FrancophonIA/ELRC3.0 huggingface dataset:
English: As with other antimuscarinics, patients should be instructed to discontinue Emselex and seek immediate medical attention if they experience oedema of the tongue or laropharynx, or difficulty breathing (see section 4.8).
Danish: Som ved andre antimuskarinika skal patienterne informeres om at stoppe med at tage Emselex og øjeblikkeligt søge lægehjælp, hvis de oplever ødem på tungen eller i svælget eller vejrtrækningsproblemer (se pkt.
English: For Emselex, these side effects have been reported to be uncommon (see section 4).
Danish: Disse bivirkninger er for Emselex rapporteret til at være ”ikke almindelige” (se pkt.
English: Injury
Danish: Skade
English: Rash, dry skin, pruritus, hyperhidrosis
Danish: Udslæt, tør hud, kløe, hyperhidrose
English: There were no effects on reproductive organs in either sex in dogs treated for 1 year at oral doses up to 6 mg/kg/day (82 times the AUC0-24h of free plasma concentration at MRHD).
Danish: Der var ingen indvirkning på reproduktionsorganerne hos hverken han- eller hunhunde behandlet i 1 år med orale doser på op til 6 mg/kg/dag (82 gange AUC0-24t af den frie plasmakoncentration ved MRHD).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON TIL MULTIPAKNINGER (INKLUSIV ”BLUE BOX”)
English: Mild hepatic impairment had no effect on the pharmacokinetics of darifenacin.
Danish: Let nedsat leverfunktion havde ingen indvirkning på darifenacins farmakokinetik.
English: For those patients requiring greater symptom relief, the dose may be increased to 15 mg daily, based on individual response.
Danish: For patienter, som behøver større symptomlindring, kan dosis øges til 15 mg daglig afhængigt af individuelt respons.
English: Other medicines and Emselex
Danish: Brug af anden medicin sammen med Emselex
English: • if you have heart diseases.
Danish: • hvis du har en hjertesygdom.
English: Aspartate aminotransferase increased, alanine aminotransferase increased Injury, poisoning, and procedural complications Uncommon
Danish: Forhøjet ASAT, forhøjet ALAT Traumer, forgiftninger og behandlingskomplikationer Ikke almindelig
English: Unbound darifenacin exposure was estimated to be 4.7-fold higher in subjects with moderate hepatic impairment than subjects with normal hepatic function (see section 4.2).
Danish: Ubundet darifenacin eksponering blev beregnet til at være 4,7 gange højere hos patienter med moderat nedsat leverfunktion sammenlignet med patienter med normal leverfunktion (se pkt.
English: Very common (may affect more than 1 in 10 people) Dry mouth, constipation.
Danish: Meget almindelige (forekomme hos mere end 1 ud af 10 patienter) Mundtørhed, forstoppelse.
English: PHARMACEUTICAL FORM AND CONTENTS 14 tablets
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 14 tabletter
English: The other ingredients are calcium hydrogen phosphate (anhydrous), hypromellose, magnesium stearate, polyethylene glycol, talc, titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172).
Danish: Øvrige indholdsstoffer: vandfrit calciumhydrogenphosphat, hypromellose, magnesiumstearat, polyethylenglycol, talcum, titandioxid (E171), rød jernoxid (E172) og gul jernoxid (E172).
English: What Emselex contains
Danish: Emselex indeholder
English: It has been shown that taking all doses at the appropriate times can greatly increase the effectiveness of your medicine.
Danish: Det er påvist, at effekten øges markant, hvis man altid tager lægemidlet på det samme tidspunkt.
English: As with other antimuscarinic agents, Emselex may produce effects such as dizziness, blurred vision, insomnia and somnolence.
Danish: Som for andre antimuskarine stoffer kan Emselex give bivirkninger såsom svimmelhed, sløret syn, søvnløshed og somnolens.
English: Emselex is contraindicated in patients with severe hepatic impairment (Child Pugh C) (see section 4.3).
