FrancophonIA/ELRC3.0 huggingface dataset:
English: Tadalafil at doses of 2 to 100 mg has been evaluated in 16 clinical studies involving 3250 patients, including patients with erectile dysfunction of various severities (mild, moderate, severe), etiologies, ages (range 21-86 years), and ethnicities.
Slovenian: Tadalafil v odmerkih od 2 do 100 mg so vrednotili v 16 kliničnih študijah, ki so zajemale 3250 bolnikov, vključno z bolniki z erektilno disfunkcijo različnih resnosti (blaga, zmerna, huda), etiologij, starosti (razpon 21-86 let) in narodnosti.
English: Tadalafil and other treatments for erectile dysfunction
Slovenian: Tadalafil in druga zdravljenja erektilne disfunkcije
English: Tadalafil Mylan is not intended for use by women.
Slovenian: Zdravilo Tadalafil Mylan ni namenjeno za uporabo pri ženskah.
English: In a subsequent study, 217 patients who were treatment-naïve to PDE5 inhibitors were randomised to tadalafil 5 mg once a day vs. placebo.
Slovenian: V nadaljnji študiji so 217 bolnikov, ki se predhodno niso zdravili z zaviralci PDE5, naključno razvrstili v jemanje tadalafila 5 mg enkrat na dan in jemanje placeba.
English: Tadalafil Mylan should not be used during breast feeding.
Slovenian: Zdravila Tadalafil Mylan ne smete uporabljati med dojenjem.
English: Ketoconazole (400 mg daily) increased tadalafil (20 mg) exposure (AUC) 4-fold and Cmax by 22%.
Slovenian: Ketokonazol (400 mg dnevno) je povečal izpostavitev (AUC) tadalafilu (20 mg) za 4-krat in Cmax za 22 %.
English: There is no relevant use of tadalafil in the paediatric population with regard to the treatment of erectile dysfunction.
Slovenian: Smotrne uporabe zdravila Tadalafil Mylan pri pediatrični populaciji v zvezi z zdravljenjem erektilne disfunkcije ni.
English: Uncommon (may affect up to 1 in 100 people) - dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty in breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired.
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) - omotica, bolečina v trebuhu, občutek slabosti, slabost (bruhanje), refluks, zamegljen vid, bolečina v očeh, težave pri dihanju, prisotnost krvi v urinu, podaljšana erekcija, občutek razbijanja srca, hitro bitje srca, visok krvni tlak, nizek krvni tlak, krvavitve iz nosu, zvonjenje v ušesih, otekanje dlani, stopal ali gležnjev in občutek utrujenosti.
English: Steady-state plasma concentrations are attained within 5 days of once-daily dosing.
Slovenian: Plazemske koncentracije ravnovesnega stanja so dosežene v 5 dneh odmerjanja enkrat dnevno.
English: If you forget to take Tadalafil Mylan
Slovenian: Če ste pozabili vzeti zdravilo Tadalafil Mylan
English: Tadalafil Mylan is not indicated for use by women.
Slovenian: Zdravilo Tadalafil Mylan ni indicirano za uporabo pri ženskah.
English: Some medicines may be affected by Tadalafil Mylan or they may affect how well Tadalafil Mylan will work.
Slovenian: Zdravilo Tadalafil Mylan lahko vpliva na delovanje nekaterih zdravil, ali pa druga zdravila vplivajo na delovanje zdravila Tadalafil Mylan.
English: Diarrhoea has been reported more frequently in men over the age of 65 taking tadalafil.
Slovenian: O diareji so pogosteje poročali pri moških nad 65. letom starosti, ki so jemali tadalafil.
English: For the treatment of erectile dysfunction using on-demand tadalafil the recommended dose of tadalafil is 10 mg taken prior to anticipated sexual activity and with or without food.
Slovenian: Za zdravljenje erektilne disfunkcije z uporabo tadalafila po potrebi je priporočeni odmerek zdravila tadalafila 10 mg, zaužit pred pričakovano spolno aktivnostjo, s hrano ali brez nje.
English: What Tadalafil Mylan contains - The active substance is tadalafil.
