FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45% of patients treated with duloxetine and 23% of patients taking placebo.
Slovenian: V kliničnih preskušanjih so se neželeni učinki ob nenadni prekinitvi zdravljenja pojavili pri približno 45 % bolnikov, ki so jemali duloksetin in pri 23 % bolnikov, ki so dobivali placebo.
English: Hepatitis Elevated liver enzymes (ALT, AST, alkaline phosphatase) Acute liver injury
Slovenian: Bolezni jeter, žolčnika in žolčevodov hepatitis zvišane vrednosti jetrnih encimov (ALT, AST, alkalna fosfataza), akutna okvara jeter odpoved jeter zlatenica
English: HDPE bottle pack, with desiccant, containing 30, 100, 250 and 500 hard gastro-resistant capsules
Slovenian: HDPE plastenka s sušilnim sredstvom s po 30, 100, 250 in 500 trdimi gastrorezistentnmimi kapsulami.
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
English: Duloxetine 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 duloksetinom 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: Your doctor will tell you if you should be taking Duloxetine Mylan.
Slovenian: Zdravnik vam bo povedal, če smete jemati zdravilo Duloksetin Mylan.
English: Major Depressive Disorder and Generalised Anxiety Disorder: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).
Slovenian: Depresija je povezana z večjim tveganjem za pojav samomorilnih misli, samopoškodovanje in samomorilnosti (s samomorom povezani dogodki).
English: Generalised anxiety disorder
Slovenian: Generalizirana anksiozna motnja
English: Duloxetine Mylan is indicated in adults.
Slovenian: Zdravilo Duloksetin Mylan je indicirano za zdravljenje odraslih.
English: Therefore Duloxetine Mylan should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Slovenian: Zato zdravila Duloksetin Mylan ne smemo dajati skupaj z močnimi zaviralci CYP1A2, denimo s fluvoksaminom (glejte poglavje 4.3).
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: Simptomi serotoninskega sindroma lahko vključujejo spremembe duševnega stanja (npr. agitacijo, halucinacije, komo), avtonomno nestabilnost (npr. tahikardijo, spremenljiv krvni tlak, povišano telesno temperaturo), živčno-mišične motnje (npr. hiperrefleksijo, motnje koordinacije) in/ali prebavne simptome (npr. navzejo, bruhanje, drisko).
English: Hard gastro-resistant capsule
Slovenian: trda gastrorezistentna kapsula
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, probleme z dihanjem in krče.
English: Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials.
Slovenian: b. V preglednici prikazan povzetek neželenih učinkov Preglednica 1 prikazuje neželene učinke, ki so jih opažali v spontanih poročanjih in v s placebom kontroliranih kliničnih preskušanjih.
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: Serotonergic agents: In rare cases, serotonin syndrome has been reported in patients using SSRIs/SNRIs concomitantly with serotonergic agents.
Slovenian: Pri bolnikih, ki so SSRI/SNRI uporabljali sočasno s serotonergičnimi zdravili, so v redkih primerih poročali o serotoninskem sindromu.
English: No malformations were observed in another study testing a higher dose of a different salt of duloxetine.
Slovenian: V drugi študiji, kjer so preskušali višji odmerek druge soli duloksetina, niso opažali malformacij.
English: Hyperglycaemia (reported especially in diabetic patients)
Slovenian: Presnovne in prehranske motnje zmanjšanje apetita hiperglikemija (poročana zlasti pri diabetičnih bolnikih)
English: Paediatric population: Pharmacokinetics of duloxetine in paediatric patients aged 7 to 17 years with major depressive disorder following oral administration of 20 to 120 mg once daily dosing regimen was characterized using population modelling analyses based on data from 3 studies.
Slovenian: Farmakokinetika duloksetina po peroralnem jemanju 20 do 120 mg enkrat dnevno je bila pri pediatričnih bolnikih z veliko depresivno motnjo, starih od 7 do 17 let, določena z uporabo analize populacijskega modeliranja na osnovi podatkov iz treh študij.
English: • chest pain, feeling cold, thirst, shivering, feeling hot, abnormal gait
Slovenian: • bolečina v prsnem košu, mrazenje, žeja, drgetanje, občutek vročine, nenormalen način hoje
English: In a relapse prevention study, patients responding to 6 months of acute treatment with open-label duloxetine were randomised to either duloxetine or placebo for a further 6-months.
