natgillin/translations-raw huggingface dataset:
Musculoskeletal and connective tissue disorders 
Poremećaji mišično-koštanog sustava i vezivnog tkiva
Atrial fibrillation has been more common in patients using concomitantly amiodarone or potent class I anti-arrhythmics. 
Fibrilacija atrija se češće javlja u bolesnika koji istodobno uzimaju amiodaron ili potentne antiaritmike skupine I.
MARKETING AUTHORISATION NUMBER(S) EU/1/05/317/001-007 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/05/317/001-007
Ivabradine is contra-indicated for use in patients with severe hepatic insufficiency, since it has not been studied in this population and a large increase in systemic exposure is anticipated (see sections 4.3 and 5.2). 
Primjena ivabradina je kontraindicirana u bolesnika s teškom jetrenom insuficijencijom, jer nema kliničkih podataka o primjeni ivabradina u toj populaciji te se očekuje veliko povećanje sustavne izloženosti lijeku (vidjeti dijelove 4.3 i 5.2).
and 45%), ivabradine did not have any deleterious influence on LVEF. 
ivabradin nije imao nikakav poguban utjecaj na LVEF.
The Ndesmethylated derivative of ivabradine has been identified as the main active metabolite in humans. 
Kao glavni aktivni metabolit u ljudi identificiran je N-desmetilirani derivat ivabradina.
Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist despite dose reduction. 
Liječenje se mora prekinuti ako srčana frekvencija ostane ispod 50/min ili simptomi bradikardije ustraju usprkos smanjenju doze.
Talk to your doctor or pharmacist before taking Corlentor - if you suffer from heart rhythm disorders (such as irregular heartbeat, palpitation, increase in chest pain) or sustained atrial fibrillation (a type of irregular heartbeat), or an abnormality of electrocardiogram (ECG) called ‘long QT syndrome', - if you have symptoms such as tiredness, dizziness or shortness of breath (this could mean that your heart is slowing down too much), - if you suffer from symptoms of atrial fibrillation (pulse rate at rest unusually high (over 110 beats per minute) or irregular, without any apparent reason, making it difficult to measure), - if you have had a recent stroke (cerebral attack), - if you suffer from mild to moderate low blood pressure, - if you suffer from uncontrolled blood pressure, especially after a change in your antihypertensive treatment, - if you suffer from severe heart failure or heart failure with abnormality of ECG called ‘bundle branch block', - if you suffer from chronic eye retinal disease, - if you suffer from moderate liver problems, - if you suffer from severe renal problems. 
- ako bolujete od poremećaja srčanog ritma (kao nepravilni rad srca, osjećaj lupanja srca, pojačan bol u prsima) ili fibrilacije atrija (vrsta nepravilnog rada srca) ili abnormalnosti u elektrokardiogramu (EKG) koje se nazivaju “sindrom dugog QT intervala”, - ako imate simptome kao što je umor, omaglica ili nedostatka zraka (to bi moglo značiti da Vam srce radi presporo), - ako imate simptome fibrilacije atrija (puls u mirovanju neuobičajeno visok (iznad 110 otkucaja u minuti) ili nepravilan, bez jasnog razloga, što otežava njegovo mjerenje), - ako ste nedavno imali moždani udar, - ako imate blago ili umjereno niski krvni tlak, - ako bolujete od visokog krvnog tlaka koji nije dobro kontroliran, osobito nakon promjene u terapiji
Ελλάδα 
I DOHVATA
The environmental risk assessment of ivabradine has been conducted in accordance to European guidelines on ERA. 
Procjena rizika koji ivabradin može imati na okoliš provedena je u skladu s Europskim smjernicama o procjeni rizika koji lijek može imati na okoliš.
Ivabradine may cause transient luminous phenomena consisting mainly of phosphenes (see section 4.8). 
Ivabradin može uzrokovati prolazne vidne poremećaje u obliku fosfena (vidjeti dio 4.8).
Measurement of heart rate 
Mjerenje srčane frekvencije
A large outcome study, BEAUTIFUL, was performed in 10917 patients with coronary artery disease and left ventricular dysfunction (LVEF<40%) on top of optimal background therapy with 86.9% of patients receiving beta-blockers. 
