FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH proposed text also included an additional comment concerning the use of ACE inhibitors in patients with liver cirrhosis and ascites, as suggested by the CHMP for the EU harmonized Vascace SPC.
Slovenian: Predlagano besedilo imetnika dovoljenja za promet z zdravilom je vključevalo tudi dodatno pripombo glede uporabe zaviralcev ACE pri bolnikih s cirozo jeter in ascitesom, v skladu s predlogom CHMP za usklajeno besedilo povzetka glavnih značilnosti zdravila Vascace v EU.
English: The MAH, to support the proposed section 4.4, presented reviews of adverse effects of ACE inhibitors and thiazide diuretics from the scientific literature avaible:
Slovenian: Imetnik dovoljenja za promet z zdravilom je v podporo predlaganemu besedilu za poglavje 4.4 na podlagi razpoložljive znanstvene literature predstavil pregled neželenih učinkov zaviralcev ACE in tiazidnih diuretikov:
English: The proposed text for hepatic disorders incorporated all the information which was provided in the CDS and in local SPCs for Vascace Plus, and was consistent with wording used in the reviews in Meyler and Martindale.
Slovenian: Predlagano besedilo za jetrna obolenja je vključevalo vse podatke, ki so bili vključeni na podatkovni list s temeljnimi podatki in lokalne povzetke glavnih značilnosti zdravila Vascace Plus, in je bilo skladno z besedilom, uporabljenim v literaturi Meylerja in Martindalea.
English: The MAH proposed as harmonised text the following wording: “Vascace Plus is indicated for the treatment of hypertension in patients whose blood pressure is not adequately controlled with cilazapril alone or hydrochlorothiazide alone and who have been stabilized on the individual components given in the same proportions.”
Slovenian: Imetnik dovoljenja za promet je za usklajeno besedilo predlagal: „Zdravilo Vascace Plus je indicirano za zdravljenje hipertenzije pri bolnikih, pri katerih zdravljenje hipertenzije bodisi samo s cilazaprilom ali samo s hidroklorotiazidom ne zagotavlja ustreznega uravnavanja krvnega tlaka in katerih stanje je bilo stabilizirano z jemanjem posameznih zdravilnih učinkovin, odmerjenih v enakem razmerju.“
English: For ADRs listed in the SPC that were not reported in the clinical trials, the relevant frequency category had been assigned using the `rule of 3' approach recommended in the SmPC guideline.
Slovenian: Za neželene učinke zdravila, ki so bili navedeni v povzetku glavnih značilnosti zdravila, vendar o njih niso poročali v kliničnem preskušanju, je bila določena kategorija pomembne pogostnosti v skladu s pristopom „pravila treh“, kot ga priporoča smernica za povzetek glavnih značilnosti zdravila.
English: The information on HCTZ overdose is consistent with other approved ACEI and hydrochlorothiazide combinations (ramipril/HCTZ) SPC.
Slovenian: Podatki o prekomernem odmerjanju hidroklorotiazida so skladni z drugimi potrjenimi povzetki glavnih značilnosti zdravil s kombinacijami zaviralcev ACE in hidroklorotiazida (ramipril/hidroklorotiazid).
English: The CHMP endorsed the harmonised text.
Slovenian: CHMP je potrdil usklajeno besedilo.
English: The CHMP agreed the following: “When concomitant diuretic therapy is required in patients with severe renal impairment, a loop diuretic rather than a thiazide diuretic is preferred for use with cilazapril.
Slovenian: CHMP je potrdil besedilo: „Kadar je pri bolnikih s hudo okvaro ledvic potrebno sočasno zdravljenje z diuretiki, se za uporabo skupaj s cilazaprilom namesto tiazidnih diuretikov priporočajo diuretiki Henlejeve zanke.
English: Section 4.2 Posology and Method of Administration
Slovenian: Poglavje 4.2 Odmerjanje in način uporabe
English: The MAH proposed to include a warning concerning gout in section 4.4.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal, da se v poglavje 4.4 doda opozorilo glede protina.
English: Description of selected adverse reactions as follows: “Headache is a commonly reported adverse event, although the incidence of headache is greater in patients receiving placebo than in those receiving cilazapril + hydrochlorothiazide”.
