FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients who experience a sustained increase in blood pressure while receiving duloxetine either dose reduction or gradual discontinuation should be considered (see section 4.8).
Slovenian: Pri bolnikih, ki so doživeli vztrajno povišanje krvnega tlaka medtem, ko so prejemali duloksetin, je potrebno pretehtati znižanje odmerka ali postopno ukinitev (glejte poglavje 4.8).
English: For any further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
English: Gender: Pharmacokinetic differences have been identified between males and females (apparent plasma clearance is approximately 50% lower in females).
Slovenian: Med moškimi in ženskami so ugotovili farmakokinetične razlike (očitni plazemski očistek je pri ženskah približno 50 % nižji).
English: The randomised, double-blind, placebo-controlled, parallel study of duloxetine was conducted in 184 adolescents aged 13 to 18 years (mean age 15.53 years) with JPFS.
Slovenian: Randomizirano, dvojno slepo, s placebom nadzorovano vzporedno študijo z duloksetinom so opravili pri 184 mladostnikih, starih od 13 do 18 let (povprečna starost 15,53 leta), z JPFS.
English: Oral anticoagulants or antiplatelet agents: Medicines which thin the blood or prevent the blood from clotting.
Slovenian: Peroralni antikoagulanti ali antitrombotiki: Zdravila za redčenje krvi ali preprečevanje strjevanja krvi.
English: This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodiumfree'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na kapsulo, kar v bistvu pomeni ''brez natrija''.
English: If your doctor thinks that you no longer need Duloxetine Mylan he or she will ask you to reduce your dose over at least 2 weeks before stopping treatment altogether.
Slovenian: Če bo zdravnik menil, da zdravila Duloksetin Mylan ne potrebujete več, vam bo naročil, da pred prenehanjem zdravljenja 2 tedna postopoma znižujte svoj odmerek.
English: • If you take Duloxetine Mylan 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 Mylan 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: Effect of duloxetine on other medicinal products
Slovenian: Učinek duloksetina na druga zdravila
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: Duloksetina 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: Marketing Authorisation Holder Mylan S.A.S., 117 Allée des Parcs, 69800 Saint-Priest, France
Slovenian: Imetnik dovoljenja za promet z zdravilom Mylan S.A.S., 117 Allée des Parcs, 69800 Saint-Priest, Francija
English: Duloxetine Mylan 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 Mylan delovati v dveh tednih po začetku zdravljenja, lahko pa traja 2 do 4 tedne, preden se boste počutili bolje.
English: The European Medicines Agency has waived the obligation to submit the results of studies with 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 duloksetinom za vse skupine pediatrične populacije pri zdravljenju velike depresivne motnje, bolečine diabetične nevropatije in generalizirane anksiozne motnje.
English: • Tell your doctor if you become pregnant, or you are trying to become pregnant, while you are taking Duloxetine Mylan.
Slovenian: • Obvestite zdravnika, če zanosite ali poskušate zanositi, medtem ko jemljete zdravilo Duloksetin Mylan.
English: The amount of duloxetine in breast milk is approximately 7 μg/day while on 40 mg twice daily dosing.
Slovenian: Količina duloksetina v materinem mleku je ob odmerku 40 mg dvakrat na dan približno 7 μg/dan.
English: What Duloxetine Mylan is and what it is used for What you need to know before you take Duloxetine Mylan How to take Duloxetine Mylan Possible side effects
Slovenian: Kaj je zdravilo Duloksetin Mylan in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Duloksetin Mylan Kako jemati zdravilo Duloksetin Mylan Možni neželeni učinki
English: Weight increased to match other children and adolescents of their age and sex after 6 months of treatment.
Slovenian: Telesna masa se je po šestih mesecih zdravljenja izenačila z otroki in mladostniki enake starosti in spola.
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: Misli na samomor in poslabšanje depresije ali anksiozne motnje Pri bolnikih z depresijo in/ali anksiozno motnjo se občasno lahko pojavijo misli na samopoškodovanje ali samomor.
English: Distribution: Duloxetine is approximately 96% bound to human plasma proteins.
