FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 509 paediatric patients aged 7 to 17 years with major depressive disorder and 241 paediatric patients aged 7 to 17 years with generalised anxiety disorder were treated with duloxetine in clinical trials.
Slovenian: V kliničnih študijah se je z duloksetinom zdravilo 509 pediatričnih bolnikov z veliko depresivno motnjo, starih od 7 do 17 let, in 241 pediatričnih bolnikov z generalizirano anksiozno motnjo, starih od 7 do 17 let.
English: Caution should also be exercised when duloxetine is used with medicinal products that may impair its metabolism (see section 4.5).
Slovenian: Previdnost je potrebna tudi pri uporabi duloksetina z zdravili, ki lahko poslabšajo presnovo (glejte poglavje 4 5).
English: In patients with uncontrolled hypertension duloxetine should not be initiated (see section 4.3).
Slovenian: Duloksetina ne smemo uvesti pri bolnikih z nenadzorovano hipertenzijo (glejte poglavje 4.3).
English: Ελλάδα
Slovenian: (MAOI).
English: Duloxetine Lilly 60 mg to 120 mg once daily demonstrated statistically significant superiority compared to placebo (p<0.001) on the prevention of relapse, as measured by time to relapse.
Slovenian: Zdravljenje z zdravilom Duloksetin Lilly 60 mg do 120 mg enkrat na dan se je izkazalo za statistično značilno boljše v primerjavi s placebom (p < 0,001) pri preprečevanju relapsa, kar so izmerili s časom do relapsa.
English: Angio-neurotic oedema6
Slovenian: angionevrotični edem6
English: In a relapse prevention study, patients responding to 6 months of acute treatment with open-label Duloxetine Lilly were randomised to either Duloxetine Lilly or placebo for a further 6-months.
Slovenian: V študiji preprečevanja relapsa so bolnike, ki so se odzvali na 6-tedensko akutno zdravljenje z znanim zdravilom Duloksetin Lilly, naključno razporedili v skupini, kjer so nadaljnjih 6 mesecev prejemali ali zdravilo Duloksetin Lilly ali placebo.
English: • difficulty or inability to pass urine, difficulty to start urinating, needing to pass urine during the night, needing to pass more urine than normal, having a decreased urine flow
Slovenian: • mišična napetost, mišično trzanje • težave ali nezmožnost odvajanja urina, težave z začetkom uriniranja, potreba po nočnem odvajanju urina, bolj pogosto odvajanje urina, slabši curek urina
English: The heart rate-corrected QT interval in duloxetine-treated patients did not differ from that seen in placebo-treated patients.
Slovenian: QT interval, korigiran s srčno frekvenco, se pri bolnikih, zdravljenih z duloksetinom, ni razlikoval od vrednosti pri bolnikih, ki so prejemali placebo.
English: Duloxetine Lilly 30 mg Duloxetine Lilly 30 mg is available in packs of 7, 28 and 98 hard gastro-resistant capsules.
Slovenian: Duloksetin Lilly 30 mg Zdravilo Duloksetin Lilly 30 mg je na voljo v pakiranjih po 7, 28 in 98 trdih gastrorezistentnih kapsul.
English: • liver failure, yellowing of the skin or whites of the eyes (jaundice)
Slovenian: • odpoved jeter, rumeno obarvanje kože ali beločnice (zlatenica)
English: How to take Duloxetine Lilly
Slovenian: Kako jemati zdravilo Duloksetin Lilly
English: Duloxetine Lilly must not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
Slovenian: Zdravila Duloksetin Lilly pri bolnikih z obolenjem jeter, ki ima za posledico okvarjeno delovanje jeter, ne smemo uporabljati (glejte poglavji 4.3 in 5.2).
English: Thoughts of suicide and worsening of your depression or anxiety disorder If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself.
Slovenian: Pri bolnikih z depresijo in/ali anksiozno motnjo se občasno lahko pojavijo misli na samopoškodovanje ali samomor.
English: Also, you need to wait at least 5 days after you stop taking Duloxetine Lilly before you take a MAOI.
Slovenian: Lilly morate počakati vsaj 5 dni, preden lahko vzamete MAOI.