Slovenian: V podpoglavje (c) Opis določenih neželenih učinkov je bila dodana pojasnjevalna opomba, ki se glasi: „Pogosto so kot o neželenem učinku poročali o glavobolu, čeprav je bila pojavnost glavobola večja pri bolnikih, ki so prejemali placebo, v primerjavi s tistimi, ki so prejemali cilazapril in hidroklorotiazid.“
English: The CHMP endorsed the harmonised wording under this section.
Slovenian: CHMP je potrdil usklajeno besedilo v tem poglavju.
English: The MAH agreed with the CHMP comment and the wording recommended by the PhVWP was used as harmonised text.
Slovenian: Imetnik dovoljenja za promet z zdravilom se je strinjal s pripombo CHMP in v usklajenem besedilu uporabil besedilo, ki ga je priporočila delovna skupina za farmakovigilanco.
English: The original proposed text concerning the hydrochlorothiazide component of Vascace Plus was already in agreement with the PhVWP wording.
Slovenian: Prvotno predlagano besedilo o učinkovini hidroklorotiazid v zdravilu Vascace Plus je bilo že skladno z besedilom delovne skupine za farmakovigilanco, zato ni bilo spremenjeno.
English: The MAH proposed to include a separate warning concerning this issue in section 4.4.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal, da se v zvezi s tem v poglavje 4.4 doda posebno opozorilo.
English: The text proposed by the MAH and endorsed by CHMP for anaphylaxis was consistent with the current Vascace Plus CDS and reviews of ACE inhibitors in Meyler and Martindale.
Slovenian: Besedilo za anafilakso, ki ga je predlagal imetnik dovoljenja za promet z zdravilom, CHMP pa ga je potrdil, je bilo skladno s trenutno veljavnim podatkovnim listom s temeljnimi podatki za zdravilo Vascace Plus in pregledom zaviralcev ACE v literaturi Meylerja in Martindalea.
English: The ADR ‘lupus like syndrome' is now listed under the SOC Immune System Disorders in both subsections of the table of ADRs (i.e., ADRs attributable to cilazapril and ADRs attributable to HCTZ).
Slovenian: Neželeni učinek „lupusu podoben sindrom“ je zdaj v razvrstitvi organskih sistemov naveden pod razdelkom Motnje imunskega sistema v obeh podpoglavjih preglednice neželenih učinkov (tj. neželenih učinkov, povezanih s cilazaprilom, in neželenih učinkov, povezanih s hidroklorotiazidom).
English: The CHMP acknowledged that the cilazapril part of this section had been aligned with the approved Vascace SPC.
Slovenian: CHMP je opazil, da je bil del tega poglavja v zvezi s cilazaprilom usklajen z odobrenim povzetkom glavnih značilnosti zdravila Vascace.
English: Several clinical trials showed that doses of 5 mg cilazapril and 12.5 mg hydrochlorothiazide generated a greater reduction in blood pressure than either of the individual components in patients with mild to moderate hypertension whose blood pressure could not be normalized with cilazapril alone.
Slovenian: Več kliničnih preskušanj je pokazalo, da je pri bolnikih z blago do zmerno hipertenzijo, pri katerih krvnega tlaka ni bilo mogoče normalizirati samo s cilazaprilom, s kombinacijo 5 mg cilazaprila in 12,5 mg hidroklorotiazida prišlo do večjega znižanja krvnega tlaka kot s katero koli posamezno sestavino.
English: Some SPCs included a detailed description of the symptoms of anaphylaxis.
Slovenian: Nekateri povzetki glavnih značilnosti zdravila so vključevali podroben opis simptomov anafilakse.
English: The CHMP asked the MAH to align the SPC for Vascace Plus with the approved SPC of Vascace and endorsed the harmonized wording for this subparagraph.
Slovenian: CHMP je imetnika dovoljenja za promet z zdravilom zaprosil, da uskladi povzetek glavnih značilnosti zdravila Vascace Plus z odobrenim povzetkom glavnih značilnosti zdravila Vascace, ter nato potrdil usklajeno besedilo tega pododstavka.
