FrancophonIA/ELRC3.0 huggingface dataset:
English: Ikorel and Dancor contain the active substance nicorandil, which works by relaxing the muscles in the walls of the blood vessels that supply the heart, thereby improving blood flow to the heart muscle and relieving the symptoms of angina.
Slovenian: Zdravili Ikorel in Dancor vsebujeta zdravilno učinkovino nikorandil, ki deluje tako, da sprošča mišice v stenah krvnih žil, ki dovajajo kri v srce, ter tako izboljšuje dotok krvi v srčno mišico in lajša simptome angine.
English: • Patients with known hypersensitivity (allergy) to nicorandil or to any of the other ingredients;
Slovenian: • bolnikih, pri katerih je bila ugotovljena preobčutljivost za (alergija na) nikorandil ali katero od drugih sestavin zdravila;
English: Additionally, Ikorel and Dancor should be used with caution in patients lacking an enzyme called glucose-6-phosphate dehydrogenase, and in patients with heart failure class III or IV (heart disease that severely limits or makes physical activity not possible without discomfort).
Slovenian: Zdravili Ikorel in Dancor je treba uporabljati previdno tudi pri bolnikih s pomanjkanjem encima, imenovanega glukoza-6-fosfat dehidrogenaza, in pri bolnikih s srčnim popuščanjem razreda III in IV (srčnim popuščanjem, ki močno omejuje ali onemogoča fizično dejavnost brez neugodja).
English: The CHMP agreed that Ikorel and Dancor should only be used as a second-line option to treat the symptoms of angina, when patients do not sufficiently respond to, do not tolerate or should not take medicines such as beta-blockers and/or calcium antagonists.
Slovenian: Odbor CHMP se je strinjal, da bi se morali zdravili Ikorel in Dancor uporabljati zgolj kot zdravilo druge izbire za zdravljenje simptomov angine pektoris, kadar se bolniki ne odzivajo dovolj na zdravila, kot so antagonisti adrenergičnih receptorjev beta in/ali zaviralci kalcijevih kanalčkov, jih ne prenašajo ali jih ne smejo jemati.
English: If ulcers develop, Ikorel or Dancor should be permanently discontinued.
Slovenian: Če pride do razjed, je treba trajno prenehati zdravljenje z zdravilom Ikorel ali Dancor.
English: Ikorel and Dancor are medicines used to treat symptoms of angina pectoris (pain in the chest due to problems with the blood flow to the heart) in adult patients for whom treatment with medicines known as beta-blockers and/or calcium antagonists is not sufficiently effective, not indicated or not tolerated.
Slovenian: Zdravili Ikorel in Dancor se uporabljata za zdravljenje simptomov angine pektoris (bolečin v prsih zaradi težav z dotokom krvi v srce) pri odraslih bolnikih, pri katerih zdravljenje z zdravili, imenovanimi antagonisti adrenergičnih receptorjev beta in/ali zaviralci kalcijevih kanalčkov, ni dovolj učinkovito, ni indicirano ali pa ga bolniki ne prenašajo.
English: Ikorel and Dancor should be used with caution in patients taking the following medicines:
Slovenian: Pri bolnikih, ki jemljejo naslednja zdravila, je treba zdravili Ikorel in Dancor uporabljati previdno:
English: On 12 December 2013, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Ikorel and Dancor in the EU.
Slovenian: Da bi Evropska komisija uskladila dovoljenja za promet z zdraviloma Ikorel in Dancor v EU, je 12. decembra 2013 zadevo napotila na odbor CHMP.
English: Gastrointestinal ulcers and ulcers on the skin and some internal (mucosal) surfaces have been reported in patients taking Ikorel or Dancor.
Slovenian: Pri bolnikih, ki so jemali zdravilo Ikorel ali Dancor, so poročali o razjedah v prebavilih ter razjedah na koži in na nekaterih notranjih (sluzničnih) površinah.
English: Ikorel and Dancor were identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Slovenian: Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila v humani medicini (CMD(h)) je ugotovila, da je za zdravili Ikorel in Dancor potrebno usklajevanje.
