FrancophonIA/ELRC3.0 huggingface dataset:
English: The table below lists the adverse reactions reported during the placebo-controlled clinical study in patients with PAH treated with ADCIRCA.
Slovenian: V preglednici prikazan povzetek neželenih učinkov Spodnja preglednica navaja neželene učinke, o katerih so poročali med s placebom kontrolirano klinično študijo, pri bolnikih s PAH, zdravljenih z zdravilom ADCIRCA.
English: No improvements were observed in the role emotional and mental health domains of the SF36.
Slovenian: V dveh domenah SF-36, čustvena vloga in duševno zdravje, izboljšanja niso opazili.
English: Therefore, administration of tadalafil to patients who are using any form of organic nitrate is contraindicated (see section 4.5).
Slovenian: Zato je dajanje tadalafila bolnikom, ki uporabljajo kakršno koli obliko organskega nitrata, kontraindicirano (glejte poglavje 4.5).
English: Protease inhibitors (e.g. ritonavir)
Slovenian: Zaviralci proteaze (npr. ritonavir)
English: What ADCIRCA looks like and contents of the pack ADCIRCA 20 mg comes as orange film-coated tablets.
Slovenian: Izgled zdravila ADCIRCA in vsebina pakiranja Zdravilo ADCIRCA 20 mg so oranžne filmsko obložene tablete.
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.
Slovenian: vključno z retinitis pigmentosa, niso bili vključeni v klinične študije, zato se uporaba pri njih ne priporoča.
English: Most but not all of those men reporting fast heart rate, irregular heartbeat, heart attack, stroke and sudden cardiac death had known heart problems before taking tadalafil.
Slovenian: - otekanje vek, bolečina v očesu, rdeče oči, srčni infarkt in možganska kap Večina, a ne vsi moški, pri katerih so poročali o hitrem bitju srca, neenakomernem bitju srca, srčnem infarktu, možganski kapi in nenadni srčni smrti, so imeli težave s srcem že pred jemanjem tadalafila.
English: ADCIRCA should not be used during breast feeding.
Slovenian: Zdravila ADCIRCA ne uporabljajte med dojenjem.
English: - In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates.
Slovenian: - V kliničnih študijah je bilo dokazano, da tadalafil okrepi hipotenzivne učinke nitratov.
English: Τηλ: +30 210 629 4600
Slovenian: ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε Τηλ: +30 210 629 4600
English: Do NOT take these tablets if you are already taking nitrates.
Slovenian: Če se zdravite z nitrati, teh tablet NE jemljite.
English: The primary efficacy endpoint was the change from baseline at week 16 in 6-minute walk distance (6MWD).
Slovenian: Glavni opazovani dogodek učinkovitosti je bila sprememba razdalje, prehojene na 6-minutnim testom hoje (6MWD), od začetka študije do 16. tedna.
English: In patients who are taking alpha1 blockers concomitant administration of tadalafil may lead to symptomatic hypotension in some patients (see section 4.5).
Slovenian: Pri bolnikih, ki jemljejo zaviralce alfa1, lahko sočasno jemanje tadalafila pri nekaterih bolnikih povzroči simptomatsko hipotenzijo (glejte poglavje 4.5).
English: Tadalafil 40 mg increased cardiac output (0.6 L/min) and reduced pulmonary artery pressures (-4.3 mmHg) and pulmonary vascular resistance (-209 dyn.s/cm5) compared to baseline (p<0.05).
Slovenian: Tadalafil v odmerku 40 mg je povečal srčni iztok (0,6 L/min) in zmanjšal tlak v pljučni arteriji (-4,3 mmHg) ter pljučni žilni upor (-029dyn.s/cm5)
English: Non-arteritic anterior ischemic optic neuropathy (NAION), Retinal vascular occlusion, Visual field defect
Slovenian: Očesne bolezni zamegljen vid nearterična anteriorna ishemična optična nevropatija (NAION), zapora retinalnih žil, okvara vidnega polja
English: Cytochrome P450 Inducers
Slovenian: Induktorji citokroma P450
English: Oral contraceptive pill
Slovenian: Peroralni kontraceptivi
English: In clinical studies, tadalafil (5, 10 and 20 mg) was shown to augment the hypotensive effects of nitrates.
Slovenian: V kliničnih študijah so ugotovili, da tadalafil (5 mg, 10 mg in 20 mg) okrepi hipotenzivne učinke nitratov.
English: 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.