English: The MAH's initially proposed SPC and CDS included some additional information concerning the use of ACE inhibitors in the 1st trimester of pregnancy as a contraindication to ACE inhibitors.
Slovenian: Povzetek glavnih značilnosti zdravila in podatkovni list s temeljnimi podatki imetnika dovoljenja za promet z zdravilom, ki ju je predlagal imetnik dovoljenja za promet z zdravilom, je vključeval nekatere dodatne informacije glede uporabe zaviralcev ACE v prvem trimesečju nosečnosti kot kontraindikacijo zaviralcev ACE.
English: The CHMP did not agree with the MAH's position.
Slovenian: CHMP se ni strinjal s stališčem imetnika dovoljenja za promet z zdravilom.
English: The Core Data Sheet (CDS) wording for patients with impaired renal function has been used in this section of the SPCs in most of the countries.
Slovenian: V tem delu povzetka glavnih značilnosti zdravila je bilo za bolnike z okvarjenim delovanjem ledvic v večini držav uporabljeno besedilo s podatkovnega lista s temeljnimi podatki.
English: The text proposed by the MAH was based on Meyler's reviews of ACE inhibitors and thiazide diuretics, and it is consistent with the CDS and most current SPCs for Vascace Plus.
Slovenian: Predlagano besedilo imetnika dovoljenja za promet z zdravilom je bilo oblikovano na podlagi pregleda zaviralcev ACE in tiazidnih diuretikov pri Meylerju ter je skladno s podatkovnim listom s temeljnimi podatki in veljavnim povzetkom glavnih značilnosti zdravila Vascace Plus.
English: Gout
Slovenian: Protin
English: As requested, the ADR “arrhythmia”, already shown in the table of ADRs attributable to cilazapril, has been added to the table of ADRs attributable to hydrochlorothiazide.
Slovenian: V skladu z zahtevo je bil neželeni učinek „aritmija“, ki je bil naveden že v preglednici neželenih učinkov, povezanih s cilazaprilom, dodan tudi v preglednico neželenih učinkov, povezanih s hidroklorotiazidom.
English: Many medicinal products were listed for Vascace Plus in one or several local SPCs.
Slovenian: V enem ali več lokalnih povzetkov glavnih značilnosti zdravila Vascace Plus je bilo za zdravilo Vascace Plus navedenih več zdravil.
English: • the summary of products characteristics, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Vascace Plus and associated names (see Annex I).
Slovenian: • Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki so jih predlagali imetniki dovoljenja za promet z zdravilom, so bili ocenjeni na podlagi predložene dokumentacije in strokovne razprave v Odboru.
English: Hepatic disorders
Slovenian: Jetrna obolenja
English: The CHMP requested the MAH to align this section with the harmonised Vascace SPC as far as ACEI component is concerned.
Slovenian: CHMP je imetnika dovoljenja za promet z zdravilom zaprosil, da glede zaviralcev ACE to poglavje uskladi z usklajenim povzetkom glavnih značilnosti zdravila Vascace.
English: The CHMP endorsed the MAH proposal after the frequency categories used in the SPC of Vascace Plus had been harmonised with the ones of the SPC for Vascace.
Slovenian: Po uskladitvi kategorij pogostnosti v povzetku glavnih značilnosti zdravila Vascace Plus s kategorijami pogostnosti v povzetku glavnih značilnosti zdravila Vascace je CHMP potrdil predlog imetnika dovoljenja za promet z zdravilom.
English: To justify the proposed dosage (5 mg cilazapril and 12.5 mg hydrochlorothiazide) the MAH presented data from several placebo controlled randomized trials.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predstavil podatke več s placebom nadzorovanih randomiziranih preskušanj, s katerimi je želel utemeljiti predlagano odmerjanje (5 mg cilazaprila in 12,5 mg hidroklorotiazida).
English: The ADR `headache' has been included in the list of ADRs attributable to cilazapril, as requested by the CHMP, in the category `common'.
Slovenian: Na zahtevo CHMP je bil na seznam neželenih učinkov, povezanih s cilazaprilom, v kategoriji „pogosto“ dodan „glavobol“.
