natgillin/translations-raw huggingface dataset:
The most abundant peaks in plasma after a single-dose of 100 mg 14C-opicapone are metabolites BIA 9-1103 (sulphate) and BIA 9-1104 (methylated), 67.1 and 20.5% of radioactive AUC respectively. 
Z največjo koncentracijo v plazmi po enkratnem odmerku 100 mg 14C-opikapona sta zastopana presnovka BIA 9-1103 (sulfat) in BIA 9-1104 (metiliran), ki predstavljata 67,1 oz. 20,5 % radioaktivne vrednosti AUC.
There is no clinical experience in patients with severe hepatic impairment (Child-Pugh Class C), therefore, Ongentys is not recommended in these patients (see section 5.2). 
Kliničnih izkušenj z bolniki s hudo okvaro jeter (stopnje C po Child-Pughu) ni, zato se zdravila Ongentys pri teh bolnikih ne priporoča (glejte poglavje 5.2).
À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal tel: +351 22 986 61 00 fax: +351 22 986 61 90 e-mail: info@bial.com 
À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugalska tel: +351 22.986 61 00 faks: +351 22 986 61 90
À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal (only for outer packaging) 
À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugalska (samo za zunanjo ovojnino)
Take Ongentys at least one hour before or after taking your levodopa medicine. 
Zdravilo Ongentys vzemite vsaj eno uro, preden vzamete zdravilo z levodopo, ali eno uro kasneje.
However, an evaluation with 50 mg opicapone was performed in subjects included in both phase 3 studies with GFR/1.73 m2 <60 mL/min (i.e. moderately decreased renal elimination capacity), and using pooled BIA 9-1103 data (major metabolite of opicapone). 
Vendar pa so opravili ovrednotenje s 50 mg opikapona pri osebah, vključenih v obe študiji 3. faze, z GFR/1,73 m2 < 60 ml/min (tj. zmerno zmanjšana zmožnost ledvičnega izločanja), in z uporabo združenih podatkov
The binding of 14C-opicapone to plasma proteins was unaffected by the presence of warfarin, diazepam, digoxin and tolbutamide, and the binding of 14C-warfarin, 2-14C-diazepam, 3H-digoxin and 14C-tolbutamide was unaffected by the presence of opicapone and opicapone sulphate, the major human metabolite. 
in na vezavo 14C-varfarina, 2-14C-diazepama, 3H-digoksina in 14C-tolbutamida ni vplivala prisotnost opikapona in opikaponijevega sulfata, glavnega presnovka pri človeku.
An in vitro study showed opicapone inhibited CYP2C8 activity. 
Študija in vitro je pokazala, da opikapon zavira aktivnost CYP2C8.
Following administration of a single oral dose of 14C-opicapone, the main excretion route of opicapone and its metabolites was faeces, accounting for 58.5% to 76.8% of the administered radioactivity (mean 67.2%). 
Po dajanju enkratnega peroralnega odmerka 14C-opikapona je bila glavna pot izločanja opikapona in njegovih presnovkov blato, kar predstavlja 58,5 % do 76,8 % uporabljene radioaktivnosti (povprečje
Taking Ongentys and quinidine together, i.e. at the same time, may decrease the effect of Ongentys. 
Sočasno jemanje zdravila Ongentys in kinidina lahko zmanjša učinek zdravila Ongentys.
Do not use this medicine after the expiry date which is stated on the bottle/blister/carton after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki/pretisnem omotu/škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
No dose adjustment is needed for elderly patients (see section 5.2). 
Pri starejših bolnikih odmerka ni treba prilagajati (glejte poglavje 5.2).
At clinically relevant concentrations, opicapone is not expected to inhibit OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2, BCRP, P-gp/MDR1, BSEP, MATE1 and MATE2-K transporters as suggested by in vitro and in vivo studies. 
Na podlagi in vitro in in vivo študij se ne pričakuje, da bo opikapon v klinično pomembnih koncentracijah zaviral prenašalce OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2, BCRP, P-gp/MDR1, BSEP, MATE1 in MATE2-K.
What Ongentys looks like and contents of the pack 
Izgled zdravila Ongentys in vsebina pakiranja
How to store Ongentys 6. 
Shranjevanje zdravila Ongentys 6.
Concomitant use with monoamine oxidase (MAO-A and MAO-B) inhibitors (e.g. phenelzine, tranylcypromine and moclobemide) other than those for the treatment of Parkinson's disease (see section 4.5). 
