natgillin/translations-raw huggingface dataset:
The 120 mg tablets are marked with M on one side of the tablet and FX4 on the other side. 
S jedne strane tableta od 120 mg nalazi se oznaka M, a s druge strane oznaka FX4.
Between 46% and 55% of subjects received treatment for gout flares from Week 8 and Week 28. 
Akutni napadi gihta liječeni su kod 46% do 55% ispitanika od 8. do 28. tjedna.
Febuxostat was shown to be a weak inhibitor of CYP2C8 in vitro. 
Febuksostat se in vitro pokazao kao slabi inhibitor CYP2C8.
• dry mouth, abdominal pain/discomfort or wind, heartburn/indigestion, constipation, more frequent passing of stools, vomiting, stomach discomfort 
• suha usta, bol/nelagoda u trbuhu ili vjetrovi, žgaravica/probavne tegobe, zatvor, češće stolice, povraćanje, osjećaj nelagode u želucu
Tumor Lysis Syndrome The recommended oral dose of Febuxostat Mylan is 120 mg once daily without regard to food. 
Preporučena peroralna doza lijeka Febuxostat Mylan je 120 mg jednom dnevno, neovisno o unosu hrane.
• severe swelling of the deeper layers of the skin, especially around the lips, eyes, genitals, 
• jako oticanje dubljih slojeva kože, osobito oko usana, očiju, genitalija, ruku, stopala ili jezika, s mogućom iznenadnom pojavom otežanog disanja
Dermatitis, urticaria, pruritus, skin discolouration, skin lesion, petechiae, rash macular, rash maculopapular, rash papular Rare 
Dermatitis, urtikarija, pruritus, diskoloracija kože, kožne lezije, petehije, makularni osip, makulopapularni osip, papularni osip Rijetko
Table 1: Adverse reactions in combined phase 3, long-term extension studies and postmarketing experience in gout patients. 
Tablica 1: Nuspojave u fazi 3 dugoročnih produžetaka ispitivanja i nakon stavljanja lijeka u promet kod bolesnika s gihtom
Oedema 
Edem
Excipient with known effect Each tablet contains 236.0 mg of lactose. 
Jedna tableta sadrži 236,0 mg laktoze.
Febuxostat 80 mg 
Febuksostat 80 mg
How to take Febuxostat Mylan 
Kako uzimati Febuxostat Mylan
Cardiac disorders: Uncommon: Left bundle branch block, sinus tachycardia 
Srčani poremećaji: Manje često: blok lijeve grane snopa, sinusna tahikardija
In this subgroup febuxostat achieved the primary efficacy endpoint (sUA < 6.0 mg/dL at the last 3 visits) in 41% (80 mg QD), 48% (120 mg QD), and 66% (240 mg QD) of patients compared to 9% in the allopurinol 300 mg/100 mg QD and 0% in the placebo groups. 
U ovoj podskupini febuksostat je postigao primarni ishod djelotvornosti (razina mokraćne kiseline u serumu <6,0 mg/dl kod zadnje 3 kontrole) kod 41% (80 mg jednom dnevno), 48% (120 mg jednom dnevno) i 66% (240 mg jednom dnevno) bolesnika, u usporedbi s 9% u skupini koja je primala alopurinol 300 mg/100 mg jednom dnevno i 0% u skupini koja je primala placebo.
The primary MACE endpoint occurred at similar rates in the febuxostat and allopurinol treatment groups (10.8% vs. 10.4% of patients, respectively; hazard ratio [HR] 1.03; two-sided repeated 95% confidence interval [CI] 0.87-1.23). 
Primarna mjera ishoda za MACE pojavila se sa sličnom stopom u skupini na febuksostatu i skupini na alopurinolu (10,8% u odnosu na 10,4% bolesnika; omjer rizika [engl. hazard ratio, HR] 1,03; dvostrani 95% ponovljeni interval pouzdanosti [engl. confidence interval, CI] 0,87 - 1,23).