Slovenian: V študiji preprečevanja relapsa so bolnike, ki so se odzvali na 6-tedensko akutno zdravljenje z znano učinkovino duloksetinom, naključno razporedili v skupini, kjer so nadaljnjih 6 mesecev prejemali ali duloksetin ali placebo.
English: Urine odour abnormal
Slovenian: • nenormalen vonj 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: Monoamine oxidase inhibitors (MAOIs): 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: • throat tightness, nose bleeds
Slovenian: • napeto grlo, krvavitve iz nosu
English: The efficacy of duloxetine 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 duloksetina 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: Response and remission rates were also higher with duloxetine compared to placebo.
Slovenian: Ob uporabi duloksetina v primerjavi s placebom so bile višje tudi stopnje odziva in remisije.
English: • dizziness, tingling feelings like pins and needles or electric shock like feelings (particularly in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, sleepiness, feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), shaking (tremor), headaches, muscle pain, feeling irritable, diarrhoea, excessive sweating or vertigo.
Slovenian: • omotica, utrujenost, ščemenje (občutek zbadanja z iglami), ali občutki, podobni električnemu šoku (predvsem v glavi), motnje spanja (žive sanje, nočne more, nezmožnost spanja), utrujenost, zaspanost, občutek nemira ali razburjenosti, občutek strahu, slabost ali bruhanje, tresenje, glavoboli, bolečina v mišicah, občutek razdraženosti, driska, prekomerno znojenje ali vrtoglavica
English: If you miss a dose, take it as soon as you remember.
Slovenian: Če ste pozabili vzeti zdravilo Duloksetin Mylan Če pozabite vzeti odmerek, ga zaužijte, kakor hitro se spomnite.
English: Estimated frequency of post-marketing surveillance reported adverse reactions; not observed in placebo-controlled clinical trials.
Slovenian: Ocenjena pogostnost neželenih učinkov, o katerih so poročali v obdobju trženja; niso bili opaženi v kliničnih preskušanjih, nadzorovanih s placeom.
English: 30 hard gastro-resistant capsules 100 hard gastro-resistant capsules 250 hard gastro-resistant capsules 500 hard gastro-resistant capsules
Slovenian: 30 trdih gastrorezistentnih kapsul 100 trdih gastrorezistentnih kapsul 250 trdih gastrorezistentnih kapsul 500 trdih gastrorezistentnih kapsul
English: In a relapse prevention study, patients responding to 12-weeks of acute treatment with open-label duloxetine 60 mg once daily were randomised to either duloxetine 60 mg once daily or placebo for a further 6-months.
Slovenian: V študiji preprečevanja relapsa so bolnike, ki so se odzvali na 12-tedensko akutno zdravljenje z znano učinkovino duloksetinom 60 mg enkrat na dan, naključno razporedili v skupini, kjer so nadaljnjih 6 mesecev prejemali ali duloksetin 60 mg enkrat na dan ali placebo.
English: Duloxetine Mylan must not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
Slovenian: Zdravila Duloksetin Mylan pri bolnikih z obolenjem jeter, ki ima za posledico okvarjeno delovanje jeter, ne smemo uporabljati (glejte poglavji 4.3 in 5.2).
English: Overall, duloxetine'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 duloksetina 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: 30 mg capsules Capsule shell Brilliant blue (E133) Titanium dioxide (E171) Gelatin
Slovenian: 30 mg kapsule Ovojnica kapsule briljantno modro FCF (E133) titanov dioksid (E171) želatina zlato črnilo
English: Diabetic peripheral neuropathic pain
Slovenian: Bolečina diabetične periferne nevropatije
English: Duloxetine Mylan contains the active substance duloxetine.
Slovenian: Zdravilo Duloksetin Mylan vsebuje učinkovino duloksetin.
English: Weight decrease Weight increase Blood creatine phosphokinase increased
Slovenian: zvišanje vrednosti holesterola v krvi zvišanje vrednosti kreatinin-fosfokinaze v krvi, zvišanje vrednosti kalija v krvi
English: Mylan BV, Dieselweg 25, 3752 LB Bunschoten, The Netherlands
Slovenian: Mylan Hungary Kft., Mylan utca 1, Komárom 2900, Madžarska Mylan BV, Dieselweg 25, 3752 LB Bunschoten, Nizozemska
English: Care should be taken if you drink alcohol while you are being treated with Duloxetine Mylan.
Slovenian: Bodite posebej previdni, če med zdravljenjem z zdravilom Duloksetin Mylan pijete alkohol.