Sočasna uporaba z zaviralci monoaminoksidaze (MAO-A in MAO-B) (npr. fenelzin, tranilcipromin in moklobemid), razen tistih za zdravljenje Parkinsonove bolezni (glejte poglavje 4.5).
Effect of opicapone on transporters 
Vpliv opikapona na prenašalce
Because of this, concomitant use of opicapone with MAO inhibitors (e.g. phenelzine, tranylcypromine and moclobemide) other than those for the treatment of Parkinson's disease is contraindicated. 
Zato je sočasna uporaba opikapona z zaviralci MAO (npr. fenelzin, tranilcipromin in moklobemid), razen tistimi za zdravljenje Parkinsonove bolezni, kontraindicirana.
After oral administration, the apparent total body clearance of opicapone at a dose of 50 mg was 22 L/h, with an inter-subject variability of 45%. 
Po peroralni uporabi je bil navidezni celotni telesni očistek opikapona v odmerku 50 mg 22 l, pri čemer je bila variabilnost med posamezniki 45 %.
No dose adjustment is necessary in patients with renal impairment, as opicapone is not excreted by the kidney (see section 5.2). 
Pri bolnikih z okvaro ledvic odmerka ni treba prilagajati, saj se opikapon ne izloča skozi ledvice (glejte poglavje 5.2).
Dyspnoea 
dispepsija
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. 
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
In healthy subjects, the opicapone elimination half-life (t1/2) was 0.7 h to 3.2 h following once-daily multiple-dose administration up to 50 mg opicapone. 
Pri zdravih osebah je bil razpolovni čas (t1/2) izločanja opikapona 0,7 ure do 3,2 ure po večkratnem odmerjanju do 50 mg opikapona enkrat na dan.
White high density polyethylene (HDPE) bottles with polypropylene (PP) child resistant closures containing 10, 30 or 90 capsules. 
Bele plastenke iz polietilena visoke gostote (HDPE, high density polyethylene) s polipropilensko (PP) za otroke varno zaporko vsebujejo 10, 30 ali 90 kapsul.
Careful monitoring of patients being treated with these medicinal products is advised when opicapone is used. 
Pri uporabi opikapona se priporoča skrbno spremljanje bolnikov, ki se zdravijo s temi zdravili.
Opicapone in association with levodopa may have major influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Opikapon v povezavi z levodopo ima lahko pomemben vpliv na sposobnost vožnje in upravljanja s stroji.
White high density polyethylene (HDPE) bottles with polypropylene (PP) child resistant closures containing 10 or 30 capsules. 
Bele plastenke iz polietilena visoke gostote (HDPE, high density polyethylene) s polipropilensko (PP) za otroke varno zaporko vsebujejo 10 ali 30 kapsul.
Blood creatine phosphokinase increased 
Preiskave zvišanje kreatin fosfokinaze v krvi zmanjšanje telesne mase
Your doctor may need to review your treatments. 
Morda bo moral zdravnik vaše zdravljenje spremeniti.
Study 1 Change in OFF-time 
Študija 1 Sprememba v času izklopa
Animal studies with opicapone do not indicate harmful effects with respect to fertility (see section 5.3). 
Študije na živalih z opikaponom ne kažejo škodljivih učinkov na sposobnost razmnoževanja (glejte poglavje 5.3).
In vitro studies have shown that opicapone is not transported by OATP1B1, but is transported by OATP1B3, and efflux transported by P-gp and BCRP. 
Študije in vitro so pokazale, da OATP1B1 ne prenaša opikapona, temveč ga prenaša OATP1B3, efluksna prenašalca pa sta P-gp in BCRP.
There is limited clinical experience in patients with moderate hepatic impairment (Child-Pugh Class B). 
Klinične izkušnje pri bolnikih z zmerno okvaro jeter (stopnje B po Child-Pughu) so omejene.
Ongentys contains lactose 
Zdravilo Ongentys vsebuje laktozo
BIA 9-1103, its major metabolite, was transported by OATP1B1 and OATP1B3, and efflux transported by BCRP, but is not a substrate for the P-gp/MDR1 efflux transporter. 
Njegov glavni presnovek BIA 9-1103 prenašata OATP1B1 in OATP1B3, efluksni prenašalec pa je BCRP, vendar ni substrat za efluksni prenašalec P-gp/MDR1.
Talk to your doctor or pharmacist before taking Ongentys: - if you have severe liver problems and suffered from loss of appetite, weight loss, weakness, or exhaustion within a short period of time. 
