FrancophonIA/ELRC3.0 huggingface dataset:
English: Major Depressive Disorder and Generalised Anxiety Disorder Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suiciderelated events).
Slovenian: Velike depresivne motnje in generalizirana anksiozna motnja Depresija je povezana z večjim tveganjem za pojav samomorilnih misli, samopoškodovanje in samomorilnosti (s samomorom povezani dogodki).
English: • fast and/or irregular heart beat;
Slovenian: • hitro ali nepravilno bitje srca
English: Taking a MAOI together with many prescription medicines, including Duloxetine Zentiva, can cause serious or even life-threatening side effects.
Slovenian: Jemanje MAOI skupaj z mnogimi zdravili na recept, vključno z zdravilom Duloksetin Zentiva, lahko povzroči resne ali celo smrtno nevarne neželene učinke.
English: Duloxetine may be associated with sedation and dizziness.
Slovenian: Duloksetin je lahko povezan s sedacijo in omotico.
English: Population pharmacokinetic analyses have shown that smokers have almost 50% lower plasma concentrations of duloxetine compared with non-smokers.
Slovenian: Analize populacijske farmakokinetike so pokazale, da imajo kadilci v primerjavi z nekadilci skoraj za 50 % nižje plazemske koncentracije duloksetina.
English: • throat inflammation that causes a hoarse voice;
Slovenian: • vnetje grla, ki povzroči hripav glas
English: 1 Cases of convulsion and cases of tinnitus have also been reported after treatment discontinuation.
Slovenian: 1 O primerih konvulzij in o primerih tinitusa so poročali tudi po prekinitvi zdravljenja.
English: − Yellow iron oxide (E172)
Slovenian: − rumeni železov oksid (E172)
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali, ali pa boste morda začeli jemati katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: Duloxetine Zentiva with food, drink and alcohol Duloxetine Zentiva may be taken with or without food.
Slovenian: Zdravilo Duloksetin Zentiva skupaj s hrano, pijačo in z alkoholom Zdravilo Duloksetin Zentiva lahko vzamete s hrano ali brez nje.
English: Do not stop taking Duloxetine Zentiva, or change your dose, without talking to your doctor.
Slovenian: Ne prenehajte jemati zdravila Duloksetin Zentiva in ne spreminjajte odmerka, ne da bi se posvetovali s svojim zdravnikom.
English: If your doctor thinks that you no longer need Duloxetine Zentiva he or she will ask you to reduce your dose over at least 2 weeks before stopping treatment altogether.
Slovenian: Če bo vaš zdravnik menil, da zdravila Duloksetin Zentiva ne potrebujete več, vam bo naročil-a, da pred prenehanjem zdravljenja 2 tedna postopoma znižujte svoj odmerek.
English: Studies in juvenile rats reveal transient effects on neurobehaviour, as well as significantly decreased body weight and food consumption; hepatic enzyme induction; and hepatocellular vacuolation at 45 mg/kg/day.
Slovenian: Študije na mladih podganah kažejo na prehodne učinke na nevrološki vedenjski vzorec ter na znatno zmanjšanje telesne mase in uživanje hrane, indukcijo jetrnih encimov in hepatocelularno vakuolacijo pri 45 mg/kg/dan.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Slovenian: PRILOGA II A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
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.
Slovenian: Dolgoročni učinki zdravila Duloksetin Zentiva na varnost glede rasti, dozorevanja in kognitivnega ter vedenjskega razvoja v tej starostni skupini tudi še niso bili ugotovljeni.
English: • lack of appetite;
Slovenian: • zmanjšanje apetita
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.
Slovenian: Oba citokroma, P450-2D6 in 1A2, katalizirata tvorbo dveh poglavitnih presnovkov glukuronidnega konjugata 4-hidroksi duloksetina in sulfatnega 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.
Slovenian: Uporaba pri otrocih in mladostnikih, mlajših od 18 let Duloksetin pri zdravljenju otrok in mladostnikov, mlajših od 18 let, ne smemo uporabljati.
English: Duloxetine should not be used in children and adolescents under the age of 18 years for the treatment of major depressive disorder because of safety and efficacy concerns (see sections 4.4, 4.8 and 5.1).
