natgillin/translations-raw huggingface dataset:
Table 1 lists adverse reactions identified in clinical studies with patients receiving Zurampic 200 mg once daily in combination with a xanthine oxidase inhibitor, allopurinol or febuxostat. 
Tablici 1 prikazane su nuspojave identificirane u kliničkim ispitivanjima s bolesnicima u kojih je primijenjen Zurampic u dozi od 200 mg jedanput dnevno u kombinaciji s inhibitorom ksantin oksidaze, alopurinolom ili febuksostatom.
Proportion of patients who met serum uric acid Target (<5.0 mg/dL) N(%) 
Udio bolesnika koji su postigli ciljnu razinu mokraćne kiseline u serumu (<5,0 mg/dL) N(%)
When Zurampic 200 mg was added to a xanthine oxidase inhibitor (i.e. febuxostat), additional 25% and 19% of sUA reductions were observed at 6 hours and 24 hours post-dose, respectively. 
Kada se Zurampic u dozi od 200 mg primijenio zajedno s inhibitorom ksantin oksidaze (tj. febuksostatom), opažena su dodatna smanjenja razine mokraćne kiseline u serumu od 25% nakon 6 sati, odnosno 19% nakon 24 sata.
HMG-CoA reductase inhibitors that are sensitive CYP3A substrates may interact with lesinurad. 
Moguća je interakcija inhibitora HMG-CoA reduktaze koji su osjetljivi supstrati CYP3A s lesinuradom.
Salicylates at doses higher than 325 mg per day may decrease the serum uric acid lowering activity of lesinurad and should not be co-administered with Zurampic. 
Pri dozama višima od 325 mg dnevno, salicilati mogu smanjiti djelovanje lesinurada na sniženje razine mokraćne kiseline u serumu, te se ne smiju primjenjivati istodobno s lijekom Zurampic.
In the subgroup of patients with a baseline sUA ≥5.0 mg/dL, after 3 weeks of febuxostat therapy, a significant difference was achieved at all study visits for Zurampic 200 mg in combination with febuxostat compared with placebo in combination with febuxostat (see Table 3). 
U podskupini bolesnika s početnom vrijednosti sUA ≥5,0 mg/dl, nakon 3 tjedna liječenja febuksostatom, značajna razlika je postignuta prilikom svih posjeta u ispitivanju za Zurampic u dozi od 200 mg u kombinaciji s febuksostatom u usporedbi s kombinacijom placeba i febuksostata (vidjeti Tablicu 3).
Gout flare prophylaxis with colchicine or an NSAID is recommended for at least 5 months when starting Zurampic therapy (see section 4.2). 
Preporučuje se profilaksa akutnih napadaja gihta kolhicinom ili NSAIL-ovima tijekom najmanje 5 mjeseci prilikom započinjanja liječenja lijekom Zurampic (vidjeti dio 4.2).
Gout flare prophylaxis with colchicine or a nonsteroidal anti-inflammatory drug (NSAID) is recommended for at least 5 months when starting therapy (see section 4.4). 
Preporučuje se profilaksa akutnih napadaja gihta kolhicinom ili nesteroidnim protuupalnim lijekom (NSAIL) tijekom najmanje 5 mjeseci prilikom započinjanja liječenja (vidjeti dio 4.4).
No overall differences in safety of Zurampic were observed in patients with mild or moderate renal impairment (eCrCL of30-89 mL/min) compared to patients with normal renal function (see sections 4.2 and 5.2). 
Nisu zamijećene sveukupne razlike u sigurnosti lijeka Zurampic u bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega (eCrCL od 30 do 89 ml/min) u usporedbi s bolesnicima s normalnom funkcijom bubrega (vidjeti dijelove 4.2 i 5.2).
Mean sUA reductions following Zurampic 200 mg administration alone were approximately 46% and 26% at 6 hours and 24 hours post-dose, respectively. 
Srednja smanjenja razine mokraćne kiseline u serumu nakon primjene samo lijeka Zurampic u dozi od 200 mg bila su približno 46% nakon 6 sati, odnosno 26% nakon 24 sata.