Slovenian: Kaj vsebuje zdravilo Tadalafil Mylan - Učinkovina je tadalafil.
English: In addition,
Slovenian: NN:
English: Myocardial infarction, Unstable angina pectoris Ventricular arrhythmia
Slovenian: Srčne bolezni tahikardija, palpitacije miokardni infarkt, nestabilna angina pektoris prekatna aritmija
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 izpostavitev tadalafilu (AUC) pri osebah z blago in zmerno okvaro jeter (razreda A in B po Child-Pughu) primerljiva z izpostavitvijo pri zdravih osebah.
English: Thus, in a patient prescribed any dose of tadalafil (2.5 mg-20 mg), where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should have elapsed after the last dose of tadalafil before nitrate administration is considered.
Slovenian: Zato naj pri bolniku, ki ima predpisan katerikoli odmerek tadalafila (2,5 mg-20 mg) in kjer je dajanje nitrata zdravstveno nujno v življenje ogrožajoči situaciji, pred dajanjem nitrata preteče vsaj 48 ur po zadnjem odmerku tadalafila.
English: Tadalafil Mylan tablets are for oral use in men only.
Slovenian: Tablete Tadalafil Mylan so namenjene le za peroralno uporabo pri moških.
English: Tadalafil Mylan 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.
Slovenian: Zdravilo Tadalafil Mylan 10 mg in 20 mg je predvideno za jemanje pred pričakovano spolno aktivnostjo in ga ni priporočljivo jemati vsak dan.
English: It is not known if tadalafil is effective in patients who have undergone pelvic surgery or radical non-nerve sparing prostatectomy.
Slovenian: Ni znano, ali je tadalafil učinkovit pri bolnikih po operacijah v medenici ali po radikalni prostatektomiji brez ohranjanja živcev.
English: Tadalafil Mylan 5 mg is available in blister packs containing 14, 28, 30, 56, 84 and 98 tablets.
Slovenian: Zdravilo Tadalafil Mylan 5 mg je na voljo v pretisnih omotih s po 14, 28, 30, 56, 84 in 98 tabletami.
English: Respiratory, thoracic and mediastinal disorders Nasal congestion Dyspnoea, Epistaxis
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora nosna kongestija dispneja, epitaksa
English: If the effect of this dose is too weak your doctor may increase the dose to 20 mg. Tadalafil Mylan is for oral use.
Slovenian: Če bo učinek zdravila prešibak, vam ebo vaš zdravnik morda povečal odmerek na 20 mg.
English: Tablet core: lactose anhydrous (see section 2 ‘Tadalafil Mylan contains lactose'), poloxamer 188, cellulose microcrystalline (pH101), povidone (K-25), croscarmellose sodium, magnesium stearate, sodium laurilsulfate, silica colloidal anhydrous.
Slovenian: Jedro tablete: laktoza, brezvodna (glejte poglavje 2 ‘Zdravilo Tadanfil Mylan vsebuje laktozo'), poloksamer 188, celuloza, mikrokristalna (pH101), povidon (K-25), natrijev karmelozat, premreženi, magnezijev stearat, natrijev lavrilsulfat, silicijev dioksid, koloidni, brezvodni.
English: Caution should be exercised when prescribing tadalafil to patients using potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin) as increased tadalafil exposure (AUC) has been observed if the medicinal products are combined (see section 4.5).
Slovenian: Ko predpisujemo zdravilo Tadalafil Mylan bolnikom, ki jemljejo močne zaviralce CYP3A4 (ritonavir, sakvinavir, ketokonazol, itrakonazol in eritromicin), je potrebna previdnost, ker so pri taki kombinaciji zdravil opažali povečano izpostavitev (AUC) tadalafilu (glejte poglavje 4.5).
English: Once daily
Slovenian: peroralna uporaba enkrat dnevno
English: Tadalafil Mylan 2.5 mg is available in blister packs containing 28 and 56 tablets.
Slovenian: Zdravilo Tadalafil Mylan 2,5 mg je na voljo v pretisnih omotih s po 28 in 56 tabletami.
English: In those patients in whom tadalafil 10 mg does not produce an adequate effect, 20 mg might be tried.
