natgillin/translations-raw huggingface dataset:
Tadalafil (10 mg and 20 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid. 
Tadalafil (10 mg in 20 mg) ni potenciral podaljšanja časa krvavitve, povzročenega z acetilsalicilno kislino.
It is not known if CIALIS is effective in patients who have had: - pelvic surgery. 
Ni znano, ali je zdravilo CIALIS učinkovito pri bolnikih, ki so imeli: - operacijo v medenici.
If you are taking riociguat or are unsure tell your doctor. 
Če jemljete riociguat ali če ste negotovi, se posvetujte z zdravnikom.
A single study has been performed in paediatric patients with Duchenne Muscular Dystrophy (DMD) in which no evidence of efficacy was seen. 
Pediatrična populacija S pediatričnimi bolniki z Duchennovo mišično distrofijo (DMD) so opravili eno samo študijo, v kateri niso opazili nobenih dokazov o učinkovitosti.
Other medicines and CIALIS Tell your doctor if you are taking, have recently taken or might take any other medicines 
Obvestite svojega zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
With regard to those interaction studies where only the 10 mg tadalafil dose was used, clinically relevant interactions at higher doses cannot be completely ruled out. 
Glede na študije medsebojnega delovanja , pri katerih je bil uporabljan samo odmerek 10 mg tadalafila, klinično pomembnih medsebojnih delovanj pri večjih odmerkih ni mogoče popolnoma izključiti.
Based on the results of a clinical study in which 150 subjects receiving daily doses of tadalafil 20 mg for 7 days and 0.4 mg sublingual nitroglycerin at various times, this interaction lasted for more than 24 hours and was no longer detectable when 48 hours had elapsed after the last tadalafil dose. 
Na podlagi rezultatov klinične študije, v kateri je 150 oseb prejemalo dnevne odmerke tadalafila 20 mg 7 dni in 0,4 mg sublingvalnega nitroglicerina ob različnih časih, je to medsebojno delovanje trajalo dalj kot 24 ur in ni bilo več zaznavno po preteku 48 ur od zadnjega odmerka tadalafila.
If you take more CIALIS than you should Contact your doctor. 
Če ste vzeli večji odmerek zdravila CIALIS, kot bi smeli Posvetujte se s svojim zdravnikom.
Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, stop taking CIALIS and contact your doctor immediately. 
Čeprav ni znano, ali je ta dogodek neposredno povezan s tadalafilom, morate v primeru poslabšanja ali nenadne izgube sluha prenehati z jemanjem zdravila CIALIS in se takoj obrniti na zdravnika.
Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males. 
Zdravljenje znakov in simptomov benigne hiperplazije prostate pri odraslih moških.
Tadalafil is readily absorbed after oral administration and the mean maximum observed plasma concentration (Cmax) is achieved at a median time of 2 hours after dosing. 
Tadalafil se po peroralnem dajanju hitro absorbira, povprečna maksimalna opažena plazemska koncentracija (Cmax) je dosežena ob medianem času 2 ur po odmerjanju.
Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. 
Imetnik dovoljenja za promet z zdravilom: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska.
This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. 
Moški z erektilno disfunkcijo ne more doseči ali obdržati trdega, pokončnega penisa, ki je potreben za spolno aktivnost.
In order for tadalafil to be effective, sexual stimulation is required. 
Za učinkovitost tadalafila je potrebna spolna stimulacija.
This metabolite is at least 13,000-fold less potent than tadalafil for PDE5. 
Ta presnovek je vsaj 13.000-krat manj učinkovit kot tadalafil za
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 CIALIS 5 mg compared to 1.8 and -3.8 with placebo, respectively. 
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 CIALIS 5 mg v primerjavi z 1,8 in -3,8 s placebom.
The table below lists the adverse reactions observed from spontaneous reporting and in placebocontrolled clinical trials (comprising a total of 8022 patients on CIALIS 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. 
Spodnja preglednica 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 zdravilo CIALIS, in 4422 bolnikov, ki so prejemali placebo) za zdravljenje erektilne disfunkcije z odmerjanjem po potrebi in enkrat na dan ter za zdravljenje benigne hiperplazije prostate z odmerjanjem enkrat na dan.
