natgillin/translations-raw huggingface dataset:
At therapeutic concentrations, entacapone does not displace other extensively bound active substances (e.g. warfarin, salicylic acid, phenylbutazone, or diazepam), nor is it displaced to any significant extent by any of these substances at therapeutic or higher concentrations. 
V terapevtskih koncentracijah entakapon ne izpodriva drugih učinkovin, ki se vežejo v velikem odstotku (npr. varfarin, salicilna kislina, fenilbutazon ali diazepam), niti ga nobena od teh učinkovin v terapevtskih ali tudi višjih koncentracijah bistveno ne izpodriva.
Entacapone slows the clearance of levodopa from the bloodstream resulting in an increased area under the curve (AUC) in the pharmacokinetic profile of levodopa. 
Entakapon upočasni izločanje levodope iz krvnega obtoka, kar ima v farmakokinetičnem profilu levodope za posledico povečano površino pod krivuljo (AUC).
Do not take Levodopa/Carbidopa/Entacapone Orion if you are taking certain medicines for treating depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors). 
Ne uporabljajte zdravila Levodopa/Carbidopa/Entacapone Orion, če jemljete nekatera zdravila za zdravljenje depresije (kombinacija selektivnih zaviralcev MAO-A in MAO-B ali neselektivnih zaviralcev MAO).
These can be symptoms of neuroleptic malignant syndrome (NMS, a rare severe reaction to medicines used to treat disorders of the central nervous system) or rhabdomyolysis (a rare severe muscle disorder). 
To so lahko simptomi nevroleptičnega malignega sindroma (NMS, zelo redka huda reakcija na zdravila, ki se uporabljajo za zdravljenje bolezni osrednjega živčnega sistema) ali rabdomiolize (redka huda bolezen mišic).
Some of these adverse reactions relate to the increased dopaminergic activity (e.g. dyskinesia, nausea and vomiting) and occur most commonly at the beginning of the treatment. 
Nekateri od teh neželenih učinkov so povezani z večjo dopaminergično aktivnostjo (npr. diskinezija, navzea in bruhanje) in se pogosto pojavijo ob začetku zdravljenja.
As levodopa is extensively metabolised in the periphery, only a small portion of a given dose reaches the central nervous system when levodopa is administered without metabolic enzyme inhibitors. 
Ker se levodopa večinoma presnavlja periferno, le majhen delež odmerka doseže osrednji živčni sistem, kadar se levodopa uporablja brez zaviralcev encimov, ki sodelujejo pri presnovi.
According to in vitro studies, significant displacement is not anticipated at therapeutic concentrations of the medicinal products. 
In vitro raziskave kažejo, da ob terapevtskih koncentracijah zdravila ni pričakovati večjega spodrivanja.
Ischemic heart disease events other than myocardial infarction (e.g. angina pectoris)**, irregular heart rhythm 
dogodki ishemične srčne bolezni razen miokardnega infarkta (npr. angina pektoris)**, nepravilen srčni ritem
- All patients treated with Levodopa/Carbidopa/Entacapone Orion should be monitored carefully for the development of mental changes, depression with suicidal tendencies, and other serious antisocial behaviour. 
- Vse bolnike, ki se zdravijo z zdravilom Levodopa/Carbidopa/Entacapone Orion, je treba skrbno spremljati, če bi prišlo do psihičnih sprememb, depresije s samomorilnimi nagnjenji ter drugih resnih oblik antisocialnega vedenja.
Each tablet is to be taken orally either with or without food (see section 5.2). 
Tableta se vzame peroralno med jedjo ali na prazen želodec (glejte poglavje 5.2).
The starting dose of Levodopa/Carbidopa/Entacapone Orion should provide either the same amount of levodopa or slightly (5-10%) more. 
Začetni odmerek zdravila Levodopa/Carbidopa/Entacapone Orion naj zagotavlja enako ali nekoliko (5-10 %) večjo količino levodope.
The elimination-half life is (t1/2) is 0.6-1.3 hours for levodopa, 2-3 hours for carbidopa and 0.4-0.7 hours for entacapone, each given separately. 
Razpolovni čas izločanja (t1/2) je 0,6-1,3 ure za levodopo, 2-3 ure za karbidopo in 0,4-0,7 ur za entakapon, ob samostojni aplikaciji vsakega posameznega zdravila.
