natgillin/translations-raw huggingface dataset:
Between 1 in 100 and 1 in 1000 patients experience
Med 1 od 100 in 1 od 1000 bolnikov izkusi:
- sinusitis
- sinusitis
- flatulence
- flatulenco
Between 1 in 1000 and 1 in 10000 patients experience
Med 1 od 1000 in 1 od 10000 bolnikov iskusi:
- impaired liver function
- okvarjeno delovanje jeter
Less than 1 in 10,000 patients experience
Manj kot 1 od 10. 000 bolnikov izkusi:
- a condition called lactic acidosis (excess of lactic acid in your blood) due to metformin,
- stanje, ki se imenuje laktacidoza (povečana količina mlečne kisline v vaši krvi) zaradi
particularly those whose kidneys are not working properly
metformina, predvsem bolniki, katerih ledvice ne delujejo pravilno
- blurred vision due to swelling (or fluid) in the back of the eye.
- motnje vida zaradi otekanja (ali tekočine) v zadnjem delu očesa
HOW TO STORE COMPETACT
SHRANJEVANJE ZDRAVILA COMPETACT
Do not use Competact after the expiry date which is stated on the carton and blister.
Zdravila Competact ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na kartonu in na pretisnem omotu.
Medicines should not be disposed of via wastewater or household waste.
25 Zdravila ne smete odvreči v odpadno vode ali med gospodinjske odpadke.
What Competact Tablets contain The active substances are 15 mg pioglitazone (as hydrochloride) and 850 mg metformin hydrochloride.
15 mg pioglitazona (kot pioglitazonijev klorid) in 850 mg metforminijevega klorida.
The other ingredients are, microcrystalline cellulose, povidone (K 30), croscarmellose sodium magnesium stearate, hypromellose, macrogol 8000, talc and titanium dioxide.
Pomožne snovi so: mikrokristalna celuloza, povidon (K 30), premreženi natrijev karmelozat, magnezijev stearat, hipromeloza, makrogol 8000, smukec in titanov dioksid.
What Competact Tablets look like and contents of the pack Competact tablets are white to off white, oblong, convex, film-coated tablets embossed ‘ 15 / 850’ on one face and ‘ 4833M’ on the other.
Tablete Competact so bele do sivkastobele barve, podolgovate, filmsko obložene, z oznako ‘ 15 / 850 ’ na eni strani in ‘ 4833M ’ na drugi.
The tablets are supplied in blister packs of 14, 28, 30, 50, 56, 60, 90, 98 or 180 tablets.
Zdravilo je na voljo v pakiranjih po 14, 28, 30, 50, 56, 60, 90, 98 ali 180 tablet.
Marketing Authorisation Holder and Manufacturer Marketing authorisation holder:
Imetnik dovoljenja za promet z zdravilom:
Takeda Global Research and Development Centre (Europe) Ltd, 61 Aldwych, London WC2B 4AE, United Kingdom.
Takeda Global Research and Development Centre (Europe) Ltd, 61 Aldwych, London WC2B 4AE, Velika Britanija.
Takeda Italia Farmaceutici SpA, Via Crosa, 86, I-28065 Cerano (NO), Italy.
Takeda Italia Farmaceutici SpA, Via Crosa, 86, I- 28065 Cerano (NO), Italija.
Lilly S. A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.
Lilly S. A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Španija.
Comtan is used to treat patients with Parkinson’ s disease.
Zdravilo Comtan se uporablja za zdravljenje bolnikov s Parkinsonovo boleznijo.
Parkinson’ s disease is a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Parkinsonova bolezen je napredujoča okvara možganov, ki povzroča tresenje, upočasnjeno izvajanje gibov in otrdelost mišic.
Comtan is used together with levodopa (either a combination of levodopa and benserazide or a combination of levodopa and carbidopa) when the patient is having ‘ fluctuations ’ towards the end of the period between two doses of their medication.
Zdravilo Comtan se uporablja skupaj z levodopo (bodisi v kombinaciji z levodopo in benserazidom ali kombinaciji z levodopo in karbidopo), kadar bolnik doživlja „ nihanja “ proti koncu obdobja med dvema odmerkoma zdravil.