Slovenian: Duloksetin se ne sme uporabljati za zdravljenje velike depresivne motnje pri otrocih in mladostnikih, mlajših od 18 let, zaradi pomislekov glede varnosti in učinkovitosti (glejte poglavja 4.4, 4.8 in 5.1).
English: Medicines like Duloxetine Zentiva (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4).
Slovenian: Zdravila, kot je Duloksetin Zentiva (tako imenovani SSRI/SNRI), lahko povzročijo simptome spolne disfunkcije (glejte poglavje 4).
English: Hallucinations Aggression and anger4
Slovenian: manija halucinacije agresija in jeza4
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.
Slovenian: • Če zdravilo Duloksetin Zentiva jemljete proti koncu nosečnosti, obstaja povečano tveganje za čezmerno krvavitev iz nožnice kmalu po porodu, sploh če ste v preteklosti že imeli motnje strjevanja krvi.
English: • night sweats, hives, cold sweats, sensitivity to sunlight, increased tendency to bruise;
Slovenian: • nočno potenje, koprivnica, hladen znoj, občutljivost na sončno svetlobo, povečano nagnjenje k modricam
English: Excipient(s) with known effect: each capsule contains 84.51 - 93.14 mg of sucrose.
Slovenian: Pomožne snovi z znanim učinkom: ena kapsula vsebuje 84,51-93,14 mg saharoze.
English: − Titanium dioxide (E171)
Slovenian: − titanov 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.
Slovenian: Pri večini bolnikov z depresijo ali anksioznostjo začne zdravilo Duloksetin Zentiva delovati v dveh tednih po začetku zdravljenja, lahko pa traja 2 do 4 tedne, preden se boste počutili boljše.
English: − Indigo carmine (E132)
Slovenian: − indigotin (E132)
English: • Medicines that cause sleepiness: These include medicines prescribed by your doctor including benzodiazepines, strong painkillers, antipsychotics, phenobarbital and antihistamines.
Slovenian: • Zdravila, ki povzročajo zaspanost: Taka zdravila vam je predpisal vaš zdravnik, med njimi so, denimo, benzodiazepini, močna zdravila proti bolečinam, antipsihotiki, fenobarbital in antihistaminiki.
English: • suffer from bipolar disorder;
Slovenian: • imate bipolarno motnjo;
English: The elimination half-life of duloxetine ranges from 8 to 17 hours (mean of 12 h).
Slovenian: Razpolovni čas izločanja duloksetina je od 8 do 17 ur (povprečno 12 ur).
English: • increased blood pressure, flushing;
Slovenian: • povišan krvni tlak, zardevanje
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.
Slovenian: Ker je CYP1A2 vpleten v presnovo duloksetina, je verjetno, da bo sočasna uporaba duloksetina z močnimi zaviralci CYP1A2 povzročila višje koncentracije duloksetina.
English: • Tell your doctor if you become pregnant, or you are trying to become pregnant, while you are taking Duloxetine Zentiva.
Slovenian: • Obvestite svojega zdravnika, če zanosite ali poskušate zanositi, medtem ko jemljete zdravilo Duloksetin Zentiva.
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.
Slovenian: Kot pri drugih zdravilih s podobnim farmakološkim delovanjem (antidepresivi) so med zdravljenjem z duloksetinom ali kmalu po prenehanju zdravljenja poročali o posameznih primerih samomorilnih idej in samomorilnega vedenja.
English: Your doctor may continue to give you Duloxetine Zentiva when you are feeling better to prevent your depression or anxiety from returning.
Slovenian: Vaš zdravnik vam bo morda še naprej predpisoval zdravilo Duloksetin Zentiva, tudi ko se boste že bolje počutili, da bi preprečil ponoven pojav depresije ali anksioznosti.
English: Opaque PVC/PCTFE/Alu blisters, paper folding box.
Slovenian: Neprozorni PVC/PCTFE/Alu pretisni omot, škatla.
English: This medicine does not require any special temperature storage conditions.
Slovenian: Za shranjevanje tega zdravila ni posebnih temperaturnih omejitev.
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
Slovenian: Kaj je zdravilo Duloksetin Zentiva in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Duloksetin Zentiva Kako jemati zdravilo Duloksetin Zentiva Možni neželeni učinki
English: Tachycardia Supra-ventricular arrhythmia, mainly atrial fibrillation
Slovenian: Srčne bolezni palpitacije tahikardija supra-ventrikularna aritmija, zlasti atrijska fibrilacija
English: You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Duloxetine Zentiva.
