natgillin/translations-raw huggingface dataset:
The elimination of entacapone occurs mainly by non-renal metabolic routes.
Eliminacija entakapona odvija se uglavnom metaboličkim putevima mimo bubrega.
Therefore, do not take Entacapone Teva and iron supplements at the same time.
Entakapon Teva i preparate željeza u isto vrijeme.
Entacapone in association with levodopa has been associated with isolated cases of excessive daytime somnolence and sudden sleep onset episodes.
Entakapon udružen s levodopom bio je povezan s izoliranim slučajevima pretjerane pospanosti tijekom dana i epizodama iznenadnog nastupa sna.
A small amount of entacapone, the (E)-isomer, is converted to its (Z)-isomer.
Mala količina entakapona, (E)-izomer, pretvara se u njegov (Z)-izomer. (E)-izomer čini 95% AUC
Very rare (may affect up to 1 in 10,000 people): - Agitation; - decreased appetite, weight loss; - hives.
Vrlo rijetko (mogu se javiti u do 1 na 10 000 osoba): - uznemirenost; - smanjeni apetit, gubitak tjelesne težine;
Consequently, adverse dopaminergic reactions may be more frequent when entacapone is added to levodopa/benserazide treatment (see also section 4.8).
Posljedično, neželjeni dopaminergički učinci mogli bi biti češći nakon dodatka entakapona liječenju levodopom/benzerazidom (vidjeti također dio 4.8).
Entacapone decreases the metabolic loss of levodopa to 3O-methyldopa (3-OMD) by inhibiting the COMT enzyme.
Entakapon smanjuje metaboličku pretvorbu levodope u 3-Ometildopu (3-OMD) inhibirajući enzim COMT.
Entacapone enhances the effects of levodopa.
Entakapon pojačava učinke levodope.
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%).
Najčešće nuspojave u kliničkim ispitivanjima, koje su zahtijevale prekid liječenja entakaponom, bile su gastrointestinalni simptomi (npr. proljev, 2,5%) i povećane dopaminergičke nuspojave levodope (npr. diskinezije, 1,7%).
Entacapone Teva in association with levodopa may have major influence on the ability to drive and use machines.
Teva udružen s levodopom može imati velik utjecaj na sposobnost upravljanja vozilima i strojevima.
Some of the side effects are often caused by the increased effects of levodopa therapy and are most common at the start of treatment.
Nuspojave su često izazvane pojačanim učinkom terapije levodopom i najčešće su na početku liječenja.
You may also use other medicines to treat Parkinson's disease at the same time.
Istovremeno smijete uzimati i druge lijekove za terapiju Parkinsonove bolesti.
Thus, control of INR is recommended when entacapone treatment is initiated for patients receiving warfarin.
Zbog toga se preporučuje kontroliranje INR-a kada se entakapon počinje primjenjivati bolesnicima koji primaju varfarin.
Hence, the precautions valid for levodopa treatment should also be taken into account for entacapone treatment.
Stoga, mjere opreza koje vrijede za liječenje levodopom treba uzeti u obzir i kod liječenja entakaponom.
Rare (may affect up to 1 in 1,000 people): - Rashes; - abnormal results in liver function test.
Rijetko (mogu se javiti u do 1 na 1000 osoba): - osipi; - abnormalni rezultati pretraga jetrene funkcije.
Therefore, caution should be exercised when driving or using machines.
Stoga je potreban oprez pri upravljanju vozilima i strojevima.
For patients experiencing diarrhoea, a follow-up of weight is recommended in order to avoid potential excessive weight decrease.
U bolesnika s proljevom preporučuje se praćenje tjelesne težine kako bi se izbjegla mogućnost prekomjernog gubitka tjelesne težine.
Entacapone thus prolongs the clinical response to levodopa.
Na taj način entakapon produžuje klinički odgovor na levodopu.
