FrancophonIA/ELRC3.0 huggingface dataset:
English: Excipient(s) with known effect: each capsule contains 42.26 - 46.57 mg of sucrose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver kapsel indeholder 42,26 - 46,57 mg saccharose.
English: Talk to your doctor before taking Duloxetine Zentiva if you:
Danish: Kontakt lægen, før du tager Duloxetine Zentiva, hvis du:
English: S.C. Zentiva S.A Theodor Pallady Nr 50 032266 Bucharest Romania
Danish: S.C. Zentiva S.A Theodor Pallady Nr 50 032266 Bucharest Rumænien
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).
Danish: Som konsekvens heraf anbefales det at udvise forsigtighed, når duloxetin tages sammen med andre centralt virkende lægemidler eller stoffer, herunder alkohol og sederende lægemidler (f.eks. benzodiazepiner, morphinlignende præparater, antipsykotika, phenobarbital, sederende antihistaminer).
English: Anticoagulants and antiplatelet agents
Danish: Antikoagulantia og antitrombotiske midler
English: Stomatitis Haematochezia Breath odour Microscopic colitis9
Danish: Stomatitis Hæmatokeksi Dårlig ånde Mikroskopisk colitis9
English: In rare cases, serotonin syndrome has been reported in patients using SSRIs/SNRIs concomitantly with serotonergic agents.
Danish: Der er i sjældne tilfælde rapporteret om serotoninsyndrom hos patienter i behandling med SSRI/SNRIpræparater sammen med serotonerge lægemidler.
English: DO NOT stop taking your capsules without the advice of your doctor even if you feel better.
Danish: Hvis du holder op med at tage Duloxetine Zentiva DU MÅ IKKE holde op med at tage kapslerne uden at have konsulteret din læge, heller ikke selv om du har fået det bedre.
English: Reproductive system and breast disorders Erectile dysfunction
Danish: Det reproduktive system og mammae Erektil dysfunktion Ejakulationsforstyrrelser
English: • Medicines that cause sleepiness: These include medicines prescribed by your doctor including benzodiazepines, strong painkillers, antipsychotics, phenobarbital and antihistamines.
Danish: • Medicin, der kan virke sløvende: Dette omfatter receptpligtig medicin inklusive benzodiazepiner, stærk smertestillende medicin, antipsykotika, phenobarbital og antihistaminer.
English: • trouble sleeping, feeling agitated, less sex drive, anxiety, difficulty or failure to experience orgasm, unusual dreams;
Danish: • søvnbesvær, ophidselse, mindre lyst til sex, angst, problemer med at opnå orgasme, mærkelige drømme
English: Suicidal ideation5,7
Danish: Selvmordstank er 5,7
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.
Danish: Erfaringer fra undersøgelser har vist, at der er en øget risiko for selvmordsadfærd hos unge under 25 år med en psykisk forstyrrelse, som bliver behandlet med antidepressiv medicin.
English: The pharmacokinetics of theophylline, a CYP1A2 substrate, were not significantly affected by coadministration with duloxetine (60 mg twice daily).
Danish: Theophyllins, et CYP1A2-substrat, farmakokinetik blev ikke påvirket signifikant ved samtidig behandling med duloxetin (60 mg to gange daglig).
English: Duloxetine should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/or seizures.
Danish: Duloxetine Zentiva skal anvendes med forsigtighed til patienter med en anamnese med mani eller en diagnose med bipolar forstyrrelse og/eller krampeanfald.
English: However, as with any medicine, caution should be exercised when treating the elderly, especially with duloxetine 120 mg per day for major depressive disorder or generalised anxiety disorder, for which data are limited (see sections 4.4 and 5.2).
Danish: Der bør dog som for al anden medicin udvises forsigtighed ved behandling af ældre, især ved behandling med duloxetin 120 mg daglig for moderate til svære depressioner eller generaliseret angst, da der er begrænsede data tilgængelige (se pkt.
English: Duloxetine Zentiva is indicated in adults.
Danish: Duloxetine Zentiva er indiceret til voksne.
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).
Danish: Duloxetin bør ikke anvendes til børn og unge under 18 år til behandling af major depression på grund af problemstillinger vedrørende sikkerhed og virkning (se pkt.