They are linked with a reduction in the effects of levodopa, when the patient experiences sudden switches between being ‘ on’ and able to move, and being ‘ off ’ and having difficulties moving about.
Nihanja so povezana z zmanjšanjem učinka levodope, ko bolnik doživlja nenadne preskoke med stanjem, ko se lahko giblje (stanje „ vklopa “), in med stanjem, ko ima z gibanjem težave (stanje „ izklopa “).
It should not be used with combinations that are ‘ modified release’ (when the levodopa is released slowly over a few hours).
Ne sme se ga uporabljati skupaj v kombinacijah s „ prilagojenim sproščanjem “ (kjer se levodopa počasi sprošča v obdobju več ur).
In patients with Parkinson’ s disease, the cells in the brain that produce the neurotransmitter dopamine begin to die and the amount of dopamine in the brain decreases.
Pri bolnikih s Parkinsonovo boleznijo začnejo celice v možganih, ki proizvajajo živčni prenašalec dopamin, odmirati, zato se količina dopamina v možganih zmanjša.
This helps to improve the symptoms of Parkinson’ s disease, such as stiffness and slowness of movement.
To olajša simptome Parkinsonove bolezni, kot sta otrdelost mišic in upočasnjeno izvajanje gibov.
Comtan has been studied in a total of 376 patients with Parkinson’ s disease, in two six-month studies that measured the effects of adding Comtan or placebo (a dummy medicine) to the patient’ s combination of levodopa and carbidopa or levodopa and benserazide.
Zdravilo Comtan so preučevali pri skupno 376 bolnikih s Parkinsonovo boleznijo v dveh šestmesečnih študijah, v katerih so merili učinke dodajanja zdravila Comtan ali placeba (zdravila brez zdravilne učinkovine) bolnikovi kombinaciji levodope in karbidope oziroma levodope in benserazida.
The main measure of effectiveness was the time spent in the ‘ on’ state (the time when levodopa is controlling the symptoms of Parkinson’ s disease) after the first levodopa dose of the morning in the first study, and over one day in the second study.
Glavno merilo učinkovitosti je bil čas, ko je bilo bolnikovo stanje dobro (stanje „ vklopa “, ko je levodopa nadzorovala simptome Parkinsonove bolezni), in sicer po prvem jutranjem odmerku levodope v prvi študiji in v teku celega dne v drugi študiji.
In the first study, adding Comtan increased the ‘ on’ time by 1 hour and 18 minutes more than adding placebo.
V prvi študiji je dodajanje zdravila Comtan podaljšalo trajanje stanja „ vklopa “ za 1 uro in 18 minut v primerjavi s placebom.
In the second study, the ‘ on’ time was increased by 35 minutes compared with placebo.
V drugi študiji je bil v primerjavi s placebom ta čas daljši za 35 minut.
Comtan should not be used in patients with: • liver disease; • phaeochromocytoma (a tumour of the adrenal gland); • a history of neuroleptic malignant syndrome (a dangerous nervous system disorder usually caused by antipsychotic medicines) or rhabdomyolysis (breakdown of muscle fibres).
Zdravila Comtan ne smejo uporabljati bolniki: • z obolenji jeter, • s feokromocitomom (tumorjem nadledvične žleze), • ki so imeli v preteklosti nevroleptični maligni sindrom (nevarno obolenje živčnega sistema, ki ga običajno povzročijo antipsihotična zdravila) ali rabdomiolizo (razgradnjo mišičnih vlaken).
Comtan should not be used together with other medicines that belong to the group ‘ monoamine oxidase inhibitors ’ (a type of antidepressant).
Zdravilo Comtan se ne sme jemati hkrati z drugimi zdravili, ki spadajo v skupino zaviralcev monoaminooksidaze (vrste antidepresivov).
The Committee for Medicinal Products for Human Use (CHMP) decided that Comtan’ s benefits are greater than its risks as an adjunct to standard preparations of levodopa/ benserazide or levodopa/ carbidopa for use in patients with Parkinson’ s disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Comtan kot dodatka k standardnima kombinacijama levodope/ benserazida oziroma levodope/ karbidope za zdravljenje bolnikov s Parkinsonovo boleznijo in motoričnimi nihanji ob koncu delovanja odmerka, ki jih ne moremo stabilizirati z navedenimi kombinacijami, večje od z njim povezanih tveganj.