Slovenian: Ritonavir (200 mg dvakrat na dan), ki je zaviralec CYP3A4, CYP2C9, CYP2C19 in CYP2D6, je biološko uporabnost (AUC) tadalafila (20 mg) povečal za 2-krat, na Cmax pa ni imel vpliva.
English: Nervous system disorders Headache6
Slovenian: Bolezni živčevja glavobol6
English: For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the use of tadalafil is not recommended (see section 4.5).
Slovenian: Pri bolnikih, ki sočasno jemljejo močne zaviralce CYP3A4, kot na primer ketokonazol ali ritonavir, se uporaba tadalafila ne priporoča (glejte poglavje 4.5).
English: Tadalafil exposure (AUC) in subjects with mild and moderate hepatic impairment (Child-Pugh Class A and B) is comparable to exposure in healthy subjects when a dose of 10 mg is administered.
Slovenian: Pri dajanju 10 mg odmerka je izpostavljenost tadalafilu (AUC) pri osebah z blago in zmerno okvarjenim delovanjem jeter (razreda A in B po Child-Pughu) primerljiva z izpostavljenostjo pri zdravih osebah.
English: The active substance is tadalafil.
Slovenian: Zdravilna učinkovina je tadalafil.
English: Therefore, administration of tadalafil to patients who are using any form of organic nitrate is contraindicated (see section 4.3).
Slovenian: Dajanje tadalafila bolnikom, ki uporabljajo kakršno koli obliko organskega nitrata, je zato kontraindicirano (glejte poglavje 4.3).
English: Ritonavir (500 mg or 600 mg twice daily) increased tadalafil (20 mg) single-dose exposure (AUC) by 32 % and decreased Cmax by 30 %.
Slovenian: Ritonavir (500 ali 600 mg dvakrat na dan) je biološko uporabnost (AUC) tadalafila (20 mg) povečala za 32 % in Cmax zmanjšala za 30 %.
English: 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.
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali in ki so se pojavili pri ≥ 10 % bolnikov, ki so se zdravili s 40 mg tadalafila na dan, so bili glavobol, navzea, bolečina v hrbtu, dispepsija, zardevanje,
English: P-glycoprotein substrates (e.g. digoxin) Tadalafil (40 mg once per day) had no clinically significant effect on the pharmacokinetics of digoxin.
Slovenian: Tadalafil (40 mg enkrat na dan) ni imel klinično pomembnega učinka na farmakokinetiko digoksina.
English: The efficacy of tadalafil in patients already on bosentan therapy has not been conclusively demonstrated (see sections 4.5 and 5.1).
Slovenian: Učinkovitost tadalafila pri bolnikih, ki se že zdravijo z bosentanom, ni bila dokončno dokazana (glejte poglavji 4.5 in 5.1).
English: Urticaria5, Hyperhydrosis (sweating)5
Slovenian: Bolezni kože in podkožja izpuščaj koprivnica5, hiperhidroza (znojenje) 5
English: 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.
Slovenian: Neželeni učinki so bili vključeni v preglednico na osnovi podatkov iz obdobja trženja ali podatkov iz kliničnih študij o uporabi tadafila za zdravljenje erektilne disfunkcije.
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.
Slovenian: Stanje dinamičnega ravnovesja je pri odmerkih od 20 mg do 40 mg z odmerjanjem enkrat na dan doseženo v petih dneh, biološka uporabnost pa je približno 1,5-krat večja kot po enkratnem odmerku.
English: (6) Headache was the most commonly reported adverse reaction.
Slovenian: (6) Najpogostejši neželeni učinek, o katerem so poročali, je bil glavobol.
English: The efficacy and safety of tadalafil co-administered with prostacyclin or its analogues has not been studied in controlled clinical studies.
Slovenian: Varnost in učinkovitost pri sočasni uporabi tadalafila s prostaciklinom in njegovimi analogi v kontroliranih kliničnih študijah ni bila preučevana, zato se pri sočasni uporabi priporoča previdnost.
English: Patients with severe hepatic cirrhosis (Child-Pugh Class C) have not been studied and, therefore, dosing of tadalafil is not recommended.
Slovenian: Študij pri bolnikih s hudo cirozo jeter (razred C po Child-Pughu) niso opravili, zato se pri njih uporaba tadalafila ne priporoča.
English: 4.4 Special warnings and precautions for use
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Srčno-žilni sistem
English: At steady-state, tadalafil (40 mg once per day) increased ethinylestradiol exposure (AUC) by 26 % and Cmax by 70 % relative to oral contraceptive administered with placebo.