For adult men being treated for both benign prostatic hyperplasia and erectile dysfunction the recommended dose is also 5 mg taken at approximately the same time every day. 
Za odrasle moške, ki se zdravijo tako zaradi benigne hiperplazije prostate kot zaradi erektilne disfunkcije, je priporočeni odmerek prav tako 5 mg, ki ga je treba vzeti vsak dan ob približno enakem času.
Due to increased tadalafil exposure (AUC), limited clinical experience and the lack of ability to influence clearance by dialysis, once-a-day dosing of CIALIS is not recommended in patients with severe renal impairment. 
Zaradi povečane izpostavljenosti (AUC) tadalafilu, pomanjkanja kliničnih izkušenj in ne vplivanja dialize na klirens, odmerjanje zdravila CIALIS enkrat na dan ni priporočljivo za bolnike s hudo okvaro ledvic.
- a 5- alpha reductase inhibitor (used to treat benign prostatic hyperplasia). 
- zaviralec 5-alfa reduktaze (ki se uporablja za zdravljenje benigne hiperplazije prostate).
METHOD AND ROUTE(S) OF ADMINISTRATION How to take CIALIS once-a-day 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Kako jemati zdravilo CIALIS enkrat na dan
Not all packs sizes may be marketed. 
Na trgu morda ni vseh navedenih pakiranj.
CIALIS tablets are for oral use in men only. 
Tablete zdravila CIALIS so namenjene le za peroralno uporabo pri moških.
Concomitant use of riociguat with PDE5 inhibitors, including tadalafil, is contraindicated (see section 4.3). 
Sočasna uporaba riociguata z zaviralci PDE5, vključno s tadalafilom, je kontraindicirana (glejte poglavje 4.3).
Consequently, it is not expected to be clinically active at observed metabolite concentrations. 
Zato ne pričakujemo, da bi bil pri opazovanih koncentracijah presnovka klinično dejaven.
5 How to store CIALIS Contents of the pack and other information 
Shranjevanje zdravila CIALIS Vsebina pakiranja in dodatne informacije
The study included a 48-week double-blind period where patients were randomised to tadalafil 0.3 mg/kg, tadalafil 0.6 mg/kg, or placebo daily. 
48-tedensko dvojno slepo obdobje, v katerem so bili bolniki randomizirani v skupine, ki so vsakodnevno prejemale tadalafil v odmerku 0,3 mg/kg, tadalafil v odmerku 0,6 mg/kg ali placebo.
Most patients in these three studies were responders to previous on-demand treatment with PDE5 inhibitors. 
Večina bolnikov v teh treh študijah se je odzivala na prejšnje zdravljenje z zaviralci PDE5 z odmerjanjem po potrebi.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN
Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). 
Tadalafil je selektivni reverzibilni zaviralec ciklični gvanozin-monofosfat (cGMP)-specifične fosfodiesteraze tipa 5 (PDE5).
CIALIS should not be used during breast feeding. 
Zdravila CIALIS ne smete uporabljati med dojenjem.
Lilly Portugal Produtos Farmacêuticos, Lda Tel: + 351-21-4126600 
Produtos Farmacêuticos, Lda Tel: + 351-21-4126600
The side effect dizziness has been reported more frequently in men over 75 years of age taking CIALIS. 
O neželenem učinku omotici so pogosteje poročali pri moških nad 75. letom starosti, ki so jemali zdravilo CIALIS.
However, as a formal drug-drug interaction study evaluating the effects of tadalafil and 5-alpha reductase inhibitors (5-ARIs) has not been performed, caution should be exercised when tadalafil is coadministered with 5-ARIs. 
Ker pa uradna študija medsebojnega delovanja zdravil, ki bi ocenila učinke tadalafila in zaviralcev 5-alfa reduktaze (5-ARI- 5-alpha reductase inhibitors), ni bila opravljena, je potrebna previdnost ob sočasni uporabi tadalafila s 5-ARI.
When tadalafil 10 mg was administered with theophylline (a non-selective phosphodiesterase inhibitor) in a clinical pharmacology study, there was no pharmacokinetic interaction. 
