natgillin/translations-raw huggingface dataset:
Patients with mild to moderate hepatic impairment (Child-Pugh class A or B) should initiate treatment with the minimum efficacious dose and adjust posology based on tolerance. 
Bolesnici s blagim do umjerenim oštećenjem jetre (Child-Pugh stadij A ili B) trebaju započeti liječenje s najnižom djelotvornom dozom, i prilagođavati dozu na temelju podnošljivosti.
It is important to note that Spedra only works if you are sexually stimulated. 
Važno je napomenuti da Spedra djeluje samo ako ste seksualno stimulirani.
Talk to your doctor or pharmacist before taking Spedra: 
Obratite se svom liječniku ili ljekarniku prije nego uzmete lijek Spedra:
It may be risky for you to have sexual intercourse 
• ako imate tegobe sa srcem; za Vas bi moglo biti rizično imati spolni odnos
In vitro studies with human platelets indicate that PDE5 inhibitors do not have an effect on platelet aggregation on their own, but at supratherapeutic doses they potentiate the anti-aggregatory effect of the nitric oxide donor sodium nitroprusside. 
In vitro ispitivanja s ljudskim trombocitima pokazuju da inhibitori PDE5 nemaju učinak na agregaciju trombocita sami za sebe, ali u supraterapijskim dozama pojačavaju antiagregacijski učinak donora dušikova oksida natrijeva nitroprusida.
Avanafil has vasodilator properties, resulting in mild and transient decreases in blood pressure (see section 4.5), and as such potentiates the hypotensive effect of nitrates (see section 4.3). 
Avanafil ima vazodilatacijska svojstva što rezultira blagim i prolaznim sniženjima krvnog tlaka (vidjeti dio 4.5), i kao takav pojačava hipotenzivni učinak nitrata (vidjeti dio 4.3).
It is eliminated predominantly by hepatic metabolism (mainly CYP3A4). 
Eliminira se uglavnom metabolizmom putem jetre (uglavnom CYP3A4).
In the long term clinical study, the percentage of patients who experienced adverse reactions decreased with increasing length of exposure. 
U dugotrajnom kliničkom ispitivanju, postotak bolesnika s nuspojavama smanjio se s duljim trajanjem izloženosti.
Patients with mild or moderate renal impairment (creatinine clearance ≥30 mL/min but <80 mL/min) who were enrolled in phase 3 studies showed decreased efficacy compared to those with normal renal function. 
Bolesnici s blagim do umjerenim oštećenjem bubrega (klirens kreatinina ≥ 30 ml/min, ali < 80 ml/min), koji su bili uključeni u ispitivanja faze 3, pokazali su smanjenu djelotvornost u usporedbi s onima s normalnom funkcijom bubrega.
The most common adverse reactions reported in clinical studies were headache, flushing, nasal and sinus congestion and back pain. 
Najčešće nuspojave prijavljene u kliničkim ispitivanjima bile su glavobolja, crvenilo uz osjećaj vrućine, kongestija nosa i sinusa te bol u leđima.
These differences were maintained with long term treatment (as per studies in the general ED population, in diabetics with EDand in men with ED following bilateral nerve-sparing radical prostatectomy and in the open-label extension trial). 
Te su se razlike održale uz dugotrajno liječenje (u ispitivanjima u općoj populaciji s ED, u bolesnika s dijabetesom i ED, u muškaraca s ED nakon bilateralne radikalne prostatektomije s očuvanjem neurovaskularnog snopa te u otvorenom produžetku ispitivanja).
Studies have shown that medicinal products that inhibit CYP3A4 can increase avanafil exposure (see section 4.2). 
Ispitivanja su pokazala da lijekovi koji inhibiraju CYP3A4 mogu povećati izloženost avanafilu (vidjeti dio 4.2).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
Unutar svake skupine učestalosti, nuspojave su prikazane opadajućim redoslijedom prema ozbiljnosti.
Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza „EXP“ ili „Rok valjanosti“.
The safety and efficacy of combinations of avanafil and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied (see section 4.4). 
Sigurnost i djelotvornost kombinacija avanafila i drugih inhibitora PDE5 ili drugih liječenja erektilne disfunkcije nisu ispitane (vidjeti dio 4.4).
