FrancophonIA/ELRC3.0 huggingface dataset:
English: Serious events of gastrointestinal haemorrhage (uncommon) and angioedema (rare) have been identified from the clinical trials with Levodopa/Carbidopa/Entacapone Orion or entacapone combined with levodopa/DDC inhibitor.
Slovenian: Huda neželena učinka, gastrointestinalne krvavitve (občasno) in angioedem (redko), so opredelili v kliničnih preskušanjih z zdravilom Levodopa/Carbidopa/Entacapone Orion ali entakapon v kombinaciji z levodopo/zaviralcem dekarboksilaze.
English: Dopamine Dysregulation Syndrome (DDS) is an addictive disorder seen in some patients treated with carbidopa/levodopa.
Slovenian: Sindrom motene regulacije dopamina (DDS) je odvistnostna motnja, opažena pri nekaterih bolnikih, zdravljenih s karbidopo/levodopo.
English: However, no interaction with carbidopa has been observed with the recommended treatment schedule (200 mg of entacapone up to 10 times daily).
Slovenian: Vendar pa ob priporočenem terapevtskem režimu (200 mg etakapona do 10-krat dnevno) niso opazili nobenih interakcij s karbidopo.
English: If you during the treatment with Levodopa/Carbidopa/Entacapone Orion experience the following symptoms, contact your doctor immediately: - Your muscles get very rigid or jerk violently, you get tremors, agitation, confusion, fever, rapid pulse, or wide fluctuations in your blood pressure.
Slovenian: Če v času zdravljenja z zdravilom Levodopa/Carbidopa/Entacapone Orion opazite naslednje simptome, o tem nemudoma obvestite zdravnika: - Mišice postanejo zelo toge ali silovito trzajo, začnete se tresti, ste vznemirjeni, zmedeni, dobite zvišano telesno temperaturo, zvišan srčni utrip ali se pojavi veliko nihanje krvnega tlaka.
English: Usually Levodopa/Carbidopa/Entacapone Orion is to be used in patients who are currently treated with corresponding doses of standard release levodopa/DDC inhibitor and entacapone.
Slovenian: Običajno naj bi se zdravilo Levodopa/Carbidopa/Entacapone Orion uporabljalo pri bolnikih, ki trenutno prejemajo ustrezne odmerke zaviralcev DDK s standardnim sproščanjem levodope in entakapona.
English: No particular studies on the pharmacokinetics of carbidopa and levodopa in patients with hepatic impairment are reported, however, it is advised that Levodopa/Carbidopa/Entacapone Orion should be administered cautiously to patients with mild or moderate hepatic impairment.
Slovenian: Ni poročil o posebnih raziskavah farmakokinetike karbidope in levodope pri bolnikih z okvaro jeter, vendar pa se priporoča previdnost pri dajanju zdravila Levodopa/Carbidopa/Entacapone Orion bolnikom z blago do zmerno okvaro jeter.
English: 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.
Slovenian: Velikosti pakiranj za 50/12,5/200 mg, 100/25/200 mg, 150/37,5/200 mg: 10, 30, 100, 130, 175 in 250 tablet.
English: The possibility that the patient has taken other active substances in addition to Levodopa/Carbidopa/Entacapone Orion should be taken into consideration.
Slovenian: Upoštevati je treba možnost, da je bolnik vzel poleg zdravila Levodopa/Carbidopa/Entacapone Orion še druga zdravila.
English: No particular studies are reported on the pharmacokinetics of levodopa and carbidopa in patients with renal insufficiency, therefore Levodopa/Carbidopa/Entacapone Orion therapy should be administered cautiously to patients in severe renal impairment including those receiving dialysis therapy (see section 5.2).
Slovenian: Študije, v katerih bi posebej preučevali farmakokinetiko levodope in karbidope pri bolnikih z ledvično insuficienco niso bile izvedene, zato je potrebna previdnost pri dajanju zdravila Levodopa/Carbidopa/Entacapone Orion bolnikom s hudo prizadetostjo ledvic kot tudi tistim, ki se zdravijo z dializo (glejte poglavje 5.2).