Clinical outcomes - tophus resolution and reduction In CRYSTAL, the proportion of subjects who experienced a complete resolution (defined as 100% resolution of at least one target tophus and no single tophus showing progression) of ≥1 target tophus was higher in the group treated with Zurampic 200 mg in combination with febuxostat compared with placebo in combination with febuxostat, although the difference was not statistically different (26% compared with 21%). 
U ispitivanju CRYSTAL, udio ispitanika u kojih je postignuto potpuno povlačenje (definirano kao 100 %-tno povlačenje najmanje jednog ciljnog tofa i bez znakova progresije bilo kojeg tofa) jednog ili više ciljnih tofa bio je veći u skupini liječenoj lijekom Zurampic u dozi od 200 mg u kombinaciji s febuksostatom, u usporedbi s kombinacijom placeba i febuksostata, iako razlika nije bila statistički značajna (26% u usporedbi s 21%).
Failure to follow these instructions may increase the risk of kidney side effects. 
Ukoliko se ove upute ne slijede, rizik od bubrežnih nuspojava može biti povećan.
Zurampic must always be taken together with your morning dose of either allopurinol or febuxostat. 
Zurampic se uvijek mora uzeti zajedno s Vašom jutarnjom dozom bilo alopurinola bilo febuksostata.
Placebo + allopurinol 
Vremenska točka Placebo + alopurinol
Including the combination long-term extension studies, the incidences of serious renal-related adverse reactions (including acute renal failure) per 100 patientyears of exposure were 0.4 and 1.4 for Zurampic 200 mg and Zurampic 400 mg in combination with a xanthine oxidase inhibitor, respectively (see sections 4.2 and 4.4). 
Uključujući dugotrajne nastavke ispitivanja kombiniranog liječenja, incidencija ozbiljnih nuspojava povezanih s bubrezima (uključujući akutno zatajenje bubrega) na 100 bolesnik-godina izloženosti bila je 0,4 za Zurampic u dozi od 200 mg, odnosno 1,4 za Zurampic u dozi od 400 mg u kombinaciji s inhibitorom ksantin oksidaze (vidjeti dijelove 4.2 i 4.4).
Table 1 Adverse reactions by System Organ Class and frequency 
Tablica 1 Nuspojave po organskim sustavima i učestalosti
Severe renal impairment (CrCL less than 30 mL/min), end-stage renal disease, kidney transplant recipients or patients on dialysis (see section 4.2). 
Teško oštećenje funkcije bubrega (CrCL manji od 30 ml/min), završni stadij bolesti bubrega, primatelji presatka bubrega ili bolesnici na dijalizi (vidjeti dio 4.2).
No dose adjustment is necessary in patients with mild or moderate hepatic impairment (Child-Pugh classes A and B) (see section 5.2). 
Nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre (ChildPugh stadij A ili B) (vidjeti dio 5.2).
In each of the studies, a greater proportion of patients treated with Zurampic 200 mg in combination with allopurinol compared with placebo in combination with allopurinol achieved a serum uric acid less than 5 mg/dL by Month 6 (CLEAR1: 29% versus 10%; CLEAR2: 35% versus 5%). 
U svakom od ispitivanja, veći je udio bolesnika liječenih lijekom Zurampic u dozi od 200 mg u kombinaciji s alopurinolom, u usporedbi s onima liječenima kombinacijom placeba i alopurinola, postigao razinu mokraćne kiseline u serumu manju od 5 mg/dl do 6. mjeseca (CLEAR1: 29% naspram 10%; CLEAR2: 35% naspram 5%).
In the pivotal clinical trials, a greater proportion of patients using lipid lowering or antihypertensive medicines that were CYP3A substrates required concomitant medicinal product change when treated with Zurampic 200 mg in combination with a xanthine oxidase inhibitor, compared with patients treated with placebo in combination with a xanthine oxidase inhibitor (35% versus 28%, respectively). 