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: Dizziness, sensory disturbances (including paraesthesia or electric shock like sensations, particularly in the head), sleep disturbances (including insomnia and intense dreams), fatigue, somnolence, agitation or anxiety, nausea and/or vomiting, tremor, headache, myalgia, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions.
Slovenian: Reakcije, o katerih najpogosteje poročajo so omotica, senzorične motnje (vključno s parestezijo ali občutki, podobnimi električnemu šoku, predvsem v glavi), motnje spanja (vključno z nespečnostjo in intenzivnimi sanjami), utrujenost, zaspanost, agitacija ali tesnobnost, slabost in/ali bruhanje, tresenje, glavobol, mialgija, razdražljivost, driska, hiperhidroza in vrtoglavica.
English: Medicinal products metabolised by CYP2D6: Duloxetine is a moderate inhibitor of CYP2D6.
Slovenian: Duloksetin je zmeren zaviralec CYP2D6.
English: 49 hard gastro-resistant capsules
Slovenian: 49 trdih gastrorezistentnih kapsul
English: Also, you need to wait at least 5 days after you stop taking Duloxetine Mylan before you take a MAOI.
Slovenian: Tudi po prenehanju jemanja zdravila Duloksetin Mylan morate počakati vsaj 5 dni, preden lahko vzamete MAOI.
English: The concomitant use of Duloxetine Mylan with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4).
Slovenian: Sočasno uporabo zdravila Duloksetin Mylan s selektivnimi reverzibilnimi MAOI, kakršen je npr. moklobemid, odsvetujemo (glejte poglavje 4.4).
English: Caution is advised if Duloxetine Mylan is co-administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone and metoprolol).
Slovenian: Če zdravilo Duloksetin Mylan dajemo sočasno z zdravili, ki jih presnavlja predvsem CYP2D6 (risperidon, triciklični antidepresivi [TCA], kot so nortriptilin, amitriptilin in imipramin) in zlasti če imajo ozek terapevtski indeks (kot na primer s flekainidom, propafenonom in metoprololom), svetujemo previdnost.
English: Estimated frequency of post-marketing surveillance reported adverse reactions; not observed in placebocontrolled clinical trials.
Slovenian: Ocenjena pogostnost pojava neželenih učinkov v študijah iz obdobja trženja zdravila; omenjenih učinkov v s placebom nadzorovanih kliničnih študijah niso opazili.
English: The active substance is duloxetine.
Slovenian: Učinkovina je duloksetin.
English: unusual dreams
Slovenian: Pomožne snovi
English: Edible gold ink: shellac, propylene glycol, strong ammonia solution, yellow iron oxide (E172).
Slovenian: Užitno zlato črnilo: šelak, propilenglikol, amoniak, koncentrirana raztopina, rumeni železov oksid (E172).
English: How to take Duloxetine Mylan
Slovenian: Kako jemati zdravilo Duloksetin Mylan
English: Concomitant use of Duloxetine Mylan with nonselective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.5).
Slovenian: Zdravila Duloksetin Mylan ne smemo uporabljati sočasno z neselektivnimi ireverzibilnimi zaviralci monoaminooksidaze - MAOI (glejte poglavje 4.5).
English: Caution is advisable if Duloxetine Mylan is used concomitantly with serotonergic agents like SSRIs, SNRIs, tricyclic antidepressants like clomipramine or amitriptyline, MAOIs like moclobemide or linezolid, St John's wort (Hypericum perforatum) or triptans, tramadol, pethidine and tryptophan (see section 4.4).
Slovenian: Če zdravilo Duloksetin Mylan uporabljamo sočasno s serotonergičnimi zdravili, kot so SSRI, SNRI, s tricikličnimi antidepresivi, denimo klomipraminom ali amitriptilinom, z MAOI, denimo moklobemidom ali linezolidom, s šentjanževko (Hypericum perforatum), triptani, tramadolom, petidinom in triptofanom, priporočamo previdnost (glejte poglavje 4.4).
English: Cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.4).
Slovenian: Med zdravljenjem z duloksetinom ali kmalu po prekinitvi zdravljenja so poročali o primerih samomorilnih misli in samomorilnega vedenja (glejte poglavje 4.4).
