natgillin/translations-raw huggingface dataset:
In a phase 3, double-blind, placebo-controlled, event-driven trial (RIVER-PCI) in 2604 patients aged ≥18 years with a history of chronic angina and incomplete revascularisation after percutaneous coronary intervention (PCI) patients were up-titrated to 1000 mg twice daily (dosage not approved in the current SmPC). 
U fazi 3, dvostruko slijepog, placebom kontroliranog, događajima uvjetovanog ispitivanja (RIVERPCI) na 2604 bolesnika u dobi od ≥18 godina, s anamnezom kronične angine i nepotpune revaskularizacije nakon perkutane koronarne intervencije (PCI), bolesnicima je postupno povećavana doza do 1000 mg dvaput dnevno (neodobreno doziranje u važećem SmPC-u).
Ranolazine is a moderate to potent inhibitor of P-gp and a mild inhibitor of CYP3A4, and may increase plasma concentrations of P-gp or CYP3A4 substrates. 
Ranolazin je umjeren do snažan inhibitor P-gp-a i blag inhibitor CYP3A4 pa može povećati koncentracije P-gp-a ili CYP3A4 supstrata u plazmi.
No proarrhythmic effects were observed in 3,162 patients treated with Ranexa based on 7-day Holter monitoring in the MERLIN-TIMI 36 study. 
Tijekom 7-dnevnog praćenja Holterom 3162 bolesnika liječenih Ranexom u istraživanju MERLINTIMI 36 nisu uočeni proaritmijski učinci.
Suomi/Finland Berlin-Chemie/A.Menarini Suomi OY Puh/Tel: +358 403 000 760 
Berlin-Chemie/A.Menarini Suomi OY Puh/Tel: +358 403 000 760
There was a large inter-individual variability in AUC in subjects with renal impairment. 
Postojala je velika varijabilnost među pojedincima u pogledu AUC-a kod ispitanika s oštećenjem funkcije bubrega.
Ranexa 750 mg twice daily increased plasma concentrations of metoprolol by 1.8-fold. 
Uzimanje Ranexe 750 mg dvaput dnevno povećava koncentraciju metoprolola u plazmi 1,8 puta.
At the dose level 500 mg twice daily, co-administration of a potent inhibitor of CYP2D6 could result in an increase in ranolazine AUC of about 62%. 
Kod doze ranolazina od 500 mg dva puta dnevno, istovremena primjena snažnog inhibitora CYP2D6 može dovesti do povećanja površine ispod krivulje (PIK) ranolazina za oko 62%.
Ranexa resulted in significant decreases in the number of angina attacks per week (p = 0.028) and consumption of short-acting nitroglycerin (p = 0.014) compared to placebo. 
U usporedbi s placebom Ranexa je dovela do značajnog tjednog smanjenja broja napadaja angine pektoris (p = 0,028) i korištenja nitroglicerina kratkog djelovanja (p = 0,014).
A population-based analysis of combined data from patients and healthy volunteers demonstrated that the slope of the plasma concentration-QTc relationship was estimated to be 2.4 msec per 1000 ng/ml, which is approximately equal to a 2- to 7-msec increase over the plasma concentration range for ranolazine 500 to 1000 mg twice daily. 
Analiza temeljena na kombiniranim podacima dobivenim iz populacije bolesnika i zdravih dobrovoljaca pokazala je da je krivulja odnosa koncentracije u plazmi i QTc-a procijenjena na 2,4 msec na 1000 ng/ml, što je otprilike jednako povećanju od 2 do 7 msec iznad raspona koncentracije ranolazina u plazmi kod doze 500 do 1000 mg dvaput dnevno.
Uncommon: anxiety, insomnia, confusional state, hallucination. 
Manje često: anksioznost, nesanica, konfuzno stanje, halucinacije.
The corresponding difference at the 1000 mg twice-daily dose was 25%. 
Kod doze od 1000 mg dvaput dnevno ta je razlika bila 25%.