Slovenian: Duloksetin se veže na človeške plazemske beljakovine v približno 96 %.
English: The following are reasons why Duloxetine Mylan may not be suitable for you.
Slovenian: Spodaj so našteti razlogi, zaradi katerih morda zdravilo Duloksetin Mylan za vas ni ustrezno.
English: • night sweats, hives, cold sweats, sensitivity to sunlight, increased tendency to bruise
Slovenian: • nočno potenje, koprivnica, hladen znoj, občutljivost na sončno svetlobo, povečana nagnjenjenost k nastanku modric
English: Although no studies have investigated the association of PPHN to SNRI treatment, this potential risk cannot be ruled out with duloxetine taking into account the related mechanism of action (inhibition of the re-uptake of serotonin).
Slovenian: Čeprav nobena študija ni preiskovala povezanost med PPHN in SNRI, tveganja ob jemanju duloksetina ni mogoče izključiti, saj je potrebno upoštevati, da gre za podoben način delovanja (zaviranje privzema serotonina).
English: Use in children and adolescents under 18 years of age Duloxetine Mylan 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 Zdravila Duloksetin Mylan pri zdravljenju otrok in mladostnikov, mlajših od 18 let, ne smemo uporabljati.
English: Sexual dysfunction
Slovenian: Spolna funkcija
English: Your doctor may continue to give you Duloxetine Mylan when you are feeling better to prevent your depression or anxiety from returning.
Slovenian: Zdravnik vam bo morda še naprej predpisoval zdravilo Duloksetin Mylan, tudi ko se boste že bolje počutili, da bi preprečil ponoven pojav depresije ali anksioznosti.
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 plazmske koncentracije duloksetina v stanju ravnotežja so bile večinoma znotraj obsega koncentracij, izmerjenih pri odraslih.
English: Tachycardia Supra-ventricular arrhythmia, mainly atrial fibrillation
Slovenian: Srčne bolezni palpitacije tahikardija, supra-ventrikularna aritmija, zlasti atrijska fibrilacija
English: The usual starting dose of Duloxetine Mylan 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 Mylan je 30 mg enkrat na dan, kasneje bo večina bolnikov prejela 60 mg enkrat na dan, vendar vam bo zdravnik predpisal odmerek, ki je pravi za vas.
English: Hepatic impairment: Moderate liver disease (Child Pugh Class B) affected the pharmacokinetics of duloxetine.
Slovenian: Zmerno okvarjeno delovanje jeter (razred Child Pugh B) je vplivalo na farmakokinetiko duloksetina.
English: Treatment of major depressive disorder.
Slovenian: Zdravljenje velikih depresivnih motenj.
English: Major Depressive Disorder: Duloxetine was studied in a clinical programme involving 3,158 patients (1,285 patient-years of exposure) meeting DSM-IV criteria for major depression.
Slovenian: Duloksetin so preučevali v kliničnem programu, v katerem je sodelovalo 3.158 bolnikov (1.285 bolniških let izpostavljenosti), ki so izpolnjevali merila DSM-IV za veliko depresivno motnjo.
English: Duloxetine showed comparable efficacy results to venlafaxine in terms of improvements on the HAM-A total score.
Slovenian: Duloksetin je pokazal primerljive rezultate učinkovitosti v primerjavi z venlafaksinom glede izboljšanja skupnega števila točk po HAM-A.
English: Medicines like Duloxetine Mylan (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4).
Slovenian: Zdravila, kot je zdravilo Duloksetin Mylan (t. i. SSRI/SNRI), lahko povzročijo simptome spolne disfunkcije (glejte poglavje 4).
English: The use of duloxetine has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still.
Slovenian: Jemanje duloksetina so povezovali s pojavom akatizije, za katero je značilen subjektivno neprijeten ali mučen nemir in potreba po gibanju, ki ju pogosto spremlja nezmožnost sedenja ali stanja pri miru.
English: In the extension phase of these studies, which lasted up to 52 weeks, there was an increase in HbA1c in both the duloxetine and routine care groups, but the mean increase was 0.3% greater in the duloxetine-treated group.