In particular, tell your doctor and do not take Spedra if you are taking “nitrate” medicines for chest pain (angina) such as amyl nitrite or glyceryl trinitrate. 
Osobito je važno da obavijestite liječnika i ne uzimate Spedru ako uzimate „nitratne“ lijekove za bolove u prsima (angina), kao što su amil nitrit ili gliceril trinitrat.
Also some other medicines can affect the way Spedra works. 
Osim toga, neki drugi lijekovi mogu utjecati na djelovanje lijeka Spedra.
• an abnormal blood test result for a prostate test called ‘PSA' 
• poremećen nalaz krvi za prostatu dobiven pretragom koja se zove ”PSA“
• feeling out of breath when you exert yourself 
• osjećaj nedostatka zraka kada se naprežete
Patients should be advised that concurrent use of avanafil and alcohol may increase the likelihood of hypotension, dizziness, or syncope. 
Bolesnike valja savjetovati da istodobno uzimanje avanafila i alkohola može povećati vjerojatnost hipotenzije, omaglice ili sinkope.
Consumption of alcohol in combination with avanafil can increase the potential for symptomatic hypotension. 
Konzumacija alkohola u kombinaciji s avanafilom može povećati mogućnost simptomatske hipotenzije.
The plasma concentrations of the major circulating metabolites, M4 and M16, are approximately 23% and 29% that of the parent compound, respectively. 
Koncentracije glavnih cirkulirajućih metabolita M4 i M16 u plazmi iznose približno 23% odnosno 29% koncentracije glavnog spoja.
The fourth study investigated the onset of action of avanafil at two doses (100 and 200 mg) in terms of per-subject proportion of sexual attempts resulting in satisfactory completion of sexual intercourse. 
U četvrtom se ispitivanju procjenjivao početak djelovanja avanafila u dvije doze (100 i 200 mg) s obzirom na udio pokušaja koji su rezultirali zadovoljavajućim spolnim odnosom po svakom ispitaniku.
You should take Spedra approximately 15 to 30 minutes before you have sexual intercourse. 
Spedru biste trebali uzeti otprilike 15 do 30 minuta prije spolnog odnosa.
Spedra works by helping the blood vessels in your penis to relax. 
Spedra djeluje tako da pomaže opuštanje krvnih žila u penisu.
A total of 1774 patients received avanafil, which was taken as needed at doses of 50 mg (one study), 100 mg and 200 mg (four studies), respectively. 
Ukupno 1774 bolesnika primilo je avanafil, prema potrebi, u dozama od 50 mg (u jednom ispitivanju), 100 mg i 200 mg (obje doze u četiri ispitivanja).
Avanafil is a highly selective and potent, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5. 
Avanafil je visoko selektivan i potentan reverzibilni inhibitor fosfodiesteraze tipa 5 specifične za ciklički gvanozin monofosfat (cGMP).
Since the in vitro data identified potential avanafil interactions with CYPs 2C19, 2C8/9, 2D6 and 3A4, further clinical studies using omeprazole, rosiglitazone and desipramine did not reveal clinically relevant interactions with CYPs 2C19, 2C8/9 and 2D6. 
Budući da su podaci in vitro pokazali mogućnost interakcija avanafila sa CYP 2C19, 2C8/9, 2D6 i 3A4, daljnja klinička ispitivanja s omeprazolom, roziglitazonom i desipraminom nisu otkrila klinički značajne interakcije sa CYP 2C19, 2C8/9 i 2D6.
Studies in vitro have shown that avanafil is highly selective for PDE5. 
Ispitivanja in vitro pokazala su da je avanafil visoko selektivan za PDE5.
If you have any further questions on the use of Spedra, ask your doctor or pharmacist. 
Ako imate dodatnih pitanja o primjeni lijeka Spedra, pitajte svoga liječnika ili ljekarnika.
When avanafil is taken with a high fat meal, the rate of absorption is reduced with a mean delay in Tmax of 1.25 hours and a mean reduction in Cmax of 39% (200 mg). 