Slovenian: Pri bolnikih, pri katerih 10 mg tadalafila ne povzroči zadostnega učinka, lahko poskusimo z 20 mg. Lahko se vzame najmanj 30 minut pred spolno aktivnostjo.
English: (2) Postmarketing surveillance reported adverse reactions not observed in placebo-controlled clinical trials.
Slovenian: (2) Med nadzorovanjem zdravila v obdobju trženja so poročali o neželenih učinkih, ki jih v s placebom kontrolirani klinični študiji niso opazili.
English: Before treatment with Tadalafil Mylan
Slovenian: Pred zdravljenjem z zdravilom Tadalafil Mylan
English: 2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 12 film-coated tablets 24 film-coated tablets
Slovenian: 2 filmsko obloženi tableti 4 filmsko obložene tablete 8 filmsko obloženih tablet 12 filmsko obloženih tablet 24 filmsko obloženih tablet
English: 4 film-coated tablets 12 film-coated tablets 24 film-coated tablets
Slovenian: 4 filmsko obložene tablete 12 filmsko obložene tablete 24 filmsko obložene tablete
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 antagoniste adrenergičnih receptorjev alfa1, lahko sočasno dajanje zdravila Tadalafil Mylan pri nekaterih bolnikih povzroči simptomatsko hipotenzijo (glejte poglavje 4.5).
English: Abdominal pain, Vomiting, Nausea, Gastro-oesophageal reflux
Slovenian: Bolezni prebavil dispepsija bolečina v trebuhu, bruhanje, navzea, gastroezofagealni refluks
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Slovenian: DATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: Pack sizes of 2, 4, 8,12 and 24 tablets
Slovenian: Velikost pakiranj 2, 4, 8, 12, in 24 tablet.
English: Prolonged erections Priapism, Penile haemorrhage, Haematospermia
Slovenian: Motnje reprodukcije in dojk podaljšana erekcija priapizem, krvavitev iz penisa, hematospermija
English: Tadalafil has no effect in the absence of sexual stimulation.
Slovenian: Tadalafil brez spolne stimulacije nima nobenega učinka.
English: Tadalafil at doses of 2.5, 5, and 10 mg taken once a day was initially evaluated in 3 clinical studies involving 853 patients of various ages (range 21-82 years) and ethnicities, with erectile dysfunction of various severities (mild, moderate, severe) and etiologies.
Slovenian: Tadalafil v odmerkih od 2,5, 5 in 10 mg enkrat na dan so prvotno vrednotili v 3 kliničnih študijah, ki so zajemale 853 bolnikov različnih starosti (od 21-82 let) in narodnosti, z erektilno disfunkcijo različnih resnosti (blaga, zmerna, huda) in etiologij.
English: As a precautionary measure, it is preferable to avoid the use of Tadalafil Mylan during pregnancy.
Slovenian: Med nosečnostjo odsvetujemo uporabo zdravila Tadalafil Mylan.
English: Hypersensitivity reactions Angioedema
Slovenian: Bolezni imunskega sistema preobčutljivostne reakcije angioedem
English: In the two primary efficacy studies of general populations, the mean per-subject proportion of successful intercourse attempts were 57 and 67% on tadalafil 5 mg, 50% on tadalafil 2.5 mg as compared to 31 and 37% with placebo.
Slovenian: V dveh primarnih študijah učinkovitosti splošne populacije je bilo v povprečju pri bolnikih, zdravljenih s tadalafilom 5 mg, uspešnih 57 in 67 % poskusov spolnega odnosa, sorazmerno z bolniki, zdravljenimi s tadalafilom 2,5 mg 50 %, v primerjavi s 31 in 37 % pri placebu.
English: A selective inhibitor of CYP3A4, ketoconazole (200 mg daily), increased tadalafil (10 mg) exposure (AUC) 2-fold and Cmax by 15%, relative to the AUC and Cmax values for tadalafil alone.
Slovenian: Selektivni zaviralec CYP3A4, ketokonazol (200 mg dnevno), je povečal izpostavitev (AUC) tadalafilu (10-mg) za 2-krat in Cmax za 15 % glede na vrednosti AUC in Cmax za sam tadalafil.
