natgillin/translations-raw huggingface dataset:
Film-coat lactose monohydrate hypromellose triacetin titanium dioxide (E171) iron oxide yellow (E172) iron oxide red (E172) talc
Film ovojnica laktoza hidrat hipromeloza triacetin titanijev dioksid (E171) željezov oksid žuti (E172) željezov oksid crveni (E172) talk
Tadalafil is
Tadalafil
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg tadalafil.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 20 mg tadalafila.
Efficacy in patients with pulmonary arterial hypertension (PAH) A randomised, double-blind, placebo-controlled study was conducted in 405 patients with pulmonary arterial hypertension.
Randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje provedeno je u 405 bolesnika s plućnom arterijskom hipertenzijom.
Protease inhibitors (e.g. ritonavir)
Inhibitori proteaze (npr. ritonavir)
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.
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.
Nervous system disorders Headache6
Poremećaji živčanog sustava glavobolja6
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.
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.
Use with CYP3A4 inducers or inhibitors
Primjena s induktorima ili inhibitorima izoenzima CYP3A4
The results suggest a lower clearance of tadalafil in patients with pulmonary hypertension compared to healthy volunteers.
Rezultati ukazuju na to da bolesnici s plućnom hipertenzijom imaju slabiji klirens tadalafila u odnosu na zdrave dobrovoljce.
Since there are no clinical data on the safety of tadalafil in these patients, the use of tadalafil is not recommended.
Budući da ne postoje klinički podaci o sigurnosti tadalafila u tih bolesnika, primjena tadalafila se ne preporučuje.
Epistaxis
epistaksa
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.
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.
Check carefully how you react to the medicines before driving or using any machinery.
Prije vožnje ili rukovanja bilo kakvim strojem dobro provjerite kako reagirate na lijekove.
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).
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)
Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), talc.
Film ovojnica: laktoza hidrat, hipromeloza, triacetin, titanijev dioksid (E171), žuti željezov oksid (E172), crveni željezov oksid (E172), talk.
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.
Inhibicija PDE5 tadalafilom povećava koncentracije cGMP-a, što dovodi do opuštanja glatkih mišićnih stanica krvnih žila u plućima i vazodilatacije plućnog krvožilja.
In clinical pharmacology studies, the potential for tadalafil (10 and 20 mg) to augment the hypotensive effects of antihypertensive medicinal products was examined.
U kliničkim farmakološkim ispitivanjima ispitivao se potencijal tadalafila (10 i 20 mg) da pojača hipotenzivne učinke antihipertenziva.
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.
Sličan porast AUC-a i Cmax zabilježen za etinilestradiol može se očekivati i kod peroralne primjene terbutalina, vjerojatno zbog inhibicije sulfatacije u crijevima tadalafilom.
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.
Nije zabilježen statistički značajan utjecaj tadalafila na levonorgestrel, što upućuje na to da je učinak na etinilestradiol posljedica tadalafilom uzrokovane inhibicije sulfatacije u crijevima.
Vomiting, Gastroesophageal reflux
gastroezofagealni refluks
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).
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).
(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.
(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.
Tablet core: lactose monohydrate, croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium laurilsulfate, magnesium stearate.
Jezgra tablete: laktoza hidrat, umrežena karmelozanatrij, hidroksipropilceluloza, mikrokristalična celuloza, natrijev laurilsulfat, magnezijev stearat.
Some side effects have been reported in men taking tadalafil for the treatment of erectile dysfunction.
Neke su nuspojave prijavljene u muškaraca koji su uzimali tadalafil za liječenje erektilne disfunkcije.
The efficacy and safety of tadalafil co-administered with prostacyclin or its analogues has not been studied in controlled clinical studies.
Prostaciklin i njegovi analozi Djelotvornost i sigurnost istodobne primjene tadalafila i prostaciklina ili njegovih analoga nije ispitana u kontroliranim kliničkim ispitivanjima.
Haematuria Reproductive system and breast disorders Increased uterine bleeding4
Poremećaji reproduktivnog sustava i dojki pojačano krvarenje iz maternice4
Tadalafil is predominantly metabolised by the cytochrome P450 (CYP) 3A4 isoform.
