FrancophonIA/ELRC3.0 huggingface dataset:
English: • If you take Duloxetine Zentiva near the end of your pregnancy there is an increased risk of excessive vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders.
Croatian: • Ako uzimate Duloxetine Zentiva pred kraj trudnoće, postoji povećan rizik od prekomjernog vaginalnog krvarenja ubrzo nakon poroda, osobito ako u povijesti bolesti imate poremećaje krvarenja.
English: • have had mania;
Croatian: • ako ste imali maniju
English: • problems getting an erection, changes in ejaculation;
Croatian: • otežano postizanje erekcije, promjene u ejakulaciji
English: What Duloxetine Zentiva is and what it is used for What you need to know before you take Duloxetine Zentiva How to take Duloxetine Zentiva Possible side effects
Croatian: Što je Duloxetine Zentiva i za što se koristi Što morate znati prije nego počnete uzimati Duloxetine Zentiva Kako uzimati Duloxetine Zentiva Moguće nuspojave
English: Despite this, your doctor may prescribe Duloxetine Zentiva for patients under 18 because he/she decides that this is in their best interests.
Croatian: Ipak, Vaš liječnik može propisati Duloxetine Zentiva bolesnicima mlađima od 18 godina ako procijeni da je to u njihovu najboljem interesu.
English: Duloxetine should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Croatian: Duloksetin se u trudnoći smije uzimati samo ako moguća korist liječenja opravdava mogući rizik za plod.
English: • tinnitus (hearing sound in the ear when there is no external sound);
Croatian: • zujanje/zvonjava u ušima (doživljaj zvuka u ušima kada nema vanjskog zvuka)
English: Duloxetine was studied in a clinical programme involving 3,158 patients (1,285 patient-years of exposure) meeting DSM-IV criteria for major depression.
Croatian: Duloksetin je ispitan u kliničkom programu koji je obuhvatio 3158 bolesnika (1285 bolesnik-godina izloženosti) koji su zadovoljavali DSM-IV kriterije za veliki depresivni poremećaj.
English: How to store Duloxetine Zentiva Contents of the pack and other information
Croatian: Kako čuvati Duloxetine Zentiva Sadržaj pakiranja i druge informacije
English: • have a history of bleeding disorders (tendency to develop bruises), especially if you are pregnant (see ‘Pregnancy and breast-feeding‘);
Croatian: • ako u povijesti bolesti imate poremećaje krvarenja (sklonost pojavi modrica), osobito ako ste trudni (pogledajte dio „Trudnoća i dojenje“)
English: − Titanium dioxide (E171)
Croatian: − titanijev dioksid (E171)
English: Duloxetine Zentiva starts to work in most people with depression or anxiety within two weeks of starting treatment, but it may take 2-4 weeks before you feel better.
Croatian: U većine osoba s depresijom ili tjeskobom Duloxetine Zentiva počinje djelovati unutar dva tjedna nakon početka liječenja, ali može biti potrebno 2-4 tjedna prije nego što se počnete osjećati bolje.
English: As with other medicinal products with similar pharmacological action (antidepressants), isolated cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation.
Croatian: Kao i kod drugih lijekova sa sličnim farmakološkim djelovanjem (antidepresivi), prijavljeni su izolirani slučajevi suicidalnih misli i suicidalnog ponašanja tijekom liječenja duloksetinom ili ubrzo nakon prekida liječenja.
English: The elimination half-life of duloxetine ranges from 8 to 17 hours (mean of 12 h).
Croatian: Poluvrijeme eliminacije duloksetina kreće se u rasponu od 8 do 17 sati (srednja vrijednost 12 sati).
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim ažuriranim verzijama RMPa-.
English: However, as with any medicine, caution should be exercised when treating the elderly, especially with duloxetine 120 mg per day for major depressive disorder or generalised anxiety disorder, for which data are limited (see sections 4.4 and 5.2).
