natgillin/translations-raw huggingface dataset:
Both levodopa and combinations of carbidopa and levodopa have caused visceral and skeletal malformations in rabbits.
Levodopa, kao i kombinacija karbidope i levodope, izazvale su visceralne i koštane malformacije u kunića.
Due to short elimination half-lives, no true accumulation of levodopa or entacapone occurs on repeated administration.
Zbog kratkog poluvremena eliminacije, prilikom ponovljene primjene zapravo ne dolazi do akumulacije levodope niti entakapona.
These include: - dopamine antagonists used to treat mental disorders, nausea and vomiting - phenytoin, used to prevent convulsions - papaverine used to relax the muscles.
Među njih se ubrajaju: - antagonisti dopamina, koji se koriste za liječenje duševnih poremećaja, mučnine i povraćanja, - fenitoin, koji se koristi za sprječavanje konvulzija, - papaverin, koji se koristi za opuštanje mišića.
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.
Oriona su diskinezije koje se javljaju u otprilike 19% bolesnika; gastrointestinalni simptomi uključujući mučninu i proljev javljaju se u otprilike 15%, odnosno 12% bolesnika; bol u mišićima, mišićnokoštana bol i bol vezivnog tkiva javlja se u otprilike 12% bolesnika; te bezopasna crvenkasto-smeđa diskoloracija mokraće (kromaturija) javlja se u otprilike 10% bolesnika.
Myocardial infarction**
Manje često: Infarkt miokarda**
Depression, hallucination, confusional state*, abnormal dreams*, anxiety, insomnia
Depresija, halucinacija, konfuzno stanje *, poremećeni snovi*, anksioznost, nesanica Manje često: Psihoza, agitacija*
Levodopa is excreted in human breast milk.
Levodopa se izlučuje u majčino mlijeko u ljudi.
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.
Ostale nuspojave sa zvjezdicom u Tablici 1., dijelu 4.8b su označene ili zbog veće učestalosti javljanja (uz razliku u učestalosti od najmanje 1%) u podacima iz kliničkih ispitivanja uz entakapon nego uz samo levodopu/DDC-inhibitor ili zbog sigurnosnih izvješća o pojedinačnom slučaju zaprimljenih nakon uvođenja entakapona na tržište.
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).
Bolesnike, koji su liječeni Levodopa/Carbidopa/Entacapone Orionom i u kojih se javlja somnolencija i/ili imaju epizode iznenadnog nastupa sna, mora se uputiti da se suzdrže od upravljanja vozilima ili od aktivnosti u kojima zbog poremećene budnosti oni ili druge osobe mogu biti pod rizikom od ozbiljne ozljede ili smrti (npr. rad sa strojevima), sve dok takve ponavljajuće epizode ne prestanu (vidjeti dio
Other antiparkinsonian medicinal products: To date there has been no indication of interactions that would preclude concurrent use of standard antiparkinsonian medicinal products with Levodopa/Carbidopa/Entacapone Orion therapy.
Drugi antiparkinsonici: do sada nema naznaka interakcija koje bi isključivale istodobnu primjenu standardnih antiparkinsonika uz liječenje Levodopa/Carbidopa/Entacapone Orionom.
Your doctor may take some regular laboratory tests during a long term treatment with Levodopa/Carbidopa/Entacapone Orion.
Vaš će Vam liječnik možda napraviti neke redovite laboratorijske pretrage tijekom dugotrajnog liječenja Levodopa/Carbidopa/Entacapone Orionom.
- a liver problem, because your dose may need to be adjusted - kidney or hormone-related diseases - stomach ulcers or convulsions - if you experience prolonged diarrhoea consult your doctor as it may be a sign of inflammation of the colon - any form of severe mental disorder like psychosis - chronic wide-angle glaucoma, because your dose may need to be adjusted and the pressure in your eyes may need to be monitored.