Ko so v študiji klinične farmakologije tadalafil v odmerku 10 mg dajali skupaj s teofilinom (neselektivnim zaviralcem fosfodiesteraze), ni bilo farmakokinetičnega medsebojnega delovanja.
In two of these studies decreases were observed in sperm count and concentration related to tadalafil treatment of unlikely clinical relevance. 
V dveh od teh študij zdravljenja s tadalafilom so opazili zmanjšanje števila semenčic in koncentracije sperme, kar je klinično verjetno nepomembno.
CIALIS has been shown to increase the effects of these medicines. 
Za zdravilo CIALIS je bilo namreč ugotovljeno, da učinke teh zdravil poveča.
PDE5 is an enzyme found in corpus cavernosum smooth muscle, vascular and visceral smooth muscle, skeletal muscle, platelets, kidney, lung, and cerebellum. 
PDE5 je encim, ki se nahaja v gladki mišičnini kavernoznega telesa, žilni in visceralni gladki mišičnini, skeletnih mišicah, trombocitih, ledvicah, pljučih in malih možganih.
The mean per-subject proportion of successful sexual intercourse attempts was 71.9% with CIALIS 5 mg compared to 48.3% with placebo. 
Povprečno število uspešnih poskusov spolnega odnosa je znašalo 71,9 % z zdravilom CIALIS 5 mg v primerjavi s 48,3% s placebom.
Erectile dysfunction in adult men 
Odmerjanje Erektilna disfunkcija pri odraslih moških
In clinical trials with tadalafil 5mg 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. 
V kliničnih preskušanjih, v katerih so bolniki jemali tadalafil 5 mg z odmerjanjem enkrat na dan za zdravljenje benigne hiperplazije prostate, so o omotici in diareji pogosteje poročali pri bolnikih nad 75. letom starosti.
Tadalafil is excreted predominantly as inactive metabolites, mainly in the faeces (approximately 61 % of the dose) and to a lesser extent in the urine (approximately 36 % of the dose). 
61 % odmerka), v manjšem obsegu pa z urinom (približno 36 % odmerka).
Tadalafil is principally metabolised by CYP3A4. 
Tadalafil se v prvi vrsti presnavlja s CYP3A4.
- other treatments for erectile dysfunction. 
- druga zdravila za zdravljenje erektilne disfunkcije.
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. 
Tadalafil (10 mg in 20 mg) ni imel klinično pomembnega učinka na izpostavljenost (AUC) Svarfarinu ali R-varfarinu (substrat CYP2C9) niti ni vplival na spremembe protrombinskega časa, ki jih je povzročil varfarin.
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. 
Pri psih, ki so tadalafil prejemali na dan 6 do 12 mesecev v odmerkih 25 mg/kg/dan (kar pomeni vsaj 3-krat večjo izpostavljenost [razpon 3,718,6], 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.
CIALIS contains lactose. 
Zdravilo CIALIS vsebuje laktozo.
There was no impairment of fertility in male and female rats. 
Pri samcih in samicah podgan plodnost ni bila okvarjena.
When initiating daily treatment with tadalafil, appropriate clinical considerations should be given to a possible dose adjustment of the antihypertensive therapy. 
Ob uvedbi dnevnega zdravljenja s tadalafilom enkrat na dan je potrebno ustrezno klinično presoditi ali je mogoče potrebna prilagoditev odmerka antihipertenzivne terapije.
For patients with severe renal impairment 10 mg is the maximum recommended dose for on-demand treatment. 
Pri bolnikih s hudo okvaro ledvic je največji priporočeni odmerek 10 mg za zdravljenje po potrebi.
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. 
kliničnih preskušanjih, v katerih so bolniki jemali tadalafil z odmerjanjem po potrebi za zdravljenje erektilne disfunkcije, so o diareji poročali pogosteje pri bolnikih, starejših od 65 let.
In clinical pharmacology studies, the potential for tadalafil to augment the hypotensive effects of antihypertensive medicinal products was examined. 
V študijah klinične farmakologije so preiskovali možnost, da tadalafil okrepi hipotenzivne učinke antihipertenzivnih zdravil.
Information on the effect of alcohol is in section 3. 
Zdravilo CIALIS skupaj s pijačo in z alkoholom Informacije o vplivu alkohola so v poglavju 3.