Tadalafil se pretežno metabolizira pomoću izoenzima (CYP) 3A4 citokroma P450.
In clinical studies, tadalafil (5, 10 and 20 mg) was shown to augment the hypotensive effects of nitrates.
U kliničkim ispitivanjima se pokazalo da tadalafil (5, 10 i 20 mg) pojačava hipotenzivne učinke nitrata.
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.
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.
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.
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.
These events have either been assigned a frequency of “Not known,” as the frequency in PAH patients cannot be estimated from the available data or assigned a frequency based on the clinical study data from the pivotal placebo-controlled study of ADCIRCA.
"nepoznato", jer se učestalost u bolesnika s PAH-om ne može procijeniti iz dostupnih podataka, ili im je dodijeljena kategorija učestalosti na temelju podataka iz pivotalnog, placebom kontroliranog ispitivanja lijeka ADCIRCA.
Also included in the table are some adverse reactions which have been reported in clinical studies and/or post marketing with tadalafil in the treatment of male erectile dysfunction.
U tablicu su uključene i neke nuspojave koje su prijavljene u kliničkim ispitivanjima i/ili nakon stavljanja u promet tadalafila za liječenje muške erektilne disfunkcije.
The following side effects have been very commonly reported in patients taking ADCIRCA (may affect more than 1 in 10 people): headache, flushing, nasal and sinus congestion (blocked nose), nausea, indigestion (including abdominal pain or discomfort), muscle aches, back pain and pain in the extremity (including limb discomfort)
Sljedeće nuspojave prijavljene su vrlo često u bolesnika koji uzimaju lijek ADCIRCA (mogu se javiti u više od 1 na 10 osoba): glavobolja, crvenilo praćeno osjećajem vrućine, kongestija sinusa i nosa (začepljenost nosa), mučnina, probavne smetnje (uključujući bolove ili nelagodu u trbuhu), bolovi u mišićima, bol u leđima i bol u udovima (uključujući i nelagodu u udovima).
CYP2C9 substrates (e.g.R-warfarin)
Supstrati izoenzima CYP2C9 (npr. R-varfarin)
Results were generally consistent in subgroups according to age, gender, PAH aetiology and baseline WHO functional class and 6MWD.
Rezultati su uglavnom bili dosljedni u podskupinama prema dobi, spolu, etiologiji PAH-a te funkcionalnom stupnju prema SZO-u i 6MWD-u na početku ispitivanja.
Single doses of up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients with erectile dysfunction.
Zdravim su ispitanicima primijenjene pojedinačne doze do 500 mg, a bolesnicima s erektilnom disfunkcijom višestruke dnevne doze do 100 mg.
Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH.
4.2 Doziranje i način primjene Liječenje mora započeti i nadzirati isključivo liječnik s iskustvom u liječenju PAH-a.
Seizures5, Transient amnesia5
napadaji5, prolazna amnezija5
The safety and efficacy of combinations of tadalafil and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied.
Nisu ispitivane sigurnost i djelotvornost istovremene primjene tadalafila s drugim inhibitorima PDE5 ili drugim lijekovima za erekcijsku disfunkciju.
In patients who are taking alpha1 blockers concomitant administration of tadalafil may lead to symptomatic hypotension in some patients (see section 4.5).
U bolesnika koji uzimaju blokatore alfa1-receptora istodobna primjena tadalafila može u nekim slučajevima dovesti do simptomatske hipotenzije (vidjeti dio 4.5).
Patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
(NAION, engl. non-arteritic anterior ischaemic optic neuropathy), bez obzira na to je li ta epizoda povezana s prethodnim izlaganjem inhibitorima PDE5 (vidjeti dio 4.4).
In two of these studies decreases were observed in sperm count and concentration related to tadalafil treatment of unlikely clinical relevance.
U dva od tih ispitivanja opaženo je smanjenje broja i koncentracije spermatozoida povezano s liječenjem tadalafilom, ali nije vjerojatno da bi ono bilo klinički značajno.