Veliko ispitivanje BEAUTIFUL, provedeno je na 10 917 bolesnika s koronarnom arterijskom bolešću i disfunkcijom lijeve klijetke (LVEF < 40%) koji su primali uobičajenu terapiju, i od kojih je 86,9%
LIST OF EXCIPIENTS Contains lactose monohydrate. 
Sadrži laktozu hidrat.
Tel: +420 222 118 111 
Servier s.r.o. Tel: +420 222 118 111
Women of childbearing potential 
Žene generativne dobi
The concomitant use of ivabradine with these medicinal products is contraindicated (see section 4.3). 
Kontraindicirana je istodobna primjena ivabradina s tim lijekovima (vidjeti dio 4.4).
QT prolonging medicinal products - Cardiovascular QT prolonging medicinal products (e.g. quinidine, disopyramide, bepridil, sotalol, 
- Kardiovaskularni lijekovi koji produljuju QT-interval (npr. kinidin, disopiramid, bepridil, sotalol,
Ivabradine 5 mg twice daily was shown to be effective on exercise test parameters within 3 to 4 weeks of treatment. 
U roku od 3 do 4 tjedna liječenja pokazalo se da je ivabradin u dozi od 5 mg dva puta na dan imao učinak na parametre testa fizičkog opterećenja.
Excipient with known effect: 61.215 mg lactose monohydrate For the full list of excipients, see section 6.1. 
Pomoćna tvar s poznatim učinkom: 61,215 mg laktoza hidrata
At usual recommended doses, heart rate reduction is approximately 10 bpm at rest and during exercise. 
Uz uobičajene preporučene doze, srčana se frekvencija u mirovanju i tijekom fizičkog napora usporava za oko 10 otkucaja u minuti.
Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. 
Ivabradin je indiciran za simptomatsko liječenje kronične stabilne angine pektoris u odraslih bolesnika s koronarnom arterijskom bolesti s normalnim sinusnim ritmom i sa srčanom frekvencijom ≥ 70 otkucaja u minuti.
Constipation Diarrhoea Abdominal pain* 
Bol u abdomenu*
The efficacy of 5 and 7.5 mg twice daily was consistent across studies on exercise test parameters (total exercise duration, time to limiting angina, time to angina onset and time to 1 mm ST segment depression) and was associated with a decrease of about 70% in the rate of angina attacks. 
Djelotvornost doza od 5 i 7,5 mg dva puta na dan na parametre testa fizičkog opterećenja bila je postojana tijekom ispitivanja (ukupno trajanje fizičkog opterećenja, vrijeme do ograničavanja angine,
Ivabradine efficacy was fully maintained throughout the 3- or 4-month treatment periods in the efficacy trials. 
U ispitivanjima djelotvornosti, ivabradin se pokazao učinkovit tijekom perioda liječenja u trajanju od 3 ili 4 mjeseca.
If heart rate increases persistently above 60 beats per minute at rest, the dose can be up titrated to the next upper dose in patients receiving 2.5 mg twice daily or 5 mg twice daily. 
Ukoliko je srčana frekvencija stalno iznad 60 otkucaja u minuti u mirovanju doza se može titrirati na višu u bolesnika koji uzimaju 2,5 mg dva puta dnevno ili 5 mg dva puta dnevno.
An updated RMP should be submitted: 
Nadopunjen RMP trebao bi biti dostavljen: • Na traženje Europske agencije za lijekove
Marketing Authorisation Holder and Manufacturer 
Nositelj odobrenja za stavljanje u promet gotovog lijeka i proizvođač:
• Obligation to conduct post-authorisation measures 
• Obveza provođenja mjera nakon stavljanja lijeka u promet
Angioedema Rash 
Angioedem Osip
A specific study to assess the possible influence of ivabradine on driving performance has been performed in healthy volunteers where no alteration of the driving performance was evidenced. 
Nije dokazan utjecaj ivabradina na sposobnost upravljanja vozilima tijekom ispitivanja provedenog na zdravim dobrovoljcima.
Eosinophilia 
Eozinofilija
Chronic heart failure 
Kronično zatajenje srca
Corlentor 7.5 mg tablets are salmon-coloured, triangular, film-coated tablets engraved with “7.5” on one face and on the other. 
Corlentor 7,5 mg tablete su trokutaste filmom obložene tablete boje lososa s utisnutom oznakom “7.5” na jednoj strani , a na drugoj.