Danish: Emselex er kontraindiceret hos patienter med svært nedsat leverfunktion (Child Pugh C) (se pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON FOR DELPAKNING AF MULTIPAKNINGER (UDEN ”BLUE BOX”)
English: At the dose of 50 mg/kg/day in rats (59 times the AUC0-24h of free plasma concentration at MRHD), delay in the ossification of the sacral and caudal vertebrae was observed.
Danish: Ved en dosis på 50 mg/kg/dag i rotter (59 gange AUC0-24t af den frie plasmakoncentration ved MRHD) blev der observeret forsinkelse i ossifikationen af sakrale og kaudale vertebrae.
English: This dose-dependency is probably caused by saturation of the CYP2D6 catalysed metabolism possibly together with some saturation of CYP3A4-mediated gut wall metabolism.
Danish: Denne dosisafhængighed skyldes formodentlig mætning af den CYP2D6 katalyserede metabolisme, muligvis sammen med mætning af CYP3A4-medieret metabolisme i tarmvæggen.
English: How much Emselex to take
Danish: Hvor meget Emselex skal du tage
English: The other ingredients are calcium hydrogen phosphate (anhydrous), hypromellose, magnesium stearate, polyethylene glycol, titanium dioxide (E171) and talc.
Danish: Øvrige indholdsstoffer: vandfrit calciumhydrogenphosphat, hypromellose, magnesiumstearat, polyethylenglycol, titandioxid (E171) og talcum.
English: Emselex may cause effects such as dizziness, blurred vision, trouble sleeping or drowsiness.
Danish: Emselex kan give bivirkninger såsom svimmelhed, sløret syn, søvnproblemer eller døsighed.
English: Darifenacin had no effect on male or female fertility in rats or any effect in the reproductive organs of either sex in rats and dogs (for details, see section 5.3).
Danish: Darifenacin havde ingen effekt på fertiliteten hos han- eller hunrotter eller på reproduktionsorganerne hos han/hunrotter og han/hunhunde (for detaljer, se pkt.
English: People who have taken an overdose may have dry mouth, constipation, headache, indigestion and nasal dryness.
Danish: Folk, der har taget en overdosis, kan få tørhed i munden, forstoppelse, hovedpine, fordøjelsesproblemer og tørhed i næsen.
English: Red iron oxide (E172)
Danish: Rød Jernoxid (E172)
English: Patients receiving concomitant treatment with substances that are potent inhibitors of CYP2D6 or moderate inhibitors of CYP3A4
Danish: Patienter i samtidig behandling med stoffer, som er potente hæmmere af CYP2D6 eller moderate hæmmere af CYP3A4
English: Polyethylene glycol
Danish: Polyethylenglycol
English: The incidence of adverse reactions with the doses of Emselex 7.5 mg and 15 mg decreased during the treatment period up to 6 months.
Danish: Hyppigheden af bivirkninger ved doseringerne af 7,5 mg og 15 mg Emselex faldt i løbet at behandlingsperioden på 6 måneder.
English: Metabolism Darifenacin is extensively metabolised by the liver following oral administration.
Danish: Metabolisme Darifenacin metaboliseres efter oral indgift hovedsagelig i leveren.
English: White round, convex tablet, debossed with “DF” on one side and “7.5” on the reverse.
Danish: Hvid rund, konveks tablet, præget med ”DF” på den ene side og ”7.5” på den modsatte.
English: Please also inform your doctor if you are taking products containing St John's wort.
Danish: Du skal også fortælle din læge, hvis du tager medicin, der indeholder perikon.
English: • Keep the blister packs in the outer carton in order to protect from light.
Danish: • Opbevar blisterpakningen i den ydre karton for at beskytte mod lys.
English: Reproductive system and breast disorders Uncommon
Danish: Det reproduktive system og mammae Ikke almindelig
English: Substances that are inducers of CYP3A4, such as rifampicin, carbamazepine, barbiturates and St John´s wort (Hypericum perforatum) are likely to decrease the plasma concentrations of darifenacin.
Danish: Stoffer, som er CYP3A4 induktorer, som rifampicin, carbamazepin, barbiturater og prikbladet perikum (Hypericum perforatum), vil sandsynligvis nedsætte plasmakoncentrationen af darifenacin.