The proportion of subjects requiring treatment for a gout flare (APEX and FACT Study) was numerically lower in the groups that achieved an average post-baseline serum urate level <6.0 mg/dL, <5.0 mg/dL, or <4.0 mg/dL compared to the group that achieved an average postbaseline serum urate level ≥6.0 mg/dL during the last 32 weeks of the treatment period (Week 20 - Week 24 to Week 49 - 52 intervals). 
Udio bolesnika kojima je bilo potrebno liječenje akutnog napada gihta (ispitivanja APEX i FACT) bio je brojčano manji u skupinama kod kojih je nakon početka liječenja postignuta prosječna razina urata u serumu <6,0 mg/dl, <5,0 mg/dl, ili <4,0 mg/dl, u usporedbi sa skupinom kod koje je nakon početka liječenja postignuta prosječna razina urata u serumu ≥6,0 mg/dl tijekom posljednja 32 tjedna liječenja (u intervalima od 20. - 24. tjedna do 49. - 52. tjedna).
In the long-term extension studies the incidences of investigator-reported APTC events were 1.2 and 0.6 events per 100 PYs for febuxostat and allopurinol, respectively. 
Tijekom dugotrajnih produžetaka kliničkih ispitivanja incidencija APTC kardiovaskularnih događaja koje su prijavili ispitivači bila je 1,2 događaja na 100 bolesnik/godina u skupini koja je primala febuksostat odnosno 0,6 događaja na 100 bolesnik/godina u skupini na alopurinolu.
The gout flare should be managed concurrently as appropriate for the individual patient. 
Istodobno treba liječiti napad gihta, individualnim pristupom ovisno o bolesniku.
A yellow, capsule shaped, biconvex tablet, approximately 18 x 8 mm, debossed with M on one side of the tablet and FX4 on the other side. 
Žuta, bikonveksna tableta u obliku kapsule, približne veličine 18 × 8 mm s utisnutom oznakom
When this happens, urate crystals may form in and around the joints and kidneys. 
Kad se to dogodi, u zglobovima, bubrezima i okolnim tkivima se mogu stvarati kristali urata.
The 80 mg tablets are marked with M on one side of the tablet and FX3 on the other side. 
S jedne strane tableta od 80 mg nalazi se oznaka M, a s druge strane oznaka FX3.
How to store Febuxostat Mylan 
Kako čuvati Febuxostat Mylan
Febuxostat Mylan 80 mg and 120 mg film-coated tablets are available in plastic bottles of 28 
Febuxostat Mylan 80 mg i 120 mg filmom obložene tablete dostupne su u plastičnim bocama s 28 i 84 tablete.
Febuxostat 120 mg 
Febuksostat 120 mg
Note: 509 patients received allopurinol 300 mg QD; 10 patients with serum creatinine >1.5 and ≤2.0 mg/dL were dosed with 100 mg QD. 
Napomena: 509 bolesnika primalo je alopurinol 300 mg jednom dnevno; 10 bolesnika s kreatininom u serumu >1,5 i ≤2,0 mg/dl primalo je dozu od 100 mg jednom dnevno (10 od 268 bolesnika u ispitivanju APEX).
Cholelithiasis 
Kolelitijaza
Respiratory system disorders 
Poremećaji dišnog sustava
Uncommon Hypertension, flushing, hot flush 
Manje često Hipertenzija, naleti crvenila, naleti vrućine
Rare serious hypersensitivity reactions to febuxostat, including Stevens-Johnson Syndrome, Toxic epidermal necrolysis and anaphylactic reaction/shock, have occurred in the postmarketing experience. 
Nakon stavljanja lijeka u promet pojavile su se rijetke ozbiljne reakcije preosjetljivosti na febuksostat, uključujući Stevens-Johnsonov sindrom, toksičnu epidermalnu nekrolizu i anafilaktičku reakciju/šok.
In a study in healthy subjects, coadministration of 120 mg febuxostat QD with a single 4 mg oral dose of rosiglitazone had no effect on the pharmacokinetics of rosiglitazone and its metabolite N-desmethyl rosiglitazone, indicating that febuxostat is not a CYP2C8 enzyme inhibitor in vivo. 