This summary was last updated in 08-2008.
Povzetek je bil nazadnje posodobljen 8- 2008.
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta
Oral use Oral use Oral use Oral use
peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba
Bottle (glass) Bottle (glass) Bottle (glass) Bottle (glass)
steklenica (steklena) steklenica (steklena) steklenica (steklena) steklenica (steklena)
Each tablet contains 1.82 mg sucrose.
Vsaka tableta vsebuje 1, 82 mg saharoze.
Brownish-orange, oval, biconvex film-coated tablet with “ Comtan ” engraved on one side.
Rjavkastooranžna, ovalna, bikonveksna filmsko obložena tableta z vtisnjenim napisom “ Comtan ” na eni strani.
Entacapone is indicated as an adjunct to standard preparations of levodopa/ benserazide or levodopa/ carbidopa for use in adult patients with Parkinson’ s disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Entakapon je indiciran kot dodatno zdravilo pri zdravljenju z običajnimi pripravki levodope/ benserazida ali levodope/ karbidope za uporabo pri odraslih bolnikih s Parkinsonovo boleznijo in motoričnimi nihanji ob koncu delovanja odmerka, ki jih ne moremo stabilizirati z navedenimi kombinacijami.
Entacapone should only be used in combination with levodopa/ benserazide or levodopa/ carbidopa.
Entakapon se uporablja samo v kombinaciji z levodopo/ benserazidom ali levodopo/ karbidopo.
Posology One 200 mg tablet is taken with each levodopa/ dopa decarboxylase inhibitor dose.
Odmerjanje Ena tableta po 200 mg se vzame z vsakim odmerkom levodope/ zaviralca dopa- dekarboksilaze.
The maximum recommended dose is 200 mg ten times daily, i. e.
Največji priporočeni odmerek je 200 mg desetkrat na dan, tj.
2,000 mg of entacapone.
2. 000 mg entakapona.
Hence, to reduce levodopa-related dopaminergic adverse reactions, e. g. dyskinesias, nausea, vomiting and hallucinations, it is often necessary to adjust levodopa dosage within the first days to first weeks after initiating entacapone treatment.
Za zmanjšanje z levodopo povezanih dopaminergičnih neželenih učinkov, na primer diskinezij, navzee, bruhanja in halucinacij, je v prvih dneh do prvih tednih po začetku zdravljenja z entakaponom pogosto potrebno prilagoditi odmerjanje levodope.
The daily dose of levodopa should be reduced by about 10– 30% by extending the dosing intervals and/ or by reducing the amount of levodopa per dose, according to the clinical condition of the patient.
Glede na bolnikovo klinično stanje je treba dnevni odmerek levodope zmanjšati za približno 10- 30%, in sicer s podaljšanjem časovnega presledka med posameznimi odmerki in/ ali z zmanjšanjem količine levodope na odmerek.
If entacapone treatment is discontinued, it is necessary to adjust the dosing of other antiparkinsonian treatments, especially levodopa, to achieve a sufficient level of control of the parkinsonian symptoms.
V primeru prekinitve zdravljenja z entakaponom je treba za dosego zadostne ravni nadzora nad parkinsonskimi simptomi prilagoditi odmerjanje drugih antiparkinsonskih zdravil, zlasti levodope.
Entacapone increases the bioavailability of levodopa from standard levodopa/ benserazide preparations slightly (5– 10%) more than from standard levodopa/ carbidopa preparations.
Entakapon nekoliko bolj (za 5- 10%) poveča biološko uporabnost levodope iz standardnih pripravkov levodope/ benserazida kot iz standardnih pripravkov levodope/ karbidope.
Hence, patients who are taking standard levodopa/ benserazide preparations may need a larger reduction of levodopa dose when entacapone is initiated.