English: • fainting, dizziness, light-headedness or fainting on standing up, cold fingers and/or toes;
Danish: • besvimelse, svimmelhed, uklarhed eller besvimelse efter at have rejst sig op, kolde fingre og/eller tæer
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).
Danish: Duloxetine Zentiva må ikke anvendes sammen med fluvoxamin, ciprofloxacin eller enoxacin (dvs. potente CYP1A2 hæmmere), idet kombinationen resulterer i forhøjet plasmakoncentration af duloxetin (se pkt.
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.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med duloxetin i alle undergrupper af den pædiatriske population med moderat til svær depression, diabetisk neuropatisk smerte og generaliseret angst.
English: A total of 467 paediatric patients initially randomized to duloxetine in clinical trials experienced a 0.1 kg mean decrease in weight at 10-weeks compared with a 0.9 kg mean increase in 353 placebotreated patients.
Danish: 467 pædiatriske patienter, som blev randomiseret til behandling med duloxetin i kliniske studier, havde efter 10 uger et gennemsnitligt vægttab på 0,1 kg sammenlignet med en gennemsnitlig vægtstigning på 0,9 kg hos 353 placebobehandlede patienter.
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.
Danish: Duloxetin viste statistisk signifikant fordel i forhold til placebo i fem ud af fem studier inklusive fire randomiserede, dobbeltblinde, placebokontrollerede akutstudier og et studie af forebyggelse af tilbagefald hos voksne patienter med generaliseret angst.
English: Manufacturer S.C. Zentiva S.A Theodor Pallady Nr 50 032266 Bucharest Romania
Danish: Fremstiller S.C. Zentiva S.A Theodor Pallady Nr 50 032266 Bukarest Rumænien
English: Duloxetine was studied in a clinical programme involving 3,158 patients (1,285 patient-years of exposure) meeting DSM-IV criteria for major depression.
Danish: I et klinisk forsøgsprogram med 3.158 patienter (svarende til 1.285 patientår) blev duloxetin undersøgt mod DSM-IV kriterierne for moderate til svære depressioner.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG
English: However, concomitant administration of duloxetine with warfarin under steady state conditions, in healthy volunteers, as part of a clinical pharmacology study, did not result in a clinically significant change in INR from baseline or in the pharmacokinetics of R- or Swarfarin.
Danish: Hos raske forsøgspersoner i et klinisk farmakologisk studie resulterede co-administration af duloxetin med warfarin ved steady state dog ikke i en klinisk signifikant ændring i INR fra baseline eller i farmakokinetikken af R- eller Swarfarin.
English: Hypromellose acetate succinate Triethyl citrate
Danish: Hypromelloseacetatsuccinat Triethylcitrat
English: Also, you need to wait at least 5 days after you stop taking Duloxetine Zentiva before you take a MAOI.
Danish: Du skal ligeledes vente mindst 5 dage, efter at du er holdt op med at tage Duloxetine Zentiva, før du må begynde at tage en MAO-hæmmer.
English: Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing Duloxetine Zentiva to patients with increased intraocular pressure, or those at risk of acute narrow-angle glaucoma.
Danish: Der er rapporteret om tilfælde af mydriasis i forbindelse med duloxetin, og der skal derfor udvises forsigtighed ved udskrivning af Duloxetine Zentiva til patienter med forhøjet intraokulært tryk eller til patienter med risiko for akut snævervinklet glaukom.
English: • abnormal vaginal bleeding, abnormal periods, including heavy, painful, irregular or prolonged periods, unusually light or missed periods, pain in the testicles or scrotum;
Danish: • unormal vaginalblødning, unormal menstruation herunder voldsom, smertefuld, uregelmæssig eller forlænget blødning, usædvanlig sparsom eller manglende menstruation, smerter i testiklerne eller pungen
English: Duloxetine Zentiva is available in 2 strengths: 30 mg and 60 mg.
Danish: Duloxetine Zentiva findes i to styrker: 30 mg og 60 mg.
English: Some fatalities have occurred, primarily with mixed overdoses, but also with duloxetine alone at a dose of approximately 1,000 mg. Signs and symptoms of overdose (duloxetine alone or in combination with other medicinal products) included somnolence, coma, serotonin syndrome, seizures, vomiting and tachycardia.