U pivotalnim je kliničkim ispitivanjima bio veći udio bolesnika u kojih je bila potrebna promjena istodobno primjenjivanog lijeka za sniženje lipida ili antihipertenzivnog lijeka koji su supstrati CYP3A kada se Zurampic primjenjivao u dozi od 200 mg u kombinaciji s inhibitorom ksantin oksidaze nego u bolesnika liječenih placebom u kombinaciji s inhibitorom ksantin oksidaze (35% naspram 28%).
Zurampic 200 mg tablets lesinurad 
Zurampic 200 mg tablete lesinurad
Zurampic 200 mg vs. placebo 
Zurampic 200 mg naspram placeba
In a 6-month double-blind, placebo-controlled monotherapy study of Zurampic, renal-related adverse reactions and serious renal-related adverse reactions (including acute renal failure) were reported in 17.8% and 4.7% of patients respectively, receiving Zurampic 400 mg alone and in no patients receiving placebo (see sections 4.2 and 4.4). 
U 6-mjesečnom, dvostruko slijepom, placebom kontroliranom ispitivanju monoterapije lijekom Zurampic, nuspojave povezane s bubrezima odnosno ozbiljne nuspojave povezane s bubrezima (uključujući akutno zatajenje bubrega) prijavljene su u 17,8% odnosno 4,7% bolesnika u kojih je primjenjivan samo lijek Zurampic u dozi od 400 mg, dok u bolesnika koji su primali placebo nisu prijavljene (vidjeti dijelove 4.2 i 4.4).
Lesinurad exposure is increased when it is co-administered with inhibitors of CYP2C9. 
Izloženost lesinuradu povećava se kada se on primjenjuje istodobno s inhibitorima CYP2C9.
Patients continued their allopurinol dose and were randomised 1:1:1 to receive Zurampic 200 mg, Zurampic 400 mg, or placebo once daily. 
Bolesnici su nastavili uzimati svoju dozu alopurinola i randomizirani su u omjeru 1:1:1 za primjenu lijeka Zurampic u dozi od 200 mg, lijeka Zurampic u dozi od 400 mg ili placeba jedanput dnevno.
In these studies, kidney stone adverse reactions (nephrolithiasis being the most frequent) were reported in patients treated with Zurampic 200 mg (0.6%), Zurampic 400 mg (2.5%) and placebo (1.7%). 
U ovim ispitivanjima, nuspojave bubrežnih kamenaca (od kojih je najčešća nefrolitijaza) prijavljene su u bolesnika liječenih lijekom Zurampic u dozi od 200 mg (0,6%), u dozi od 400 mg (2,5%) i placebom (1,7%).
Lesinurad is mainly metabolised by CYP2C9 and mEH, and to a lesser extent by CYP1A1, CYP2C19 and CYP3A. 
Lesinurad se pretežno metabolizira putem CYP2C9 i mEH, te u manjoj mjeri putem CYP1A1, CYP2C19 i CYP3A.
Zurampic must not be initiated in patients with severe renal impairment (CrCL less than 30 mL/min), with end-stage renal disease or in patients on dialysis (see sections 4.3 and 4.4). 
Primjena lijeka Zurampic ne smije se započeti u bolesnika s teškim oštećenjem funkcije bubrega (CrCL manji od 30 ml/min) ili završnim stadijem bolesti bubrega ili u bolesnika koji su na dijalizi (vidjeti dijelove 4.3 i 4.4).
Rare cases of hypersensitivity (photodermatosis, photosensitivity reaction, dermatitis allergic, pruritus and urticaria) have been reported with lesinurad during the clinical programme. 
Tijekom kliničkog programa s lesinuradom prijavljeni su rijetki slučajevi preosjetljivosti (fotodermatoza, reakcija fotoosjetljivosti, alergijski dermatitis, pruritus i urtikarija).