Kada se avanafil uzme uz punomasni obrok, brzina apsorpcije se smanjuje s prosječnom odgodom Tmax od 1,25 sati i prosječnim smanjenjem vrijednosti Cmax od 39% (200 mg).
Across all of the pivotal trials of avanafil, the percentage of successful intercourse attempts was significantly higher for all doses of avanafil compared to placebo for attempts at all post-dosing time intervals examined. 
U svim ključnim ispitivanjima avanafila, postotak uspješnih pokušaja spolnih odnosa bio je značajno viši za sve doze avanafila u usporedbi s placebom, za pokušaje u svim ispitivanim vremenskim intervalima poslije uzimanja doze.
Use in patients using other medicinal products 
Primjena u bolesnika koji uzimaju druge lijekove
If any of the above apply to you talk to your doctor or pharmacist before taking Spedra. 
Ako se nešto od gore navedenog odnosi na Vas, obratite se liječniku ili ljekarniku prije nego što uzmete Spedru.
In vitro results showed for avanafil a modest potential for acting as P-gp substrate and P-gp inhibitor with digoxin as a substrate at concentrations lower than the calculated intestinal concentration. 
Rezultati in vitro pokazali su skromnu mogućnost da avanafil djeluje kao supstrat P-gp i inhibitor P-gp s digoksinom kao supstratom pri koncentracijama nižim od izračunate intestinalne koncentracije.
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 s gubitkom vida na jednom oku zbog nearterijske anteriorne ishemijske optičke neuropatije (NAION), bez obzira je li ta epizoda bila povezana s prethodnom izloženošću inhibitoru PDE5 ili nije (vidjeti dio 4.4).
You should take Spedra about 30 minutes before you have sexual intercourse. 
Spedru biste trebali uzeti otprilike 30 minuta prije spolnog odnosa.
• penile disorder 
• poremećaj penisa
There was no evidence of favourable clinical effect of the combination in the population studied. 
U ispitivanoj populaciji nije bilo dokaza o povoljnom kliničkom učinku ove kombinacije.
After oral administration, avanafil is excreted as metabolites predominantly in the faeces (approximately 63% of administered oral dose) and to a lesser extent in the urine (approximately 21% of the administered oral dose). 
Nakon peroralne primjene, avanafil se izlučuje u obliku metabolita uglavnom u stolici (približno 63% primijenjene peroralne doze) a u manjoj mjeri u mokraći (približno 21% primijenjene peroralne doze).
In the rabbit study, maternal toxicity was observed at 240 mg/kg/day. 
U ispitivanju na kunićima, toksičnost u majki opažena je pri dozi od 240 mg/kg/dan.
• If you have a serious liver or kidney problem 
• ako imate ozbiljan problem s jetrom ili bubrezima
If you are taking a medicine such as erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir or verapamil (‘moderate CYP3A4 inhibitors') the recommended dose of Spedra is a 100 mg tablet, with an interval of at least 2 days between doses. 
Ako uzimate lijek kao što je eritromicin, amprenavir, aprepitant, diltiazem, flukonazol, fosamprenavir ili verapamil (‘umjereni inhibitori CYP3A4'), preporučena doza Spedre je tableta od 100 mg, s razmakom između doza od najmanje 2 dana.
The patient should be advised that in case of sudden visual effects, he should stop taking Spedra and consult a physician immediately (see section 4.3). 
Bolesniku treba savjetovati da u slučaju iznenadnih učinaka na vid prekine uzimanje Spedre i odmah zatraži mišljenje liječnika (vidjeti dio
If you are not sure, talk to your doctor or pharmacist before taking Spedra. 
Ako niste sigurni, obratite se liječniku ili ljekarniku prije nego što uzmete lijek Spedra.
In subjects with mild (creatinine clearance ≥ 50 - < 80 mL/min) and moderate (creatinine clearance ≥ 30 - < 50 mL/min) renal impairment, the pharmacokinetics of a single 200 mg dose of avanafil were not altered. 
U bolesnika s blagim (klirens kreatinina ≥ 50 - < 80 ml/min) i umjerenim (klirens kreatinina ≥ 30< 50 ml/min) oštećenjem bubrega, farmakokinetike jednokratne doze avanafila od 200 mg nisu se promijenile.
These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors. 