English: At the dose of 30 mg/kg/day in rabbits (28 times the AUC0-24h of free plasma concentration at MRHD), maternal toxicity and foetotoxicity (increased post implantation loss and decreased number of viable foetuses per litter) were observed.
Danish: Ved en dosis på 30 mg/kg/dag i kaniner (28 gange AUC0-24t af den frie plasmakoncentration ved MRHD) blev der observeret maternal toksicitet og føtotoksicitet (øget post-implantationstab og nedsat antal levedygtige fostre per kuld).
English: There were no effects on fertility in male and female rats treated at oral doses up to 50 mg/kg/day (78 times the AUC0-24h of free plasma concentration at maximum recommended human dose [MRHD]).
Danish: Der var ikke nogen indvirkning på fertiliteten hos han- og hunrotter behandlet med orale doser på op til 50 mg/kg/dag (78 gange AUC0-24t af den frie plasmakoncentration ved den maksimalt anbefalede humane dosis [MRHD]).
English: INFORMATION IN BRAILLE Emselex 7.5 mg
Danish: INFORMATION I BRAILLE-SKRIFT Emselex 7,5 mg
English: Constipation, dry mouth
Danish: Forstoppelse, tør mund
English: What you need to know before you take Emselex 3.
Danish: Det skal du vide, før du begynder at tage Emselex 3.
English: Common (may affect up to 1 in 10 people) Headache, abdominal pain, indigestion, feeling sick, dry eyes, nasal dryness.
Danish: Almindelige bivirkninger (forekommer hos op til 1 ud af 10 patienter) Hovedpine, mavesmerter, nedsat fordøjelse, utilpashed, tørre øjne, tørhed i næsen.
English: Baseline (median)
Danish: Basisniveau (median)
English: Darifenacin AUC24 and Cmax from 30 mg once daily dosing in subjects who are extensive metabolisers were 95% and 128% higher when erythromycin (moderate CYP3A4 inhibitor) was co-administered with darifenacin than when darifenacin was taken alone.
Danish: Hos patienter med stor metabolisme var AUC24 og Cmax for darifenacin 95% og 128% højere ved doseringen 30 mg 1 gang daglig, når erythromycin (moderat CYP3A4 hæmmer) blev co-administreret med darifenacin, end når darifenacin blev taget alene.
English: Emselex should be used with caution in patients being treated for narrow-angle glaucoma (see section 4.3).
Danish: Emselex bør anvendes med forsigtighed hos patienter, som er i behandling for snævervinkel glaukom (se pkt.
English: The recommended starting dose is 7.5 mg daily.
Danish: Den anbefalede startdosering er 7,5 mg daglig.
English: Concomitant treatment with potent CYP3A4 inhibitors (see section 4.5).
Danish: • Samtidig behandling med potente CYP3A4 hæmmere (se pkt.
English: When co-administered with moderate CYP3A4 inhibitors such as erythromycin, clarithromycin, telithromycin, fluconazole and grapefruit juice, the recommended starting dose of darifenacin should be 7.5 mg daily.
Danish: Ved co-administrering med moderate CYP3A4 hæmmere, som erythromycin, clarithromycin, telithromycin, fluconazol og grapefrugtjuice, bør den anbefalede begyndelsesdosis af darifenacin være 7,5 mg daglig.
English: How long to take Emselex
Danish: Hvor længe skal man tage Emselex
English: What Emselex can be used for
Danish: Hvad bruges Emselex til
English: If you forget to take Emselex
Danish: Hvis du har glemt at tage Emselex
English: INFORMATION IN BRAILLE Emselex 15 mg
Danish: INFORMATION I BRAILLE-SKRIFT Emselex 15 mg
English: Emselex 7.5 mg and 15 mg doses significantly reduced both the severity and number of urinary urgency episodes and the number of micturitions, while significantly increasing the mean volume voided from baseline.
Danish: Emselex doser á 7,5 mg og 15 mg reducerede signifikant både alvorlighed og antallet af imperiøs vandladning og antallet af sygelig trang til vandladning, mens der ses en signifikant øgning af middelvolumen målt fra basisniveau.
