolizatora CYP2D6
The effect in the individual studies was supported by the meta-analysis (MMRM) of the mean change from baseline in MADRS total score at Week 6/8 in the short-term, placebo-controlled studies in adults. 
Učinak u pojedinačnim ispitivanjima je podržana meta analizom (MMRM) srednje promjene od početnih vrijednosti na ukupnom rezultatu MADRS-a u 6/8 tjednu u kratkoročnim, placebo kontroliranim ispitivanjima u odraslih.
Vortioxetine was not teratogenic in rats or rabbits, but reproductive toxicity in terms of effects on foetal weight and delayed ossification were seen in the rat at exposures more than 10-fold the human exposure at the maximum recommended therapeutic dose of 20 mg/day. 
Vortioksetin nije bio teratogen u štakora ili zečeva, ali bila je opažena reproduktivna toksičnost u pogledu učinaka na fetalnu težinu i odgođeno okoštavanje u štakora kod izloženosti koja je 10 puta veća od izloženosti ljudi pri maksimalnim preporučenim terapeutskim dozama od 20 mg dnevno.
For elderly people 65 years of age or older, the starting dose is 5 mg vortioxetine taken once daily. 
Za starije osobe u dobi 65 godina ili starije, početna doza je 5 mg vortioksetina koja se uzima jednom dnevno.
No significant effects, relative to placebo, were observed in the levels of sex hormones following co-administration of vortioxetine with a combined oral contraceptive (ethinyl estradiol 30 µg/ levonorgestrel 150 µg). 
Nisu bili opaženi značajni učinci na nivo spolnih hormona u usporedbi s placebom, nakon istodobne primjene vortioksetina i kombinacije oralnih kontraceptiva (etinil estradiol 30 µg/levonorgestrel 150 µg).
The European Medicines Agency has deferred the obligation to submit the results of studies in major depressive disorder with vortioxetine in children and adolescents aged 7 to 18 years (see section 4.2 for information on paediatric use). 
Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka vortioksetin kod velike depresivne epizode u djece i adolescenata u dobi od 7 do 18 godina (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni)
In a pre- and post-natal study in rats, vortioxetine was associated with increased pup mortality, reduced bodyweight gain, and delayed pup development at doses that did not result in maternal toxicity and with associated exposures similar to those achieved in humans following administration of vortioxetine 20 mg/day (see section 4.6). 
U prenatalnom i postnatalnom ispitivanju u štakora vortioksetin je povezan s povećanom smrtnošću mladunčadi, smanjenim prirastom tjelesne težine te odgođenim razvojem mladunčadi pri dozama koje nisu rezultirale maternalnom toksičnošću te s povezanim izloženostima sličnim onima postignutima u ljudi nakon primjene vortioksetina 20 mg/dan (vidjeti dio 4.6).
Twelve double-blind, placebo-controlled, 6/8-week, fixed-dose studies have been conducted to investigate the short-term efficacy of vortioxetine in MDD in adults (including the elderly). 
Provedeno je dvanaest dvostruko slijepih placebom kontroliranih, 6/8 tjednih ispitivanja fiksnih doza kako bi se istražila kratkoročna djelotvornost vortioksetina kod MDD-a u odraslih (uključujući starije osobe).
The most common adverse reaction was nausea. 
Najčešća nuspojava bila je mučnina.
You may be more likely to think like this if you: - have previously had thoughts about killing or harming yourself. 
Možda ćete biti skloniji takvim mislima ako: - ste prije imali misli o samoozljeđivanju ili samoubojstvu. - ste mlada odrasla osoba.
Lithium, tryptophan 
Litij, triptofan
- tramadol (a strong painkiller). 
- tramadol (snažni lijek protiv bolova).
Vortioxetine did not separate from placebo on subjective measures when evaluated using the Cognitive and Physical Functioning Questionnaire with results of -8.1 for vortioxetine versus -6.9 for placebo (p=0.086). 
Vortioksetin se nije odvojio od placeba u subjektivnim mjerilima, procijenjeno korištenjem Upitnika za kognitivno i fizičko funkcioniranje, s rezultatima od -8,1 za vortioksetin naspram -6,9 za placebo (p=0,086).
H. Lundbeck A/S Tel: +45 36301311(Danija) lietuva@lundbeck.com 
Lundbeck A/S Tel: +45 36301311(Danija) lietuva@lundbeck.com
- warfarin, dipyridamole, phenprocoumon, low-dose acetylsalicylic acid (blood thinning medicines). 
varfarin, dipiridamol, fenprokumon, niske doze acetilsalicilne kiseline (lijekovi za razrjeđivanje krvi).
