FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients taking multiple antihypertensive medicinal products whose hypertension was not well controlled, greater reductions in blood pressure were observed compared to patients whose blood pressure was well controlled, where the reduction was minimal and similar to that in healthy subjects.
Croatian: U bolesnika koji su uzimali više antihipertenziva, a hipertenzija im nije bila dobro kontrolirana, opaženo je veće sniženje krvnog tlaka nego u bolesnika s dobro kontroliranim krvnim tlakom, u kojih je sniženje bilo minimalno i podjednako onom u zdravih ispitanika.
English: Posology The recommended dose is 40 mg (2 x 20 mg) taken once daily with or without food.
Croatian: Doziranje Preporučena doza je 40 mg (2 x 20 mg) jedanput na dan, s hranom ili bez nje.
English: Sudden decrease or loss of hearing has also been reported.
Croatian: Prijavljeno je i iznenadno smanjenje ili gubitak sluha.
English: The mean baseline 6-minute-walk-distance (6MWD) was 343.6 meters.
Croatian: 6-minute walk distance, 6MWD) na početku ispitivanja bila je 343,6 metara.
English: The safety and efficacy of combinations of tadalafil and other endothelin-1 receptor antagonists have not been studied.
Croatian: Nisu ispitivane sigurnost i djelotvornost kombinacija tadalafila i drugih antagonista receptora endotelina-1.
English: - priapism, a prolonged and possibly painful erection after taking ADCIRCA (frequency uncommon).
Croatian: - prijapizam, dugotrajna te moguće i bolna erekcija nakon uzimanja lijeka ADCIRCA (manje često).
English: The overall frequency of discontinuation due to adverse events was low (ADCIRCA 11 %, placebo 16 %).
Croatian: Ukupna je učestalost prekida liječenja zbog nuspojava bila niska (ADCIRCA 11%, placebo 16%).
English: PDE5 is the predominant phosphodiesterase in the pulmonary vasculature.
Croatian: PDE5 je prevladavajuća fosfodiesteraza u plućnom krvožilju.
English: Unstable angina pectoris, Ventricular arrhythmia, Myocardial Infarction2
Croatian: nestabilna angina pektoris, ventrikularna aritmija, infarkt miokarda2
English: Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD).
Croatian: Plućni vazodilatatori mogu značajno pogoršati kardiovaskularni status bolesnika s okluzivnom bolešću plućnih vena (OBPV).
English: In patients with pulmonary hypertension not receiving concomitant bosentan, the average tadalafil exposure at steady-state following 40 mg was 26 % higher when compared to those of healthy volunteers.
Croatian: U bolesnika s plućnom hipertenzijom koji istodobno nisu primali bosentan prosječna izloženost tadalafilu u stanju dinamičke ravnoteže nakon doze od 40 mg bila je 26% veća nego u zdravih dobrovoljaca.
English: Patients were at least 12 years of age and had a diagnosis of PAH that was idiopathic, related to collagen disease, related to anorexigen use, related to human immunodeficiency virus (HIV) infection, associated with an atrial-septal defect, or associated with surgical repair of at least 1 year in duration of a congenital systemic-to-pulmonary shunt (for example, ventricular septal defect, patent ductus arteriosus).
Croatian: Bolesnici su imali najmanje 12 godina i dijagnozu PAH-a koji je mogao biti idiopatski, povezan s kolagenskom bolešću, povezan s uporabom anoreksika, povezan s infekcijom virusom humane imunodeficijencije (HIV), povezan s defektom atrijskog septuma ili povezan s kirurškim popravkom, koji je postojao najmanje godinu dana, prirođenog sustavno-plućnog spoja (npr. defekta ventrikulskog septuma, otvorenog arterijskog kanala).
English: Three studies were conducted in men to assess the potential effect on spermatogenesis of tadalafil 10 mg (one 6-month study) and 20 mg (one 6-month and one 9-month study) administered daily.
Croatian: Provedena su tri ispitivanja u muškaraca kako bi se procijenio potencijalni utjecaj svakodnevne primjene tadalafila u dozi od 10 mg (jedno 6-mjesečno ispitivanje) i 20 mg (jedno 6-mjesečno i jedno 9-mjesečno ispitivanje) na spermatogenezu.