In the pharmacokinetic studies with Levodopa/Carbidopa/Entacapone Orion the bioavailability of levodopa is higher in women than in men, primarily due to the difference in body weight, while there is no gender difference with carbidopa and entacapone. 
V raziskavah farmakokinetike zdravila Levodopa/Carbidopa/Entacapone Orion je biološka uporabnost levodope pri ženskah večja kot pri moških predvsem zaradi razlike v telesni masi, medtem ko pri karbidopi in entakaponu razlike med spoloma ni bilo.
Rhabdomyolysis* 
rabdomioliza*
Levodopa/Carbidopa/Entacapone Orion should not be used during pregnancy unless the benefits for the mother outweigh the possible risks to the foetus. 
Zdravila Levodopa/Carbidopa/Entacapone Orion ne smete uporabljati pri nosečnicah, razen če koristi za mater ne odtehtajo morebitnega tveganja za plod.
Entacapone showed little or no inhibition of other types of P450 isoenzymes (CYP1A2, CYP2A6, CYP2D6, CYP2E1, CYP3A and CYP2C19); see section 4.5. 
Zaviralni učinek entakapona na druge vrste izoencimov P450 (CYP1A2, CYP2A6, CYP2D6, CYP2E1, CYP3A in CYP2C19) pa je bil majhen ali ga sploh ni bilo (glejte poglavje 4.5).
The most frequently reported adverse reactions with Levodopa/Carbidopa/Entacapone Orion are dyskinesias occurring in approximately 19% of patients; gastrointestinal symptoms including nausea and diarrhoea occurring in approximately 15% and 12% of patients, respectively; muscle, musculoskeletal and connective tissue pain occurring in approximately 12% of patients; and harmless reddish-brown discolouration of urine (chromaturia) occurring in approximately 10% of patients. 
Najpogostejši neželeni učinki, o katerih so poročali pri zdravilu Levodopa/Carbidopa/Entacapone Orion, so diskinezija, ki se pojavi pri približno 19 % bolnikov; gastrointestinalni simptomi vključno z navzeo in drisko, ki se pojavijo pri 15 % oz. 12 % bolnikov, bolečina mišic, mišično-skeletna bolečina in bolečina vezivnega tkiva, ki se pojavi pri približno 12 % bolnikov; neškodljivo rdečkastorjavkasto obarvanje urina (kromaturija), ki se pojavi pri približno 10 % bolnikov.
Dopamine dysregulation syndrome is a well-recognised risk for dopaminergic medication used in Parkinson's disease. 
Sindrom motene regulacije dopamina je dobro znano tveganje pri dopaminergičnih zdravilih, ki se uporabljajo za zdravljenje Parkinsonove bolezni.
You may experience the following side effects: - Inability to resist the impulse to perform an action that could be harmful, which may include: - strong impulse to gamble excessively despite serious personal or family consequences - altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive - uncontrollable excessive shopping or spending - binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger). 
Lahko pride do naslednjih neželenih učinkov: - nezmožnost upiranja nagibom za izvajanje dejavnosti, ki so lahko škodljive in lahko vključujejo: - močno željo po pretiranem igranju iger na srečo kljub resnim posledicam, ki jih ima to lahko za bolnika osebno ali za njegovo družino; - spremenjeno ali povečano zanimanje za spolnost in zaskrbljujoče spolno vedenje, na primer povečano spolno slo; - neobvladljivo prekomerno nakupovanje ali zapravljanje; - prenajedanje (uživanje velikih količin hrane v kratkem času) ali kompulzivno prenajedanje (uživanje večjih količin hrane kot običajno oziroma več, kot je potrebno za potešitev lakote).
Affected patients show a compulsive pattern of dopaminergic drug misuse above doses adequate to control motor symptoms, which may in some cases result in severe dyskinesias (see also section 4.4). 
Pri teh bolnikih se kaže kompulzivna oblika zlorabe dopaminergičnih zdravil z odmerki, večjimi od tistih, ki so ustrezni za obvladovanje motoričnih simptomov, kar lahko v nekaterih primerih vodi do hude diskinezije (glejte tudi poglavje 4.4).
Label Orion Corporation 
Nalepka Orion Corporation
The CHMP recommends that the terms of the Marketing Authorisations should be varied. 