English: The mean per-subject proportion of successful sexual intercourse attempts was 68% for tadalafil patients compared to 52% for patients on placebo.
Slovenian: Pri bolnikih, ki so jemali tadalafil, je bilo v povprečju uspešnih 68 % poskusov spolnega odnosa, v primerjavi z 52 % pri bolnikih, ki so jemali placebo.
English: Tadalafil Mylan 20 mg is available in blister packs containing 2, 4, 8, 12 and 24 tablets.
Slovenian: Zdravilo Tadalafil Mylan 20 mg je na voljo v pretisnih omotih s po 2, 4, 8, 12 in 24 tabletami.
English: In the primary efficacy studies, 75% of intercourse attempts were successful in tadalafil treated patients as compared to 32% with placebo.
Slovenian: V primarnih študijah učinkovitosti je bilo pri bolnikih, zdravljenih z zdravilom Tadalafil Mylan, uspešnih 75 % poskusov spolnega odnosa v primerjavi z 32 % pri placebu.
English: Excipient with known effect: Each film-coated tablet contains 118.96 mg of lactose.
Slovenian: Pomožna snov z znanim učinkom: Ena filmsko obložena tableta vsebuje 118,96 mg laktoze.
English: Grapefruit juice may affect how well Tadalafil Mylan will work and should be taken with caution.
Slovenian: Zdravilo Tadalafil Mylan skupaj s pijačo in z alkoholom Grenivkin sok lahko vpliva na delovanje zdravila Tadalafil Mylan, zato ga je treba uživati previdno.
English: Serious cardiovascular events, including myocardial infarction, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischemic attacks, chest pain, palpitations and tachycardia, have been reported either post marketing and/or in clinical trials.
Slovenian: V obdobju trženja zdravila in/ali kliničnih preskušanj so bili opisani resni srčnožilni dogodki, vključno z miokardnim infarktom, nenadno srčno smrtjo, nestabilno angino pektoris, ventrikularno aritmijo, možgansko kapjo, tranzitorno ishemično atako, bolečinami v prsih, palpitacijami in tahikardijo.
English: Tadalafil has no effect in the treatment of erectile dysfunction in the absence of sexual stimulation.
Slovenian: Tadalafil pri zdravljenju erektilne disfunkcije brez spolne stimulacije nima nobenega učinka.
English: Tadalafil Mylan 10 mg is available in blister packs containing 4, 12 and 24 tablets.
Slovenian: Zdravilo Tadalafil Mylan 10 mg je na voljo v pretisnih omotih s po 4, 12 in 24 tabletami.
English: Cytochrome P450 inducers
Slovenian: Induktorji citokroma P450
English: A slightly higher incidence of ECG abnormalities, primarily sinus bradycardia, has been reported in patients treated with tadalafil once a day as compared with placebo.
Slovenian: Pri bolnikih, ki so bili zdravljeni s tadalafilom enkrat na dan, so v primerjavi s placebom poročali o nekoliko povečani incidenci nepravilnosti EKG-ja, zlasti sinusni bradikardiji.
English: There is limited clinical data on the safety of tadalafil in patients with severe hepatic impairment (Child-Pugh Class C); if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.
Slovenian: Pri bolnikih s hudo okvaro jeter (razred C po Child-Pughu) so na voljo le omejeni klinični podatki o varnosti tadalafila; v kolikor ga predpišemo, naj zdravnik, ki zdravilo predpiše, skrbno ovrednoti razmerje med koristmi in tveganjem pri posamezniku.
English: For once-a-day evaluation of tadalafil at doses of 2.5, 5, and 10 mg 3 clinical studies were initially conducted involving 853 patients of various ages (range 21-82 years) and ethnicities, with erectile dysfunction of various severities (mild, moderate, severe) and etiologies.
Slovenian: Za oceno, izvedeno enkrat na dan, za tadalafil v odmerkih 2,5, 5 in 10 mg so bile prvotno opravljene 3 klinične študije, ki so zajemale 853 bolnikov različnih starosti (od 21-82 let) in narodnosti, z erektilno disfunkcijo različnih resnosti (blaga, zmerna, huda) in etiologij.
