natgillin/translations-raw huggingface dataset:
rifabutin Cmax darunavir AUC ↑ 53% darunavir Cmin ↑ 68% darunavir Cmax ↑ 39% sum of active moieties of rifabutin (parent drug + 25-O-desacetyl metabolite) The interaction trial showed a comparable daily systemic exposure for rifabutin between treatment at 300 mg once daily alone and 150 mg once every other day in combination with darunavir/ritonavir (600/100 mg twice daily) with an about 10fold increase in the daily exposure to the active metabolite 25-O-desacetylrifabutin. 
Simeprevir simeprevir AUC ↑ 159% simeprevir Cmin ↑ 358% simeprevir Cmax ↑ 79% darunavir AUC ↑ 18% darunavir Cmin ↑ 31% darunavir Cmax ↔ Doza simeprevira u ovom ispitivanju interakcija bila je 50 mg kada se istodobno primjenjivao u kombinaciji s darunavirom/ritonavirom, u usporedbi sa 150 mg u skupini liječenoj samim simeprevirom.
No dose adjustment is required for darunavir/ritonavir during pregnancy and postpartum. 
Tijekom trudnoće i postpartalnog razdoblja prilagodba doze darunavira/ritonavira nije potrebna.
When administration of pravastatin and darunavir co-administered with low dose ritonavir is required, it is recommended to start with the lowest possible dose of pravastatin and titrate up to the desired clinical effect while monitoring for safety. 
Kada je potrebno primijeniti pravastatin i darunavir primijenjen istodobno s niskom dozom ritonavira, preporučuje se početi s najnižom mogućom dozom pravastatina te dozu titrirati do željenog kliničkog učinka i pritom pratiti sigurnost primjene.
Outcomes darunavir/ ritonavir 800/100 mg once daily N=343 
TITAN 48. tjedan darunavir/ritonavir 800/100 mg jedanput na dan N=343
If efavirenz is to be used in combination with darunavir /ritonavir, the darunavir/ritonavir 
TITAN 48. tjedan darunavir/ritonavi
Darunavir co-administered with low dose ritonavir and didanosine can be used without dose adjustments. 
Darunavir se može istodobno primijeniti s niskom dozom ritonavira i didanozinom bez prilagodbe doze.
St John's wort is expected to decrease the plasma concentrations of darunavir or its pharmacoenhancers. 
Za gospinu travu se očekuje da snizi koncentracije darunavira ili njegovih farmakokinetičkih pojačivača u plazmi. (indukcija CYP450)
St John's wort is expected to decrease the plasma concentrations of darunavir and ritonavir. 
Za gospinu travu se očekuje da snizi koncentracije darunavira i ritonavira u plazmi. (indukcija CYP450)
The Summary of Product Characteristics of cobicistat or ritonaviras appropriate, must therefore be consulted prior to initiation of therapy with darunavir. 
Stoga se, prije početka terapije darunavirom mora pročitati odgovarajući sažetak opisa svojstava lijeka za kobicistat ili ritonavir.
Film coating: 
Film ovojnica tablete:
Triazolam and oral (taken by mouth) midazolam to help you sleep and/or relieve anxiety 
Svrha uzimanja lijeka avanafil liječenje erektilne disfunkcije astemizol ili terfenadin liječenje simptoma alergije triazolam i oralni (uzima se kroz usta) midazolam pomaže Vam spavati i/ili ublažava tjeskobu cisaprid liječenje nekih stanja želuca kolhicin (ako imate tegobe s bubregom i/ili jetrom)
Crospovidone 
Vinkristin
KRKA Pharma Dublin, Ltd. Tel: + 353 1 293 91 80 
KRKA Farmacéutica, S.L. Tel: + 34 911 61 03 81
KI.PA. 
- proljev.
Rifampicin to treat some infections such as tuberculosis 
LIJEKOVI ZA LIJEČENJE INFEKCIJA MIKOBAKTERIJAMA
The combination of rifampicin and boosted darunavir is contraindicated (see section 4.3). 
