natgillin/translations-raw huggingface dataset:
While receiving treatment: During treatment, blood tests will be done in the following time intervals: every 2 weeks during the first 12 months of therapy, every 4 weeks during the following 6 months of therapy, every 8 weeks during further treatment.
Med zdravljenjem boste opravljali krvne preiskave v naslednjih intervalih: - vsake 2 tedna v prvih 12 mesecih zdravljenja, - vsake 4 tedne naslednjih 6 mesecev, - ter vsakih 8 tednov v nadaljevanju zdravljenja.
It should also be noted that female patients may have a higher risk of liver injury (see section 4.8).
Prav tako je treba omeniti, da je lahko tveganje za poškodbo jeter večje pri ženskah (glejte poglavje
Number (proportion) with ≥1 hour ON time response 32 (43 %) 40 (53 %) p=0.191 -5.2;26.6 Secondary Outcome
32 (43 %) 40 (53 %) p = 0,191 -5,2; 26,6
MAO inhibitors: Tasmar should not be given in conjunction with non-selective monoamine oxidase (MAO) inhibitors (e.g. phenelzine and tranylcypromine).
Zaviralci MAO: zdravila Tasmar ne smemo jemati skupaj z neselektivnimi zaviralci monoaminooksidaze (MAO), npr. fenelzinom ali tranilciprominom.
Do not take a double dose to make up for forgotten individual doses.
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnjega.
Orange yellow to brown yellow, hexagonal, biconvex, film-coated tablet.
Oranžno rumena do rjavo rumena, heksagonalna, bikonveksna, filmsko obložena tableta.
Dyskinesia, nausea and other levodopa-associated adverse reactions: Patients may experience an increase in levodopa-associated adverse reactions.
Diskinezija, slabost in drugi neželeni učinki, povezani z levodopo: bolniki lahko izkusijo več neželenih učinkov povezanih z levodopo.
Tasmar is indicated in combination with levodopa/benserazide or levodopa/carbidopa for use in patients with levodopa-responsive idiopathic Parkinson's disease and motor fluctuations, who failed to respond to or are intolerant of other catechol-o-methyltransferase (COMT) inhibitors (see section 5.1).
Zdravilo Tasmar se uporablja v kombinaciji z levodopo/benserazidom ali levodopo/karbidopo pri bolnikih z na levodopo odzivno idiopatsko Parkinsonovo boleznijo in motoričnimi fluktuacijami, ki se niso odzvali na ostale zaviralce katehol-O-metiltransferaze (COMT), ali pa jih ne prenašajo (glejte poglavje 5.1).
No dose adjustment of Tasmar is recommended for patients with mild or moderate renal impairment (creatinine clearance of 30 ml/min or greater).
Prilagajanje odmerkov zdravila Tasmar pri bolnikih z blažjo ali zmerno okvaro ledvic (očistek kreatinina 30 ml/min ali več) ni priporočljivo.
Date of first authorisation: 27 August 1997 Renewal of the authorisation: 31 August 2004 Date of latest renewal: 21 July 2014
Datum zadnjega podaljšanja: 21 julij 2014
Tasmar can be combined with all pharmaceutical formulations of levodopa/benserazide and levodopa/carbidopa (see also section 4.5).
Zdravilo Tasmar lahko kombiniramo z vsemi farmacevtskimi formulacijami levodope/benserazida in levodope/karbidope (glejte poglavje 4.5).
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost za razmnoževanje ne kažejo posebnega tveganja za človeka.
Tasmar therapy should only be initiated by physicians experienced in the management of advanced Parkinson's disease, to ensure an appropriate risk-benefit assessment.
Zdravljenje z zdravilom Tasmar naj uvedejo le zdravniki, izkušeni v zdravljenju napredovale Parkinsonove bolezni, da je zagotovljena primerna ocena razmerja med tveganjem in koristjo zdravljenja.
A previous history of Neuroleptic Malignant Syndrome (NMS) Symptom Complex and /or non-traumatic Rhabdomyolysis or Hyperthermia.
• anamneza malignega nevroleptičnega sindroma (MNS) s kompleksom simptomov in/ali netravmatske rabdomiolize ali hipertermije,
Tasmar is used when all other alternative medicines cannot stabilise your Parkinson's disease.