English: Tadalafil Mylan contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Slovenian: Zdravilo Tadalafil Mylan vsebuje natrij To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na tableto, kar v bistvu pomeni ''brez natrija''.
English: Tadalafil Mylan contains lactose.
Slovenian: Zdravilo Tadalafil Mylan vsebuje laktozo.
English: These include: - migraine, swelling of the face, serious allergic reaction which causes swelling of the face or throat,
Slovenian: Ti vključujejo: - migreno, otekanje obraza, resno alergično reakcijo, ki povzroči otekanje obraza in grla, resne kožne izpuščaje, nekatere motnje, ki vplivajo na pretok krvi v oči, nepravilno bitje srca, angino pektoris in nenadno srčno smrt.
English: Other medicines and Tadalafil Mylan Tell your doctor if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
English: Tadalafil Mylan 10 mg and 20 mg film-coated tablets cannot be divided and should be swallowed whole.
Slovenian: Tablet zdravila Tadalafil Mylan 10 mg in 20 mg filmsko obložene tablete se ne sme deliti.
English: In the study in patients with erectile dysfunction secondary to diabetes, the mean per-subject proportion of successful attempts were 41 and 46% on tadalafil 5 mg and 2.5 mg, respectively, as compared to 28% with placebo.
Slovenian: V študiji pri bolnikih z erektilno disfunkcijo poleg diabetesa je bilo v povprečju pri bolnikih, zdravljenih s tadalafilom 5 mg oziroma 2,5 mg, uspešnih 41 in 46 % poskusov spolnega odnosa, v primerjavi z 28 % pri placebu.
English: Once-a-day dosing of tadalafil both for the treatment of erectile dysfunction and benign prostatic hyperplasia has not been evaluated in patients with hepatic impairment; therefore, if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician (see sections 4.4 and 5.2).
Slovenian: Pri bolnikih z okvaro jeter niso ocenjevali odmerjanja tadalafila enkrat na dan za zdravljenje erektilne disfunkcije in benigne hiperplazije prostate; torej, v kolikor ga predpišemo, naj zdravnik, ki zdravilo predpiše, skrbno ovrednoti razmerje med koristmi in tveganjem pri posamezniku (glejte poglavji 4.4 in 5.2).
English: Some men taking tadalafil in clinical studies have reported dizziness.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Nekateri moški, ki so tadalafil jemali v kliničnih študijah, so poročali o omotici.
English: Your doctor may adjust the dose to 2.5 mg based on your response to Tadalafil Mylan.
Slovenian: Glede na vaš odziv na zdravilo Tadalafil Mylan vam bo vaš zdravnik morda prilagodil odmerek na 2,5 mg. Tega boste prejeli kot 2,5 mg tableto.
English: Excipient with known effect: Each film-coated tablet contains 59.48 mg of lactose.
Slovenian: Pomožna snov z znanim učinkom: Ena filmsko obložena tableta vsebuje 59,48 mg laktoze.
English: Rare (may affect up to 1 in 1,000 people) - fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing and hives (itchy red welts on the surface of the skin), penile bleeding, presence of blood in semen and increased sweating.
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1000 bolnikov) - omedlevica, epileptični napadi in prehodna izguba spomina, otekanje vek, rdeče oči, nenadno zmanjšanje sluha ali gluhost, koprivnica (srbeče rdeče maroge na površini kože), krvavitev iz penisa, prisotnost krvi v spermi in povečano potenje.
English: Excipient with known effect: Each film-coated tablet contains 237.92 mg of lactose.
Slovenian: Pomožna snov z znanim učinkom: Ena filmsko obložena tableta vsebuje 237,92 mg laktoze.
English: Tadalafil Mylan contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Slovenian: Zdravilo Tadalafil Mylan vsebuje manj kot 1 mmol natrija (23 mg) na tableto, kar v bistvu pomeni ''brez natrija''.
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 kakršnokoli obliko organskega nitrata, kontraindicirano (glejte poglavje 4.5).
English: Musculoskeletal and connective tissue disorders Back pain,
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečina v hrbtu, mialgija, bolečina v okončinah
English: The recommended dose of tadalafil is 10 mg taken prior to anticipated sexual activity and with or without food.