Odbor CHMP zato priporoča spremembo pogojev dovoljenja (dovoljenj) za promet z zdravilom.
Adverse reactions that are mainly attributable to entacapone or are more frequent with entacapone than levodopa/DDC inhibitor alone are indicated with an asterisk in Table 1, section 4.8b. 
Neželeni učinki, ki se pripisujejo pretežno entakaponu ali pa so z njim bolj pogosti kot samo z levodopo/zaviralcem dekarboksilaze, so označeni z zvezdico v preglednici 1, poglavje 4.8b.
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATIONS 
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO POGOJEV DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
This is translated to a mean increase of 35 min in the daily ON time. 
To odgovarja srednjemu povečanju dnevnega trajanja intervala »ON« za 35 min.
Do not use this medicine after the expiry date which is stated on the bottle and the carton after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na steklenici in na škatli poleg oznake Uporabno do. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
- Levodopa/Carbidopa/Entacapone Orion contains sucrose, and therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucraseisomaltase insufficiency should not take this medicine. 
- Zdravilo Levodopa/Carbidopa/Entacapone Orion vsebuje saharozo, zato bolniki z redkimi prirojenimi motnjami, kot so intoleranca za fruktozo, malabsorpcija glukoze-galaktoze ali pomanjkanje saharaze-izomaltaze, ne smejo jemati tega zdravila.
Hepatic impairment: The metabolism of entacapone is slowed in patients with mild to moderate hepatic impairment (Child-Pugh Class A and B) leading to an increased plasma concentration of entacapone both in the absorption and elimination phases (see sections 4.2 and 4.3). 
Okvara jeter: Pri bolnikih z blago do zmerno okvaro jeter (razred A-B po Child-Pughovi klasifikaciji) je presnova entakapona upočasnjena, zaradi česar pride do povečanih koncentracij entakapona v plazmi tako v fazi absorpcije kot tudi v fazi izločanja (glejte poglavji 4.2 in 4.3).
Carbidopa and entacapone improve the antiparkinson effects of levodopa. 
Karbidopa in entakapon izboljšata antiparkinsonski učinek levodope.
Hepatic function test abnormal* 
nenormalni testi delovanja jeter*
Therefore, the use of Levodopa/Carbidopa/Entacapone Orion in children or adolescents is not recommended. 
Zato se uporaba zdravila Levodopa/Carbidopa/Entacapone Orion pri otrocih ali mladostnikih ne priporoča.
Other adverse reactions with an asterisk in Table 1, section 4.8b are marked based on either their more frequent occurring (by the frequency difference of at least 1%) in the clinical trial data with entacapone than levodopa/DDCI alone or the individual case safety reports received after the introduction of entacapone into the market. 
Drugi neželeni učinki z zvezdico v preglednici 1, poglavje 4.8b, so označeni na podlagi bodisi pogostejše pojavnosti (pri čemer je razlika v pogostnosti vsaj 1 %) v podatkih iz kliničnih preskušanj z entakaponom kot samo z levodopo/zaviralcem dekarboksilaze ali posameznih primerov varnostnih poročil, prejetih po uvedbi entakapona na trg.
Take a tablet as soon as you remember, wait 1 hour, then take another tablet. 
Če je do naslednjega odmerka manj kot 1 uro časa: vzemite tableto takoj, ko se spomnite, počakajte 1 uro in nato vzemite naslednjo tableto.
Patients being treated with Levodopa/Carbidopa/Entacapone Orion and presenting with somnolence and/or sudden sleep onset episodes must be instructed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. operating machines) until such recurrent episodes have resolved (see section 4.4). 
Bolnikom, ki se zdravijo z zdravilom Levodopa/Carbidopa/Entacapone Orion in navajajo pojav zaspanosti in nenadnega spanca, je treba odsvetovati da vozijo ali se udejstvujejo v dejavnostih, pri katerih lahko zaradi zmanjšane pozornosti sebe ali druge izpostavljajo nevarnosti resne poškodbe ali smrti (npr. upravljanje strojev), vse dokler te epizode ne minejo (glejte poglavje 4.4).
In repeated dose toxicity studies with entacapone, anaemia most likely due to iron chelating properties of entacapone was observed. 