Pred začetkom jemanja zdravila Ongentys se posvetujte z zdravnikom ali farmacevtom: - če imate resne težave z jetri in so se vam v kratkem času pojavili izguba apetita, izguba telesne mase,
- The other ingredients are: o capsule content: lactose monohydrate, sodium starch glycolate (Type A), pregelatinized maize starch and magnesium stearate o capsule shell: gelatine, indigo carmine aluminium lake (E132), erythrosine (E127) and titanium dioxide (E171) o printing ink: shellac, titanium dioxide (E171), propylene glycol, ammonia, simethicone 
o vsebina kapsule: laktoza monohidrat, natrijev karboksimetilškrob (vrsta A), predgeliran koruzni škrob in magnezijev stearat o ovojnica kapsule: želatina, indigotin (E132), eritrozin (E127) in titanov dioksid (E171) o tiskarsko črnilo: šelak, titanov dioksid (E171), propilenglikol, amoniak, simetikon
There is limited experience with opicapone when used concomitantly with tricyclic antidepressants and noradrenaline re-uptake inhibitors (e.g. venlafaxine, maprotiline and desipramine). 
Izkušnje z opikaponom, uporabljenim sočasno s tricikličnimi antidepresivi in zaviralci ponovnega privzema noradrenalina (npr. venlafaksin, maprotilin in dezipramin), so omejene.
Caution must be exercised in these patients and dose adjustment may be necessary (see section 
Pri teh bolnikih je potrebna previdnost in morebitna prilagoditev odmerka (glejte poglavje 5.2).
Pharmacokinetic results showed that opicapone is rapidly absorbed, with a tmax of 1.0 h to 2.5 h following once-daily multiple-dose administration up to 50 mg opicapone. 
Farmakokinetični rezultati kažejo, da se opikapon hitro absorbira, s tmax 1,0 ure do 2,5 ure po večkratnem odmerjanju do 50 mg opikapona enkrat na dan.
Ongentys contains lactose. 
Zdravilo Ongentys vsebuje laktozo.
It is unknown whether opicapone or its metabolites are excreted in human milk. 
Ni znano, ali se opikapon ali njegovi presnovki izločajo v materino mleko.
A study conducted in healthy volunteers showed that when a single dose of 50 mg opicapone was coadministered (within 1 hour) with a single dose of quinidine (600 mg), systemic exposure of opicapone decreased by 37% (AUC0-tlast). 
Študija z zdravimi prostovoljci je pokazala zmanjšanje sistemske izpostavljenosti opikaponu za 37 % (AUC0-tlast) pri sočasnem dajanju (z razmikom do 1 ure) enkratnega odmerka 50 mg opikapona z enkratnim odmerkom kinidina (600 mg).
- muscle spasm - dizziness - headache - sleepiness - difficulty falling or staying asleep - strange dreams - experiencing or seeing things which do not exist (hallucinations) - a fall in blood pressure on standing up which causes dizziness, light-headedness or fainting 
- težave zaspati ali zbujanje ponoči - čudne sanje - doživljanje ali videnje neobstoječih stvari (halucinacije) - padec krvnega tlaka pri vstajanju, ki lahko povzroči omotico, vrtoglavost ali omedlevico
Breast-feeding should be discontinued during treatment with Ongentys. 
Med zdravljenjem z zdravilom Ongentys je treba prenehati z dojenjem.
Increases in liver enzymes were reported in studies with nitrocatechol inhibitors of catechol-Omethyltransferase (COMT). 
Drugo V študijah z nitrokateholnimi zaviralci katehol-O-metil transferaze (COMT) so poročali o zvišanju ravni jetrnih encimov.
Hence, the precautions valid for levodopa treatment should also be taken into account for Ongentys. 
Zato je treba pri zdravilu Ongentys upoštevati vse previdnostne ukrepe, ki veljajo za zdravljenje z levodopo.
Opicapone demonstrated clinical efficacy superior to placebo during the double-blind treatment, both for the primary efficacy variable used in both pivotal studies, i.e. reduction in OFF-time (Table 2), the proportion of OFF-time responders (i.e. a subject who had a reduction in OFF-time of at least 1 hour from baseline to endpoint) (Table 3) and for most diary-derived secondary endpoints. 
