natgillin/translations-raw huggingface dataset:
Potent inhibitors of cytochrome P450 3A4 increase the risk of myopathy and rhabdomyolysis by increasing the concentration of HMG-CoA reductase inhibitory activity in plasma during simvastatin therapy. 
Potentni inhibitori citokroma P450 3A4 povećavaju rizik od miopatije i rabdomiolize povećavajući koncentraciju inhibitorne aktivnosti HMG-CoA reduktaze u plazmi tijekom terapije simvastatinom.
Additional information on the individual active substances of the fixed dose combination Additional adverse reactions associated with the use of medicinal products containing simvastatin or fenofibrate observed in clinical trials and postmarketing experience that may potentially occur with Cholib are listed below. 
Dodatne informacije o pojedinačnim djelatnim tvarima u fiksnoj kombinaciji doze Dodatne nuspojave povezane uz primjenu lijekova koji sadrže simvastatin ili fenofibrat opažene u kliničkim ispitivanjima i nakon stavljanja lijeka u promet koje bi se mogle pojaviti s Cholibom navedene su u nastavku.
Your doctor may do a blood test to check your muscles before and after starting treatment. 
Liječnik Vas može uputiti na pretragu krvi radi provjere Vaših mišića prije početka liječenja.
Tendinopathy Immune-mediated necrotizing myopathy (see section 4.4) 
Tendinopatija Imunološki posredovana nekrotizirajuća miopatija (vidjeti dio 4.4)
In one study the AUC of the simvastatin acid (SVA), a major active metabolite of simvastatin, was reduced by 42% (90% CI 24%-56%) when a single dose of 40 mg simvastatin was combined with repeated administration of fenofibrate 160 mg. 
U jednom ispitivanju AUC simvastatinske kiseline (SVA), glavnog aktivnog metabolita simvastatina, bio je smanjen za 42% (90% CI 24%-56%) kada je jednokratna doza od 40 mg simvastatina kombinirana s ponovljenom primjenom 160 mg fenofibrata.
Blood homocysteine level increased (see section 4.4)***** 
Povišenje razine homocisteina u krvi (vidjeti dio 4.4)*****
Intake of grapefruit juice during treatment with Cholib should therefore be avoided. 
Zato je potrebno izbjegavati unos soka od grejpa tijekom liječenja Cholibom.
This medicine contains less than 1 mmol sodium (23 mg) per one tablet, that is to say essentially ‘sodium-free'. 
Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po tableti, tj. zanemarive količine natrija.
Elevations in serum creatinine were generally stable over time with no evidence for continued increases in serum creatinine with long term therapy and tended to return to baseline following discontinuation of treatment. 
Općenito su povišenja serumskog kreatinina bila stabilna tijekom vremena i nije bilo dokaza o njegovim daljnjim povišenjima kod dugotrajne terapije, a vrijednosti su se vratile na početne nakon prekida liječenja.
The risk of myopathy and rhabdomyolysis is significantly increased by concomitant use of simvastatin with potent inhibitors of (CYP) 3A4 (see section 4.5). 
Rizik od miopatije i rabdomiolize značajno se povećava istodobnom primjenom simvastatina s potentnim inhibitorima (CYP) 3A4 (vidjeti dio 4.5).
0.3% of patients receiving co-administration had clinically relevant increases in creatinine to values >200 µmol/l. 
0,3% bolesnika koji su istodobno primali navedene lijekove imalo je klinički značajna povišenja kreatinina do vrijednosti >200 µmol/l.
• ciclosporin (a medicine often used in organ transplant patients) 
• ciklosporin (lijek koji često uzimaju bolesnici s presađenim organom)
Secondary causes of hyperlipidaemia, such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, pharmacological treatment (like oral oestrogens), alcoholism should be adequately treated, before Cholib therapy is considered and patients should be placed on a standard cholesterol and triglycerides-lowering diet which should be continued during treatment. 
Sekundarni uzroci hiperlipidemije, kao što je nekontrolirana šećerna bolest tipa 2, hipotireoza, nefrotski sindrom, disproteinemija, opstruktivna bolest jetre, farmakološko liječenje (poput peroralnih estrogena) i alkoholizam moraju se odgovarajuće liječiti prije razmatranja terapije Cholibom, a bolesnici se moraju staviti na standardnu dijetu za snižavanje kolesterola i triglicerida koju trebaju nastaviti tijekom liječenja.