Slovenian: V podaljšani fazi teh študij, ki je trajala do 52 tednov, se je vrednost HbA1c zvišala tako v skupini z duloksetinom kot v skupini bolnikov, ki so prejemali rutinsko oskrbo, vendar je bilo srednje zvišanje v skupini, zdravljeni z duloksetinom, večje za 0,3 %.
English: Multipack: 98 (2 packs of 49) hard gastro-resistant capsules
Slovenian: Skupno pakiranje: 98 (2 škatli po 49) trdih gastrorezistentnih kapsul
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 5-hydroxyl 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: To help you remember to take Duloxetine Mylan, you may find it easier to take it at the same times every day.
Slovenian: Morda se boste lažje spomnili vzeti zdravilo Duloksetin Mylan, če ga boste jemali vsak dan ob isti uri.
English: In both studies, duloxetine 60 mg once daily and 60 mg twice daily significantly reduced pain compared with placebo.
Slovenian: V obeh študijah je duloksetin 60 mg enkrat na dan in 60 mg dvakrat na dan značilno zmanjšal bolečino v primerjavi s placebom.
English: Elimination: The elimination half-life of duloxetine ranges from 8 to 17 hours (mean of 12 hours).
Slovenian: Razpolovni čas izločanja duloksetina je od 8 do 17 ur (povprečno 12 ur).
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 zdravnik, med njimi so, denimo, benzodiazepini, močna zdravila proti bolečinam, antipsihotiki, fenobarbital in antihistaminiki.
English: Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of Duloxetine Mylan in this age group have not yet been demonstrated.
Slovenian: Dolgoročnih učinkov zdravila Duloksetin Mylan na varnost glede rasti, dozorevanja in kognitivnega ter vedenjskega razvoja v tej starostni skupini še niso ugotovili.
English: Duloxetine Mylan increases the levels of serotonin and noradrenaline in the nervous system.
Slovenian: Zdravilo Duloksetin Mylan zviša nivo serotonina in noradrenalina v živčnem sistemu.
English: Your doctor should decide whether you can take Duloxetine Mylan with other medicines.
Slovenian: Zdravnik se mora odločiti, ali lahko jemljete zdravilo Duloksetin Mylan z drugimi zdravili.
English: Duloxetine Mylan is available in 2 strengths: 30 mg and 60 mg.
Slovenian: Zdravilo Duloksetin Mylan je na voljo v dveh jakostih: 30 mg in 60 mg.
English: When stopping treatment with Duloxetine Mylan 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 Mylan 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 initiation of treatment with Duloxetine Mylan is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis (see sections 4.4 and 4.8).
Slovenian: Uvedba zdravljenja z zdravilom Duloksetin Mylan je kontraindicirana pri bolnikih z nenadzorovano hipertenzijo, ki lahko izpostavi bolnike možnemu tveganju za hipertenzivno krizo (glejte poglavje 4.4 in 4.8).
English: • If you take Duloxetine Mylan near the end of your pregnancy, your baby might have some symptoms when it is born.
Slovenian: • Če zdravilo Duloksetin Mylan jemljete proti koncu nosečnosti, se lahko po rojstvu pri vašem otroku pojavijo nekateri simptomi.
English: Duloxetine Mylan may cause a sensation of restlessness or an inability to sit or stand still.
Slovenian: Zdravilo Duloksetin Mylan lahko povzroči občutek nemira ali nezmožnosti sedenja ali stanja pri miru.
English: Patients should be instructed that if they experience sedation or dizziness they should avoid potentially hazardous tasks such as driving or operating machinery.
Slovenian: Zato je treba bolnikom naročiti, naj se izogibajo potencialno nevarnim nalogam, kot je vožnja ali upravljanje strojev, če izkusijo sedacijo ali omotico.
English: Akathisia/psychomotor restlessness
Slovenian: Akatizija/psihomotorični nemir
English: In patients responding to duloxetine, and with a history of repeated episodes of major depression, further long-term treatment at a dose of 60 to 120 mg/day could be considered.