V študijah toksičnosti ponavljajočih se odmerkov entakapona poročajo o anemiji, ki nastane verjetno kot posledica lastnosti entakapona, da kelira železo.
On the basis of the scientific conclusions for carbidopa/entacapone/levodopa the CHMP is of the opinion that the benefit-risk balance of the medicinal products containing carbidopa/entacapone/levodopa is unchanged subject to the proposed changes to the product information. 
Na podlagi znanstvenih zaključkov za carbidopo/entakapon/levodopo odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) carbidopo/entakapon/levodopo nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
With inhibition of the decarboxylase by a DDC inhibitor, catechol-O-methyltransferase (COMT) becomes the major peripheral metabolic pathway catalyzing the conversion of levodopa to 3-Omethyldopa (3-OMD), a potentially harmful metabolite of levodopa. 
Po zavrtju dekarboksilaze z zaviralcem DDK postane katehol-O-metiltransferaza (COMT) glavna periferna pot presnove, ki katalizira pretvorbo levodope v 3-O-metildopo (3-OMD), potencialno škodljiv presnovek levodope.
- In clinical studies, dopaminergic adverse reactions, e.g. dyskinesia, were more common in patients who received entacapone and dopamine agonists (such as bromocriptine), selegiline or amantadine compared to those who received placebo with this combination. 
- V kliničnih raziskavah so bili neželeni dopaminergični učinki (npr. diskinezija) pogostejši pri bolnikih, ki so prejemali entakapon in agoniste dopamina (kot je bromokriptin), selegilin ali amantadin, kot pa pri tistih, ki so prejemali to kombinacijo s placebom.
No particular studies are reported on the pharmacokinetics of levodopa and carbidopa in patients with renal impairment. 
Ni poročil o posebnih raziskavah farmakokinetike levodope in karbidope pri bolnikih z okvaro ledvic.
Due to entacapone's affinity to cytochrome P450 2C9 in vitro (see section 5.2), Levodopa/Carbidopa/Entacapone Orion may potentially interfere with active substances whose metabolism is dependent on this isoenzyme, such as S-warfarin. 
Ker ima entakapon afiniteto za citokrom P450 2C9 in vitro (glejte poglavje 5.2), lahko zdravilo Levodopa/Carbidopa/Entacapone Orion potencialno vpliva na delovanje učinkovin katerih presnova je odvisna od tega izoencima, kot je to S-varfarin.
Regarding reproduction toxicity of entacapone, decreased foetal weight and a slightly delayed bone development were noticed in rabbits treated at systemic exposure levels in the therapeutic range. 
V zvezi z vplivom na sposobnost razmnoževanja entakapona poročajo o manjši masi ploda in nekoliko zapoznelem razvoju kosti pri zajcih ob sistemski izpostavljenosti koncentracijam znotraj terapevtskega razpona.
Levodopa is excreted in human breast milk. 
Levodopa se izloča v materino mleko.
Chest pain, peripheral oedema, fall, gait disturbance, asthenia, fatigue 
bolečina v prsih, periferni edem, padanje, motnje aktivnosti, astenija, utrujenost
Experience with Levodopa/Carbidopa/Entacapone Orion in patients under 18 years is limited. 
Izkušnje z zdravilom Levodopa/Carbidopa/Entacapone Orion pri bolnikih, starih manj kot 18 let, so omejene.
Chromaturia* 
kromaturija*
If you have accidentally taken more Levodopa/Carbidopa/Entacapone Orion tablets than you should, talk to your doctor or pharmacist immediately. 
Če ste po naključju vzeli več tablet zdravila Levodopa/Carbidopa/Entacapone Orion, kot bi smeli, se nemudoma posvetujte s svojim zdravnikom ali farmacevtom.
The evidence of the therapeutic effects of Levodopa/Carbidopa/Entacapone Orion is based on two phase III double-blind studies, in which 376 Parkinson's disease patients with end-of-dose motor fluctuations received either entacapone or placebo with each levodopa/DDC inhibitor dose. 
Dokazi o terapevtskih učinkih zdravila Levodopa/Carbidopa/Entacapone Orion temeljijo na dveh dvojno slepih raziskavah III. faze, v katerih je 376 bolnikov s Parkinsonovo boleznijo in motoričnimi fluktuacijami na koncu odmernega obdobja ob vsakem odmerku levodope/zaviralca DDK prejemalo bodisi entakapon ali placebo.