Tijekom ispitivanja na zdravim ispitanicima, istodobna primjena 120 mg febuksostata jednom dnevno s jednokratnom oralnom dozom od 4 mg roziglitazona nije imala učinak na farmakokinetiku roziglitazona i njegova metabolita
Febuxostat is a 2-arylthiazole derivative that achieves its therapeutic effect of decreasing serum uric acid by selectively inhibiting XO. Febuxostat is a potent, nonpurine selective inhibitor of XO (NP-SIXO) with an in vitro inhibition Ki value less than one nanomolar. 
Febuksostat je derivat 2-ariltiazola koji postiže terapijski učinak smanjivanjem razine mokraćne kiseline u serumu selektivnim inhibiranjem XO.
A total of 1,086 patients were enrolled: Febuxostat 80 mg QD (n=649), febuxostat 120 mg QD (n=292) and allopurinol 300/100 mg QD (n=145). 
Ukupno je bilo uključeno 1086 bolesnika: dobivali su febuksostat 80 mg jednom dnevno (n=649), febuksostat 120 mg jednom dnevno (n=292) i alopurinol 300/100 mg jednom dnevno (n=145).
(PVC/oPA/Alu)/Alu (desiccant embedded) blisters of 14, 28, 84 tablets, calendar blisters of 28, 84 tablets and perforated unit dose blisters of 28 x 1 tablets. 
6.5 Vrsta i sadržaj spremnika (PVC/oPA/Al)/Al (s umetnutim sredstvom za sušenje) blisteri s 14, 28, 84 tablete, kalendarski blisteri s 28, 84 tablete i perforirani blisteri s jediničnim dozama s 28 × 1 tabletom.
A yellow, capsule shaped, biconvex tablet approximately 16 x 7 mm, debossed with M on one side of the tablet and FX3 on the other side. 
Žuta, bikonveksna tableta u obliku kapsule, približne veličine 16 × 7 mm s utisnutom oznakom
Allopurinol 
Alopurinol
What you need to know before you take Febuxostat Mylan 
Što morate znati prije nego počnete uzimati Febuxostat Mylan Nemojte uzimati Febuxostat Mylan:
Each tablet contains 80 mg febuxostat. 
Jedna tableta sadrži 80 mg febuksostata.
No difference in the proportion of patients requiring treatment for gout flares was observed between the febuxostat 80 mg and 40 mg groups. 
Nije uočena razlika između postotka bolesnika u skupini liječenoj febuksostatom od 80 mg i od 40 mg kojima je bilo potrebno liječenje akutnog napada gihta.
Febuxostat can be co-administered with naproxen with no dose adjustment of febuxostat or naproxen being necessary. 
Febuksostat se može primjenjivati istodobno s naproksenom, bez potrebe prilagođavanja doze febuksostata ili naproksena.
Other side effects which are not mentioned above are listed below. 
Ostale nuspojave su navedene u tekstu koji slijedi.
Primary endpoint in the sub group of patients with sUA ≥ 10 mg/dL Approximately 40% of patients (combined APEX and FACT) had a baseline sUA of ≥ 10 mg/dL. 
Oko 40% bolesnika (kombinirani podaci iz ispitivanja APEX i FACT) imalo je početnu razinu mokraćne kiseline ≥ 10 mg/dl.
An analysis in patients with gout and renal impairment was prospectively defined in the CONFIRMS study, and showed that febuxostat was significantly more efficacious in lowering serum urate levels to < 6 mg/dL compared to allopurinol 300 mg/200 mg in patients who had gout with mild to moderate renal impairment (65% of patients studied). 
U CONFIRMS ispitivanju je prospektivno analizirana skupina bolesnika s gihtom i oštećenom funkcijom bubrega, te je pokazano da je kod bolesnika s gihtom i blago do umjereno oštećenom funkcijom bubrega (65% promatranih ispitanika), febuksostat značajno djelotvorniji u sniženju razine serumskih urata na <6,0 mg/dl u odnosu na alopurinol 300 mg/200 mg.
Somnolence, dizziness, paraesthesia and blurred vision have been reported with the use of febuxostat. 