Ti događaji, koji mogu biti popraćeni tinitusom i omaglicom, prijavljeni su u vremenskoj povezanosti s unosom inhibitora PDE5.
• weight gain 
• porast težine
Avanafil has not been evaluated in patients with erectile dysfunction due to spinal cord injury or other neurological disorders and in subjects with severe renal or hepatic impairment. 
Avanafil nije procjenjivan u bolesnika s erektilnom disfunkcijom zbog ozljede leđne moždine ili drugih neuroloških poremećaja te u ispitanika s teškim oštećenjem bubrega ili jetre.
• serious chest pain 
• ozbiljna bol u prsima
• The other ingredients are mannitol, fumaric acid, hydroxypropylcellulose, hydroxypropylcellulose low substituted, calcium carbonate, magnesium stearate and ferric oxide yellow (E172). 
• Ostali sastojci su manitol, fumaratna kiselina, hidroksipropilceluloza, hidroksipropilceluloza nisko supstituirana, kalcijev karbonat, magnezijev stearat i željezov oksid, žuti (E172).
In the fourth study patients were encouraged to attempt sexual intercourse approximately 15 minutes post-dosing, to assess the onset of the erectogenic effect of avanafil, taken on an as needed basis, at 100 and 200 mg dose. 
U četvrtom ispitivanju se bolesnike poticalo da pokušaju spolni odnos oko 15 minuta nakon uzimanja doze, kako bi se procijenio početak erektogenog učinka avanafila uzetog prema potrebi, u dozi od 100 i 200 mg.
There was a statistically significant difference in maximum decrease from baseline in supine diastolic blood pressure with enalapril and avanafil only, which returned to baseline 4 hours after the dose of avanafil. 
Postojala je statistički značajna razlika u maksimalnom smanjenju od početnih vrijednosti u dijastoličkom krvnom tlaku u ležećem položaju na leđima samo uz enalapril i avanafil, a one su se vratile na početne vrijednosti 4 sata nakon doze avanafila.
• heartbeat changes seen on a heart tracing (ECG) 
• promjene srčanih otkucaja vidljive na elektrokardiogramu (EKG-u)
In a penile plethysmography (RigiScan) study, avanafil 200 mg produced erections considered sufficient for penetration (60% rigidity by RigiScan) in some men as early as 20 minutes after dosing and overall response of these subjects to avanafil was statistically significant, compared to placebo, in the 20-40 minute time interval. 
U ispitivanju u kojemu se provodila pletizmografija penisa (RigiScan), avanafil u dozi od 200 mg izazvao je u nekih muškaraca erekcije koje su se smatrale dovoljnima za penetraciju (60% ukrućenosti prema RigiScanu) već 20 minuta nakon doziranja i sveukupni odgovor tih ispitanika na avanafil bio je statistički značajan u usporedbi s placebom u vremenskom intervalu od 20-40 minuta.
At a maternally toxic dose of 1000 mg/kg/day (approximately 49 times the MRHD on a mg/m basis), decreased fetal body weight occurred with no signs of teratogenicity. 
Pri dozama toksičnim za majke od 1000 mg/kg/dan (približno 49 puta veća doza od MRHD na bazi mg/m 2), tjelesna težina fetusa se smanjila ali bez znakova teratogenosti.
• congestion in the nose, sinuses or upper part of the airway bringing air into the lungs 
• začepljenost nosa, sinusa ili gornjeg dijela dišnih puteva
Avanafil is a substrate of and predominantly metabolised by CYP3A4. 
Avanafil je supstrat i većinom se metabolizira putem CYP3A4.
In total, 7/24 subjects experienced values or decreases from baseline that were of potential clinical significance following avanafil dosing (see section 4.4). 
Ukupno 7/24 ispitanika imalo je vrijednosti ili smanjenja u odnosu na početne vrijednosti koje su bile od potencijalnog kliničkog značaja nakon doziranja avanafila (vidjeti dio 4.4).
Avanafil was shown to augment the hypotensive effects of nitrates compared to placebo in healthy subjects. 
Pokazalo se da avanafil u zdravih ispitanika pojača hipotenzivne učinke nitrata u usporedbi s placebom.
