natgillin/translations-raw huggingface dataset:
The risk of myopathy including rhabdomyolysis may be increased by the concomitant administration of systemic fusidic acid with statins. 
Rizik od miopatije, uključujući rabdomiolizu, može biti povećan istodobnom primjenom sistemske fusidatne kiseline sa statinima.
The most commonly reported adverse reactions (ADRs) during Pravafenix therapy are increased transaminase and gastrointestinal disorders. 
Najčešće prijavljene nuspojave tijekom terapije Pravafenixom su povišene transaminaze i gastrointestinalni poremećaji.
Since it is less well absorbed from an empty stomach, Pravafenix should always be taken with food (see sections 4.5. and 
Budući se lošije apsorbira na prazan želudac, Pravafenix treba uvijek uzimati s hranom (vidjeti dijelove 4.5. i 5.2).
Thromboembolism (pulmonary embolism, deep vein thrombosis)* 
Krvožilni poremećaji tromboembolije (plućna embolija, duboka venska tromboza)*
What you need to know before you take pravafenix 
Što morate znati prije nego počnete uzimati Pravafenix
Plasma elimination half-life of oral pravastatin is 1.5 to 2 hours. 
Poluvijek eliminacije peroralno uzetog pravastatina je 1,5 do 2 sata.
Pravastatin is a competitive inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme catalysing the early rate-limiting step in cholesterol biosynthesis, and produces its lipid-lowering effect in two ways. 
Pravastatin je kompetitivni inhibitor 3-hidroksi-3-metilglutaril-koenzim A (HMG-KoA) reduktaze, enzima koji katalizira ranu sporu fazu biosinteze kolesterola, i time djeluje na snižavanje razine lipida na dva načina.
Additional information on the individual active substances of the fixed dose combination Pravafenix contains pravastatin and fenofibrate. 
Dodatne informacije o pojedinim djelatnim tvarima fiksne kombinirane doze Pravafenix sadrži pravastatin i fenofibrat.
Patients at risk (fasting glucose 5.6 to 6.9 mmol/L, BMI>30kg/m 2, raised triglycerides, hypertension) should be monitored both clinically and biochemically according to national guidelines. 
Rizične bolesnike (glukoza natašte 5,6 do 6,9 mmol/l, BMI>30kg/m2, povišeni trigliceridi, hipertenzija) treba pratiti klinički i laboratorijski prema nacionalnim smjernicama.
Pravafenix is used if you are an adult with an elevated risk for heart disease and need to improve cholesterol and triglycerides fat levels in your blood when your ‘bad' cholesterol levels are being adequately controlled with pravastatin alone (a statin, a cholesterol-lowering medicine). 
Pravafenix se koristi ako ste odrasla osoba s povećanim rizikom za srčanu bolest i trebate popraviti razine kolesterola i triglicerida u svojoj krvi, a razine Vašeg "lošeg" kolesterola nisu odgovarajuće kontrolirane samo s pravastatinom (statin, lijek za snižavanje kolesterola).
- Moderate to severe renal impairment (defined as an estimated creatinine clearance < 60 ml/min). 
- Umjereno do teško oštećenje bubrega (definiran kao procijenjeni klirens kreatinina < 60 ml/min).
Pharmacotherapeutic group: Lipid modifying agents, HMG CoA reductase inhibitors in combination with other lipid modifying agents, ATC code: C10BA03 
Farmakoterapijska skupina: lijekovi koji modificiraju lipide, inhibitori HMG KoA reduktaze u kombinaciji s drugim lijekovima koji modificiraju lipide, ATK oznaka: C10BA03
This is because colestyramine or other bile acid binding resins frequently reduce the absorption of medicines when taken too closely together and so may impede the absorption of Pravafenix. 
Ovo iz razloga što kolestiramin ili druge smole koje na sebe vežu žučne kiseline često smanjuju apsorpciju drugih lijekova ako se uzimaju vrlo blizu jedan s drugim, pa tako također mogu smanjiti i apsorpciju Pravafenixa.
Additional adverse reactions associated with the use of medicinal products containing pravastatin or fenofibrate observed in clinical trials and postmarketing experience that may potentially occur with Pravafenix are listed below. 