In patients who anticipate a frequent use of CIALIS (i.e., at least twice weekly) a once daily regimen with the lowest doses of CIALIS might be considered suitable, based on patient choice and the physician's judgement. 
Pri bolnikih, ki pričakujejo pogosto uporabo zdravila CIALIS (tj. vsaj dvakrat tedensko) je morda primerno odmerjanje najmanjših odmerkov zdravila CIALIS enkrat na dan, glede na izbiro bolnika in presojo zdravnika.
In clinical studies, tadalafil (5, 10 and 20 mg) was shown to augment the hypotensive effects of nitrates. 
V kliničnih študijah je bilo prikazano, da tadalafil (5 mg, 10 mg in 20 mg) okrepi hipotenzivne učinke nitratov.
Caution should be exercised when prescribing CIALIS 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). 
Ko predpisujemo zdravilo CIALIS bolnikom, ki jemljejo močne zaviralce CYP3A4 (ritonavir, sakvinavir, ketokonazol, itrakonazol in eritromicin), je potrebna previdnost, ker so pri taki kombinaciji zdravil opažali povečano izpostavljenost (AUC) tadalafilu (glejte poglavje 4.5).
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. 
V kliničnem preskušanju, v katerem so primerjali tadalafil v odmerku 5 mg, uporabljan sočasno s finasteridom v odmerku 5 mg, in placebo skupaj s finasteridom v odmerku 5 mg za lajšanje simptomov benigne hiperplazije prostate, niso odkrili nobenih novih neželenih učinkov.
- multiple myeloma (cancer of the bone marrow). 
- multipli mielom (rakavo obolenje kostnega mozga).
It is important to note that CIALIS does not work if there is no sexual stimulation. 
Pomembno je omeniti, da zdravilo CIALIS brez spolne stimulacije ne deluje.
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). 
Sočasno dajanje zaviralcev PDE5, vključno s tadalafilom, skupaj s stimulatorji gvanilat-ciklaze, kot je riociguat, je kontraindicirano, saj lahko potencialno privede do simptomatske hipotenzije (glejte poglavje 4.5).
Cytochrome P450 metabolised medicinal products Tadalafil is not expected to cause clinically significant inhibition or induction of the clearance of medicinal products metabolised by CYP450 isoforms. 
Tadalafil naj ne bi povzročal klinično pomembnega zaviranja ali indukcije očistka zdravil, ki se presnavljajo z izooblikami CYP450.
Therefore, administration of CIALIS to patients who are using any form of organic nitrate is contraindicated (see section 4.5). 
Zato je dajanje zdravila CIALIS bolnikom, ki uporabljajo kakršnokoli obliko organskega nitrata, kontraindicirano (glejte poglavje 4.5).
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. 
Zdrave starejše osebe (65 let ali več) so imele nižji peroralni očistek tadalafila, kar je povzročilo 25 %
Therefore, administration of CIALIS to patients who are using any form of organic nitrate is contraindicated (see section 4.3). 
Zato je dajanje zdravila CIALIS bolnikom, ki uporabljajo kakršnokoli obliko organskega nitrata, kontraindicirano (glejte poglavje 4.3).
5- alpha reductase inhibitors 
Zaviralci 5-alfa reduktaze
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. 
V študijah klinične farmakologije z uporabo enkratnega odmerka tadalafila (5 mg do 20 mg) se je izpostavljenost (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.
If the effect of this dose is too weak your doctor may increase the dose to 20 mg. CIALIS tablets are for oral use. 
Če je učinek tega odmerka prešibek, vam lahko zdravnik poveča odmerek na 20 mg.
Tabulated summary of adverse reactions 
V preglednici prikazan povzetek neželenih učinkov
Protein binding is not affected by impaired renal function. 
Okvarjeno delovanje ledvic ne vpliva na vezavo na beljakovine.
CIALIS is not indicated for use by women. 
Zdravilo CIALIS ni indicirano za uporabo pri ženskah.
- an alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia). 
- antagonist adrenergičnih receptorjev alfa (ki se uporablja za zdravljenje visokega krvnega tlaka ali simptomov sečil, povezanih z benigno hiperplazijo prostate).
What CIALIS contains - The active substance is tadalafil. 