Zurampic as add-on to allopurinol in inadequate responders CLEAR1 and CLEAR2 enrolled patients with gout who were on a stable dose of allopurinol of at least 300 mg (or 200 mg for moderate renal impairment), had serum uric acid levels greater than 6.5 mg/dL and reported at least 2 gout flares in the previous 12 months. 
Zurampic kao dodatak alopurinolu u bolesnika s nezadovoljavajućim odgovorom U ispitivanja CLEAR1 i CLEAR2 uključeni su bolesnici s gihtom koji su liječeni stabilnom dozom alopurinola od najmanje 300 mg (ili 200 mg u slučaju umjerenog oštećenja funkcije bubrega), koji su imali razine mokraćne kiseline u serumu iznad 6,5 mg/dl i u kojih su prijavljena najmanje 2 akutna napadaja gihta u prethodnih 12 mjeseci.
Figure 1 Mean serum uric acid levels in pooled clinical studies with Zurampic in combination with allopurinol in patients with inadequate response (sUA ≥6 mg/dL) to allopurinol alone 
Slika 1 Srednje razine mokraćne kiseline u serumu u združenim kliničkim ispitivanjima kombinacije lijeka Zurampic i alopurinola u bolesnika s nezadovoljavajućim odgovorom (sUA ≥6 mg/dl) na liječenje samo alopurinolom
CYP2C9 poor metabolisers 
Spori CYP2C9 metabolizatori
Among serious renal-related adverse reactions: renal failure, renal failure acute and renal impairment were reported in 1.9%, 1.9% and 0.9% respectively, of patients receiving lesinurad 400 mg monotherapy and in no patients receiving placebo. 
Među ozbiljnim nuspojavama povezanima s bubrezima: zatajenje bubrega, akutno zatajenje bubrega i oštećenje funkcije bubrega prijavljeni su u 1,9%, 1,9% odnosno 0,9% bolesnika u kojih je primjenjivana monoterapija lesinuradom u dozi od 400 mg, dok u bolesnika koji su primali placebo nisu prijavljene.
Patients who are known or suspected to be CYP2C9 poor metabolisers based on previous history or experience with other CYP2C9 substrates should use Zurampic with caution (see section 4.4). 
Zurampic se treba primjenjivati s oprezom u bolesnika za koje je poznato ili se sumnja da su spori CYP2C9 metabolizatori, s obzirom na prethodnu anamnezu ili iskustvo s drugim supstratima CYP2C9 (vidjeti dio 4.4).
Patients received febuxostat 80 mg once daily for 3 weeks and then were randomised 1:1:1 to once daily doses of Zurampic 200 mg, Zurampic 400 mg, or placebo in combination with febuxostat. 
U bolesnika je primjenjivan febuksostat u dozi od 80 mg jedanput dnevno tijekom 3 tjedna nakon čega su randomizirani u omjeru 1:1:1 za primjenu lijeka Zurampic u dozi od 200 mg, lijeka Zurampic u dozi od 400 mg ili placeba jedanput dnevno u kombinaciji s febuksostatom.
Consistent serum uric acid lowering was observed in patients who were receiving low dose acetylsalicylic acid in the placebo-controlled clinical studies in combination with allopurinol or febuxostat. 
Opaženo je konzistentno sniženje razine mokraćne kiseline u serumu u bolesnika u kojih su primjenjivane niske doze acetilsalicilatne kiseline u placebom kontroliranim kliničkim ispitivanjima, u kombinaciji s alopurinolom ili febuksostatom.
Atropisomer 1 is extensively metabolised by CYP2C9 whereas atropisomer 2 is minimally metabolised by both CYP2C9 and CYP3A4. 
Atropoizomer 1 opsežno se metabolizira putem CYP2C9, dok se atropoizomer 2 minimalno metabolizira i putem CYP2C9 i CYP3A4.
Serious renal-related adverse reactions, e.g. acute renal failure and renal impairment, were reported in patients treated with lesinurad 400 mg (1%) and placebo (0.4%) and in no patients on lesinurad 200 mg. 