Zdravilo Tasmar uporabljamo, ko z drugimi zdravili ne moremo urediti vaše Parkinsonove bolezni.
Diarrhoea: In clinical trials, diarrhoea developed in 16 % and 18 % of patients receiving Tasmar 100 mg tid and 200 mg tid respectively, compared to 8 % of patients receiving placebo.
Diareja: v kliničnih preskušanjih se je diareja pojavila pri 16 % bolnikov, ki so prejemali 100 mg trikrat na dan, in pri 18 %, ki so prejemali 200 mg trikrat na dan, v primerjavi z 8 % bolnikov, ki so prejemali placebo.
In rats and rabbits, embryo-foetal toxicity was observed after tolcapone administration (see section 5.3).
Toksični vpliv na zarodek ali plod je bil opažen po dajanju tolkapona pri podganah in zajcih (glejte poglavje 5.3).
Pharmacodynamic effects
Farmakodinamični učinki:
Hepatocellular injury, in rare cases with fatal outcome* (see section 4.4)
Bolezni jeter, žolčnika in žolčevodov občasni hepatocelularne poškodbe, v redkih primerih s smrtim izzidom* (glejte poglavje 4.4)
Tasmar contains lactose
Zdravilo Tasmar vsebuje laktozo
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, 4.2)
Predpisovanje in izdaja zdravila je le s posebnim režimom (Glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
Outer Carton and bottle label, 30, 60, 100, 200 film-coated tablets
Zunanja kartonska škatla, nalepka na steklenici, 30, 60, 100, 200 filmsko obloženih tablet
While receiving treatment:
Med zdravljenjem:
Dose and frequency of administration
Odmerek in pogostnost jemanja
Film-coat: Hydroxypropylmethylcellulose, Talc, Yellow iron oxide, Ethylcellulose, Titanium dioxide, Triacetin, Sodium lauril sulfate.
Filmska obloga: hipromeloza, smukec, rumeni železov oksid, etilceluloza, titanov dioksid, triacetin, natrijev lavrilsulfat.
The average reduction in daily levodopa dose was about 30 % in those patients requiring a levodopa dose reduction.
Bolnikom, ki so potrebovali zmanjšanje odmerka, so dnevne odmerke levodope v povprečju zmanjšali za okoli 30 %.
If you have further questions, please ask your doctor or your pharmacist.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
Possible side effects Like all medicines, this medicine can have side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Tasmar neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The peak plasma concentrations of tolcapone at this dose were on average 30 µg/ml (compared to 3 and 6 µg/ml with 100 mg tid and 200 mg tid of tolcapone respectively).
Najvišje plazemske koncentracije tolkapona pri tem odmerku so bile v povprečju 30 g/ml (v primerjavi s 3 g/ml pri 100 mg odmerku trikrat na dan in 6 g/ml pri 200 mg tolkapona trikrat na dan).
Pale to light yellow, hexagonal, biconvex, film-coated tablet.
Svetla do rahlo rumena, heksagonalna, bikonveksna, filmsko obložena tableta.
If the dose is increased to 200 mg tid, liver enzyme monitoring should take place before increasing the dose and then be reinitiated following the same sequence of frequencies as above (see sections 4.4 and 4.8).
Če odmerek povečamo na 200 mg trikrat na dan, moramo pred tem kontrolirati jetrne encime in spremljanje nadaljevati z enako pogostnostjo, kot je navedeno zgoraj (glejte poglavji 4.4 in 4.8).
Special populations: Patients with severe renal impairment (creatinine clearance <30 ml/min) should be treated with caution.
Posebne skupine bolnikov: bolnike s hudo okvaro ledvic (očistek kreatinina  30 ml/min) je treba zdraviti s previdnostjo.
The highest dose of tolcapone administered to humans was 800 mg three times daily, with and without levodopa coadministration, in a one week study in healthy elderly volunteers.
Največji odmerek tolkapona pri zdravih starejših prostovoljcih s sočasnim dajanjem in brez sočasnega dajanja levodope v enotedenski študiji je bil 800 mg trikrat na dan.
How to take Tasmar
Kako jemati zdravilo Tasmar
Treatment with non-selective mono amino oxidase (MAO) inhibitors
zdravljenje z neselektivnimi zaviralci monoaminooksidaze (MAO).