Kaj vsebuje zdravilo CIALIS - Zdravilna učinkovina je tadalafil.
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. 
Naslednje skupine bolnikov s srčno-žilno boleznijo niso bile vključene v klinična preskušanja, zato je pri njih uporaba tadalafila kontraindicirana: - bolniki, ki s imeli miokardni infarkt v zadnjih 90 dneh, - bolniki z nestabilno angino pektoris ali angino pektoris, ki se pojavlja med spolnim odnosom, - bolniki s srčnim popuščanjem razreda 2 ali višjim po NYHA (New York Heart Association) v zadnjih 6 mesecih, - bolniki z nenadzorovanimi aritmijami, hipotenzijo (< 90/50 mm Hg) ali neuravnano hipertenzijo, - bolniki, ki so v zadnjih 6 mesecih doživeli možgansko kap.
Diarrhoea has been reported more frequently in men over 65 years of age taking CIALIS. 
O diareji so pogosteje poročali pri bolnikih nad 65. letom starosti, ki so jemali zdravilo CIALIS.
CIALIS is not intended for use by women. 
Zdravilo CIALIS ni namenjeno za uporabo pri ženskah.
For the treatment of erectile dysfunction using on-demand CIALIS the recommended dose of CIALIS is 10 mg taken prior to anticipated sexual activity and with or without food. 
Moški z okvaro jeter Za zdravljenje erektilne disfunkcije z uporabo zdravila CIALIS po potrebi je priporočeni odmerek zdravila CIALIS 10 mg, zaužit pred pričakovano spolno aktivnostjo, s hrano ali brez nje.
In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors. 
V kliničnih študijah so za riociguat dokazali, da povečuje hipotenzijske učinke zaviralcev PDE5.
- urinary symptoms associated with a common condition called benign prostatic hyperplasia. 
simptomi sečil, povezani s pogostim obolenjem, imenovanim benigna hiperplazija prostate.
There are no available data about the administration of doses higher than 10 mg of tadalafil to patients with hepatic impairment. 
Podatkov o dajanju odmerkov tadalafila, večjih od 10 mg, bolnikom z okvaro jeter ni.
What Cialis looks like and contents of the pack 
Izgled zdravila CIALIS in vsebina pakiranja
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. 
Odmerjanje tadalafila po 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).
Tadalafil is > 10,000-fold more potent for PDE5 than for PDE3, an enzyme found in the heart and blood vessels. 
> 10.000-krat močnejši za PDE5 kot za PDE3, encim, ki se nahaja v srcu in krvnih žilah.
CIALIS contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. 
Zdravilo CIALIS vsebuje učinkovino tadalafil, ki spada v skupino zdravil, imenovanih zaviralci fosfodiesteraze tipa 5 (zaviralci PDE 5).
Some additional rare side effects have been reported in men taking CIALIS that were not seen in clinical trials. 
Pri moških, ki so jemali zdravilo CIALIS so poročali o nekaterih dodatnih redkih neželenih učinkih, ki jih niso opažali v kliničnih preskušanjih.
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. 
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
Ketoconazole (400 mg daily) increased tadalafil (20 mg) exposure (AUC) 4-fold and Cmax by 22 %. 
Ketokonazol (400 mg na dan) je povečal izpostavljenost (AUC) tadalafilu (20 mg) za 4-krat in Cmax za 22 %.
In a subsequent study, 217 patients who were treatmentnaïve to PDE5 inhibitors were randomized to CIALIS 5 mg once a day vs. placebo. 
V nadaljnji študiji so 217 bolnikov, ki se predhodno niso zdravili z zaviralci PDE5, naključno razvrstili v jemanje zdravila CIALIS v odmerku 5 mg enkrat na dan in jemanje placeba.
These include: migraine, swelling of the face, serious allergic reaction which causes swelling of the face or throat, serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death. 
- migreno, otekanje obraza, resno alergijsko reakcijo, ki povzroči otekanje obraza in grla, resne kožne izpuščaje, nekatere motnje, ki vplivajo na dotok krvi v oči, nepravilno bitje srca, angino pektoris in nenadno srčno smrt.
CIALIS 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). 
Zdravilo CIALIS je kontraindicirano 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).