Kombinacija rifampicina i pojačanog darunavira je kontraindicirana (vidjeti dio
Brownish red, oval, biconvex film-coated tablets, engraved with a mark S3 on one side. 
Smećkastocrvene, ovalne, bikonveksne filmom obložene tablete, s utisnutom oznakom S3 na jednoj strani.
This can be seen in a blood test. high blood pressure, flushing red or dry eyes fever, swelling of lower limbs due to fluids, malaise, irritability, pain symptoms of infection, herpes simplex erectile dysfunction, enlargement of breasts sleeping problems, sleepiness, depression, anxiety, abnormal dreams, decrease in sexual drive 
ekcem, prekomjerno znojenje, noćno znojenje, gubitak kose, akne, ljuskasta koža, obojenje noktiju - bolovi u mišićima, grčevi u mišićima ili slabost, bolovi u udovima, osteoporoza - usporavanje funkcije štitnjače, može se vidjeti iz rezultata krvnih pretraga - povišeni krvni tlak, naleti vrućine - crvene ili suhe oči - vrućica, oticanje nogu zbog nakupljanja tekućine, opća slabost, razdražljivost,
NC=F 
Tip C
Vardenafil darunavir and low dose ritonavir. 
Kombinacija avanafila i darunavira s niskom dozom
Methadone (to treat opiate dependance) 
- metformin (za liječenje šećerne bolesti tipa 2).
Boosted darunavir is expected to increase these antipsychotic plasma concentrations. 
Očekuje se da će pojačan darunavir povećati koncentracije tih antipsihotika u plazmi. (CYP3A inhibicija)
If you take more Darunavir Krka than you should Contact your doctor, pharmacist or nurse immediately. 
Odmah kontaktirajte svog liječnika, ljekarnika ili medicinsku sestru.
Dose for children of 3 years of age and above, weighing at least 15 kilograms who have taken antiretroviral medicines before (your child's doctor will determine this) The doctor will work out the right dose based on the weight of the child (see table below). 
Doza za djecu u dobi od 3 godine starosti i više, težine najmanje 15 kilograma koja su prethodno uzimala antiretrovirusne lijekove (to će odrediti liječnik Vašeg djeteta)
Careful patient monitoring and dose adjustment of metformin is recommended in patients who are taking darunavir co-administered with cobicistat. 
U bolesnika koji uzimaju darunavir istodobno primijenjen s kobicistatom, preporučuje se pažljivo praćenje bolesnika i prilagodba doze metformina (nije primjenjivo na darunavir istodobno primijenjen s ritonavirom)
Concentrate for solution for injection 
Veličina pakovanja koncentrat za otopinu za injekciju otopina za injekciju
Komárom, 2900 Hungary 
Komárom, 2900 Mađarska
2 Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors. 
2 U većine bolesnika u kojih su prijavljeni ovi događaji već su postojali kardiovaskularni faktori rizika.
Severe hypotension (< 90/50 mm Hg). 
Teška hipotenzija (< 90/50 mmHg).
If you have taken or are planning to take Talmanco, avoid excessive drinking (over 5 units of alcohol), since this may increase the risk of dizziness when standing up. 
Ako ste uzeli ili planirate uzeti Talmanco, izbjegavajte prekomjernu konzumaciju alkohola (više od 5 jedinica alkohola), jer to može povećati rizik od omaglice pri ustajanju.
Across all clinical studies, reports of changes in colour vision were rare (< 0.1%). 
U svim su kliničkim ispitivanjima izvješća o promjenama u raspoznavanju boja bila rijetka (< 0,1%).
If you stop taking Talmanco Do not stop taking your tablets, unless advised otherwise by your doctor. 
Ako prestanete uzimati Talmanco Nemojte prestati uzimati tablete, osim ako Vam liječnik nije savjetovao drugačije.
Do not take this medicine when pregnant, unless it is strictly necessary and you have discussed this with your doctor. 
Nemojte uzimati ovaj lijek u trudnoći, osim ako je to nužno potrebno i ako ste o tome razgovarali sa svojim liječnikom.