Warfarin: Since clinical information is limited regarding the combination of warfarin and tolcapone, coagulation parameters should be monitored when these drugs are co-administered.
Varfarin: klinične informacije o kombinaciji varfarina in tolkapona so omejene, zato je treba ob sočasnem dajanju teh dveh zdravil spremljati koagulacijske parametre.
Plasma levels of 3OMD were markedly and dose-dependently decreased by tolcapone when given with levodopa/AADC-I (aromatic amino acid decarboxylase - inhibitor) (benserazide or carbidopa).
Tolkapon je znatno in od odmerka odvisno znižal plazemske vrednosti 3OMD, kadar se je dajal skupaj z levodopo/AADC-I (zaviralcem aromatske aminokislinske dekarboksilaze) (benserazidom ali karbidopo).
A diagnosis of NMS should be considered even if not all the above findings are present.
Tudi brez vseh zgoraj naštetih pojavov je potrebno pretehtati diagnozo MNS.
Tolcapone is a low-extraction-ratio drug (extraction ratio = 0.15), with a moderate systemic clearance of about 7 L/h.
Tolkapon je zdravilo z nizkim razmerjem izločanja (razmerje izločanja = 0,15) z zmernim sistemskim očistkom približno 7 l/h, t1/2 tolkapona je približno 2 uri.
For oral use The tablets should be swallowed whole.
Peroralna uporaba Tablete morate pogoltniti cele.
If substantial clinical benefits are not seen within 3 weeks of the initiation of the treatment (regardless of dose) Tasmar should be discontinued.
Če se v 3 tednih od začetka zdravljenja ne pokažejo bistvene klinične koristi (ne glede na odmerek), je zdravljenje z zdravilom Tasmar treba prekiniti.
Tasmar blocks this enzyme and thus slows the breakdown of levodopa.
Zdravilo Tasmar zavira encim COMT in upočasni razgradnjo levodope.
Always follow the instructions of your doctor about the duration of the treatment with Tasmar.
Glede dolžine zdravljenja z zdravilom Tasmar vedno upoštevajte zdravnikova navodila.
“TASMAR” and “200” are engraved on one side.
Na eni strani tablete je vgravirano “TASMAR” in “200”.
To improve efficacy your doctor should only increase the dose to 3 times daily 2 tablets (200 mg three times a day) if the increase in how your Parkinson´s disease symptoms are controlled outweighs the expected increase in side effects.The side effects at the higher dose can often be severe and affect your liver.
Za izboljšanje učinkovitosti lahko vaš zdravnik odmerek poveča na trikrat na dan po dve tableti (na 200 mg trikrat na dan) le, če povečan nadzor nad simptomi vaše Parkinsonove bolezni odtehta pričakovano povečanje neželenih učinkov.
For the treatment of Parkinson´s disease, Tasmar is used together with the medicinal product levodopa (as levodopa/benserazide or levodopa/carbidopa).
Zdravilo Tasmar se uporablja za zdravljenje Parkinsonove bolezni skupaj z zdravilom, ki vsebuje levodopo (kot levodopa/beserazid ali levodopa/karbidopa).
Diarrhoea led to withdrawal of 5% and 6% of patients receiving Tasmar 100 mg tid and 200 mg tid respectively, compared to 1 % of patients receiving placebo.
Diareja je bila vzrok ukinitvi zdravila Tasmar pri 5 % bolnikov, ki so jemali zdravilo Tasmar 100 mg trikrat na dan, in 6 % bolnikov z odmerjanjem 200 mg trikrat na dan v primerjavi z 1 % bolnikov, ki so prejemali placebo.
Therefore, if you feel unwell, you should contact your doctor since you may need to have your levodopa dose changed.
Zato v primeru slabega počutja, kontaktirajte svojega zdravnika, saj bo morda treba prilagoditi vaš odmerek levodope.
Outer Carton and blister packs, 30 and 60 film-coated tablets
Zunanja kartonska škatla za pretisni omot, 30 in 60 filmsko obloženih tablet
Before starting treatment: To reduce the risk of NMS, Tasmar should not be prescribed for patients with severe dyskinesia or a previous history of NMS including rhabdomyolysis or hyperthermia (see section 4.3).