Hospitalisation is advised and general supportive measures should be employed with immediate gastric lavage and repeated doses of charcoal over time. 
Svetuje se hospitalizacija s splošnimi podpornimi ukrepi, takojšnjim izpiranjem želodca in večkratnimi odmerki aktivnega oglja v času zdravljenja.
BOTTLE LABEL AND OUTER CARTON TEXT 
NALEPKA NA STEKLENIČKI IN BESEDILO NA ZUNANJI OVOJNINI
- Entacapone in association with levodopa has been associated with somnolence and episodes of sudden sleep onset in patients with Parkinson's disease and caution should therefore be exercised when driving or operating machines (see section 4.7). 
- Entakapon v kombinaciji z levodopo povezujejo s pojavom zaspanosti in nenadnega spanca pri bolnikih s Parkinsonovo boleznijo, zaradi česar je potrebna previdnost pri vožnji in upravljanju strojev (glejte poglavje 4.7).
*Adverse reactions that are mainly attributable to entacapone or are more frequent (by the frequency difference of at least 1% in the clinical trial data) with entacapone than levodopa/DDC inhibitor alone. 
*Neželeni učinki, ki se v glavnem pripisujejo entakaponu ali so z entakaponom pogostejši (z razliko v pogostnosti vsaj 1 % po podatkih iz kliničnih preskušanj) kot samo z levodopo/zaviralcem dekarboksilaze.
- Patients with chronic wide-angle glaucoma may be treated with Levodopa/Carbidopa/Entacapone Orion with caution, provided the intra-ocular pressure is well controlled and the patient is monitored carefully for changes in intra-ocular pressure. 
- Bolniki s kroničnim glavkomom odprtega zakotja se ob primerni previdnosti lahko zdravijo z zdravilom Levodopa/Carbidopa/Entacapone Orion, pod pogojem, da je intraokularni tlak dobro obvladovan in da bolnika skrbno spremljamo, če bi se pojavile spremembe v intraokularnem tlaku.
MAO-B inhibitors, or non-selective MAO-inhibitors) - have ever had neuroleptic malignant syndrome (NMS - this is a rare reaction to medicines used to treat severe mental disorders) - have ever had non-traumatic rhabdomyolysis (a rare muscle disorder) - have a severe liver disease. 
MAO-A in MAO-B ali neselektivne zaviralce MAO); - če ste že kdaj imeli maligni nevroleptični sindrom (NMS - to je redka reakcija na zdravila, ki se uporabljajo za zdravljenje hudih duševnih motenj); - če ste že kdaj imeli netravmatsko rabdomiolizo (redko obolenje mišic); - če imate hudo bolezen jeter.
Tell your doctor if you or your family/carer notices you are developing addiction-like symptoms leading to craving for large doses of Levodopa/Carbidopa/Entacapone Orion and other medicines used to treat Parkinson's disease. 
Obvestite zdravnika, če vi ali kdo od družinskih članov/negovalec opazi(te), da se pri vas razvijajo simptomi, podobni odvisnosti, ki vodijo do potrebe po velikih odmerkih zdravila Levodopa/Carbidopa/Entacapone Orion in drugih zdravil za zdravljenje Parkinsonove bolezni.
Levodopa/Carbidopa/Entacapone Orion is not recommended to be used for treatment of extrapyramidal symptoms (e.g. involuntary movements, shaking, muscle rigidity and muscle contractions) caused by other medicines. 
Zdravilo Levodopa/Carbidopa/Entacapone Orion se ne priporoča za zdravljenje ekstrapiramidnih simptomov (npr. nehotnih gibov, tremorja, otrdelosti mišic in mišičnih kontrakcij), ki jih povzročajo druga zdravila.
When decarboxylation of levodopa is reduced with the co-administration of a DDC inhibitor, a lower dose of levodopa can be used and the incidence of adverse reactions such as nausea is reduced. 
Kadar se dekarboksilacija levodope zmanjša s pomočjo sočasne uporabe zaviralca DDK, se lahko uporabi manjši odmerek levodope, s tem pa se zmanjša incidenca neželenih učinkov, kot je npr. bruhanje.
