natgillin/translations-raw huggingface dataset:
Simvastatin is a substrate of the Breast Cancer Resistant Protein (BCRP) efflux transporter. 
Breast Cancer Resistant Protein, BCRP) koji je efluksni transportni protein.
EU/1/13/866/001 10 film-coated tablets EU/1/13/866/002 30 film-coated tablets EU/1/13/866/005 90 film coated tablets 
EU/1/13/866/001 10 filmom obloženih tableta EU/1/13/866/002 30 filmom obloženih tableta EU/1/13/866/005 90 filmom obloženih tableta
No hepatic microsomal metabolism is involved. 
Nije uključen u metabolizam u jetrenim mikrosomima.
There have been reports of rhabdomyolysis (including some fatalities) in patients receiving this combination. 
U bolesnika koji su primali tu kombinaciju bilo je prijava rabdomiolize (uključujući nekoliko smrtnih ishoda).
Simvastatin is an inactive lactone which is readily hydrolyzed in vivo to the corresponding beta-hydroxyacid, a potent inhibitor of HMG-CoA reductase. 
Simvastatin je inaktivni lakton koji se in vivo brzo hidrolizira u odgovarajuću beta-hidroksi kiselinu, potentan inhibitor HMG-CoA reduktaze.
Thromboembolism * In the FIELD study, a statistically significant increase was reported in the incidence of pulmonary embolism (0.7% [32/4900 patients] in the placebo group versus 1.1% [53/4895 patients] in the fenofibrate group; p = 0.022) and a statistically non-significant increase in deep vein thromboses (placebo: 1.0% [48/4900 patients] versus fenofibrate 1.4% [67/4895 patients]; p=0.074). 
Tromboembolija * U ispitivanju FIELD, prijavljeno je statistički značajno povećanje incidencije plućne embolije (0,7% [32/4900 bolesnika] u placebo skupini, naspram1,1% [53/4895 bolesnika] u fenofibrat skupini; p= 0,022) i statistički neznačajno povećanje duboke venske tromboze (placebo: 1,0% [48/4900 bolesnika] naspram fenofibrata 1,4% [67/4895 bolesnika]; p=0,074).
The geomean maximum plasma level (Cmax) of the inactive parent simvastatin was 2.7 ng/mL for the fixed dose combination Cholib 145 mg/20 mg tablet and 3.9 ng/mL for the co-administration of the separate 145 mg fenofibrate and 20 mg simvastatin tablets as used in the clinical program. 
Geometrijska sredina maksimalne razine u plazmi (Cmax) inaktivnog ishodišnog simvastatina bila je 2,7 ng/ml za tabletu fiksne kombinacije doze Choliba 145 mg/20 mg i 3,9 ng/ml za istodobnu primjenu odvojenih tableta 145 mg fenofibrata i 20 mg simvastatina kao što je korišteno u kliničkom programu.
EU/1/13/866/003 10 film-coated tablets EU/1/13/866/004 30 film-coated tablets EU/1/13/866/006 90 film coated tablets 
EU/1/13/866/003 10 filmom obloženih tableta EU/1/13/866/004 30 filmom obloženih tableta EU/1/13/866/006 90 filmom obloženih tableta
*Treatment Comparison consists of the difference between the LS-means for Feno 145 + Simva 40 an d Simva 40, as well as the corresponding 95% CI. 
* Usporedba liječenja sastoji se od razlike između srednjih vrijednosti najmanjih kvadrata (LS) za feno 145 + simva 40 i simva 40, kao i odgovarajući 95%-tni CI.
Therefore, Cholib is contraindicated during breast-feeding (see section 4.3). 
Stoga je Cholib kontraindiciran tijekom dojenja (vidjeti dio 4.3).