Palpitations and cardiac extra beats, feeling sick (nausea), constipation, diarrhoea, abdominal pain, spinning sensation (vertigo), difficulty breathing (dyspnoea), muscle cramps, changes in laboratory parameters : high blood levels of uric acid, an excess of eosinophils (a type of white blood cell) and elevated creatinine in blood (a breakdown product of muscle), skin rash, angioedema (such as swollen face, tongue or throat, difficulty in breathing or swallowing), low blood pressure, fainting, feeling of tiredness, feeling of weakness, abnormal ECG heart tracing, double vision, impaired vision. 
Osjećaj lupanja srca i neuobičajeni otkucaji srca, osjećaj slabosti (mučnina), zatvor, proljev, bol u trbuhu, osjećaj vrtnje (vrtoglavica), poteškoće u disanju (dispneja), grčevi u mišićima i promjene u laboratorijskim pretragama: visoka razina mokraćne kiseline u krvi, prekomjeran broj eozinofila (vrsta bijelih krvnih stanica) i povišena razina kreatinina u krvi (nastaje zbog raspada mišića), kožni osip,
Dyspnoea 
Diplopija
Ivabradine does not influence intracardiac conduction, contractility (no negative inotropic effect) or ventricular repolarisation: - in clinical electrophysiology studies, ivabradine had no effect on atrioventricular or intraventricular conduction times or corrected QT intervals; - in patients with left ventricular dysfunction (left ventricular ejection fraction (LVEF) between 30 
- u kliničkim ispitivanjima elektrofiziologije, ivabradin nije imao učinka na atrioventrikulska ili na intraventrikulska vremena provođenja ili korigirane QT-intervale; - u bolesnika s disfunkcijom lijeve klijetke (istisna frakcija lijeve klijetke (LVEF) između 30 i 45%),
In patients treated with ivabradine the risk of developing atrial fibrillation is increased (see section 4.8). 
Povećan je rizik nastanka fibrilacije atrija u bolesnika koji se liječe ivabradinom (vidjeti dio 4.8).
If during treatment, heart rate decreases persistently below 50 beats per minute (bpm) at rest or the patient experiences symptoms related to bradycardia, the dose must be titrated downward to the next lower dose in patients receiving 7.5 mg twice daily or 5 mg twice daily. 
Ukoliko se, tijekom liječenja, nastavi usporavati srčana frekvencija ispod 50 otkucaja u minuti (50/min) u mirovanju, ili u bolesnika nastupe simptomi koji su povezani s bradikardijom, doza se mora titrirati na slijedeću nižu u bolesnika koji primaju 7,5 mg dva puta dnevno ili 5 mg dva puta dnevno.
Use in patients with congenital QT syndrome or treated with QT prolonging medicinal products The use of ivabradine in patients with congenital QT syndrome or treated with QT prolonging medicinal products should be avoided (see section 4.5). 
Treba izbjegavati primjenu ivabradina u bolesnika s QT-sindromom ili onih koji se liječe s pripravcima koji produljuju QT-interval (vidjeti dio 4.5).
In the subgroup of patients with HR ≥ 75 bpm and on the recommended target dose of beta-blocker, no statistically significant benefit was observed on the primary composite endpoint (hazard ratio: 0.97, 95%CI [0.74;1.28]) and other secondary endpoints, including hospitalisation for worsening heart failure (hazard ratio: 0.79, 95% CI [0.56;1.10]) or death from heart failure (hazard ratio: 0.69, 95% CI [0.31;1.53]). 
U podskupini bolesnika sa srčanom frekvencijom ≥ 75/min koji primaju preporučenu ciljnu dozu beta-blokatora nije zabilježena značajna korist za primarni kompozitni ishod (omjer ugroženosti (HR): 0,97, 95%CI [0,74;1,28]) niti za ostale sekundarne ishode uključujući hospitalizaciju zbog pogoršanja zatajenja srca (omjer ugroženosti
Glycerol (E 422) Magnesium stearate (E 470 B) Yellow iron oxide (E172) Red iron oxide (E172) 
Film ovojnica hipromeloza (E 464) titanijev dioksid (E171) makrogol 6000 glicerol (E 422) magnezijev stearat (E 470 B) željezov oksid, žuti (E172) željezov oksid, crveni (E172)
The possible occurrence of such luminous phenomena should be taken into account when driving or using machines in situations where sudden variations in light intensity may occur, especially when driving at night. 