Na začetku zdravljenja z entakaponom je zato včasih treba bolnikom, ki jemljejo standardne pripravke levodope/ benserazida, bolj zmanjšati odmerek levodope.
Renal impairment:
2 Okvare ledvic:
However, for patients who are receiving dialysis therapy, a longer 2 dosing interval may be considered (see section 5.2).
Vendar je pri bolnikih, zdravljenih z dializo, včasih treba podaljšati časovni razmik med posameznimi odmerki (glejte poglavje 5. 2).
Hepatic impairment: see section 4.3.
Okvare jeter: glejte poglavje 4. 3.
Elderly:
Starejše osebe:
Comtan is not recommended for use in children below age 18 due to lack of data on safety and efficacy.
Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba zdravila Comtan pri otrocih pod 18 let ni priporočljiva.
Method of administration Entacapone is administered orally and simultaneously with each levodopa/ carbidopa or levodopa/ benserazide dose.
Način uporabe Entakapon se uporablja peroralno in sočasno z vsakim odmerkom levodope/ karbidope ali levodope/ benserazida.
Entacapone can be taken with or without food (see section 5.2).
Entakapon se lahko jemlje s hrano ali brez nje (glejte poglavje 5. 2).
- Concomitant use of entacapone and non-selective monoamine oxidase (MAO-A and MAO-B)
- Sočasna uporaba entakapona in neselektivnih zaviralcev monoaminooksidaze (MAO- A in
inhibitors (e. g. phenelzine, tranylcypromine).
MAO- B) (na primer fenelzina in tranilcipromina).
- Concomitant use of a selective MAO-A inhibitor plus a selective MAO-B inhibitor and
- Sočasna uporaba selektivnega zaviralca MAO- A in selektivnega zaviralca MAO- B ter
entacapone (see section 4.5).
entakapona (glejte poglavje 4. 5).
- A previous history of neuroleptic malignant syndrome (NMS) and/ or non-traumatic
- Anamneza nevroleptičnega malignega sindroma (NMS - ‘ Neuroleptic Malignant Syndrome ’)
rhabdomyolysis.
in/ ali netravmatske rabdomiolize.
Rhabdomyolysis secondary to severe dyskinesias or neuroleptic malignant syndrome (NMS) has been observed rarely in patients with Parkinson’ s disease.
Redko so opažali rabdomiolizo, ki nastane sekundarno pri težkih diskinezijah ali nevroleptičnem malignem sindromu (NMS) pri bolnikih s Parkinsonovo boleznijo.
NMS, including rhabdomyolysis and hyperthermia, is characterised by motor symptoms (rigidity, myoclonus, tremor), mental status changes (e. g. agitation, confusion, coma), hyperthermia, autonomic dysfunction (tachycardia, labile blood pressure) and elevated serum creatine phosphokinase.
Za NMS, skupaj z rabdomiolizo in hipertermijo, so značilni motorični simptomi (rigidnost, mioklonus, tremor), spremembe v mentalnem statusu (npr. agitiranost, zmedenost, koma), hipertermija, avtonomna disfunkcija (tahikardija, labilen krvni tlak) in povečana aktivnost serumske kreatinske fosfokinaze.
In individual cases, only some of these symptoms and/ or findings may be evident.
Pri posameznih primerih se lahko pokažejo le nekateri od teh simptomov ali laboratorijskih izvidov ali obojega.
When considered necessary, withdrawal of entacapone and other dopaminergic treatment should proceed slowly, and if signs and/ or symptoms occur despite a slow withdrawal of entacapone, an increase in levodopa dosage may be necessary.
Kadar se ukinitev entakapona in drugih dopaminergičnih zdravil zdi potrebna, naj bo počasna in če se kljub počasnemu ukinjanju entakapona pojavijo znaki in/ ali simptomi, je lahko potrebno zvečanje odmerjanja levodope.
Thus, entacapone should be administered cautiously to patients being treated with medicinal products metabolised by catechol-O- methyl transferase (COMT), e. g. rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa, and apomorphine (see also section 4.5).