After oral administration, fenofibrate is rapidly hydrolyzed by esterases to the active metabolite fenofibric acid. 
Nakon peroralne primjene fenofibrat se brzo hidrolizira uz pomoć esteraza u aktivni metabolit fenofibričnu kiselinu.
In the other study [Bergman et al, 2004] repeated co-administration of both simvastatin 80 mg and fenofibrate 160 mg led to a reduction in the AUC of the SVA of 36% (90% CI 30%-42%). 
U drugom ispitivanju [Bergman et al, 2004] ponovljena istodobna primjena 80 mg simvastatina i 160 mg fenofibrata dovela je do smanjenja AUC-a SVA-a za 36% (90% CI 30%-42%).
Simvastatin is a substrate of CYP 3A4 and of the efflux transporter BCRP. 
Simvastatin je supstrat CYP 3A4 i efluksnog transportera BCRP-a.
The use of micronised fenofibrate and NanoCrystal® technology for the formulation of the fenofibrate 145 mg tablet enhances its absorption. 
Uporaba mikroniziranog fenofibrata i tehnologije NanoCrystal za formulaciju tablete fenofibrata 145 mg poboljšava njezinu apsorpciju.
Reduced function of hepatic OATP transport proteins can increase the systemic exposure of simvastatin and increase the risk of myopathy and rhabdomyolysis. 
Smanjena funkcija jetrenih transportnih proteina OATP (polipeptidni transporter anorganskih aniona) može povećati sistemsku izloženost simvastatinu i povećati rizik od miopatije i rabdomiolize.
• amiodarone (a medicine for an irregular heartbeat) or verapamil (a medicine for high blood pressure, chest pain associated with heart disease, or other heart conditions) 
• amiodaron (lijek za nepravilne otkucaje srca) ili verapamil (lijek za povišeni krvni tlak, boli u prsima povezana s bolešću srca ili s drugim srčanim tegobama)
You may need to stop taking Cholib for a short time. 
Možda ćete trebati nakratko prestati uzimati
During four double blind clinical trials of 24-week duration 1,237 patients have received treatment with co-administered fenofibrate and simvastatin. 
Tijekom četiri dvostruko slijepa klinička ispitivanja u trajanju od 24 tjedna, 1237 bolesnika istodobno je liječeno fenofibratom i simvastatinom.
• If you have liver or gallbladder problems 
• Ako imate problema s jetrom ili žučnim mjehurom
Veno-thromboembolic events 
Venski tromboembolijski događaji
Cholib is not expected to affect you being able to drive or use tools or machines. 
Ne očekuje se da će Cholib utjecati na Vašu sposobnost upravljanja vozilima ili rada na strojevima.
Maternal treatment with simvastatin may reduce the foetal levels of mevalonate which is a precursor of cholesterol biosynthesis. 
Liječenje majke simvastatinom može smanjiti fetalne razine mevalonata, koji je prekursor biosinteze kolesterola.
In a pooled analysis of these four trials, the rate of discontinuation due to treatment emergent adverse reactions was 5.0% (51 subjects on 1012) after 12 weeks of treatment with fenofibrate and simvastatin 145 mg/20 mg per day and 1.8% (4 subjects on 225) after 12 weeks of treatment with fenofibrate and simvastatin 145 mg/40 mg per day. 
U objedinjenoj analizi iz ta četiri ispitivanja, stopa prekida liječenja zbog liječenja nuspojava bila je 5,0% (51 ispitanika na 1012) nakon 12 tjedana liječenja fenofibratom i simvastatinom 145 mg/20 mg dnevno i 1,8% (4 ispitanika na 225) nakon 12 tjedana liječenja fenofibratom i simvastatinom 145 mg/40 mg dnevno.
Cholib is indicated as adjunctive therapy to diet and exercise in high cardiovascular risk adult patients with mixed dyslipidaemia to reduce triglycerides and increase HDL-C levels when LDL-C levels are adequately controlled with the corresponding dose of simvastatin monotherapy. 
Cholib je indiciran kao dodatna terapija dijeti i tjelovježbi u odraslih bolesnika s visokim kardiovaskularnim rizikom s miješanom dislipidemijom radi smanjivanja razina triglicerida i povećavanja razina HDL-C-a kada su razine LDL-C-a odgovarajuće kontrolirane s odgovarajućom dozom monoterapije simvastatinom.