Dodatne nuspojave povezane s primjenom lijekova koji sadrže pravastatin i fenofibrat opažene u kliničkim ispitivanjima i iskustvu nakon stavljanja lijeka u promet, a koje se mogu javiti s Pravafenixom, navedene su u nastavku.
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. 
Ispitivanje lipida pod nazivom Akcija za kontroliranje kardiovaskularnog rizika kod oboljelih od dijabetesa (ACCORD) bila je randomizirana placebom kontrolirana studija koja je uključivala 5518 bolesnika s dijabetesom mellitusom tipa 2 koji su uz simvastatin dobijali i fenofibrat.
If you take indigestion remedies (used to neutralise acid in your stomach), take Pravafenix 1 hour after. 
Koristite li sredstva za liječenje probavnih tegoba (za neutralizaciju želučane kiseline), tada Pravafenix uzmite 1 sat nakon toga.
If a hereditary muscular disease is suspected in such patients, restarting Pravafenix therapy is not recommended. 
Ako se u ovih bolesnika sumnja na nasljednu mišićnu bolest ne preporučuje se ponovni početak terapije Pravafenixom.
Blood urea increased 
Pretrage povišena urea u krvi
Pravastatin is not metabolised to a clinically significant extent by the cytochrome P450 system. 
Pravastatin se ne metabolizira u klinički značajnom opsegu putem sustava citokroma P450.
The drug is excreted mainly in the urine. 
Lijek se uglavnom izlučuje mokraćom.
Some severe cases of reversible renal function impairment have been reported during concomitant administration of fenofibrate and ciclosporin. 
Prijavljeno je nekoliko teških slučajeva reverzibilnog oštećenja funkcije bubrega tijekom istodobne primjene fenofibrata i ciklosporina.
No studies in lactating animals have been conducted with Pravafenix. 
Nisu provedena ispitivanja s Pravafenixom na životinjama u laktaciji.
Caution should be exercised when Pravafenix is administered to patients with a history of liver disease or heavy alcohol ingestion. 
Nužan je oprez kada se Pravafenix primjenjuje bolesnicima koji u anamnezi imaju bolest jetre ili obilno konzumiraju alkohol.
The pharmacokinetics properties of Pravafenix are not completely identical to the co-administration of the existing monotherapies when taken with fat-meal or in fasting state. 
Farmakokinetička svojstva Pravafenixa nisu potpuno identična svojstvima istodobno primjenjivanih postojećih monoterapija kada se uzimaju s masnim obrokom ili natašte.
Mean (%)± SEb 
Srednja vrijednost (%)±
Skeletal muscle: Marked and persistent increases of creatine phosphokinase (CK) have been reported infrequently. 
Skeletni mišić: znatna i stalna povišenja kreatinin fosfokinaze (KF) prijavljena su sporadično.
EU/1/11/679/007 14 hard capsules EU/1/11/679/004 30 hard capsules EU/1/11/679/005 60 hard capsules EU/1/11/679/006 90 hard capsules 
EU/1/11/679/007 14 tvrdih kapsula EU/1/11/679/004 30 tvrdih kapsula EU/1/11/679/005 60 tvrdih kapsula EU/1/11/679/006 90 tvrdih kapsula
Adverse reaction (fenofibrate) 
Nuspojava (fenofibrat)
The following statements reflect the information available on the individual active substances (fenofibrate and pravastatin). 
Sljedeće tvrdnje odražavaju dostupne za svaku djelatnu tvar posebno (fenofibrat i pravastatin).
Embryotoxic effects have been shown at doses in the range of maternal toxicity (see section 5.3). 
Embriotoksični učinci viđeni su pri dozama toksičnim za majku (vidjeti dio 5.3).
If confirmed, the treatment should definitively not be initiated (see section 4.3). 
Ako su vrijednosti i dalje povišene s liječenjem se ne smije započeti (vidjeti dio 4.3).
Pravafenix is used in addition to low fat diet in adults - To lower the level of your ‘bad' cholesterol (LDL cholesterol). 
Pravafenix se u odraslih dodatno koristi uz dijetu s niskim udjelom masnoća - za snižavanje razine "lošeg" kolesterola (LDL kolesterol).
When your doctor has prescribed Pravafenix along with colestyramine or any other bile acid binding resins (medicines for lowering cholesterol), take Pravafenix 1 hour before, or 4 to 6 hours after the resin. 