English: Talk to your doctor before you take Duloxetine Mylan if you: - are taking other medicines to treat depression (see ‘Other medicines and Duloxetine Mylan') - are taking St. John's Wort, a herbal treatment (Hypericum perforatum) - have kidney disease - have had seizures (fits) - have had mania - suffer from bipolar disorder - have eye problems, such as certain kinds of glaucoma (increased pressure in the eye) - have a history of bleeding disorders (tendency to develop bruises), especially if you are pregnant
Slovenian: Mylan«) - jemljete šentjanževko, zdravilo rastlinskega izvora (Hypericum perforatum) - imate ledvično bolezen - ste imeli epileptične napade (krče) - ste imeli manijo - imate bipolarno motnjo - imate težave z očmi, denimo določene vrste glavkoma (zvišan očesni tlak) - ste v preteklosti imeli motnje strjevanja krvi (nagnjenost k razvoju podplutb), sploh če ste noseči (glejte ‘Nosečnost in dojenje‘) - imate tveganje za nizek nivo natrija (če na primer jemljete diuretike, sploh če ste starejši) - se trenutno zdravite z drugimi zdravili, ki lahko povzročijo poškodbo jeter - jemljete druga zdravila, ki vsebujejo duloksetin (glejte »Druga zdravila in zdravilo Duloksetin
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 Mylan') - are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat some infections - are taking other medicines containing duloxetine (see ‘Other medicines and Duloxetine Mylan')
Slovenian: Ne jemljite zdravila Duloksetin Mylan, če: - ste alergični na duloksetin ali katerokoli drugo sestavino tega zdravila (navedeno v poglavju 6) - imate obolenje jeter - imate hudo obolenje ledvic - jemljete ali ste v zadnjih 14 dneh jemali drugo antidepresivno zdravilo, imenovano zaviralec monoaminooksidaze (MAOI) (glejte »Druga zdravila in zdravilo Duloksetin Mylan«) - jemljete fluvoksamin, ki se običajno uporablja za zdravljenje depresije, ciprofloksacin ali enoksacin, ki se uporablja za zdravljenje nekaterih okužb
English: Syncope Hypertension Orthostatic hypotension Peripheral coldness
Slovenian: Žilne bolezni zvišan krvni tlak rdečica sinkopa hipertenzija ortostatska hipotenzija hladne okončine hipertenzivna kriza
English: There was no statistically significant difference in discontinuation due to adverse events between duloxetine and placebo groups during the 10 week acute treatment phase.
Slovenian: Med skupino z duloksetinom in skupino s placebom v 10tedenski fazi akutnega zdravljenja ni bilo statistično pomembne razlike v prekinitvi zdravljenja zaradi neželenih učinkov.
English: Hepatic failure Jaundice
Slovenian: Okvarjeno delovanje ledvic
English: The 60 mg capsules have an opaque blue cap and opaque yellow body, imprinted in white ink with ‘MYLAN' over ‘DL 60' on both the cap and the body.
Slovenian: 60 mg kapsule imajo rumeno neprozorno telo in moder neprozoren pokrovček ter z belim črnilom vtisnjeno oznako ‘MYLAN' preko 'DL 60' na pokrovčku in telesu kapsule.
English: heat, cold or pressure may cause pain)
Slovenian: V prizadetem področju lahko pride do izgube zaznavanja, ali pa lahko občutki, denimo dotik, toplota, mraz ali pritisk, povzročajo bolečino)
English: The efficacy and safety of duloxetine 30-120 mg once daily in elderly patients with generalised anxiety disorder was similar to that seen in studies of younger adult patients.
Slovenian: 120 mg enkrat na dan pri starejših bolnikih z generalizirano anksiozno motnjo sta bili podobni kot vštudijah z mlajšimi odraslimi bolniki.
English: Puh/Tel: +358 20 720 9555
Slovenian: Suomi/Finland Mylan Finland OY Puh/Tel: +358 20 720 9555
English: Gastrointestinal disorders Nausea
Slovenian: gastrointestinalna krvavitev gastroenteritis,
English: PVC/PCTFE/Aluminium or OPA/Aluminium/PVC - Aluminium perforated unit dose blister pack containing 7 x 1, 28 x 1 and 30 x 1 hard gastro-resistant capsules.
Slovenian: PVC/PCTFE/aluminijevi ali OPA/Al/PVC - aluminijevi perforirani enoodmerni pretisni omoti s po 7 x 1, 28 x 1 in 30 x 1 trdo gastrorezistentno kapsulo.
English: You should ask your doctor or pharmacist for advice.
Slovenian: Posvetujte se z zdravnikom ali farmacevtom.
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: Sočasno dajanje duloksetina (60 mg dvakrat na dan) ni značilno vplivalo na farmakokinetiko teofilina, substrata CYP1A2.
English: The 30 mg capsules have an opaque blue cap and opaque white body, imprinted in gold ink with ‘MYLAN' over ‘DL 30' on both the cap and the body.