Tijekom primjene febuksostata prijavljene su somnolencija, omaglica, parestezija i zamagljen vid.
If you stop taking Febuxostat Mylan your uric acid levels may begin to rise and your symptoms may worsen due to the formation of new crystals of urate in and around your joints and kidneys. 
Ako prestanete uzimati Febuxostat Mylan, razina mokraćne kiseline može početi rasti i simptomi
No dose adjustment was required for enrolled patients on the basis of hepatic function. 
Kod ispitanika uključenih u ispitivanje nije bila potrebna prilagodba doze prema funkciji jetre.
Rare reports of serious allergic/hypersensitivity reactions, including life-threatening StevensJohnson Syndrome, Toxic epidermal necrolysis and acute anaphylactic reaction/shock, have been collected in the post-marketing experience. 
Nakon stavljanja lijeka u promet su prikupljene rijetke prijave ozbiljnih alergijskih reakcija/reakcija preosjetljivosti, uključujući Stevens-Johnsonov sindrom, toksičnu epidermalnu nekrolizu i akutnu anafilaktičku reakciju/šok.
Two thousand and two hundred-sixty nine (2269) patients were randomized: febuxostat 40 mg QD (n=757), febuxostat 80 mg QD (n=756), or allopurinol 300/200 mg QD (n=756). 
Bilo je randomizirano 2269 bolesnika: febuksostat 40 mg jednom dnevno (n=757), febuksostat 80 mg jednom dnevno (n=756) ili alopurinol 300/200 mg jednom dnevno (n=756).
In the CONFIRMS study, the proportion of patients achieving the primary efficacy endpoint (sUA <6.0 mg/dL at the final visit) for patients with a baseline serum urate level of ≥ 10 mg/dL treated with febuxostat 40 mg QD was 27% (66/249), with febuxostat 80 mg QD 49% (125/254) and with allopurinol 300 mg/200 mg QD 31% (72/230), respectively. 
Udio bolesnika koji su postigli primarni ishod djelotvornosti (razina mokraćne kiseline u serumu <6,0 mg/dl na završnoj kontroli) u CONFIRMS ispitivanju, a kojima je početna razina urata u serumu bila ≥ 10 mg/dl bio je 27% (66/249) kod bolesnika liječenih febuksostatom od 40 mg jednom dnevno, 49% (125/254) kod liječenih febuksostatom od 80 mg jednom dnevno te 31% (72/230) kod bolesnika liječenih alopurinolom 300 mg/200 mg jednom dnevno.
Clinical Outcomes: proportion of patients requiring treatment for a gout flare Apex study: During the 8-week prophylaxis period, a greater proportion of subjects in the febuxostat 120 mg (36%) treatment group required treatment for gout flare compared to febuxostat 80 mg (28%), allopurinol 300 mg (23%) and placebo (20%). 
Klinički ishodi: udio bolesnika koji zahtijevaju liječenje akutnog napada gihta APEX ispitivanje: Tijekom razdoblja provođenja profilakse u trajanju od 8 tjedana zabilježen je veći udio ispitanika kojima je bilo potrebno liječenje akutnog napada gihta u skupini na febuksostatu 120 mg (36%), u odnosu na skupinu na febuksostatu 80 mg (28%), alopurinolu 300 mg (23%) i placebu (20%).
Acute gouty attacks (gout flare) 
Akutni napadaji gihta
EXP After first opening use within 180 days 
Nakon prvog otvaranja iskoristiti u roku od 180 dana.
Pharmacokinetic modelling and simulation of rat data suggests that, when co-administered with febuxostat, the clinical dose of mercaptopurine/azathioprine should be reduced to 20% or less of the previously prescribed dose in order to avoid possible haematological effects (see section 4.4 and 4.5). 
Farmakokinetičko modeliranje i simulacija podataka na štakorima ukazuju da je, kad se istodobno primjenjuju s febuksostatom, kliničku dozu merkaptopurina/azatioprina potrebno smanjiti na 20% ili manje od prethodno propisane doze kako bi se izbjegli mogući hematološki učinci (vidjeti dijelove 4.4. i 4.5).
