FrancophonIA/ELRC3.0 huggingface dataset:
English: Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Iron oxide yellow (E172) Triacetin
Slovenian: laktoza monohidrat hipromeloza (E464) titanov dioksid (E171) rumeni železov oksid (E172) triacetin
English: - removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non nerve sparing prostatectomy).
Slovenian: - odstranitev celotne prostate ali dela prostate, pri kateri so bili živci prostate prerezani (radikalna prostatektomija brez ohranjanja živcev).
English: Tadalafil has been shown to increase the effects of these medicines.
Slovenian: Za tadalafil je bilo namreč ugotovljeno, da učinke teh zdravil poveča.
English: It is not known if tadalafil is effective in patients who have had: - pelvic surgery.
Slovenian: Ni znano, če je zdravilo Tadalafil Mylan učinkovito pri bolnikih, ki so imeli: - operacijo v medenici.
English: The improvement in the total international prostate symptom score with tadalafil 5 mg in the four studies were -4.8, -5.6, -6.1 and -6.3 compared to -2.2, -3.6, -3.8 and -4.2 with placebo.
Slovenian: Izboljšanje skupnega rezultata na mednarodni lestvici prostatičnih simptomov z zdravilom Tadalafil Mylan 5 mg v štirih študijah je znašalo -4,8, -5,6, -6,1 in -6,3 v primerjavi z -2,2, -3,6, -3,8 in -4,2 s placebom.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction.
Slovenian: Ne-klinični podatki dobljeni na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
English: Tadalafil (10 mg and 20 mg) had no clinically significant effect on exposure (AUC) to S-warfarin or R-warfarin (CYP2C9 substrate), nor did tadalafil affect changes in prothrombin time induced by warfarin.
Slovenian: Tadalafil (10 mg in 20 mg) ni imel klinično pomembnega učinka na izpostavitev (AUC) S-varfarinu ali R-varfarinu (substrat CYP2C9) niti ni vplival na spremembe protrombinskega časa, ki jih povzroča varfarin.
English: Tadalafil Mylan will not help you if you do not have erectile dysfunction.
Slovenian: Zdravilo Tadalafil Mylan vam ne bo pomagalo, če nimate erektilne disfunkcije.
English: In clinical trials with tadalafil taken on demand for the treatment of erectile dysfunction, diarrhoea was reported more frequently in patients over 65 years of age.
Slovenian: V kliničnih preskušanjih, v katerih so bolniki jemali tadalafil po potrebi za zdravljenje erektilne disfunkcije, so o diareji poročali pogosteje pri bolnikih, starejših od 65 let.
English: Due to increased tadalafil exposure (AUC), limited clinical experience and the lack of ability to influence clearance by dialysis, once-a-day dosing of tadalafil is not recommended in patients with severe renal impairment.
Slovenian: Zaradi povečane izpostavljenosti (AUC) tadalafilu, pomanjkanja kliničnih izkušenj in ne vplivanja dialize na klirens, odmerjanje tadalafila enkrat na dan ni priporočljivo za bolnike s hudo okvaro ledvic.
English: Tadalafil is > 10,000-fold more potent for PDE5 than for PDE1, PDE2, and PDE4 enzymes which are found in the heart, brain, blood vessels, liver, and other organs.
Slovenian: Tadalafil je > 10.000-krat močnejši za PDE5 kot za PDE1, PDE2 in PDE4, encime, ki se nahajajo v srcu, možganih, krvnih žilah, jetrih in drugih organih.
English: When tadalafil 10 mg was administered with theophylline (a non-selective phosphodiesterase inhibitor) in a clinical pharmacology study, there was no pharmacokinetic interaction.
Slovenian: Ko so v študiji klinične farmakologije tadalafil 10 mg dajali skupaj s teofilinom (neselektivnim zaviralcem fosfodiesteraze), ni bilo farmakokinetičnega medsebojnega delovanja.