English: Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on haemodialysis (creatinine clearance <30 ml/min).
Slovenian: Pri bolnikih s hudo okvarjenim delovanjem ledvic na hemodializi (očistek kreatinina < 30 ml/min) se pojavijo povišane plazemske koncentracije duloksetina.
English: The pharmacokinetics of duloxetine and its metabolites have not been studied in patients with mild or severe hepatic insufficiency.
Slovenian: Farmakokinetike duloksetina in njegovih presnovkov pri bolnikih z blago ali hudo okvarjenim delovanjem jeter niso preučevali.
English: Duloxetine Lilly may have a mild to moderate influence on the ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Duloksetin Lilly ima blag do zmeren vpliv na sposobnost vožnje in upravljanja strojev.
English: • fainting, dizziness, lightheadedness or fainting on standing up, cold fingers and/or toes
Slovenian: • omedlevica, omotica, občutek omotičnosti ali omedlevice ob prehitrem vstajanju, občutek mraza v prstih in/ali prstih na nogah • napeto grlo, krvavitve iz nosu
English: EU/1/14/972/008 (100 hard gastro-resistant capsules) (5 packs of 20) EU/1/14/972/009 (500 hard gastro-resistant capsules) (25 packs of 20)
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/14/972/008 (100 trdih gastrorezistentnih kapsul) (5 pakiranj po 20) EU/1/14/972/009 (500 trdih gastrorezistentnih kapsul) (25 pakiranj po 20)
English: • coughing, wheezing and shortness of breath which may be accompanied by a high temperature inflammation of the mouth, passing bright red blood in your stools, bad breath, inflammation of the large intestine (leading to diarrhoea)
Slovenian: • vnetje ust, svetlo rdeča kri v blatu, slab zadah, vnetje debelega črevesa (ki povzroča drisko)
English: Care should be taken if you drink alcohol while you are being treated with Duloxetine Lilly.
Slovenian: Bodite posebej previdni, če med zdravljenjem z zdravilom Duloksetin Lilly pijete alkohol.
English: Anticoagulants and antiplatelet agents: 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.
Slovenian: Antikoagulanti in antitrombotična zdravila: zaradi možnega povečanega tveganja za krvavitev, ki ga lahko pripišemo farmakodinamični interakciji, je potrebna previdnost pri kombinaciji duloksetina s peroralnimi antikoagulanti ali antitrombotičnimi zdravili.
English: It is therefore advised that duloxetine should be gradually tapered when discontinuing treatment over a period of no less than 2 weeks, according to the patient's needs (see section 4.2).
Slovenian: da se ob prekinjanju zdravljenja v skladu z bolnikovimi potrebami odmerek duloksetina postopoma zmanjšuje v obdobju ne manj kot 2 tednov (glejte poglavje 4.2).
English: • increased yawning
Slovenian: • več zehanja
English: Medicinal products metabolised by CYP1A2: The pharmacokinetics of theophylline, a CYP1A2 substrate, were not significantly affected by co-administration with duloxetine (60 mg twice daily).
Slovenian: Učinek duloksetina na druga zdravila Zdravila, ki jih presnavlja CYP1A2: sočasno dajanje duloksetina (60 mg dvakrat na dan) ni značilno vplivalo na farmakokinetiko teofilina, substrata CYP1A2.
English: The efficacy of Duloxetine Lilly at the recommended dose of 60 mg once a day was demonstrated in three out of three randomised, double-blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder.
Slovenian: Učinkovitost zdravila Duloksetin Lilly v priporočenem odmerku 60 mg enkrat na dan so pokazali v treh od treh randomiziranih dvojno slepih s placebom kontroliranih akutnih preskušanjih z določenim odmerkom pri odraslih bolnikih z veliko depresivno motnjo, zdravljenih ambulantno.
English: Paediatric population Duloxetine has not been studied in patients under the age of 7.
Slovenian: Pri bolnikih, mlajših od 7 let, študij z duloksetinom niso opravili.
English: As the safety of duloxetine in infants is not known, the use of Duloxetine Lilly while breast-feeding is not recommended.