Patients who had 3 consecutive sUA levels >6.0 mg/dL were withdrawn. 
Bolesnici kojima je u tri uzastopna mjerenja razina mokraćne kiseline u serumu bila veća od 6,0 mg/dl bili su isključeni iz ispitivanja.
Gout 
Giht
Each tablet contains 120 mg febuxostat. 
Jedna tableta sadrži 120 mg febuksostata.
During the CONFIRMS study, the percentages of patients who required treatment for gout flares (Day 1 through Month 6) were 31% and 25% for the febuxostat 80 mg and allopurinol groups, respectively. 
Udio bolesnika kojima je bilo potrebno liječenje akutnog napada gihta tijekom CONFIRMS ispitivanja (od 1. dana do 6. mjeseca) bio je 31% u skupini na febuksostatu 80 mg i 25% u skupini na alopurinolu.
• fatigue, chest pain, chest discomfort 
• umor, bol u prsištu, osjećaj nelagode u prsištu
Gout: The recommended dose in patients with mild hepatic impairment is 80 mg. Limited information is available in patients with moderate hepatic impairment. 
Giht: preporučeno doziranje kod bolesnika s blagim oštećenjem funkcije jetre je 80 mg.
The FACT study showed the statistically significant superiority of both febuxostat 80 mg and febuxostat 120 mg QD treatment arms versus the conventionally used dose of allopurinol 300 mg treatment arm in reducing and maintaining sUA below 6 mg/dL (357 µmol/L). 
Ispitivanje FACT pokazalo je statistički značajnu superiornost liječenja, kako febuksostatom 80 mg tako i febuksostatom 120 mg jednom dnevno u odnosu na liječenje uobičajeno korištenim dozama alopurinola 300 mg, s obzirom na snižavanje razine mokraćne kiseline u serumu ispod 6 mg/dl (357 µmol/l).
Seven hundred sixty (760) patients were randomized: febuxostat 80 mg QD (n=256), febuxostat C 120 mg QD (n=251), or allopurinol 300 mg QD (n=253). 
Sedamsto šezdeset (760) bolesnika je randomizirano te su primali: febuksostat 80 mg jednom dnevno (n = 256), febuksostat C 120 mg jednom dnevno (n = 251), ili alopurinol 300 mg jednom dnevno (n = 253).
The APEX study showed statistically significant superiority of both the febuxostat 80 mg QD and the febuxostat 120 mg QD treatment arms versus the conventionally used doses of allopurinol 300 mg (n=258) /100 mg (n = 10) treatment arm in reducing the sUA below 6 mg/dL (357 µmol/L) (see Table 2 and Figure 1). 
Ispitivanje APEX pokazalo je statistički značajnu superiornost liječenja, kako febuksostatom 80 mg jednom dnevno tako i febuksostatom 120 mg jednom dnevno u odnosu na liječenje uobičajeno korištenim dozama alopurinola 300 mg (n = 258)/100 mg (n = 10), s obzirom na snižavanje razine mokraćne kiseline u serumu ispod 6 mg/dl (357 µmol/l) (vidjeti tablicu 2 i sliku 1).
The APEX study showed statistically significant superiority of both the febuxostat 80 mg QD and the febuxostat 120 mg QD treatment arms versus the conventionally used doses of allopurinol 300 mg (n = 258) /100 mg (n = 10) treatment arm in reducing the sUA below 6 mg/dL (357 µmol/L) (see Table 2 and Figure 1). 
Ispitivanje APEX pokazalo je statistički značajnu superiornost liječenja, kako febuksostatom 80 mg jednom dnevno tako i febuksostatom 120 mg jednom dnevno u odnosu na liječenje uobičajeno korištenim dozama alopurinola 300 mg (n = 258)/100mg (n = 10), s obzirom na snižavanje razine mokraćne kiseline u serumu ispod 6 mg/dl (357 µmol/l) (vidjeti tablicu 2 i sliku 1).
Seven hundred sixty (760) patients were randomized: febuxostat 80 mg QD (n=256), febuxostat 120 mg QD (n=251), or allopurinol 300 mg QD (n=253). 