Ozbiljne nuspojave povezane s bubrezima, npr. akutno zatajenje bubrega i oštećenje funkcije bubrega, prijavljene su u bolesnika liječenih lesinuradom u dozi od 400 mg (1%) i placebom (0,4%), te nisu prijavljene u bolesnika liječenih lesinuradom u dozi od 200 mg.
Continuous treatment with Zurampic decreases the frequency of gout flares. 
Kontinuirano liječenje lijekom Zurampic smanjuje učestalost akutnih napadaja gihta.
In the randomised, double-blind, placebo-controlled combination therapy clinical studies, the incidences of patients with adjudicated Major Adverse Cardiovascular Events (CV death, non-fatal myocardial infarction or non-fatal stroke) per 100 patient-years of exposure were: 0.71 (95% CI 0.23, 2.21) for placebo, 0.96 (95% CI 0.36, 2.57) for Zurampic 200 mg, and 1.94 (95% CI 0.97, 3.87) for Zurampic 400 mg, when used in combination with a xanthine oxidase inhibitor. 
Major Adverse Cardiovascular Events) (KV smrt, ne-fatalni infarkt miokarda ili nefatalni moždani udar) na 100 bolesnik-godina izloženosti bile su: 0,71 (95% CI 0,23, 2,21) za placebo, 0,96 (95% CI 0,36, 2,57) za Zurampic u dozi od 200 mg te 1,94 (95% CI 0,97, 3,87) za Zurampic u dozi od 400 mg, kada se primjenjuje u kombinaciji s inhibitorom ksantin oksidaze.
How to take Zurampic 
Kako uzimati Zurampic
Look out for side effects 
Obratite pažnju na nuspojave
Consistent serum uric acid lowering was observed in patients who were receiving thiazide diuretics in the placebo-controlled clinical studies in combination with allopurinol or febuxostat. 
Opaženo je konzistentno sniženje razine mokraćne kiseline u serumu u bolesnika u kojih su primjenjivani tiazidni diuretici u placebom kontroliranim kliničkim ispitivanjima, u kombinaciji s alopurinolom ili febuksostatom.
The stability of the sustained response was demonstrated with a greater proportion of patients treated with Zurampic 200 mg in combination with allopurinol achieving the target serum uric acid level at each visit for 3 consecutive months (Months 4, 5 and 6) compared to patients treated with placebo in combination with allopurinol (see Table 2). 
Stabilnost održanog odgovora na liječenje dokazana je s većim udjelom u bolesnika liječenih lijekom Zurampic u dozi od 200 mg u kombinaciji s alopurinolom koji su postigli ciljnu razinu mokraćne kiseline u serumu pri svakom posjetu tijekom 3 uzastopna mjeseca (4., 5. i 6. mjesec) u usporedbi s bolesnicima liječenjima placebom u kombinaciji s alopurinolom (vidjeti Tablicu 2).
Your doctor will check how well your kidneys are working before starting and during treatment with Zurampic. 
Vaši bubrezi prije početka i tijekom liječenja lijekom Zurampic.
Campus 21, Liebermannstraße A01/501 2345 Brunn am Gebirge Tel: +43(0)2236 379 550-0 
2345 Brunn am Gebirge Tel: +43(0)2236 379 550-0
In three 12-month placebo-controlled trials of Zurampic in combination with a xanthine oxidase inhibitor versus a xanthine oxidase inhibitor alone (placebo), serum creatinine elevations between 1.5fold and 2-fold over baseline occurred in 3.9% of patients on Zurampic 200 mg, 10.0% of patients on Zurampic 400 mg and 2.3% on placebo; serum creatinine elevations 2-fold or greater over baseline occurred in 1.8% of patients on Zurampic 200 mg, 6.7% of patients on Zurampic 400 mg and 0% on placebo. 