Slovenian: Ker varnost uporabe duloksetina pri dojenčkih ni znana,
English: Extra-pyramidal symptoms6
Slovenian: psihomotorični nemir6 ekstrapiramidni simptomi6
English: Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g. hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea).
Slovenian: halucinacije, komo), avtonomno nestabilnost (npr. tahikardijo, spremenljiv krvni tlak, povišano telesno temperaturo), živčnomišične motnje (npr. hiperrefleksijo, motnje koordinacije) in/ali prebavne simptome (npr. navzejo, bruhanje, drisko).
English: Overall, Duloxetine Lilly's efficacy has been demonstrated at daily doses between 60 and 120 mg in a total of five out of seven randomised, double-blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder.
Slovenian: Splošno so učinkovitost zdravila Duloksetin Lilly pokazali pri dnevnih odmerkih med 60 in 120 mg v skupaj petih od sedmih randomiziranih dvojno slepih s placebom kontroliranih akutnih preskušanjih z določenim odmerkom pri odraslih bolnikih z veliko depresivno motnjo, zdravljenih ambulantno.
English: Duloxetine Lilly hard gastro-resistant capsules contain sucrose.
Slovenian: Zdravilo Duloksetin Lilly trde gastrorezistentne kapsule vsebuje saharozo.
English: Duloxetine Lilly is used in adults to treat:
Slovenian: Zdravilo Duloksetin Lilly pri odraslih se uporablja za zdravljenje: • depresije
English: Suicide-related behaviours (suicide attempts and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger), were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
Slovenian: V kliničnih preskušanjih med otroki in mladostniki, zdravljenimi z antidepresivi, v primerjavi s tistimi, ki so prejemali placebo, so pogosteje opažali s samomorom povezana vedenja (poskusi samomora in samomorilne misli) in sovražnost (zlasti nasilnost, nasprotovalno vedenje in jezo).
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
Slovenian: Podatki iz kliničnih preskušanj kažejo, da pri mlajših odraslih osebah (mlajših od 25 let) z motnjami razpoloženja med zdravljenjem z antidepresivi obstaja večje tveganje za pojav samomorilnega vedenja
English: There have been reports of bleeding abnormalities, such as ecchymoses, purpura and gastrointestinal haemorrhage with selective serotonin reuptake inhibitors (SSRIs) and serotonin/noradrenaline reuptake inhibitors (SNRIs), including duloxetine.
Slovenian: Pri selektivnih zaviralcih prevzema serotonina (SSRI - selective serotonin reuptake inhibitors) in selektivnih zaviralcih prevzema noradrenalina (SNRI - selective noradrenaline reuptake inhibitors),
English: Protein binding is not affected by renal or hepatic impairment.
Slovenian: Okvarjeno delovanje ledvic ali jeter na vezavo na beljakovine ne vpliva.
English: Only a small proportion of patients included in pivotal clinical trials had severe depression (baseline HAM-D>25).
Slovenian: je imel hudo depresijo (izhodiščno število točk po HAM-D > 25).
English: In an open label long-term uncontrolled study, the pain reduction in patients responding to 8-weeks of acute treatment of Duloxetine Lilly 60 mg once daily was maintained for a further 6-months as measured by change on the Brief Pain Inventory (BPI) 24-hour average pain item.
Slovenian: 8-tedensko akutno zdravljenje z zdravilom Duloksetin Lilly 60 mg enkrat na dan, ohranilo nadaljnjih 6 mesecev (merjeno s spremembo postavke 24-urne povprečne bolečine vprašalnika BPI (Brief Pain Inventory).
English: Musculoskeletal and connective tissue disorders Musculo-skeletal pain
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva mišično-skeletna bolečina mišični krč napetost mišic trzanje mišic trizem
English: The pattern of liver damage was predominantly hepatocellular.
Slovenian: Pretežno je šlo za hepatocelularno okvaro jeter.
English: Eli Lilly Slovakia, s.r.o.
Slovenian: Slovenská republika Eli Lilly Slovakia, s.r.o.