English: - Dopamine Dysregulation Syndrome (DDS) is an addictive disorder resulting in excessive use of the product seen in some patients treated with carbidopa/levodopa.
Slovenian: - Sindrom motene regulacije dopamina (DDS - Dopamine Dysregulation Syndrome) je odvistnostna motnja, ki se odraža s pretirano uporabo zdravila, kar so opazili pri nekaterih bolnikih, zdravljenih s karbidopo/levodopo.
English: Sucrose
Slovenian: Hrvatska
English: - If you are taking Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg,
Slovenian: - Če jemljete zdravilo Levodopa/Carbidopa/Entacapone Orion 50 mg/12,5 mg/200 mg,
English: The safety of levodopa, carbidopa or entacapone in the infant is not known.
Slovenian: Varnost levodope, karbidope ali entakapona za dojene novorojence/otroke ni znana.
English: Do not stop taking Levodopa/Carbidopa/Entacapone Orion unless your doctor tells you to.
Slovenian: Ne prenehajte z jemanjem zdravila Levodopa/Carbidopa/Entacapone Orion razen po navodilih zdravnika.
English: Levodopa/Carbidopa/Entacapone Orion is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment.
Slovenian: Zdravilo Levodopa/Carbidopa/Entacapone Orion je indicirano pri odraslih bolnikih s Parkinsonovo boleznijo in motoričnimi fluktuacijami na koncu odmernega obdobja, ki jih zdravljenje z levodopo/zaviralci dopa-dekarboksilaze (DDK) ne stabilizira.
English: Dopamine dysregulation syndrome was included in five adverse drug reaction reports during this PSUR reporting period.
Slovenian: Sindrom motene regulacije dopamina je bil vključen v pet poročil o neželenih učinkih zdravil v obdobju tega PSUR-a. Kumulativno je bil vključen sindrom motene regulacije dopamina v 10 poročil.
English: - 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.
Slovenian: - Previdnost je potrebna tudi pri dajanju zdravila Levodopa/Carbidopa/Entacapone Orion bolnikom z ishemično boleznijo srca, s hudim kardiovaskularnim ali pljučnim obolenjem, bronhialno astmo, boleznijo ledvic ali žlez z notranjim izločanjem, kot tudi tistim, ki so kdaj v preteklosti imeli želodčno razjedo ali konvulzije.
English: Angioedema
Slovenian: angioedem
English: Urticaria*
Slovenian: urtikarija*
English: - 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.
Slovenian: - Če jemljete zdravilo Levodopa/Carbidopa/Entacapone Orion 175 mg/43,75 mg/200 mg tablete, ne vzemite več kot 8 tablet dnevno.
English: - Levodopa/Carbidopa/Entacapone Orion may induce orthostatic hypotension.
Slovenian: - Zdravilo Levodopa/Carbidopa/Entacapone Orion lahko povzroči ortostatsko hipotenzijo.
English: Levodopa/Carbidopa/Entacapone Orion with food and drink
Slovenian: Zdravilo Levodopa/Carbidopa/Entacapone Orion skupaj s hrano in pijačo
English: - If you are taking Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg, do not take more than 7 tablets of this strength per day.
Slovenian: - Če jemljete zdravilo Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg tablete, ne vzemite več kot 7 tablet dnevno.
English: - Levodopa/carbidopa may cause false positive result when a dipstick is used to test for urinary ketone and this reaction is not altered by boiling the urine sample.
Slovenian: - Levodopa/karbidopa lahko povzročita lažno pozitivne rezultate, če se za testiranje ketonov uporablja testni trak.
English: Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg film-coated tablets
Slovenian: Levodopa/Carbidopa/Entacapone Orion 50 mg/12,5 mg/200 mg filmsko obložene tablete Levodopa/Carbidopa/Entacapone Orion 75 mg/18,75 mg/200 mg filmsko obložene tablete Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg filmsko obložene tablete Levodopa/Carbidopa/Entacapone Orion 125 mg/31,25 mg/200 mg filmsko obložene tablete Levodopa/Carbidopa/Entacapone Orion 150 mg/37,5 mg/200 mg filmsko obložene tablete Levodopa/Carbidopa/Entacapone Orion 175 mg/43,75 mg/200 mg filmsko obložene tablete Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg filmsko obložene tablete
English: Management of acute overdose with Levodopa/Carbidopa/Entacapone Orion therapy is similar to acute overdose with levodopa.
