FrancophonIA/ELRC3.0 huggingface dataset:
English: Tadalafil is readily absorbed after oral administration and the mean maximum observed plasma concentration (Cmax) is achieved at a median time of 4 hours after dosing.
Slovenian: Tadalafil se po peroralnem dajanju hitro absorbira, povprečna maksimalna opažena plazemska koncentracija (Cmax) je dosežena ob medianem času 4 ure po odmerjanju.
English: Pharmacokinetic studies have included subjects and patients from different ethnic groups, and no differences in the typical exposure to tadalafil have been identified.
Slovenian: Farmakokinetične študije so vključevale osebe in bolnike različnih etničnih skupin; opazili niso nobenih razlik v izpostavljenosti tadalafilu.
English: A single study has been performed in paediatric patients with Duchenne Muscular Dystrophy (DMD) in which no evidence of efficacy was seen.
Slovenian: S pediatričnimi bolniki z Duchennovo mišično distrofijo (DMD) so opravili eno samo študijo, v kateri niso opazili nobenih dokazov o učinkovitosti.
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).
Slovenian: Tadalafil je potrebno previdno uporabljati pri bolnikih z anatomsko deformacijo penisa (kot so ukrivljenost, kavernozna fibroza ali Peyroniejeva bolezen), ali pri bolnikih s stanji, ki bi lahko povečala dovzetnost za priapizem (kot so srpastocelična anemija, multipli mielom ali levkemija).
English: Tadalafil is
Slovenian: Tadalafil je
English: Between 20 mg to 40 mg, a less than proportional increase in exposure is observed.
Slovenian: Pri odmerkih od 20 mg do 40 mg so opazili manj sorazmerno rast.
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.
Slovenian: Pri breji podgani je bila AUC za izračunano prosto učinkovino pri tem odmerku približno 18-kratna AUC človeka pri 20 mg odmerku.
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.
Slovenian: Pri bolnikih s pljučno hipertenzijo, ki se sočasno niso zdravili z bosentanom, je bila povprečna izpostavljenost tadalafilu v stanju dinamičnega ravnovesja po prejetju odmerka 40 mg za 26 % višja v primerjavi z zdravimi prostovoljci.
English: Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, contact your doctor immediately.
Slovenian: Čeprav ni znano, ali je ta dogodek neposredno povezan s tadalafilom, se morate v primeru poslabšanja ali nenadne izgube sluha takoj obrniti na zdravnika.
English: Posology The recommended dose is 40 mg (2 x 20 mg) taken once daily with or without food.
Slovenian: Odmerjanje Priporočeni odmerek je 40 mg (2 x 20 mg) enkrat na dan, zaužit s hrano ali brez nje.
English: The safety and efficacy of combinations of tadalafil and other endothelin-1 receptor antagonists have not been studied.
Slovenian: Varnost in učinkovitost kombinacij tadalafila z drugimi antagonisti receptorja za endotelin-1 nista bili preučevani.
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.
Slovenian: Pri bolnikih, ki so jemali več različnih antihipertenzivnih zdravil in pri katerih krvni tlak ni bil dobro nadzorovan, so opazili večje znižanje krvnega tlaka v primerjavi z bolniki, pri katerih je bil krvni tlak dobro nadzorovan.
English: OTHER Mon, Tue, Wed, Thu, Fri, Sat, Sun.
Slovenian: PON, TOR, SRE, ČET, PET, SOB, NED
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.
Slovenian: Spada v skupino zdravil, imenovanih zaviralci fosfodiesteraze tipa 5 (zaviralci PDE5), ki delujejo tako, da pomagajo pri sproščanju (širjenju) krvnih žil okoli pljuč, kar izboljša pretok krvi v pljuča.
English: 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.
Slovenian: Pogostnost teh učinkov je označena ali kot pogostnost »neznana«, saj se pogostnosti pri bolnikih s PAH ne more oceniti na osnovi podatkov, ki so na voljo, ali kot pogostnost na osnovi podatkov kliničnih študij iz ključne, s placebom kontrolirane študije zdravila ADCIRCA.