Slovenian: Priporočeni odmerek tadalafila je 10 mg, zaužit pred pričakovano spolno aktivnostjo, s hrano ali brez nje.
English: Therefore, administration of tadalafil to patients who are using any form of organic nitrate is contraindicated (see section 4.3).
Slovenian: Zato je dajanje tadalafila bolnikom, ki uporabljajo kakršnokoli obliko organskega nitrata, kontraindicirano (glejte poglavje 4.3).
English: Cases of sudden hearing loss have been reported after the use of tadalafil.
Slovenian: Po uporabi tadalafila so poročali o primerih nenadne gluhosti.
English: Decreased or sudden hearing loss has been noted in some patients taking tadalafil.
Slovenian: Pri nekaterih bolnikih, ki so jemali tadalafil, je bil opažen zmanjšan sluh ali nenadna gluhost.
English: How to take Tadalafil Mylan
Slovenian: Kako jemati zdravilo Tadalafil Mylan
English: Varnavas Hadjipanayis LtdTel: + 357 22207723
Slovenian: Κύπρος (Cyprus) Varnavas Hadjipanayis Ltd Tel: + 357 22207723
English: Visual field defect, Swelling of eyelids, Conjunctival hyperaemia, Non-arteritic anterior ischemic optic neuropathy (NAION) Retinal vascular occlusion
Slovenian: Očesne bolezni zamegljen vid, občutki opisani kot bolečina v očeh izpad v vidnem polju, otečene veke, konjuktivalna hiperemija, nearterična anteriorna ishemična optična nevropatija (NAION) zapora retinalnih žil
English: Each tablet contains 2.5 mg tadalafil.
Slovenian: Ena tableta vsebuje 2,5 mg tadalafila.
English: Excipient with known effect: Each film-coated tablet contains 29.74 mg of lactose.
Slovenian: Pomožna snov z znanim učinkom: Ena filmsko obložena tableta vsebuje 29,74 mg laktoze.
English: There is limited clinical data on the safety of tadalafil in patients with severe hepatic insufficiency (Child-Pugh Class C).
Slovenian: O varnosti zdravila Tadalafil Mylan pri bolnikih s hudo insuficienco jeter (razred C po Child-Pughu) obstajajo le omejeni klinični podatki.
English: Each tablet contains 20 mg tadalafil.
Slovenian: Ena tableta vsebuje 20 mg tadalafila.
English: - a severe kidney problem.
Slovenian: - hude težave z ledvicami.
English: Alcohol concentrations (mean maximum blood concentration 0.08%) were not affected by co-administration with tadalafil (10 mg or 20 mg).
Slovenian: Sočasno dajanje tadalafila (10 mg ali 20 mg) ni vplivalo na koncentracije alkohola (povprečna maksimalna koncentracija v krvi 0,08 %).
English: Common (may affect up to 1 in 10 people) - headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion and indigestion.
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) - glavobol, bolečina v hrbtu, bolečine v mišicah, bolečina v rokah in nogah, zardevanje v obraz,
English: For tadalafil on demand, three clinical studies were conducted in 1054 patients in an at-home setting to define the period of responsiveness.
Slovenian: Erektilna disfunkcija Opravljene so bile tri klinične študije za določitev obdobja odzivnosti na zdravilo Tadalafil Mylan zaužito po potrebi, v katerih je bilo vključenih 1054 bolnikov v domačem okolju.
English: Cytochrome P450 inhibitors
Slovenian: Zaviralci citokroma P450
English: Luxembourg/Luxemburg Mylan bvba/sprl Tel: + 32 (0)2 658 61 00 (Belgique/Belgien)
Slovenian: Tel: + 32 (0)2 658 61 00 (Belgique/Belgien)
English: Lactose, anhydrous Poloxamer 188
Slovenian: laktoza, brezvodna poloksamer 188 celuloza, mikrokristalna (pH101)
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja izpuščaj koprivnica,
English: Transient ischaemic attacks Migraine
Slovenian: Bolezni sečil hematurija
English: - if you ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.
Slovenian: - ste kadarkoli izgubili vid zaradi nearteritične anteriorne ishemične optične nevropatije (NAION),
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 NAION.