V dvojno slepem zdravljenju je bilo dokazano, da je klinična učinkovitost opikapona boljša kot pri placebu, tako za primarno spremenljivko učinkovitosti, uporabljeno v obeh osrednjih študijah, tj. skrajšanje časa izklopa (preglednica 2), delež odzivnih oseb glede čas izklopa (tj. oseb, ki so imele zmanjšanje časa izklopa za vsaj 1 uro od izhodišča do končne točke) (preglednica 3), in za večino sekundarnih opazovanih dogodkov,
A second study conducted showed that, at steady state, opicapone 50 mg had no effect on repaglinide systemic exposure. 
Druga študija je pokazala, da odmerek 50 mg opikapona ni vplival na sistemsko izpostavljenost repaglinidu v stanju dinamičnega ravnovesja.
How to take Ongentys 
Kako jemati zdravilo Ongentys
Shellac, propylene glycol, ammonia, indigo carmine aluminium (E132) 
Tiskarsko črnilo šelak, propilenglikol, amoniak, indigotin (E132)
The pharmacokinetics of opicapone was evaluated in elderly subjects (aged 65-78 years old) after 7day multiple-dose administration of 30 mg. An increase in both the rate and extent of systemic exposure was observed for the elderly population when compared to the young population. 
Farmakokinetiko opikapona so ovrednotili pri starejših osebah (starih od 65 do 78 let) po 7-dnevnem večkratnem odmerjanju 30 mg.
ongentys 25 mg (only on the outer packaging) 
ongentys 25 mg (samo za zunanjo ovojnino)
ongentys 50 mg (only on the outer packaging) 
ongentys 50 mg (samo za zunanjo ovojnino)
HDPE bottles: Keep the bottle tightly closed in order to protect from moisture. 
Plastenke HDPE: Plastenko shranjujte tesno zaprto za zagotovitev zaščite pred vlago.
Do not drive or operate machinery if you experience any of these side effects. 
Če imate katerega od teh neželenih učinkov, ne vozite in ne upravljajte strojev.
Package leaflet: Information for the patient Ongentys 50 mg hard capsules opicapone This medicine is subject to additional monitoring. 
Navodilo za uporabo Ongentys 50 mg trde kapsule opikapon Za to zdravilo se izvaja dodatno spremljanje varnosti.
There is no clinical experience in patients with severe hepatic impairment (Child-Pugh Class C) (see section 4.2). 
Pri bolnikih s hudo okvaro jeter (razred C po Child-Pughu) ni kliničnih izkušenj (glejte poglavje 4.2).
Package leaflet: Information for the patient Ongentys 25 mg hard capsules opicapone This medicine is subject to additional monitoring. 
Navodilo za uporabo Ongentys 25 mg trde kapsule opikapon Za to zdravilo se izvaja dodatno spremljanje varnosti.
The pharmacokinetics of opicapone was not directly evaluated in subjects with chronic renal impairment. 
Farmakokinetike opikapona pri osebah s kronično okvaro ledvic niso ovrednotili neposredno.
Other metabolites were not found in quantifiable concentrations in the majority of plasma samples collected during a clinical mass balance study. 
V večini vzorcev plazme, zbranih med klinično študijo masnega ravnovesja, niso našli drugih presnovkov v merljivih koncentracijah.
Light blue capsules, size 1, approximately 19 mm, imprinted “OPC 25” on the cap and “Bial” on the body. 
Svetlomodre kapsule, velikost 1, približno 19 mm, z oznako »OPC 25« na pokrovčku in »Bial« na telesu.
Anxiety, Depression, Hallucination auditory, Nightmare, Sleep disorder., 
slušne halucinacije, nočne more, motnje spanja
Abnormal dreams, Hallucination, Hallucination visual, Insomnia 
halucinacije, vizualne halucinacije, nespečnost anksioznost, depresija,
Responders, n (%) 55 (45.5) 
Odzivne osebe, n (%) 55 (45,5) Razlika glede na placebo vrednost p
Ongentys may increase its effect; - medicines containing quinidine, a medicine used to treat abnormal heart rhythms or malaria. 
Zdravilo Ongentys lahko poveča njihov učinek; - zdravila, ki vsebujejo kinidin, ki se uporablja za zdravljenje nenormalnega srčnega utripa ali malarije.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OPA/Al/PVC//Al 
PRETISNI OMOT OPA/Al/PVC//Al
It is not known if Ongentys passes into breast milk in humans. 
Ni znano, ali se zdravilo Ongentys izloča v materino mleko.
Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). 