Feno 145+Simva 20 (N=493) 
Parametar feno 145+simva 20 (n=493) srednja vrijednost (SD)
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir 
• inhibitore proteaze HIV-a kao što su indinavir, nelfinavir, ritonavir i sakvinavir (lijekovi koji se koriste kod HIV-infekcija i AIDS-a)
Contraindicated with Cholib 145 mg/40 mg 
Kontraindicirano s Cholibom 145 mg/40 mg
Butylhydroxyanisole (E320), lactose monohydrate, sodium laurilsulfate, starch, pregelatinised (maize), docusate sodium, sucrose, citric acid monohydrate (E330), hypromellose (E464), crospovidone (E1202), magnesium stearate (E572), silicified microcrystalline cellulose (comprised of cellulose, microcrystalline and silica, colloidal anhydrous), ascorbic acid (E300). 
Butilhidroksianizol (E320), laktoza hidrat, natrijev laurilsulfat, prethodno geliran kukuruzni škrob, natrijev dokuzat, saharoza, citratna kiselina hidrat (E330), hipromeloza (E464), krospovidon (E1202), magnezijev stearat (E572), silicirana mikrokristalična celuloza (sastoji se od mikrokristalične celuloze i koloidnog, bezvodnog silicijevog dioksida), askorbatna kiselina (E300).
• you have an underactive thyroid gland (hypothyroidism) 
• ako imate smanjenu aktivnost štitnjače (hipotireoza)
• you are taking hepatitis C antiviral agents such as elbasvir or grazoprevir (used to treat hepatitis 
• ako uzimate antivirusne lijekove za hepatitis C kao što su elbasvir ili grazoprevir (koji se upotrebljavaju za liječenje infekcije virusom hepatitisa C)
Non-HDL-C (mmol/L) 
Ne-HDL-C (mmol/l)
• increase in blood platelets count 
• povećanje broja trombocita u krvi
The mechanism of the LDL lowering effect of simvastatin may involve both reduction of VLDL-C concentration and induction of the LDL receptor, leading to reduced production and increased catabolism of LDL-C. Apolipoprotein B also falls substantially during treatment with simvastatin. 
Mehanizam kojim simvastatin snižava LDL može uključivati i snižavanje koncentracije VLDL kolesterola (VLDL-C) i indukciju LDL receptora, što dovodi do smanjenog stvaranja i pojačane razgradnje LDL-C-a.
• If you are already taking the following medicines: o danazol (a man-made hormone used to treat endometriosis) o ciclosporin (a medicine often used in organ transplant patients) o itraconazole, ketoconazole, fluconazole or posaconazole (medicines for fungal infections) o HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (medicines used for HIV infection and AIDS) o glecaprevir or pibrentasvir (used to treat hepatitis C virus infection) o erythromycin, clarithromycin, or telithromycin (medicines for bacterial infections) o nefazodone (a medicine for depression) 
• Ako već uzimate sljedeće lijekove:  danazol (sintetski hormon za liječenje endometrioze)  ciklosporin (lijek koji često uzimaju bolesnici s presađenim organom)  itrakonazol, ketokonazol, flukonazol ili posakonazol (lijekovi za gljivične infekcije)  inhibitore proteaze HIV-a kao što su indinavir, nelfinavir, ritonavir i sakvinavir (lijekovi koji se koriste kod HIV-infekcija i AIDS-a)  glekaprevir ili pibrentasvir (koji se upotrebljavaju za liječenje infekcije virusom hepatitisa C)  eritromicin, klaritromicin ili telitromicin (lijekovi za bakterijske infekcije)  nefazodon (lijek za depresiju)
• increase in “alkaline phosphatase” - produced by the bile system - shown in tests 
• povišenje “alkalne fosfataze" - koju stvara žučni sustav - vidljivo u pretragama
Concomitant administration of amiodarone, verapamil, amlodipine or diltiazem (see section 4.5) 4.4 Special warnings and precautions for use 
• Istodobna primjena amiodarona, verapamila, amlodipina ili diltiazema (vidjeti dio 4.5)
Blood creatine phosphokinase level increase rare 
Povišenje kreatin-fosfokinaze u krvi rijetko
Glitazones 
Glitazoni
Rare side effects (may affect up to 1 in 1,000 people): 
Rijetke nuspojave (mogu se javiti kod manje od 1 od 1000 osoba):
In elderly patients, the fenofibric acid apparent total plasma clearance is not modified. 