Palpitations2, 5
Srčani poremećaji palpitacije2, 5
The most commonly reported adverse reactions, occurring in ≥ 10 % of patients in the tadalafil 40 mg treatment arm, were headache, nausea, back pain, dyspepsia, flushing, myalgia, nasopharingitis and pain in extremity.
Najčešće prijavljene nuspojave, koje su se javile u ≥ 10% bolesnika u skupini koja je primala tadalafil u dozi od 40 mg, bile su glavobolja, mučnina, bol u leđima, dispepsija, crvenilo praćeno osjećajem užarenosti ili vrućine, mialgija, nazofaringitis i bol u udovima.
Dizziness has been reported.
Prijavljena je omaglica.
The table below lists the adverse reactions reported during the placebo-controlled clinical study in patients with PAH treated with ADCIRCA.
U sljedećoj su tablici navedene nuspojave prijavljene tijekom placebom kontroliranog kliničkog ispitivanja u bolesnika s PAH-om liječenih lijekom ADCIRCA.
Additionally, improvements compared to placebo were observed with tadalafil 40 mg in the physical functioning, role-physical, bodily pain, general health, vitality and social functioning domains of the SF-36.
Osim toga, u odnosu na placebo su kod primjene tadalafila u dozi od 40 mg uočena poboljšanja u sljedećim domenama upitnika SF-36: fizičkom funkcioniranju, ograničenju zbog fizičkih tegoba, tjelesnim bolovima, općem zdravlju, vitalnosti i socijalnom funkcioniranju.
They are in the shape of almonds and have "4467" marked on one side.
"4467" na jednoj strani.
Cytochrome P450 Inducers
Induktori citokroma P450
Bosentan (125 mg twice daily), a substrate of CYP2C9 and CYP3A4 and a moderate inducer of CYP3A4, CYP2C9 and possibly CYP2C19, reduced tadalafil (40 mg once per day) systemic exposure by 42 % and Cmax by 27 % following multiple dose co-administration.
Antagonisti receptora endotelina-1 (npr. bosentan) Bosentan (125 mg dvaput na dan), supstrat CYP2C9 i CYP3A4 i umjeren induktor CYP3A4, CYP2C9, a možda i CYP2C19, je nakon istodobne primjene višestrukih doza smanjio sistemsku izloženost tadalafilu (40 mg jedanput na dan) za 42%, a Cmax za 27%.
In the pivotal placebo-controlled study of ADCIRCA for the treatment of PAH, a total of 323 patients were treated with ADCIRCA at doses ranging from 2.5 mg to 40 mg once daily and 82 patients were treated with placebo.
U pivotalnom placebom kontroliranom ispitivanju lijeka ADCIRCA u liječenju PAH-a ukupno su 323 bolesnika liječena lijekom ADCIRCA u dozama od 2,5 mg do 40 mg jedanput na dan, dok su
How to take ADCIRCA
Kako uzimati lijek ADCIRCA
(4) Clinical non-MedDRA term to include reports of abnormal/excessive menstrual bleeding conditions such as menorrhagia, metrorrhagia, menometrorrhagia, or vaginal hemorrhage.
(4) Klinički izraz koji nije iz MedDRA terminologije, a obuhvaća izvješća o neuobičajenom/prekomjernom menstrualnom krvarenju kao što su menoragija, metroragija,
If tadalafil is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.
Ako se propisuje tadalafil, liječnik koji ga propisuje mora pomno procijeniti koristi i rizike liječenja za svakog pojedinog bolesnika.
Anti-hypertensives (including Calcium channel blockers) The co-administration of doxazosin (4 and 8 mg daily) and tadalafil (5 mg daily dose and 20 mg as a single dose) increases the blood pressure-lowering effect of this alpha-blocker in a significant manner.
Istodobna primjena doksazosina (4 i 8 mg na dan) i tadalafila (dnevna doza od 5 mg i 20 mg u jednoj dozi) značajno pojačava učinak ovog alfa-blokatora na sniženje krvnog tlaka.
3 years.
6.3 Rok valjanosti 3 godine.
Ritonavir (200 mg twice daily), which is an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil (20 mg) single dose exposure (AUC) 2-fold with no change in Cmax.