Kada bolesnik upravlja vozilom ili radi na stroju, u situacijama u kojima može iznenada doći do promjene u intenzitetu svjetla, osobito tijekom noćne vožnje, treba voditi računa o mogućnosti nastupanja vidnih poremećaja.
See package leaflet for the other excipients. 
Vidjeti Uputu o lijeku za ostale pomoćne tvari.
NAME OF THE MEDICINAL PRODUCT Corlentor 5 mg film-coated tablets 
NAZIV LIJEKA Corlentor 5 mg filmom obložene tablete
This increase in heart rate can cause the chest pain in people who suffer from angina. 
U ljudi koji boluju od angine, to povećanje srčane frekvencije može uzrokovati bol u prsima.
NAME OF THE MEDICINAL PRODUCT Corlentor 7.5 mg film-coated tablets 
NAZIV LIJEKA Corlentor 7,5 mg filmom obložene tablete
If, during treatment, heart rate decreases below 50 beats per minute (bpm) at rest or the patient experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, the dose must be titrated downward including the lowest dose of 2.5 mg twice daily (one half 5 mg tablet twice daily). 
Ukoliko tijekom liječenja srčana frekvencija padne ispod 50 otkucaja u minuti (50/min) u mirovanju ili u bolesnika nastupe simptomi koji su povezani s bradikardijom, kao što su omaglica, umor ili hipotenzija, doza se mora titrirati na nižu, uključujući najnižu dozu od 2,5 mg dva puta na dan (polovica tablete od 5
Respiratory, 
Omaglica,
Excipient with known effect: 63.91 mg lactose monohydrate For the full list of excipients, see section 6.1. 
Pomoćna tvar s poznatim učinkom: 63,91 mg laktoze hidrata
possibly related to bradycardia 
moguće povezano s bradikardijom
Corlentor 5 mg: one film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride). 
Corlentor 5 mg: jedna filmom obložena tableta sadrži 5 mg ivabradina (što odgovara 5,390 mg ivabradinklorida).
Syncope, possibly related to bradycardia 
Sinkopa, moguće povezano s bradikardijom
6.4 Special precautions for storage 
6.6 Posebne mjere za zbrinjavanje
Precautions for use 
Mjere opreza pri primjeni
- if your resting heart rate before treatment is too slow (below 70 beats per minute); - if you are suffering from cardiogenic shock (a heart condition treated in hospital); - if you suffer from a heart rhythm disorder; - if you are having a heart attack; - if you suffer from very low blood pressure; - if you suffer from unstable angina (a severe form in which chest pain occurs very frequently and with or without exertion); - if you have heart failure which has recently become worse; - if your heart beat is exclusively imposed by your pacemaker; - if you suffer from severe liver problems; - if you are already taking medicines for the treatment of fungal infections (such as ketoconazole, 
- ako Vam je srčana frekvencija u mirovanju prije liječenja prespora (manje od 70 otkucaja u minuti); - ako bolujete od kardiogenog šoka (medicinsko stanje koje se liječi u bolnici); - ako bolujete od poremećaja srčanog ritma; - ako imate srčani udar;
- The other ingredients in the tablet core are: lactose monohydrate, magnesium stearate (E 470 B), maize starch, maltodextrin, colloidal anhydrous silica (E 551), and in the tablet coating: hypromellose (E 464), titanium dioxide (E 171), macrogol 6000, glycerol (E 422), magnesium stearate (E 470 B), yellow iron oxide (E 172), red iron oxide (E 172). 
- Pomoćne tvari u jezgri tablete su: laktoza hidrat, magnezijev stearat (E 470 B), kukuruzni škrob, maltodekstrin, bezvodni koloidni silicijev dioksid (E 551); a u ovojnici tablete: hipromeloza (E 464),
SIA Servier Latvia Tel: + 371 6750 2039 
Tel: + 371 6750 2039
Laboratorios Servier, S.L. 
Servier Laboratories (Ireland) Ltd.
Corlentor 7.5 mg: one film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride). 