Sedamsto šezdeset (760) bolesnika je randomizirano te su primali: febuksostat 80 mg jednom dnevno (n = 256), febuksostat 120 mg jednom dnevno (n = 251), ili alopurinol 300 mg jednom dnevno (n = 253).
With regard to secondary endpoints, no significant difference was detected in terms of incidence of laboratory TLS (8.1% and 9.2% in febuxostat and allopurinol arm, respectively; relative risk: 0.875 [95% confidence interval: 0.4408 ; 1.7369]; p=0.8488) nor of clinical TLS (1.7% and 1.2% in febuxostat and allopurinol arm, respectively; relative risk: 
STL-a (8,1% u skupini na febuksostatu, 9,2% u skupini na alopurinolu; relativni rizik 0,875 [95%-tni interval pouzdanosti: 0,4408 ; 1,7369]; p=0,8488) niti kliničkog STL-a (1,7% u skupini na febuksostatu, 1,2% u skupini na alopurinolu; relativni rizik 0,994 [95%-tni interval pouzdanosti: 0,9691 ; 1,0199]; p=1,0000).
Possible symptoms of allergic reactions might be: - rash including severe forms (e.g. blisters, nodules, itchy, exfoliative rash), itchiness - swelling of limbs or face - difficulties in breathing - fever with enlarged lymph nodes - but also serious life threatening allergic conditions with cardiac and circulatory arrest. 
svrbež - oticanje udova ili lica - poteškoće s disanjem - vrućica s povećanim limfnim čvorovima - te ozbiljna alergijska stanja opasna po život sa srčanim i cirkulatornim zastojem.
Lot 
UTO
Immune system disorders 
Poremećaji imunološkog sustava Rijetko
Theophylline 
Teofilin
Febuxostat Mylan 80 mg film-coated tablets Febuxostat Mylan 120 mg film-coated tablets febuxostat 
Febuxostat Mylan 80 mg filmom obložene tablete Febuxostat Mylan 120 mg filmom obložene tablete febuksostat
Hepatic impairment 
Jetreni poremećaji
FACT study: During the 8-week prophylaxis period, a greater proportion of subjects in the febuxostat 120 mg (36%) treatment group required treatment for a gout flare compared to both the febuxostat 80 mg (22%) and allopurinol 300 mg (21%) treatment groups. 
FACT ispitivanje: Tijekom razdoblja provođenja profilakse u trajanju od 8 tjedana, zabilježen je veći udio ispitanika kojima je bilo potrebno liječenje akutnog napada gihta u skupini na febuksostatu 120 mg (36%), u odnosu na skupinu na febuksostatu 80 mg (22%) i alopurinolu 300 mg (21%).
Study 
Pretrage
Based on modelling and simulation analysis of data from a pre-clinical study in rats, when coadministered with febuxostat, the dose of mercaptopurine/azathioprine should be reduced to the 20% or less of the previously prescribed dose in order to avoid possible haematological effects (see section 4.5 and 5.3). 
Na osnovu analize podataka iz modeliranja i simulacije u nekliničkom ispitivanju na štakorima, kad se istodobno primjenjuje s febuksostatom, dozu merkaptopurina/azatioprina potrebno je smanjiti na 20% ili niže od prethodno propisane doze, kako bi se izbjegli mogući hematološki učinci (vidjeti dijelove 4.5 i 5.3).
• urgent need to urinate 
• osjećaj hitnosti mokrenja
See leaflet for further information. 
Za daljnje informacije vidjeti uputu o lijeku.
Febuxostat Mylan 120 mg film-coated tablets 
Febuxostat Mylan 120 mg filmom obložene tablete
SUN 
NED
Fatigue, chest pain, chest discomfort Rare 
Umor, bol u prsištu, osjećaj nelagode u prsištu Rijetko
Modelling and simulation analysis of data from a pre-clinical study in rats, indicates that, in case of concomitant administration with febuxostat, the dose of mercaptopurine/azathioprine should be reduced to the 20% or less of the previously prescribed dose (see section 4.4 and 5.3). 