Pred začetkom zdravljenja: da bi zmanjšali tveganje za MNS, bolnikom s hudo diskinezijo in anamnezo MNS, vključno z rabdomiolizo ali hipertermijo, zdravila Tasmar ne predpisujemo (glejte 4.3).
Tasmar is available in PVC/PE/PVDC blisters (pack sizes of 30 and 60 film-coated tablets) and in amber glass bottles without desiccant (pack sizes of 100 film-coated tablets).
Zdravilo Tasmar je na voljo v PVC/PE/PVDC pretisnih omotih (velikosti pakiranja po 30 in 60 filmsko obloženih tablet) in rumenorjavih steklenicah brez sušila (velikost pakiranja po 100 filmsko obloženih tablet).
“TASMAR” and “100” are engraved on one side.
Na eni strani tablete je vgravirano “TASMAR” in “100”.
In the therapeutic range, tolcapone pharmacokinetics are linear and independent of levodopa/AADC-I (benserazide or carbidopa) coadministration.
V terapevtskih odmerkih je farmakokinetika tolkapona linearna in neodvisna od sočasnega dajanja levodope/AADC-I (benserazida ali karbidope).
Evidence of liver disease or increased liver enzymes Severe dyskinesia
• znaki bolezni jeter ali povišane ravni jetrnih encimov,
The most common of these are increased dyskinesia, nausea, vomiting, abdominal pain, syncope, orthostatic complains, constipation, sleep disorders, somnolence, hallucination.
Najpogostejši od teh neželenih učinkov so povečana diskinezija, slabost, bruhanje, bolečina v trebuhu, sinkopa, ortostatske težave, zaprtje, motnje spanja, somnolenca, halucinacije.
It is available in blisters in pack sizes of 30 and 60 tablets and in glass bottles in pack sizes of 100 tablets.
Na voljo je v pretisnih omotih v pakiranjih po 30 in 60 tablet in v steklenicah v pakiranju po 100 tablet.
severe symptoms of muscle stiffening, fever or mental confusion (Neuroleptic Malignant Syndrome) when antiparkinsonian treatments are abruptly reduced or withdrawn.
Redki: - hudi simptomi mišične togosti, visoka telesna temperatura in duševna zmedenost (maligni nevroleptični sindrom), ko nenadno zelo zmanjšamo odmerek ali prekinemo zdravljenje z antiparkinsoniki.
However, no evidence of renal toxicity was observed in the low-dose group.
V skupini z nizkimi odmerki pa znakov škodljivih učinkov za ledvice niso opazili.
Renal impairment: The pharmacokinetics of tolcapone have not been investigated in patients with renal impairment.
Okvara ledvic: pri bolnikih z okvaro ledvic farmakokinetike tolkapona niso proučevali.
Tell your doctor if you experience any of these behaviours; these will discuss ways of managing or reducing the symptoms.
Predlagal vam bo načine za obvladovanje ali zmanjšanje teh simptomov.
Since clinical information is limited regarding the combination of warfarin and tolcapone, coagulation parameters should be monitored when these drugs are co-administered.
Klinične informacije o kombinaciji varfarina in tolkapona so omejene, zato je treba ob sočasnem dajanju teh dveh zdravil spremljati koagulacijske parametre.
Contact your doctor, pharmacist or hospital immediately as you may need urgent medical attention.
Če ste vzeli večji odmerek zdravila Tasmar, kot bi smeli Nemudoma stopite v stik z zdravnikom, farmacevtom ali bolnišnico, saj boste verjetno potrebovali takojšnjo medicinsko pomoč.
During the day 1 film-coated tablet Tasmar Evening
Skupaj s prvim odmerkom levodope tekom dneva 1 filmsko obložena tableta zdravila Tasmar večer
Tasmar is available in PVC/PE/PVDC blisters (pack sizes of 30 and 60 film-coated tablets) and in amber glass bottles without desiccant (pack sizes of 30, 60,100 and 200 film-coated tablets).
Zdravilo Tasmar je na voljo v PVC/PE/PVDC pretisnih omotih (velikosti pakiranja po 30 in 60 filmsko obloženih tablet) in rumenorjavih steklenicah brez sušila (velikosti pakiranja po 30, 60, 100 in 200 filmsko obloženih tablet).
EU/1/97/044/006 100 tablets
EU/1/97/044/006 100 tablet
Tablet core: Calcium hydrogen phosphate, Microcrystalline cellulose, Povidone K30, Sodium starch glycollate, Lactose, Talc, Magnesium stearate.