U tri 12-mjesečna placebom kontrolirana ispitivanja lijeka Zurampic u kombinaciji s inhibitorom ksantin oksidaze u usporedbi sa samo inhibitorom ksantin oksidaze (uz placebo), razina serumskog kreatinina povisila se za 1,5 do 2 puta u odnosu na početnu vrijednost u 3,9% bolesnika liječenih lijekom Zurampic u dozi od 200 mg, 10% bolesnika liječenih lijekom Zurampic u dozi od 400 mg te 2,3% bolesnika liječenih placebom; do dvostrukog ili većeg povišenja razine serumskog kreatinina u odnosu na početnu vrijednost došlo je u 1,8% bolesnika u kojih je primjenjivan Zurampic u dozi od 200 mg, te 6,7% bolesnika u kojih je primjenjivan Zurampic u dozi od 400 mg i u 0% bolesnika koji su primali placebo.
CYP2C9 inhibitors and inducers 
Inhibitori i induktori CYP2C9
EU/1/15/1080/005 100x1 film-coated tablets (unit dose) 
EU/1/15/1080/005 100x1 filmom obloženih tableta (jedinična doza)
In both studies, significantly more patients treated with Zurampic 200 mg in combination with allopurinol achieved the target serum uric acid level of less than 6 mg/dL by Month 6 and by Month 12 compared with patients receiving placebo in combination with allopurinol (see Table 2). 
U oba ispitivanja, značajno je više bolesnika liječenih lijekom Zurampic u dozi od 200 mg u kombinaciji s alopurinolom postiglo ciljnu razinu mokraćne kiseline u serumu manju od 6 mg/dl do šestog i do dvanaestog mjeseca u usporedbi s bolesnicima u kojih je primijenjen placebo u kombinaciji s alopurinolom (vidjeti Tablicu 2).
Table 3 Proportion of patients with baseline sUA ≥5.0 mg/dLwho achieve target serum uric acid levels (<5 mg/dL) with Zurampic in combination with febuxostat 
Tablica 3 Udio bolesnika s početnom vrijednosti sUA >5,0 mg/dl koji su postigli ciljne razine mokraćne kiseline u serumu (<5 mg/dl) uz liječenje lijekom Zurampic u kombinaciji s febuksostatom
The most common adverse reaction leading to discontinuation of Zurampic was blood creatinine increased 
Najčešća nuspojava koja je dovela do prekida primjene lijeka Zurampic bila je povišen kreatinin u krvi (0,8%).
Table 2 Proportion of patients who achieved target serum uric acid levels (<6mg/dL) with Zurampic in combination with allopurinol - Pooled data from CLEAR1 and CLEAR2 studies 
Tablica 2 Udio bolesnika koji su postigli ciljne razine mokraćne kiseline u serumu (<6 mg/dl) uz primjenu lijeka Zurampic u kombinaciji s alopurinolom - združeni podaci iz ispitivanja CLEAR1 i CLEAR2 Udio bolesnika koji su postigli ciljnu razinu mokraćne kiseline u serumu (<6,0 mg/dl) N (%)
How to store Zurampic 
Kako čuvati Zurampic
Treatment should be interrupted in patients who report symptoms that may indicate acute uric acid nephropathy including flank pain, nausea or vomiting, and measure serum creatinine promptly. 
Liječenje treba prekinuti i što prije izmjeriti serumski kreatinin u bolesnika koji prijave simptome koji mogu upućivati na akutnu uričnu nefropatiju, uključujući bol u slabinama, mučninu ili povraćanje.
Adverse reactions related to renal function can occur after initiating Zurampic (see section 4.8). 
Nakon početka primjene lijeka Zurampic, mogu se javiti nuspojave povezane s funkcijom bubrega (vidjeti dio 4.8).
Indigo Carmine Brilliant Blue FCF 
Ovojnica tablete hipromeloza titanijev dioksid triacetin boja Indigo Carmine boja Brilliant Blue FCF
Name and address of the manufacturer responsible for batch release 
Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Grünenthal GmbH
Zurampic should not be restarted without another explanation for the serum creatinine abnormalities. 
Ako ne postoji drugo objašnjenje za abnormalnosti serumskog kreatinina, primjena lijeka Zurampic se ne smije ponovno započeti.