Slovenian: 30 mg kapsule imajo belo neprozorno telo in moder neprozoren pokrovček ter z zlatim črnilom vtisnjeno oznako ‘MYLAN' preko 'DL 30' na pokrovčku in telesu kapsule.
English: The use of Duloxetine Mylan while breast-feeding is not recommended.
Slovenian: Uporabo zdravila Duloksetin Mylan v času dojenja odsvetujemo.
English: Method of administration For oral use.
Slovenian: Način uporabe peroralna uporaba
English: The effect of duloxetine 60 mg once a day in elderly depressed patients (≥65 years) was specifically examined in a study that showed a statistically significant difference in the reduction of the HAMD17
Slovenian: Pri starejših depresivnih bolnikih ( 65 let) so posebej preučevali učinek duloksetina 60 mg enkrat na dan v študiji, ki je pokazala statistično pomembno razliko v zmanjšanju HAMD17 rezultata za bolnike, ki so bili zdravljeni z duloksetinom, v primerjavi s tistimi, ki so prejemali placebo.
English: Opaque blue cap and opaque yellow body approximately 21.7 mm, imprinted in white ink with ‘MYLAN' over ‘DL 60' on both the cap and the body.
Slovenian: Rumena neprozorna kapsula z modrim neprozornim pokrovčkom, velikosti priližno 21,7 mm in z belim črnilom vtisnjeno oznako ‘MYLAN' preko 'DL 60', na pokrovčku in telesu kapsule.
English: - If you get any side effects talk to your doctor or pharmacist.
Slovenian: - Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: • increased pressure in the eye (glaucoma)
Slovenian: • zvišan očesni tlak (glavkom)
English: 60 mg capsules Each capsule contains 60 mg of duloxetine (as hydrochloride).
Slovenian: 60 mg kapsule Ena kapsula vsebuje 60 mg duloksetina (v obliki duloksetinijevega klorida).
English: Duloxetine Mylan with food, drink and alcohol
Slovenian: Zdravilo Duloksetin Mylan skupaj s hrano, pijačo in alkoholom Zdravilo Duloksetin Mylan lahko vzamete s hrano ali brez nje.
English: 60 mg capsules EU/1/15/1010/011 EU/1/15/1010/012 EU/1/15/1010/013 EU/1/15/1010/014 EU/1/15/1010/015
Slovenian: 30 mg kapsule EU/1/15/1010/001 EU/1/15/1010/002 EU/1/15/1010/003 EU/1/15/1010/004 EU/1/15/1010/005 EU/1/15/1010/006 EU/1/15/1010/007
English: Each capsule contains 30 mg or 60 mg of duloxetine (as hydrochloride).
Slovenian: Ena kapsula vsebuje 30 mg ali 60 mg duloksetina (v obliki duloksetinijevega klorida).
English: Opaque blue cap and opaque white body approximately 15.9 mm, imprinted in gold ink with ‘MYLAN' over ‘DL 30' on both the cap and the body.
Slovenian: Bela neprozorna kapsula z modrim neprozornim pokrovčkom, velikosti približno 15,9 mm in z zlatim črnilom vtisnjeno oznako ‘MYLAN' preko 'DL 30' na pokrovčku in telesu kapsule.
English: • blurred eyesight
Slovenian: • zamegljen vid
English: Adverse reactions may be more common during concomitant use of Duloxetine Mylan and herbal preparations containing St John's wort (Hypericum perforatum).
Slovenian: Ob sočasni uporabi zdravila Duloksetin Mylan in pripravkov rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), so lahko neželeni učinki pogostejši.
English: What Duloxetine Mylan contains
Slovenian: Kaj vsebuje zdravilo Duloksetin Mylan
English: PVC/PE/PVdC/Aluminium perforated unit dose blister pack containing 7 x 1 and 28 x 1 hard gastro-resistant capsules.
Slovenian: PVC/PE/PVdC/aluminijevi perforirani enoodmerni pretisni omoti s po 7 x 1 in 28 x 1 trdo gastrorezistentno kapsulo.
English: Duloxetine Mylan 30 mg hard gastro-resistant capsules Duloxetine Mylan 60 mg hard gastro-resistant capsules duloxetine (as hydrochloride)
Slovenian: Duloksetin Mylan 30 mg trde gastrorezistentne kapsule Duloksetin Mylan 60 mg trde gastrorezistentne kapsule duloksetin (v obliki duloksetinijevega klorida)
English: Malaise
Slovenian: Midriaza