Croatian: Međutim, kao i kod svih drugih lijekova, mora se s oprezom liječiti starije osobe, osobito kada se primjenjuje duloksetin u dozi od 120 mg dnevno za liječenje velikog depresivnog poremećaja ili generaliziranog anksioznog poremećaja, za što su podaci ograničeni (vidjeti dijelove 4.4 i 5.2).
English: • Duloxetine Zentiva may cause effects that you may not be aware of, such as increases in liver enzymes or blood levels of potassium, creatine phosphokinase, sugar, or cholesterol.
Croatian: • Duloxetine Zentiva može uzrokovati nuspojave kojih možda i niste svjesni, poput povišenih vrijednosti jetrenih enzima ili povišene koncentracije kalija, kreatin fosfokinaze, šećera ili kolesterola u krvi
English: Excipient(s) with known effect: each capsule contains 84.51 - 93.14 mg of sucrose.
Croatian: Pomoćne tvari s poznatim učinkom: jedna kapsula sadrži 84,51 - 93,14 mg saharoze.
English: Anticoagulants and antiplatelet agents
Croatian: Antikoagulansi i antitrombotici
English: Population pharmacokinetic analyses have shown that smokers have almost 50% lower plasma concentrations of duloxetine compared with non-smokers.
Croatian: Populacijske farmakokinetičke analize pokazale su da su u pušača koncentracije duloksetina u plazmi gotovo 50% niže nego u nepušača.
English: Do not stop taking Duloxetine Zentiva, or change your dose, without talking to your doctor.
Croatian: Nemojte prestati uzimati Duloxetine Zentiva niti mijenjati dozu lijeka a da se prethodno niste posavjetovali sa svojim liječnikom.
English: Opaque PVC/PCTFE/Alu blisters, paper folding box.
Croatian: Neprozirni PVC/PCTFE/Al blisteri, složiva kartonska kutija.
English: Paediatric population Duloxetine has not been studied in patients under the age of 7.
Croatian: Pedijatrijska populacija Duloksetin nije ispitivan u bolesnika mlađih od 7 godina.
English: Hyponatraemia may be due to a syndrome of inappropriate anti-diuretic hormone secretion (SIADH).
Croatian: Hiponatrijemija može biti uzrokovana sindromom neprikladnog izlučivanja antidiuretskog hormona (engl. syndrome of inappropriate anti-diuretic hormone secretion, SIADH).
English: Medicines like Duloxetine Zentiva (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4).
Croatian: Lijekovi poput Duloxetine Zentiva (takozvani SSRI-ovi/SNRI-ovi) mogu uzrokovati simptome poremećaja seksualne funkcije (vidjeti dio 4).
English: Antacids and H2 antagonists
Croatian: Antacidi i antagonisti H2 receptora
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D.
English: The co-administration of duloxetine (40 mg twice daily) increases steady state AUC of tolterodine (2 mg twice daily) by 71 %, but does not affect the pharmacokinetics of its active 5hydroxyl metabolite and no dosage adjustment is recommended.
Croatian: Istodobna primjena duloksetina (40 mg dvaput dnevno) povećava AUC tolterodina (2 mg dvaput dnevno) u stanju dinamičke ravnoteže za 71%, ali ne utječe na farmakokinetiku njegova aktivnog 5-hidroksil metabolita pa se prilagodba doze ne preporučuje.
English: • night sweats, hives, cold sweats, sensitivity to sunlight, increased tendency to bruise;
Croatian: • noćno znojenje, koprivnjača, hladan znoj, osjetljivost na sunčevu svjetlost, povećana sklonost nastanku modrica
English: What you need to know before you take Duloxetine Zentiva
Croatian: Što morate znati prije nego počnete uzimati Duloxetine Zentiva
English: • Monoamine oxidase inhibitors (MAOIs): You should not take Duloxetine Zentiva if you are taking, or have recently taken (within the last 14 days) another antidepressant medicine called a monoamine oxidase inhibitor (MAOI).
Croatian: • inhibitore monoaminooksidaze (MAOI): Ne smijete uzimati Duloxetine Zentiva ako uzimate ili ste nedavno (u posljednjih 14 dana) uzimali drugi antidepresiv koji se naziva inhibitorom monoaminooksidaze (MAOI).