Slovenian: Svojega zdravnika obvestite, če se kateri od zgoraj naštetih simptomov pri bolniku, mlajšemu od 18 let, ki jemlje zdravilo Duloksetin Zentiva, pojavi ali poslabša.
English: • are taking St. John's Wort, a herbal treatment (Hypericum perforatum);
Slovenian: • jemljete šentjanževko, pripravek rastlinskega izvora (Hypericum perforatum);
English: Fluvoxamine (100 mg once daily), a potent inhibitor of CYP1A2, decreased the apparent plasma clearance of duloxetine by about 77% and increased AUCo-t 6-fold.
Slovenian: Fluvoksamin (100 mg enkrat na dan), močan zaviralec CYP1A2, je znižal očitni plazemski očistek duloksetina za približno 77 % in povečal AUCo-t za 6-krat.
English: Your doctor should decide whether you can take Duloxetine Zentiva with other medicines.
Slovenian: Vaš zdravnik se mora odločiti, ali lahko jemljete zdravilo Duloksetin Zentiva z drugimi zdravili.
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.
Slovenian: Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z referenčnim zdravilom, ki vsebuje duloksetin, za vse skupine pediatrične populacije pri zdravljenju velike depresivne motnje, bolečine diabetične nevropatije in generalizirane anksiozne motnje.
English: Excipient(s) with known effect: each capsule contains 42.26 - 46.57 mg of sucrose.
Slovenian: Pomožne snovi z znanim učinkom: ena kapsula vsebuje 42,26-46,57 mg saharoze.
English: To help you remember to take Duloxetine Zentiva, you may find it easier to take it at the same times every day.
Slovenian: Morda se boste lažje spomnili vzeti zdravilo Duloksetin Zentiva, če ga boste jemali vsak dan ob isti uri.
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).
Slovenian: Ob prenehanju zdravljenja z zdravilom Duloksetin Zentiva je treba odmerek zdravila v obdobju najmanj enega do dveh tednov postopoma zmanjševati, da zmanjšamo tveganje za pojav odtegnitvenih reakcij (glejte poglavji 4.4 in 4.8).
English: The following are reasons why Duloxetine Zentiva may not be suitable for you.
Slovenian: Spodaj so našteti razlogi, zaradi katerih morda zdravilo Duloksetin Zentiva za vas ni ustrezno.
English: Monoamine oxidase inhibitors (MAOIs)
Slovenian: Zaviralci monoaminooksidaze (MAOI)
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.
Slovenian: Zaradi nevarnosti za serotoninski sindrom duloksetina ne smemo uporabljati v kombinaciji z neselektivnimi ireverzibilnimi zaviralci monoaminooksidaze (MAOI) ali v 14 dneh po prenehanju zdravljenja z MAOI.
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: • težave ali nezmožnost odvajanja urina, težave z začetkom uriniranja, potreba po nočnem odvajanju urina, bolj pogosto odvajanje urina, slabši curek urina
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.
Slovenian: Običajen začetni odmerek zdravila Duloksetin Zentiva je 30 mg enkrat na dan, kasneje bo večina bolnikov prejela 60 mg enkrat na dan, vendar vam bo vaš zdravnik predpisal odmerek, ki je pravi za vas.
English: Do not take more than the daily amount of Duloxetine Zentiva that has been prescribed for you in one day.
Slovenian: Ne zaužijte več zdravila Duloksetin Zentiva v enem dnevu, kot vam je bilo predpisano.
English: • trouble sleeping, feeling agitated, less sex drive, anxiety, difficulty or failure to experience orgasm, unusual dreams;
Slovenian: • težave s spanjem, občutek razdraženosti, manjša želja po spolnosti, nemirnost, težave ali nezmožnost doseči orgazem, nenavadne sanje
English: • If you take Duloxetine Zentiva near the end of your pregnancy, your baby might have some symptoms when it is born.
Slovenian: • Če zdravilo Duloksetin Zentiva jemljete proti koncu nosečnosti, se lahko po rojstvu pri vašem otroku pojavijo nekateri simptomi.
English: As the safety of duloxetine in infants is not known, the use of duloxetine while breast-feeding is not recommended.