Danish: Der har dog også været tilfælde med duloxetin alene i doser på omkring 1000 mg. Tegn og symptomer på overdosering (duloxetin alene eller sammen med andre lægemidler) omfatter søvnighed, koma, serotoninsyndrom, kramper, opkastning og takykardi.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Danish: Bør ikke anvendes til patienter med hereditær fructoseintolerans, glucose/galactosemalabsorption og sucrase-isomaltasemangel.
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).
Danish: Ved ophør af behandling med Duloxetine Zentiva skal dosis gradvis reduceres over en periode på mindst en til to uger for at mindske risikoen for seponerings-symptomer (se pkt.
English: Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on haemodialysis (creatinine clearance <30 ml/min).
Danish: Forhøjede plasmakoncentrationer af duloxetin forekommer hos patienter med svært nedsat nyrefunktion i hæmodialyse (kreatininclearance < 30 ml/min).
English: Duloxetine demonstrated statistical superiority over placebo as measured by improvement in the 17item Hamilton Depression Rating Scale (HAM-D) total score (including both the emotional and somatic symptoms of depression).
Danish: Duloxetin viste sig signifikant bedre end placebo målt som forbedring i total score på Hamilton 17punkts skalaen (HAM-D) (inklusiv både følelses og somatiske symptomer ved depression).
English: The elimination half-life of duloxetine ranges from 8 to 17 hours (mean of 12 h).
Danish: Halveringstiden for duloxetin ligger på 8-17 timer (gns.
English: The concomitant use of Duloxetine Zentiva with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4).
Danish: Samtidig brug af Duloxetine Zentiva og selektive, reversible MAO-hæmmere, som f.eks. moclobemid, anbefales ikke (se pkt.
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.
Danish: Idet data for ældre patienter udsat for den maksimale dosis (120 mg daglig) er begrænset anbefales det derfor at der udvises forsigtighed, når denne befolkningsgruppe behandles.
English: • are taking St. John's Wort, a herbal treatment (Hypericum perforatum);
Danish: • tager et naturlægemiddel, som indeholder perikon (Hypericum perforatum).
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.
Danish: Behandling med duloxetin gav en statistisk signifikant større forbedring af symptomerne på generaliseret angst målt med PARS sværhedsscore for generaliseret angst (gennemsnitlig forskel på 2,7 point [95 % CI 1,3-4,0] mellem duloxetin og placebo) efter 10 ugers behandling.
English: Duloxetine Zentiva 30 mg gastro-resistant hard capsules EU/1/15/1028/001
Danish: Duloxetine Zentiva 30 mg hårde enterokapsler EU/1/15/1028/001
English: • dehydration, low levels of sodium in the blood (mostly in elderly people; the symptoms may include feeling dizzy, weak, confused, sleepy or very tired, or feeling or being sick, more serious symptoms are fainting, fits or falls), syndrome of inappropriate secretion of anti-diuretic hormone (SIADH);
Danish: • dehydrering (væskemangel), lavt indhold af natrium i blodet (oftest hos ældre mennesker; symptomerne omfatter bl.a. svimmelhed, svaghed, forvirring, søvnighed eller udpræget træthed eller kvalme og opkastning; mere alvorlige symptomer er besvimelse, krampeanfald eller fald), syndrom med uhensigtsmæssig sekretion af anti-diuretisk hormon (SIADH)
English: • increased pressure in the eye (glaucoma);
Danish: • øget tryk i øjet (grøn stær, glaukom)
English: Therefore Duloxetine Zentiva should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Danish: Duloxetine Zentiva bør derfor ikke gives i kombination med potente CYP1A2-hæmmere som fluvoxamin (se pkt.
English: The efficacy of duloxetine 30-120 mg (flexible dosing) once a day in elderly patients (>65 years) with generalised anxiety disorder was evaluated in a study that demonstrated statistically significant improvement in the HAM-A total score for duloxetine treated patients compared to placebo treated patients.
Danish: Effekten af duloxetin 30-120 mg (fleksibel dosering) en gang dagligt hos ældre patienter (> 65 år) med generaliseret angst blev evalueret i et studie, som viste statistisk signifikant forbedring i HAM-A totalscoren hos duloxetinbehandlede patienter sammenlignet med placebobehandlede patienter.
English: Current available data are described in sections 4.8, 5.1 and 5.2.
Danish: 4.4, 4.8 og 5.1).