Ako Vam je liječnik propisao Pravafenix zajedno s kolestiraminom ili bilo kojim drugim smolama žučnih kiselina (lijekovi za snižavanje kolesterola), Pravafenix uzmite 1 sat prije ili 4 do 6 sati nakon smole žučnih kiselina.
LDL cholesterol is often called ‘bad' cholesterol because it can build up in the walls of your arteries and form plaque. 
LDL kolesterol često se naziva "lošim" kolesterolom jer se može nakupljati u stijenki arterija i tamo formirati naslage (plak).
Bile acid binding resins frequently reduce the absorption of medicinal products and when resins are being co-administered, fenofibrate should be taken 1 hour before, or 4 to 6 hours after, the resin so as not to impede the absorption of fenofibrate. 
Smole koje se vežu na žučne kiseline često smanjuju apsorpciju lijekova i kada se smole primjenjuju istodobno, fenofibrat treba uzeti 1 sat prije ili 4 do 6 sati nakon smole kako ne bi ometali apsorpciju fenofibrata.
The medicine must be discontinued because of the potential risk to the foetus. 
Uzimanje lijeka mora se prekinuti jer postoji rizik za plod.
IMNM is clinically characterized by persistent proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment. 
IMNM je klinički karakterizirana perzistentnom slabošću proksimalnih mišića te povišenim razinama kreatin kinaze u serumu, koje se ne povlače unatoč prekidu liječenja statinom.
Embryotoxic effects were observed at doses in the range of maternal toxicity. 
Embriotoksični učinci primijećeni su u rasponima doza toksičnim za majku.
Toxicological findings in these co-administration studies were consistent with those seen with pravastatin and fenofibrate administered individually. 
Toksikološki nalazi u ovim ispitivanjima istodobne primjene bili su u skladu s onima viđenim u ispitivanjima s individualnom primjenom pravastatina i fenofibrata.
Vision disturbance (including blurred vision and diplopia) 
Poremećaji oka smetnje vida (uključujući zamućen vid i diplopiju)
The safety of concomitant administration of pravastatin and fenofibrate was assessed in rats. 
Sigurnost istodobne primjene pravastatina i fenofibrata ispitivana je na štakorima.
A small amount of pravastatin is excreted in human breast milk; therefore pravastatin is contraindicated during breastfeeding (see section 4.3). 
Mala količina pravastatina izlučuje se u majčino mlijeko u ljudi; stoga je pravastatin kontraindiciran tijekom dojenja (vidjeti dio 4.3).
Pravafenix does not usually affect your ability to drive or use machines. 
Pravafenix obično ne utječe na sposobnost upravljanja vozilima i rada na strojevima.
Opaque white HDPE bottles containing 14, 30, 60 and 90 hard capsules. 
Neprozirne bijele HDPE boce koje sadrže 14, 30, 60 i 90 tvrdih kapsula.
Immune-mediated necrotizing myopathy (see section 4.4). 
Imunološki posredovana nekrotizirajuća miopatija (vidjeti dio 4.4)
Triglycerides are another fat in your blood. 
Trigliceridi su još jedna vrsta masnoća u našem organizmu.
This metabolite has one-tenth to one-fortieth the HMG-CoA reductase inhibitor activity of the parent compound. 
Ovaj metabolit ima jednu desetinu do jednu četrnaestinu inhibitorne aktivnosti osnovnog lijeka za HMG-KoA reduktazu.
Do not use Pravafenix after the expiry date which is stated on the carton and the blister/bottle after EXP. 
Pravafenix se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru/boci iza „Rok valjanosti“.
The lipid-lowering properties of fenofibrate seen in clinical practice have been explained in vivo in transgenic mice and in human hepatocyte cultures by activation of Peroxisome Proliferator Activated 
Svojstva fenofibrata da snižava lipide viđeno u kliničkoj praksi objašnjeno je in vivo na transgeničnim miševima i na kulturama ljudskih hepatocita aktivacijom peroksisom proliferator aktiviranog receptora tipa α (PPARα).
If treatment with fusidic acid is necessary, pravastatin treatment should be discontinued throughout the duration of the fusidic acid treatment. 
Ako je liječenje fusidatnom kiselinom neophodno, liječenje pravastatinom treba prekinuti kroz svo vrijeme trajanja liječenja fusidatnom kiselinom.