English: Therefore Duloxetine Lilly should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section
Slovenian: Zato zdravila Duloksetin Lilly ne smemo dajati skupaj z močnimi zaviralci CYP1A2, denimo s fluvoksaminom (glejte poglavje 4.3).
English: 5 Cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.4).
Slovenian: 5Med zdravljenjem z duloksetinom ali kmalu po prekinitvi zdravljenja so poročali o primerih razmišljanja o samomoru in samomorilnem obnašanju (glejte poglavje 4.4).
English: Duloxetine Lilly 60 mg
Slovenian: Duloksetin Lilly 60 mg
English: Cases of suicidal thoughts and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.8).
Slovenian: Med zdravljenjem z duloksetinom ali kmalu po prenehanju zdravljenja so poročali o primerih samomorilnih misli in samomorilnega vedenja (glejte poglavje 4.8).
English: • constipation, diarrhoea, stomach pain, being sick (vomiting), heartburn or indigestion, breaking wind
Slovenian: • zaprtje, driska, bolečina v trebuhu, slabost (bruhanje), zgaga ali slaba prebava, vetrovi
English: The concomitant use of Duloxetine Lilly with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4).
Slovenian: Sočasno uporabo zdravila Duloksetin Lilly s selektivnimi reverzibilnimi MAOI, kakršen je npr. moklobemid, odsvetujemo (glejte poglavje 4.4).
English: Eosinophilic pneumonia6
Slovenian: eozinofilna pljučnica6
English: • muscle pain, muscle spasm
Slovenian: • mišična bolečina, mišični krč
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK- INNER CARTON FOR 60 MG HARD GASTRO-RESISTANT CAPSULES (without blue box)
Slovenian: VEČJE PAKIRANJE - NOTRANJE ŠKATLE ZA 60 MG TRDE GASTROREZISTENTNE KAPSULE (brez modrega okenca)
English: Duloxetine Lilly 30 mg
Slovenian: Duloksetin Lilly 30 mg
English: EU/1/14/972/004 (28 hard gastro-resistant capsules) EU/1/14/972/005 (56 hard gastro-resistant capsules) EU/1/14/972/006 (84 hard gastro-resistant capsules) EU/1/14/972/007 (98 hard gastro-resistant capsules)
Slovenian: EU/1/14/972/004 (28 trdnih gastrorezistentnih kapsul) EU/1/14/972/005 (56 trdnih gastrorezistentnih kapsul) EU/1/14/972/006 (84 trdnih gastrorezistentnih kapsul) EU/1/14/972/007 (98 trdnih gastrorezistentnih kapsul)
English: • decreased thyroid gland activity which can cause tiredness or weight gain
Slovenian: • zmanjšana aktivnost žleze ščitnice, kar lahko povzroči utrujenost ali zvečanje telesne mase
English: Some fatalities have occurred, primarily with mixed overdoses, but also with duloxetine alone at a dose of approximately 1000 mg. Signs and symptoms of overdose (duloxetine alone or in combination with other medicinal products) included somnolence, coma, serotonin syndrome, seizures, vomiting and tachycardia.
Slovenian: Znaki in simptomi prevelikega odmerjanja (duloksetina samega ali v kombinaciji z drugimi zdravili) so vključevali zaspanost, komo, serotoninski sindrom, epileptične napade, bruhanje in tahikardijo.
English: 10Estimated frequency based on placebo-controlled clinical trials.
Slovenian: 10Ocenjena pogostnost na podlagi kliničnih preskušanj, nadzorovanih s placebom c. Opis izbranih neželenih učinkov
English: b. Tabulated list of adverse reactions
Slovenian: b. Seznam neželenih učinkov
English: Concomitant use of Duloxetine Lilly with nonselective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.5).
Slovenian: Zdravila Duloksetin Lilly ne smemo uporabljati sočasno z neselektivnimi ireverzibilnimi zaviralci monoaminooksidaze - MAOI (glejte poglavje 4.5).
English: No malformations were observed in another study testing a higher dose of a different salt of duloxetine.
Slovenian: kjer so preskušali višji odmerek druge soli duloksetina, niso opažali malformacij.