- certain medicines to treat allergies (e.g. terfenadine, astemizole, mizolastine), heart rhythm disorders (e.g. disopyramide, procainamide), and depression (e.g. imipramine, doxepin, amitriptyline), as these medicines may affect your ECG. 
- određene lijekove za liječenje alergija (npr. terfenadin, astemizol, mizolastin), poremećaja srčanog ritma (npr. disopiramid, prokainamid) i depresije (npr. imipramin, doksepin, amitriptilin), budući da ti lijekovi mogu utjecati na Vaš EKG.
CYP3A4 or P-gp inhibitors: Ranolazine is a substrate of cytochrome CYP3A4. 
Inhibitori CYP3A4 ili P-gp: Ranolazin je supstrat citokroma CYP3A4.
Your doctor may decide to give you a lower dose or take other precautions if any of these apply to you. 
Ako se bilo što od navedenog odnosi na Vas, liječnik može odlučiti dati Vam manju dozu ili poduzeti druge preventivne mjere.
- if you have mild liver problems. 
- ako imate blage probleme s jetrom.
QT prolongation: Ranolazine blocks IKr and prolongs the QTc interval in a dose-related manner. 
Produljeni QT interval: Ranolazin blokira IKr i produljuje QTc interval, ovisno o dozi.
Additional excipients for 750 mg tablet: 
Dodatne pomoćne tvari u tabletama od 750 mg:
Rare: amnesia, depressed level of consciousness, loss of consciousness, coordination abnormal, gait disturbance, parosmia. 
Rijetko: amnezija, smanjena razina svijesti, nesvjestica, poremećena koordinacija pokreta, poremećeno hodanje, parosmija.
PVC/PVDC/Aluminium blisters of 15 or 20 tablets per blister card. Each carton contains 2, 3, or 5 blister cards (30, 60, or 100 tablets) or one HDPE bottle containing 60 tablets. 
Jedna kutija sadrži 2, 3 ili 5 blister kartica (30, 60 ili 100 tableta) ili jednu bočicu od polietilena visoke gustoće (HDPE) sa 60 tableta.
Hepatic impairment: The pharmacokinetics of ranolazine have been evaluated in patients with mild or moderate hepatic impairment. 
Oštećenje jetrene funkcije: Procjenjivana je farmakokinetika ranolazina kod bolesnika s blagim ili umjerenim oštećenjem jetrene funkcije.
Common: constipation, vomiting, nausea. 
Često: konstipacija, povraćanje, mučnina.
France MENARINI France Tél: +33 (0)1 45 60 77 20 
Tél: +33 (0)1 45 60 77 20
Sodium: This medicine contains less than 1 mmol sodium (23 mg) per prolonged-release tablet, that is to say essentially ‘sodium-free'. 
Natrij: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po tableti s produljenim oslobađanjem, tj. zanemarive količine natrija.
When the submission of a PSUR and the update of a RMP coincide, they should be submitted at the same time. 
Ako se rokovi podnošenja periodičkog izvješća o neškodljivosti (PSUR) podudaraju s nadopunama plana (RMP) dokumenti mogu biti podneseni istodobno.
One-hundred and ninety-one patients were randomised to treatment with Ranexa 500 mg twice daily, 1000 mg twice daily, 1500 mg twice daily, and matching placebo, each for 1 week in a crossover design. 
Stotinu devedeset i jedan bolesnik odabran je da prima nasumce Ranexu 500 mg dvaput dnevno, 1000 mg dvaput dnevno, 1500 mg dvaput dnevno ili placebo, tijekom 1 tjedna, u križno dizajniranom ispitivanju.
500 and 750 mg twice daily were 1.9 and 4.9 msec, respectively. 
(korekcija prema Fridericiji) nakon doza od 500 i 750 mg dvaput dnevno bile 1,9, odnosno 4,9 msec.
If you get any any side effects talk to your doctor or pharmacist. 
Ako primjetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
Ranexa is contraindicated in patients with moderate or severe hepatic impairment (see sections 4.3 and 5.2). 