English: Duloxetine Zentiva 60 mg gastro-resistant hard capsules EU/1/15/1028/004
Danish: Duloxetine Zentiva 60 mg hårde enterokapsler EU/1/15/1028/004
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.
Danish: Duloxetin 60 mg til 120 mg en gang daglig viste statistisk signifikant fordel sammenlignet med placebo (p<0.0001) ved forebyggelse af tilbagefald målt som tid til tilbagefald.
English: If you forget to take Duloxetine Zentiva
Danish: Hvis du har glemt at tage Duloxetine Zentiva
English: The main ingredient of Duloxetine Zentiva, duloxetine, is used in other medicines for other conditions: diabetic neuropathic pain, depression, anxiety and urinary incontinence.
Danish: Det aktive stof (duloxetin) i Duloxetine Zentiva bruges i andre lægemidler mod andre tilstande: Diabetisk neuropatisk smerte, depression, angst og stressinkontinens.
English: • inflammation of the mouth, passing bright red blood in your stools, bad breath, inflammation of the large intestine (leading to diarrhoea);
Danish: • betændelse i mundhulen, frisk rødt blod i afføringen, dårlig ånde, betændelse i tyktarmen (medfører diaré)
English: • suicidal thoughts, difficulty sleeping, grinding or clenching the teeth, feeling disorientated, lack of motivation;
Danish: • selvmordstanker, søvnbesvær, tænderskæren eller sammenbidte tænder, desorientering, manglende motivation
English: • liver failure, yellowing of the skin or whites of the eyes (jaundice);
Danish: • leversvigt, gulfarvning af huden eller det hvide i øjnene (gulsot)
English: • Medicines that increase the level of serotonin: Triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), SNRIs (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, St. John's Wort and MAOIs (such as moclobemide and linezolid).
Danish: • Medicin, der øger niveauet af serotonin: Triptaner, tramadol, tryptophan, SSRI-præparater (såsom paroxetin og fluoxetin), SNRI-præparater (såsom venlafaxin), tricykliske antidepressiva (såsom clomipramin, amitriptylin), pethidin, perikon og MAO-hæmmere (såsom moclobemid og linezolid).
English: Eosinophilic pneumonia6
Danish: Eosinofil pneumoni6
English: The initiation of treatment with Duloxetine Zentiva is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis (see sections 4.4 and
Danish: For patienter med ukontrolleret hypertension er der kontraindikation for opstart af behandling med Duloxetine Zentiva, da det kan udsætte patienterne for en potentiel risiko for hypertensive kriser (se pkt.
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.
Danish: Blødningsabnormaliteter såsom ekkymoser, purpura og gastrointestinal blødning er set ved brug af selektive serotoningenoptagshæmmere (SSRI-præparater) og serotonin/noradrenalingenoptagshæmmere (SNRI-præparater), herunder duloxetin.
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).
Danish: På baggrund af duloxetins halveringstid skal der gå mindst 5 dage efter endt behandling med Duloxetine Zentiva, før en behandling med en MAO-hæmmer påbegyndes (se pkt.
English: Data on the use of duloxetine 120 mg in elderly patients with major depressive disorder and generalised anxiety disorder are limited.
Danish: Der er begrænsede data om brug af duloxetin 120 mg til ældre patienter med svær depression eller generaliseret angst.
English: • feeling of dizziness or “spinning” (vertigo), ear pain;
Danish: • følelse af at være ”rundtosset” (vertigo), ørepine
English: Duloxetine Zentiva is used in adults to treat:
Danish: Duloxetine Zentiva anvendes hos voksne til behandling af
English: During 52 weeks of placebo-controlled double blind treatment, duloxetine-treated patients with recurrent MDD had a significantly longer symptom free period (p < 0.001) compared with patients randomised to placebo.
Danish: I løbet af 52 ugers placebo-kontrolleret dobbeltblind behandling, havde duloxetin-behandlede patienter med tilbagevendende moderat til svær depression, en signifikant længere symptomfri periode (p < 0,001) sammenlignet med placebo-randomiserede patienter.
English: Serotonin syndrome6 Convulsion1
Danish: Serotonin-syndrom6 Kramper1
English: Duloxetine Zentiva contains the active substance duloxetine.
Danish: Duloxetine Zentiva indeholder det aktive stof duloxetin.