Prividni klirens fenofibrične kiseline iz plazme u starijih se osoba ne mijenja.
Tel: + 386 (0)123 63 180 
GSP Proizvodi d.o.o. Tel: + 386 (0)123 63 180
Photosensitivity reactions rare 
Fotosenzitivne reakcije rijetko Sindrom preosjetljivosti*** rijetko
The risk of myopathy and rhabdomyolysis is significantly increased by concomitant use of gemfibrozil with simvastatin. 
Rizik od miopatije i rabdomiolize značajno je povećan istodobnom primjenom gemfibrozila sa simvastatinom.
(see section 4.3). 
(vidjeti dio 4.3).
Therefore, the co-administration of Cholib with danazol is contraindicated (see section 4.3). 
Stoga je istodobna primjena Choliba s danazolom kontraindicirana (vidjeti dio 4.3).
Prescribing recommendations 
Preporuke za propisivanje
• increase in “creatine phosphokinase” - produced by the muscle - shown in tests 
• povišenje “kreatin-fosfokinaze" - koju stvaraju mišići - vidljivo u pretragama
Do not exceed one Cholib 145 mg/20 mg per day 
Ne smije se prekoračiti doza od jedne tablete Cholib 145 mg/20 mg dnevno.
Mylan Healthcare Sp. z o.o. 
Mylan Healthcare B.V.
CYP 3A4 inhibitors: fluconazole, verapamil, or diltiazem (see sections 4.3 and 4.4). 
Nužan je oprez kada se Cholib kombinira s određenim drugim manje potentnim inhibitorima CYP 3A4: flukonazol, verapamil, ili diltiazem (vidjeti dijelove 4.3 i 4.4).
Sexual dysfunction uncommon 
Seksualna disfunkcija manje često
Renal function Cholib is contraindicated in moderate to severe renal impairment (see section 4.3). 
Bubrežna funkcija Cholib je kontraindiciran kod umjerenog do teškog oštećenja bubrega (vidjeti dio 4.3).
• you have kidney disease 
• ako imate bolest bubrega
NA 
nd
TG 
K
Some cases of reversible paradoxical reduction of HDL-C have been reported during concomitant administration of fenofibrate and glitazones. 
Tijekom istodobne primjene fenofibrata i glitazona, prijavljeno je nekoliko slučajeva reverzibilnog paradoksalnog smanjenja HDL-C-a.
The primary efficacy criterion was superiority of the combination fenofibrate 145 and simvastatin 40 mg versus simvastatin 40 mg on TG and LDL-C decrease and HDL-C increase at 12 weeks. 
Primarni kriterij djelotvornosti bila je superiornost kombincije fenofibrata 145 i simvastatina 40 mg naspram simvastatina 40 mg u snižavanju TG-a i LDL-C-a te povišenju HDL-C-a u 12. tjednu.
The primary efficacy criterion was superiority of the combination fenofibrate 145 and simvastatin 20 mg versus simvastatin 40 mg on TG decrease and HDL-C increase and non-inferiority for LDL-C decrease at 12 weeks. 
Primarni kriterij djelotvornosti bila je superiornost kombinacije fenofibrata 145 i 20 mg simvastatina naspram 40 mg simvastatina u snižavanju TG-a i povišenju HDL-C-a te neinferiornost u snižavanju LDL-C-a u 12. tjednu.
In patients taking products containing elbasvir or grazoprevir concomitantly with Cholib the dose of simvastatin should not exceed 20 mg/day. 
U bolesnika koji istodobno s lijekom Cholib uzimaju lijekove koji sadrže elbasvir ili grazoprevir doza simvastatina ne bi smjela prelaziti 20 mg dnevno. (Vidjeti dijelove 4.4 i 4.5.)
Effects on the pharmacokinetics of other medicinal products Fenofibrate and simvastatin are not CYP 3A4 inhibitors or inducers. 