A food-effect study involving administration of this formulation of fenofibrate 145 mg tablets to healthy male and female subjects under fasting conditions and with a high fat meal indicated that exposure (AUC and Cmax) to fenofibric acid is not affected by food. 
Ispitivanje učinka hrane primjenom te formulacije tableta fenofibrata od 145 mg kod zdravih muških i ženskih ispitanika natašte i nakon uzimanja visokomasnog obroka, pokazalo je da hrana ne utječe na izloženost (AUC i Cmax) fenofibričnoj kiselini.
You should continue a low-fat diet or other measures (e.g. exercise, weight reduction) whilst taking Cholib. 
Morate nastaviti s dijetom s niskim sadržajem masnoća ili poduzeti druge mjere (npr. tjelovježba, smanjenje težine) dok uzimate Cholib.
Severe cutaneous reactions (e.g erythema multiforme, Ste vens-Johnson syndrome, toxic epidermal necrolysis, etc.) 
Teške kožne reakcije (npr. multiformni eritem, Stevens-Johnsonov sindrom, toksična epidermalna nekroliza i sl.)
The Action to Control Cardiovascular Risk in Diabetes (ACCORD) lipid trial was a randomized placebo-controlled study of 5,518 patients with type 2 diabetes mellitus treated with fenofibrate in addition to simvastatin. 
Kliničko ispitivanje lipida "Action to Control Cardiovascular Risk in Diabetes" (ACCORD) bilo je randomizirano, placebom kontrolirano ispitivanje na 5518 bolesnika sa šećernom bolešću tipa 2 liječenih fenofibratom kao dodatak simvastatinu.
Adverse reactions (simvastatin) 
Nuspojave (simvastatin)
HIV protease inhibitors (e.g. nelfinavir) Nefazodone 
Inhibitori proteaze HIV-a (npr. nelfinavir) Nefazodon
Of these, 2,474 subjects were randomized for 24 weeks treatment, 1,237 subjects received fenofibrate and simvastatin co-administration and 1,230 subjects received statin monotherapy all administered in the evening. 
Od njih, 2474 ispitanika randomizirano je za 24-tjedno liječenje, 1237 ispitanika istodobno je primalo fenofibrat i simvastatin, a 1230 ispitanika primalo je monoterapiju statinom, sve primjenjivano navečer.
Cases of myopathy/rhabdomyolysis have been associated with concomitant administration of statins and niacin (nicotinic acid) at lipid-modifying doses (≥ 1 g/day), knowing that niacin and statins can cause myopathy when given alone. 
Slučajevi miopatije/rabdomiolize povezani su s istodobnom primjenom statina i niacina (nikotinske kiseline) pri hipolipemičnim dozama (≥1 g/dan), a poznato je da niacin i statini mogu uzrokovati miopatiju kada se primjenjuju pojedinačno.
As a result of these changes the ratios of TC to HDL-C and LDL-C to HDL-C are reduced. 
Rezultat tih promjena su sniženi omjeri UK-a prema HDL-C-u i LDL-a prema HDL-C-u.
Danazol Ciclosporin 
Danazol Ciklosporin
The most commonly reported adverse drug reactions (ADRs) during Cholib therapy are increased blood creatinine, upper respiratory tract infection, increased platelet count, gastroenteritis and increased alanine- aminotransferase. 
Najčešće prijavljivane nuspojave tijekom liječenja Cholibom bile su povišenje kreatinina u krvi, infekcija gornjeg respiratornog trakta, povećanje broja trombocita, gastroenteritis i povišenje alanin- aminotransferaze.
• danazol (a man-made hormone used to treat endometriosis) 
• danazol (sintetski hormon koji se koristi za liječenje endometrioze)
In a three-month oral nonclinical study in the rat species with fenofibric acid, the active metabolite of fenofibrate, toxicity for the skeletal muscles (particularly those rich in type I -slow oxidative- myofibres) and cardiac degeneration, anemia and decreased body weight were seen at exposure levels ≥50- fold the human exposure for the skeletal toxicity and >15 fold for the cardiomyotoxicity. 