Slovenian: V stanju dinamičnega ravnovesja je tadalafil (40 mg enkrat na dan) biološko uporabnost (AUC) etinilestradiola zvišal za 26 % in Cmax za 70 % v primerjavi z jemanjem peroralnega kontraceptiva s placebom.
English: 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.
Slovenian: Sočasno jemanje doksazocina (4 mg in 8 mg na dan) in tadalafila (5 mg na dan in 20 mg v enkratnem odmerku) znatno poveča učinek zniževanja krvnega tlaka tega antagonista adrenergičnih receptorjev alfa.
English: Chest pain2 (1) Events not reported in registration studies and cannot be estimated from the available data.
Slovenian: Splošne težave in spremembe na mestu aplikacije otečen obraz, bolečina v prsnem košu2 (1) O dogodkih v študijah za pridobitev dovoljenja za promet niso poročali in jih iz razpoložljivih podatkov ni mogoče oceniti.
English: 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).
Slovenian: Induktor CYP3A4, rifampicin (600 mg na dan), je zmanjšal AUC tadalafila za 88 % in Cmax za 46 % v primerjavi z vrednostmi AUC in Cmax za tadalafil sam (10 mg odmerek).
English: 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.
Slovenian: Ker o uporabi tadalafila pri bolnikih z veno okluzivno boleznijo ni kliničnih podatkov, se uporaba tadalafila pri teh bolnikih ne priporoča.
English: 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.
Slovenian: ADCIRCA v odmerkih od 2,5 mg do 40 mg enkrat na dan dobivalo skupno 323 bolnikov, 82 bolnikov je dobivalo placebo.
English: Film-coated tablet core lactose monohydrate croscarmellose sodium hydroxypropylcellulose microcrystalline cellulose sodium laurilsulfate magnesium stearate
Slovenian: Jedro filmsko obložene tablete laktoza monohidrat natrijev karmelozat, premreženi hidroksipropilceluloza mikrokristalna celuloza natrijev lavrilsulfat magnezijev stearat
English: For patients chronically taking potent inducers of CYP3A4, such as rifampicin, the use of tadalafil is not recommended (see section 4.5).
Slovenian: Pri bolnikih, ki sočasno jemljejo močne induktorje CYP3A4, kot na primer rifampicin, se uporaba tadalafila ne priporoča (glejte poglavje 4.5).
English: The efficacy of tadalafil in patients already on bosentan therapy has not been conclusively demonstrated (see sections 4.4 and 5.1).
Slovenian: Učinkovitost tadalafila pri bolnikih, ki se zdravijo z bosentanom, ni bila dokončno dokazana (glejte poglavji 4.4 in 5.1).
English: Cytochrome P450 Inhibitors
Slovenian: Zaviralci citokroma P450
English: Physicians should carefully consider whether their patients with certain underlying conditions, such as severe left ventricular outflow obstruction, fluid depletion, autonomic hypotension or patients with resting hypotension, could be adversely affected by such vasodilatory effects.
Slovenian: Zdravnik naj skrbno ovrednoti, ali bi lahko vazodilatacijski učinek negativno vplival na določena že prisotna stanja, kot so huda zapora iztoka iz levega ventrikla, izguba tekočine, autonomna hipotenzija ali prikrita hipotenzija.
English: NAME OF THE MEDICINAL PRODUCT ADCIRCA 20 mg tablets tadalafil
Slovenian: IME ZDRAVILA ADCIRCA 20 mg tablete tadalafil
English: The following groups of patients with cardiovascular disease were not included in PAH clinical studies:
Slovenian: Naslednje skupine bolnikov s srčno-žilno boleznijo niso bile vključene v klinične študije PAH: - bolniki s klinično pomembno okvaro aortne in mitralne zaklopke,
English: 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).
Slovenian: (p=0,0004; 95 % interval zaupanja: 9,5, 44,0; predhodno določena Hodges-Lehmanova metoda) (povprečna vrednost 33 metrov, 95 % interval zaupanja: 15,2, 50,3).
English: - 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.
Slovenian: - bolniki s konstrikcijo perikarda, - bolniki z restriktivno ali kongestivno kardiomiopatijo, - bolniki z znatno poslabšanim delovanjem levega ventrikla,
English: ADCIRCA 20 mg film-coated tablets Tadalafil
Slovenian: ADCIRCA 20 mg filmsko obložene tablete tadalafil
English: Method of administration ADCIRCA is for oral use.
Slovenian: Zdravilo ADCIRCA je za peroralno uporabo.
English: Patients with severe hepatic cirrhosis (Child-Pugh Class C) have not been studied and therefore dosing of tadalafil in these patients is not recommended.