Slovenian: Ker varnost uporabe duloksetina pri dojenčkih ni znana, odsvetujemo uporabo duloksetina med dojenjem.
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.
Slovenian: Sočasno dajanje duloksetina (40 mg dvakrat na dan) poveča AUC tolterodina (2 mg dvakrat na dan) v stanju dinamičnega ravnovesja za 71 %, ne vpliva pa na farmakokinetiko njegovega aktivnega 5-hidroksi presnovka, zato ne priporočamo prilagajanja odmerjanja.
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).
Slovenian: • Zaviralci monoaminooksidaze (MAOI): Zdravila Duloksetin Zentiva ne smete jemati, če jemljete ali ste v zadnjih 14 dneh vzeli drugo antidepresivno zdravilo, imenovano zaviralec monoaminooksidaze (MAOI).
English: The model-predicted duloxetine steady state plasma concentrations in paediatric patients were mostly within the concentration range observed in adult patients.
Slovenian: Z modelom predvidene plazemske koncentracije duloksetina v stanju ravnotežja so bile večinoma znotraj obsega koncentracij, izmerjenih pri odraslih.
English: S.C. Zentiva S.A Theodor Pallady Nr 50 032266 Bucharest Romania
Slovenian: S.C. Zentiva S.A Theodor Pallady Nr 50 032266 Bucharest Romunija
English: Duloxetine Zentiva increases the levels of serotonin and noradrenaline in the nervous system.
Slovenian: Zdravilo Duloksetin Zentiva zviša nivo serotonina in noradrenalina v živčnem sistemu.
English: Duloxetine Zentiva should normally not be used for children and adolescents under 18 years.
Slovenian: Zdravila Duloksetin Zentiva pri otrocih in mladostnikih, mlajših od 18 let, običajno ne uporabljamo.
English: Duloxetine is a moderate inhibitor of CYP2D6.
Slovenian: Duloksetin je zmeren zaviralec CYP2D6.
English: Over the entire 36-week course of the study, 6 out of 333 patients initially randomized to duloxetine and 3 out of 225 patients initially randomized to fluoxetine experienced suicidal behaviour (exposure adjusted incidence 0.039 events per patient year for duloxetine, and 0.026 for fluoxetine).
Slovenian: V celotnem 36-tedenskem obdobju študije je samomorilno vedenje občutilo 6 od 333 bolnikov, ki so bili na začetku randomizirani za zdravljenje z duloksetinom in 3 od 225 bolnikov, ki so bili na začetku randomizirani za zdravljenje z fluoksetinom (pogostost, prilagojena na izpostavljenost, je bila 0,039 dogodkov na bolnika na leto za duloksetin in 0,026 za fluoksetin).
English: • 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 črevesja (ki vodi v diarejo)
English: Duloxetine Zentiva is available in 2 strengths: 30 mg and 60 mg.
Slovenian: Duloksetin Zentiva je na voljo v dveh jakostih: 30 mg in 60 mg.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu.
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.
Slovenian: Sočasno dajanje duloksetina z antacidi, vsebujočimi aluminij in magnezij, ali duloksetina s famotidinom ni imelo pomembnega učinka na hitrost ali obseg absorpcije duloksetina po dajanju 40 mg peroralnega odmerka.
English: Manufacturer S.C. Zentiva S.A Theodor Pallady Nr 50 032266 Bucharest Romania
Slovenian: Izdelovalec S.C. Zentiva S.A Theodor Pallady Nr 50 032266 Bucharest Romunija
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.
Slovenian: Duloksetin se je izkazal za statistično značilno boljšega kot placebo v petih izmed petih študij, vključno s štirimi randomiziranimi, dvojno slepimi, s placebom kontroliranimi akutnimi študijami in študijo preprečevanja relapsa pri odraslih bolnikih z generalizirano anksiozno motnjo.
English: Medicinal products metabolised by CYP2D6
Slovenian: Zdravila, ki jih presnavlja CYP2D6
English: The main ingredient of Duloxetine Zentiva, duloxetine, is used in other medicines for other conditions: diabetic neuropathic pain, depression, anxiety and urinary incontinence.
Slovenian: Poglavitno sestavino zdravila Duloksetin Zentiva, duloksetin, uporabljamo tudi v drugih zdravilih za zdravljenje drugih bolezni: bolečina diabetične nevropatije, depresije, anksioznosti in urinske inkontinence.