Ranexa je kontraindicirana kod bolesnika s umjerenim ili teškim oštećenjem jetrene funkcije (vidjeti dijelove 4.3 i 5.2).
Uncommon: lethargy, syncope, hypoaesthesia, somnolence, tremor, postural dizziness, paresthesia. 
Manje često: letargija, sinkopa, hipoestezija, pospanost, tremor, posturalna vrtoglavica, parestezija.
Latvija SIA Berlin-Chemie/Menarini Baltic Tel: +371 67103210 
SIA Berlin-Chemie/Menarini Baltic Tel: +371 67103210
Blue #1/Brilliant Blue FCF Aluminium Lake (E133) and Yellow #5/Tartrazine Aluminium Lake (E102) 
gliceroltriacetat laktoza hidrat boja plava #1/Brilliant Blue FCF Aluminium Lake (E133) i žuta #5/Tartrazine Aluminium Lake (E102)
Inhibitors of P-gp (e.g. ciclosporin, verapamil) increase plasma levels of ranolazine. 
Inhibitori P-gp-a (npr. ciklosporin, verapamil) povećavaju koncentraciju ranolazina u plazmi.
Detailed information on this medicine is available on the European Medicines Agency web site http://www.ema.europa.eu. 
Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
- if you are using certain medicines to treat bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazol, posaconazol), HIV infection (protease inhibitors), depression (nefazodone) or heart rhythm disorders (e.g. quinidine, dofetilide, or sotalol). 
- ako uzimate određene lijekove za liječenje bakterijskih infekcija (klaritromicin, telitromicin), gljivičnih infekcija (itrakonazol, ketokonazol, vorikonazol, posakonazol), HIV infekcije (inhibitori proteaza), depresije (nefazodon) ili poremećaja srčanog ritma (npr. kinidin, dofetilid ili sotalol).
This value is consistent with data from pivotal clinical studies, where mean changes from baseline in QTcF (Fridericia's correction) after doses of 
Ova je vrijednost konzistentna s podacima iz pivotalnih kliničkih istraživanja, kod kojih su srednje promjene od početnih vrijednosti u QTcF
• Concomitant administration of P-gp inhibitors (see sections 4.2 and 4.5). 
• Kod istovremene primjene inhibitora P-gp (vidjeti dijelove 4.2 i 4.5).
Ranexa 750 mg prolonged-release tablets contain lactose monohydrate. 
Ranexa 750 mg tablete s produljenim oslobađanjem sadrže laktozu hidrat.
Also, transient ischemic attack occurred more frequently in patients treated with ranolazine 1000 mg twice daily compared with placebo (1.0% vs 0.2%, respectively); however, the incidence of stroke was similar between treatment groups (ranolazine 1.7% vs placebo 1.5%). 
Tranzitorna ishemička ataka se također pojavila češće kod bolesnika liječenih ranolazinom od 1000 mg dvaput dnevno u usporedbi s placebom (1,0% u odnosu na 0,2%); međutim,
Ranolazine 
Hrvatska
Moderate or severe hepatic impairment (see sections 4.2 and 5.2). 
Umjereno ili teško oštećenje jetrene funkcije (vidjeti dijelove 4.2 i 5.2).
In patients with mild or moderate renal impairment (creatinine clearance ≥ 30-80 ml/min) compared to those with normal renal function (creatinine clearance > 80 ml/min), the most commonly reported events and their placebo-corrected frequencies included: constipation (8% versus 4%), dizziness (7% versus 5%), and nausea (4% versus 2%). 
u usporedbi s bolesnicima s normalnom funkcijom bubrega (klirens kreatinina > 80 ml/min), najčešće zabilježene nuspojave i njihove učestalosti korigirane u odnosu na placebo uključivale su: konstipaciju (8% u odnosu na 4%), omaglicu (7% u odnosu na 5%) i mučninu (4% u odnosu na 2%).