U tromjesečnom peroralnom nekliničkom ispitivanju u štakora provedenom s fenofibričnom kiselinom, aktivnim metabolitom fenofibrata, zapažene su toksičnost skeletne muskulature (naročito one bogate nisko-oksidativnim mišićnim vlaknima tipa I) i degeneracija srca, anemija i smanjena tjelesna težina pri razinama izlaganja ≥50 puta ljudske izloženosti za skeletnu toksičnost i >15 puta za kardiomiotoksičnost.
Patients carrying the SLCO1B1 gene allele (c.521T>C) coding for a less active OATP1B1 protein have an increased systemic exposure of simvastatin and increased risk of myopathy. 
Bolesnici koji su nositelji alela (c.521T>C) gena SLCO1B1, koji kodira manje aktivni protein OATP1B1, imaju povećanu sistemsku izloženost simvastatinu i povećani rizik od miopatije.
Other statins and fibrates 
Drugi statini i fibrati
Monitor HDL-C and stop either therapy (glitazone or Cholib) if HDL-C is too low 
Pratite HDL-C i prekinite jednu od terapija (glitazon ili Cholib) ako je HDL-C prenizak
• elevations in blood tests of liver function (transaminases) 
• povišene vrijednosti jetrene funkcije u pretragama krvi (transaminaze)
Skeletal muscle toxicity, including rare cases of rhabdomyolysis with or without renal failure, has been reported with administration of lipid-lowering substances like fibrates and statins. 
Prijavljena je toksičnost skeletne muskulature, uključujući rijetke slučajeve rabdomiolize sa ili bez zatajenja bubrega pri primjeni lijekova za snižavanje lipida poput fibrata i statina.
Gastrointestinal disorders Gastrointestinal signs and symptoms (abdominal pain, nausea, vomiting, diarrhoea, flatulence) 
Gastrointestinalni znakovi i simptomi (bol u abdomenu, mučnina, povraćanje, proljev, vjetrovi)
Cholib has not been studied in patients with hepatic impairment and is therefore contraindicated in this population (see section 4.3). 
Cholib nije ispitivan u bolesnika s oštećenjem jetre i stoga je kontraindiciran u toj populaciji (vidjeti dio 4.3).
Adverse reactions (fenofibrate) 
Nuspojave (fenofibrat)
The adverse reactions of Cholib are in line with what is known from its two active substances: fenofibrate and simvastatin. 
Nuspojave Choliba u skladu su sa saznanjima o njegovim dvjema djelatnim tvarima: fenofibratu i simvastatinu.
• Concomitant administration of fibrates, statins, danazol, ciclosporin or potent cytochrome 
• Istodobna primjena fibrata, statina, danazola, ciklosporina ili potentnih inhibitora citokroma
Concomitant administration of amlodipine and simvastatin caused a 1.6-fold increase in exposure of simvastatin acid. 
Istodobna primjena amlodipina i simvastatina uzrokovala je povećanje izloženosti simvastatinskoj kiselini od 1,6 puta.
Embryotoxic effects were observed at doses in the range of maternal toxicity. 
Uočeni su toksični učinci pri rasponu doza koje izazivaju materinsku toksičnost.
• If you have a history of muscle problems during treatment to lower the level of fats in the blood with either of the active substances in this medicine, or with other statins (such as atorvastatin, pravastatin or rosuvastatin) or fibrates (such as bezafibrate or gemfibrozil) 
• Ako ste imali probleme s mišićima tijekom liječenja za smanjivanje razine masnoća u krvi bilo kojom djelatnom tvari u ovom lijeku, ili s drugim statinima (kao što su atorvastatin, pravastatin ili rosuvastatin) ili fibratima (kao što su bezafibrat ili gemfibrozil)
Myopathy ** In a clinical trial, myopathy occurred commonly in patients treated with simvastatin 80 mg/day compared to patients treated with 20 mg/day (1.0% vs 0.02%, respectively). 
Miopatija ** U kliničkim ispitivanju, miopatija se obično pojavljivala u bolesnika liječenih simvastatinom 80 mg/dan u usporedbi s bolesnicima liječenima s 20 mg/dan (1,0%, naspram 0,02%).
Effects of repeated administration of fenofibrate on the pharmacokinetics of single or multiple doses of simvastatin have been investigated in two small studies (n=12) followed by a larger one (n= 85) in healthy subjects. 
Učinci ponovljene primjene fenofibrata na farmakokinetiku jednokratnih ili višestrukih doza simvastatina istraženi su u dva mala ispitivanja (n=12) kojima je uslijedilo jedno veće ispitivanje (n=85) na zdravim ispitanicima.