Zato je potrebna previdnost pri predpisovanju entakapona bolnikom, zdravljenim z zdravili, ki jih presnavlja katehol- O- metiltransferaza (COMT), npr. z rimiterolom, izoprenalinom, adrenalinom, noradrenalinom, dopaminom, dobutaminom, alfametildopo in apomorfinom (glejte tudi poglavje 4. 5).
Hence, the precautions valid for 3 levodopa treatment should also be taken into account for entacapone treatment.
Zato je treba pri zdravljenju z entakaponom upoštevati tudi previdnostne ukrepe, ki veljajo za zdravljenje z levodopo.
Entacapone increases the bioavailability of levodopa from standard levodopa/ benserazide preparations 5– 10% more than from standard levodopa/ carbidopa preparations.
Entakapon poveča biološko uporabnost levodope v standardnih pripravkih levodope/ benserazida za 5- 10% bolj kot v standardnih pripravkih levodope/ karbidope.
Consequently, adverse dopaminergic reactions may be more frequent when entacapone is added to levodopa/ benserazide treatment (see also section 4.8).
Zato so lahko neželeni dopaminergični učinki pogostejši, kadar je entakapon dodan zdravljenju z levodopo/ benserazidom (glejte tudi poglavje 4. 8).
To reduce levodopa-related dopaminergic adverse reactions, it is often necessary to adjust levodopa dosage within the first days to first weeks after initiating entacapone treatment, according to the clinical condition of the patient (see sections 4.2 and 4.8).
Za zmanjšanje dopaminergičnih neželenih učinkov, povezanih z levodopo, je v prvih dnevih ali prvih tednih po uvedbi zdravljenja z entakaponom glede na bolnikovo klinično stanje pogosto potrebno prilagoditi odmerjanje levodope (glejte poglavji 4. 2 in 4. 8).
In clinical studies, adverse dopaminergic 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 študijah so bili neželeni dopaminergični učinki, na primer diskinezija, pogostejši pri bolnikih, ki so dobivali entakapon in agoniste dopamina (na primer bromokriptin), selegilin ali amantadin, kot pri tistih, ki so skupaj s to kombinacijo dobivali placebo.
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 also section 4.7).
Pri bolnikih s Parkinsonovo boleznijo je entakapon v povezavi z levodopo povezan s somnolenco in epizodami nenadnih napadov spanja, zato je pri upravljanju motornih vozil in strojev potrebna previdnost (glejte tudi poglavje 4. 7).
Pathological gambling, increased libido and hypersexuality have been reported in Parkinson’ s disease patients treated with dopamine agonists and other dopaminergic treatments such as entacapone in association with levodopa.
Pri bolnikih s Parkinsonovo boleznijo, ki so se zdravili z agonisti dopamina in drugimi dopaminergičnimi zdravili, kot je entakapon v povezavi z levodopo, so opisovali patološko hazardiranje, povečan libido in hiperseksualnost.
For patients who experience progressive anorexia, asthenia and weight decrease within a relatively short period of time, a general medical evaluation including liver function should be considered.
Pri bolnikih, pri katerih pride do progresivne anoreksije, astenije in zmanjšanje telesne mase v razmeroma kratkem obdobju, je treba razmisliti o splošnem zdravniškem pregledu, vključno z oceno jetrne funkcije.
Therefore, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Zato bolniki z redko dedno intoleranco za fruktozo, malabsorpcijo glukoze/ galaktoze ali zmanjšano aktivnostjo saharoza- izomaltaze, ne smejo jemati tega zdravila.
However, the experience of the clinical use of entacapone with several medicinal products, 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: rimiterol, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa, apomorphine, and paroxetine) is still limited.
Vendar so izkušnje s klinično uporabo entakapona z več zdravili, med drugim z zaviralci MAO- A, tricikličnimi antidepresivi, zaviralci ponovnega privzema noradrenalina, kot so desipramin, maprotilin in venlafaksin, in zdravili, ki jih presnavlja COMT (na primer spojine s kateholno skupino: rimiterol, izoprenalin, adrenalin, noradrenalin, dopamin, dobutamin, alfa- metildopa, apomorfin in paroksetin), še omejene.
Caution should be exercised when these medicinal products are used concomitantly with entacapone (see also sections 4.3 and 4.4).