English: Sudden cardiac death2, 5, Tachycardia2, 5
Slovenian: nenadna srčna smrt2,5, tahikardija2,5
English: Long-term treatment
Slovenian: Dolgotrajno zdravljenje
English: Allowed background therapy included bosentan (stable maintenance dose up to 125 mg twice daily) and chronic anticoagulation, digoxin, diuretics and oxygen.
Slovenian: Dovoljena osnovna terapija je vključevala bosentan (stabilen vzdrževalni odmerek do 125 mg dvakrat na dan), kronično antikoagulantno zdravljenje, digoksin,
English: PDE5 is the predominant phosphodiesterase in the pulmonary vasculature.
Slovenian: PDE5 je poglavitna fosfodiesteraza v pljučnem žilju.
English: Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD).
Slovenian: Pljučni vazodilatatorji lahko znatno poslabšajo srčno-žilno stanje bolnika z veno-okluzivno boleznijo pljuč (PVOD - pulmonary veno-occlusive disease).
English: When dogs were treated there was reduced sperm development in the testes.
Slovenian: Ko so zdravilo dajali psom, so opazili zmanjšano nastajanje sperme v modih.
English: > 10,000-fold more potent for PDE5 than for PDE3, an enzyme found in the heart and blood vessels.
Slovenian: > 10.000-krat močnejši za PDE5 kot za PDE3, encim, ki se nahaja v srcu in krvnih žilah.
English: However, post hoc analyses demonstrated that changes from baseline in cardiopulmonary hemodynamic parameters for the tadalafil 40 mg treatment group were not significantly different compared to placebo.
Slovenian: Vendar so post-hoc analize pokazale, da se vrednosti parametrov srčno-pljučnega pretoka glede na osnovno vrednost pri skupini, ki se je zdravila s 40 mg tadalafila, v primerjavi s placebom niso pomembno razlikovale.
English: Other side effects have been reported:
Slovenian: Poročali so o tudi o drugih neželenih učinkih:
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).
Slovenian: Izboljšanje pri uporabi 40 mg tadalafila v primerjavi s placebom so opazili na lestvici EuroQol (EQ5D), ki je ameriška in britanska lestvica za oceno mobilnosti, samooskrbe, rutinskih dejavnosti, bolečine/nelagodja in anksioznosti/depresije na vizualni analogni lestvici.
English: Additionally, 6 minute walk distance and WHO functional class status appeared to be stable in those treated with tadalafil for 1 year.
Slovenian: Poleg tega sta bila 6MWD in funkcijski razred po razvrstitvi SZO pri bolnikih, ki so se zdravili 1 leto, stabilna.
English: ADCIRCA contains lactose monohydrate.
Slovenian: Zdravilo ADCIRCA vsebuje laktozo monohidrat.
English: The usual dose is two 20 mg tablets taken once a day.
Slovenian: Običajni odmerek sta dve 20 mg tableti enkrat na dan.
English: In healthy female and male subjects following single and multiple-doses of tadalafil, no clinically relevant differences in exposure were observed.
Slovenian: Pri zdravih moških in ženskah po dajanju enkratnega in večkratnega odmerku tadalafila klinično pomembnih sprememb v izpostavljenosti niso opazili.
English: Sudden decrease or loss of hearing has also been reported.
Slovenian: Poročali so tudi o nenadnem poslabšanju ali izgubi sluha.
English: Due to increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis, tadalafil is not recommended in patients with severe renal impairment.
Slovenian: Zaradi povečane biološke uporabnosti (AUC) tadalafila, malo kliničnih izkušenj in nezmožnosti vplivanja na očistek z dializo, se uporaba tadalafila pri bolnikih s hudo okvaro ledvic ne priporoča.
English: Tadalafil has systemic vasodilatory properties that may result in transient decreases in blood pressure.
Slovenian: Tadalafil ima sistemsko vazodilatorno delovanje, kar lahko povzroči prehodna znižanja krvnega tlaka.
English: Use with CYP3A4 inducers or inhibitors
Slovenian: Uporaba z induktorji in zaviralci CYP3A4
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).