English: Tadalafil Mylan contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Slovenian: Zdravilo Tadalafil Mylan vsebuje zdravilno učinkovino tadalafil, ki spada v skupino zdravil, imenovanih zaviralci fosfodiesteraze tipa 5.
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.
Slovenian: V študijah klinične farmakologije z uporabo enkratnega odmerka tadalafila (5 mg do 20 mg) se je izpostavitev (AUC) tadalafilu pri osebah z blago (očistek kreatinina 51 do 80 ml/min) ali zmerno (očistek kreatinina 31 do 50 ml/min) okvaro ledvic ter pri osebah s končno odpovedjo ledvic na dializi približno podvojila.
English: Tabulated summary of adverse reactions
Slovenian: V tabeli prikazan povzetek neželenih učinkov
English: As this may be relevant for all patients exposed to tadalafil, the patient should be advised that in case of sudden visual defect, he should stop taking Tadalafil Mylan and consult a physician immediately (see section 4.3).
Slovenian: Ker je lahko to pomembno za druge bolnike, izpostavljene tadalafilu, je bolnika treba opozoriti, da naj v primeru nenadne okvare vida preneha jemati zdravilo Tadalafil Mylan in o tem nemudoma obvesti svojega zdravnika (glejte poglavje 4.3).
English: Tadalafil 10 and 20 mg is intended for use prior to anticipated sexual activity and it is not recommended for continuous daily use.
Slovenian: Tadalafil 10 in 20 mg je namenjen za uporabo pred pričakovano spolno aktivnostjo in ga ne priporočamo za dolgotrajno vsakodnevno uporabo.
English: Aspirin Tadalafil (10 mg and 20 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid.
Slovenian: Tadalafil (10 mg in 20 mg) ni potenciral podaljšanja časa krvavitve, povzročenega z acetilsalicilno kislino.
English: 5-alpha reductase inhibitors
Slovenian: Zaviralci 5-alfa reduktaze
English: The majority of headaches reported with tadalafil once-a-day dosing are experienced within the first 10 to 30 days of starting treatment.
Slovenian: Večino glavobolov, o katerih poročajo bolniki, ki jemljejo zdravilo Tadalafil Mylan v odmerku enkrat na dan, bolniki občutijo v prvih 10 do 30 dneh po začetku zdravljenja.
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.
Slovenian: Randomizirana, dvojno slepa, s placebom nadzorovana, vzporedna študija tadalafila s 3 kraki je bila izvedena pri 331 fantih, starih od 7 do 14 let, z DMD, ki so sočasno prejemali kortikosteroidno zdravljenje.
English: What Tadalafil Mylan is and what it is used for
Slovenian: Kaj je zdravilo Tadalafil Mylan in za kaj ga uporabljamo
English: The following groups of patients with cardiovascular disease were not included in clinical trials and the use of tadalafil is therefore contraindicated: - patients with myocardial infarction within the last 90 days, - patients with unstable angina or angina occurring during sexual intercourse, - patients with New York Heart Association Class 2 or greater heart failure in the last 6 months, - patients with uncontrolled arrhythmias, hypotension (< 90/50 mm Hg), or uncontrolled hypertension, - patients with a stroke within the last 6 months.
Slovenian: Naslednje skupine bolnikov s srčnožilno boleznijo niso bile vključene v klinična preskušanja, zato je pri njih uporaba tadalafila kontraindicirana: - bolniki z miokardnim infarktom v zadnjih 90 dneh, - bolniki z nestabilno angino pektoris ali angino pektoris, ki se pojavlja med spolnim odnosom, - bolniki s srčnim odpovedovanjem razreda 2 ali višjim po NYHA (New York Heart Association)
English: In clinical trials with tadalafil 5 mg taken once a day for the treatment of benign prostatic hyperplasia, dizziness and diarrhoea were reported more frequently in patients over 75 years of age.
Slovenian: V kliničnih preskušanjih, v katerih so bolniki jemali tadalafil 5 mg enkrat na dan za zdravljenje benigne hiperplazije prostate, so o omotici in diareji pogosteje poročali pri bolnikih nad 75. letom starosti.