The amount recovered in the faeces represents absorbed medicinal product equivalents excreted in bile as well as unabsorbed medicinal product. 
Količina nađena u stolici predstavlja apsorbirani lijek izlučen putem žuči, kao i neapsorbirani lijek.
Effects of repeated administration of fenofibrate on the pharmacokinetics of single or multiple doses of simvastatin have been investigated in two small studies (n=12) followed by a larger one (n=85) in healthy subjects. 
Učinci ponovljene primjene fenofibrata na farmakokinetiku jednokratnih ili višestrukih doza simvastatina istraženi su u dvjema malim ispitivanjima (n=12) nakon kojih je uslijedilo jedno veće ispitivanje (n=85) na zdravim ispitanicima.
Therefore, caution should be exercised in patients with history of pulmonary embolism. 
Stoga je nužan oprez u bolesnika koji imaju plućnu emboliju u anamnezi.
Physicians contemplating combined therapy with Cholib and lipid-modifying doses (≥ 1 g/day) of niacin (nicotinic acid) or medicinal products containing niacin should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs and symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and when the dose of either medicinal product is increased. 
Liječnici koji razmatraju kombiniranu terapiju Cholibom i hipolipemičnim dozama (≥1 g/dan) niacina (nikotinske kiseline) ili lijekovima koji sadrže niacin trebaju pažljivo odvagnuti moguće koristi i rizike te pažljivo pratiti bolesnike na bilo koje znakove i simptome boli, osjetljivosti ili slabosti mišića, naročito tijekom početnih mjeseci terapije i kada se povećava doza bilo kojeg lijeka.
The protein binding of simvastatin and its active metabolite is > 95%. 
>95% simvastatina i njegovih aktivnih metabolita veže se za proteine plazme.
Simvastatin is a substrate of cytochrome P450 3A4. 
Simvastatin je supstrat citokroma P450 3A4.
Study 0502 was evaluated a constant dose of fenofibrate-simvastatin combination and statin comparator throughout the 24 week double-blind period. 
U ispitivanju 0502 procijenjena je konstantna doza kombinacije fenofibrat-simvastatin uz statin kao komparator tijekom 24-tjednog dvostruko-slijepog razdoblja.
Co- administration of elbasvir and grazoprevir with simvastatin has not been studied; however, the dose of simvastatin should not exceed 20 mg daily in patients receiving concomitant medication with products containing elbasvir or grazoprevir (see section 4.5). 
Istodobna primjena elbasvira i grazoprevira sa simvastatinom nije ispitivana, no ipak doza simvastatina ne bi smjela prelaziti 20 mg dnevno u bolesnika koji istodobno primaju lijekove koji sadrže elbasvir ili grazoprevir (vidjeti dio 4.5).
• Hypersensitivity reaction to Cholib with symptoms like: pain or inflammation of the joints, inflammation of blood vessels, unusual bruising, skin eruptions and swelling, hives, skin sensitivity to the sun, fever, flushing, shortness of breath and feeling unwell, lupus-like disease picture (including rash, joint disorders, and effects on white blood cells) 
• reakcija preosjetljivosti na Cholib sa simptomima kao što su: bol ili upala zglobova, upala krvnih žila, neuobičajen nastanak modrica, izbijanje kožnih promjena i oticanje, koprivnjača, osjetljivost kože na sunce, vrućica, crvenilo uz osjećaj vrućine, nedostatak zraka i loše osjećanje, slika bolesti nalik lupusu (uključujući osip, poremećaje zglobova i učinke na bijele krvne stanice)
Studies with fenofibrate on lipoprotein fractions show decreases in levels of LDL and VLDL cholesterol (VLDL-C). 
Ispitivanja s fenofibratom na frakcijama lipoproteina pokazala su sniženja u razinama LDL-C-a i VLDL-C-a.
Mylan IRE Healthcare Ltd, Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13Ireland. 
Mylan IRE Healthcare Ltd, Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13 - Irska.
How to take Cholib 
Kako uzimati Cholib
Haemoglobin decreased White blood cell count decreased rare 
Sniženi hemoglobin Smanjeni broj bijelih krvnih stanica rijetko
Memory impairment/ Memory loss rare 
Poremećaj pamćenja/Gubitak pamćenja rijetko
Increases in transaminase levels have been reported in some patients treated with simvastatin or fenofibrate. 