This results in an increase in the number of LDL-receptors on cell surfaces and enhanced receptor-mediated catabolism and clearance of circulating LDL-cholesterol. 
Ovo rezultira povećanjem broja LDLreceptora na površini stanica i pojačanim katabolizmom i klirensom LDL kolesterola posredovanim aktivacijom receptora.
In such cases CK levels should be measured (see below). 
U takvim slučajevima mora se mjeriti razine CK (vidjeti dolje).
Pravafenix has no or negligible influence on the ability to drive and use machines. 
Pravafenix ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada na strojevima.
The systemic clearance of pravastatin is 0.81 l/h/kg and the renal clearance is 0.38 l/h/kg indicating tubular secretion. 
Sistemski klirens pravastatina je 0,81 l/h/kg a bubrežni klirens je 0,38 l/h/kg što ukazuje na tubularno izlučivanje.
Keep this medicine out of the sight and reach of children. 
Kako čuvati pravafenix Lijek čuvajte izvan pogleda i dohvata djece.
If overdose is suspected, treat symptomatically and institute appropriate supportive measures as required. 
Ako se sumnja na predoziranje, liječiti simptomatski i po potrebi započeti s odgovarajućim potpornim mjerama.
Patients receiving Pravafenix 40 mg/160 mg were compared to those receiving pravastatin 40 mg: Pravafenix significantly lowered non-HDL-C, LDL-C, TG and significantly increased HDL-C to a greater extent than pravastatin 40 mg (table). 
40 mg/160 mg uspoređeni su s onima koji su primali pravastatin 40 mg: Pravafenix je značajno snizio non-HDL-C, LDL-C, TG i značajno povisio HDL-C u većem opsegu nego pravastatin 40 mg (tablica).
Fenofibric acid is not eliminated by haemodialysis. 
Fenofibrična kiselina ne eliminira se hemodijalizom.
If a markedly elevated (> 5 times the ULN) CK level is detected and confirmed, Pravafenix therapy must be discontinued. 
Ako se utvrdi i mjerenjem potvrdi znatno povišena razina CK (> 5 puta GGN), terapija Pravafenixom se mora prekinuti.
If it is suspected a patient has developed interstitial lung disease, Pravafenix therapy should be discontinued. 
Ako se sumnja da se u bolesnika razvila intersticijska bolest pluća, terapija Pravafenixom mora se prekinuti.
Therefore the fixed dose combination (Pravafenix) could not be considered interchangeable with the free co-administration of fenofibrate and pravastatin mono-component drug products. 
Stoga se kombinacija fiksne doze (Pravafenix) ne može smatrati zamjenjivim s istodobnom primjenom odvojenih monokomponentnih lijekova fenofibrata i pravastatina.
Liver reactions: Marked and persistent increases of serum transaminases have been reported infrequently. 
Reakcije jetre: znatna i stalna povišenja transaminaza u serumu prijavljena su sporadično.
The usual dose is one capsule taken daily during the evening meal. 
Uobičajena doza je jedna kapsula dnevno uzeta kroz usta uz večernji obrok.
There have been no formal interaction studies for Pravafenix; however the concomitant use of the active substances in patients in clinical studies has not resulted in any unexpected interactions. 
4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Nisu provedena formalna ispitivanja interakcija za Pravafenix; ipak istodobna primjena djelatnih tvari u bolesnika tijekom kliničkih ispitivanja nije rezultiralo bilo kakvim neočekivanim interakcijama.
Fenofibrate may increase cholesterol excretion into the bile, potentially leading to cholelithiasis. 
Fenofibrat može povećati izlučivanje kolesterola u žuč, što može dovesti do kolelitijaze.
Treatment initiation with Pravafenix should be decided after renal function has been evaluated (see section 4.4 Renal and urinary disorders). 
Odluku o početku liječenja Pravafeniksom treba donijeti nakon što se procijeni funkcija bubrega (vidjeti dio 4.4 Poremećaji bubrega i mokraćnih puteva).
Studies with fenofibrate on lipoprotein fractions show decreases in levels of LDL and VLDL cholesterol. 
Ispitivanja s fenofibratom na frakcije lipoproteina pokazuju snižavanje razina LDL i VLDL
The recommended dose is one capsule taken daily during the evening meal. 
Preporučena doza je jedna kapsula dnevno uzeta uz večernji obrok.