Slovenian: Pogostnost kliničnega poslabšanje do 16. tedna je bila nižja pri bolnikih, ki so dobivali 40 mg tadalafila (5 %; 4 od 79 bolnikov) kot pri bolnikih, ki so prejemali placebo (16 %; 13 od 82 bolnikov).
English: Syncope, Migraine5
Slovenian: sinkopa, migrena5
English: The safety and efficacy of combinations of tadalafil and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied.
Slovenian: Varnosti in učinkovitosti kombinacij tadalafila z drugimi zaviralci PDE5 ali drugimi zdravili za erektilno disfunkcijo niso preučevali.
English: Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.
Slovenian: Učinkovitost je bila dokazana pri idiopatski pljučni arterijski hipertenziji (IPAH) in PAH, povezani z žilno sistemsko boleznijo veziva.
English: CYP2C9 substrates (e.g.R-warfarin)
Slovenian: Substrati CYP2C9 (npr. R-varfarin)
English: ADCIRCA is a treatment for pulmonary arterial hypertension in adults.
Slovenian: Zdravilo ADCIRCA je indicirano za zdravljenje pljučne arterijske hipertenzije pri odraslih.
English: Immune system disorders Hypersensitivity reactions5
Slovenian: Bolezni imunskega sistema preobčutljivostne reakcije5
English: Each film-coated tablet contains 233 mg lactose (as monohydrate).
Slovenian: Pomožna snov z znanim učinkom: ena filmsko obložena tableta vsebuje 233 mg laktoze (v obliki monohidrata).
English: 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 %).
Slovenian: Delež bolnikov z izboljšanjem v funkcijskem razredu po razvrstitvi po SZO do 16. tedna je bil pri skupinah, ki so jemale tadalafil in placebo, podoben (23 % in 21 %).
English: Over a dose range of 2.5 to 20 mg, tadalafil exposure (AUC) increases proportionally with dose in healthy subjects.
Slovenian: V razponu odmerkov od 2,5 mg do 20 mg izpostavljenost (AUC) tadalafilu pri zdravih osebah raste sorazmerno z odmerkom.
English: Seizures5, Transient amnesia5
Slovenian: epileptični napadi5, tranzitorna amnezija5
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.
Slovenian: Randomizirana, dvojno slepa, s placebom kontrolirana študija je bila opravljena pri 405 bolnikih s pljučno arterijsko hipertenzijo.
English: Tadalafil is a potent and selective inhibitor of phosphodiesterase type 5 (PDE5), the enzyme responsible for the degradation of cyclic guanosine monophosphate (cGMP).
Slovenian: Mehanizem delovanja Tadalafil je močan in selektiven zaviralec fosfodiesteraze tipa 5 (PDE5); encima, ki je odgovoren za razgradnjo cikličnega gvanozinmonofosfata (cGMP).
English: Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Slovenian: Imetnik dovoljenja za promet z zdravilom: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska
English: PDE5 inhibitors, such as ADCIRCA, have been shown to increase the hypotensive effects of this medicine.
Slovenian: Zaviralci PDE5, kot je zdravilo ADCIRCA, dokazano povečujejo hipotenzivne učinke tega zdravila.
English: Epistaxis
Slovenian: epistaksa
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) okvarjenim delovanjem ledvic ter pri osebah z ledvičnim popuščanjem v zadnjem stadiju v programu dialize približno podvojila.
English: Should signs of pulmonary oedema occur when tadalafil is administered, the possibility of associated PVOD should be considered.
Slovenian: Če se ob uporabi tadalafila pojavijo znaki pljučnega edema, je potrebno pomisliti na možnost povezanosti s
English: 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 okrepil podaljšanja časa krvavitve, povzročenega z acetilsalicilno kislino.
English: Acetylsalicylic acid
Slovenian: Acetilsalicilna kislina
English: There are limited data from the use of tadalafil in pregnant women.
Slovenian: Podatkov o uporabi tadalafila pri ženskah je malo.
English: Check carefully how you react to the medicines before driving or using any machinery.