English: Prior to initiating treatment with tadalafil for benign prostatic hyperplasia patients should be examined to rule out the presence of carcinoma of the prostate and carefully assessed for cardiovascular conditions (see section 4.3).
Slovenian: Pred uvedbo zdravljenja benigne hiperplazije prostate s tadalafilom je treba bolnike pregledati in izključiti prisotnost karcinoma prostate ter natančno oceniti njihove srčnožilne bolezni (glejte poglavje 4.3).
English: Tadalafil 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.
Slovenian: Tadalafil, ki so ga dali zdravim posameznikom, v primerjavi s placebom ni povzročil pomembne razlike sistoličnega in diastoličnega krvnega tlaka leže (povprečni maksimalni padec 1,6 oziroma 0,8 mm Hg), sistoličnega in diastoličnega krvnega tlaka stoje (povprečni maksimalni padec 0,2 oziroma 4,6 mm Hg) ter nobene pomembne spremembe srčne frekvence.
English: Tadalafil did not show efficacy in slowing the decline in ambulation as measured by the primary 6 minute walk distance (6MWD) endpoint: least squares (LS) mean change in 6MWD at 48 weeks was -51.0 meters (m) in the placebo group, compared with -64.7 m in the tadalafil 0.3 mg/kg group (p = 0.307) and -59.1 m in the tadalafil 0.6 mg/kg group (p = 0.538).
Slovenian: Tadalafil ni pokazal učinkovitosti pri upočasnitvi zmanjšanja dolžine hoje, kar so ugotavljali s primarnim opazovanim dogodkom razdalje, izmerjene pri 6-minutni hoji (6MWD): povprečna sprememba 6MWD pri metodi najmanjših kvadratov (LS) v 48. tednu je bila -51,0 metra (m) v skupini, ki je prejemala placebo, v primerjavi s -64,7 m v skupini, ki je prejemala 0,3 mg/kg tadalafila dnevno (p = 0,307), ter -59,1 m v skupini, ki je prejemala 0,6 mg/kg tadalafila dnevno (p = 0,538).
English: In two of these studies decreases were observed in sperm count and concentration related to tadalafil treatment of unlikely clinical relevance.
Slovenian: V dveh od teh študij zdravljenja s tadalafilom so opazili znižanje števila semenčic in koncentracije sperme, kar je klinično verjetno nepomembno.
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 povprečnega znižanja krvnega tlaka, ki ga je povzročil alkohol (0,7 g/kg ali približno 180 ml 40 % alkohola [vodke] pri 80-kg moškem), pri nekaterih osebah pa so opažali osturalno omotico in ortostatsko hipotenzijo.
English: Tadalafil has vasodilator properties, resulting in mild and transient decreases in blood pressure (see section 5.1) and as such potentiates the hypotensive effect of nitrates (see section 4.3).
Slovenian: Tadalafil ima vazodilatatorne lastnosti, to pa povzroča blaga in prehodna znižanja krvnega tlaka (glejte poglavje 5.1) in kot tak krepi hipotenzivni učinek nitratov (glejte poglavje 4.3).
English: The side effect dizziness has been reported more frequently in men over 75 years of age taking tadalafil.
Slovenian: O neželenem učinku omotici so pogosteje poročali pri moških nad 75. letom starosti, ki so jemali tadalafil.
English: In a clinical trial that compared tadalafil 5 mg coadministered with finasteride 5 mg to placebo plus finasteride 5 mg in the relief of BPH symptoms, no new adverse reactions were identified.
Slovenian: V kliničnem preskušanju, v katerem so primerjali tadalafil 5 mg, uporabljan sočasno s finasteridom 5 mg, in placebo skupaj s finasteridom 5 mg za lajšanje simptomov benigne hiperplazije prostate, niso odkrili nobenih novih neželenih učinkov.
English: In dogs given tadalafil daily for 6 to 12 months at doses of 25 mg/kg/day (resulting in at least a 3-fold greater exposure [range 3.7 - 18.6] than seen in humans given a single 20 mg dose) and above, there was regression of the seminiferous tubular epithelium that resulted in a decrease in spermatogenesis in some dogs.