Slovenian: Pri bolnikih, ki se odzovejo na zdravljenje z duloksetinom in imajo v anamnezi ponavljajoče epizode velikih depresij, lahko razmislimo o nadaljnjem dolgotrajnem zdravljenju z odmerkom od 60 do 120 mg na dan.
English: Do not take more than the daily amount of Duloxetine Mylan that has been prescribed for you in one day.
Slovenian: Ne zaužijte več zdravila Duloksetin Mylan v enem dnevu, kot vam je bilo predpisano.
English: Duloxetine did not show efficacy in reducing pain as measured by primary outcome measure of Brief Pain Inventory (BPI) average pain score endpoint: least squares (LS) mean change from baseline in BPI average pain score at 13 weeks was0.97 in the placebo group, compared with -1.62 in the duloxetine 30/60 mg group (p = 0.052).
Slovenian: Duloksetin ni pokazal učinkovitosti pri zmanjševanju bolečine, izmerjene z merilom primarnega izida, tj. z opazovanim dogodkom povprečne ocene bolečine po vprašalniku BPI: povprečna sprememba po metodi najmanjših kvadratov (LS) od izhodišča povprečne ocene bolečine po vprašalniku BPI po 13 tednih je bila -0,97 v skupini, ki je prejemala placebo, in -1,62 v skupini, ki je prejemala duloksetin 30/60 mg (p = 0,052).
English: You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Duloxetine Mylan.
Slovenian: Zdravnika obvestite, če se kateri od zgoraj naštetih simptomov pri bolniku, mlajšemu od 18 let, ki jemlje zdravilo Duloksetin Mylan, pojavi ali poslabša.
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, pogostejše odvajanje urina, slabši curek urina
English: 60 mg capsules
Slovenian: 60 mg kapsule
English: 30 mg capsules
Slovenian: 30 mg kapsule
English: Estimated frequency based on placebo-controlled clinical trials.
Slovenian: Ocenjena pogostnost na podlagi kliničnih preskušanj, nadzorovanih s placebom.
English: Duloxetine Mylan should normally not be used for children and adolescents under 18 years.
Slovenian: Zdravila Duloksetin Mylan pri otrocih in mladostnikih, mlajših od 18 let, običajno ne uporabljamo.
English: In the 12 week acute phase of three clinical trials of duloxetine in patients with diabetic neuropathic pain, small but statistically significant increases in fasting blood glucose were observed in duloxetine-treated patients.
Slovenian: V 12 tednov trajajoči akutni fazi treh kliničnih preskušanj duloksetina pri bolnikih z bolečino diabetične nevropatije so pri bolnikih, zdravljenih z duloksetinom, opažali majhna, a statistično značilna povišanja koncentracij glukoze v krvi na tešče.
English: • large pupils (the dark centre of the eye), problems with eyesight
Slovenian: • povečanje zenice (temni osrednji del očesa), motnje vida
English: • diabetic neuropathic pain (often described as burning, stabbing, stinging, shooting or aching or like an electric shock.
Slovenian: • bolečine pri diabetični nevropatiji (pogosto jo opisujejo kot pekočo, zbadajočo, pikajočo, prebadajočo ali podobno stresanju elektrike.
English: Duloxetine Mylan should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/or seizures.
Slovenian: Zdravilo Duloksetin Mylan je treba pri bolnikih z manijo v anamnezi ali z diagnozo bipolarne motnje in/ali epileptičnimi napadi uporabljati previdno.
English: Selective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction (see section 4.8).
Slovenian: Selektivni zaviralci ponovnega privzema serotonina (SSRI)/zaviralci ponovnega privzema serotonina in noradrenalina (SNRI) lahko povzročijo simptome spolne disfunkcije (glejte poglavje 4.8).
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 8tedensko 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: • 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: When duloxetine was administered at a dose of 60 mg twice daily with a single dose of desipramine, a CYP2D6 substrate, the AUC of desipramine increased 3-fold.
Slovenian: Pri dajanju duloksetina v odmerku 60 mg dvakrat na dan z enkratnim odmerkom dezipramina, substrata CYP2D6, je AUC dezipramina narasel 3-kratno.