Pri sočasni uporabi teh zdravil z entakaponom je potrebna previdnost (glejte tudi poglavji 4. 3 in 4. 4).
Entacapone may be used with selegiline (a selective MAO-B inhibitor), but the daily dose of selegiline should not exceed 10 mg.
Entakapon se sme uporabljati s selegilinom (selektivni zaviralec MAO- B), vendar dnevni odmerek selegilina ne sme preseči 10 mg.
Entacapone and iron preparations should be taken at least 2– 3 hours apart (see section 4.8).
Entakapon in pripravke železa je treba jemati s 4 časovnim presledkom vsaj 2- 3 ur (glejte poglavje 4. 8).
4 Entacapone binds to human albumin binding site II which also binds several other medicinal products, including diazepam and ibuprofen.
Entakapon se veže na humanem albuminu na vezavno mesto II, kamor se vežejo tudi številna druga zdravila, vključno z diazepamom in ibuprofenom.
Due to its affinity to cytochrome P450 2C9 in vitro (see section 5.2), entacapone may potentially interfere with medicinal products with metabolism dependent on this isoenzyme, such as S-warfarin.
Zaradi svoje afinitete do citokroma P450 2C9 in vitro (glejte poglavje 5. 2) lahko entakapon potencialno ovira presnovo zdravil, ki je odvisna od tega izoencima, na primer presnovo S- varfarina.
However, in an interaction study in healthy volunteers, entacapone did not change the plasma levels of S-warfarin, while the AUC for R-warfarin increased on average by 18% [CI90 11– 26%].
Vendar v študiji medsebojnega delovanja na zdravih prostovoljcih entakapon ni spremenil plazemskih koncentracij S- varfarina, medtem ko se je AUC za R- varfarin povečala povprečno za 18% [IZ90 11- 26%].
The INR values increased on average by 13% [CI90 6– 19%].
Vrednosti INR so se povečale povprečno za 13% [IZ90 6- 19%].
Comtan in association with levodopa may have major influence on the ability to drive and use machines.
Comtan ima skupaj z levodopo pomemben vpliv na sposobnost vožnje in upravljanja s stroji.
Entacapone may, together with levodopa, cause dizziness and symptomatic orthostatism.
Entakapon lahko skupaj z levodopo povzroča vrtoglavico in simptomatski ortostatizem.
Patients being treated with entacapone in association with levodopa 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 also section 4.4).
Bolnikom, ki se zdravijo z entakaponom v povezavi z levodopo in ki poročajo o zaspanosti in/ ali nenadnih napadih spanja, je treba naročiti, naj ne upravljajo motornih vozil in naj se ne ukvarjajo z dejavnostmi, pri katerih lahko zaradi zmanjšane pazljivosti sebe ali druge spravijo v nevarnost resne poškodbe ali smrti (na primer uporaba strojev), dokler takšni ponavljajoči se napadi ne izginejo (glejte tudi poglavje 4. 4).
In clinical studies the most common adverse reactions leading to discontinuation of entacapone treatment have been gastrointestinal symptoms (e. g. diarrhoea, 2.5%) and increased dopaminergic adverse reactions of levodopa (e. g. dyskinesias, 1.7%).
V kliničnih študijah so bili najpogostejši neželeni učinki, ki so povzročili prekinitev zdravljenja z entakaponom, simptomi s strani prebavil (na primer diareja v 2, 5%) in zvečani dopaminergični neželeni učinki levodope (na primer diskinezije v 1, 7%).
Dyskinesias (27%), nausea (11%), diarrhoea (8%), abdominal pain (7%) and dry mouth (4.2%) were reported significantly more often with entacapone than with placebo in pooled data from clinical studies involving 406 patients taking the medicinal product and 296 patients taking placebo.
Pri jemanju entakapona so bistveno pogosteje poročali o diskinezijah (27%), navzei (11%), driski (8%), bolečinah v trebuhu (7%) in suhih ustih (4, 2%) kot pri jemanju placeba po podatkih, združenih iz kliničnih študij s 406 bolniki, ki so jemali zdravilo, in 296 bolniki, ki so jemali placebo.