English: During the 10-week acute treatment period, suicidal behaviours were reported (duloxetine 0/333 [0%], fluoxetine 2/225 [0.9%], placebo 1/220 [0.5%]).
Slovenian: (duloksetin 0/333 [0 %], fluoksetin 2/225 [0,9 %], placebo 1/220 [0,5 %]).
English: Duloxetine Zentiva may cause a sensation of restlessness or an inability to sit or stand still.
Slovenian: Zdravilo Duloksetin Zentiva lahko povzroči občutek nemira ali nezmožnosti sedenja ali stanja pri miru.
English: Duloxetine should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/or seizures.
Slovenian: Duloksetin je treba pri bolnikih z manijo v anamnezi ali z diagnozo bipolarne motnje in/ali epileptičnimi napadi uporabljati previdno.
English: What Duloxetine Zentiva is and what it is used for
Slovenian: Kaj je zdravilo Duloksetin Zentiva in za kaj ga uporabljamo
English: Duloxetine Zentiva is used in adults to treat:
Slovenian: Zdravilo Duloksetin Zentiva pri odraslih se uporablja za zdravljenje:
English: • large pupils (the dark centre of the eye), problems with eyesight;
Slovenian: • večje zenice (temni osrednji del očesa), motnja vida
English: Capsule cap: Indigo carmine (E132), titanium dioxide (E171), gelatin Capsule body: yellow iron oxide (E172), titanium dioxide (E171), gelatin
Slovenian: Pokrovček kapsule: indigotin (E132), titanov dioksid (E171), želatina Telo kapsule: rumeni železov oksid (E172), titanov dioksid (E171) želatina
English: After an intravenous dose the plasma clearance of duloxetine ranges from 22 l/h to 46 l/h (mean of 36 l/h).
Slovenian: Po intravenskem odmerku plazemski očistek duloksetina dosega vrednosti od 22 l/h do 46 l/h (povprečno 36 l/h).
English: Do not take Duloxetine Zentiva if you:
Slovenian: Ne jemljite zdravila Duloksetin Zentiva, če:
English: In an open label long-term uncontrolled study, the pain reduction in patients responding to 8-weeks of acute treatment of duloxetine 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: V odprti, dolgoročni nekontrolirani študiji se je zmanjšanje bolečine pri bolnikih, ki so se odzvali na 8-tedensko akutno zdravljenje z duloksetinom 60 mg enkrat na dan, ohranilo nadaljnjih 6 mesecev (merjeno s spremembo postavke 24-urne povprečne bolečine vprašalnika BPI (Brief Pain Inventory).
English: • coughing, wheezing and shortness of breath which may be accompanied by a high temperature;
Slovenian: • kašelj, piskanje v pljučih in zadihanost, ki jih lahko spremlja visoka telesna temperatura
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).
Slovenian: Na podlagi razpolovnega časa duloksetina pa mora po prenehanju jemanja zdravila Duloksetin Zentiva preteči vsaj 5 dni pred začetkom jemanja MAOI (glejte poglavje 4.3).
English: Consequently, caution is advised when duloxetine is taken in combination with other centrally acting medicinal products or substances, including alcohol and sedative medicinal products (e.g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Slovenian: Zato je pri jemanju zdravila Duloksetin Zentiva v kombinaciji z drugimi centralno delujočimi zdravili ali snovmi, ki vključujejo alkohol in pomirjevala (denimo benzodiazepini, morfinomimetiki, antipsihotiki, fenobarbital, sedirajoči antihistaminiki), potrebna previdnost.
English: Do not use this medicine after the expiry date which is stated on the carton/blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli/pretisnem omotu poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Extra-pyramidal symptoms6
Slovenian: ekstrapiramidni simptomi6
English: Duloxetine Zentiva should not be used in combination with fluvoxamine, ciprofloxacin or enoxacin (i.e. potent CYP1A2 inhibitors) since the combination results in elevated plasma concentrations of duloxetine (see section 4.5).
Slovenian: Zdravila Duloksetin Zentiva ne smemo uporabljati v kombinaciji s fluvoksaminom, ciprofloksacinom ali enoksacinom (tj. močnimi zaviralci CYP1A2), saj kombinacija povzroči povišane plazemske koncentracije duloksetina (glejte poglavje 4.5).