Children and adolescents This medicine is not indicated for use by children and adolescents under the age of 18. 
Ovaj lijek nije namijenjen za primjenu u djece i adolescenata mlađih od 18 godina.
Other medicines and Talmanco 
Drugi lijekovi i Talmanco
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
Obavijestite svog liječnika ili ljekarnika ako uzimate nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
Patients should be informed not to take tadalafil with these medicinal products. 
Bolesnicima treba napomenuti da ne uzimaju tadalafil s tim lijekovima.
What Talmanco is and what it is used for 2. 
Što je Talmanco i za što se koristi 2.
At therapeutic concentrations, 94% of tadalafil in plasma is bound to proteins. 
Pri terapijskim koncentracijama se 94% tadalafila u plazmi vezuje za proteine.
Frequency estimate: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data). 
Procjena učestalosti: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09 January 2017 
Datum prvog odobrenja: 09 siječanj 2017
Some medicines may be affected by Talmanco or they may affect how well Talmanco will work. 
Talmanco može utjecati na neke lijekove ili oni mogu utjecati na djelovanje lijeka Talmanco.
Talmanco is a treatment for pulmonary arterial hypertension in adults. 
Talmanco je lijek za liječenje plućne arterijske hipertenzije u odraslih.
What you need to know before you take Talmanco 3. 
Što morate znati prije nego počnete uzimati Talmanco 3.
Talmanco with alcohol 
Talmanco s alkoholom
BATCH NUMBER Lot: 
4. BROJ SERIJE Lot:
if you have ever had loss of vision - a condition described as “stroke of the eye” (non-arteritic anterior ischemic optic neuropathy - NAION) if you have had a heart attack in the last 3 months if you have low blood pressure if you are taking riociguat. 
ako ste ikada doživjeli gubitak vida - stanje koje se opisuje kao "očni udar" (nearterijska prednja ishemijska optička neuropatija (NAION, engl. non-arteritic anterior ischaemic optic neuropathy)) ako ste u posljednja 3 mjeseca imali srčani udar ako imate nizak krvni tlak ako uzimate riocigvat.
Significant improvement (p < 0.01) in the 6MWD was demonstrated at week 12 when the patients were asked to delay taking study medicinal product in order to reflect trough active substance concentration. 
Značajno poboljšanje (p <0,01) 6MWD-a dokazano je u 12. tjednu, kada su bolesnici zamoljeni da odgode uzimanje ispitivanog lijeka kako bi test odražavao najniže koncentracije djelatne tvari.
If you forget to take Talmanco 
Ako ste zaboravili uzeti Talmanco
Vomiting, Gastroesophageal reflux 
povraćanje, gastroezofagealni refluks
More than half (53.3%) of the patients in the study were receiving concomitant bosentan therapy. 
Više od polovice (53,3%) bolesnika u ispitivanju istodobno je primalo bosentan.
swelling of the eyelids, eye pain, red eyes, heart attack and stroke. 
oticanje kapaka, bol u oku, crvene oči, srčani udar i moždani udar.
Less than 0.0005% of the administered dose appeared in the semen of healthy subjects. 
Manje od 0,0005% primijenjene doze ustanovljeno je u spermi zdravih ispitanika.
Elderly Dose adjustments are not required in elderly patients. 
Nije potrebno prilagođavati dozu u starijih bolesnika.
If you experience any of the following side effects stop using the medicine and seek medical help immediately: 
Ako primijetite neku od sljedećih nuspojava, prestanite uzimati lijek i odmah zatražite liječničku pomoć:
Most but not all of those men reporting fast heart rate, irregular heartbeat, heart attack, stroke and sudden cardiac death had known heart problems before taking tadalafil. 
Većina muškaraca, ali ne i svi oni u kojih su prijavljeni ubrzani srčani otkucaji, nepravilni otkucaji srca, srčani udar, moždani udar i iznenadna srčana smrt imala je poznate srčane tegobe prije uzimanja tadalafila.
The safety and efficacy of tadalafil in the paediatric population has not yet been established. 