Slovenian: Pri psih, ki so tadalafil prejemali dnevno 6 do 12 mesecev v odmerkih 25 mg/kg/dan (kar pomeni vsaj 3-krat večjo izpostavitev [razpon 3,7-18,6], kot je bila opažena pri ljudeh pri enkratnem odmerku 20 mg) in več, je prišlo do regresije epitela semenskih cevk, kar je pri nekaterih psih povzročilo zmanjšanje spermatogeneze.
English: Some additional rare side effects have been reported in men taking tadalafil that were not seen in clinical trials.
Slovenian: Pri moških, ki so jemali tadalafil so poročali o nekaterih dodatnih redkih neželenih učinkih, ki jih niso opažali v kliničnih preskušanjih.
English: Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, stop taking Tadalafil Mylan and contact your doctor immediately.
Slovenian: Čeprav ni znano, ali je dogodek neposredno povezan s tadalafilom, morate, če opazite zmanjšan sluh ali nenadno gluhost, prenehati jemati zdravilo Tadalafil Mylan in se takoj obrniti na svojega zdravnika.
English: The most commonly reported adverse reactions in patients taking tadalafil for the treatment of erectile dysfunction or benign prostatic hyperplasia were headache, dyspepsia, back pain and myalgia, in which the incidences increase with increasing dose of tadalafil.
Slovenian: Neželeni učinki, o katerih so pri bolnikih, ki so jemali tadalafil za zdravljenje erektilne disfunkcije ali benigne hiperplazije prostate, najpogosteje poročali, so bili glavobol, dispepsija, bolečina v hrbtu in mialgija, pri kateri se incidenca povečuje s povečanjem odmerka tadalafila.
English: In a 12-week study performed in 186 patients (142 tadalafil, 44 placebo) with erectile dysfunction secondary to spinal cord injury, tadalafil significantly improved the erectile function leading to a mean per-subject proportion of successful attempts in patients treated with tadalafil 10 or 20 mg (flexible-dose, on demand) of 48% as compared to 17% with placebo.
Slovenian: V 12-tedenski študiji, ki so jo izvedli pri 186 bolnikih (142 jih je jemalo tadalafilu, 44 pa placebo) z erektilno disfunkcijo zaradi poškodbe hrbtenjače, je tadalafil bistveno izboljšal erektilno funkcijo, kar je vodilo v povprečno sorazmerno število uspešnih poskusov na osebo pri bolnikih, zdravljenih s tadalafilom 10 ali 20 mg (prilagodljiv odmerek, po potrebi) pri 48 % bolnikov, v primerjavi s 17 % pri placebu.
English: The improvements in the erectile function domain of the international index of erectile function and the total international prostate symptom score in this study were 6.5 and -6.1 with tadalafil 5 mg compared to 1.8 and -3.8 with placebo, respectively.
Slovenian: Izboljšanje na področju erektilne funkcije po mednarodnem indeksu erektilne funkcije in skupni rezultat na mednarodni lestvici prostatičnih simptomov sta v tej študiji znašala 6,5 in -6,1 z zdravilom Tadalafil Mylan 5 mg v primerjavi z 1,8 in 3,8 s placebom.
English: The mean persubject proportion of successful sexual intercourse attempts was 71.9% with tadalafil 5 mg compared to 48.3% with placebo.
Slovenian: Povprečno število uspešnih poskusov spolnega odnosa je znašalo 71,9 % z zdravilom Tadalafil Mylan 5 mg v primerjavi s 48,3 % s placebom.
English: Tadalafil Mylan is available as 2.5, 5, 10, and 20 mg film-coated tablets for oral use.
Slovenian: Zdravilo Tadalafil Mylan je na voljo v obliki 2,5, 5, 10 in 20 mg filmsko obloženih tablet za peroralno uporabo.
English: Ritonavir, a protease inhibitor (200 mg twice daily), which is an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil (20 mg) exposure (AUC) 2-fold with no change in Cmax.