English: This could be very harmful to your health.
Slovenian: To je lahko zelo škodljivo za vaše zdravje.
English: Date of first authorisation: 18.12.2018
Slovenian: Datum prve odobritve: 18.12.2018
English: Severe systemic manifestations are responsible for a 10% mortality rate.
Slovenian: Hude sistemske manifestacije so odgovorne za 10-odstotno smrtnost.
English: The treatment is mainly symptomatic.
Slovenian: Zdravljenje je v glavnem simptomatsko.
English: The seriousness of the symptoms may require hospital supervision.
Slovenian: Resnost simptomov lahko zahteva bolnišnični nadzor.
English: The dose should not exceed 500 mg/day.
Slovenian: Odmerek ne sme preseči 500 mg/dan.
English: Symptoms typically occur 1-8 weeks after exposure to the medicinal product.
Slovenian: Simptomi se običajno pojavijo 1-8 tednov po izpostavitvi zdravilu.
English: Period preferred
Slovenian: Preferenčno obdobje
English: Incidence of DRESS has been reported between 1:100 and 1:10.000 patients treated.
Slovenian: Poročali so o pojavnosti DRESS med 1 : 100 in 1 : 10.000 zdravljenih bolnikov.
English: Do not take more than 3 capsules a day.
Slovenian: Na dan ne smete vzeti več kot 3 kapsule.
English: Read the Alert Card in conjunction with this leaflet and keep the card it with you at all times.
Slovenian: Opozorilno kartico preberite skupaj s tem navodilom in jo imejte ves čas pri sebi.
English: Primary Analysis
Slovenian: Primarna analiza
English: Results for the primary and key secondary endpoints are summarised in the table below.
Slovenian: Rezultati za primarne in ključne sekundarne opazovane dogodke so povzeti v spodnji preglednici.
English: Median value at Day 18
Slovenian: Srednja vrednost na 18. dan
English: Preference between the 2 treatment periods Number of subjects
Slovenian: Preferenca med obema obdobjema zdravljenja Število udeležencev
English: The most serious side effects are:
Slovenian: Najresnejši neželeni učinki so:
English: Mexiletine is weakly bound to plasma proteins (55%).
Slovenian: Meksiletin se šibko veže na plazemske proteine (55 %).
English: See section “Warnings and precautions”.
Slovenian: Glejte poglavje »Opozorila in previdnostni ukrepi«.
English: Mexiletine Placebo
Slovenian: Meksiletin Placebo
English: • Heart failure with mid-range (40-49%) and reduced (<40%) ejection fraction
Slovenian: • Srčno popuščanje s srednjim (40-49 %) in zmanjšanim (< 40 %) iztisnim deležem
English: Therefore, mexiletine can be taken with or without food.
Slovenian: Meksiletin je tako mogoče jemati s hrano ali brez.
English: See also sections 4.3 and 4.5 regarding association with other products with arrhythmogenic effects.
Slovenian: Glejte tudi poglavji 4.3 in 4.5 glede povezave z drugimi zdravili z aritmičnimi učinki.
English: Substrates of other enzymes and transporters
Slovenian: Substrati drugih encimov in prenašalcev
English: Epileptic patients need to be monitored because mexiletine can increase the frequency of seizure episodes.
Slovenian: Epileptične bolnike je treba spremljati, saj lahko meksiletin poveča pogostnost napadov.
English: The safety and efficacy of mexiletine in children and adolescents aged 0 to 18 years have not been established.
Slovenian: Varnost in učinkovitost meksiletina pri otrocih in mladostnikih, starih od 0 do 18 let, nista bili dokazani.
English: Patients should be carefully monitored if co-treated with other medicinal products with especially emphasis to medicinal products with narrow therapeutic windows.
Slovenian: Bolnike je treba pozorno spremljati, če sočasno jemljejo druga zdravila, s posebnim poudarkom na zdravila z ozkim terapevtskim oknom.
English: In case of digestive intolerance, capsules should be taken during a meal.
Slovenian: V primeru prebavne intolerance je treba kapsule vzeti med obrokom.