English: Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of duloxetine in this age group have not yet been demonstrated.
Croatian: Nadalje, dugoročni sigurnosni učinci duloksetina na rast, sazrijevanje te intelektualni razvoj i razvoj ponašanja nisu još dokazani u ovoj dobnoj skupini.
English: Other medicines and Duloxetine Zentiva
Croatian: Drugi lijekovi i Duloxetine Zentiva
English: • Make sure your midwife and/or doctor knows you are on Duloxetine Zentiva.
Croatian: • Budite sigurni da primalja i/ili liječnik znaju da uzimate Duloxetine Zentiva.
English: However, concomitant administration of duloxetine with warfarin under steady state conditions, in healthy volunteers, as part of a clinical pharmacology study, did not result in a clinically significant change in INR from baseline or in the pharmacokinetics of R- or Swarfarin.
Croatian: Međutim, istodobna primjena duloksetina s varfarinom u stanju dinamičke ravnoteže u zdravih dobrovoljaca, u okviru kliničkog farmakološkog ispitivanja, nije rezultirala klinički značajnom promjenom INR-a u odnosu na početne vrijednosti, kao ni farmakokinetike R- ili S-varfarina.
English: Duloxetine is a moderate inhibitor of CYP2D6.
Croatian: Duloksetin je umjereni inhibitor CYP2D6.
English: You should use Duloxetine Zentiva only after discussing the potential benefits and any potential risks to your unborn child with your doctor.
Croatian: Smijete uzimati Duloxetine Zentiva tek nakon što razgovarate s liječnikom o mogućim koristima i rizicima za nerođeno dijete.
English: − Yellow iron oxide (E172)
Croatian: − željezov oksid, žuti (E172)
English: Both cytochromes P450-2D6 and 1A2 catalyse the formation of the two major metabolites glucuronide conjugate of 4-hydroxy duloxetine and sulphate conjugate of 5-hydroxy 6-methoxy duloxetine.
Croatian: Citokromi P450 2D6 i 1A2 kataliziraju stvaranje dvaju glavnih metabolita, glukuronidnog konjugata 4-hidroksi duloksetina i sulfatnog konjugata 5-hidroksi 6-metoksi duloksetina.
English: Use in children and adolescents under 18 years of age Duloxetine should not be used in the treatment of children and adolescents under the age of 18 years.
Croatian: Primjena u djece i adolescenata mlađih od 18 godina Duloksetin se ne smije primjenjivati u liječenju djece i adolescenata mlađih od 18 godina.
English: Excipient(s) with known effect: each capsule contains 42.26 - 46.57 mg of sucrose.
Croatian: Pomoćne tvari s poznatim učinkom: jedna kapsula sadrži 42,26 - 46,57 mg saharoze.
English: Do not use this medicine after the expiry date which is stated on the carton/blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji/blisteru iza oznake 'Rok valjanosti' ili 'EXP'.
English: Because CYP1A2 is involved in duloxetine metabolism, concomitant use of duloxetine with potent inhibitors of CYP1A2 is likely to result in higher concentrations of duloxetine.
Croatian: Budući da CYP1A2 sudjeluje u metabolizmu duloksetina, istodobna primjena duloksetina s potentnim inhibitorima CYP1A2 vjerojatno će dovesti do povišenih koncentracija duloksetina.
English: Care should be taken if you drink alcohol while you are being treated with Duloxetine Zentiva.
Croatian: Budite oprezni ako pijete alkohol dok se liječite lijekom Duloxetine Zentiva.
English: • Medicines that cause sleepiness: These include medicines prescribed by your doctor including benzodiazepines, strong painkillers, antipsychotics, phenobarbital and antihistamines.
Croatian: • lijekove koji izazivaju pospanost: Tu se ubrajaju lijekovi koje Vam je propisao liječnik, uključujući benzodiazepine, jake lijekove protiv bolova, antipsihotike, fenobarbital i antihistaminike.