Slovenian: Ukrepi pri akutnem prevelikem odmerjanju zdravila Levodopa/Carbidopa/Entacapone Orion so podobni kot pri akutnem prevelikem odmerjanju levodope.
English: Review of treatment is recommended if such symptoms develop.
Slovenian: Če pride do takih simptomov, je treba pregledati ustreznost zdravljenja.
English: Patients should be instructed to take only one Levodopa/Carbidopa/Entacapone Orion tablet per dose administration.
Slovenian: Bolnikom je treba razložiti, da naj ob vsakem odmerku vzamejo samo eno tableto zdravila Levodopa/Carbidopa/Entacapone Orion.
English: The daily dose should be preferably optimised using one of the seven available tablet strengths (50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg, 150 mg/37.5 mg/200 mg, 175 mg/43.75 mg/200 mg or 200 mg/50 mg/200 mg levodopa/carbidopa/entacapone).
Slovenian: Dnevni odmerek naj se po možnosti optimizira z uporabo tablet ustrezne jakosti - ene od sedmih, ki so na razpolago (50 mg/12,5 mg/200 mg, 75 mg/18,75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31,25 mg/200 mg, 150 mg/37,5 mg/200 mg, 175 mg/43,75 mg/200 mg ali 200 mg/50 mg/200 mg levodopa/karbidopa/entakapon).
English: A syndrome resembling the neuroleptic malignant syndrome including muscular rigidity, elevated body temperature, mental changes and increased serum creatine phosphokinase has been reported with the abrupt withdrawal of antiparkinsonian agents.
Slovenian: Ob nenadni ukinitvi antiparkinsonikov poročajo o pojavu sindroma podobnega malignemu nevroleptičnemu sindromu, ki vključuje otrplost mišic, povišano telesno temperaturo, duševne spremembe in povišane vrednosti serumske kreatin fosfokinaze.
English: Croscarmellose sodium Magnesium stearate Maize starch Mannitol (E421) Povidone K 30 (E1201)
Slovenian: Jedro tablete: natrijev karmelozat, premreženi (E468) magnezijev stearat koruzni škrob manitol (E421) povidon K 30 (E1201)
English: Initiation of Levodopa/Carbidopa/Entacapone Orion may be considered at corresponding doses to current treatment in some patients with Parkinson's disease and end-of-dose motor fluctuations, who are not stabilised on their current standard release levodopa/DDC inhibitor treatment.
Slovenian: O uvedbi zdravljenja z zdravilom Levodopa/Carbidopa/Entacapone Orion z odmerki, ki ustrezajo obstoječi terapiji, velja razmisliti pri nekaterih bolnikih s Parkinsonovo boleznijo in motoričnimi fluktuacijami na koncu odmernega obdobja, ki jih trenutno zdravljenje s standardnim sproščanjem levodope/zaviralci DDK ne stabilizira.
English: Colitis*, dysphagia
Slovenian: kolitis*, disfagija
English: 5 How to store Levodopa/Carbidopa/Entacapone Orion Contents of the pack and other information
Slovenian: 5 Shranjevanje zdravila Levodopa/Carbidopa/Entacapone Orion Vsebina pakiranja in dodatne informacije
English: Ten tablets of Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg equals 375 mg of carbidopa a day.
Slovenian: Deset tablet zdravila Levodopa/Carbidopa/Entacapone Orion 150 mg/37,5 mg/200 mg je enako 375 mg karbidope na dan.
English: Serious hepatitis with mainly cholestatic features, rhabdomyolysis and neuroleptic malignant syndrome may occur with Levodopa/Carbidopa/Entacapone Orion although no cases have been identified from the clinical trial data.
Slovenian: Pri zdravilu Levodopa/Carbidopa/Entacapone Orion se lahko pojavi huda oblika hepatitisa s pretežno holestatskimi značilnostmi, rabdomioliza in nevroleptični maligni sindrom, čeprav v podatkih s kliničnega preskušanja niso opredelili nobenega primera.