English: Approximately 10% is excreted unchanged by the kidney.
Slovenian: Približno 10 % ga nespremenjenega izločijo ledvice.
English: Your doctor will also regularly reassess your treatment to make sure Namuscla is still the best medicine for you.
Slovenian: Vaš zdravnik bo tudi redno ocenjeval vaše zdravljenje, da se prepriča, da je zdravilo Namuscla za vas še vedno najboljše zdravilo.
English: Individualised neuromuscular quality of life - Overall quality of life
Slovenian: Individualna nevrovaskularna kakovost življenja - splošna kakovost življenja
English: However, these studies were not performed in accordance with contemporary standards and are, hence, of unclear clinical relevance.
Slovenian: Vendar te študije niso bile izvedene v skladu s sodobnimi standardi, zato imajo omejen klinični pomen.
English: • Hypersensitivity to any local anaesthetic
Slovenian: • Preobčutljivost na kateri koli lokalni anestetik
English: If you forget to take Namuscla If you have forgotten a dose, do not take a double dose and take the next dose at your regular schedule.
Slovenian: Če ste pozabili vzeti odmerek, ne jemljite dvojnega odmerka, temveč vzemite naslednji odmerek po rednem urniku.
English: Frequency categories are derived according to the following conventions: 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), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: Kategorije pogostnosti so oblikovane v skladu z naslednjimi konvencijami: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: The recommended starting dose is 1 capsule per day.
Slovenian: Priporočen začetni odmerek je 1 kapsula dnevno.
English: Children and adolescents Namuscla should not be used in children and adolescents younger than 18 years old.
Slovenian: Otroci in mladostniki Zdravila Namuscla se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
English: In case of bradycardia with hypotension, intravenous atropine should be used.
Slovenian: V primeru bradikardije s hipotenzijo je treba uporabiti atropin intravensko.
English: Food does not affect the rate or extent of absorption of mexiletine.
Slovenian: Hrana ne vpliva na hitrost ali obseg absorpcije meksiletina.
English: Other side effects that may occur:
Slovenian: Drugi neželeni učinki, ki se lahko pojavijo:
English: Mexiletine is rapidly distributed in the body; its volume of distribution is large and varies from 5 to 9 L/kg in healthy individuals.
Slovenian: Meksiletin se v telesu hitro porazdeli; njegov volumen porazdelitve je velik in se pri zdravih posameznikih giblje med 5 in 9 l/kg.
English: • Patients should not take more than 3 capsules of Namuscla per day or a double dose to make up for a forgotten dose;
Slovenian: • Bolniki ne smejo vzeti več kot 3 kapsule zdravila Namuscla na dan, ali dvojnega odmerka če so pozabili vzeti prejšnji odmerek;
English: OCT2 substrates
Slovenian: Substrati OCT2
English: How often these tests will be performed depends on your heart function.
Slovenian: Pogostnost pregledov bo odvisna od delovanja vašega srca.
English: CGI as judged efficient by the investigators CGI as judged efficient by the patients Effect of treatment (Mc Nemar test)
Slovenian: CGI, kot so učinkovitost presodili raziskovalci CGI, kot so učinkovitost presodili bolniki Učinek zdravljenja (McNemarjev test)
English: • Symptomatic coronary artery disease
Slovenian: • Simptomatska koronarna arterijska bolezen
English: The doctor will increase the dose gradually depending on how well the medicine is working.
Slovenian: Zdravnik bo odmerek postopoma zviševal glede na učinek zdravila.
English: Lupin Healthcare (UK) Ltd The Urban Building, second floor, 3-9 Albert Street SL1 2BE Slough, Berkshire, United Kingdom
Slovenian: Lupin Healthcare (UK) Ltd The Urban Building, second floor, 3-9 Albert Street SL1 2BE Slough, Berkshire, Velika Britanija
English: Mexiletine is eliminated slowly in humans (with a mean elimination half-life of 10 hours, ranging from 5 to 15 hours).
Slovenian: Meksiletin se pri ljudeh izloča počasi (s povprečno razpolovno dobo izločanja 10 ur, ki variira od 5 do 15 ur).