INFORMATION IN BRAILLE Pravafenix 
16. PODACI NA BRAILLEOVOM PISMU Pravafenix
In rats a 2-year carcinogenicity study demonstrates at a dose of 100 mg/kg/day (125 times the maximum human mg/kg/dose) a statistically significant increase in the incidence of hepatocellular carcinomas in males only. 
Na štakorima 2-godišnje ispitivanje karcinogenosti pravastatina pokazalo je u dozama od 100 mg/kg/dan (125 puta maksimalne doze za ljude u mg/kg), statistički značajno povećanje incidencije hepatocelularnih karcinoma samo u mužjaka.
• Inflammation of the liver (hepatitis), symptoms of which may be mild yellowing of the skin and whites of the eyes (jaundice), abdominal pain and itching. 
• Upala jetre (hepatitis), simptomi koje mogu biti blago žutilo kože i bjeloočnica (žutica), bol u trbuhu i svrbež.
Laboratoires SMB s.a. Rue de la Pastorale, 26-28 B-1080 Brussels Belgium 
Laboratoires SMB s.a. rue de la Pastorale, 26-28 B-1080 Brussels Belgija
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE FOR 14 AND 30 HARD CAPSULES 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU BOCA S 14 I 30 TVRDIH KAPSULA
Secondly, pravastatin inhibits LDL production by inhibiting the hepatic synthesis of VLDLcholesterol, the LDL-cholesterol precursor. 
Drugo, pravastatin inhibira stvaranje LDL-a inhibicijom sinteze VLDL kolesterola u jetri, prekursora LDL kolesterola.
Four multicenter studies with either Pravafenix 40 mg/160 mg or Pravastatin 40 mg or Simvastatin 20 mg were conducted: 3 studies included a 12 week randomized, double-blind, active controlled period with an open-label extension phase and one was a 24-week open-label study. 
Provedena su četiri multicentrična ispitivanja s Pravafenixom 40 mg/160 mg ili Pravastatin 40 mg ili Simvastatin 20 mg: 3 ispitivanja uključivala su razdoblje od 12 tjedana randomiziranog, dvostruko slijepog, aktivno kontroliranog razdoblja, s fazom produženog otvorenog ispitivanja, a jedno je bilo otvoreno ispitivanje u trajanju od 24 tjedna.
Frequency categories are based on information available from pravastatin and fenofibrate Summary of Product characteristics available in the EU. 
Kategorije učestalosti temelje se na podacima dostupnim iz sažetaka opisa lijeka za pravastatin i fenofibrat dostupnih u EU.
- You suffer from liver disease. 
- ako bolujete od bolesti bubrega,
Therefore, caution should be exercised in patients with history of pulmonary embolism. 
Stoga je nužan oprez u bolesnika koji u anamnezi imaju plućnu emboliju.
Fenofibrate cannot be eliminated by haemodialysis. 
Fenofibrat se ne može eliminirati hemodijalizom.
The bioavailability of fenofibric acid is lower in fasting conditions after a single dose administration of the Fenofibrate-Pravastatin 160/40 mg combination. 
Bioraspoloživost fenofibrične kiseline je niža nakon primjene jednokratne doze kombinacije fenofibrat-pravastatin 160/40 mg natašte.
The capsules are hard gelatine capsule with olive cap and light green body containing a waxy white beige mass and a tablet. 
Kapsule su tvrde želatinske kapsule s maslinastozelenom kapicom i svijetlozelenim tijelom koje sadrže voštanu bijelo-bež masu i tabletu.
This risk, however, is outweighed by the reduction in vascular risk with statins and therefore should not be a reason for stopping statin treatment. 
Budući da je korist statina u smanjenu vaskularnog rizika puno veća od rizika razvoja dijabetesa, ovo ne treba biti razlog za prekid liječenja statinima.
Rare * In the FIELD-study (fenofibrate study), a randomised placebo-controlled trial performed in 9,795 patients with type 2 diabetes mellitus, a statistically significant increase in pancreatitis cases was observed in patients receiving fenofibrate versus patients receiving placebo (0.8% versus 0.5%; p = 0.031). 