Urine may be discoloured reddish-brown by entacapone, but this is a harmless phenomenon.
Entakapon može obojiti mokraću crvenkasto-smeđe, no to je bezopasna pojava.
Entacapone Teva taken together with levodopa may lower your blood pressure, which may make you feel light-headed or dizzy.
Teva uzet zajedno s levodopom može sniziti Vaš krvni tlak zbog čega možete osjetiti laganu ošamućenost ili omaglicu.
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.
Ako se liječenje entakaponom prekine, nužno je prilagoditi doziranje ostalih lijekova za Parkinsonovu bolest, posebno levodope, kako bi se postigao zadovoljavajući nadzor nad simptomima
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).
Bolesnike koji se liječe entakaponom u kombinaciji s levodopom te osjećaju pospanost i/ili imaju epizode iznenadnog nastupa sna treba uputiti da se suzdržavaju od upravljanja vozilima ili od aktivnosti u kojima bi poremećena budnost mogla biti opasna za njih ili druge osobe zbog rizika od teške ozljede ili smrti (npr. rad sa strojevima) sve dok ponavljanje takvih epizoda ne prestane (vidjeti također dio 4.4).
Regarding reproduction toxicity, decreased foetal weight and a slightly delayed bone development were noticed in rabbits at systemic exposure levels in the therapeutic range.
Vezano uz reproduktivnu toksičnost, zabilježeno je smanjenje težine ploda i malo usporen razvoj kostiju u kunića tretiranih dozama kojima se postižu sistemske razine izloženosti u terapijskom rasponu.
Entacapone Teva may make it harder for you to digest iron.
Entakapon Teva može otežati probavu željeza.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (30 film-coated tablets)
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA (30 filmom obloženih tableta)
Patients with hepatic impairment See section 4.3.
Bolesnici s oštećenjem funkcije jetre Vidjeti dio 4.3.
The safety of entacapone in infants is unknown.
Neškodljivost entakapona za dojenče nije poznata.
One 200 mg tablet is taken with each levodopa/dopa decarboxylase inhibitor dose.
Jedna tableta od 200 mg uzima se sa svakom dozom levodope/inhibitora dopa dekarboksilaze.
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).
Entakapon udružen s levodopom je povezan sa somnolencijom i epizodama iznenadnog nastupa sna u bolesnika s Parkinsonovom bolešću pa se preporučuje oprez prilikom upravljanja vozilima i rukovanja strojevima (vidjeti također dio 4.7).
Since the introduction into the market, isolated cases of NMS have been reported, especially following abrupt reduction or discontinuation of entacapone and other concomitant dopaminergic medicinal products.
Otkada se nalazi na tržištu zabilježeni su izolirani slučajevi NMS-a, posebno nakon naglog smanjenja doze ili prekida primjene entakapona i ostalih istovremeno primijenjenih dopaminergičkih lijekova.
Skin, hair, beard and nail discolorations
Promjene boje kože, kose, brade i noktiju
• The other ingredients in the tablet core are cellulose microcrystalline, povidone, starch pregelatinised, magnesium stearate and in the film-coating are poly(vinyl alcohol), talc, titanium dioxide (E171), macrogol, iron oxide yellow (E172), lecithin (soya), iron oxide red (E172).
- Drugi sastojci u jezgri tablete su mikrokristalična celuloza, povidon, prethodno geliran škrob, magnezijev stearat, a u ovojnici tablete poli(vinilni alkohol), talk, titanijev dioksid (E171), makrogol, žuti željezov oksid (E172), sojin lecitin, crveni željezov oksid (E172)
There were corresponding decreases in OFF time.
U „OFF“ fazi uočena su odgovarajuća smanjenja.
Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms.
Liječnik će s Vama razgovarati o načinima za kontroliranje ili umanjivanje simptoma.
In repeated dose toxicity studies, anaemia most likely due to iron chelating properties of entacapone was observed.