Ni dovolj študij na živalih o vplivu zdravila na sposobnost razmnoževanja (glejte tudi poglavje 5.3).
Dry eye 
Očesne bolezni suho oko
Hypertension, Hypotension 
Žilne bolezni ortostatska hipotenzija hipertenzija, hipotenzija
Opicapone showed a marked (>90%) and long-lasting (>24 hours) COMT inhibition in healthy subjects after administration of 50 mg opicapone. 
Opikapon je pri zdravih prostovoljcih po dajanju 50 mg opikapona pokazal izrazito (> 90 %) in dolgotrajno (> 24 ur) zaviranje COMT.
CI = confidence interval; LS mean = least square mean; N = number of non-missing values; OPC = opicapone. 
IZ = interval zaupanja; Povprečje LS = povprečje po metodi najmanjših kvadratov [LS, least squares]; N = število nemanjkajočih vrednosti; OPC = opikapon a. Čas vklopa brez obremenjujočih diskinezij = čas vklopa z neobremenjujočimi diskinezijami + čas vklopa brez diskinezij
Ongentys may increase their effect; - medicines used to treat heart failure such as dobutamine, dopamine or dopexamine. 
Zdravilo Ongentys lahko poveča njihov učinek; - zdravilo, ki se uporablja za zdravljenje srčne odpovedi, kot so dobutamin, dopamin ali dopeksamin.
Ongentys 50 mg hard capsules are dark blue, approximately 19 mm length, with “OPC 50” and “Bial” printed on the capsules. 
Zdravilo Ongentys 50 mg trde kapsule so temnomodre kapsule, dolge približno 19 mm, na njih sta natisnjeni oznaki »OPC 50« in »Bial«.
Decreased appetite, Hypertriglyceridaemia 
Presnovne in prehranske motnje zmanjšan apetit, hipertrigliceridemija
Common: may affect up to 1 in 10 people - constipation - dry mouth - vomiting (being sick) - increased levels of the enzyme (creatine kinase) in your blood 
- suha usta - bruhanje - povečane ravni encima (kreatin kinaze) v krvi
A study conducted in healthy subjects showed that there were no changes in repaglinide's exposure when repaglinide was administered following multiple once-daily administration of opicapone 50 mg. 
Študija z zdravimi prostovoljci je pokazala, da se izpostavljenost repaglinidu pri dajanju repaglinida po večkratnih odmerkih 50 mg opikapona enkrat na dan ni spremenila.
Ongentys is to be administered as an adjunct to levodopa treatment. 
Zdravilo Ongentys se daje kot dodatno zdravljenje k levodopi.
Uncommon: may affect up to 1 in 100 people - palpitations or irregular heartbeat - blocked ear - dry eye - pain or swelling of the abdomen - indigestion - weight loss - loss of appetite - increased levels of triglycerides (fats) in your blood - muscle twitching, stiffness or pain - pain in arms or legs - altered sense of taste - excessive body movements - fainting - anxiety - depression - hearing things which do not exist - nightmares - sleep disorder - abnormal colour of urine - need to wake and pass urine at night - shortness of breath - high or low blood pressure 
- povečane ravni trigliceridov (maščob) v krvi - trzanje, togost ali bolečine v mišicah - bolečine v rokah ali nogah - spremenjen občutek za okus - pretirani telesni gibi - omedlevica - anksioznost - depresija - slišanje neobstoječih stvari - nočne more - motnja spanja
Bottles: 10, 30 or 90 capsules. 
Plastenke: 10, 30 ali 90 kapsul.
Ongentys may increase their effect; - medicines used to treat allergic reactions such as adrenaline. 
- zdravila, ki se uporabljajo za zdravljenje alergijskih reakcij, kot je adrenalin.
Muscle twitching, Musculoskeletal stiffness, Myalgia, Pain in extremity 
Bolezni mišičnoskeletnega sistema in vezivnega tkiva mišični spazmi trzanje mišice, mišično-skeletna togost, mialgija,
10 hard capsules 30 hard capsules 
30 trdih kapsul
Lactose monohydrate Sodium starch glycolate, Type A Maize starch, pregelatinized Magnesium stearate 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Vsebina kapsule laktoza monohidrat natrijev karboksimetilškrob, vrsta A koruzni škrob, predgeliran magnezijev stearat
OPA/Al/PVC//Al blisters containing 10, 30 or 90 capsules Not all pack sizes may be marketed. 
Pretisni omoti iz OPA/Al/PVC//Al vsebujejo 10, 30 ali 90 kapsul.