English: As with other serotonergic agents, serotonin syndrome, a potentially life-threatening condition, may occur with duloxetine treatment, particularly with concomitant use of other serotonergic agents (including SSRIs, SNRIs tricyclic antidepressants or triptans), with agents that impair metabolism of serotonin such as MAOIs, or with antipsychotics or other dopamine antagonists that may affect the serotonergic neurotransmitter systems (see sections 4.3 and 4.5).
Danish: Som ved andre serotonerge lægemidler kan den potentielt livstruende tilstand, serotoninsyndrom, forekomme ved behandling med duloxetin, især i kombination med andre serotonerge lægemidler (inklusive SSRI'er, SNRI'er, tricykliske antidepressiva eller triptaner), med lægemidler, som hæmmer metabolismen af serotonin som f.eks. MAOI'er, eller med antipsykotika eller andre dopaminantagonister, som kan påvirke de serotonerge transmittersystemer (se pkt.
English: • have a history of bleeding disorders (tendency to develop bruises), especially if you are pregnant (see ‘Pregnancy and breast-feeding‘);
Danish: • tidligere har lidt af blødningsforstyrrelser (tendens til blå mærker), især hvis du er gravid (se
English: • are taking other medicines containing duloxetine (see ‘Other medicines and Duloxetine Zentiva')
Danish: • hvis du tager andre lægemidler indeholdende duloxetin (se "Brug af anden medicin sammen med Duloxetine Zentiva").
English: Medicinal products metabolised by CYP1A2
Danish: Lægemidler, der metaboliseres via CYP1A2
English: • inflammation of the liver that may cause abdominal pain and yellowing of the skin or whites of the eyes;
Danish: • betændelse i leveren, som kan give mavesmerter og gulfarvning af huden eller det hvide i øjnene
English: Caution is advised if duloxetine 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).
Danish: Det anbefales at udvise forsigtighed ved administration af duloxetin sammen med præparater, som hovedsageligt metaboliseres via CYP2D6 (risperidon, tricycliske antidepressiva [TCA'er] såsom nortriptylin, amitriptylin og imipramin), specielt hvis disse præparater har et snævert terapeutisk indeks (som f.eks. flecainid, propafenon og metoprolol).
English: Gynaecological haemorrhage Menstrual disorder Sexual dysfunction Testicular pain
Danish: Menstruations forstyrrelser Seksuel dysfunktion Smerter i testiklerne
English: • chest pain, feeling cold, thirst, shivering, feeling hot, abnormal gait;
Danish: • brystsmerter, kuldefølelse, tørst, skælven, varmefølelse, unormal gangart
English: As the safety of duloxetine in infants is not known, the use of duloxetine while breast-feeding is not recommended.
Danish: Eftersom sikkerheden af duloxetin hos spædbørn ikke er kendt, frarådes behandling med duloxetin i ammeperioden.
English: • are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI) (see ‘Other medicines and Duloxetine Zentiva');
Danish: • tager, eller inden for de sidste 14 dage har været i behandling med, en monoaminoxidasehæmmer (MAO-hæmmer) (se "Brug af anden medicin sammen med
English: Pharmacotherapeutic group: Other antidepressants, ATC code: N06AX21
Danish: ATC-kode: N06AX21
English: LIST OF EXCIPIENTS Contains sucrose.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder succharose.
English: Capsule content Sucrose
Danish: Kapselindhold Saccharose
English: • decreased thyroid gland activity which can cause tiredness or weight gain;
Danish: • nedsat aktivitet af skjoldbruskkirtlen, som kan forårsage træthed eller vægtøgning
English: Hyponatraemia has been reported when administering duloxetine, including cases with serum sodium lower than 110 mmol/l.
Danish: Hyponatriæmi, herunder tilfælde med serum-natriumværdier under 110 mmol/l, er blevet rapporteret efter indgivelse af duloxetin.
English: These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with Duloxetine Zentiva, you should see your doctor.
Danish: Oplever du uventede virkninger, mens du tager en af disse typer medicin sammen med Duloxetine Zentiva, skal du kontakte din læge.
English: Duloxetine Zentiva 60 mg is available in packs of 28, 56, 84 and 98 capsules.
Danish: Duloxetine Zentiva 60 mg findes i pakning med 28, 56, 84 og 98 kapsler.
English: Extra-pyramidal symptoms6
Danish: Psykomotorisk uro6 Ekstra-pyramidale symptomer6