Zurampic 200 mg film-coated tablets lesinurad 
Zurampic 200 mg filmom obložene tablete lesinurad
Primary end-point in patients with renal impairment Consistent with the overall population, the proportion of patients with mild to moderate renal impairment (eCrCL 30-89 mL/min) who achieved target serum uric acid levels at Month 6 was 56% for Zurampic 200 mg versus 29% for placebo when added to allopurinol, and 40% for Zurampic 200 mg versus 26% for placebo when added to febuxostat in patients with baseline sUA ≥5.0 mg/dL. 
U skladu sa sveukupnom populacijom, udio bolesnika s blagim do umjerenim oštećenjem funkcije bubrega (eCrCL od 30 do 89 ml/min) koji su postigli ciljne razine mokraćne kiseline u serumu nakon 6 mjeseci bio je 56% za Zurampic u dozi od 200 mg, naspram 29% za placebo, kada su se primjenjivali u kombinaciji s alopurinolom, te 40% za Zurampic u dozi od 200 mg, naspram 26% za placebo kada su se primjenjivali u kombinaciji s febuksostatom u bolesnika s početnom vrijednosti sUA >5,0 mg/dl.
Zurampic 200 mg film-coated tablets 
Zurampic 200 mg filmom obložene tablete
A higher incidence of serum creatinine elevations and renal-related adverse reactions including serious adverse reactions was observed with Zurampic 400 mg when given alone or in combination with a xanthine oxidase inhibitor, with the highest incidence when Zurampic was given as monotherapy. 
Kada se Zurampic primjenjivao u dozi od 400 mg, samostalno ili u kombinaciji s inhibitorom ksantin oksidaze, opažena je veća incidencija povišenja serumskog kreatinina i nuspojava povezanih s bubrezima, uključujući i ozbiljne nuspojave, uz najvišu incidenciju kada se Zurampic primjenjivao kao monoterapija.
Acute gouty attacks (gout flares) 
Akutni napadaji gihta
Zurampic contains lactose 
Zurampic sadrži laktozu
Lesinurad should only be used in combination with a xanthine oxidase inhibitor because combination use reduces the amount of uric acid available for excretion and decreases the risk of renal-related events. 
Lesinurad primijenjen u kombinaciji s inhibitorom ksantin oksidaze povećava izlučivanje i smanjuje stvaranje mokraćne kiseline, što rezultira jačim sniženjem sUA. Lesinurad se smije primjenjivati samo u kombinaciji s inhibitorom ksantin oksidaze zato što primjena u kombinaciji smanjuje količinu mokraćne kiseline dostupne za izlučivanje i smanjuje rizik od događaja povezanih s bubrezima.
Zurampic should not be initiated in kidney transplant recipients. 
Primjena lijeka Zurampic ne smije se započeti u primatelja presatka bubrega.
(200 mg) in patients with mild renal impairment (eCrCL 60 to 89 mL/min), 20% and 73% higher (200 mg) and 3% and 50% higher (400 mg) in patients with moderate renal impairment (eCrCL 30 to 59 mL/min), and 13% higher and 113% higher (400 mg) in patients with severe renal impairment (eCrCL <30 mL/min). 
Nakon primjene jednokratne doze lesinurada u osoba s oštećenjem funkcije bubrega, u usporedbi s onima koji imaju normalnu funkciju bubrega, vrijednosti Cmax odnosno AUC lesinurada bile su 36% odnosno 30% veće (200 mg) u bolesnika s blagim oštećenjem funkcije bubrega (eCrCL 60 do 89 ml/min), 20% odnosno 73% veće (200 mg) i 3% odnosno 50% (400 mg) veće u bolesnika s umjerenim oštećenjem funkcije bubrega (eCrCL 30 do 59 ml/min) te 13% više odnosno 113% veće (400 mg) u bolesnika s teškim oštećenjem funkcije bubrega (eCrCL <30 ml/min).
EU/1/15/1080/004 98 film-coated tablets 
EU/1/15/1080/004 98 filmom obloženih tableta