English: Mania and seizures
Slovenian: Manija in epileptični napadi
English: These symptoms may include floppy muscles, trembling, jitteriness, not feeding properly, trouble with breathing and fits.
Slovenian: Simptomi lahko vključujejo ohlapnost mišic, tresenje, živčnost, probleme s hranjenjem,
English: Package leaflet: information for the user
Slovenian: Vsebina pakiranja in dodatne informacije
English: Dista S.A.. Tel: + 34 91 623 17 32
Slovenian: Tel: + 34 91 623 17 32
English: Capsule content: hypromellose, hypromellose acetate succinate, sucrose, sugar spheres, talc, titanium dioxide (E171), triethyl citrate (See end of section 2 for further information on sucrose).
Slovenian: Vsebina kapsule: hipromeloza, hipromeloza acetat sukcinat, saharoza, sladkorne kroglice, smukec, titanov dioksid (E171), trietilcitrat.
English: Furthermore, increases in INR values have been reported when duloxetine was co-administered to patients treated with warfarin.
Slovenian: Pri sočasnem dajanju duloksetina pri bolnikih, zdravljenih z varfarinom so poročali o povišanjih vrednosti INR.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN
English: • headache, feeling sleepy • feeling sick (nausea), dry mouth
Slovenian: • glavobol, občutek zaspanosti
English: Gynaecological haemorrhage Menstrual disorder Sexual dysfunction Testicular pain
Slovenian: Motnje reprodukcije in dojk erektilna disfunkcija motnje ejakulacije zapoznela ejakulacija ginekološka krvavitev motnje menstruacije spolna disfunkcija bolečina v testisih menopavzalni simptomi galaktoreja hiperprolaktinemija
English: See section 4.2 for information on patients with mild or moderate renal dysfunction.
Slovenian: Za podatke o bolnikih z blago ali zmerno okvarjenim delovanjem ledvic glejte poglavje 4.2.
English: Medicines that cause sleepiness: These include medicines prescribed by your doctor including benzodiazepines, strong painkillers, antipsychotics, phenobarbital and antihistamines.
Slovenian: benzodiazepini, močna zdravila proti bolečinam, antipsihotiki, fenobarbital in antihistaminiki.
English: Response and remission rates were also statistically significantly higher with Duloxetine Lilly compared with placebo.
Slovenian: Ob uporabi zdravila Duloksetin Lilly v primerjavi s placebom so bile višje tudi stopnje odziva in remisije.
English: Hard gastro-resistant capsule.
Slovenian: FARMACEVTSKA OBLIKA Trda gastrorezistentna kapsula.
English: • “Serotonin syndrome” (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits
Slovenian: • “serotoninski sindrom” (redka reakcija, ki lahko povzroči občutke velike sreče, zaspanost,
English: Very common side effects (may affect more than 1 in 10 people)
Slovenian: Zelo pogosti neželeni učinki (se lahko pojavijo pri več kot 1 od 10 bolnikov)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK-OUTER CARTON FOR 60 MG HARD GASTRO-RESISTANT CAPSULES (with blue box)
Slovenian: VEČJE PAKIRANJE - ZUNANJE ŠKATLE ZA 60 MG TRDE GASTROREZISTENTNE KAPSULE (z modrim okencem)
English: Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day have been evaluated from a safety perspective in clinical trials.
Slovenian: V kliničnih preskušanjih so z vidika varnosti vrednotili odmerjanja prek 60 mg enkrat na dan, do najvišjega odmerka 120 mg na dan.
English: EU/1/14/972/001 (7 hard gastro-resistant capsules) EU/1/14/972/002 (28 hard gastro-resistant capsules) EU/1/14/972/003 (98 hard gastro-resistant capsules)
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/14/972/001 (7 trdnih gastrorezistentnih kapsul) EU/1/14/972/002 (28 trdnih gastrorezistentnih kapsul) EU/1/14/972/003 (98 trdnih gastrorezistentnih kapsul)
English: The use of Duloxetine Lilly while breastfeeding is not recommended.
Slovenian: Uporabo zdravila Duloksetin Lilly v času dojenja odsvetujemo.