Slovenian: Pred vožnjo ali upravljanjem s stroji skrbno preverite, kako reagirate na zdravila.
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.
Slovenian: Pljučna arterijska hipertenzija je povezana z okvarjenim sproščanjem dušikovega oksida iz žilnega endotelija, kar vodi do zmanjšanja koncentracije cGMP v gladkih mišičnih celicah pljučnega žilja.
English: (4) Clinical non-MedDRA term to include reports of abnormal/excessive menstrual bleeding conditions such as menorrhagia, metrorrhagia, menometrorrhagia, or vaginal hemorrhage.
Slovenian: (4) Klinični izrazi (ne po MedDRA) vključujejo poročila o nenormalnem/prekomernem krvavenju med menstruacijo kot so menoreja, metroragija, menometroragija in vaginalna krvavitev.
English: When tadalafil 10 mg was administered with theophylline (a non-selective phosphodiesterase inhibitor) there was no pharmacokinetic interaction.
Slovenian: Ko so v študiji klinične farmakologije tadalafil v odmerku 10 mg dajali skupaj s teofilinom (neselektivnim zaviralcem fosfodiesteraze), do farmakokinetičnih interakcij ni prišlo.
English: Azole Antifungals (e.g. ketoconazole)
Slovenian: Azolni antimikotiki (npr. ketokonazol)
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, večjih od 10 mg, bolnikom z okvarjenim delovanjem jeter ni.
English: (3) Actual MedDRA terms included are abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, and stomach discomfort.
Slovenian: (3) Dejanski izrazi po MedDRA vključujejo izraze nelagodje v trebuhu, bolečina v trebuhu, bolečina v spodnjem delu trebuha, bolečina v zgornjem delu trebuha, nelagodje v želodcu.
English: Patients who experience erections lasting 4 hours or more should be instructed to seek immediate medical assistance.
Slovenian: 4 ure ali več, je potrebno opozoriti, naj nemudoma poiščejo zdravniško pomoč.
English: 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).
Slovenian: Bolniki, 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
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 biološko uporabnost (AUC) Svarfarina ali R-varfarina (substrat CYP2C9), prav tako pa tadalafil ni vplival na spremembe protrombinskega časa, povzročene z varfarinom.
English: In clinical pharmacology studies, the potential for tadalafil (10 and 20 mg) to augment the hypotensive effects of antihypertensive medicinal products was examined.
Slovenian: V študijah klinične farmakologije so preiskovali zmožnost tadalafila (10 mg in 20 mg), da okrepi hipotenzivne učinke antihipertenzivnih zdravil.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite navodilo za uporabo.
English: Some side effects have been reported in men taking tadalafil for the treatment of erectile dysfunction.
Slovenian: O nekaterih neželenih učinkih so poročali pri moških, ki so jemali tadalafil za zdravljenje erektilne disfunkcije.
English: The mean baseline 6-minute-walk-distance (6MWD) was 343.6 meters.
Slovenian: Povprečna razdalja, dosežena na 6-minutnem testu hoje (6MWD - 6-minute walk distance), ob začetku študije je bila 343,6 metrov.
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.
Slovenian: Podobno povečanje AUC in Cmax kot pri etinilestradiolu lahko pričakujemo tudi pri peroralnem dajanju terbutalina, verjetno zato, ker tadalafil zavira sulfacijo v prebavilih.
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.
Slovenian: Povprečni peroralni očistek tadalafila v stanju dinamičnega ravnovesja je pri zdravih osebah 3,4 l/h, povprečni končni razpolovni čas pa 16 ur.
English: If tadalafil is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.
Slovenian: Če zdravnik predpiše tadalafil, mora skrbno ovrednotiti razmerje med koristmi in tveganjem pri posamezniku.
English: 5 How to store ADCIRCA Contents of the pack and other information
Slovenian: Shranjevanje zdravila ADCIRCA Vsebina pakiranja in dodatne informacije
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.
Slovenian: Zaviranje PDE5 s tadalfilom zviša koncentracijo cGMP, kar povroči sproščanje gladkih mišičnih celicah pljučnega ožilja in vazodilatacijo v povirju pljučnih žil.