English: How to take Emselex 4.
Danish: Sådan skal du tage Emselex 4.
English: Urinary retention, urinary tract disorder, bladder pain
Danish: Urinretension, urinvejsforstyrrelse, blæresmerter
English: The recommended starting dose for the elderly is 7.5 mg daily.
Danish: Den anbefalede startdosis for ældre er 7,5 mg daglig.
English: Film coat
Danish: Filmcoating
English: Keep the blister packs in the outer carton in order to protect from light.
Danish: Opbevar blisterpakningen i den ydre karton for at beskytte mod lys.
English: • antipsychotic medicines (e.g. thioridazine),
Danish: • antipsykotisk medicin (fx thioridazin),
English: • other antimuscarinic medicines (e.g. tolterodine, oxybutynin and flavoxate).
Danish: • andre antimuskarine lægemidler (fx tolterodin, oxybutynin og flavoxat).
English: Abdominal pain, nausea, dyspepsia
Danish: Mavesmerter, kvalme, dyspepsia
English: If you stop taking Emselex
Danish: Hvis du holder op med at tage Emselex
English: Darifenacin is metabolised by CYP3A4 and CYP2D6.
Danish: Darifenacin metaboliseres af CYP3A4 og CYP2D6.
English: The pharmacokinetics of darifenacin at steady state are dose-dependent, due to saturation of the CYP2D6 enzyme.
Danish: Darifenacins farmakokinetik er dosisafhængig ved steady state på grund af mætning af CYP2D6 enzymet.
English: Darifenacin is a moderate inhibitor of the enzyme CYP2D6.
Danish: Darifenacin er en moderat hæmmer af enzymet CYP2D6.
English: The information below applies to subjects who have normal CYP2D6 activity (extensive metabolisers) unless otherwise stated.
Danish: Med mindre andet er angivet gælder informationerne herunder for patienter med et normalt CYP2D6 aktivitet (stor metabolisme).
English: In the pivotal clinical trials with doses of Emselex 7.5 mg and 15 mg, adverse reactions were reported as presented in the table above.
Danish: I de kliniske studier med doseringen af 7,5 mg og 15 mg Emselex var bivirkningsrapporteringen som vist i ovenstående tabel.
English: 15 mg once daily
Danish: 1 gang daglig
English: Darifenacin pharmacokinetics were investigated in subjects with mild (Child Pugh A) or moderate (Child Pugh B) impairment of hepatic function given darifenacin 15 mg once daily to steady state.
Danish: Darifenacins farmakokinetik blev undersøgt hos en gruppe patienter med mild (Child Pugh A) eller moderat (Child Pugh B) nedsat leverfunktion.
English: Dyspnoea, cough, rhinitis
Danish: Dyspnø, hoste, rinit
English: • antifungal medicines (e.g. ketoconazole and itraconazole),
Danish: • medicin mod svampeinfektion (fx ketoconazol og itraconazol),
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 October 2004
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Emselex should be taken with caution while breast-feeding.
Danish: Brug af Emselex bør ske med forsigtighed under amning.
English: • antiviral medicines (e.g. nelfinavir and ritonavir),
Danish: • antivirale lægemidler (fx nelfinavir og ritonavir),
English: In patients receiving substances that are potent CYP2D6 inhibitors (e.g. paroxetine, terbinafine, cimetidine and quinidine) the recommended starting dose should be 7.5 mg daily.
Danish: Til patienter, som får stoffer, der er potente CYP2D6 hæmmere (f.eks. paroxetin, terbinafin, cimetidin og quinidin), er den anbefalede begyndelsesdosis 7,5 mg daglig.
English: Darifenacin undergoes significant metabolism by cytochrome CYP3A4 and CYP2D6 in the liver and by CYP3A4 in the gut wall.
Danish: Darifenacin undergår signifikant metabolisme af cytochrom CYP3A4 og CYP2D6 i leveren og i tarmvæggen af CYP3A4.