English: Pack sizes of 75/18.75/200 mg, 125/31.25/200 mg, 175/43.75/200 mg and 200/50/200 mg: 10, 30, 100, 130 and 175 tablets.
Slovenian: Velikosti pakiranj za 75/18,75/200 mg, 125/31,25/200 mg, 175/43,75/200 mg in 200/50/200 mg: 10, 30, 100, 130 in 175 tablet.
English: What Levodopa/Carbidopa/Entacapone Orion is and what it is used for
Slovenian: Kaj je zdravilo Levodopa/Carbidopa/Entacapone Orion in za kaj ga uporabljamo
English: Levodopa/Carbidopa/Entacapone Orion may make it harder for you to digest iron.
Slovenian: Zaradi zdravila Levodopa/Carbidopa/Entacapone Orion boste morda težje presnavljali železo.
English: 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).
Slovenian: Motnje pri obvladovanju impulzov: Pri bolnikih, ki se zdravijo z agonisti dopamina in/ali drugimi dopaminergičnimi zdravljenji, ki vsebujejo levodopo, vključno z zdravilom Levodopa/Carbidopa/Entacapone Orion, lahko pride do patološkega hazardiranja, povečanega libida, hiperseksualnosti, kompulzivnega zapravljanja ali nakupovanja, prenajedanja ali kompulzivnega prenajedanja (glejte poglavje 4.4).
English: Musculoskeletal and connective tissue disorders Very common:
Slovenian: Bolezni mišično-skeletnega sistema Zelo pogosti:
English: b. When initiating Levodopa/Carbidopa/Entacapone Orion therapy for patients currently treated with entacapone and levodopa/carbidopa in doses not equal to Levodopa/Carbidopa/Entacapone Orion tablets (50 mg/12.5 mg/200 mg or 75 mg/18.75 mg/200 mg or 100 mg/25 mg/200 mg or 125 mg/31.25 mg/200 mg or 150 mg/37.5 mg/200 mg or 175 mg/43.75 mg/200 mg or 200 mg/50 mg/200 mg), Levodopa/Carbidopa/Entacapone Orion dosing should be carefully titrated for optimal clinical response.
Slovenian: b. Ob uvajanju terapije z zdravilom Levodopa/Carbidopa/Entacapone Orion pri bolnikih, ki trenutno prejemajo entakapon in levodopo/karbidopo v odmerkih, ki se razlikujejo od tablet zdravila Levodopa/Carbidopa/Entacapone Orion (50 mg/12,5 mg/200 mg ali 75 mg/18,75 mg/200 mg ali 100 mg/25 mg/200 mg ali 125 mg/31,25 mg/200 mg ali 150 mg/37,5 mg/200 mg ali 175 mg/43,75 mg/200 mg ali 200 mg/50 mg/200 mg), je treba za dosego optimalnega kliničnega odgovora odmerjanje zdravila Levodopa/Carbidopa/Entacapone Orion skrbno titrirati.
English: Grounds for the variation to the terms of the Marketing Authorisations
Slovenian: Podlaga za spremembe pogojev dovoljenja (dovoljenj) za promet z zdravilom
English: Uncommon (may affect up to 1 in 100 people) - heart attack - bleeding in the gut - changes in the blood cell count which may result in bleeding, abnormal liver function tests - convulsions - feeling agitated - psychotic symptoms - colitis (inflammation of the colon) - discolourations other than urine (e.g. skin, nail, hair, sweat) - swallowing difficulties - inability to urinate
Slovenian: Občasni neželeni učinki (lahko se pojavijo pri največ 1 od 100 bolnikov): - srčni napad - krvavitve v črevesju - spremembe v številu krvničk, kar lahko povzroči krvavitve, nenormalne rezultate jetrnih testov - konvulzije - občutek vznemirjenosti - psihotični simptomi - kolitis (vnetje debelega črevesa) - obarvanja, razen urina (npr. kože, nohtov, las, znoja)
English: If therapy has to be stopped temporarily, Levodopa/Carbidopa/Entacapone Orion may be restarted as soon as oral medicinal products can be taken at the same daily dose as before.