- probleme s jetrom, jer tada Vašu dozu možda treba prilagoditi, - bolesti povezane s bubrezima ili hormonima, - čireve želuca ili konvulzije, - ako dobijete dugotrajan proljev posavjetujte se sa svojim liječnikom, jer to može biti znak upale debelog crijeva, - bilo kakav oblik teškog duševnog poremećaja poput psihoze, - kronični glaukom otvorenog kuta, jer tada Vašu dozu možda treba prilagoditi i pratiti očni tlak.
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 između entakapona i selegilina ispitivane su u studijama ponovljenih doza u bolesnika s Parkinsonovom bolešću liječenih levodopom/DDC-inhibitorom te nisu opažene nikakve interakcije.
If any of this happens, contact your doctor immediately - feel depressed, have suicidal thoughts, or notice unusual changes in your behaviour - find yourself suddenly falling asleep, or if you feel very drowsy.
- osjetite depresiju, ako imate samoubilačke misli ili primjećujete neobične promjene u svome ponašanju, - ustanovite da iznenada zapadate u san ili osjećate jaku pospanost.
Very common (may affect more than 1 in 10 people) - uncontrolled movements (dyskinesias) - feeling sick (nausea) - harmless reddish-brown discolouration of urine - muscle pain - diarrhoea
Vrlo često (može se javiti kod više od 1 na 10 osoba) - nekontrolirani pokreti (diskinezije) - mučnina - bezopasna crvenkasto-smeđa promjena boje mokraće - bol u mišićima - 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 containing levodopa including Levodopa/Carbidopa/Entacapone Orion.
Bolesnici i skrbnici trebaju znati da se simptomi u ponašanju kod poremećaja kontrole impulsa uključujući patološko kockanje, pojačani libido, hiperseksualnost, kompulzivno trošenje ili kupovanje, prejedanje i kompulzivno jedenje mogu javiti u bolesnika liječenih agonistima dopamina i/ili drugim dopaminergičkim lijekovima koji sadrže levodopu, uključujući Levodopa/Carbidopa/Entacapone Orion.
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 containing levodopa including Levodopa/Carbidopa/Entacapone Orion (see section 4.4).
Poremećaji kontrole impulsa: Patološko kockanje, pojačani libido, hiperseksualnost, kompulzivno trošenje ili kupovanje, prejedanje i kompulzivno jedenje mogu se javiti u bolesnika liječenih agonistima dopamina i/ili drugim dopaminergičkim lijekovima koji sadrže levodopu, uključujući Levodopa/Carbidopa/Entacapone Orion (vidjeti dio 4.4).
Convulsions have occurred rarely with levodopa/carbidopa; however a causal relationship to levodopa/carbidopa therapy has not been established.
Konvulzije su se rijetko javile uz levodopu/karbidopu; međutim uzročna veza s liječenjem levodopom/karbidopom nije utvrđena.
Levodopa and entacapone may form chelates with iron in the gastrointestinal tract.
Levodopa i entakapon mogu stvarati kelate sa željezom u probavnom traktu.
For adults and elderly: - Your doctor will tell you exactly how many tablets of Levodopa/Carbidopa/Entacapone Orion to take each day.
Odrasli i starije osobe: - Vaš liječnik će odrediti točno koliko tableta Levodopa/Carbidopa/Entacapone
Few adverse reactions are known to be directly attributable to the active substance entacapone including diarrhoea and reddish-brown discolouration of urine.
Mali broj nuspojava za koje se zna da su direktno pripisive djelatnoj tvari entakaponu obuhvaća proljev i crvenkasto-smeđu diskoloraciju mokraće.
- Coadministration of Levodopa/Carbidopa/Entacapone Orion with non-selective monoamine oxidase (MAO-A and MAO-B) inhibitors (e.g. phenelzine, tranylcypromine).