English: Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the clinical studies, and use in these patients is not recommended.
Croatian: Bolesnici s poznatim nasljednim degenerativnim poremećajima mrežnice, uključujući retinitis pigmentosa, nisu bili uključeni u klinička ispitivanja te se primjena ovog lijeka u tih bolesnika ne preporučuje.
English: Tadalafil should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
Croatian: Tadalafil treba primjenjivati uz oprez u bolesnika s anatomskim deformacijama penisa (poput angulacije, kavernozne fibroze ili Peyronijeve bolesti) i u bolesnika koji pate od nekih stanja koja mogu biti predispozicija za prijapizam (poput anemije srpastih stanica, multiplog mijeloma ili leukemije).
English: The active substance is tadalafil.
Croatian: Djelatna tvar je tadalafil.
English: Tadalafil is a potent and selective inhibitor of phosphodiesterase type 5 (PDE5), the enzyme responsible for the degradation of cyclic guanosine monophosphate (cGMP).
Croatian: Mehanizam djelovanja Tadalafil je snažan i selektivan inhibitor fosfodiesteraze tipa 5 (PDE5), enzima odgovornog za razgradnju cikličkog gvanozin monofosfata (cGMP).
English: Do not use this medicine after the expiry date stated on the carton and blister after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza „Rok valjanosti“ ili oznake „EXP“.
English: The only pharmacodynamic effect was a small (3.5 bpm) increase in heart rate.
Croatian: Jedini farmakodinamički učinak bilo je malo (3,5 otkucaja u minuti) ubrzanje srčanog ritma.
English: 357 patients from the placebo-controlled study entered a long-term extension study.
Croatian: 357 bolesnika iz placebom kontroliranog ispitivanja uključeno je u dugoročno produljenje ispitivanja.
English: There are limited data from the use of tadalafil in pregnant women.
Croatian: Podaci o primjeni tadalafila u trudnica su ograničeni.
English: The time of dosing (morning versus evening after a single 10 mg administration) had no clinically relevant effects on the rate and extent of absorption.
Croatian: Vrijeme doziranja (jedna doze od 10 mg ujutro ili navečer) nije imalo klinički značajnih učinaka na brzinu i opseg apsorpcije.
English: Pharmacotherapeutic group: Urologicals, drugs used in erectile dysfunction, ATC code: G04BE08.
Croatian: Farmakoterapijska skupina: Pripravci koji djeluju na mokraćni sustav, lijekovi koji se primjenjuju kod erektilne disfunkcije, ATK oznaka: G04BE08.
English: The usual dose is two 20 mg tablets taken once a day.
Croatian: Uobičajena doza je dvije tablete od 20 mg jedanput na dan.
English: Doses studied were 20 mg and 40 mg once daily.
Croatian: Ispitivane su doze od 20 mg i 40 mg jedanput na dan.
English: In addition, no changes in tadalafil concentrations were seen after co-administration with alcohol.
Croatian: Nadalje, nakon istodobne primjene s alkoholom nisu opažene promjene u koncentracijama tadalafila.
English: Tadalafil is excreted predominantly as inactive metabolites, mainly in the faeces (approximately 61 % of the dose) and to a lesser extent in the urine (approximately 36 % of the dose).
Croatian: Tadalafil se pretežno izlučuje u obliku neaktivnih metabolita, uglavnom fecesom (približno 61% doze) te u manjoj mjeri mokraćom
English: Lilly France SAS Tél: +33-(0) 1 55 49 34 34
Croatian: Lilly France S.A.S Tél: +33-(0)1 55 49 34 34
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/476/005-006
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/476/005-006
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Croatian: Istraživanja na životinjama ne ukazuju na izravne niti neizravne štetne učinke na trudnoću, razvoj embrija i fetusa, okot i postnatalni razvoj
English: Although the frequency of reports of dizziness in placebo and tadalafil arms in clinical studies was similar, patients should be aware of how they react to ADCIRCA, before driving or operating machinery.