12x1 tablets 
12x1 tableta
Patients with left ventricular outflow obstruction (e.g. aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure can be particularly sensitive to the actions of vasodilators including avanafil (see section 4.4). 
Bolesnici s opstrukcijom izlaznog trakta lijevog ventrikula (npr. aortna stenoza, idiopatska hipertrofična subaortna stenoza) i oni s teško oštećenom autonomnom kontrolom krvnog tlaka mogu biti posebno osjetljivi na djelovanja vazodilatatora uključujući avanafil (vidjeti dio 4.4).
Common (may affect up to 1 in 10 people) 
Česte (mogu se pojaviti u do 1 od 10 osoba)
Results showed a mean maximum decrease in supine blood pressure of 2/3 mmHg compared to placebo with enalapril and 1/-1 mmHg with amlodipine when avanafil was co-administered. 
Rezultati su pokazali srednju vrijednost maksimalnog sniženja krvnog tlaka u ležećem položaju na leđima od 2/3 mmHg u usporedbi s placebom uz enalapril i 1/-1 mmHg uz amlodipin, kada su se primjenjivali istodobno s avanafilom.
Use in men with diabetes Dose adjustments are not required in diabetic patients. 
U muškaraca s dijabetesom nisu potrebne prilagodbe doze.
In a single-dose three-way crossover design study evaluating healthy subjects, the mean maximum reduction in diastolic blood pressure was significantly greater following avanafil administered in combination with alcohol than following avanafil alone (3.2 mmHg) or alcohol alone (5.0 mmHg) (see section 4.4). 
U ispitivanju jednokratne doze s trostrukim ukrižavanjem u kojemu su se procjenjivali zdravi ispitanici, srednja vrijednost maksimalnog smanjenja dijastoličkog krvnog tlaka bila je značajno veća nakon primjene avanafila u kombinaciji s alkoholom nego nakon primijene samo avanafila (3,2 mmHg) ili samo alkohola (5,0 mmHg) (vidjeti dio 4.4).
Single dose of up to 800 mg of avanafil have been given to healthy subjects and multiple daily doses up to 300 mg have been given to patients. 
Zdravi ispitanici dobili su jednokratnu dozu do 800 mg avanafila, dok su bolesnici dobili višekratne dnevne doze do 300 mg.
NAME OF THE MARKETING AUTHORISATION HOLDER Menarini Luxembourg 
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Menarini Luxembourg
In in vitro studies in human liver microsomes, avanafil showed a negligible potential for drug-drug interactions with CYP1A1/2, 2A6, 2B6 and 2E1. 
U ispitivanjima avanafila in vitro na ljudskim mikrosomima jetre, avanafil je pokazao zanemariv potencijal za interakcije lijekova s CYP1A1/2, 2A6, 2B6 i 2E1.
Avanafil was evaluated in 4 randomized, double-blind, placebo-controlled, parallel group trials of up to 3 months in duration in the general population with ED, in patients with Type 1 or Type 2 diabetes and ED, and in patients with ED following bilateral nerve-sparing radical prostatectomy. 
Avanafil je procijenjen u 4 randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja na usporednim skupinama u trajanju do 3 mjeseca u općoj populaciji s ED, u bolesnika s dijabetesom tipa 1 ili tipa 2 i ED te u bolesnika s ED nakon bilateralne radikalne prostatektomije s očuvanjem neurovaskularnog snopa.
Patients with known hereditary degenerative retinal disorders. 
Bolesnici s potvrđenim nasljednim degenerativnim poremećajima mrežnice.
Patients with left ventricular outflow obstruction, e.g. aortic stenosis and idiopathic hypertrophic subaortic stenosis, can be sensitive to the action of vasodilators, including PDE5 inhibitors. 
Bolesnici s opstrukcijom izlaznog trakta lijevog ventrikula, npr. aortnom stenozom i idiopatskom hipertrofičnom subaortnom stenozom, mogu biti osjetljivi na djelovanje vazodilatatora, uključujući inhibitore PDE5.
Consumption of alcohol in combination with avanafil can increase the potential for symptomatic hypotension (see section 4.5). 