- Istodobna primjena Levodopa/Carbidopa/Entacapone Oriona s neselektivnim inhibitorima monoaminooksidaze (MAO-A i MAO-B) (npr. fenelzin, tranilcipromin).
The Package leaflet is updated accordingly.
Uputa o lijeku je ažurirana u skladu s tim.
Therefore, the use of Levodopa/Carbidopa/Entacapone Orion in children or adolescents is not recommended.
Stoga se primjena Levodopa/Carbidopa/Entacapone Oriona u djece ili adolescenata ne preporučuje.
Diarrhoea*, nausea*
Proljev*, mučnina*
- A previous history of Neuroleptic Malignant Syndrome (NMS) and/or non-traumatic rhabdomyolysis.
- Neuroleptički maligni sindrom (NMS) i/ili netraumatska rabdomioliza u anamnezi.
If you must undergo surgery, please tell your doctor that you are using Levodopa/Carbidopa/Entacapone Orion.
Ako morate na kirurški zahvat, obavijestite svog liječnika da uzimate Levodopa/Carbidopa/Entacapone
- 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.
Orion sadržava saharozu te stoga bolesnici s rijetkim nasljednim problemima nepodnošenja fruktoze, malapsorpcije glukoze-galaktoze ili nedostatka saharaza-izomaltaze ne bi smjeli uzimati ovaj lijek.
Pyridoxine, however, is not effective in reversing the actions of Levodopa/Carbidopa/Entacapone Orion.
Piridoksin, međutim, nije učinkovit u suzbijanju djelovanja Levodopa/Carbidopa/Entacapone Oriona.
maprotiline, venlafaxine and paroxetine, - rimiterole and isoprenaline, used to treat respiratory diseases - adrenaline, used for severe allergic reactions - noradrenaline, dopamine and dobutamine, used to treat heart diseases and low blood pressure - alpha-methyldopa, used to treat high blood pressure - apomorphine, which is used to treat Parkinson's disease.
maprotilin, venlafaksin i paroksetin, - rimiterol i izoprenalin, koji se koriste za liječenje respiratornih bolesti, - adrenalin, koji se koristi za teške alergijske reakcije, - noradrenalin, dopamin i dobutamin, koji se koriste za liječenje srčanih bolesti i niskog krvnog tlaka, - alfa-metildopu, koja se koristi za liječenje visokog krvnog tlaka, - apomorfin, koji se koristi za liječenje Parkinsonove bolesti.
For some patients, Levodopa/Carbidopa/Entacapone Orion may not be well absorbed if it is taken with, or shortly after eating protein-rich food (such as meats, fish, dairy products, seeds and nuts).
Orion možda neće dobro apsorbirati ako se uzme tijekom ili kratko nakon obroka bogatog bjelančevinama (npr. meso, riba, mliječni proizvodi, sjemenke i orašasti plodovi).
150 mg/37.5 mg/200 mg tablets, do not take more than 10 tablets per day.
150 mg/37,5 mg/200 mg tablete ne smijete uzeti više od 10 tableta na dan.
- are allergic to levodopa, carbidopa or entacapone, or any of the other ingredients of this medicine (listed in section 6) - have narrow-angle glaucoma (an eye disorder) - have a tumour of the adrenal gland - are taking certain medicines for treating depression (combinations of selective MAO-A and
- ako ste alergični na levodopu, karbidopu ili entakapon, ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.), - ako imate glaukom zatvorenog kuta (očni poremećaj), - ako imate tumor nadbubrežne žlijezde, - ako uzimate određene lijekove za liječenje depresije (kombinaciju selektivnih MAO-A i MAO-B
Discontinuation of Levodopa/Carbidopa/Entacapone Orion therapy: If Levodopa/Carbidopa/Entacapone Orion treatment (levodopa/carbidopa/entacapone) is discontinued and the patient is transferred to levodopa/DDC inhibitor therapy without entacapone, it is necessary to adjust the dosing of other antiparkinsonian treatments, especially levodopa, to achieve a sufficient level of control of the parkinsonian symptoms.