Croatian: Iako je u kliničkim ispitivanjima učestalost prijavljivanja omaglice bila podjednaka u skupinama koje su primale placebo odnosno tadalafil, bolesnici moraju biti svjesni kako reagiraju na lijek ADCIRCA prije nego upravljaju vozilom ili rukuju strojevima.
English: Additionally, tadalafil is approximately 700-fold more potent for PDE5 than for PDE6, an enzyme which is found in the retina and is responsible for phototransduction.
Croatian: Osim toga, tadalafil oko 700 puta snažnije djeluje na PDE5 nego na PDE6, enzim koji se nalazi u mrežnici i odgovoran je za fototransdukciju.
English: Syncope, Migraine5
Croatian: sinkopa, migrena5
English: Tadalafil has systemic vasodilatory properties that may result in transient decreases in blood pressure.
Croatian: Tadalafil ima sistemske vazodilatacijske učinke koji mogu rezultirati prolaznim sniženjem krvnog tlaka.
English: Should signs of pulmonary oedema occur when tadalafil is administered, the possibility of associated PVOD should be considered.
Croatian: Pojave li se kod primjene tadalafila znakovi plućnog edema, treba uzeti u obzir mogućnost pridruženog OBPV-a.
English: Contents of the pack and other information
Croatian: Sadržaj pakiranja i druge informacije Što ADCIRCA sadrži
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 1 October 2008
Croatian: Datum prvog odobrenja: 1. listopada 2008.
English: Cardiac disorders
Croatian: Kardiovaskularni poremećaji
English: Over a dose range of 2.5 to 20 mg, tadalafil exposure (AUC) increases proportionally with dose in healthy subjects.
Croatian: U rasponu doza od 2,5 do 20 mg izloženost tadalafilu (AUC) u zdravih ispitanika raste proporcionalno dozi.
English: Improvements compared to placebo were observed with tadalafil 40 mg in the EuroQol (EQ-5D) US and UK index scores comprising mobility, self-care, usual activities, pain/discomfort, anxiety/depression components, and in the visual analogue scale (VAS).
Croatian: Poboljšanja kod primjene tadalafila u dozi od 40 mg u odnosu na placebo uočena su i u američkim i britanskim rezultatima upitnika EuroQol (EQ-5D), koji obuhvaća komponente mobilnosti, brige o sebi, uobičajenih aktivnosti, boli/nelagode, tjeskobe/depresije, te na vizualno analognoj skali (VAS).
English: It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors which work by helping the blood vessels around your lungs relax, improving the flow of blood into your lungs.
Croatian: Pripada skupini lijekova koji se zovu inhibitori fosfodiesteraze tipa 5 (PDE5), a djeluju tako što pomažu opustiti krvne žile u plućima te se time poboljšava dotok krvi u pluća.
English: In the pregnant rat the AUC for calculated free active substance at this dose was approximately 18 times the human AUC at a 20 mg dose.
Croatian: U skotnih je štakorica pri toj dozi AUC izračunate slobodne djelatne tvari bio približno 18 puta veći od AUC-a u ljudi pri dozi od 20 mg.
English: In patients receiving concomitant antihypertensive medicinal products, tadalafil 20 mg may induce a blood pressure decrease, which (with the exception of doxazosin -see above) is, in general, minor and not likely to be clinically relevant.
Croatian: U bolesnika koji se istodobno liječe antihipertenzivima, tadalafil u dozi od 20 mg može izazvati sniženje krvnog tlaka, koje je (s izuzetkom doksazosina - vidjeti prethodni odlomak) u pravilu malo i nije vjerojatno da će biti klinički značajno.
English: The primary efficacy endpoint was the change from baseline at week 16 in 6-minute walk distance (6MWD).
Croatian: Primarna mjera ishoda za djelotvornost bila je promjena od početne udaljenosti prijeđene za 6 minuta hodanja (6MWD) u 16. tjednu.
English: Healthy elderly subjects (65 years or over), had a lower oral clearance of tadalafil, resulting in 25 % higher exposure (AUC) relative to healthy subjects aged 19 to 45 years after a 10 mg dose.
Croatian: Zdravi stariji ispitanici (65 godina i stariji) imali su manji klirens tadalafila nakon peroralne primjene doze od 10 mg, što je rezultiralo 25% većom izloženošću (AUC) u odnosu na zdrave ispitanike u dobi od 19 do 45 godina.