U ispitivanjima toksičnosti ponovljenih doza opažena je anemija, najvjerojatnije zbog svojstva entakapona da stvara kelate sa željezom.
Reduction of levodopa dosage decreases the severity and frequency of these reactions.
Smanjenje doze levodope smanjuje težinu i učestalost tih nuspojava.
The prescribing information for these levodopa preparations is applicable to their concomitant use with entacapone.
Uputa za propisivanje tih preparata levodope primjenjiva je i za njihovu istovremenu primjenu s entakaponom.
Entacapone increases the bioavailability of levodopa from standard levodopa/benserazide preparations 5-10% more than from standard levodopa/carbidopa preparations.
Entakapon povećava bioraspoloživost levodope iz standardnih preparata levodope/benzerazida za 5-10% više nego iz standardnih preparata levodope/karbidope.
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.
U bolesnika s progresivnom anoreksijom, astenijom i smanjenjem tjelesne težine unutar relativno kratkog vremenskog perioda potrebno je razmisliti o općem liječničkom pregledu, uključujući pretragu jetrene funkcije.
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.
U kliničkim ispitivanjima neželjeni dopaminergički učinci, npr. diskinezija, bili su češći u bolesnika koji su primali entakapon i agoniste dopamina (kao bromokriptin), selegilin ili amantadin u usporedbi s onima koji su primali placebo s tom kombinacijom.
Ischemic heart disease events other than myocardial infarction (e.g. angina pectoris)
Događaji vezani uz ishemijsku srčanu bolest koji ne uključuju infarkt miokarda (npr. angina pektoris)
The bioavailability of entacapone is about 35% after an oral dose.
Bioraspoloživost entakapona nakon peroralne doze iznosi oko 35%.
The maximum recommended dose is 200 mg ten times daily, i.e. 2,000 mg of entacapone.
Maksimalna preporučena doza je 200 mg deset puta dnevno, odnosno 2000 mg entakapona.
Renal insufficiency does not affect the pharmacokinetics of entacapone and there is no need for dose adjustment.
Bubrežna insuficijencija ne utječe na farmakokinetiku entakapona pa nije potrebno posebno prilagođavanje doze.
The most frequent adverse reactions caused by entacapone relate to the increased dopaminergic activity and occur most commonly at the beginning of the treatment.
Najčešće nuspojave izazvane entakaponom odnose se na povišenu dopaminergičku aktivnost, a najčešće se javljaju na početku liječenja.
Food does not affect the absorption of entacapone to any significant extent.
Hrana ne utječe značajnije na apsorpciju entakapona.
Entacapone Teva 200 mg
Entakapon Teva 200 mg
inhibitors (e.g. phenelzine, tranylcypromine).
MAO-B) (npr. fenelzin, tranilcipromin).
Similarly, no interactions between entacapone and selegiline were observed in repeated-dose studies in parkinsonian patients.
Slično tome, nisu uočene interakcije između entakapona i selegilina u ispitivanjima ponovljenih doza u bolesnika s Parkinsonovom bolešću.
Diarrhoea, abdominal pain, dry mouth, constipation, vomiting
Proljev, bol u trbuhu, suha usta, konstipacija, povraćanje
Entacapone increases the bioavailability of levodopa from standard levodopa/benserazide preparations slightly (5-10%) more than from standard levodopa/carbidopa preparations.
Entakapon povećava bioraspoloživost levodope iz standardnih preparata levodope/benzerazida nešto više (5-10%) nego iz standardnih preparata levodope/karbidope.
The metabolism of the medicinal product is slowed in patients with mild to moderate liver insufficiency (Child-Pugh Class A and B), which leads to an increased plasma concentration of entacapone in both the absorption and elimination phases (see section 4.3).
U osoba s blagom do umjerenom insuficijencijom jetre (Child-Pugh stadij A i B) usporen je metabolizam lijeka, što dovodi do povišene koncentracije entakapona u plazmi i u fazi apsorpcije kao i u fazi eliminacije (vidjeti dio
Women should not breast-feed during treatment with entacapone.