Konzumacija alkohola u kombinaciji s avanafilom može povećati mogućnost simptomatske hipotenzije (vidjeti dio 4.5).
Subjects with mild hepatic impairment (Child-Pugh A) had comparable exposure to subjects with normal hepatic function when a single dose of 200 mg avanafil was administered. 
Ispitanici s blagim oštećenjem jetre (Child-Pugh A) imali su usporedivu izloženost kao i ispitanici s normalnom funkcijom jetre kada im je primijenjena jednokratna doza avanafila od 200 mg.
Metabolism and nutrition disorders 
Poremećaji metabolizma i prehrane giht
8x1 tablets 
8x1 tableta
• blurred vision. 
• zamućen vid.
Also do not take Spedra if you are taking medicines for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir or if you are taking medicines for fungal infections such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin (see beginning of section 2 under ‘Do not take Spedra'). 
Također, nemojte uzimati Spedru ako uzimate lijekove protiv HIV-a ili AIDS-a kao što su ritonavir, indinavir, sakvinavir, nelfinavir ili atazanavir ili ako uzimate lijekove protiv gljivičnih infekcija kao što su ketokonazol, itrakonazol ili vorikonazol ili određene antibiotike protiv bakterijskih infekcija, kao što su klaritromicin ili telitromicin (vidjeti početak dijela 2 'Nemojte uzimati lijek Spedra').
In a rat fertility and early embryonic development trial, a decrease in fertility and sperm motility, altered estrous cycles, and an increased percentage of abnormal sperm occurred at 1000 mg/kg/day, a dose which also caused parental toxicity in the treated males and females. 
U ispitivanju plodnosti i ranog embrionalnog razvoja štakora, smanjenje plodnosti i pokretljivosti spermija, promijenjenih ciklusa estrusa i povećanog postotka abnormalne sperme javljale su se pri dozi od 1000 mg/kg/dan, koja je u liječenih ženki i mužjaka uzrokovala roditeljsku toksičnost.
The co-administration of type 5 phosphodiesterase (PDE5) inhibitors, including avanafil, with guanylate cyclase stimulators, such as riociguat is contraindicated as it may potentially lead to symptomatic hypotension (see section 4.5). 
Istodobna primjena inhibitora fosfodiesteraze tipa 5 (PDE5), uključujući avanafil, sa stimulatorima gvanilat ciklaze poput riocigvata, je kontraindicirana, jer može dovesti do simptomatske hipotenzije (vidjeti dio 4.5).
Concomitant use of other treatments for erectile dysfunction The safety and efficacy of combinations of Spedra and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied. 
Istodobna primjena drugih liječenja za erektilnu disfunkciju Sigurnost i djelotvornost Spedre u kombinaciji s drugim inhibitorima PDE5 ili drugim liječenjima erektilne disfunkcije nisu ispitane.
The concomitant use of alpha-blockers and avanafil may lead to symptomatic hypotension in some patients due to additive vasodilatory effects (see section 4.5). 
Istodobna primjena alfa blokatora i avanafila može u nekih bolesnika dovesti do simptomatske hipotenzije zbog dodatnih vazodilatacijskih učinaka (vidjeti dio 4.5).
Avanafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes. 
Avanafil se uklanja uglavnom putem jetrenih mikrosomalnih izoenzima CYP3A4 (glavni put) i CYP2C9 (manje važan put).
Angina pectoris Tachycardia 
Srčani poremećaji palpitacije angina pektoris tahikardija
Dose adjustments are not required in patients with mild to moderate renal impairment (creatinine clearance ≥ 30 mL/min). 
Prilagodbe doze nisu potrebne u bolesnika s blagim do umjerenim oštećenjem bubrega (klirens kreatinina ≥ 30 ml/min).
Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat. 
Pretklinička ispitivanja su pokazala aditivni učinak na sniženje sistemskog krvnog tlaka kada su se inhibitori PDE5 primjenjivali u kombinaciji s riocigvatom.
• If you are taking medicines for fungal infections such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin 
• ako uzimate lijekove protiv gljivičnih infekcija kao što su ketokonazol, itrakonazol ili vorikonazol ili određene antibiotike protiv bakterijskih infekcija, kao što su klaritromicin ili telitromicin