English: ADCIRCA contains lactose monohydrate.
Croatian: ADCIRCA sadrži laktozu hidrat.
English: In patients with mild to moderate renal impairment a starting dose of 20 mg once per day is recommended.
Croatian: U bolesnika s blagim do umjerenim oštećenjem bubrega preporučuje se početna doza od 20 mg jedanput na dan.
English: The incidence of clinical worsening by week 16 in patients treated with tadalafil 40 mg (5 %; 4 of 79 patients) was less than placebo (16 %; 13 of 82 patients).
Croatian: Incidencija kliničkog pogoršanja do 16. tjedna bila je manja u bolesnika liječenih tadalafilom u dozi od 40 mg (5%; 4 od 79 bolesnika) nego u bolesnika koji su primali placebo (16%; 13 od 82 bolesnika).
English: During tadalafil 20 mg and 40 mg once daily dosing, steady-state plasma concentrations are attained within 5 days, and exposure is approximately 1.5 fold of that after a single dose.
Croatian: Kod primjene tadalafila u dozama od 20 mg i 40 mg jedanput na dan koncentracije u plazmi u stanju dinamičke ravnoteže postižu se u roku od 5 dana, a izloženost je oko 1,5 puta veća nego nakon primjene jedne doze.
English: The randomised, double-blind, placebo-controlled, parallel, 3-arm study of tadalafil was conducted in 331 boys aged 7-14 years with DMD receiving concurrent corticosteroid therapy.
Croatian: placebom kontrolirano ispitivanje tadalafila s tri paralelne skupine provedeno je u 331 dječaka s DMD-om u dobi od 7 do 14 godina koji su istodobno primali terapiju kortikosteroidima.
English: Film-coat lactose monohydrate hypromellose triacetin titanium dioxide (E171) iron oxide yellow (E172) iron oxide red (E172) talc
Croatian: Film ovojnica laktoza hidrat hipromeloza triacetin titanijev dioksid (E171) željezov oksid žuti (E172) željezov oksid crveni (E172) talk
English: Tadalafil is
Croatian: Tadalafil
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg tadalafil.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 20 mg tadalafila.
English: Efficacy in patients with pulmonary arterial hypertension (PAH) A randomised, double-blind, placebo-controlled study was conducted in 405 patients with pulmonary arterial hypertension.
Croatian: Randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje provedeno je u 405 bolesnika s plućnom arterijskom hipertenzijom.
English: Protease inhibitors (e.g. ritonavir)
Croatian: Inhibitori proteaze (npr. ritonavir)
English: The mean oral clearance for tadalafil is 3.4 l/h at steady state and the mean terminal half-life is 16 hours in healthy subjects.
Croatian: Prosječan klirens tadalafila nakon peroralne primjene iznosi 3,4 l/h u stanju dinamičke ravnoteže, a prosječan terminalni poluvijek u zdravih je ispitanika 16 sati.
English: Nervous system disorders Headache6
Croatian: Poremećaji živčanog sustava glavobolja6
English: In clinical pharmacology studies using single-dose tadalafil (5 to 20 mg), tadalafil exposure (AUC) approximately doubled in subjects with mild (creatinine clearance 51 to 80 ml/min) or moderate (creatinine clearance 31 to 50 ml/min) renal impairment and in subjects with end-stage renal disease on dialysis.
Croatian: U kliničkim farmakološkim ispitivanjima s primjenom jedne doze tadalafila (5 do 20 mg), izloženost tadalafilu (AUC) se otprilike udvostručila u ispitanika s blagim (klirens kreatinina 51 do 80 ml/min) ili umjerenim (klirens kreatinina 31 do 50 ml/min) oštećenjem bubrega i u ispitanika u terminalnoj fazi bubrežne bolesti na dijalizi.
English: Use with CYP3A4 inducers or inhibitors
Croatian: Primjena s induktorima ili inhibitorima izoenzima CYP3A4
English: The results suggest a lower clearance of tadalafil in patients with pulmonary hypertension compared to healthy volunteers.