Orionom: ako se liječenje Levodopa/Carbidopa/Entacapone Orionom (levodopa/karbidopa/entakapon) prekida i bolesnici prelaze na terapiju levodopom/DDC-inhibitorom bez entakapona, potrebno je prilagoditi doziranje drugog antiparkinsonika, osobito levodope, da bi se postigla dovoljna razina kontrole simptoma parkinsonizma.
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.
Kada se istodobnom primjenom DDCinhibitora smanji dekarboksilacija levodope, može se koristiti niža doza levodope, čime se smanjuje učestalost nuspojava kao što je mučnina.
time with and without entacapone was recorded in home-diaries by patients.
Dnevno trajanje "ON" faze sa ili bez entakapona bolesnici su bilježili u dnevnik.
Consult your doctor if during the treatment with Levodopa/Carbidopa/Entacapone Orion you: - notice that your muscles get very rigid or jerk violently, or if you get tremors, agitation, confusion, fever, rapid pulse, or wide fluctuations in your blood pressure.
Savjetujte se sa svojim liječnikom ako tijekom liječenja Levodopa/Carbidopa/Entacapone Orionom: - primijetite da Vam mišići postaju jako ukočeni ili se snažno trzaju, ako se pojavi drhtanje, uznemirenost, smetenost, vrućica, ubrzani puls ili izrazite promjene krvnoga tlaka.
The starting dose of Levodopa/Carbidopa/Entacapone Orion should provide either the same amount of levodopa or slightly (5-10%) more.
Oriona koje osigurava istu količinu levodope ili malo (5-10%) veću.
Levodopa/Carbidopa/Entacapone Orion contains three active substances (levodopa, carbidopa and entacapone) in one film-coated tablet.
Orion sadrži tri djelatne tvari (levodopu, karbidopu i entakapon) u jednoj filmom obloženoj tableti.
Total clearance for levodopa is in the range of 0.55-1.38 l/kg/h and for entacapone is in the range of 0.70 l/kg/h.
Ukupni klirens za levodopu nalazi se u rasponu od 0,55-1,38 l/kg/h, dok za entakapon iznosi oko 0,70 l/kg/h.
Croscarmellose sodium Magnesium stearate Maize starch Mannitol (E421) Povidone K 30 (E1201)
Jezgra tablete: karmelozanatrij, umrežena magnezijev stearat kukuruzni škrob manitol (E421) povidon K 30 (E1201)
75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg or
75 mg/18,75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31,25 mg/200 mg ili
Levodopa, carbidopa and entacapone together may cause dizziness and symptomatic orthostatism.
Levodopa, karbidopa i entakapon mogu zajedno izazvati omaglicu i simptomatsku ortostatsku hipotenziju.
- 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.
Orionom treba pažljivo pratiti glede razvoja mentalnih promjena, depresije sa suicidalnim tendencijama i drugog teškog antisocijalnog ponašanja.
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.
B inhibitora, ili neselektivne MAO-inhibitore), - ako ste ikada imali neuroleptički maligni sindrom (NMS - to je rijetka reakcija na lijekove koji se koriste za liječenje teških duševnih poremećaja), - ako ste bilo kada imali netraumatsku rabdomiolizu (rijetki mišićni poremećaj), - ako imate tešku bolest jetre.
Parkinsonism aggravated (e.g. bradykinesia)*, tremor, on and off phenomenon, dystonia, mental impairment (e.g. memory impairment, dementia), somnolence, dizziness*, headache
Pogoršanje parkinsonizma (npr. bradikinezija)*, tremor, on-off fenomen, distonija, mentalni poremećaj (npr. poremećaj pamćenja, demencija), somnolencija, omaglica*, glavobolja
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.