English: Do not stop taking Emselex until your doctor tells you to. You should not experience any effects when you stop treatment.
Danish: Du må ikke stoppe behandlingen med Emselex, før din læge siger, at du skal.
English: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
English: Table 1: Adverse reactions with Emselex 7.5 mg and 15 mg prolonged-release tablets
Danish: Tabel 1: Bivirkninger for Emselex 7,5 mg og 15 mg depottabletter
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Psychiatric disorders Uncommon
Danish: Psykiske forstyrrelser Ikke almindelig
English: CYP2D6 inhibitors
Danish: CYP2D6 substrater
English: What Emselex looks like and contents of the pack Emselex 7.5 mg prolonged-release tablets are round, convex white tablets and are debossed with “DF” on one side and “7.5” on the other.
Danish: Emselex 7,5 mg depottabletter er runde, konvekse, hvide tabletter, som er præget med ”DF” på den ene side og ”7.5” på den anden.
English: Each tablet contains 15 mg darifenacin (as hydrobromide).
Danish: Hver tablet indeholder 15 mg darifenacin (som hydrobromid).
English: Antimuscarinic agents
Danish: Antimuskarine stoffer
English: Each tablet contains 7.5 mg darifenacin (as hydrobromide).
Danish: Hver tablet indeholder 7,5 mg darifenacin (som hydrobromid).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF UNIT PACK
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL ENKELT PAKNING
English: • certain antidepressants (e.g. imipramine),
Danish: • bestemte typer af medicin mod depression (fx imipramin),
English: How Emselex works
Danish: Hvordan virker Emselex
English: You should check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller på apoteket hvis der er noget, du er i tvivl om.
English: Oedema peripheral, asthenia, face oedema, oedema
Danish: Perifert ødem, asteni, ansigtsødem, ødem
English: Food had no effect on darifenacin pharmacokinetics during multiple-dose administration of prolonged-release tablets.
Danish: Fødeindtagelse har ingen indvirkning på darifenacins farmakokinetik ved kontinuerlig indtagelse af depottabletterne.
English: During treatment with Emselex, tell your doctor straight away and stop taking Emselex if you experience swelling of the face, lips, tongue and/or throat (signs of angioedema).
Danish: Hvis du oplever hævelse af ansigt, læber, tunge og/eller svælg (tegn på angioødem) under behandling med Emselex, skal du straks kontakte lægen og stoppe med at tage Emselex.
English: CYP2D6 poor metabolisers
Danish: Patienter med beskeden CYP2D6 metabolisme
English: What Emselex looks like and contents of the pack Emselex 15 mg prolonged-release tablets are round, convex light peach tablets and are debossed with “DF” on one side and “15” on the other.
Danish: Emselex 15 mg depottabletter er runde, konvekse, let ferskenfarvede tabletter, som er præget med ”DF” på den ene side og ”15” på den anden.
English: Change from baseline (median)
Danish: Ændring fra basisniveau (median)
English: • if you suffer from urinary retention (inability to empty your bladder).
Danish: • hvis du har besvær med at tømme blæren (urinretension).
English: Light peach round, convex tablet debossed with “DF” on one side and “15” on the reverse.
Danish: Let ferskenfarvet rund, konveks tablet præget med ”DF” på den ene side og ”15” på den anden.
English: • if you have liver problems.
Danish: • hvis du har fordøjelsesproblemer.
English: Effects of darifenacin on other medicinal products CYP2D6 substrates
Danish: Effekt af darifenacin på andre lægemidler
English: Effects of other medicinal products on darifenacin Darifenacin metabolism is primarily mediated by the cytochrome P450 enzymes CYP2D6 and CYP3A4.
Danish: Darifenacins metabolisme medieres primært af cytochrom P450 enzymer CYP2D6 og CYP3A4.
English: What you need to know before you take Emselex
Danish: Det skal du vide, før du begynder at tage Emselex
English: • if you suffer from uncontrolled narrow-angle glaucoma (high pressure in the eyes with loss of eyesight that is not being adequately treated).
Danish: • hvis du har højt tryk i øjet med tab af synet og ikke bliver behandlet for dette (snævervinklet glaukom).