Slovenian: Ritonavir, zaviralec proteaze (200 mg dvakrat dnevno), ki je zaviralec CYP3A4, CYP2C9, CYP2C19 in CYP2D6, je povečal izpostavitev (AUC) tadalafilu (20 mg) za 2-krat brez spremembe Cmax.
English: Tadalafil is > 10,000-fold more potent for PDE5 than for PDE3, an enzyme found in the heart and blood vessels.
Slovenian: Tadalafil je > 10.000-krat močnejši za PDE5 kot za PDE3, encim, ki se nahaja v srcu in krvnih žilah.
English: For patients with severe renal impairment 10 mg is the maximum recommended dose for on-demand treatment.
Slovenian: Pri bolnikih s hudo okvaro ledvic je najvišji priporočeni odmerek 10 mg za zdravljenje po potrebi.
English: Warnings and precautions Talk to your doctor before taking Tadalafil Mylan.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Tadalafil Mylan se posvetujte s svojim zdravnikom.
English: Once-a-day dosing of 2.5 or 5 mg tadalafil both for the treatment of erectile dysfunction or benign prostatic hyperplasia is not recommended in patients with severe renal impairment (see sections 4.4 and 5.2).
Slovenian: Odmerjanje tadalafila 2,5 ali 5 mg enkrat na dan za zdravljenje erektilne disfunkcije ali benigne hiperplazije prostate ni priporočljivo za bolnike s hudo okvaro ledvic (glejte poglavji 4.4 in 5.2).
English: It is important to note that tadalafil does not work if there is no sexual stimulation.
Slovenian: Pomembno je omeniti, da tadalafil brez spolne stimulacije ne deluje.
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 84 film-coated tablets 98 film-coated tablets
Slovenian: 14 filmsko obloženih tablet 28 filmsko obloženih tablet 30 filmsko obloženih tablet 56 filmsko obloženih tablet 84 filmsko obloženih tablet 98 filmsko obloženih tablet
English: There are no available data about the administration of doses higher than 10 mg of tadalafil to patients with hepatic impairment.
Slovenian: Podatkov o dajanju odmerkov tadalafila, višjih od 10 mg, bolnikom z okvaro jeter ni.
English: The table below lists the adverse reactions observed from spontaneous reporting and in placebo controlled clinical trials (comprising a total of 8022 patients on tadalafil and 4422 patients on placebo) for on-demand and once-a-day treatment of erectile dysfunction and the once-a-day treatment of benign prostatic hyperplasia.
Slovenian: Spodnja tabela navaja neželene učinke, ki so jih opažali v spontanih poročanjih in v kliničnih preskušanjih, nadzorovanih s placebom (v katera je bilo skupno vključenih 8022 bolnikov, ki so prejemali tadalafil, in 4422 bolnikov, ki so prejemali placebo) za zdravljenje erektilne disfunkcije po potrebi in enkrat na dan ter za zdravljenje benigne hiperplazije prostate enkrat na dan.
English: Film-coat: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), iron oxide yellow (E172), triacetin.
Slovenian: Filmska obloga: laktoza monohidrat, hipromeloza (E464), titanov dioksid (E171), rumeni železov oksid (E172), triacetin.
English: 28 film-coated tablets 56 film-coated tablets
Slovenian: 28 filmsko obloženih tablet 56 filmsko obloženih tablet
English: Although specific interactions have not been studied, other protease inhibitors, such as saquinavir, and other CYP3A4 inhibitors, such as erythromycin, clarithromycin, itraconazole and grapefruit juice should be co-administered with caution as they would be expected to increase plasma concentrations of tadalafil (see section 4.4).
Slovenian: Čeprav specifičnih medsebojnih delovanj niso preučevali, je potrebno druge zaviralce proteaze, kot je sakvinavir, ter druge zaviralce CYP3A4, kot so eritromicin, klaritromicin, itrakonazol in grenivkin sok, sočasno dajati previdno, saj lahko pričakujemo, da povišajo plazemske koncentracije tadalafila (glejte poglavje 4.4).