Orion se ne preporučuje koristiti za liječenje ekstrapiramidnih simptoma (npr. nevoljnih pokreta, tresenja, mišićne ukočenosti i mišićnih kontrakcija) uzrokovanih drugim lijekovima.
BOTTLE LABEL AND OUTER CARTON TEXT
TEKST NA NALJEPNICI BOČICE I NA VANJSKOM PAKIRANJU
- If you are taking Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg,
- Ako uzimate Levodopa/Carbidopa/Entacapone Orion 50 mg/12,5 mg/200 mg,
No particular studies are reported on the pharmacokinetics of levodopa and carbidopa in patients with renal impairment.
Nisu objavljena posebna ispitivanja farmakokinetike levodope i karbidope kod bolesnika s oštećenjem bubrega.
Common (may affect up to 1 in 10 people) - light-headedness or fainting due to low blood pressure, high blood pressure - worsening of Parkinson`s symptoms, dizziness, drowsiness - vomiting, abdominal pain and discomfort, heartburn, dry mouth, constipation - inability to sleep, hallucinations, confusion, abnormal dreams (including nightmares), tiredness - mental changes - including problems with memory, anxiety and depression (possibly with thoughts of suicide) - heart or artery disease events (e.g. chest pain), irregular heart rate or rhythm - more frequent falling - shortness of breath - increased sweating, rashes - muscle cramps, swelling of legs - blurred vision - anaemia - decreased appetite, decreased weight - headache, joint pain - urinary tract infection
Često (može se javiti kod do 1 na 10 osoba) - ošamućenost ili nesvjestica zbog niskog krvnog tlaka, visok krvni tlak - pogoršanje simptoma Parkinsonove bolesti, omaglica, omamljenost - povraćanje, bol i nelagoda u trbuhu, žgaravica, suha usta, zatvor - nesanica, halucinacije, smetenost, poremećeni snovi (uključujući noćne more), umor - duševne promjene - uključujući probleme s pamćenjem, tjeskobu, depresiju (uz moguće samoubilačke misli) - događaji vezani uz bolest srca ili arterija (npr. bol u prsištu), nepravilan puls ili ritam srca - češći padovi - nedostatak zraka - pojačano znojenje, osip - grčevi mišića, oticanje nogu - zamagljen vid - anemija - smanjeni apetit, smanjenje tjelesne težine - glavobolja, bol u zglobovima - upala mokraćnog sustava.
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.
Obavijestite svog liječnika ako Vi ili Vaša obitelj/njegovatelj primijetite da se kod Vas razvijaju simptomi nalik na ovisnost, zbog kojih žudite za velikim dozama lijeka Levodopa/Carbidopa/Entacapone
Muscle spasms, arthralgia
Spazmi mišića, artralgija
Levodopa/Carbidopa/Entacapone Orion with food and drink
Levodopa/Carbidopa/Entacapone Orion s hranom i pićem
Because the effects of Levodopa/Carbidopa/Entacapone Orion tablets are equivalent with entacapone 200 mg tablet administered concomitantly with the commercially available standard release carbidopa/levodopa preparations in corresponding doses these results are applicable to describe the effects of Levodopa/Carbidopa/Entacapone Orion as well.
Orion tableta ekvivalentni s entakapon 200 mg tabletom primijenjenom istodobno s komercijalno dostupnim preparatima karbidope/levodope sa standardnim oslobađanjem u odgovarajućim dozama, ovi su rezultati isto tako primjenjivi za opis učinaka Levodopa/Carbidopa/Entacapone Oriona.
If this happens, a general medical evaluation including liver function should be considered - feel the need to stop using Levodopa/Carbidopa/Entacapone Orion, see section 'If you stop taking Levodopa/Carbidopa/Entacapone Orion'.