Corlentor 7,5 mg: jedna filmom obložena tableta sadrži 7,5 mg ivabradina (što odgovara 8,085 mg ivabradinklorida).
de los Madroños, 33 -28043 Madrid, Spain The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch. 
Na tiskanoj uputi o lijeku mora se navesti naziv i adresa proizvođača odgovornog za puštanje navedene serije u promet.
However, in the absence of extensive data, non urgent DC-cardioversion should be considered 24 hours after the last dose of ivabradine. 
kardioverzija se može učiniti 24 sata nakon posljednje doze ivabradina.
What Corlentor looks like and contents of the pack Corlentor 5 mg tablets are salmon-coloured, oblong film-coated tablets scored on both sides, engraved with “5” on one face and on the other. 
Corlentor 5 mg tablete su duguljaste filmom obložene tablete boje lososa s razdjelnom crtom na obje strane, s utisnutom oznakom “5” na jednoj strani, a na drugoj.
Asthenia, possibly related to bradycardia Fatigue, possibly related to bradycardia 
Astenija, moguće povezana s bradikardijom Umor, moguće povezan s bradikardijom
Make sure to tell your doctor if you are taking any of the following medicines, as a dose adjustment of Corlentor or monitoring should be required: - fluconazole (an antifungal medicine) - rifampicin (an antibiotic) - barbiturates (for difficult sleeping or epilepsy) - phenytoin (for epilepsy) - Hypericum perforatum or St John's Wort (herbal treatment for depression) - QT prolonging medicines to treat either heart rhythm disorders or other conditions : - quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders) - bepridil (to treat angina pectoris) - certain types of medicines to treat anxiety, schizophrenia or other psychoses (such as pimozide, ziprasidone, sertindole) - anti-malarial medicines (such as mefloquine or halofantrine) - intravenous erythromycin (an antibiotic) - pentamidine (an antiparasitic medicine) - cisapride (against the gastro-oesophageal reflux) - Some types of diuretics which may cause decrease in blood potassium level, such as furosemide, hydrochlorothiazide, indapamide (used to treat oedema, high blood pressure). 
Ako uzimate neke od slijedećih lijekova, svakako o tome obavijestite svog liječnika koji bi trebao prilagoditi dozu Corlentora ili pratiti liječenje: - flukonazol (antifungik) - rifampicin (antibiotik) - barbiturati (za otežano spavanje ili epilepsiju) - fenitoin (za epilepsiju) - Hypericum perforatum ili Gospina trava (biljna terapija za depresiju) - lijekovi koji produljuju QT-interval i primjenjuju se za liječenje poremećaja srčanog ritma ili drugih bolesti:
PK/PD relationship analysis has shown that heart rate decreases almost linearly with increasing ivabradine and S 18982 plasma concentrations for doses of up to 15-20 mg twice daily. 
Analiza PK/PD odnosa pokazala je da se srčana frekvencija gotovo linearno smanjuje, kako se povećavaju koncentracije ivabradina i metabolita
Salmon-coloured, oblong, film-coated tablet scored on both sides, engraved with “5” on one face and on the other face. 
Duguljasta filmom obložena tableta boje lososa s razdjelnom crtom na obje strane, s utisnutom oznakom “5” na jednoj strani a na drugoj.
Therefore the intake of grapefruit juice should be avoided. 
Stoga je tijekom liječenja ivabradinom potrebno izbjegavati konzumiranje soka od grejpa.
In the subgroup of patients with HR ≥ 75 bpm (n=4150), a greater reduction was observed in the primary composite endpoint of 24 % (hazard ratio: 0.76, 95%CI [0.68;0.85] - p<0.0001) and for other secondary endpoints, including all cause death (hazard ratio: 0.83, 95%CI [0.72;0.96] - p=0.0109) and CV death (hazard ratio: 0.83, 95%CI [0.71;0.97] - p=0.0166). 
U podskupini bolesnika sa srčanom frekvencijom ≥ 75/min (n=4 150), zabilježeno je izraženije smanjenje primarnog kompozitnog ishoda od 24% (omjer ugroženosti (HR): 0,76, 95%CI [0,68;0,85] - p<0,0001)
It may harm them, even if their signs of illness are the same as yours. 