Fenofibrat i simvastatin nisu inhibitori ni induktori CYP 3A4.
Cholib is contraindicated in patients with moderate to severe renal insufficiency whose estimated glomerular filtration rate is < 60 mL/min/1.73 m 
Cholib je kontraindiciran u bolesnika s umjerenom do teškom insuficijencijom bubrega čija je procijenjena brzina glomerularne filtracije <60 ml/min/1,73 m
Adverse reactions observed with the co-administration of fenofibrate and simvastatin (Cholib) 
Nuspojave opažene kod istodobne primjene fenofibrata i simvastatina (Cholib) Klasifikacija organskih sustava
In addition, simvastatin moderately increases HDL-C and reduces plasma TG. 
Simvastatin, dodatno, umjereno povisuje razine HDL-C-a te snizuje TG u plazmi.
Cholib should be used with caution in patients with mild renal insufficiency whose estimated glomerular filtration rate is 60 to 89 mL/min/1.73 m 
Cholib se mora koristiti s oprezom u bolesnika s blagom insuficijencijom bubrega čija je procijenjena brzina glomerularne filtracije 60 do 89 ml/min/1,73 m
Musculoskeletal, connective tissue disorders 
Poremećaji mišićno-koštanog sustava i vezivnog tkiva
• If you are already taking the following medicines: o danazol (a man-made hormone used to treat endometriosis) o ciclosporin (a medicine often used in organ transplant patients) o itraconazole, ketoconazole, fluconazole or posaconazole (medicines for fungal infections) o HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (medicines used for HIV infection and AIDS) o erythromycin, clarithromycin, or telithromycin (medicines for bacterial infections) o nefazodone (a medicine for depression) o 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) o hepatitis C antiviral agents such as elbasvir, grazoprevir, glecaprevir or pibrentasvir (used to treat hepatitis C virus infection) 
• Ako već uzimate sljedeće lijekove:  danazol (sintetski hormon za liječenje endometrioze)  ciklosporin (lijek koji često uzimaju bolesnici s presađenim organom)  itrakonazol, ketokonazol, flukonazol ili posakonazol (lijekovi za gljivične infekcije)  inhibitore proteaze HIV-a kao što su indinavir, nelfinavir, ritonavir i sakvinavir (lijekovi koji se koriste kod HIV-infekcija i AIDS-a)  eritromicin, klaritromicin ili telitromicin (lijekovi za bakterijske infekcije)  nefazodon (lijek za depresiju)  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)
Your doctor may also want you to have blood tests to check how well your liver is working after you start taking Cholib. 
Vaš liječnik Vas možda uputi na pretrage krvi radi provjere koliko dobro radi
The dose of simvastatin should not exceed 10 mg daily in patients taking danazol. 
U bolesnika koji uzimaju danazol, doza simvastatina ne smije prijeći 10 mg dnevno.
Fibrinogen* (g/L) Feno 145 + Simva 40 
UK (mmol/l) feno 145 + simva 40 simva 40
Potent CYP 3A4 inhibitors: 
Potentni inhibitori CYP 3A4: Itrakonazol
If treatment with fusidic acid is necessary, Cholib treatment should be discontinued throughout the duration of the fusidic acid treatment. 
Ako je neophodno liječenje fusidatnom kiselinom, liječenje Cholibom mora se prekinuti tijekom trajanja liječenja fusidatnom kiselinom. (također vidjeti dio 4.4).
There have been reports of rhabdomyolysis (including some fatalities) in patients receiving a statin in combination with fusidic acid (see section 4.5). 
U bolesnika koji su primali statin u kombinaciji s fusidatnom kiselinom (vidjeti dio 4.5) prijavljena je rabdomioliza (uključujući nekoliko smrtnih ishoda).
Uncommon side effects (may affect up to 1 in 100 people): 
Manje česte nuspojave (mogu se javiti kod manje od 1 od 100 osoba):
Poly (vinyl alcohol), partially hydrolysed (E1203), titanium dioxide (E171), talc (E553b), lecithin (derived from soya bean (E322)), xanthan gum (E415), iron oxide red (E172). 