Sigurnost i djelotvornost tadalafila u pedijatrijskoj populaciji još nisu ustanovljene.
Do not breast-feed while taking these tablets as it is not known if the medicine passes into human breast milk. 
Nemojte dojiti dok uzimate ove tablete jer nije poznato izlučuje li se lijek u majčino mlijeko.
Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH. 
Liječenje mora započeti i nadzirati isključivo liječnik s iskustvom u liječenju PAH-a.
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 and consult a physician immediately (see section 4.3). 
Budući da bi to moglo biti značajno za sve bolesnike izložene tadalafilu, bolesnicima treba savjetovati da u slučaju iznenadnog poremećaja vida prestanu uzimati lijek tadalafil i odmah se obrate liječniku (vidjeti dio 4.3).
The mean age of all patients was 54 years (range 14 to 90 years) with the majority of patients being Caucasian (80.5%) and female (78.3%). 
Prosječna dob svih bolesnika bila je 54 godine (raspon od 14 do 90 godina), a većina je bolesnika bila bijele rase (80,5%) i ženskog spola (78,3%).
The European Medicines Agency has deferred the obligation to submit the results of studies with tadalafil 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). 
Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja tadalafila u jednoj ili više podskupina pedijatrijske populacije u liječenju plućne arterijske hipertenzije (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
Three hundred and fifty seven (357) patients who completed the pivotal study entered a long-term extension study. 
Tri stotine i pedeset sedam (357) bolesnika koji su završili pivotalno ispitivanje uključeno je u dugoročni produžetak ispitivanja.
28 film-coated tablets 28 x 1 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablets 
28 filmom obloženih tableta 28 x 1 filmom obložena tableta 56 filmom obloženih tableta 56 x 1 filmom obložena tableta
Tadalafil should not be used during breast-feeding. 
Tadalafil se ne smije primjenjivati tijekom dojenja.
Uncommon (may affect up to 1 in 100 people) priapism, a prolonged and possibly painful erection after taking this medicine. 
Manje često (mogu se javiti u do 1 na 100 osoba) prijapizam, dugotrajna te moguće i bolna erekcija nakon uzimanja ovoga lijeka.
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). 
Tadalafil se pretežno izlučuje u obliku neaktivnih metabolita, uglavnom fecesom (približno 61% doze) te u manjoj mjeri mokraćom (približno 36% doze).
Rare (may affect up to 1 in 1,000 people) sudden loss of vision. 
Rijetko (mogu se javiti u do 1 na 1000 osoba) iznenadan gubitak vida
What you need to know before you take Talmanco 
Što morate znati prije nego počnete uzimati Talmanco
Pulmonary arterial hypertension (PAH) etiologies were predominantly idiopathic PAH (61.0%) and related to collagen vascular disease (23.5%). 
Etiologija plućne arterijske hipertenzije (PAH) pretežno je bila idiopatska (61,0%) ili povezana s kolagenozom krvnih žila (23,5%).
These events were not seen in clinical studies for pulmonary arterial hypertension and therefore frequency is not known (frequency cannot be estimated from the available data): 
Ti događaji nisu zabilježeni u kliničkim ispitivanjima za plućnu arterijsku hipertenziju te im je stoga učestalost nepoznata (učestalost se ne može procijeniti iz dostupnih podataka):
What Talmanco contains 
Što Talmanco sadrži
In haemodialysis patients, Cmax was 41% higher than that observed in healthy subjects. 
U bolesnika na hemodijalizi je Cmax bio 41% veći nego u zdravih ispitanika.
INFORMATION IN BRAILLE Talmanco 20 mg 
16. PODACI NA BRAILLEOVOM PISMU Talmanco 20 mg
Efficacy in patients with pulmonary arterial hypertension (PAH) A randomised, double-blind, placebo-controlled study was conducted in 405 patients with pulmonary arterial hypertension. 
Djelotvornost u bolesnika s plućnom arterijskom hipertenzijom (PAH) Randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje provedeno je u 405 bolesnika s plućnom arterijskom hipertenzijom.
If you or anyone else takes more tablets than they should, tell your doctor or go to a hospital immediately, taking the medicine or pack with you. 