Može im štetiti, čak i ako su njihovi znakovi bolesti jednaki Vašima.
josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone (see sections 4.5 and 5.2) - Combination with verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate reducing properties (see section 4.5) - Pregnancy, lactation and women of child-bearing potential not using appropriate contraceptive measures (see section 4.6) 
Istodobna primjena s inhibitorima citokroma P450 3A4 kao što su azolni antimikotici (ketokonazol, itrakonazol), makrolidni antibiotici (klaritromicin, eritromicin per os, jozamicin, telitromicin), inhibitori proteaze HIV-a (nelfinavir, ritonavir) i nefazodon (vidjeti dijelove 4.5 i 5.2) Istodobna primjena s verapamilom ili diltiazemom koji su umjereni inhibitori CYP3A4 s učinkom na smanjenje srčane frekvencije (vidjeti dio 4.5)
Erythema Pruritus Urticaria 
Tablični prikaz nuspojava
Caution should be exercised when using ivabradine in patients with moderate hepatic impairment. 
Pri primjeni ivabradina u bolesnika s umjerenim oštećenjem jetre potreban je oprez.
NAME OF THE MEDICINAL PRODUCT Corlentor 5 mg film-coated tablets ivabradine 
Corlentor 5 mg filmom obložene tablete ivabradin
Visual function 
NAVOĐENJE DJELATNE/IH
Dizziness, possibly related to bradycardia 
Malaksalost, moguće povezano s bradikardijom
Patients with hypotension 
Mjere opreza pri primjeni Bolesnici s hipotenzijom
NAME OF THE MEDICINAL PRODUCT Corlentor 7.5 mg film-coated tablets ivabradine 
Corlentor 7,5 mg filmom obložene tablete ivabradin
- Non cardiovascular QT prolonging medicinal products (e.g. pimozide, ziprasidone, sertindole, 
- lijekovi za liječenje anksioznosti, shizofrenije ili drugih psihoza (kao što su pimozid, ziprasidon,
There is no evidence of risk of (excessive) bradycardia on return to sinus rhythm when pharmacological cardioversion is initiated in patients treated with ivabradine. 
Pri farmakološkoj konverziji u sinusni ritam, u bolesnika koji se liječe ivabradinom, nije zabilježena opasnost od razvoja (prekomjerne) bradikardije.
One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride). 
Jedna filmom obložena tableta sadrži 7,5mg ivabradina (što odgovara 8,085 mg ivabradinklorida)
Concomitant use with precautions - Moderate CYP3A4 inhibitors: the concomitant use of ivabradine with other moderate CYP3A4 inhibitors (e.g. fluconazole) may be considered at the starting dose of 2.5 mg twice daily and if resting heart rate is above 70 bpm, with monitoring of heart rate. 
inhibitorima (npr. flukonazol) je moguća uz početnu dozu od 2,5 mg dva puta na dan, te ako je srčana frekvencija u mirovanju veća od 70/min te uz praćenje frekvencije srca.
0.5% of patients experienced a severe bradycardia below or equal to 40 bpm. 
bolesnika imalo je tešku bradikardiju s brojem otkucaja u minuti ispod ili jednako 40.
Therefore, ivabradine is contra-indicated during breast-feeding (see section 4.3). 
Stoga je ivabradin kontraindiciran u žena koje doje (vidjeti dio 4.3).
No dose adjustment is required in patients with mild hepatic impairment. 
U bolesnika s blagim oštećenjem jetrene funkcije nije potrebno prilagođavati dozu.
Salmon-coloured, triangular, film-coated tablet engraved with “7.5” on one face and on the other face. 
Trokutasta filmom obložena tableta boje lososa s utisnutom oznakom “7,5” na jednoj strani, a na drugoj.
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Resting heart rate below 70 beats per minute prior to treatment - Cardiogenic shock - Acute myocardial infarction - Severe hypotension (< 90/50 mmHg) - Severe hepatic insufficiency - Sick sinus syndrome - Sino-atrial block - Unstable or acute heart failure - Pacemaker dependent (heart rate imposed exclusively by the pacemaker) - Unstable angina - AV-block of 3rd degree - Combination with strong cytochrome P450 3A4 inhibitors such as azole antifungals 
Akutni infarkt miokarda Teška hipotenzija (< 90/50 mmHg) Teška insuficijencija jetre Sindrom bolesnog sinusnog čvora Sinusatrijski blok Nestabilno ili akutno zatajenje srca