- Pomožne snovi so: Jedro tablete: kalcijev hidrogenfosfat, mikrokristalna celuloza, povidon K30, natrijev karboksimetilškrob, laktoza, smukec, magnezijev stearat.
Neuroleptic Malignant Syndrome Symptom Complex (see section 4.4)
Neželeni učinki omotica somnolenca ortostatične motnje redki maligni nevroleptični sindrom s kompleksom simptomov (glejte poglavje 4.4)
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 Tasmar in association with Levedopa (see section 4.4 `special warnings and precautions for use´).
Motnje nadzora impulzov: Pri bolnikih, zdravljenih z dopaminskimi agonisti in/ali drugimi dopaminergičnimi zdravili, kot je zdravilo Tasmar v povezavi z levodopo, se lahko pojavi patološko igranje iger na srečo, povečan libido, hiperseksualnost, kompulzivno nakupovanje, prenajedanje in kompulzivno hranjenje (glejte poglavje 4.4 »Posebna opozorila in previdnostni ukrepi«).
If the dose is increased to 200 mg tid, liver enzyme monitoring should take place before increasing the dose and then be re-initiated following the sequence of frequencies as above.
Če odmerek povečamo na 200 mg trikrat na dan, moramo raven jetrnih encimov kontrolirati pred tem in nadaljevati z enako pogostnostjo, kot je navedeno zgoraj.
EU/1/97/044/007 30 tablets EU/1/97/044/008 60 tablets EU/1/97/044/003 100 tablets EU/1/97/044/0010 200 tablets
EU/1/97/044/007 30 tablet EU/1/97/044/008 60 tablet EU/1/97/044/003 100 tablet EU/1/97/044/0010 200 tablet
You should not breast-feed your infant during treatment with Tasmar.
Med zdravljenjem z zdravilom Tasmar ne smete dojiti.
It is available in blisters in pack sizes of 30 and 60 tablets and in glass bottles in pack sizes of 30, 60 ,100 and 200 filmcoated tablets.
Na voljo je v pretisnih omotih v pakiranjih po 30 in 60 tablet in v steklenicah v pakiranju po 30, 60, 100 in 200 tablet.
The first tablet Tasmar is to be taken in the morning together with your other parkinsonian medicine ‘levodopa'.
Prvi odmerek zdravila Tasmar se vzame s prvim dnevnim odmerkom vašega drugega zdravila za zdravljenje Parkinsonove bolezni, ki vsebuje levodopo.
Mechanism of action
Mehanizem delovanja:
As Tasmar decreases the breakdown of levodopa in the body, side effects due to increased levodopa concentrations may occur when beginning Tasmar treatment.
Prilagajanje odmerka levodope med zdravljenjem z zdravilom Tasmar Ker zdravilo Tasmar zmanjša razgradnjo levodope v telesu, se lahko ob začetku zdravljenja z zdravilom Tasmar zaradi zvišanih koncentracij levodope pojavijo neželeni učinki.
Tasmar, as a COMT inhibitor, is known to increase the bioavailability of the co-adminstered levodopa.
Zdravilo Tasmar, kot COMT zaviralec, zviša biološko uporabnost sočasno dajane levodope.
No studies on the effects of Tasmar on the ability to drive and use machines have been performed.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Študije o vplivu zdravila Tasmar na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
Increases to more than three times the upper limit of normal (ULN) in alanine aminotransferase (ALT) occurred in 1 % of patients receiving Tasmar 100 mg three times daily, and 3 % of patients at 200 mg three times daily.
Povišanje alanin-aminotransferaze (ALT) do več kot trikratne zgornje referenčne vrednosti (ULN), se je pojavilo pri 1 % bolnikov, ki so prejemali zdravilo Tasmar 100 mg trikrat na dan in pri 3 % bolnikov, ki so prejemali zdravilo Tasmar 200 mg trikrat na dan. Povišanja so bila približno dvakrat verjetnejša pri ženskah.
NMS (Neuroleptic Malignant Syndrome): Symptoms of Neuroleptic Malignant Syndrome (NMS) may occur during Tasmar treatment.