Ritonavir (200 mg dvaput na dan), inhibitor CYP3A4, CYP2C9, CYP2C19 i CYP2D6, je dvostruko povećao izloženost tadalafilu (AUC) nakon primjene jedne doze (20 mg), bez promjena Cmax.
Studies in vitro have shown that tadalafil is a selective inhibitor of PDE5.
Ispitivanja in vitro su pokazala da je tadalafil selektivan inhibitor PDE5.
PDE5 is an enzyme found in corpus cavernosum smooth muscle, vascular and visceral smooth muscle, skeletal muscle, platelets, kidney, lung, and cerebellum.
PDE5 je enzim koji se nalazi u glatkom mišičju šupljikavog tijela, glatkom mišičju krvnih žila i unutarnjih organa, mišićima kostura, trombocitima, bubrezima, plućima i malom mozgu.
Only tadalafil 40 mg achieved the protocol defined level of significance with a placeboadjusted median increase in 6MWD of 26 metres (p=0.0004; 95 % CI: 9.5, 44.0; Pre-specified Hodges-Lehman method) (mean 33 metres, 95 % CI: 15.2, 50.3).
26 metara (p = 0,0004; 95% CI: 9,5; 44,0; prethodno definirana Hodges-Lehmanova metoda) (srednja vrijednost 33 metra, 95% CI: 15,2; 50,3).
CYP1A2 substrates (e.g. theophylline)
Supstrati izoenzima CYP1A2 (npr. teofilin)
Tadalafil is also > 10,000-fold more potent for PDE5 than for PDE7 through PDE10.
Tadalafil također djeluje > 10 000 puta jače na PDE5
Since there are no clinical data on administration of tadalafil to patients with veno-occlusive disease, administration of tadalafil to such patients is not recommended.
S obzirom da ne postoje klinički podaci o primjeni tadalafila u bolesnika s okluzivnom bolešću vena, ne preporučuje se primjena tadalafila u takvih bolesnika.
Film-coated tablet core lactose monohydrate croscarmellose sodium hydroxypropylcellulose microcrystalline cellulose sodium laurilsulfate magnesium stearate
Jezgra filmom obložene tablete laktoza hidrat umrežena karmelozanatrij hidroksipropilceluloza mikrokristalična celuloza natrijev laurilsulfat magnezijev stearat
The proportion of patients with improvement in WHO functional class by week 16 was similar in the tadalafil 40 mg and placebo groups (23 % vs. 21 %).
Udio bolesnika kojima se do 16. tjedna poboljšao funkcionalni stupanj prema SZO-u bio je podjednak u skupini koja je primala tadalafil u dozi od 40 mg i skupini koja je primala placebo (23% u odnosu na 21%).
> 10,000-fold more potent for PDE5 than for PDE3, an enzyme found in the heart and blood vessels.
Tadalafil djeluje > 10 000 puta jače na PDE5 nego na PDE3, enzim koji se nalazi u srcu i krvnim žilama.
Dyspepsia (including abdominal pain/discomfort3)
(uključujući i bol/nelagodu u abdomenu3)
Ritonavir (500 mg or 600 mg twice daily) increased tadalafil (20 mg) single-dose exposure (AUC) by 32 % and decreased Cmax by 30 %.
Ritonavir (500 mg ili 600 mg dvaput na dan) je povećao izloženost tadalafilu (AUC) nakon primjene jedne doze za 32%, a smanjio Cmax za 30%.
No improvements were observed in the role emotional and mental health domains of the SF36.
Nisu zabilježena poboljšanja u domenama upitnika SF-36: ograničenje zbog emocionalnih tegoba i psihičko zdravlje.
(3) Actual MedDRA terms included are abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, and stomach discomfort.
(3) Obuhvaća MedDRA termine: nelagoda u abdomenu, bol u abdomenu, bol u donjem dijelu abdomena, bol u gornjem dijelu abdomena i nelagoda u želucu.
How to store ADCIRCA
Kako čuvati lijek ADCIRCA
- Patients with clinically significant aortic and mitral valve disease - Patients with pericardial constriction - Patients with restrictive or congestive cardiomyopathy - Patients with significant left ventricular dysfunction - Patients with life-threatening arrhythmias - Patients with symptomatic coronary artery disease - Patients with uncontrolled hypertension.