Slovenian: Pri bolnikih s hudo okvarjenim delovanjem jeter (razred C po Child-Pughu) študij niso opravljali, zato se uporaba tadalafila pri teh bolnikih ne priporoča.
English: Tadalafil (20 mg) did not augment the mean blood pressure decrease produced by alcohol (0.7 g/kg or approximately 180 ml of 40 % alcohol [vodka] in an 80 kg male), but in some subjects, postural dizziness and orthostatic hypotension were observed.
Slovenian: Tadalafil (20 mg) ni povečal srednjega znižanja krvnega tlaka, ki ga je povzročil alkohol (0,7 g/kg ali približno 180 ml
English: Tell your doctor or pharmacist if you are already taking: - bosentan (another treatment for pulmonary aterial hypertension) - nitrates (for chest pain) - alpha blockers used to treat high blood pressure or prostate problems.
Slovenian: Povejte zdravniku ali farmacevtu, če že jemljete: - bosentan (drugo zdravljenje pljučne arterijske hipertenzije),
English: NAME OF THE MEDICINAL PRODUCT ADCIRCA 20 mg film-coated tablets
Slovenian: IME ZDRAVILA ADCIRCA 20 mg filmsko obložene tablete
English: Palpitations2, 5
Slovenian: Srčne bolezni palpitacije2,5
English: ADCIRCA is supplied as a 20 mg tablet.
Slovenian: Zdravilo ADCIRCA je na voljo kot 20 mg tableta.
English: No dose adjustment is warranted.
Slovenian: Prilagoditev odmerka ni potrebna.
English: Analyses of observational data suggest an increased risk of acute NAION in men with erectile dysfunction following exposure to tadalafil or other PDE5 inhibitors.
Slovenian: NAION pri moških z erektilno disfunkcijo po izpostavljenosti tadalafilu ali drugim zaviralcem PDE5.
English: The effect of alcohol on cognitive function was not augmented by tadalafil (10 mg).
Slovenian: Tadalafil (10 mg) ni okrepil učinka alkohola na kognitivne funkcije.
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.
Slovenian: Zdrave starejše osebe (65 let ali več) so imele nižji peroralni očistek tadalafila, kar je po odmerku 10
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).
Slovenian: Če se pojavijo kateri koli od naslednjih neželenih učinkov, prenehajte jemati zdravilo in takoj poiščite zdravniško pomoč:
English: Τηλ: +357 22 715000
Slovenian: Phadisco Ltd Τηλ: + 357 22 715000
English: In patients with mild to moderate renal impairment a starting dose of 20 mg once per day is recommended.
Slovenian: Okvarjeno delovanje ledvic: Pri bolnikih z blago do zmerno okvarjenim delovanjem ledvic je priporočen začetni odmerek 20 mg enkrat na dan. Odmerek se lahko zveča na 40 mg enkrat na dan, odvisno od učinkovitosti in prenašanja zdravila pri posamezniku.
English: Oy Eli Lilly Finland Ab Puh/Tel: + 358-(0) 9 85 45 250
Slovenian: Puh/Tel: + 358-(0) 9 85 45 250
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).
Slovenian: interval zaupanja: -2,4, 47,8) in pri bolnikih, ki so prejemali samo 40 mg tadalafila (n=37), 39 metrov (p<0,01; 95 % interval zaupanja: 13,0, 66,0; predhodno določena Hodges-Lehmanova metoda)
English: If you get any side effects, talk to your doctor or pharmacist.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali s farmacevtom.
English: ADCIRCA is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity (see section 5.1).
Slovenian: funkcijskem razredu po razvrstitvi SZO pri odraslih, za izboljšanje sposobnosti za telesno obremenitev (glejte poglavje 5.1).
English: These events were not seen in clinical studies for pulmonary arterial hypertension and therefore frequency is unknown: - swelling of the eyelids, eye pain, red eyes, heart attack and stroke.
Slovenian: Teh učinkov v kliničnih študijah za pljučno arterijsko hipertenzijo niso opazili, zato je pogostnost neznana:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg tadalafil.
Slovenian: Ena filmsko obložena tableta vsebuje 20 mg tadalafila.
English: Pain in extremity (including limb discomfort)
Slovenian: bolečina v hrbtu, bolečina v udih (vključno z nelagodjem v udih)
English: Alcohol concentrations were not affected by co-administration with tadalafil (10 mg or 20 mg).
Slovenian: Alkohol Sočasno jemanje tadalafila (10 mg ali 20 mg) ni vplivalo na koncentracije alkohola.