English: • certain medicines used to treat heart problems (e.g. flecainide, verapamil and digoxin),
Danish: • visse typer af medicin som bruges til behandling af problemer med hjertet (fx flecainid,
English: Gastric retention.
Danish: • Ventrikelretention.
English: Yellow iron oxide (E172)
Danish: Gul Jernoxid (E172)
English: Emselex 15 mg prolonged-release tablets Darifenacin
Danish: Emselex 15 mg depottabletter Darifenacin
English: The metabolism of darifenacin in CYP2D6 poor metabolisers is principally mediated by CYP3A4.
Danish: Principielt er metabolismen af darifenacin hos patienter med beskeden CYP2D6 metabolisme medieret af CYP3A4.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg darifenacin (as hydrobromide).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 15 mg darifenacin (som hydrobromid).
English: Emselex 7.5 mg prolonged-release tablets Darifenacin
Danish: Emselex 7,5 mg depottabletter Darifenacin
English: NAME OF THE MEDICINAL PRODUCT Emselex 7.5 mg prolonged-release tablets
Danish: LÆGEMIDLETS NAVN Emselex 7,5 mg depottabletter
English: NAME OF THE MEDICINAL PRODUCT Emselex 15 mg prolonged-release tablets
Danish: LÆGEMIDLETS NAVN Emselex 15 mg depottabletter
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 7.5 mg darifenacin (as hydrobromide).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 7,5 mg darifenacin (som hydrobromid).
English: The initial products of the hydroxylation and N-dealkylation pathways are major circulating metabolites but none contribute significantly to the overall clinical effect of darifenacin.
Danish: De initiale metabolitter som dannes ved hydroxylering og N-dealkylering er de vigtigste cirkulerende hovedmetabolitter.
English: (PVC/PVDC/alu blisters)
Danish: (PVC/PVDC/ALU blister)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 7.5 mg of darifenacin (as hydrobromide) For the full list of excipients, see section 6.1.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 7,5 mg darifenacin (som hydrobromid) Alle hjælpestoffer er anført under pkt.
English: For both doses of 7.5 mg and 15 mg, the percentage median reduction from baseline in the number of incontinence episodes per week was similar between males and females.
Danish: Den procentvise median reduktion i antallet af inkontinensepisoder pr. uge i forhold til basisniveau var for både 7,5 mg og 15 mg, ens for mænd og kvinder.
English: • if you have gastric retention (problems emptying the contents of the stomach).
Danish: • hvis du har svært ved at tømme mavesækken for indhold (ventrikelretention).
English: (PVC/CTFE/alu blisters)
Danish: (PVC/CTFE/alu blister)
English: NAME OF THE MEDICINAL PRODUCT Emselex 7.5 mg prolonged-release tablets darifenacin
Danish: LÆGEMIDLETS NAVN Emselex 7,5 mg depottabletter darifenacin
English: NAME OF THE MEDICINAL PRODUCT Emselex 15 mg prolonged-release tablets darifenacin
Danish: LÆGEMIDLETS NAVN Emselex 15 mg depottabletter darifenacin
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 15 mg of darifenacin (as hydrobromide) For the full list of excipients, see section 6.1.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 15 mg darifenacin (som hydrobromid) Alle hjælpestoffer er anført under pkt.
English: A decision whether to avoid breast-feeding or to abstain from Emselex therapy during lactation should be based on a benefit and risk comparison.
Danish: Der bør foretages en vurdering af fordele og risiciene, når der skal tages en beslutning om at undlade amning eller at undlade Emselexbehandling under amning.
English: Darifenacin should not be used together with potent CYP3A4 inhibitors (see section 4.3) such as protease inhibitors (e.g. ritonavir), ketoconazole and itraconazole.
Danish: 4.3), så som proteasehæmmere (f.eks. ritonavir), ketoconazol og itraconazol.
English: Paediatric patients The pharmacokinetics of darifenacin have not been established in the paediatric population.
Danish: Børn Der er ikke foretaget farmakokinetiske undersøgelser med darifenacin hos børn.