Ranexa 750 mg prolonged-release tablets contain the azo colouring agent E102. 
Ranexa 750 mg tablete s produljenim oslobađanjem sadrže azo bojilo E102.
The 375 mg tablets are pale blue and are engraved with 375 on one side. 
Tablete od 375 mg su blijedoplave s utisnutim 375 s jedne strane.
Blue #2/Indigo Carmine Aluminium Lake (E132) 
makrogol polisorbat 80 boja plava #2/Indigo Carmine Aluminium Lake (E132)
A population analysis of combined data from 1,308 patients and healthy volunteers demonstrated a mean increase in QTc from baseline of 2.4 msec per 1000 ng/ml ranolazine plasma concentration. 
Analiza kombiniranih podataka na populaciji od 1308 bolesnika i zdravih dobrovoljaca pokazala je srednje produljenje QTc za 2,4 msec od početnih vrijednosti kod koncentracije ranolazina u plazmi od 1000 ng/ml.
Pharmacotherapeutic group: Other cardiac preparations, ATC code: C01EB18 
Farmakoterapijska skupina: ostali lijekovi s djelovanjem na srce, ATK oznaka: C01EB18 Mehanizam djelovanja: Mehanizam djelovanja ranolazina uvelike je nepoznat.
Severe renal impairment (creatinine clearance < 30 ml/min) (see sections 4.2 and 5.2). 
Teško oštećenje funkcije bubrega (klirens kreatinina < 30 ml/min) (vidjeti dijelove 4.2 i 5.2).
It is recommended that tacrolimus blood levels are monitored when co-administering Ranexa and tacrolimus and that tacrolimus dosage is adjusted accordingly. 
Kada se istodobno daju Ranexa i takrolimus, preporučuje se praćenje razina takrolimusa u krvi i u skladu s tim, prilagodba doze takrolimusa.
Diltiazem (180 to 360 mg once daily), a moderately potent CYP3A4 inhibitor, causes dose-dependent increases in average ranolazine steady-state concentrations of 1.5- to 2.4-fold. 
Diltiazem (180 do 360 mg jednom dnevno), umjereno snažan inhibitor CYP3A4, dovodi do povećanja prosječnih koncentracija ranolazina u stanju dinamičke ravnoteže od 1,5 to 2,4 puta,ovisno o dozi diltiazema.
An increased incidence of adverse events was seen among ranolazine treated patients in the RIVERPCI trial (see section 5.1) where patients with incomplete revascularization post-PCI were given ranolazine up to 1000 mg twice daily or placebo for approximately 70 weeks. 
RIVER-PCI (vidjeti dio 5.1), u kojem je bolesnicima s nepotpunom revaskularizacijom nakon PCI-a dan ranolazin do 1000 mg dvaput dnevno ili placebo tijekom oko 70 tjedana.
Uncommon: abdominal pain, dry mouth, dyspepsia, flatulence, stomach discomfort. 
Manje često: bolovi u abdomenu, suhoća usta, dispepsija, flatulencija, želučane smetnje.
Metabolism and nutrition disorders Uncommon: anorexia, decreased appetite, dehydration. 
Manje često: anoreksija, smanjen apetit, dehidracija.
Ranexa demonstrated greater efficacy than placebo in prolonging exercise time at trough at 12 weeks for both doses studied when used as an add-on therapy. 
Ranexa je kao dodatni lijek u obje doze pokazala veću djelotvornost od placeba u produljenju vremena opterećenja nakon 12 tjedana.
Renal impairment: Careful dose titration is recommended in patients with mild to moderate renal impairment (creatinine clearance 30-80 ml/min) (see sections 4.4, 4.8, and 5.2). 
Oštećenje funkcije bubrega: Preporučuje se pažljivo prilagođavanje doze kod bolesnika s blagim do umjerenim oštećenjem funkcije bubrega (klirens kreatinina 30-80 ml/min) (vidjeti dijelove 4.4, 4.8, i 5.2).
There is a lower need for precautions in patients with CYP2D6 EM status. 