- bolesnici sa značajnom disfunkcijom lijeve klijetke - bolesnici sa životno ugrožavajućim aritmijama - bolesnici sa simptomatskom bolešću koronarnih arterija
Suomi/Finland
Belgique/België/Belgien
(6) Headache was the most commonly reported adverse reaction.
(6) Najčešće prijavljena nuspojava bila je glavobolja.
- In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates.
U kliničkim se ispitivanjima pokazalo da tadalafil pojačava hipotenzivne učinke nitrata.
ADCIRCA has negligible influence on the ability to drive or use machines.
4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima ADCIRCA zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Therefore, administration of tadalafil to patients who are using any form of organic nitrate is contraindicated (see section 4.3).
Stoga je kontraindicirana primjena tadalafila u bolesnika koji uzimaju bilo koji oblik organskih nitrata (vidjeti dio 4.3).
In patients with severe renal impairment the use of tadalafil is not recommended (see sections 4.4 and 5.2).
U bolesnika s teškim oštećenjem bubrega primjena tadalafila se ne preporučuje (vidjeti dijelove 4.4 i 5.2).
Therefore, administration of tadalafil to patients who are using any form of organic nitrate is contraindicated (see section 4.5).
Stoga je kontraindicirana primjena tadalafila u bolesnika koji uzimaju bilo koji oblik organskih nitrata (vidjeti dio 4.5).
P-glycoprotein substrates (e.g. digoxin) Tadalafil (40 mg once per day) had no clinically significant effect on the pharmacokinetics of digoxin.
Tadalafil (40 mg jedanput na dan) nije imao klinički značajnog učinka na farmakokinetiku digoksina.
ADCIRCA is supplied as a 20 mg tablet.
ADCIRCA je dostupna u obliku tablete od 20 mg.
Antimicrobial medicinal products (e.g. rifampicin) A CYP3A4 inducer, rifampicin (600 mg daily), reduced tadalafil AUC by 88 % and Cmax by 46 %, relative to the AUC and Cmax values for tadalafil alone (10 mg).
Induktor izoenzima CYP3A4 rifampicin (600 mg na dan) smanjio je AUC tadalafila za 88%, a Cmax za 46% u odnosu na vrijednosti AUC-a i Cmax kod primjene samog tadalafila (10 mg).
Patients with severe hepatic cirrhosis (Child-Pugh Class C) have not been studied and therefore dosing of tadalafil is not recommended (see sections 4.4 and 5.2).
Bolesnici s teškom cirozom jetre (Child-Pugh stadij C) nisu ispitivani te se stoga primjena tadalafila ne preporučuje (vidjeti dijelove 4.4 i 5.2).
OTHER Mon, Tue, Wed, Thu, Fri, Sat, Sun.
Pon, Uto, Sri, Čet, Pet, Sub, Ned
Chest pain2 (1) Events not reported in registration studies and cannot be estimated from the available data.
(1) Događaji koji nisu prijavljeni u ispitivanjima u svrhu registracije lijeka i učestalost im se ne može se procijeniti iz dostupnih podataka.
riociguat.
- riocigvat
Common (may affect up to 1 in 10 people) - blurred vision, low blood pressure, nosebleed, vomiting, increased or abnormal uterine bleeding, swelling of the face, acid reflux, migraine, irregular heartbeat and fainting.
- zamagljen vid, nizak krvni tlak, krvarenje iz nosa, povraćanje, pojačano ili neuobičajeno krvarenje iz maternice, oticanje lica, refluks kiseline, migrena, nepravilno kucanje srca i nesvjestica.
Urticaria5, Hyperhydrosis (sweating)5
Poremećaji kože i potkožnog tkiva osip urtikarija5, hiperhidroza (znojenje)5
Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.
Dokazana je djelotvornost u idiopatskoj plućnoj arterijskoj hipertenziji (IPAH) kao i u plućnoj arterijskoj hipertenziji povezanoj s kolagenozom krvnih žila.