English: Elderly
Slovenian: Starejše osebe
English: Apart from some additional information which is provided on the distribution of cilazapril and hydrochlorothiazide the text suggested for this section of the harmonized label was identical to the wording in the CDS of the MAH.
Slovenian: Predlagano besedilo v tem poglavju usklajenega označevanja je bilo enako besedilu v podatkovnem listu s temeljnimi podatki imetnika dovoljenja za promet z zdravilom, razen nekaterih dodatnih informacij o porazdelitvi cilazaprila in hidroklorotiazida.
English: 196 (2 x 98) capsules (multipack)
Slovenian: 196 (2 x 98) kapsul (večje pakiranje)
English: Conclusions presented by the European Medicines Agency on:
Slovenian: Sklepne ugotovitve, ki jih je predstavila Evropska agencija za zdravila o:
English: The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the marketing authorisation under exceptional circumstances as further explained in the European Public Assessment Report.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) po obravnavi vloge meni, da je razmerje med tveganji in koristmi ugodno, da lahko priporoči izdajo dovoljenja za promet z zdravilom v izjemnih okoliščinah, kot je podrobneje razloženo v evropskem javnem poročilu o oceni zdravila.
English: • Marketing authorisation under exceptional circumstances
Slovenian: • pridobitvi dovoljenja za promet z zdravilom v izjemnih okoliščinah
English: CONCLUSIONS ON THE GRANTING OF THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES AND PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Slovenian: SKLEPNE UGOTOVITVE O PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: Date of first authorisation: 20 April 2007 Date of latest renewal: 15 March 2012
Slovenian: Datum prve odobritve: 20. april 2007 Datum zadnjega podaljšanja: 15. marec 2012
English: Fesoterodine may not always be suitable for you.
Slovenian: Fesoterodin morda ne bo vedno primeren za vas.
English: Treatment should be symptomatic and supportive.
Slovenian: Zdravljenje mora biti simptomatsko in podporno.
English: Adults (including elderly)
Slovenian: Odrasli (vključno s starejšimi bolniki)
English: Should be avoided
Slovenian: Se je treba izogniti
English: Full treatment effect was observed between 2 and 8 weeks.
Slovenian: Poln učinek zdravljenja so opazili med 2 in 8 tedni.
English: This effect is usually mild or moderate.
Slovenian: Ta učinek je običajno blag ali zmeren.
English: You should swallow your tablet whole with a glass of water.
Slovenian: Tableto morate pogoltniti celo, s kozarcem vode.
English: Serious allergic reactions including angioedema occurred rarely.
Slovenian: Resne alergijske reakcije, vključno z angioedemom, so se pojavile redko.
English: If you experience any of these effects, do not drive or use any tools or machines.
Slovenian: Če se pri vas pojavi katerikoli od teh učinkov, ne vozite ali upravljajte orodij ali strojev.
English: Show them your pack of tablets.
Slovenian: Pokažite jim svojo škatlo s tabletami.
English: A dose reduction to 4 mg may be needed (see section 4.4).
Slovenian: Morda bo potrebno zmanjšanje odmerka na 4 mg (glejte poglavje 4.4).
English: A total of 33% of patients were ≥65 years of age and 11% were ≥75 years of age.
Slovenian: Skupaj 33 % bolnikov je bilo starih 65 let ali več, 11 % pa je bilo starih 75 let ali več.
English: Tablets are to be taken once daily with liquid and swallowed whole.
Slovenian: Tablete je treba jemati enkrat na dan s tekočino in jih pogoltniti cele.
English: Your doctor will tell you whether you can take TOVIAZ with other medicines.
Slovenian: Zdravnik vam bo povedal, ali lahko jemljete zdravilo TOVIAZ z drugimi zdravili.
English: Maximum plasma levels are reached after approximately 5 hours.
Slovenian: Največje koncentracije v plazmi so dosežene po približno 5 urah.
English: In patients with a combination of these factors, additional exposure increases are expected.
Slovenian: Pri bolnikih s kombinacijo teh faktorjev lahko pričakujemo dodatno povečano izpostavljenost zdravilu.