English: Major classes of antihypertensive medicinal products were studied, including calcium channel blockers (amlodipine), angiotensin converting enzyme (ACE) inhibitors (enalapril), beta-adrenergic receptor blockers (metoprolol), thiazide diuretics (bendroflumethiazide), and angiotensin II receptor blockers (various types and doses, alone or in combination with thiazides, calcium channel blockers, beta-blockers, and/or alpha-blockers).
Slovenian: Preučevali so poglavitne razrede antihipertenzivnih zdravil, vključno z zaviralci kalcijevih kanalčkov (amlodipin), zaviralci angiotenzin konvertaze (enalapril), zaviralci adrenergičnih receptorjev beta (metoprolol), tiazidnimi diuretiki (bendrofluazid) in zaviralci receptorjev angiotenzina II (različni tipi in odmerki, posamezno ali v kombinaciji s tiazidi, zaviralci kalcijevih kanalčkov, zaviralci adrenergičnih receptorjev beta in/ali zaviralci adrenergičnih receptorjev alfa).
English: Pack sizes of 4, 12 and 24 tablets.
Slovenian: Velikost pakiranj 4, 12, in 24 tablet.
English: In a study to assess the effects of tadalafil on vision, no impairment of colour discrimination (blue/green) was detected using the Farnsworth-Munsell 100-hue test.
Slovenian: V študiji ugotavljanja učinkov tadalafila na vid z uporabo Farnsworth-Munsellovega testa s 100 odtenki niso zaznali nobene okvare razlikovanja barv (modro/zeleno).
English: The co-administration of PDE5 inhibitors, including tadalafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section 4.5).
Slovenian: Sočasno dajanje zaviralcev PDE5, vključno s tadalafilom, skupaj s stimulatorji gvanilat-ciklaze, kot je riociguat, je kontraindicirano, saj lahko privede do simptomatske hipotenzije (glejte poglavje 4.5).
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.
Slovenian: Pri moških so izvedli tri študije za ugotavljanje možnega učinka zdravila Tadalafil Mylan 10 mg (ena 6-mesečna študija) in 20 mg (ena 6-mesečna in ena 9-mesečna študija), ki so ga dajali dnevno, na spermatogenezo.
English: What you need to know before you take Tadalafil Mylan
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Tadalafil Mylan
English: Tadalafil Mylan is a treatment for adult men with erectile dysfunction.
Slovenian: Zdravilo Tadalafil Mylan je namenjeno zdravljenju odraslih moških z erektilno disfunkcijo.
English: Tel: + 44 1707 853000
Slovenian: Tel: + 44 1707 853000 (United Kingdom)
English: Tadalafil is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
Slovenian: Tadalafil je kontraindiciran pri bolnikih, ki so izgubili vid na enem očesu zaradi nearteritične anteriorne ishemične optične nevropatije (NAION), tudi če ta dogodek ni bil povezan s predhodnim jemanjem zaviralcev PDE5 (glejte poglavje 4.4).
English: The rate and extent of absorption of tadalafil are not influenced by food, thus Tadalafil may be taken with or without food.
Slovenian: Ker hrana ne vpliva na stopnjo in obseg absorpcije tadalafila, se lahko tadalafil vzame s hrano ali brez nje.
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: Antihipertenzivi (vključno z zaviralci kalcijevih kanalčkov) Sočasno jemanje doksazosina (4 in 8 mg dnevno) in tadalafila (dnevni odmerek 5 mg in enkratni odmerek 20 mg) signifikantno okrepi hipotenzivni učinek zaviralca adrenergičnih receptorjev alfa.
English: A CYP3A4 inducer, rifampicin, reduced tadalafil AUC by 88%, relative to the AUC values for tadalafil alone (10 mg).
Slovenian: Induktor CYP3A4, rifampicin, je AUC tadalafila zmanjšal za 88 % v primerjavi z vrednostmi AUC za sam tadalafil (10 mg).