Ako uzmete više lijeka Talmanco nego što ste trebali Ako ste Vi ili netko drugi uzeli više tableta nego što ste trebali, odmah obavijestite svog liječnika ili se javite u bolnicu i sa sobom ponesite lijek ili pakiranje lijeka.
Tadalafil is a potent and selective inhibitor of phosphodiesterase type 5 (PDE5), the enzyme responsible for the degradation of cyclic guanosine monophosphate (cGMP). 
Tadalafil je snažan i selektivan inhibitor fosfodiesteraze tipa 5 (PDE5), enzima odgovornog za razgradnju cikličkog gvanozin monofosfata (cGMP).
The majority of patients had a World Health Organization (WHO) Functional Class III (65.2%) or II (32.1%). 
Većina je bolesnika imala bolest funkcionalnog stupnja III (65,2%) ili II (32,1%) prema klasifikaciji Svjetske zdravstvene organizacije (SZO).
Tadalafil is also > 10,000-fold more potent for PDE5 than for PDE7 through PDE10. 
Tadalafil također djeluje > 10 000 puta jače na PDE5 nego na PDE7 do PDE10.
Tell your doctor or pharmacist if you are already taking: bosentan (another treatment for pulmonary arterial hypertension) nitrates (for chest pain) alpha blockers used to treat high blood pressure or prostate problems riociguat rifampicin (to treat bacterial infections) ketoconazole tablets (to treat fungal infections) ritonavir (for HIV treatment) tablets for erectile dysfunction (PDE5 inhibitors) 
Obavijestite svog liječnika ili ljekarnika ako već uzimate: bosentan (drugi lijek za liječenje plućne arterijske hipertenzije) nitrate (za ublažavanje boli u prsnom košu) alfa-blokatore koji se koriste za liječenje visokog krvnog tlaka ili tegoba s prostatom riocigvat rifampicin (za liječenje bakterijskih infekcija) tablete ketokonazola (za liječenje gljivičnih infekcija) ritonavir (za liječenje HIV infekcije) tablete za erekcijsku disfunkciju (inhibitore PDE5).
Each film-coated tablet contains 237.9 mg lactose (234.5 mg as anhydrous and 3.4 mg as monohydrate). 
Jedna filmom obložena tableta sadrži 237,9 mg laktoze (234,5 mg bezvodne i 3,4 mg u obliku hidrata).
PVC/PE/PVdC-Alu blisters in carton containing 28 and 56 film-coated tablets. 
PVC/PE/PVdC-Al blisteri u kutijama koje sadrže 28 i 56 filmom obloženih tableta.
Headache may occur at the beginning of therapy; and decreases over time even if treatment is continued. 
a vremenom se smanjuje čak i ako se liječenje nastavi.
Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake “Rok valjanosti” ili oznake “EXP”.
Talmanco is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity (see section 5.1). 
Talmanco je indiciran u odraslih bolesnika za liječenje plućne arterijske hipertenzije (PAH) funkcionalnog stupnja II i III prema klasifikaciji SZO-a, u cilju poboljšanja tjelesne sposobnosti (vidjeti dio 5.1).
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. 
U bolesnika s plućnom hipertenzijom koji istodobno nisu primali bosentan prosječna izloženost tadalafilu u stanju dinamičke ravnoteže nakon doze od 40 mg bila je 26% veća nego u zdravih dobrovoljaca.
P-glycoprotein substrates (e.g. digoxin) Tadalafil (40 mg once per day) had no clinically significant effect on the pharmacokinetics of digoxin. 
Supstrati P-glikoproteina (npr. digoksin) Tadalafil (40 mg jedanput na dan) nije imao klinički značajnog učinka na farmakokinetiku digoksina.
EXPIRY DATE EXP: 
3. ROK VALJANOSTI EXP:
Although the frequency of reports of dizziness in placebo and tadalafil arms in clinical studies was similar, patients should be aware of how they react to tadalafil, before driving or operating machinery. 