Djelomično hidroliziran poli(vinilni alkohol) (E1203), titanijev dioksid (E171), talk (E553b), lecitin (iz soje (E322)), ksantanska guma (E415), crveni željezov oksid (E172).
There have been very rare reports of an immune-mediated necrotizing myopathy (IMNM) during or after treatment with some statins. 
Tijekom ili nakon liječenja nekim statinima vrlo rijetko je prijavljena imunološki posredovana nekrotizirajuća miopatija.
The geometric mean ratios and 90% CIs for the comparison of plasma exposure (AUC and AUC(0-t)) to simvastatin after administration of the fixed dose combination Cholib 145 mg/20 mg tablet and after co-administration of the separate 145 mg fenofibrate and 20 mg simvastatin tablets as used in the clinical program, were within the 80-125% bioequivalence interval. 
Omjeri geometrijske sredine i 90%-tni CI-evi za usporedbu izloženosti u plazmi (AUC i AUC(0-t)) simvastatinu nakon primjene tablete fiksne kombinacije doze Choliba 145 mg/20 mg i nakon istodobne primjene odvojenih tableta fenofibrata 145 mg i simvastatina 20 mg kao što je korišteno u kliničkom programu, bili su unutar bioekvivalentnog intervala od 80-125%.
Simva 40 Simva 40 Fibrinogen* (g/L) Feno 145 + Simva 40 Simva 40 *Treatment Comparison consists of the difference between the LS-means for Feno 145 + Simva 40 an d Simva 40, as well as the corresponding 95% CI. 
simva 40 *Usporedba liječenja sastoji se od razlike između srednjih vrijednosti LS za feno 145 + simva 40 i simva 40, kao i odgovarajući 95%-tni CI.
Interacting substances 
Lijekovi s interakcijama
Mean Percent Change from Baseline to 12 Weeks Full Analysis Subject Sample 
Srednja vrijednost postotka promjene nakon 12 tjedna od početne vrijednosti
The geometric mean ratios and 90% CIs for the comparison of AUC, AUC(0-t) and Cmax for fenofibric acid, simvastatin and simvastatin acid of the fixed dose combination Cholib 145 mg/40 mg tablet and the co-administration of the separate 145 mg fenofibrate and 40 mg simvastatin tablets as used in the clinical program, were all within the 80-125% bioequivalence interval. 
Omjeri geometrijske sredine i 90%-tni CI-evi za usporedbu AUC, AUC(0-t) i Cmax fenofibrične kiseline, simvastatina i simvastatinske kiseline tablete fiksne kombinacije doze Choliba 145 mg/40 mg i istodobne primjene odvojenih tableta fenofibrata 145 mg i simvastatina 40 mg kao što je korišteno u kliničkom programu, bili su svi unutar bioekvivalentnog intervala od 80-125%.
• elbasvir, grazoprevir, glecaprevir or pibrentasvir (used to treat hepatitis C virus infection)erythromycin, clarithromycin, or telithromycin (medicines for bacterial infections) 
• elbasvir, grazoprevir, glekaprevir ili pibrentasvir (koji se upotrebljavaju za liječenje infekcije virusom hepatitisa C)
• colchicine (a medicine used to treat gout). 
• kolhicin (lijek za liječenje gihta).
Poly (vinyl alcohol), partially hydrolysed (E1203), titanium dioxide (E171), talc (E553b), lecithin (derived from soya bean (E322)), xanthan gum (E415), iron oxide red (E172), iron oxide yellow (E172), sunset yellow FCF (E110). 
Djelomično hidroliziran poli(vinilni alkohol) (E1203), titanijev dioksid (E171), talk (E553b), lecitin (iz soje (E322)), ksantanska guma (E415), crveni željezov oksid (E172), žuti željezov oksid (E172), bojilo sunset yellow FCF (E110).