Croatian: Rezultati ukazuju na to da bolesnici s plućnom hipertenzijom imaju slabiji klirens tadalafila u odnosu na zdrave dobrovoljce.
English: Since there are no clinical data on the safety of tadalafil in these patients, the use of tadalafil is not recommended.
Croatian: Budući da ne postoje klinički podaci o sigurnosti tadalafila u tih bolesnika, primjena tadalafila se ne preporučuje.
English: Epistaxis
Croatian: epistaksa
English: Pulmonary arterial hypertension is associated with impaired release of nitric oxide by the vascular endothelium and consequent reduction of cGMP concentrations within the pulmonary vascular smooth muscle.
Croatian: Plućna arterijska hipertenzija povezana je s poremećajem otpuštanja dušikova oksida iz krvožilnog endotela i posljedičnim sniženjem koncentracija cGMP-a u glatkom mišičju plućnih krvnih žila.
English: Check carefully how you react to the medicines before driving or using any machinery.
Croatian: Prije vožnje ili rukovanja bilo kakvim strojem dobro provjerite kako reagirate na lijekove.
English: If you experience any of the following side effects stop using the medicine and seek medical help immediately: - allergic reactions including skin rashes (frequency common).
Croatian: Ako primijetite neku od sljedećih nuspojava, prestanite uzimati lijek i odmah zatražite liječničku pomoć: - alergijske reakcije, uključujući kožne osipe (često) - bol u prsnom košu - nemojte uzimati nitrate nego odmah zatražite liječničku pomoć (često)
English: Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), talc.
Croatian: Film ovojnica: laktoza hidrat, hipromeloza, triacetin, titanijev dioksid (E171), žuti željezov oksid (E172), crveni željezov oksid (E172), talk.
English: Inhibition of PDE5 by tadalafil increases the concentrations of cGMP resulting in relaxation of the pulmonary vascular smooth muscle cell and vasodilation of the pulmonary vascular bed.
Croatian: Inhibicija PDE5 tadalafilom povećava koncentracije cGMP-a, što dovodi do opuštanja glatkih mišićnih stanica krvnih žila u plućima i vazodilatacije plućnog krvožilja.
English: In clinical pharmacology studies, the potential for tadalafil (10 and 20 mg) to augment the hypotensive effects of antihypertensive medicinal products was examined.
Croatian: U kliničkim farmakološkim ispitivanjima ispitivao se potencijal tadalafila (10 i 20 mg) da pojača hipotenzivne učinke antihipertenziva.
English: A similar increase in AUC and Cmax seen with ethinylestradiol may be expected with oral administration of terbutaline, probably due to inhibition of gut sulphation by tadalafil.
Croatian: Sličan porast AUC-a i Cmax zabilježen za etinilestradiol može se očekivati i kod peroralne primjene terbutalina, vjerojatno zbog inhibicije sulfatacije u crijevima tadalafilom.
English: There was no statistically significant effect of tadalafil on levonorgestrel which suggests the effect of ethinylestradiol is due to inhibition of gut sulphation by tadalafil.
Croatian: Nije zabilježen statistički značajan utjecaj tadalafila na levonorgestrel, što upućuje na to da je učinak na etinilestradiol posljedica tadalafilom uzrokovane inhibicije sulfatacije u crijevima.
English: Vomiting, Gastroesophageal reflux
Croatian: gastroezofagealni refluks
English: The placebo-adjusted median increase in 6MWD was 17 metres (p=0.09; 95 % CI: : -7.1, 43.0; Prespecified Hodges-Lehman method) (mean 23 metres, 95 % CI; -2.4, 47.8) in those patients who received tadalafil 40 mg in addition to their concomitant bosentan (n=39), and was 39 metres (p<0.01, 95 % CI:13.0, 66.0; Pre-specified Hodges-Lehman method) (mean 44 metres, 95 % CI: 19.7, 69.0) in those patients who received tadalafil 40 mg alone (n=37).