Slovenian: Če je treba terapijo začasno prekiniti, se lahko zdravljenje z zdravilom Levodopa/Carbidopa/Entacapone Orion nadaljuje z enakim režimom odmerjanja kot pred prekinitvijo takoj, ko je možna peroralna aplikacija.
English: If you take more Levodopa/Carbidopa/Entacapone Orion than you should
Slovenian: Če ste vzeli večji odmerek zdravila Levodopa/Carbidopa/Entacapone Orion, kot bi smeli
English: - The active substances of Levodopa/Carbidopa/Entacapone Orion are levodopa, carbidopa and entacapone.
Slovenian: - Učinkovine zdravila Levodopa/Carbidopa/Entacapone Orion so levodopa, karbidopa in entakapon.
English: Talk to your doctor or pharmacist before taking Levodopa/Carbidopa/Entacapone Orion if you have or have ever had: - a heart attack or any other diseases of the heart including cardiac arrhythmias, or of the blood vessels - asthma or any other disease of the lungs
Slovenian: Pred začetkom jemanja zdravila Levodopa/Carbidopa/Entacapone Orion se posvetujte z zdravnikom ali farmacevtom: - srčni napad ali katero koli drugo bolezen srca, vključno z srčnimi aritmijami, ali bolezni ožilja; - astmo ali druge pljučne bolezni; - težave z jetri, saj bo morda treba odmerek prilagoditi;
English: 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
Slovenian: Pogosti neželeni učinki (lahko se pojavijo pri največ 1 od 10 bolnikov): - vrtoglavica ali omedlevica zaradi nizkega krvnega tlaka, visok krvni tlak - poslabšanje simptomov Parkinsonove bolezni, omotičnost, zaspanost - bruhanje, bolečine in nelagodje v trebuhu, zgaga, suha usta, zaprtje - nespečnost, halucinacije, zmedenost, nenormalne sanje (vključno z nočnimi morami), utrujenost - duševne motnje - vključno s težavami s pomnjenjem, anksioznostjo in depresijo (lahko s samomorilnimi mislimi) - dogodki, povezani z boleznijo srca ali arterij (npr. bolečina v prsih), neenakomeren srčni utrip ali ritem - pogosto padanje - zasoplost - močnejše potenje, izpuščaj - mišični krči, oteklost nog - zamegljen vid - anemija - zmanjšanje apetita, zmanjšanje telesne mase - glavobol, bolečine sklepov - okužbe sečil
English: General characteristics of the active substances
Slovenian: Glavne značilnosti učinkovin
English: Levodopa/Carbidopa/Entacapone Orion comes in six different pack sizes (10, 30, 100, 130, 175 or 250 tablets).
Slovenian: Zdravilo Levodopa/Carbidopa/Entacapone Orion je na razpolago v šestih različnih velikostih pakiranja (10, 30, 100, 130, 175 ali 250 tablet).
English: 10 film-coated tablets 30 film-coated tablets 100 film-coated tablets 130 film-coated tablets 175 film-coated tablets 250 film-coated tablets
Slovenian: 10 filmsko obloženih tablet 30 filmsko obloženih tablet 100 filmsko obloženih tablet 130 filmsko obloženih tablet 175 filmsko obloženih tablet 250 filmsko obloženih tablet
English: In such patients it is advisable to introduce entacapone treatment as a separate treatment (entacapone tablets) and adjust the levodopa dose if necessary, before switching to Levodopa/Carbidopa/Entacapone Orion.
Slovenian: Pri takih bolnikih je priporočljivo pred prehodom na zdravilo Levodopa/Carbidopa/Entacapone Orion uvesti zdravljenje z entakaponom kot samostojnim zdravljenjem (entakapon v obliki tablet), odmerek levodope pa po potrebi prilagoditi.
English: If this happens, your doctor may need to change the dose of your antiparkinson medicine - experience diarrhoea: monitoring of your weight is recommended in order to avoid potentially excessive weight loss - experience progressive anorexia, asthenia (weakness, exhaustion) and weight decrease within a relatively short period of time.