SN: 
n.s.
Tell your doctor if you are taking: - medicines for depression or anxiety such as venlafaxine, maprotiline and desipramine. 
- zdravila proti depresiji ali tesnobi, kot so venlafaksin, maprotilin in dezipramin.
Contents of the pack and other information What Ongentys contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Ongentys - Učinkovina je opikapon.
Bottles: Keep the bottle tightly closed in order to protect from moisture. 
Plastenke: Plastenko shranjujte tesno zaprto za zagotovitev zaščite pred vlago.
Ongentys is for oral use. 
Zdravilo Ongentys se jemlje peroralno.
Abdominal distention, Abdominal pain, Abdominal pain upper, Dyspepsia 
Bolezni prebavil zaprtost, suha usta, bruhanje abdominalna distenzija, bolečina v trebuhu, bolečina v zgornjem delu trebuha,
Contact your doctor straight away if you experience any side effects at the start of treatment. 
Če se na začetku zdravljenja pojavijo kateri neželeni učinki, se takoj posvetujte z zdravnikom.
Indigo carmine aluminium lake (E132) Erythrosine (E127) 
Ovoj kapsule želatina indigotin (E132) eritrozin (E127) titanov dioksid (E171)
How to store Ongentys 
Shranjevanje zdravila Ongentys
Common: may affect up to 1 in 10 people - constipation - dry mouth - vomiting (being sick) - increased levels of the enzyme (creatine kinase) in your blood - muscle spasm 
- suha usta - bruhanje - povečane ravni encima (kreatin kinaze) v krvi - mišični krči - omotičnost
Blisters: 10 or 30 capsules. 
Plastenke: 10 ali 30 kapsul.
The bioavailability of opicapone was significantly higher in patients with moderate chronic hepatic impairment and no safety concerns were observed. 
Farmakokinetiko opikapona so ovrednotili pri zdravih osebah in pri bolnikih z zmerno kronično okvaro jeter po dajanju enega odmerka 50 mg. Biološka uporabnost opikapona je bila občutno višja pri bolnikih z zmerno kronično okvaro jeter, pomislekov glede varnosti pa niso opazili.
Ear and labyrinth disorders 
Ušesne bolezni, vključno z motnjami labirinta kongestija ušesa
Each hard capsule contains 50 mg of opicapone. 
Ena trda kapsula vsebuje 50 mg opikapona.
Chromaturia, Nocturia 
Bolezni sečil kromaturija, nikturija
Each hard capsule contains 25 mg of opicapone. 
Ena trda kapsula vsebuje 25 mg opikapona.
Each capsule contains 25 mg of opicapone. 
Ena kapsula vsebuje 25 mg opikapona.
Dizziness, Headache, Somnolence 
- glavobol - zaspanost
Ongentys may increase their effects; - medicines for high cholesterol such as rosuvastatin, simvastatin, atorvastatin or pravastatin Ongentys may increase their effects; - medicines that affect the immune system such as methotrexate. 
Zdravilo Ongentys lahko poveča njihov učinek; - zdravila, ki se uporabljajo za visok holesterol, kot so rosuvastatin, simvastatin, atorvastatin ali pravastatin.
PHARMACEUTICAL FORM AND CONTENTS 
FARMACEVTSKA OBLIKA IN VSEBINA 10 trdih kapsul
Bial - Portela & Cª., S.A. 
Imetnik dovoljenja za promet z zdravilom in izdelovalec Bial - Portela & Cª, S.A.
OPC 25 mg OPC 50 mg OPC 5 mg - Placebo OPC 25 mg - Placebo OPC 50 mg - Placebo 
OPC 5 mg - placebo OPC 25 mg - placebo
DATE OF REVISION OF THE TEXT 
Sprememba v času izklopa
Ongentys 25 mg hard capsules are light blue, approximately 19 mm length, with “OPC 25” and “Bial” printed on the capsules. 
Izgled zdravila Ongentys in vsebina pakiranja Zdravilo Ongentys 25 mg trde kapsule so svetlomodre kapsule, dolge približno 19 mm, na njih sta natisnjeni oznaki »OPC 25« in »Bial«.
Opicapone exposure increased in a dose proportional manner following once-daily multiple dose administration up to 50 mg opicapone. 
Po večkratnem odmerjanju do 50 mg opikapona enkrat na dan se je izpostavljenost opikaponu povečala sorazmerno z odmerkom.