Croatian: Medijan povećanja 6MWD-a korigiran za placebo iznosio je 17 metara (p = 0,09; 95% CI: -7,1; 43,0; prethodno definirana Hodges-Lehmanova metoda) (srednja vrijednost 23 metra, 95% CI: -2,4; 47,8) u onih bolesnika koji su primali tadalafil u dozi od 40 mg kao dodatak istodobno primijenjenom bosentanu (n = 39), a 39 metara (p < 0,01, 95% CI: 13,0; 66,0; prethodno definirana HodgesLehmanova metoda) (prosječno 44 metara, 95% CI: 19,7; 69,0) u onih bolesnika koji su primali samo tadalafil u dozi od 40 mg (n = 37).
English: (5) The adverse reactions have been included in the table as a result of postmarketing or clinical study data from the use of tadalafil in the treatment of erectile dysfunction; and in addition, the frequency estimates are based on only 1 or 2 patients experiencing the adverse reaction in the pivotal placebocontrolled study of ADCIRCA.
Croatian: (5) Ove su nuspojave uključene u tablicu na temelju podataka prikupljenih nakon stavljanja lijeka u promet, odnosno u kliničkim ispitivanjima primjene tadalafila u liječenju erektilne disfunkcije, a dodatno se procjena učestalosti temelji na samo jednom ili dva bolesnika koji su dobili tu nuspojavu u pivotalnom placebom kontroliranom ispitivanju lijeka ADCIRCA.
English: Tablet core: lactose monohydrate, croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium laurilsulfate, magnesium stearate.
Croatian: Jezgra tablete: laktoza hidrat, umrežena karmelozanatrij, hidroksipropilceluloza, mikrokristalična celuloza, natrijev laurilsulfat, magnezijev stearat.
English: Some side effects have been reported in men taking tadalafil for the treatment of erectile dysfunction.
Croatian: Neke su nuspojave prijavljene u muškaraca koji su uzimali tadalafil za liječenje erektilne disfunkcije.
English: The efficacy and safety of tadalafil co-administered with prostacyclin or its analogues has not been studied in controlled clinical studies.
Croatian: Prostaciklin i njegovi analozi Djelotvornost i sigurnost istodobne primjene tadalafila i prostaciklina ili njegovih analoga nije ispitana u kontroliranim kliničkim ispitivanjima.
English: Haematuria Reproductive system and breast disorders Increased uterine bleeding4
Croatian: Poremećaji reproduktivnog sustava i dojki pojačano krvarenje iz maternice4
English: Tadalafil is predominantly metabolised by the cytochrome P450 (CYP) 3A4 isoform.
Croatian: Tadalafil se pretežno metabolizira pomoću izoenzima (CYP) 3A4 citokroma P450.
English: In clinical studies, tadalafil (5, 10 and 20 mg) was shown to augment the hypotensive effects of nitrates.
Croatian: U kliničkim ispitivanjima se pokazalo da tadalafil (5, 10 i 20 mg) pojačava hipotenzivne učinke nitrata.
English: Tadalafil 20 mg administered to healthy subjects produced no significant difference compared to placebo in supine systolic and diastolic blood pressure (mean maximal decrease of 1.6/0.8 mm Hg, respectively), in standing systolic and diastolic blood pressure (mean maximal decrease of 0.2/4.6 mm Hg, respectively), and no significant change in heart rate.
Croatian: Tadalafil primijenjen u dozi od 20 mg u zdravih ispitanika nije u odnosu na placebo doveo do značajne razlike u vrijednostima sistoličkog i dijastoličkog krvnog tlaka u ležećem položaju (prosječno maksimalno sniženje za 1,6 odnosno 0,8 mmHg), u vrijednostima sistoličkog i dijastoličkog krvnog tlaka u stojećem položaju (prosječno maksimalno sniženje za 0,2 odnosno 4,6 mmHg) kao ni do značajne promjene brzine otkucaja srca.
English: Due to limited clinical experience in patients with mild to moderate hepatic cirrhosis (Child-Pugh Class A and B), following single doses of 10 mg, a starting dose of 20 mg once per day may be considered.
Croatian: Na temelju ograničenog kliničkog iskustva s primjenom jedne doze od 10 mg u bolesnika s blagom do umjerenom cirozom jetre (Child-Pugh stadij A i B), može se razmotriti početna doza od 20 mg jedanput na dan.