English: Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
Croatian: Podaci iz kliničkih ispitivanja pokazali su povećan rizik od samoubilačkog ponašanja u odraslih koji su mlađi od 25 godina, a zbog psihijatrijskih stanja su liječeni antidepresivima.
English: Dehydration Hyponatraemia SIADH6
Croatian: dehidracija hiponatrijemija SIADH6
English: Your doctor should decide whether you can take Duloxetine Zentiva with other medicines.
Croatian: Liječnik mora donijeti odluku o tome smijete li uzimati Duloxetine Zentiva s drugim lijekovima.
English: Duloxetine Zentiva is used in adults to treat:
Croatian: Duloxetine Zentiva se primjenjuje u odraslih za liječenje:
English: As the safety of duloxetine in infants is not known, the use of duloxetine while breast-feeding is not recommended.
Croatian: Budući da sigurnost primjene duloksetina u dojenčadi nije poznata, ne preporučuje se primjena duloksetina u dojilja.
English: • feeling the heart pumping in the chest;
Croatian: • osjećaj lupanja srca u prsnom košu
English: Due to the risk of serotonin syndrome, duloxetine should not be used in combination with non-selective irreversible monoamine oxidase inhibitors (MAOIs), or within at least 14 days of discontinuing treatment with an MAOI.
Croatian: Zbog rizika od serotoninskog sindroma duloksetin se ne smije uzimati u kombinaciji s neselektivnim ireverzibilnim inhibitorima monoaminooksidaze (MAOI) niti najmanje 14 dana nakon prekida liječenja inhibitorima MAO.
English: Duloxetine Zentiva is indicated in adults.
Croatian: Duloxetine Zentiva je indiciran u odraslih.
English: Talk with your doctor about how long you should keep taking Duloxetine Zentiva.
Croatian: Razgovarajte s liječnikom o tome koliko dugo trebate uzimati Duloxetine Zentiva.
English: Duloxetine Zentiva may cause a sensation of restlessness or an inability to sit or stand still.
Croatian: Duloxetine Zentiva može izazvati osjećaj nemira ili nemogućnost mirnog sjedenja ili stajanja.
English: Duloxetine Zentiva increases the levels of serotonin and noradrenaline in the nervous system.
Croatian: Duloxetine Zentiva povećava razinu serotonina i noradrenalina u živčanom sustavu.
English: • are taking St. John's Wort, a herbal treatment (Hypericum perforatum);
Croatian: • ako uzimate biljni lijek gospinu travu (Hypericum perforatum)
English: The usual starting dose of Duloxetine Zentiva is 30 mg once a day after which most patients will receive 60 mg once a day, but your doctor will prescribe the dose that is right for you.
Croatian: Uobičajena početna doza lijeka Duloxetine Zentiva je 30 mg jednom na dan, nakon čega će većina bolesnika primati 60 mg jednom na dan, no liječnik će propisati dozu koja Vama najbolje odgovara.
English: When stopping treatment with Duloxetine Zentiva the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 and 4.8).
Croatian: Kada se liječenje lijekom Duloxetine Zentiva prekida, doza se mora smanjivati postupno tijekom razdoblja od najmanje jednog do dva tjedna kako bi se smanjio rizik od pojave simptoma ustezanja (vidjeti dijelove 4.4 i 4.8).
English: • trouble sleeping, feeling agitated, less sex drive, anxiety, difficulty or failure to experience orgasm, unusual dreams;
Croatian: • tegobe sa spavanjem, uznemirenost, smanjena seksualna želja, tjeskoba, poteškoće ili nemogućnost postizanja orgazma, neuobičajeni snovi
English: Capsule cap: Indigo carmine (E132), titanium dioxide (E171), gelatin Capsule body: yellow iron oxide (E172), titanium dioxide (E171), gelatin
Croatian: Kapica kapsule: indigo karmin (E132), titanijev dioksid (E171), želatina Tijelo kapsule: žuti željezov oksid (E172), titanijev dioksid (E171), želatina
English: • serious allergic reaction which causes difficulty in breathing or dizziness with swollen tongue or lips, allergic reactions;
Croatian: • teška alergijska reakcija koja uzrokuje otežano disanje ili omaglicu te oticanje jezika ili usana,
English: Taking a MAOI together with many prescription medicines, including Duloxetine Zentiva, can cause serious or even life-threatening side effects.