Med zdravljenjem z zdravilom Tasmar se lahko pojavijo simptomi malignega nevroleptičnega sindroma (MNS).
may affect more than 1 in 10 people
pojavijo se lahko pri več kot 1 od 10 bolnikov pogosti:
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 Tasmar in association with levodopa.
Bolniki in negovalci morajo vedeti, da se pri bolnikih, zdravljenih z dopaminskimi agonisti in/ali drugimi dopaminergičnimi zdravili, kot je zdravilo Tasmar v povezavi z levodopo, lahko pojavijo vedenjski simptomi motenj nadzora impulzov, vključno s patološkim igranjem iger na srečo, povečanim libidom, hiperseksualnostjo, kompulzivnim nakupovanjem, prenajedanjem in kompulzivnim hranjenjem.
The following suggestions are based on pharmacological considerations and have not been evaluated in clinical trials.
Prilagajanje odmerka levodope ob prekinitvi zdravljenja z zdravilom Tasmar Naslednji predlogi so osnovani glede na farmakologijo in niso bili vrednoteni v kliničnih preskušanjih.
The maximum therapeutic dose of 200 mg three times daily should not be exceeded, as there is no evidence of additional efficacy at higher doses.
Ker ni podatkov o dodatni učinkovitosti pri večjih odmerkih, največjega terapevtskega odmerka 200 mg trikrat na dan ne smemo preseči.
Transient elevation above pretreatment levels of erythrocyte COMT activity was observed after withdrawal of tolcapone.
Po ukinitvi tolkapona so opazili prehodno povečanje eritrocitne aktivnosti COMT nad vrednosti pred zdravljenjem.
Very common: involuntary movement (dyskinesia), nausea, decreased appetite, diarrhoea, headache, dizziness sleep problems, somnolence, feeling lightheaded while you stand, (orthostatic complaints),mental confusion and hallucinations, movement disorder with involuntary muscle spasms or malpositions (dystonia), dreaming excessive.
Zelo pogosti: - nehoteno gibanje (diskinezija), - slabost, izguba apetita, driska, - glavobol, omotica, - težave s spanjem, somnolenca, - občutek vrtoglavice, ko stojite (ortostatske težave), zmedenost in halucinacije, - motnje gibanja z neželenimi mišičnimi krči (distonija), - prekomerne sanje.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton and bottle label, 100 film-coated tablets
PODATKI NA ZUNANJI OVOJNINI IN STIČNI OVOJNINI Škatla in nalepka na steklenici, 100 filmsko obloženih tablet
Calcium hydrogen phosphate Microcrystalline cellulose Povidone K30
Jedro tablete: kalcijev hidrogenfosfat mikrokristalna celuloza povidon K30 natrijev karboksimetilškrob laktoza smukec magnezijev stearat
Talk to your doctor or pharmacist before taking Tasmar.
Pred začetkom jemanja zdravila Tasmar se posvetujte z zdravnikom ali farmacevtom.
If you get any side effects talk to you doctor or pharmacist.
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
Impulse control disorders* (Libido increased, hypersexuality, pathological gambling, compulsive spending or buying, binge eating, compulsive eating (see section 4.4))
Psihiatrične motnje zelo pogosti motnje spanja prekomerne sanje somnolenca zmedenost halucinacija redki motnje nadzora impulzov* (povečan libido, hiperseksualnost, patološko igranje iger na srečo, kompulzivno nakupovanje, prenajedanje in kompulzivno hranjenje (glejte poglavje 4.4))
Common: chest pain, constipation, dyspepsia, stomach ache, vomiting, dry mouth, fainting increased sweating, influenza-like symptoms reduced voluntary and involuntary movement (hypokinesia) upper respiratory tract infection increase of specific liver enzymes, urine discoloration
Pogosti: - bolečine v prsih, - zaprtje, dispepsija, bolečine v želodcu, bruhanje, suha usta, - omedlevanje, - povečano potenje, - gripi podobni simptomi, - zmanjšano prostovoljno in neprostovolno gibanje (hipokinezija), - okužba zgornjih dihal, - povišanje specifičnih jetrnih encimov, - sprememba barve urina.
Tolcapone does not accumulate with three times daily dosing of 100 or 200 mg. At these doses, Cmax is approximately 3 and 6 µg/ml, respectively.
Tolkapon se ne kopiči pri odmerjanju 100 ali 200 mg trikrat na dan.