English: Bioavailability of the active metabolite is 52%.
Slovenian: Biološka uporabnost aktivnega presnovka je 52 %.
English: TOVIAZ should be used with caution in patients with:
Slovenian: Zdravilo TOVIAZ je treba uporabljati previdno pri bolnikih:
English: The safety and efficacy of TOVIAZ in children below 18 years of age have not yet been established.
Slovenian: Varnost in učinkovitost zdravila TOVIAZ pri otrocih, starih do 18 let, še nista bili dokazani.
English: To help you remember to take your medicine, you may find it easier to take it at the same time every day.
Slovenian: Morda si boste lažje zapomnili, da morate vzeti zdravilo, če ga boste vsak dan jemali ob istem času.
English: Fesoterodine is a competitive, specific muscarinic receptor antagonist.
Slovenian: Fesoterodin je kompetitiven, specifičen antagonist muskarinskih receptorjev.
English: There are no adequate data from the use of fesoterodine in pregnant women.
Slovenian: Ni zadostnih podatkov o uporabi fesoterodina pri nosečnicah.
English: Very common (may affect more than 1 in 10 people) You may get a dry mouth.
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 oseb) Morda boste imeli suha usta.
English: • Toxic megacolon.
Slovenian: • toksični megakolon.
English: Hence, it is recommended to reevaluate the efficacy for the individual patient after 8 weeks of treatment.
Slovenian: Po 8 tednih zdravljenja je torej priporočljivo ponovno oceniti učinkovitost za posameznega bolnika.
English: The relation to fesoterodine treatment is unclear.
Slovenian: Povezava z zdravljenjem s fesoterodinom ni jasna.
English: Female (79%) and male (21%) patients with a mean age of 58 years (range 19-91 years) were included.
Slovenian: V študijah so sodelovale bolnice (79 %) in bolniki (21 %) povprečne starosti 58 let (od 19 do 91 let).
English: Women of child bearing potential should be made aware of the lack of human fertility data, and TOVIAZ should only be given after consideration of individual risks and benefits.
Slovenian: Ženske v rodni dobi je treba seznaniti s pomanjkanjem podatkov o plodnosti pri ljudeh in zdravilo TOVIAZ uporabiti le po pretehtanju posameznih tveganj in koristi.
English: Contains lactose and soya lecithin: see the package leaflet for further information.
Slovenian: Vsebuje laktozo in sojin lecitin: za dodatne informacije glejte navodilo za uporabo.
English: What TOVIAZ is and what it is used for
Slovenian: Kaj je zdravilo TOVIAZ in za kaj ga uporabljamo
English: Treat symptoms as follows:
Slovenian: Simptome je treba zdraviti na naslednji način:
English: • Hypersensitivity to the active substance or to peanut or soya or to any of the excipients listed in section 6.1
Slovenian: • preobčutljivost na učinkovino, arašide ali sojo ali katerokoli pomožno snov, navedeno v poglavju 6.1;
English: • an uncomfortable feeling in the stomach
Slovenian: • neprijeten občutek v želodcu
English: You should not take TOVIAZ if you are pregnant, as the effects of fesoterodine on pregnancy and the unborn baby are not known.
Slovenian: Če ste noseči, zdravila TOVIAZ ne smete jemati, ker učinki fesoterodina na nosečnost in nerojenega otroka niso znani.
English: Therefore, you should brush your teeth regularly twice daily and see a dentist when in doubt.
Slovenian: To lahko zveča tveganje za nastanek zobne gnilobe, zato si morate redno, dvakrat na dan umivati zobe in obiskati zobozdravnika, če ste v dvomih.
English: The adverse reactions are reported in this table with the following frequency convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000).
Slovenian: Neželeni učinki v preglednici so navedeni po naslednjih pogostnostih: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000).
English: See sections 4.3, 4.4 and 4.5
Slovenian: Glejte poglavja 4.3, 4.4 in 4.5.
English: Do not stop taking TOVIAZ without talking to your doctor, as your symptoms of overactive bladder may come back again or become worse once you stop taking TOVIAZ.