English: The studies in rats on carcinogenic potential were negative, but not performed in accordance with current standards and therefore of unclear clinical relevance.
Slovenian: Študije kancerogenega potenciala pri podganah so bile negativne, vendar niso bile izvedene skladno s trenutno veljavnimi standardi, zato njihov klinični pomen ni znan.
English: In a clinical study in 12 subjects (5 healthy subjects and 7 patients with cardiac arrhythmias), the clearance of caffeine was decreased by 50% following the administration of mexiletine.
Slovenian: V klinični študiji z 12 udeleženci (5 zdravih oseb in 7 bolnikov s srčnimi aritmijami) se je očistek kofeina po jemanju meksiletina zmanjšal za 50 %.
English: Effect of treatment (binomial test)
Slovenian: Učinek zdravljenja (bionomski test)
English: Regular reassessment should be implemented, not to continue long-term treatment in a patient not responding or not experiencing benefit of the treatment.
Slovenian: Treba je izvajati redno ponovno ocenjevanje učinkovitosti, da se prepreči dolgotrajno zdravljenje pri bolnikih, ki se ne odzivajo, ali pri katerih ni koristi od zdravljenja.
English: A linear relationship between mexiletine dose and plasma concentration has been observed in the dose range of 83 to 500 mg.
Slovenian: Linearno razmerje med odmerkom meksiletina in koncentracijo v plazmi so opazili v razponu odmerkov od 83 do 500 mg.
English: • Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1
Slovenian: • Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: In these patients, it is recommended that the dose should only be increased after at least 2 weeks of treatment.
Slovenian: Pri njih se zvišanje odmerka priporoča šele po najmanj dveh tednih zdravljenja.
English: Before starting treatment with Namuscla, you will have tests to check how well your heart is working, including ECG (Electrocardiogram).
Slovenian: Pred začetkom zdravljenja z zdravilom Namuscla bodo preverili, kako dobro deluje vaše srce, vključno z EKG (elektrokardiogramom).
English: The effects of mexiletine on fertility in humans have not been studied.
Slovenian: Učinkov meksiletina na plodnost pri ljudeh niso preučevali.
English: Electrolytic imbalance such as hypokalaemia, hyperkalaemia or hypomagnesaemia may increase the proarrhythmic effects of mexiletine.
Slovenian: Elektrolitska neravnovesja, kot so hipokaliemija, hiperkaliemija ali hipomagneziemija, lahko povečajo proaritmične učinke meksiletina.
English: Very common and common adverse reactions are derived from data from the MYOMEX study; less common adverse effects are derived from post-marketing data.
Slovenian: Zelo pogosti in pogosti neželeni učinki temeljijo na podatkih iz študije MYOMEX, manj pogosti neželeni učinki pa na podatkih po pridobitvi dovoljenja za promet.
English: 30 hard capsules 50 hard capsules 100 hard capsules 200 hard capsules
Slovenian: 30 trdih kapsul 50 trdih kapsul 100 trdih kapsul 200 trdih kapsul
English: Fatal outcomes have been reported for acute overdoses at 4.4 g of mexiletine hydrochloride ingestion but survival has also been reported following acute overdose of approximately 4 g of oral mexiletine hydrochloride.
Slovenian: O smrtnih izidih so poročali pri zaužitju akutnih prevelikih odmerkov 4,4 g meksiletinijevega klorida, a so preživetje zaznali tudi po akutnem prevelikem odmerjanju približno 4 g peroralnega meksiletinijevega klorida.
English: Capsules are packed in Aluminium/PVC/PVDC blisters containing 30, 50, 100 or 200 capsules.
Slovenian: Kapsule so pakirane v pretisne omote iz aluminija/PVC/PVDC po 30, 50, 100 ali 200 kapsul.
English: Excretion of mexiletine essentially occurs through the kidney (90% of the dose, including 10% as unchanged mexiletine).
Slovenian: Izločanje meksiletina v glavnem poteka preko ledvic (90 % odmerka, vključno z 10 % nespremenjenega meksiletina).