Slovenian: Če se to zgodi, se morate posvetovati s svojim zdravnikom, ker je morda pri vas treba spremeniti odmerek antiparkinsonskih zdravil; - dobite drisko: se priporoča nadziranje telesne mase, da preprečite morebitno preveliko izgubo telesne mase; - pojavi progresivna anoreksija, astenija (slabost, izčrpanost) in zmanjšanje telesne mase v relativno kratkem časovnem obdobju, je treba pomisliti na splošni zdravstveni pregled, vključno z ocenitvijo delovanja jeter; - začutite, da bi morali prenehati jemati zdravilo Levodopa/Carbidopa/Entacapone Orion, glejte poglavje »Če ste prenehali jemati zdravilo Levodopa/Carbidopa/Entacapone Orion«
English: What you need to know before you take Levodopa/Carbidopa/Entacapone Orion
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Levodopa/Carbidopa/Entacapone Orion
English: When more levodopa is required, an increase in the frequency of doses and/or the use of an alternative strength of Levodopa/Carbidopa/Entacapone Orion should be considered, within the dose recommendations.
Slovenian: Kadar je potreben večji odmerek levodope, se je treba odločiti za pogostejše odmerjanje in/ali uporabiti zdravilo Levodopa/Carbidopa/Entacapone Orion drugačne (večje) jakosti, seveda v mejah priporočenega odmerjanja.
English: 10 film-coated tablets 30 film-coated tablets 100 film-coated tablets 130 film-coated tablets 175 film-coated tablets
Slovenian: 10 filmsko obloženih tablet 30 filmsko obloženih tablet 100 filmsko obloženih tablet 130 filmsko obloženih tablet 175 filmsko obloženih tablet
English: 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.
Slovenian: Bolnike in njihove skrbnike je treba opozoriti, da pri bolnikih, ki se zdravijo z agonisti dopamina in/ali drugimi dopaminergičnimi zdravljenji, ki vsebujejo levodopo, vključno z zdravilom Levodopa/Carbidopa/Entacapone Orion, lahko pride do vedenjskih simptomov, ki so znak motenj pri obvladovanju impulzov, kar vključuje patološko hazardiranje, povečan libido,
English: Film-coating of 50/12.5/200 mg, 100/25/200 mg and 150/37.5/200 mg: Glycerol (85 per cent) (E422)
Slovenian: Filmska obloga pri 50/12,5/200 mg, 100/25/200 mg in 150/37,5/200 mg: glicerol (85 odstotkov) (E422) hipromeloza (E464) magnezijev stearat polisorbat 80 (E433)
English: Do not take Levodopa/Carbidopa/Entacapone Orion if you:
Slovenian: Ne jemljite zdravila Levodopa/Carbidopa/Entacapone Orion:
English: Cardiac disorders Common:
Slovenian: Srčne bolezni Pogosti:
English: Other medicines and Levodopa/Carbidopa/Entacapone Orion
Slovenian: Druga zdravila in zdravilo Levodopa/Carbidopa/Entacapone Orion
English: - Rhabdomyolysis secondary to severe dyskinesias or neuroleptic malignant syndrome (NMS) has been observed rarely in patients with Parkinson's disease.
Slovenian: - Pri bolnikih s Parkinsonovo boleznijo redko opažajo pojav rabdomiolize, ki bi bila posledica hude diskinezije ali malignega nevroleptičnega sindroma (NMS).
English: Label 10 tablets 30 tablets 100 tablets 130 tablets 175 tablets
Slovenian: Nalepka 10 tablet 30 tablet 100 tablet 130 tablet 175 tablet
English: 125 mg/31.25 mg/200 mg Light brownish red, oval film-coated tablets marked with ‘LCE 125' on one side.
Slovenian: 125 mg/31,25 mg/200 mg Svetlorjavkasto rdeče ovalne filmsko obložene tablete z oznako »LCE 125« na eni strani.
English: Brownish or greyish red, elongated-ellipse shaped, unscored film-coated tablets marked with ‘LCE 150' on one side.
Slovenian: Rjavkaste ali sivkasto-rdeče podolgovate filmsko obložene tablete v obliki elipse brez zareze z oznako »LCE 150« na eni strani.