Potreba za mjerama opreza manja je kod bolesnika koji su jaki metabolizatori CYP2D6.
Common side effects (occur in 1 to 10 users in 100) are: Constipation 
Česte nuspojave (pojavljuju se kod 1 do 10 od 100 korisnika) su: konstipacija omaglica glavobolja osjećaj mučnine, povraćanje osjećaj slabosti
Electrocardiographic effects: Dose and plasma concentration-related increases in the QTc interval (about 6 msec at 1000 mg twice daily), reductions in T wave amplitude, and in some cases notched 
Djelovanje na elektrokardiogram: Kod bolesnika liječenih Ranexom uočeno je produljenje QTc intervala, ovisno o dozi i koncentraciji u plazmi (oko 6 msec kod doze od 1000 mg dvaput dnevno), smanjenje amplitude T vala i, u nekim slučajevima, šiljastih T valova.
Examples of such drugs include certain antihistamines (e.g. terfenadine, astemizole, mizolastine), certain antiarrhythmics (e.g. quinidine, disopyramide, procainamide), erythromycin, and tricyclic antidepressants (e.g. imipramine, doxepin, amitriptyline). 
Primjeri takvih lijekova uključuju određene antihistaminike (npr. terfenadin, astemizol, mizolastin), određene antiaritmike (npr. kinidin, disopiramid, prokainamid), eritromicin i triciklične antidepresive (npr. imipramin, doksepin, amitriptilin).
Nederland Menarini Benelux NV/SA Tel: +32 (0)2 721 4545 
Menarini Benelux NV/SA Tel: +32 (0)2 721 4545
Of the most commonly reported, the following events occurred more often with Ranexa (placebo-corrected frequencies) in elderly (≥ 75 years of age) than younger patients (< 75 years of age): constipation (8% versus 5%), nausea (6% versus 3%), hypotension (5% versus 1%), and vomiting (4% versus 1%). 
Među najčešće zabilježenim nuspojavama, slijedeće su se nuspojave pojavljivale češće kod primjene Ranexe (učestalosti su korigirane u odnosu na placebo) kod starijih (≥ 75 godina života) nego kod mlađih bolesnika (< 75 godina života): konstipacija (8% u odnosu na 5%), mučnina (6% u odnosu na 3%),
Congestive heart failure (CHF): Dose titration in patients with moderate to severe CHF (NYHA Class III-IV) should be exercised with caution (see sections 4.4 and 5.2). 
Kongestivno zatajenje srca: Kod bolesnika s umjerenim do teškim kongestivnim zatajenjem srca (NYHA klasa III-IV) treba pažljivo prilagođavati dozu (vidjeti dijelove 4.4 i 5.2).
Ranexa is contraindicated in patients with severe renal impairment (creatinine clearance < 30 ml/min) (see sections 4.3 and 5.2). 
Ranexa je kontraindicirana kod bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina < 30 ml/min) (vidjeti dijelove 4.3 i 5.2).
which is approximately equal to a 2- to 7-msec increase over the plasma concentration range for ranolazine 500 to 1000 mg twice daily. 
1000 ng/ml, što je otprilike jednako povećanju od 2 do 7 msec iznad raspona koncentracije ranolazina u plazmi kod doze 500 do 1000 mg dvaput dnevno.
This medicine contains less than 1 mmol sodium (23 mg) per prolonged-release tablet, that is to say essentially ‘sodium-free'. 
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po tableti s produljenim oslobađanjem, tj.
• Concomitant administration of moderate CYP3A4 inhibitors (see sections 4.2 and 4.5). 
• Kod istovremene primjene umjerenih inhibitora CYP3A4 (vidjeti dijelove 4.2 i 4.5).
Digoxin: An increase in plasma digoxin concentrations by an average of 1.5-fold has been reported when Ranexa and digoxin are co-administered. 
Digoksin: kod istovremene primjene Ranexe i digoksina zabilježeno je povećanje koncentracija digoksina u plazmi prosječno 1,5 puta.