Levodopa/Carbidopa/Entacapone Orion may lower your blood pressure, which may make you feel light-headed or dizzy. 
Zdravilo Levodopa/Carbidopa/Entacapone Orion lahko zniža vaš krvni tlak, zaradi česar se boste počutili vrtoglavi in omotični.
- In patients with a history of myocardial infarction who have residual atrial nodal or ventricular arrhythmias; cardiac function should be monitored with particular care during the period of initial dose adjustments. 
- Pri bolnikih z anamnezo miokardnega infarkta, ki imajo rezidualne preddvorne nodalne ali prekatne motnje srčnega ritma, je treba delovanje srca še posebej skrbno spremljati v obdobju prilagajanja začetnega odmerka.
Dopamine does not cross the blood-brain barrier. 
Dopamin ne prehaja skozi krvnomožgansko pregrado.
- If general anaesthesia is required, therapy with Levodopa/Carbidopa/Entacapone Orion may be continued for as long as the patient is permitted to take fluids and medicinal products by mouth. 
- Če je potrebna splošna anestezija, se lahko terapija z zdravilom Levodopa/Carbidopa/Entacapone Orion nadaljuje vse dokler sme bolnik jemati tekočine in zdravila peroralno.
Paediatric population: The safety and efficacy of Levodopa/Carbidopa/Entacapone Orion in children aged below 18 years have not been established. 
Pediatrična populacija: Varnost in učinkovitost zdravila Levodopa/Carbidopa/Entacapone Orion pri otrocih starih do 18 let nista bili dokazani.
A significant number of Parkinson's disease patients have been treated with the combination of levodopa, carbidopa and entacapone with several active substances including MAO-A inhibitors, tricyclic antidepressants, noradrenaline reuptake inhibitors such as desipramine, maprotiline and venlafaxine and medicinal products that are metabolised by COMT (e.g. catechol-structured compounds, paroxetine). 
Znatno število bolnikov s Parkinsonovo boleznijo so zdravili s kombinacijo levodope, karbidope in entakapona ter mnogimi učinkovinami, vključno z zaviralci MAO-A, tricikličnimi antidepresivi, zaviralci ponovnega privzema noradrenalina, kot so dezipramin, maprotilin in venlafaksin, ter zdravila, ki se presnavljajo preko COMT (npr. učinkovine, ki imajo v svoji strukturi katehol, paroksetin).
You should be aware that Levodopa/Carbidopa/Entacapone Orion may make these reactions worse. 
Zavedati se morate, da lahko zdravilo Levodopa/Carbidopa/Entacapone Orion te reakcije še poslabša.
Interactions between entacapone and selegiline have been investigated in repeated dose studies in Parkinson's disease patients treated with levodopa/DDC inhibitor and no interaction was observed. 
Interakcije med entakaponom in selegilinom so proučevali v raziskavah z večkratnimi odmerki pri bolnikih s Parkinsonovo boleznijo, ki so bili zdravljeni z levodopo/zaviralci DDK in niso ugotovili nobenih interakcij.
The following adverse reactions, listed in Table 1, have been accumulated both from a pooled data of eleven double-blind clinical trials consisting of 3230 patients (1810 treated with Levodopa/Carbidopa/Entacapone Orion or entacapone combined with levodopa/DDC inhibitor, and 1420 treated with placebo combined with levodopa/DDC inhibitor or cabergoline combined with levodopa/ DDC inhibitor), and from the post-marketing data since the introduction of entacapone into the market for the combination use of entacapone with levodopa/DDC inhibitor. 
Neželeni učinki v nadaljevanju, našteti v preglednici 1, so bili zbrani iz združenih podatkov enajstih dvojno slepih kliničnih preskušanj, ki so zajela 3.230 bolnikov (1.810 zdravljenih z zdravilom Levodopa/Carbidopa/Entacapone Orion ali entakaponom v kombinaciji z levodopo/zaviralcem dekarboksilaze, in 1.420 zdravljenih s placebom v kombinaciji z levodopo/zaviralcem dekarboksilaze ali kabergolinom v kombinaciji z levodopo/zaviralcem dekarboksilaze), in iz podatkov v obdobju trženja, od uvedbe entekapona za kombinirano uporabo z levodopo/zaviralcem dekarboksilaze.