Analiza podataka iz modeliranja i simulacije u nekliničkom ispitivanju na štakorima ukazuje da je, u slučaju istodobne primjene s febuksostatom, dozu merkaptopurina/azatioprina potrebno smanjiti na 20% ili niže od prethodno propisane doze (vidjeti dijelove 4.4 i 5.3).
Febuxostat Mylan 120 mg film-coated tablets febuxostat 
Febuxostat Mylan 120 mg filmom obložene tablete febuksostat
• nausea 
• mučnina
Over time, gout flares will occur less often and be less painful if you keep taking Febuxostat Mylan every day. 
S vremenom će se, ako nastavite uzimati Febuxostat Mylan svaki dan, napadaji gihta pojavljivati rjeđe i biti manje bolni.
Prevention and treatment of high uric acid levels in patients undergoing cancer chemotherapy Febuxostat Mylan is available as a 120 mg tablet. 
Prevencija i liječenje visokih razina mokraćne kiseline kod bolesnika koji su podvrgnuti kemoterapiji za rak
Contact your doctor immediately if you experience muscle pain, tenderness or weakness 
Ako osjetite bol, osjetljivost ili slabost mišića, odmah se javite svom liječniku
In the post registrational CARES trial (see section 5.1 for detailed characteristics of the study) the rate of MACE events was similar in febuxostat versus allopurinol treated patients (HR 1.03;95% CI 0.87-1.23), but a higher rate of cardiovascular deaths was observed (4.3% vs. 3.2% of patients; HR 1.34; 95% CI 1.03-1.73). 
Major Adverse Cardiovascular Events, MACE) bila je slična u bolesnika liječenih febuksostatom i bolesnika liječenih alopurinolom (HR 1,03; 95% CP 0,87 - 1,23), ali je u bolesnika liječenih febuksostatom primijećena viša stopa kardiovaskularne smrti (4,3% u odnosu na 3,2% bolesnika; HR 1,34; 95% CI 1,03 - 1,73).
Febuxostat Mylan is available as either an 80 mg tablet or a 120 mg tablet. 
Dostupne su tablete lijeka Febuxostat Mylan od 80 mg i 120 mg.
Febuxostat Mylan 80 mg film-coated tablets febuxostat 
Febuxostat Mylan 80 mg filmom obložene tablete febuksostat
Reporting of side effects 
Opis pojedinih nuspojava
100 mg QD 
100 mg jednom dnevno
Lactose 
Dojenje
Tablet coating 
Tabelarni prikaz nuspojava
Febuxostat Mylan 80 mg film-coated tablets 
Febuxostat Mylan 80 mg filmom obložene tablete
Uncommon Dyspnoea, bronchitis, upper respiratory tract infection, cough 
Dispneja, bronhitis, infekcija gornjega dišnog sustava, kašalj Poremećaji probavnog sustava Često Proljev**, mučnina
Authorisation Holder. 
Način primjene Peroralna primjena.
Liver function abnormalities** Uncommon 
Abnormalni nalazi testova jetrenih funkcija** Manje često
Febuxostat Mylan 80 mg 
Mylan 80 mg
• reddening of the skin (erythema), rash in various types (e.g. itchy, with white spots, with blisters, with blisters containing pus, with shedding of the skin, measles-like rash), 
• crvenilo kože (eritem), razne vrste osipa (npr. sa svrbežom, bijelim mrljama, mjehurima,
It is not known if febuxostat may harm your unborn child. Febuxostat Mylan should not be used during pregnancy. 
Febuxostat Mylan se ne smije uzimati tijekom trudnoće.
The recommended dose in patients with mild hepatic impairment is 80 mg. Limited information is available in patients with moderate hepatic impairment. 
Preporučeno doziranje kod bolesnika s blagim oštećenjem funkcije jetre je 80 mg.
Thereafter, the frequency of gout flare decreases in a time-dependent manner. 
Nakon toga se učestalost napada gihta smanjuje tijekom vremena.
Description of selected adverse reactions 
Opći poremećaji i reakcije na
Invented name 
Zaštićeno ime