English: Uncommon side effects (may affect up to 1 in 100 people)
Slovenian: Občasni neželeni učinki (se lahko pojavijo pri največ 1 od 100 bolnikov)
English: Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride).
Slovenian: Ena kapsula vsebuje 30 ali 60 mg duloksetina (v obliki klorida).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR 30 MG HARD GASTRO-RESISTANT CAPSULES
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLE ZA 30 MG TRDE GASTROREZISTENTNE KAPSULE
English: Very rare side effects (may affect up to 1 in 10,000 people)
Slovenian: Zelo redki neželeni učinki (se lahko pojavijo pri največ 1 od 10.000 bolnikov)
English: Edible green ink: synthetic black iron oxide (E172), synthetic yellow iron oxide (E172), propylene glycol, shellac.
Slovenian: Užitno zeleno črnilo: sintetični črni železov oksid (E172), sintetični rumeni železov oksid (E172),
English: Duloxetine Lilly 60 mg Opaque green body, imprinted with ‘60 mg' and an opaque blue cap, imprinted with ‘9542'.
Slovenian: Neprozorno zeleno telo z vtisnjenim napisom ‘60 mg' ter neprozoren moder pokrovček z vtisnjeno oznako ‘9542'.
English: Duloxetine Lilly 30 mg Opaque white body, imprinted with ‘30 mg' and an opaque blue cap, imprinted with ‘9543'.
Slovenian: Neprozorno belo telo z vtisnjenim napisom ‘30 mg' ter neprozoren moder pokrovček z vtisnjeno oznako ‘9543'.
English: A randomised, double-blind, placebo-controlled study was performed in 272 patients aged 7-17 years with generalised anxiety disorder.
Slovenian: Pri 272 bolnikih z generalizirano anksiozno motnjo, starih od 7 do 17 let, so opravili randomizirano, dvojno slepo, s placebom kontrolirano študijo.
English: Clinical response rates in patients experiencing somnolence were 60% on duloxetine and 30% on placebo.
Slovenian: V skupini bolnikov, ki so poročali o zaspanosti, so klinični odziv opažali pri 60 % bolnikov, zdravljenih z duloksetinom, in pri 30 % bolnikov, ki so prejemali placebo.
English: Malaise
Slovenian: Starost
English: België/Belgique/Belgien
Slovenian: België/Belgique/Belgien Eli Lilly Benelux S.A./N.V.
English: Hyperglycaemia (reported especially in diabetic patients)
Slovenian: (poročana zlasti pri diabetičnih bolnikih)
English: Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day administered in evenly divided doses, have been evaluated from a safety perspective in clinical trials.
Slovenian: V kliničnih preskušanjih so z vidika varnosti vrednotili odmerjanja prek 60 mg enkrat na dan, do najvišjega odmerka 120 mg na dan, dajanega razdeljeno na enake odmerke.
English: You should ask your doctor or pharmacist for advice.
Slovenian: Posvetujte se z zdravnikom ali s farmacevtom.
English: Constipation Diarrhoea Abdominal pain Vomiting Dyspepsia Flatulence
Slovenian: Bolezni sečil disurija polakiurija zastajanje urina odlašanje uriniranja nokturija poliurija slabši curek urina nenormalen vonj urina
English: Duloxetine Lilly contains the active substance duloxetine.
Slovenian: Kaj vsebuje zdravilo Duloksetin Lilly Učinkovina je duloksetin.
English: Gastrointestinal haemorrhage7 Gastroenteritis Eructation Gastritis Dysphagia
Slovenian: Bolezni prebavil navzea suha usta zaprtje driska bolečina v trebuhu bruhanje dispepsija napenjanje gastrointestinalna krvavitev7 gastroenteritis kolcanje gastritis disfagija stomatitis hematohezija slab zadah mikroskopski kolitis9
English: Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Yellow iron oxide (E172) Edible white ink
Slovenian: Duloksetin Lilly 60 mg želatina natrijev lavrilsulfat titanov dioksid (E171) indigotin (E132) rumeni železov oksid (E172)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR 60 MG HARD GASTRO-RESISTANT CAPSULES
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLE ZA 60 MG TRDE GASTROREZISTENTNE KAPSULE