Prijavljena su povišenja razina transaminaza u nekih bolesnika liječenih simvastatinom ili fenofibratom.
The risk of myopathy is increased by high levels of HMG CoA reductase inhibitory activity in plasma (i.e., elevated simvastatin and simvastatin acid plasma levels), which may be due, in part, to interacting drugs that interfere with simvastatin metabolism and/or transporter pathways (see section 
Rizik od miopatije raste s povećanjem inhibitorne aktivnosti HMG Co-A reduktaze u plazmi (npr. povišene razine simvastatina i simvastatinske kiseline u plazmi), što može biti djelomično uzrokovano interakcijom s lijekovima koji ometaju metabolizam simvastatina i/ili putove transportnih proteina (vidjeti dio 4.5).
Whether fenofibrate had an effect on other active metabolites of simvastatin was not investigated. 
Nije istraživano ima li fenofibrat učinak na druge aktivne metabolite simvastatina.
This enzyme catalyses the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in the biosynthesis of cholesterol. 
Taj enzim katalizira pretvorbu HMG-CoA u mevalonat, što je rani i ograničavajući korak u biosintezi kolesterola.
• Concomitant administration of glecaprevir/ pibrentasvir (see section 4.5) 
• Istodobna primjena glekaprevira/pibrentasvira (vidjeti dio 4.5)
Therefore it is recommended to monitor HDL-C if Cholib is co-administered with a glitazone and stopping either therapy if HDL-C is too low. 
Stoga se preporučuje praćenje HDL-C-a ako se Cholib istodobno primjenjuje s glitazonom i prekid jedne od terapija ako je HDL-C prenizak.
• severe allergic skin rash with blisters 
• teški alergijski kožni osip s mjehurićima
very common 
vrlo često
Drugs or herbal products that inhibit certain enzymes (e.g. CYP3A4) and/or transporter (e.g. OATP1B) pathways may increase simvastatin and simvastatin acid plasma concentrations and may lead to an increased risk of myopathy/rhabdomyolysis. 
Lijekovi ili biljni pripravci koji inhibiraju određene enzime (npr. CYP3A4) i/ili putove transportnih proteina (npr. OATP1B) mogu povećati koncentracije simvastatina i simvastatinske kiseline u plazmi i dovesti do povećanog rizika od miopatije/rabdomiolize.
• pioglitazone (a particular class of medicines to treat diabetes) 
• pioglitazon (posebna skupina lijekova za liječenje šećerne bolesti)
Patients at risk (fasting glucose 5.6 to 6.9 mmol/L, BMI>30 kg/m2, raised triglycerides, hypertension) should be monitored both clinically and biochemically according to national guidelines. 
Rizični bolesnici (glukoza natašte 5,6 do 6,9 mmol/l, BMI >30 kg/m2, povišeni trigliceridi, hipertenzija) moraju biti praćeni klinički i biokemijski prema nacionalnim smjernicama.
LDL is formed from very-low-density protein (VLDL) and is catabolised predominantly by the high affinity LDL receptor. 
LDL nastaje iz lipoproteina vrlo niske gustoće (VLDL) i razgrađuje se ponajprije putem LDL receptora s visokim afinitetom za LDL.
Plasma concentrations are stable during continuous treatment in any given individual. 
Pri kontinuiranom liječenju, u svakom su pojedincu koncentracije u plazmi stabilne.
• yellowing of the skin and whites of the eyes (jaundice), or an increase in liver enzymes - these may be signs of an inflamed liver (hepatitis and hepatic failure). 
• žutilo kože i bjeloočnica (žutica), ili povišenje jetrenih enzima - to mogu biti znakovi upaljene jetre (hepatitis i zatajenje jetre)
Concomitant administration of products that are inhibitors of BCRP (e.g., elbasvir and grazoprevir) may lead to increased plasma concentrations of simvastatin and an increased risk of myopathy; therefore, a dose adjustment of simvastatin should be considered depending on the prescribed dose. 
Istodobna primjena lijekova koji su inhibitori BCRP-a (npr. elbasvir i grazoprevir) može dovesti do povećane koncentracije simvastina u plazmi i povećanog rizika od miopatije, stoga treba razmotriti prilagodbu doze simvastina ovisno o propisanoj dozi.