English: The proportions of different ethnic populations across these various classes are tabulated below.
Slovenian: V spodnji preglednici so navedeni deleži različnih etničnih populacij v teh razredih.
English: Effect of mexiletine on other medicinal products
Slovenian: Vpliv meksiletina na druga zdravila
English: Mexiletine may interact with drugs transported by OCT2 (such as metformin and dofetilide).
Slovenian: Meksiletin lahko medsebojno deluje z drugimi zdravili, ki jih prenaša OCT2 (kot sta metformin in dofetilid).
English: The VAS is constructed as an absolute measure, with a 100 mm straight horizontal line having the endpoints “no stiffness at all” (0) and “worst possible stiffness” (100).
Slovenian: Lestvica VAS je zasnovana kot absolutno merilo s 100-milimetrsko ravno vodoravno linijo, pri kateri je na enem skrajnem koncu stanje »brez okorelosti« (0), na drugem pa »najhujša možna okorelost« (100).
English: The main secondary endpoints were changes in health-related quality of life as measured by individualised neuromuscular quality of life (INQoL) scale and the time needed to stand up from a chair, walk around the chair and sit down again (chair test).
Slovenian: Glavni sekundarni opazovani dogodek so bile spremembe z zdravjem povezane kakovosti življenja, merjene individualno po lestvici nevrovaskularne kakovosti življenja (INQoL - individualised neuromuscular quality of life), ter čas potreben za dviganje s stola, hojo okrog stola in ponovno usedanje (test s stolom).
English: Depending on your heart function you may also need testing before and after any dose adjustment.
Slovenian: Glede na to, kako deluje vaše srce bo morda treba opraviti teste pred vsako prilagoditvijo odmerka in po njej.
English: The recommended starting dose of mexiletine is 167 mg daily (1 capsule per day).
Slovenian: Priporočen začetni odmerek meksiletina je 167 mg dnevno (1 kapsula na dan).
English: Limited clinical data of the use of mexiletine in pregnant women shows that mexiletine crosses the placenta and reaches the foetus.
Slovenian: Omejeni klinični podatki o uporabi meksiletina pri nosečnicah kažejo, da meksiletin prehaja skozi posteljico in doseže plod.
English: Mexiletine may induce an arrhythmia or accentuate a pre-existing arrhythmia, either diagnosed or undiagnosed.
Slovenian: Meksiletin lahko inducira aritmijo ali poudari obstoječo aritmijo, bodisi diagnosticirano ali brez diagnoze.
English: A cardiac evaluation is recommended shortly after treatment start (e.g. within 48 hours).
Slovenian: Pregled srca se priporoča kmalu po začetku zdravljenja (npr. v 48 urah).
English: Tell your doctor or pharmacist if you start to smoke or quit smoking while taking Namuscla because smoking impacts the Namuscla blood levels and your dose may need to be adjusted accordingly.
Slovenian: Povejte zdravniku ali farmacevtu, če med jemanjem zdravila začnete ali prenehate kaditi, ker kajenje vpliva na ravni zdravila Namuscla v krvi in bo morda treba skladno s tem prilagoditi vaš odmerek.
English: Not known: atrioventricular block
Slovenian: Neznana: atrioventrikularni blok
English: See section “Do not take Namuscla”.
Slovenian: Glejte poglavje »Ne jemljite zdravila Namuscla«.
English: You may take Namuscla during a meal to avoid belly pain (see section “Possible side effects”).
Slovenian: Zdravilo Namuscla lahko vzamete med obrokom, da se izognete bolečinam v trebuhu (glejte poglavje »Možni neželeni učinki«).
English: Do not take Namuscla with certain medicines which have a so called narrow therapeutic window (these are medicines where small differences in dose or blood concentration may impact the effect of the medicine or side effects).
Slovenian: Ne jemljite zdravila Namuscla skupaj z nekaterimi zdravili s tako imenovanim ozkim terapevtskim oknom (to so zdravila, pri katerih majhne razlike v odmerku ali koncentraciji v krvi lahko vplivajo na učinek zdravila ali neželene učinke).