Croatian: Uzimanje inhibitora MAO zajedno s mnogim lijekovima koji se izdaju na recept, uključujući Duloxetine Zentiva, može izazvati ozbiljne, čak i po život opasne nuspojave.
English: • fainting, dizziness, light-headedness or fainting on standing up, cold fingers and/or toes;
Croatian: • nesvjestica, omaglica, ošamućenost ili nesvjestica pri ustajanju, hladni prsti na rukama i/ili nogama
English: The disposition of duloxetine was studied in 6 lactating women who were at least 12-weeks postpartum.
Croatian: Raspoloživost duloksetina ispitana je u 6 dojilja kojima je prošlo najmanje 12 tjedana od poroda.
English: Pack size:
Croatian: Veličine pakiranja:
English: • vomiting blood, or black tarry stools (faeces), gastroenteritis, burping, difficulty swallowing;
Croatian: • povraćanje krvi ili crna katranasta stolica (feces), gastroenteritis, podrigivanje, otežano gutanje
English: Duloxetine should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/or seizures.
Croatian: Duloksetin se mora s oprezom davati bolesnicima s manijom u anamnezi ili s dijagnozom bipolarnog poremećaja i/ili napadaja.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing duloxetine in all subsets of the paediatric population in the treatment of major depressive disorder, diabetic neuropathic pain and generalised anxiety disorder.
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja referentnog lijeka koji sadrži duloksetin u svim podskupinama pedijatrijske populacije u liječenju velikog depresivnog poremećaja, boli kod dijabetičke neuropatije i generaliziranog anksioznog poremećaja.
English: The usual dose of Duloxetine Zentiva is 60 mg once a day, but your doctor will prescribe the dose that is right for you.
Croatian: Uobičajena doza lijeka Duloxetine Zentiva je 60 mg jednom na dan, no liječnik će Vam propisati dozu koja Vama najbolje odgovara.
English: Caution should be exercised when duloxetine is combined with oral anticoagulants or antiplatelet agents due to a potential increased risk of bleeding attributable to a pharmacodynamic interaction.
Croatian: Duloksetin se mora s oprezom kombinirati s oralnim antikoagulansima ili antitrombocitnim lijekovima jer je moguć povećan rizik od krvarenja koji se pripisuje farmakodinamičkoj interakciji.
English: Duloxetine Zentiva is available in 2 strengths: 30 mg and 60 mg.
Croatian: Duloxetine Zentiva dostupan je u 2 jačine: 30 mg i 60 mg.
English: S.C. Zentiva S.A Theodor Pallady Nr 50 032266 Bucharest Romania
Croatian: S.C. Zentiva S.A Theodor Pallady Nr 50 032266 Bukurešt Rumunjska
English: Oral contraceptives and other steroidal agents Results of in vitro studies demonstrate that duloxetine does not induce the catalytic activity of CYP3A.
Croatian: Rezultati ispitivanja in vitro pokazuju da duloksetin ne inducira katalitičku aktivnost CYP3A.
English: • are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI) (see ‘Other medicines and Duloxetine Zentiva');
Croatian: • ako uzimate ili ste u posljednjih 14 dana uzimali drugi lijek koji se zove inhibitor monoaminooksidaze (MAOI) (pogledajte ‘Drugi lijekovi i Duloxetine Zentiva')
English: In rare cases, serotonin syndrome has been reported in patients using SSRIs/SNRIs concomitantly with serotonergic agents.
Croatian: U rijetkim je slučajevima prijavljen serotoninski sindrom u bolesnika koji su uzimali SSRI-je/SNRI-je istodobno sa serotoninergičkim lijekovima.
English: Monoamine oxidase inhibitors (MAOIs)
Croatian: Inhibitori monoaminooksidaze (MAOI)
English: Duloxetine Zentiva should normally not be used for children and adolescents under 18 years.