English: Film-coat lactose monohydrate hypromellose triacetin titanium dioxide (E171) iron oxide yellow (E172) iron oxide red (E172) talc
Slovenian: Filmska obloga laktoza monohidrat hipromeloza triacetin titanov dioksid (E171) rumeni železov oksid (E172)
English: Prostacyclin and its analogues
Slovenian: Prostaciklin in njegovi analogi
English: What ADCIRCA contains
Slovenian: Kaj vsebuje navodilo
English: How to take ADCIRCA
Slovenian: Kako jemati zdravilo ADCIRCA
English: If you stop taking ADCIRCA Do not stop taking your tablets, unless advised otherwise by your doctor.
Slovenian: Če ste prenehali jemati zdravilo ADCIRCA Zdravila ne nehajte jemati, če vam tega ne naroči zdravnik.
English: 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.
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) - zamegljen vid, nizek krvni tlak, krvavitev iz nosu, bruhanje, povečano ali nenormalno krvavenje iz maternice, otekanje obraza, kislinski refluks, migrena, neenakomerno bitje srca in omedlevica.
English: Since there are no clinical data on the safety of tadalafil in these patients, the use of tadalafil is not recommended.
Slovenian: Ker za te bolnike kliničnih podatkov o varnosti tadalafila ni, se uporaba tadalafila pri njih ne priporoča.
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.
Slovenian: Tadalafil v odmerku 20 mg, ki so ga dali zdravim posameznikom, v primerjavi s placebom ni povzročil pomembne razlike sistoličnega oz. diastoličnega krvnega tlaka leže (povprečni maksimalni padec 1,6 mmHg oziroma 0,8 mm Hg), sistoličnega oz. diastoličnega krvnega tlaka stoje (povprečni maksimalni padec 0,2 mmHg oziroma 4,6 mm Hg) ter nobene pomembne spremembe srčne frekvence.
English: - rifampicin (to treat bacterial infections) - ketoconazole tablets (to treat fungal infections) - ritonavir (for HIV treatment) - tablets for erectile dysfunction (PDE5 inhibitors).
Slovenian: - nitrate (za zdravljenje bolečine v prsnem košu) - antagoniste adrenergičnih receptorjev alfa za zdravljenje visokega krvnega tlaka ali težav s prostato, - riociguat, - rifampicin (za zdravljenje bakterijskih okužb), - ketokonazol (za zdravljenje glivičnih okužb), - ritonavir (za zdravljenje okužbe z virusom HIV), - tablete za erektilno disfunkcijo (zaviralce PDE5).
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.
Slovenian: Tadalafil ni imel statistično značilnega učinka na levonorgestrel, kar kaže, da je do učinka na etinilestradiol prišlo zato, ker tadalafil zavira sulfation v prebavilih.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with ADCIRCA in one or more subsets of the paediatric population in the treatment of pulmonary arterial hypertension (see section 4.2 for information on paediatric use).
Slovenian: ADCIRCA za eno ali več podskupin pediatrične populacije za zdravljenje pljučne arterijske hipertenzije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Tablet core: lactose monohydrate, croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium laurilsulfate, magnesium stearate.
Slovenian: Jedro tablete: laktoza monohidrat, premreženi natrijev karmelozat, hidroksipropilceluloza, mikrokristalna celuloza, natrijev lavrilsulfat, magnezijev stearat.
English: In patients with severe renal impairment the use of tadalafil is not recommended (see sections 4.4 and 5.2).
Slovenian: Pri bolnikih s hudo okvarjenim delovanjem ledvic se uporaba tadalafila ne priporoča (glejte poglavji 4.4 in 5.2).
English: Musculoskeletal, connective tissue and bone disorders Myalgia,
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva mialgija,
English: 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.
Slovenian: V preglednico so vključeni tudi nekateri neželeni učinki, o katerih so poročali v kliničnih študijah in/ali v obdobju trženja tadalafila za zdravljenje moške erektilne disfunkcije.