Žene ne smiju dojiti tijekom liječenja entakaponom.
Entacapone may, together with levodopa, cause dizziness and symptomatic orthostatism.
Entakapon može, zajedno s levodopom, izazvati omaglicu i simptomatsku ortostatsku hipotenziju.
As Entacapone Teva tablets will be taken together with other levodopa medicines, please also read the package leaflets of these medicines carefully.
Teva tablete uzimaju zajedno s lijekovima na bazi levodope, molimo da pažljivo pročitate upute o lijeku i tih drugih lijekova.
- A previous history of neuroleptic malignant syndrome (NMS) and/or non-traumatic rhabdomyolysis.
- Neuroleptički maligni sindrom (NMS) i/ili netraumatska rabdomioliza u anamnezi.
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. catecholstructured compounds: rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa, apomorphine, and paroxetine) is still limited.
Međutim, još uvijek je ograničeno iskustvo kliničke primjene entakapona s nekoliko lijekova, uključujući MAO-A inhibitore, tricikličke antidepresive, inhibitore ponovne pohrane noradrenalina kao što su dezipramin, maprotilin i venlafaksin te lijekove koji se metaboliziraju putem COMT-a (npr. spojevi s kateholskom strukturom: rimiterol, izoprenalin, adrenalin, noradrenalin, dopamin, dobutamin, alfa-metildopa, apomorfin i paroksetin).
Iron oxide yellow (E172) Lecithin (soya) Iron oxide red (E172)
Film ovojnica poli(vinilni alkohol) talk titanijev dioksid (E171) makrogol željezov oksid, žuti (E172) lecitin (soja) željezov oksid, crveni (E172)
Entacapone therapy should be administered cautiously to patients with ischemic heart disease.
Terapiju entakaponom treba provoditi uz oprez u bolesnika s ishemijskom bolešću srca.
Entacapone belongs to a new therapeutic class, catechol-O-methyl transferase (COMT) inhibitors.
Entakapon pripada novoj terapijskoj skupini, inhibitorima katehol-O-metil transferaze (COMT).
No interaction of entacapone with carbidopa has been observed with the recommended treatment schedule.
Interakcija entakapona s karbidopom uz preporučenu shemu liječenja nije uočena.
Entacapone is always given as an adjunct to levodopa treatment.
Entakapon se uvijek daje kao dodatak liječenju levodopom.
Characteristics in patients
Svojstva u bolesnika
Renal impairment does not affect the pharmacokinetics of entacapone.
Oštećenje bubrega ne utječe na farmakokinetiku entakapona.
Do not use Entacapone Teva during pregnancy or if you are breast-feeding.
Teva nemojte koristiti tijekom trudnoće i dojenja.
What you need to know before you take Entacapone Teva Do NOT take Entacapone Teva
Što morate znati prije nego počnete uzimati Entakapon Teva
In study I, daily ON time (hours) was measured from home diaries and in study II, the proportion of daily ON time.
„ON“ faze (sati) mjereno je na temelju dnevnika vođenih kod kuće, dok je u ispitivanju II mjeren udio dnevnog trajanja „ON“ faze.
- Concomitant use of entacapone and non-selective monoamine oxidase (MAO-A and MAO-B)
- Istovremena primjena entakapona i neselektivnih inhibitora monoaminooksidaze (MAO-A i
Not known (frequency cannot be estimated from the available data): - Inflammation of the colon (colitis), inflammation of the liver (hepatitis) with yellowing of the skin and whites of the eyes; - discolouration of skin, hair, beard and nails.
Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka): - upala debelog crijeva (kolitis), upala jetre (hepatitis) s požutjelom kožom i bjeloočnicama;
Entacapone should only be used in combination with levodopa/benserazide or levodopa/carbidopa.