Slovenian: Zdravila TOVIAZ ne prenehajte jemati, ne da bi se posvetovali z zdravnikom, ker se lahko simptomi čezmerno aktivnega sečnega mehurja ponovijo ali poslabšajo, ko prenehate jemati zdravilo TOVIAZ.
English: The majority of adverse reactions occurred during the first month of treatment with the exception of cases classified as urinary retention or post void residual urine greater than 200 ml, which could occur after long term treatment and was more common in male than female subjects.
Slovenian: Večina neželenih učinkov se je pojavila v prvem mesecu zdravljenja, razen primerov, klasificiranih kot retencija urina ali rezidualni urin po uriniranju, večji od 200 ml, ki se lahko pojavijo po dolgotrajnem zdravljenju in so pogostejši pri moških kot pri ženskah.
English: Do not give this medicine to children and adolescents below 18 years of age because it is yet to be established whether it would work for them and whether it would be safe.
Slovenian: Tega zdravila se ne sme dajati otrokom in mladostnikom, mlajšim od 18 let, ker varnost in učinkovitost zdravila pri njih še nista bili dokazani.
English: Please inform your doctor if you are taking medicines according to the following list.
Slovenian: Obvestite zdravnika, če jemljete zdravila s spodnjega seznama.
English: The interaction with CYP2D6 inhibitors was not tested clinically.
Slovenian: Interakcije z zaviralci encima CYP2D6 niso klinično preskušali.
English: Likewise, the response rate (% of patients reporting that their condition has been “greatly improved” or “improved” using a 4-point Treatment Benefit Scale) was significantly greater with fesoterodine compared to placebo.
Slovenian: Podobno je bil odziv (% bolnikov, ki so po 4-stopenjski lestvici koristi zdravljenja poročali, da se je njihovo stanje “zelo izboljšalo” ali “izboljšalo”) pomembno večji pri bolnikih, ki so prejemali fesoterodin, kot pri bolnikih, ki so prejemali placebo.
English: In non-clinical safety pharmacology, general toxicity, genotoxicity and carcinogenicity studies no clinically relevant effects have been observed, except those related to the pharmacological effect of the active substance.
Slovenian: Pri predkliničnih študijah farmakološke varnosti, splošne toksičnosti, genotoksičnosti in kancerogenosti niso opazili nobenih klinično pomembnih učinkov, razen tistih, ki so povezani s farmakološkim učinkom učinkovine.
English: Therapeutic plasma levels are achieved after the first administration of fesoterodine.
Slovenian: Terapevtske koncentracije v plazmi so dosežene po prvem odmerku fesoterodina.
English: Furthermore, fesoterodine improved the mean change in the voided volume per micturition, and the mean change in the number of continent days per week (see Table 1 below).
Slovenian: Poleg tega je fesoterodin izboljšal povprečno spremembo izločenega urina na uriniranje in povprečno spremembo števila kontinentnih dni na teden (glejte spodnjo preglednico 1).
English: The effect of weak CYP3A4 inhibitors (e.g. cimetidine), was not examined; it is not expected to be in excess of the effect of moderate inhibitor.
Slovenian: Učinka šibkih zaviralcev CYP3A4 (npr. cimetidin) niso preučevali; ni pričakovati, da bi učinek presegel učinke zmernih zaviralcev.
English: Pfizer Europe MA EEIG (as MA Holder logo)
Slovenian: Pfizer Europe MA EEIG (kot logotip imetnika DzP)
English: Overdose with antimuscarinics, including fesoterodine can result in severe anticholinergic effects.
Slovenian: Preveliko odmerjanje antimuskarinikov, vključno s fesoterodinom, lahko povzroči hude antiholinergične učinke.
English: A clinical study in healthy volunteers has shown that fesoterodine 8 mg once daily has no significant effect on the pharmacokinetics or the anticoagulant activity of a single dose of warfarin.
Slovenian: Klinična študija pri zdravih prostovoljcih je pokazala, da odmerek 8 mg fesotreodina enkrat na dan nima pomembnega učinka na farmakokinetiko ali antikoagulacijsko aktivnost enkratnega odmerka varfarina.