English: Mexiletine is, therefore, mostly active on muscle fibres subject to repeated discharges (such as skeletal muscles).
Slovenian: Meksiletin torej deluje predvsem na mišična vlakna, ki so predmet večkratnih sproščanj (kot so skeletne mišice).
English: The Educational guide for HCPs, which should always be read in conjunction with the Summary of Product Characteristics (SmPC) before prescribing Namuscla, should contain the following key elements:
Slovenian: Izobraževalni vodnik za zdravstvene delavce, ki ga je treba vedno prebrati skupaj s povzetkom glavnih značilnosti zdravila (SmPC) pred predpisovanjem zdravila Namuscla, mora vsebovati naslednje ključne elemente:
English: Some patients may have higher blood levels of Namuscla because of slower break down in the liver and the dose may need to be adjusted accordingly.
Slovenian: Pri nekaterih bolnikih so lahko ravni zdravila Namuscla v krvi povišane zaradi počasnejše razgradnje v jetrih, zato je treba odmerek skladno s tem prilagoditi.
English: The maintenance dose is 1 to 3 capsules daily taken at regular intervals throughout the day.
Slovenian: Vzdrževalni odmerek je 1 do 3 kapsule dnevno, ki jih jemljete v rednih presledkih tekom dneva.
English: Mexiletine is a substrate for the metabolic pathways involving hepatic enzymes; inhibition or induction of these enzymes is expected to alter mexiletine plasma concentrations.
Slovenian: Meksiletin je substrat za metabolične poti, ki vključujejo jetrne encime; pričakuje se inhibicija ali indukcija teh encimov, ki naj bi spremenila koncentracije meksiletina v plazmi.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Namuscla in all subsets of the paediatric population in the symptomatic treatment of myotonic disorders (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odložila zahtevo za predložitev rezultatov študij z zdravilom Namuscla za vse podskupine pediatrične populacije pri simptomatskem zdravljenju miotoničnih motenj (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Africans
Slovenian: Afričani
English: As a precautionary measure, it is preferable to avoid the use of mexiletine during pregnancy.
Slovenian: Iz previdnostnih razlogov se je med nosečnostjo uporabi meksiletina bolje izogibati.
English: It improves myotonic symptoms by decreasing muscle stiffness through reduction of the delay of muscle relaxation.
Slovenian: Izboljšuje miotonične simptome z zmanjševanjem okorelosti mišic na podlagi krajšega zamika pri sprostitvi mišice.
English: Patients with known hypersensitivity to mexiletine or any other ingredients of this product or to any local anaesthetic are at high risk of developing DRESS and should not receive mexiletine.
Slovenian: Pri bolnikih z znano preobčutljivostjo na meksiletin ali katero koli sestavino tega zdravila oziroma na kateri koli lokalni anestetik obstaja visoko tveganje za pojav DRESS, zato ne smejo prejemati meksiletina.
English: Prior to launch of Namuscla in each Member State (MS) the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority (NCA).
Slovenian: Pred sprostitvijo zdravila Namuscla na trg v vsaki državi članici mora imetnik dovoljenja za promet z zdravilom dogovoriti s pristojnim nacionalnim organom glede vsebine in oblike izobraževalnega programa, vključno z mediji za komunikacijo, načini distribucije in vsemi drugimi vidiki programa.
English: Swallow the capsule with a glass of water, while standing or sitting up.
Slovenian: Kapsulo pogoltnite v stoječem ali sedečem položaju s kozarcem vode.
English: Mexiletine is rapidly and almost completely absorbed following oral administration with a bioavailability of about 90% in healthy subjects.
Slovenian: Meksiletin se hitro in skoraj popolnoma absorbira pri peroralni uporabi z biološko uporabnostjo okoli 90 % pri zdravih osebah.
English: Mexiletine is mainly (90%) metabolized in the liver, the primary pathway being CYP2D6 metabolism, although it is also a substrate for CYP1A2.
Slovenian: Meksiletin se večinoma (90 %) presnavlja v jetrih, pri čemer je primarna pot presnove CYP2D6, čeprav je tudi substrat za CYP1A2.