Iako je u kliničkim ispitivanjima učestalost prijavljivanja omaglice bila podjednaka u skupinama koje su primale placebo odnosno tadalafil, bolesnici moraju biti svjesni kako reagiraju na tadalafil prije nego upravljaju vozilom ili rukuju strojevima.
The filmcoating contains lactose monohydrate (see section 2 ‘Talmanco contains lactose'), hypromellose (E464), titanium dioxide (E171) and triacetin. 
Film ovojnica sadrži laktozu hidrat (pogledajte dio 2 „Talmanco sadrži laktozu”), hipermelozu (E464), titanijev dioksid (E171) i triacetin.
This medicine is available in blister packs containing 28 or 56 tablets and in perforated unit dose blister packs containing 28 x 1 or 56 x 1 tablets. 
Ovaj lijek dostupan je u blister pakiranjima koja sadrže 28 ili 56 tableta i perforiranim jediničnu dozu blister pakiranjima koja sadrže 28 x 1 ili 56 x 1 tabletu.
The efficacy and safety of tadalafil co-administered with prostacyclin or its analogues has not been studied in controlled clinical studies. 
Djelotvornost i sigurnost istodobne primjene tadalafila i prostaciklina ili njegovih analoga nije ispitana u kontroliranim kliničkim ispitivanjima.
The overall frequency of discontinuation due to adverse events was low (tadalafil 11%, placebo 16%). 
Ukupna je učestalost prekida liječenja zbog nuspojava bila niska (tadalafil 11%, placebo 16%).
6 Headache was the most commonly reported adverse reaction. 
6 Najčešće prijavljena nuspojava bila je glavobolja.
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). 
Bolesnici koji su izgubili vid na jednom oku zbog nearterijske prednje ishemijske optičke neuropatije (NAION, engl. non-arteritic anterior ischaemic optic neuropathy), bez obzira na to je li ta epizoda povezana s prethodnim izlaganjem inhibitorima PDE5 (vidjeti dio 4.4).
Patients with clinically significant aortic and mitral valve disease Patients with pericardial constriction Patients with restrictive or congestive cardiomyopathy Patients with significant left ventricular dysfunction Patients with life-threatening arrhythmias Patients with symptomatic coronary artery disease Patients with uncontrolled hypertension. 
bolesnici s klinički značajnom bolešću aortnog i mitralnog zaliska bolesnici s konstrikcijom perikarda bolesnici s restriktivnom ili kongestivnom kardiomiopatijom bolesnici sa značajnom disfunkcijom lijeve klijetke bolesnici sa životno ugrožavajućim aritmijama bolesnici sa simptomatskom bolešću koronarnih arterija bolesnici s nekontroliranom hipertenzijom.
Respiratory, thoracic and mediastinal disorders Nasopharyngitis (including nasal congestion, sinus congestion and rhinitis) 
Poremećaji dišnog sustava, prsišta i sredoprsja nazofaringitis (uključujući kongestiju nosa, kongestiju sinusa i rinitis)
Reproductive system and breast disorders Increased uterine bleeding4 
Poremećaji reproduktivnog sustava i dojki pojačano krvarenje iz maternice4
Hypromellose (2910/15 mPa·s) (E464) Titanium dioxide (E171) 
Film ovojnica: laktoza hidrat hipromeloza (2910/15 mPa·s) (E464) titanijev dioksid (E171) triacetin
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). 
Incidencija kliničkog pogoršanja do 16. tjedna bila je manja u bolesnika liječenih tadalafilom u dozi od 40 mg (5%; 4 od 79 bolesnika) nego u bolesnika koji su primali placebo (16%; 13 od 82 bolesnika).
During tadalafil 20 mg and 40 mg once daily dosing, steady-state plasma concentrations are attained within 5 days, and exposure is approximately 1.5-fold of that after a single dose. 
Kod primjene tadalafila u dozama od 20 mg i 40 mg jedanput na dan koncentracije u plazmi u stanju dinamičke ravnoteže postižu se u roku od 5 dana, a izloženost je oko 1,5 puta veća nego nakon primjene jedne doze.