Lot See embossed stamp. 
Vidjeti otisnuti žig.
Depending on individual patient response, a dose adjustment may be considered (see section 4.2). 
Može se razmotriti prilagodba doze ovisno o individualnom odgovoru bolesnika (vidjeti dio 4.2).
Brintellix 5 mg film-coated tablets Brintellix 10 mg film-coated tablets Brintellix 15 mg film-coated tablets Brintellix 20 mg film-coated tablets 
Brintellix 5 mg filmom obložene tablete Brintellix 10 mg filmom obložene tablete Brintellix 15 mg filmom obložene tablete Brintellix 20 mg filmom obložene tablete
Haemorrhage (including contusion, ecchymosis, epistaxis, gastrointestinal or vaginal bleeding) 
Krvarenje (uključujući kontuziju, ekhimozu, epistaksu, gastrointestinalno ili vaginalno krvarenje)
How to take Brintellix 
Kako uzimati Brintellix
In the meta-analyses (ANCOVA, LOCF) of the mean change from baseline in DSST number of correct symbols in all 3 studies, vortioxetine separated from placebo (p<0.05) with a standardised effect size of 0.35. 
U meta analizama (ANCOVA, LOCF) srednje promjene od početnih vrijednosti u broju točnih simbola DSST-a u sva 3 ispitivanja, vortioksetin se odvojio od placeba (p<0,05) sa standardiziranom veličinom učinka od 0,35.
- The active substance is vortioxetine. 
- Djelatna tvar je vortioksetin.
In one study, vortioxetine was superior to placebo on subjective measures, evaluated using the Perceived Deficits Questionnaire with results of -14.6 for vortioxetine and -10.5 for placebo (p=0.002). 
U jednom ispitivanju vortioksetin je bio superioran placebu u subjektivnim mjerilima, procijenjeno korištenjem Upitnika za primijećene deficite, s rezultatima od -14,6 za vortioksetin i -10,5 za placebo (p=0,002).
2D barcode carrying the unique identifier included. 
17. JEDINSTEVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom.
Suomi/Finland 
Suomi/Finland Oy H.
Co-administration of strong inhibitors of CYP3A4 (such as itraconazol, voriconazole, clarithromycin, telithromycin, nefazodone, conivaptan and many of the HIV protease inhibitors) and inhibitors of CYP2C9 (such as fluconazole and amiodarone) to CYP2D6 poor metabolisers (see section 5.2) has not been investigated specifically, but it is anticipated that it will lead to a more marked increased exposure of vortioxetine in these patients as compared to the moderate effect described above. 
Istodobna primjena snažnih CYP3A4 inhibitora (kao što su itrakonazol, vorikonazol, klaritromicin, telitromicin, nefazodon, konivaptan i mnogi od inhibitora HIV proteaze) i CYP2C9 inhibitora (kao što su flukonazol i amiodaron) kod slabih metabolizatora CYP2D6 (vidjeti dio 5.2) nije posebno ispitivana, ali se predviđa da će to dovesti do značajnijeg povećanja izloženosti ovih bolesnika vortioksetinu u usporedbi s umjerenim učinkom opisanim iznad.
Based on the above, it was considered that anaphylactic reaction should be included as an adverse drug reaction in the product information of vortioxetine. 
Na temelju navedenog smatra se da anafilaktička reakcija treba biti navedena kao nuspojava u informacijama o lijeku za vortioksetin.
For doses of 20 mg vortioxetine once daily, the incidences of nausea and constipation were higher in patients aged ≥65 years (42% and 15%, respectively) than in patients aged <65 years (27% and 4%, respectively)(see section 4.4). 
Incidencija mučnine i konstipacije kod doza od 20 mg vortioksetina jednom dnevno je bila viša kod bolesnika u dobi ≥ 65 godina (42% odnosno 15%) nego kod bolesnika u dobi < 65 godina (27% odnosno 4%) (vidjeti dio 4.4).
The starting and recommended dose of Brintellix is 10 mg vortioxetine once daily in adults less than 65 years of age. 
Početna i preporučena doza Brintellixa je 10 mg vortioksetina jednom dnevno u odraslih osoba u dobi manjoj od 65 godina.
Your doctor will treat you cautiously if you have a history of fits or have unstable fit disorders/epilepsy. 
Vaš liječnik će Vas liječiti oprezno ako imate napadaje ili nestabilni poremećaj s napadajima/epilepsiju u povijesti bolesti.