Ako se to dogodi, mora se razmotriti opća medicinska procjena uključujući procjenu jetrene funkcije. - osjetite potrebu da prestanete uzimati Levodopa/Carbidopa/Entacapone
Yellow iron oxide (E172)
željezov oksid, crveni (E172) saharoza titanijev dioksid (E171) željezov oksid, žuti (E172)
- Levodopa/Carbidopa/Entacapone Orion therapy should be administered cautiously to patients with ischemic heart disease, severe cardiovascular or pulmonary disease, bronchial asthma, renal or endocrine disease, history of peptic ulcer disease or history of convulsions.
Orionom treba provoditi uz oprez u bolesnika s ishemijskom bolešću srca, teškom kardiovaskularnom ili plućnom bolešću, bronhijalnom astmom, bubrežnom ili endokrinom bolešću, kao i u bolesnika s peptičkim ulkusom ili konvulzijama u anamnezi.
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.
Oriona temelji se na dva dvostruko slijepa klinička ispitivanja faze III, u kojima je 376 bolesnika s Parkinsonovom bolešću i motoričkim fluktuacijama na kraju intervala doziranja, uz svaku dozu levodope/DDC-inhibitora primalo ili entakapon ili placebo.
Chest pain, peripheral oedema, fall, gait disturbance, asthenia, fatigue
Bol u prsištu, periferni edem, pad, poremećaj hoda, astenija, umor Manje često: Malaksalost
Rare:
(rijetko).
- Coadministration with a selective MAO-A inhibitor and a selective MAO-B inhibitor (see section 4.5).
- Istodobna primjena sa selektivnim MAO-A inhibitorom i selektivnim MAO-B inhibitorom
- If you are taking Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg tablets, do not take more than 8 tablets of this strength per day.
- Ako uzimate Levodopa/Carbidopa/Entacapone Orion 175 mg/43,75 mg/200 mg tablete, nemojte uzeti više od 8 tableta dnevno.
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).
Orion ako uzimate određene lijekove za liječenje depresije (kombinaciju selektivnih MAO-A i MAO-B inhibitora, ili neselektivne MAO inhibitore).
Pack sizes of 50/12.5/200 mg, 100/25/200 mg and 150/37.5/200 mg: 10, 30, 100, 130, 175 and 250 tablets.
Veličine pakiranja za 50/12,5/200 mg, 100/25/200 mg i 150/37,5/200 mg: 10, 30, 100, 130, 175 i 250 tableta.
Orion Pharma (Ireland) Ltd. c/o Allphar Services Ltd. Tel: +353 1 428 7777
Orion Pharma (Ireland) Ltd. c/o Allphar Services Ltd.
Antihypertensives: Symptomatic postural hypotension may occur when levodopa is added to the treatment of patients already receiving antihypertensives.
Antihipertenzivi: kada se levodopa dodaje bolesnicima koji već uzimaju antihipertenzive može se javiti simptomatska posturalna hipotenzija.
Constipation*, vomiting*, dyspepsia, abdominal pain and discomfort*, dry mouth*
Konstipacija*, povraćanje*, dispepsija, bol i nelagoda u abdomenu*, suha usta* Manje često: Kolitis*, disfagija
Grounds for the variation to the terms of the Marketing Authorisations
Razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet
Discolourations other than urine (e.g. skin, nail, hair, sweat)*
Manje često: Diskoloracije nevezane uz mokraću (npr. koža, nokti, kosa, znoj)* Rijetko:
As part of this PSUSA procedure, update of the levodopa/carbidopa/entacapone SmPCs with identical changes regarding dopamine dysregulation syndrome as agreed previously by the CMDh in the PSUSA process for levodopa/carbidopa containing products is considered warranted.
Smatra se opravdanim da se u sklopu ovog PSUSA postupka ažuriraju sažeci opisa svojstava lijeka za levodopu/karbidopu/entakapon s identičnim promjenama vezano uz sindrom poremećene regulacije dopamina, kako je dogovoreno s CMDh-om u prethodnom PSUSA postupku za lijekove koji sadrže levodopu/karbidopu.