Entakapon treba primjenjivati samo u kombinaciji s levodopom/benzerazidom ili levodopom/karbidopom.
The maximum recommended dose is 10 tablets per day, i.e. 2,000 mg of Entacapone Teva.
Najveća preporučena doza je 10 tableta na dan, odnosno 2000 mg Entakapona
Teva Operations Poland Sp.z.o.o.
Teva Operations Poland Sp.z.o.o. ul.
Puh/Tel:+358 20 180 5900
Finnland Puh/Tel: +358 20 180 5900
Light brown, biconvex, ellipse-shaped film-coated tablets with approximately 18 mm length and 10 mm width, embossed ‘E200' on one side, plain on the other side.
Svijetlosmeđe, bikonveksne, filmom obložene tablete eliptičnog oblika, duljine oko 18 mm i širine 10 mm, s otisnutom oznakom "E200" na jednoj strani te bez oznake na drugoj strani.
60 film-coated tablets 100 film-coated tablets 175 film-coated tablets
60 filmom obloženih tableta 100 filmom obloženih tableta 175 filmom obloženih tableta
The other major class of adverse reactions are gastrointestinal symptoms, including nausea, vomiting, abdominal pain, constipation and diarrhoea.
Drugu veću skupinu nuspojava čine probavni simptomi, uključujući mučninu, povraćanje, bol u trbuhu, konstipaciju i proljev.
Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments such as Entacapone Teva in association with levodopa.
Bolesnici i osobe koje se brinu o njima trebaju biti svjesni da se simptomi poremećaja ponašanja kontrole impulsa kao što su patološko kockanje, pojačan libido, hiperseksualnost, kompulzivno trošenje ili kupovanje, nekontrolirano prejedanje i kompulzivno jedenje mogu javiti u bolesnika liječenih agonistima dopamina i/ili drugim dopaminergicima poput Entakapona Teva u kombinaciji s levodopom.
30 film-coated tablets 60 film-coated tablets 100 film-coated tablets 175 film-coated tablets
30 filmom obloženih tableta 60 filmom obloženih tableta 100 filmom obloženih tableta 175 filmom obloženih tableta
Entacapone Teva film-coated tablets are light brown, biconvex ellipse-shaped with approximately 18 mm length and 10 mm width, embossed with “E200” on one side and plain on the other side.
Entakapon Teva filmom obložene tablete su svijetlosmeđe, bikonveksne, filmom obložene tablete eliptičnog oblika, duljine oko 18 mm i širine 10 mm, s otisnutom oznakom "E200" na jednoj strani te bez oznake na drugoj strani.
Contents of the pack and other information What Entacapone Teva contains
Sadržaj pakiranja i druge informacije Što Entakapon
If you stop taking Entacapone Teva
Ako prestanete uzimati Entakapon Teva
If you forget to take the Entacapone Teva tablet with your levodopa dose, you should continue the treatment by taking the next Entacapone Teva tablet with your next levodopa dose.
Ako uz dozu levodope zaboravite uzeti Entakapon Teva, nastavite Vaše liječenje uzimanjem sljedeće
If you forget to take Entacapone Teva
Ako ste zaboravili uzeti Entakapon Teva
Entacapone Teva aids levodopa in relieving the symptoms of Parkinson's disease.
Entakapon Teva pomaže levodopi u ublažavanju simptoma Parkinsonove bolesti.
Hepatic function tests abnormal
Abnormalni nalazi jetrene funkcije
Package leaflet: information for the user Entacapone Teva 200 mg film-coated tablets entacapone
Uputa o lijeku: Informacija za korisnika Entakapon Teva 200 mg filmom obložene tablete entakapon
Entacapone is administered orally and simultaneously with each levodopa/carbidopa or levodopa/benserazide dose.
Entakapon se primjenjuje peroralno i istovremeno sa svakom dozom levodope/karbidope ili levodope/benzerazida.