Following a single dose of 10 mg vortioxetine, no impact of mild or moderate hepatic impairment (Child-Pugh Criteria A or B; n=8 per group) was observed on the pharmacokinetics of vortioxetine (changes in AUC were less than 10%). 
Nakon jedne doze vortioksetina od 10 mg, nije opažen utjecaj blagog ili umjerenog oštećenja jetre (Child-Pugh kriteriji A ili B; n=8 po skupini) na farmakokinetiku vortioksetina (promjene u AUC-u bile su manje od 10%).
20 mg corresponding to 20 drops. 
20 mg odgovara 20 kapi.
However, by recommended patient usage vortioxetine is considered to pose negligible risk to the aquatic and terrestrial environment (see section 
Međutim, smatra se da vortioksetin pri preporučenoj primjeni kod bolesnika predstavlja zanemariv rizik za vodeni i zemljani okoliš (vidjeti dio 6.6).
Post-marketing experience mainly concerns vortioxetine overdoses of up to 80 mg. 
Razdoblje nakon stavljanja lijeka u promet uglavnom se odnosi na predoziranje vortioksetinom do 80 mg.
The European Medicines Agency has waived the obligation to submit the results of studies in major depressive disorder with vortioxetine in children aged less than 7 years (see section 4.2 for information on paediatric use). 
Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka vortioksetin kod velike depresivne epizode u djece mlađe od 7 godina (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
There is limited experience with vortioxetine overdoses above 80 mg. 
Iskustvo s predoziranjem vortioksetinom iznad 80 mg je ograničeno.
Additionally, the class warning on haemorrhage should be updated, to add that haemorrhage has been reported with vortioxetine as well. 
Nadalje, potrebno je ažurirati upozorenje vezano uz skupinu te u njega dodati da je krvarenje prijavljeno i za vortioksetin.
No inhibitory effect of 40 mg single-dose omeprazole (CYP2C19 inhibitor) was observed on the multiple-dose pharmacokinetics of vortioxetine in healthy subjects. 
Nije opažen inhibitorni učinak jedne doze od 40 mg omeprazola (inibitor CYP2C19) na farmakokinetiku višekratnih doza vortioksetina u zdravih ispitanika.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER FOR TABLETS 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER ZA TABLETE
The changes in the kidney in rats (glomerulonephritis, renal tubular obstruction, crystalline material in renal tubule) and in the liver of mice and rats (hepatocellular hypertrophy, hepatocyte necrosis, bile duct hyperplasia, crystalline material in bile ducts) were seen at exposures more than 10-fold (mice) and 2-fold (rats) the human exposure at the maximum recommended therapeutic dose of 20 mg/day. 
Opažene su promjene na bubrezima u štakora (glomerulonefritis, opstrukcija bubrežnih tubula, kristalični materijal u bubrežnim tubulima) i promjene na jetri u miševa i štakora (hepatocelularna hipertrofija, nekroza hepatocita, hiperplazija žučovoda, kristalični materijal u žučovodu) kod izloženosti koja je veća 10 puta (miševi) i 2 puta (štakori) od izloženosti ljudi pri maksimalnim preporučenim terapeutskim dozama od 20 mg dnevno.
These findings were mainly attributed to rodent-specific vortioxetine-related crystalline material obstruction of the renal tubules and the bile ducts, respectively, and considered of low risk to humans. 
Ova otkrića su uglavnom pripisivana opstrukciji bubrežnih tubula i žučnih vodova kristaličnom tvari specifičnom za glodavce i povezanom s vortioksetinom, te se smatraju niskim rizikom za ljude.
Irreversible, selective MAO-B inhibitor (selegiline, rasagiline) Although a lower risk of serotonin syndrome is expected with selective MAO-B inhibitors than with MAO-A inhibitors, the combination of vortioxetine with irreversible MAO-B inhibitors, such as selegiline or rasagiline should be administered with caution. 
Iako se sa selektivnim MAO-B inhibitorima očekuje manji rizik od serotoninskog sindroma nego s MAO-A inhibitorima, kombinaciju vortioksetina s ireverzibilnim MAO-B inhibitorima, poput selegilina ili razagilina, treba primjenjivati s oprezom.
Therefore, vortioxetine should be introduced cautiously in patients who have a history of seizures or in patients with unstable epilepsy (see section 4.5). 
Stoga liječenje vortioksetinom treba započeti oprezno u bolesnika s anamnezom napadaja ili u bolesnika s nestabilnom epilepsijom (vidjeti dio 4.5).