English: As the safety of duloxetine in infants is not known, the use of Duloxetine Mylan while breast-feeding is not recommended.
Slovenian: Ker varnost uporabe duloksetina pri dojenčkih ni znana, odsvetujemo uporabo zdravila Duloksetin Mylan med dojenjem.
English: Stevens-Johnson Syndrome Angio-neurotic oedema
Slovenian: Stevens-Johnsonov sindrom angionevrotični edem kožni vaskulitis
English: Duloxetine is a combined serotonin (5-HT) and noradrenaline (NA) reuptake inhibitor.
Slovenian: Duloksetin je kombinirani zaviralec privzema serotonina (5-HT) in noradrenalina (NA).
English: Monoamine oxidase inhibitors (MAOIs): You should not take Duloxetine Mylan 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 Mylan ne smete jemati, če jemljete ali ste v zadnjih 14 dneh vzeli drugo antidepresivno zdravilo, imenovano zaviralec monoaminooksidaze (MAOI).
English: Talk with your doctor about how long you should keep taking Duloxetine Mylan.
Slovenian: Z zdravnikom se pogovorite o tem, kako dolgo boste jemali zdravilo Duloksetin Mylan.
English: Tolerability of duloxetine 60 mg once daily in elderly patients was comparable to that seen in the younger adults.
Slovenian: Prenašanje duloksetina 60 mg enkrat na dan pri starejših bolnikih je bilo primerljivo s tistim, ki je bilo opaženo pri mlajših odraslih.
English: Capsule shell: Brilliant blue (E133), yellow iron oxide (E172) (60 mg only), titanium dioxide (E171), gelatin and edible gold ink (30 mg only) or edible white ink (60 mg only).
Slovenian: Ovojnica kapsule: briljantno modro FCF (E133), rumeni železov oksid (E172) (samo za 60 mg), titanov dioksid (E171), želatina in užitno zlato črnilo (samo za 30 mg) ali užitno belo črnilo (samo za 60 mg).
English: Not statistically significantly different from placebo.
Slovenian: Glede na placebo razlika ni statistično značilna.
English: However, data on elderly patients exposed to the maximum dose (120 mg per day) are limited and thus, caution is recommended when treating this population.
Slovenian: Vendar pa je podatkov pri starejših bolnikih, ki so bili izpostavljeni maksimalnemu odmerku (120 mg na dan) malo, in je zato pri zdravljenju te populacije potrebna previdnost.
English: A single study has been performed in paediatric patients with juvenile primary fibromyalgia syndrome (JPFS) in which the duloxetine-treated group did not separate from placebo group for the primary efficacy measure.
Slovenian: Opravili so študijo pri pediatričnih bolnikih z juvenilnim primarnim sindromom fibromialgije (JPFSjuvenile primary fibromyalgia syndrome), pri kateri se skupina, zdravljena z duloksetinom, glede primarnega opazovanega dogodka učinkovitosti ni razlikovala od skupine, ki je prejemala placebo.
English: Treatment with duloxetine showed a statistically significantly greater improvement in GAD symptoms, as measured by PARS severity score for GAD (mean difference between duloxetine and placebo of 2.7 points [95% CI 1.3-4.0]), after 10 weeks of treatment.
Slovenian: Zdravljenje z duloksetinom je pokazalo statistično pomembnejše veliko izboljšanje simptomov generalizirane anksiozne motnje, merjeno z lestvico PARS izraženosti simptomov generalizirane anksiozne motnje (povprečna razlika med duloksetinom in placebom je znašala 2,7 točke [95 % IZ 1,3 - 4,0]), po 10 tednih zdravljenja.
English: Consequently, caution is advised when Duloxetine Mylan 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 Mylan v kombinaciji z drugimi centralno delujočimi zdravili ali snovmi, ki vključujejo alkohol in pomirjevala (denimo benzodiazepini, morfinomimetiki, antipsihotiki, fenobarbital, sedirajoči antihistaminiki), potrebna previdnost.