The slope is higher in patients with clinically significant hepatic impairment. 
Promjene su bile veće kod bolesnika s klinički značajnom oštećenom jetrenom funkcijom.
CHF: CHF NYHA Class III and IV were estimated to have about 1.3-fold higher plasma concentrations. 
klase III i IV imaju oko 1,3 puta veće koncentracije u plazmi.
In a large outcome study (MERLIN-TIMI 36) in 6,560 patients with UA/NSTEMI ACS, there was no difference in the risk of all-cause mortality (relative risk ranolazine:placebo 0.99), sudden cardiac death (relative risk ranolazine:placebo 0.87), or the frequency of symptomatic documented arrhythmias (3.0% versus 3.1%) between Ranexa and placebo when added to standard medical therapy (including beta-blockers, calcium channel blockers, nitrates, anti-platelet agents, lipid-lowering medicinal products, and ACE inhibitors). 
U velikom istraživanju ishoda (MERLIN-TIMI 36) na 6560 bolesnika s nestabilnom anginom ili akutnim koronarnim sindromom bez elevacije ST-segmenta (NSTEMI) nije bilo razlike u riziku od smrtnosti od svih uzroka (relativni rizik ranolazin:placebo 0,99), nagle srčane smrti (relativni rizik ranolazin:placebo 0,87) niti učestalosti simptomatskih dokumentiranih aritmija (3,0% u odnosu na 3,1%) između Ranexe i placeba kad su bili korišteni kao dodatna terapija uz standardnu (uključujući beta-blokatore, blokatore kalcijevih kanala, nitrate, antitrombocitne lijekove, hipolipemike i ACE inhibitore).
The 500 mg tablets are light orange and are engraved with 500 on one side. 
Tablete od 500 mg su svijetlonarančaste s utisnutim 500 s jedne strane.
AUTHORISATION 
PRIMJENU
The potent CYP2D6 inhibitor paroxetine, at a dose of 20 mg once daily, increased steady-state plasma concentrations of ranolazine 1000 mg twice daily by an average of 1.2-fold. 
Paroxetin, snažni inhibitor CYP2D6, u dozi od 20 mg jednom dnevno, povećao je koncentraciju ranolazina u stanju dinamičke ravnoteže, primijenjenog dvaput dnevno u dozi od 1000 mg, prosječno 1,2 puta.
Concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazol, posaconazol, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone) (see sections 4.2 and 4.5). 
Istovremena primjena snažnih inhibitora CYP3A4 (npr. itrakonazola, ketokonazola, vorikonazola, posakonazola, inhibitora HIV proteaze, klaritromicina, telitromicina, nefazodona) (vidjeti dijelove 4.2 i 4.5).
A population-based analysis of combined data from patients and healthy volunteers demonstrated that the slope of the plasma concentration-QTc relationship was estimated to be 2.4 msec per 1000 ng/ml, 
Analiza temeljena na kombiniranim podacima dobivenim iz populacije bolesnika i zdravih dobrovoljaca pokazala je da je krivulja odnosa koncentracije u plazmi i QTc-a procijenjena na 2,4 msec na
Musculoskeletal and connective tissue disorders Uncommon: pain in extremity, muscle cramp, joint swelling, muscular weakness. 
Manje često: bolovi u ekstremitetima, grčevi u mišićima, oticanje zglobova, mišićna slabost.
What Ranexa looks like and contents of the pack Ranexa prolonged-release tablets are oval shaped tablets. 
Ranexa tablete s produljenim oslobađanjem ovalnog su oblika.
Uncommon: dyspnoea, cough, epistaxis. 
Manje često: dispneja, kašalj, epistaksa.
- Keep this leaflet. 
- Sačuvajte ovu uputu o lijeku.
Dose limitation of atorvastatin and appropriate clinical monitoring may be considered when taking Ranexa. 
Kod bolesnika koji uzimaju Ranexu treba razmotriti ograničenje doze atorvastatina i odgovarajuće kliničko praćenje bolesnika.