In the meta-analysis, the overall mean difference to placebo across the studies was statistically significant: -2.3 points (p = 0.007), -3.6 points (p <0.001), and -4.6 points (p <0.001) for the 5, 10, and 20 mg/day doses, respectively; the 15 mg/day dose did not separate from placebo in the meta-analysis, but the mean difference to placebo was -2.6 points. 
U meta analizama, ukupna srednja razlika od placeba kroz ispitivanja je bila statistički značajna: -2,3 boda (p=0,007), -3,6 bodova (p < 0,001 i -4,6 bodova (p < 0,001) za doze od 5, 10 odnosno 20 mg dnevno; doza od 15 mg dnevno se nije udaljila od placeba u meta analizi, ali je razlika od placeba bila -2,6 bodova.
In clinical studies, sexual dysfunction was assessed using the Arizona Sexual Experience Scale (ASEX). 
U kliničkim ispitivanjima je spolna disfunkcija bila ocjenjena Arizona ljestvicom spolnog iskustva (engl.
No effect on the pharmacokinetics of vortioxetine or ethanol and no significant impairment, relative to placebo, in cognitive function were observed when vortioxetine in a single dose of 20 mg or 40 mg was co-administered with a single dose of ethanol (0.6 g/kg) in healthy subjects. 
Nije bio opažen učinak na farmakokinetiku vortioksetina ili alkohola kao ni značajno pogoršanje kognitivne funkcije u usporedbi s placebom, kada su pojedinačne doze vortioksetina od 20 mg ili 40 mg bile istodobno primjenjene s pojedinačnom dozom etanola (0,6 g/kg) u zdravih ispitanika.
The exposure to vortioxetine increased 2.3-fold for area under the curve (AUC) when vortioxetine 10 mg/day was co-administered with bupropion (a strong CYP2D6 inhibitor 150 mg twice daily) for 14 days in healthy subjects. 
Izloženost vortioksetinu povećala je površinu ispod krivulje (AUC) 2,3 puta kada je vortioksetin 10 mg/dan bio istodobno primijenjen s bupropionom (snažnim inhibitorom CYP2D6 150 mg dvaput dnevno) tijekom 14 dana u zdravih ispitanika.
The combination of vortioxetine with a weak reversible and non-selective MAOI, such as the antibiotic linezolid, is contraindicated (see section 4.3). 
Kontraindicirana je kombinacija vortioksetina i slabog reverzibilnog i neselektivnog MAOI-a kao što je antibiotik linezolid (vidjeti dio 4.3).
- if you are taking other medicines for depression known as non-selective monoamine oxidase inhibitors or selective MAO-A inhibitors. 
- ako uzimate druge lijekove za depresiju, kao što su neselektivni inhibitori monoaminooksidaze ili selektivni MAO-A inhibitori.
Depending on individual patient response, a lower dose of vortioxetine may be considered if a strong inhibitor of CYP3A4 or CYP2C9 is co-administered in CYP2D6 poor metabolisers. 
Ovisno o individualnom odgovoru bolesnika, može se razmotriti niža doza vortioksetina ako će se snažni inhibitor CYP3A4 ili CYP2C9 istodobno primijeniti kod slabih metabolizatora CYP2D6.
In elderly healthy subjects (aged ≥65 years; n=20), the exposure to vortioxetine increased up to 27% (Cmax and AUC) compared to young healthy control subjects (aged ≤45 years) after multiple doses of 
U starijih zdravih ispitanika (u dobi ≥65 godina; n=20), izloženost vortioksetinu povećala se do 27% (Cmax i AUC) u usporedbi s mladim zdravim kontrolnim ispitanicima (u dobi ≤45 godina) nakon višekratnih doza od 10 mg/dan.
Do not use this medicine after the expiry date that is stated on the packaging after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju iza oznake „Rok valjanosti“ ili kratice „EXP“.
In clinical studies in children and adolescents treated with other antidepressants, suicide-related behaviour (suicide attempt and suicidal thoughts) and hostility (predominantly aggression, oppositional behaviour, anger) were more frequently observed than in those treated with placebo. 
U kliničkim ispitivanjima češće je opaženo ponašanje povezano sa samoubojstvom (pokušaj samoubojstva i suicidalne misli) i netrpeljivost (najviše agresija, opozicijsko ponašanje, bijes) u djece i adolescenata liječenih drugim antidepresivima, nego u onih koji su primali placebo.