Croatian: Duloxetine Zentiva u načelu se ne smije primjenjivati u djece i adolescenata mlađih od 18 godina.
English: Each capsule of Duloxetine Zentiva contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid.
Croatian: Jedna Duloxetine Zentiva kapsula sadrži pelete duloksetinklorida s ovojnicom koja ih štiti od želučane kiseline.
English: Based on the half-life of duloxetine, at least 5 days should be allowed after stopping Duloxetine Zentiva before starting an MAOI (see section 4.3).
Croatian: S obzirom na poluvijek duloksetina, mora proći najmanje 5 dana nakon prestanka uzimanja lijeka Duloxetine Zentiva prije započinjanja liječenja inhibitorom MAO (vidjeti dio 4.3).
English: • falls (mostly in elderly people), fatigue;
Croatian: • padovi (najčešće u starijih osoba), umor
English: A total of 467 paediatric patients initially randomized to duloxetine in clinical trials experienced a 0.1 kg mean decrease in weight at 10-weeks compared with a 0.9 kg mean increase in 353 placebotreated patients.
Croatian: U ukupno 467 pedijatrijskih bolesnika koji su u kliničkim ispitivanjima inicijalno randomizirani za primanje duloksetina, zabilježena je srednja vrijednost smanjenja tjelesne težine od 0,1 kg u 10. tjednu, u usporedbi sa srednjom vrijednošću porasta težine od 0,9 kg u 353 bolesnika koja su primala placebo.
English: During the 52-week placebocontrolled double blind treatment phase 14.4% of the duloxetine-treated patients and 33.1% of the placebo-treated patients experience a return of their depressive symptoms (p < 0.001).
Croatian: Tijekom 52 tjedna placebom kontrolirane dvostruko slijepe faze liječenja u 14,4% bolesnika liječenih duloksetinom te u 33,1% bolesnika koji su primali placebo došlo je do povratka simptoma depresije (p<0,001).
English: Manufacturer S.C. Zentiva S.A Theodor Pallady Nr 50 032266 Bucharest Romania
Croatian: Proizvođač S.C. Zentiva S.A Theodor Pallady Nr 50 032266 Bukurešt Rumunjska
English: • coughing, wheezing and shortness of breath which may be accompanied by a high temperature;
Croatian: • kašalj, piskanje pri disanju i nedostatak zraka mogu biti popraćeni visokom temperaturom
English: Talk to your doctor before taking Duloxetine Zentiva if you:
Croatian: Obratite se svom liječniku prije nego uzmete Duloxetine Zentiva:
English: • increased pressure in the eye (glaucoma);
Croatian: • povišen očni tlak (glaukom)
English: Co-administration of duloxetine with aluminium- and magnesium-containing antacids or duloxetine with famotidine had no significant effect on the rate or extent of duloxetine absorption after administration of a 40 mg oral dose.
Croatian: Istodobna primjena duloksetina i antacida koji sadrže aluminij ili magnezij ili duloksetina i famotidina nije značajno utjecala na brzinu ni opseg apsorpcije duloksetina nakon peroralne primjene doze od 40 mg.
English: Capsule cap: Indigo carmine (E132), titanium dioxide (E171), gelatin Capsule body: titanium dioxide (E171), gelatin
Croatian: Kapica kapsule: indigo karmin (E132), titanijev dioksid (E171), želatina Tijelo kapsule: titanijev dioksid (E171), želatina
English: Duloxetine demonstrated statistically significant superiority over placebo in five out of five studies including four randomised, double-blind, placebo-controlled acute studies and a relapse prevention study in adult patients with generalised anxiety disorder.
Croatian: Duloksetin se pokazao statistički značajno superiornim u odnosu na placebo u pet od pet provedenih ispitivanja, od kojih su četiri bila randomizirana, dvostruko slijepa, placebom kontrolirana kratkoročna ispitivanja, a jedno ispitivanje prevencije relapsa u odraslih bolesnika s generaliziranim anksioznim poremećajem.