English: NN:
Slovenian: Kljub temu,
English: Priapism has been reported in men treated with PDE5 inhibitors.
Slovenian: Priapizem in anatomska deformacija penisa Pri moških, ki so se zdravili z zaviralci PDE5, so poročali o priapizmu.
English: Pulmonary arterial hypertension (PAH) etiologies were predominantly idiopathic PAH (61.0 %) and related to collagen vascular disease (23.5 %).
Slovenian: (61,0 %) in povezana z vaskularno sistemsko boleznijo veziva (23,5 %).
English: Uncommon (may affect up to 1in 100 people) - seizures, passing memory loss, hives, excessive sweating, penile bleeding, presence of blood in semen and/or urine, high blood pressure, fast heart rate, sudden cardiac death and ringing in the ears.
Slovenian: prisotnost krvi v spermi in/ali v urinu, zvišan krvni tlak, hitro bitje srca, nenadna srčna smrt in zvonjenje v ušesih.
English: Dyspepsia (including abdominal pain/discomfort3)
Slovenian: (vključno z bolečino/nelagod jem v trebuhu3)
English: 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)
Slovenian: Zelo pogosto so pri bolnikih, ki so jemali zdravilo ADCIRCA, poročali o naslednjih neželenih učinkih (pojavijo se lahko pri več kot 1 od 10 bolnikov): glavobol, zardevanje, nosna in sinusna kongestija
English: Warnings and precautions Talk to your doctor before taking ADCIRCA.
Slovenian: Pred začetkom jemanja zdravila ADCIRCA se posvetujte s svojim zdravnikom.
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.
Slovenian: Zaradi malo kliničnih izkušenj pri bolnikih z blago do zmerno cirozo jeter (razred A in B po Child
English: Before taking the tablets, tell your doctor if you have:
Slovenian: Pred jemanjem zdravila se pogovorite s svojim zdravnikom, če imate: - poleg pljučne hipertenzije še kakšno drugo težavo s srcem,
English: 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.
Slovenian: 36: fizično funkcioniranje, fizična vloga, telesna bolečina, splošno zdravstveno stanje, vitalnost in socialna funkcija.
English: Vascular disorders Flushing
Slovenian: Žilne bolezni zardevanje hipotenzija hipertenzija
English: Haematuria Reproductive system and breast disorders Increased uterine bleeding4
Slovenian: Motnje reprodukcije in dojk podaljšano krvavenje iz maternice priapizem5, krvavitev iz penisa, hematospermija podaljšane erekcije
English: Ketoconazole (200 mg daily), increased tadalafil (10 mg) single dose exposure (AUC) 2-fold and Cmax by 15 %, relative to the AUC and Cmax values for tadalafil alone.
Slovenian: Ketokonazol (200 mg na dan) je biološko uporabnost (AUC) tadalafila (10 mg) po enkratnem odmerku povečal za 2-krat in Cmax za 15 % glede na vrednosti AUC in Cmax za tadalafil sam. Ketokonazol (400 mg na dan) je povečal biološko uporabnost (AUC) tadalafila (20 mg) za 4-krat in Cmax za 22 %.
English: 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.
Slovenian: Antagonisti receptorja za endotelin -1 (npr. bosentan) Bosentan (125 mg dvakrat na dan), ki je substrat CYP2C9 in CYP3A4 in zmeren induktor CYP3A4,
English: Ask your doctor or pharmacist for advice before taking any medicine while pregnant or breastfeeding.
Slovenian: Če ste noseči ali dojite, se po nasvet o uporabi katerega koli zdravila obrnite na zdravnika ali farmacevta.
English: Hypotension Hypertension Respiratory, thoracic and mediastinal disorders Nasopharyngitis (including nasal congestion, sinus congestion and rhinitis)
Slovenian: (vključno s nosno kongestijo, sinusno kongestijo in rinitisom)
English: Alcohol
Slovenian: ZDRAVILA
English: SN:
Slovenian: PC: SN: NN:
English: How to store ADCIRCA
Slovenian: Shranjevanje zdravila ADCIRCA
English: Visual defects and cases of NAION have been reported in connection with the intake of tadalafil and other PDE5 inhibitors.
Slovenian: V povezavi z jemanjem tadalafila in drugih zaviralcev PDE5 so poročali o okvarah vida in primerih
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.
Slovenian: (5) Neželeni učinki so bili vključeni v preglednico kot posledica podatkov iz obdobja trženja ali podatkov iz kliničnih študij o uporabi tadafila za zdravljenje erektilne disfunkcije.