Ranexa should not be used in patients treated with CYP3A4 inducers (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, St. John's Wort) (see section 4.5). 
Ranexa se ne smije koristiti kod bolesnika liječenih induktorima CYP3A4 (npr. rifampicinom, fenitoinom, fenobarbitalom, karbamazepinom, gospinom travom) (vidjeti dio 4.5).
The 750 mg tablets are pale green and are engraved with 750 on one side. 
Tablete od 750 mg su blijedozelene s utisnutim 750 s jedne strane.
INFORMATION IN BRAILLE Ranexa 375 mg 
Ranexa 375 mg
Combining ranolazine with potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazole, posaconazole, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone) is contraindicated (see section 4.3). 
Kombinacija ranolazina sa snažnim inhibitorima CYP3A4 (npr. itrakonazolom, ketokonazolom, vorikonazolom, posakonazolom, inhibitorima HIV proteaze, klaritromicinom, telitromicinom, nefazodonom) je kontraindicirana (vidjeti dio 4.3).
INFORMATION IN BRAILLE Ranexa 500 mg 
Ranexa 500 mg
Initiation of treatment with Ranexa should be avoided during administration of inducers of CYP3A4 (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, St. John's Wort) (see section 4.4). 
Treba izbjegavati početak liječenja Ranexom tijekom primjene induktora CYP3A4 (npr. rifampicina, fenitoina, fenobarbitala, karbamazepina, gospine trave) (vidjeti dio 4.4).
Hepatic impairment: Careful dose titration is recommended in patients with mild hepatic impairment (see sections 4.4 and 5.2). 
Oštećenje funkcije jetre: Preporučuje se pažljivo prilagođavanje doze kod bolesnika s blagim oštećenjem jetrene funkcije (vidjeti dijelove 4.4 i 5.2).
Reproductive system and breast disorders Rare: erectile dysfunction. 
Rijetko: erektilna disfunkcija.
Swallow whole. 
Menarini Kft.
Österreich A. Menarini Pharma GmbH. 
Menarini Pharma GmbH.
Ranexa 1000 mg twice daily increased plasma concentrations of simvastatin lactone, simvastatin acid by about 2 fold. 
Ranexa primijenjena u dozi od 1000 mg dvaput dnevno povisila je koncentracije simvastatin laktona u plazmi, simvastatinske kiseline oko 2 puta.
Drugs transported by the Organic Cation Transporter-2 (OCT2): Plasma exposure of metformin (1000 mg twice daily) increased 1.4- and 1.8-fold in subjects with type 2 diabetes mellitus when coadministered with RANEXA 500 mg and 1000 mg twice daily respectively. 
Organic Cation Transporter-2, OCT2): Kod bolesnika s diabetesom mellitusom tipa 2 se izloženost metforminu u plazmi (u dozi od 1000 mg, dvaput dnevno) povećala 1,4 odnosno 1,8 puta kada su istodobno uzimali
Uncommon: hot flush, hypotension. 
Manje često: navale vrućine, hipotenzija.
Light orange oval-shaped tablet engraved with 500 on one side. 
Svijetlonarančaste ovalne tablete s utisnutim natpisom 500 s jedne strane.
EU/1/08/462/003 60 tablets in blister pack EU/1/08/462/004 60 tablets in bottle EU/1/08/462/009 30 tablets in blister pack EU/1/08/462/010 100 tablets in blister pack 
EU/1/08/462/003 60 tableta u blister pakiranju EU/1/08/462/004 60 tableta u bočici EU/1/08/462/009 30 tableta u blister pakiranju EU/1/08/462/010 100 tableta u blister pakiranju
Uncommon: increased blood creatinine, increased blood urea, prolonged QT corrected interval, 
Manje često: povišen kreatinin u krvi, povišena urea u krvi, produljen korigirani QT interval, povišen broj trombocita ili leukocita, smanjenje tjelesne težine.