The geometric mean ratios and 90% CIs for the comparison of AUC, AUC(0-t) and Cmax of the active metabolites, fenofibric acid and simvastatin acid, of the fixed dose combination Cholib 145 mg/20 mg tablet and the co-administration of the separate 145 mg fenofibrate and 20 mg simvastatin tablets as used in the clinical program, were all within the 80-125% bioequivalence interval. 
Omjeri geometrijske sredine i 90%-tni CI-evi za usporedbu AUC, AUC(0-t) i Cmax aktivnih metabolita, fenofibrične kiseline i simvastatinske kiseline, tablete fiksne kombinacije doze Choliba 145 mg/20 mg i nakon istodobne primjene odvojenih tableta fenofibrata 145 mg i simvastatina 20 mg kao što je korišteno u kliničkom programu, bili su svi unutar bioekvivalentnog intervala od 80-125%.
The risk of myopathy and rhabdomyolysis is increased by concomitant administration of danazol with simvastatin. 
Rizik od miopatije i rabdomiolize povećan je kada se istodobno primjenjuje danazol sa simvastatinom.
Nervous system disorders Headache uncommon 
Poremećaji živčanog sustava
N Means (SD) Treatment Comparison* 
Usporedba liječenja* P-vrijednost
Dizziness has been reported rarely in post-marketing experience with simvastatin. 
Nakon stavljanja lijeka u promet, rijetko je prijavljena omagalica.
TG (mmol/L) 
UK (mmol/l)
Common side effects (may affect up to 1 in 10 people): 
Česte nuspojave (mogu se javiti kod manje od 1 od 10 osoba):
• Concomitant administration of glecaprevir, pibrentasvir, elbasvir or grazoprevir (see section 
• Istodobna primjena glekaprevira, pibrentasvira, elbasvira ili grazoprevira (vidjeti dio 4.5)
One film-coated tablet contains 145 mg of fenofibrate and 20 mg of simvastatin. 
Jedna filmom obložena tableta sadrži 145 mg fenofibrata i 20 mg simvastatina.
The risk of myopathy/rhabdomyolysis is increased by concomitant administration of ciclosporin with simvastatin. 
Rizik od miopatije/rabdomiolize povećan je istodobnom primjenom ciklosporina sa simvastatinom.
One film-coated tablet contains 145 mg of fenofibrate and 40 mg of simvastatin. 
Jedna filmom obložena tableta sadrži 145 mg fenofibrata i 40 mg simvastatina.
Cholib 145 mg/40 mg tablets fenofibrate/simvastatin 
Cholib 145 mg/40 mg tablete fenofibrat/simvastatin
Cholib 145 mg/20 mg tablets fenofibrate/simvastatin 
Cholib 145 mg/20 mg tablete fenofibrat/simvastatin
Cholib 145 mg/40 mg film-coated tablets 
Cholib 145 mg/40 mg filmom obložene tablete
Cholib 145 mg/20 mg film-coated tablets 
Cholib 145 mg/20 mg filmom obložene tablete
Galepharma Ltd. Tel: +356-21-22 14 22 
Tel: +356-21-22 14 22
Fenofibrate/Simvas tatin in combination 
Kombinacija fenofibrat / simvastatin
The film-coated tablet (tablet) is a, oval, biconvex, brick red coloured 19.3 x 9.3 mm tablet with bevelled edges and the inscription 145/40 on one side and the Abbott logo on the other side. 
Filmom obložena tableta (tableta) je ovalna, bikonveksna, ciglasto crvena tableta veličine 19,3 x 9,3 mm s kosim rubovima i oznakom 145/40 na jednoj strani i logotipom
The film-coated tablet (tablet) is a, oval, biconvex, tan coloured 19.3 x 9.3 mm tablet with bevelled edges and the inscription 145/20 on one side and the Abbott logo on the other side. 