* U ispitivanju FIELD (ispitivanje fenofibrata), randomiziranom placebom kontroliranom ispitivanju provedenom na 9795 bolesnika sa šećernom bolešću tipa 2, primijećen je statistički značajano povećanje broja slučajeva pankreatitisa u bolesnika koji su primali fenofibrat naspram bolesnika koji su primali placebo (0,8% naspram 0,5%; p = 0,031).
- You have had photoallergy (allergic reaction caused by sunlight or exposure to UV light) or phototoxic reactions (damage to skin caused by exposure to sunlight or UV light) during treatment with fibrates (lipid-modifying medicines) or ketoprofen (an anti-inflammatory medicine that can be used orally or on the skin for muscle and bone disorders, and orally for gout or period pain) - You suffer from gallbladder disease. 
- ako ste imali fotoalergiju (alrgijska reakcija uzrokovana izlaganju sunčevu ili UV svjetlu) ili fototoksične reakcije (oštećenje kože uzrokovano izlaganjem sunčevu ili UV svjetlu) tijekom liječenja fibratima (lijekovima koji modificiraju lipide) ili ketoprofenu (protuupalnom lijeku koji se uzima kroz usta ili nanosi na kožu zbog poremećaja mišića i kostiju, ili kroz usta zbog bolova izazvanih gihtom ili menstrualnih bolova),
In mice, a 2-year carcinogenicity study with pravastatin demonstrates at doses of 250 and 500 mg/kg/day (> 310 times the maximum human mg/kg dose), statistically significant increases in the incidence of hepatocellular carcinomas in males and females, and lung adenomas in females only. 
Na miševima 2-godišnje ispitivanje karcinogenosti pravastatina pokazalo je u dozama od 250 i 500 mg/kg/dan (> 310 puta maksimalne doze za ljude u mg/kg), statistički značajna povećanja incidencije hepatocelularnih karcinoma u mužjaka i ženki, i adenomima pluća samo u ženki.
Therefore, taking into account the contra indication of pravastatin during lactation, Pravafenix is contraindicated during breastfeeding (see section 4.3). 
Stoga, imajući u vidu kontraindikaciju za pravastatin tijekom laktacije, Pravafenix je kontraindiciran tijekom dojenja (vidjeti dio 4.3).
There are no data from the use of fenofibrate in pregnant women. 
Nema podataka o primjeni fenofibrata u trudnica.
• Abnormal heartbeat (palpitations), formation of blood clots in veins (deep vein thrombosis) and blockage of the lung arteries by blood clots (pulmonary embolism) 
• Nenormalni srčani otkucaji (palpitacije), stvaranje krvnih ugrušaka u venama (duboka venska tromboza) i začepljenje plućnih arterija ugrušcima (plućna embolija)
The respective effects of pravastatin and fenofibrate are complementary. 
Pravafenix Učinci pravastatina i fenofibrata su komplementarni.
Prolongation of the gestation period and difficulties during delivery were observed at high doses. 
Pri visokim dozama primijećeno je produženje vremena gestacije i teškoće tijekom okota.
Pancreatitis has been reported in patients taking fenofibrate or pravastatin (see sections 4.3). 
Pankreatitis je prijavljen u bolesnika koji su uzimali fenofibrat ili pravastatin (vidjeti dio 4.3).
Pravafenix versus PRAVASTATIN 
Pravafenix naspram PRAVASTATINA
Activation of PPARα also induces an increase in the synthesis of Apoproteins A-I, 
Aktivacijom PPARα također se inducira povećanje sinteze apoproteina A-I, A-II i HDL kolesterola.
Your doctor will monitor you while you are taking this medicine. 
Dok uzimate ovaj lijek liječnik će Vas pratiti.
Myopathy must be considered in any patient presenting with unexplained muscle symptoms such as pain or tenderness, muscle weakness, or muscle cramps. 
Miopatiju se mora uzeti u obzir kod bilo kojeg bolesnika u kojeg su se pojavili neobjašnjivi mišićni simptomi poput boli ili osjetljivosti, mišićne slabosti ili mišićnih grčeva.
The capsules are supplied in Polyamide-Aluminium-PVC/aluminium blister packs containing 30, 60, or 90 capsules, and in opaque white plastic bottles containing either 14, 30, 60 or 90 capsules. 
Kapsule se isporučuju u poliamid-aluminij-PVC/aluminij blisterima koji sadrže 30, 60 ili 90 kapsula, i u neprozirnim bijelim plastičnim bocama koje sadrže 14,