Parkinsonism aggravated, dizziness, dystonia, hyperkinesia
Pogoršanje parkinsonizma, omaglica, distonija, hiperkinezija
The substance is subject to extensive first-pass metabolism.
Pri prvom prolasku kroz jetru lijek se opsežno metabolizira.
** The incidence rates of myocardial infarction and other ischemic heart disease events (0.43% and 1.54%, respectively) are derived from an analysis of 13 double-blind studies involving 2082 patients with end-of-dose motor fluctuations receiving entacapone.
(0,43%, odnosno, 1,54%) su izvedene iz analize 13 dvostruko slijepih ispitivanja u koja su bila uključena 2082 bolesnika s motoričkim fluktuacijama pri kraju doze, a koji su primali entakapon.
When Entacapone Teva is given at higher doses:
Teva primijenjen u visokim dozama:
Entacapone Teva taken with levodopa may cause drowsiness and may cause you to sometimes suddenly fall asleep.
Teva uzet s levodopom može izazvati pospanost i može dovesti do toga da ponekad iznenada utonete u san.
Entacapone may aggravate levodopa-induced orthostatic hypotension.
Entakapon može pogoršati ortostatsku hipotenziju izazvanu levodopom.
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.
mioklonus, tremor), promjene mentalnog stanja (npr. agitiranost, konfuzija, koma), hipertermija, autonomna disfunkcija (tahikardija, varijabilni krvni tlak) i povišena kreatin fosfokinaza u serumu.
- Neuroleptic Malignant Syndrome (NMS) is a rare severe reaction to medicines used to treat disorders of the nervous system.
• NMS je rijetka teška reakcija na lijekove koji se koriste za liječenje poremećaja središnjeg živčanog sustava.
NAME OF THE MEDICINAL PRODUCT AND ROUTE (S) OF ADMINISTRATION
NAZIV LIJEKA I PUT(EVI) PRIMJENA LIJEKA
vivid dreams, and confusion; - heart or artery disease events (e.g. chest pain).
- simptomi srčane ili arterijske bolesti (npr. bol u prsima).
305, 74770 Opava-Komarov Czech Republic
Ostravska 29, c.p. 305, 74770 Opava-Komarov
Entacapone may form chelates with iron in the gastrointestinal tract.
U gastrointestinalnom traktu entakapon može sa željezom stvarati kelate.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (30, 60, 100 or 175 film-coated tablets)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (30, 60, 100 or 175 filmom obloženih tableta)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL (60, 100 or 175 film-coated tablets)
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA (60, 100 ili 175 filmom obloženih tableta)
The % change from baseline in OFF time was -24% in the entacapone group and 0% in the placebo group in study I. The corresponding figures in study II were -18% and -5%.
Postotak promjene trajanja „OFF“ faze u odnosu na početnu vrijednost iznosio je -24% u skupini koja je primala entakapon, a 0% u skupini koja je primala placebo u ispitivanju I.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
DODATAK II A. PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
How to take Entacapone Teva
Kako uzimati Entakapon Teva
What Entacapone Teva looks like and contents of the pack
Teva izgleda i sadržaj pakiranja
Entacapone Teva tablets contain entacapone and are used together with levodopa to treat Parkinson's disease.
Teva tablete sadrže entakapon i primjenjuju se zajedno s levodopom za liječenje
Pregnancy, breast-feeding and fertility
Trudnoća, dojenje i plodnost Entakapon
Impulse control disorders: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments such as Entacapone Teva in association with levodopa (see section 4.4).
Poremećaji kontrole impulsa: patološko kockanje, pojačan libido, hiperseksualnost, kompulzivno trošenje ili kupovanje, nekontrolirano prejedanje i kompulzivno jedenje mogu se javiti u bolesnika liječenih agonistima dopamina i/ili drugim dopaminergicima poput Entakapona