Filmom obložena tableta (tableta) je ovalna, bikonveksna, žućkastosmeđa tableta veličine 19,3 x 9,3 mm s kosim rubovima i oznakom 145/20 na jednoj strani i logotipom
Stud y 
Ispitivanj e
Some patients have experienced the following side effects whilst taking Cholib, fenofibrate or simvastatin: 
Neki bolesnici imali su sljedeće nuspojave dok su uzimali Cholib, fenofibrat ili simvastatin: Vrlo česte nuspojave (mogu se javiti kod više od 1 od 10 osoba):
Oval, biconvex, brick red coloured, 19.3 x 9.3 mm film-coated tablet with bevelled edges and the inscription 145/40 on one side and the Abbott logo on the other side. 
Ovalna, bikonveksna, ciglasto crvena, filmom obložena tableta veličine 19,3 x 9,3 mm s kosim rubovima i oznakom 145/40 na jednoj strani i logotipom
Rash, pruritus, urticaria) 
Preosjetljivost kože (npr. osip, svrbež, urtikarija)
Cholib 145 mg/40 mg film-coated tablets fenofibrate/simvastatin 
Cholib 145 mg/40 mg filmom obložene tablete fenofibrat/simvastatin
% Change Mean (SD) 
Nakon 12 tjedana Srednja vrijednost (SD) % promjene TG
Cholib 145 mg/20 mg film-coated tablets fenofibrate/simvastatin 
Cholib 145 mg/20 mg filmom obložene tablete fenofibrat/simvastatin
There have been reports of myopathy and rhabdomyolysis with the concomitant administration of colchicine and simvastatin in patients with renal insufficiency. 
U bolesnika s insuficijancijom bubrega, pri istodobnoj primjeni kolhicina i simvastatina prijavljene su miopatija i rabdomioliza.
Immune system disorders Hypersensitivity rare 
Poremećaji imunološkog sustava
Each tablet contains 145 mg of fenofibrate and 20 mg of simvastatin 
Jedna tableta sadrži 145 mg fenofibrata i 20 mg simvastatina
Each tablet contains 145 mg of fenofibrate and 40 mg of simvastatin 
Jedna tableta sadrži 145 mg fenofibrata i 40 mg simvastatina
• Renal impairment 
• osjećaj omaglice
Each tablet contains 145 mg of fenofibrate and 20 mg of simvastatin. 
Jedna tableta sadrži 145 mg fenofibrata i 20 mg simvastatina.
Blood urea increased rare 
Povišenje ureje u krvi rijetko
• increase in “urea” - produced by the kidneys - shown in tests 
• povišenje “ureje” - koju stvaraju bubrezi - vidljivo u pretragama
Each tablet contains 145 mg of fenofibrate and 40 mg of simvastatin. 
Jedna tableta sadrži 145 mg fenofibrata i 40 mg simvastatina.
Hepatobiliary disorders Transaminases increased common 
Povišene transaminaze često
Oval, biconvex, tan coloured, 19.3 x 9.3 mm film-coated tablet with bevelled edges and the inscription 145/20 on one side and the Abbott logo on the other side. 
Ovalna, bikonveksna, žućkastosmeđa, filmom obložena tableta veličine 19,3 x 9,3 mm s kosim rubovima i oznakom 145/20 na jednoj strani i logotipom
Mylan Healthcare B.V. Tel: +31 (0)20 426 33 00 
Mylan Hrvatska d.o.o. Tel: + 385 (0)1 2350 599
Lecithin (derived from soya bean (E322)) Xanthan gum (E415) Iron oxide red (E172) Iron oxide yellow (E172) Sunset yellow FCF (E110) 
poli(vinilni alkohol), djelomično hidroliziran (E1203) titanijev dioksid (E171) talk (E553b) lecitin (iz soje (E322)) ksantanska guma (E415) željezov oksid, crveni (E172) željezov oksid, žuti (E172) sunset yellow FCF (E110)
Parameter 
BROJEVI
ANNEX III 
13. BROJ SERIJE
Rhabdomyolysis with or without renal failure (see section 4.4), 
Rabdomioliza sa ili bez zatajenja bubrega (vidjeti rijetko
LIST OF EXCIPIENTS 
Potpuna analiza uzorka ispitanika
Brilique ticagrelor 
Brilique tikagrelor