natgillin/translations-raw huggingface dataset:
Tolcapone does not distribute widely into tissues due to its high plasma protein binding (> 99.9%).
Tolkapon se v tkiva ne porazdeli v velikem obsegu zaradi njegove visoke vezave na plazemske proteine (> 99, 9%).
Tolcapone is almost completely metabolised prior to excretion, with only a very small amount (0.5% of dose) found unchanged in urine.
Presnova/ izločanje: tolkapon se pred izločanjem skoraj popolnoma presnovi, zelo majhne količine nespremenjenega (0, 5% odmerka) pa najdemo v urinu.
In addition, the compound is methylated by COMT to 3-O-methyl-tolcapone and metabolised by cytochromes P450 3A4 and P450 2A6 to a primary alcohol (hydroxylation of the methyl group), which is subsequently oxidised to the carboxylic acid.
Dodatno se spojina metilira s COMT v 3- O- metil tolkapon in presnavlja s citokromi P450 3A4 in P450 2A6 v primarni alkohol (hidroksilacija metilne skupine), ki se nato oksidira v karboksilno kislino.
The reduction to a putative amine, as well as the subsequent N-acetylation, occurs to a minor extent.
Redukcija v domnevni amin se tako kot posledična N - acetilacija pojavi v manjšem obsegu.
After oral administration, 60% of drug-related material is excreted into urine and 40% into faeces.
Po peroralnem jemanju se 60% z zdravilom povezanih substanc izloči v urin in 40% v blato.
The t1/ 2 of tolcapone is approximately 2 hours.
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.
Because of the risk of liver injury observed during post-marketing use, Tasmar is contraindicated in patients with liver disease or increased liver enzymes.
Jetrna okvara: zaradi tveganja za jetrno poškodbo, opaženega med uporabo v času trženja, je zdravilo Tasmar kontraindicirano pri bolnikih z jetrno boleznijo ali povišanimi jetrnimi encimi.
A study in patients with hepatic impairment has shown that moderate non-cirrhotic liver disease had no impact on the pharmacokinetics of tolcapone.
Študija pri bolnikih z jetrno okvaro je pokazala, da zmerna necirotična jetrna bolezen ni imela vpliva na farmakokinetiko tolkapona.
However, in patients with moderate cirrhotic liver disease, clearance of unbound tolcapone was reduced by almost 50%.
V nasprotju s tem se je pri bolnikih z zmerno cirotično jetrno boleznijo očistek nevezanega tolkapona zmanjšal za skoraj 50%.
The pharmacokinetics of tolcapone have not been investigated in patients with renal impairment.
Ledvična okvara: pri bolnikih z ledvično okvaro farmakokinetike tolkapona niso proučevali.
The data of more than 400 patients have confirmed that over a wide range of creatinine clearance values (30-130 mL/ min) the pharmacokinetics of tolcapone are unaffected by renal function.
Podatki več kot 400 bolnikov so potrdili, da je v velikem razponu vrednosti očistka kreatinina (30 do 130 ml/ min) farmakokinetika tolkapona neodvisna od ledvične funkcije.
This could be explained by the fact that only a negligible amount of unchanged tolcapone is excreted in the urine, and the main metabolite, tolcapone-glucuronide, is excreted both in urine and in bile (faeces).
To lahko razložimo z dejstvom, da se samo zanemarljiva količina nespremenjenega tolkapona izloča v urin in da se glavni presnovek, tolkapon- glukuronid izloča v urin in z žolčem (blatom).
3% and 5% of rats in the mid- and high- dose groups, respectively, of the 24-month carcinogenicity study were shown to have renal epithelial tumours (adenomas or carcinomas).
Kancerogenost, mutageneza: v 24- mesečni študiji kancerogenega potenciala se je izkazalo, da je 3% podgan v skupini s srednje velikimi odmerki in 5% podgan v skupini z velikimi odmerki, imelo ledvične epitelijske tumorje (adenome ali karcinome).
Tolcapone was shown not to be genotoxic in a complete series of mutagenicity studies.
Mutageneza: tolkapon se ni izkazal za genotoksičnega v vseh serijah študij mutagenosti.
Tolcapone, when administered alone, was shown to be neither teratogenic nor to have any relevant effects on fertility.
Vplivi na sposobnost za razmnoževanje: tolkapon, dajan samostojno, se ni izkazal za teratogenega, niti da bi neugodno vplival na plodnost.
Calcium hydrogen phosphate (anhydrous) Microcrystalline cellulose Polyvidone K30 Sodium starch glycollate Lactose monohydrate Talc Magnesium stearate.
Jedro tablete: brezvodni kalcijev hidrogenfosfat, mikrokristalna celuloza, povidon K30, natrijev karboksimetilškrob, monohidrat laktoze, smukec, magnezijev stearat.
Methylhydroxypropylcellulose, Talc Yellow iron oxide (E 172) Ethylcellulose Titanium dioxide (E 171) Triacetin Sodium lauryl sulfate
Filmska obloga: hipromeloza, smukec, rumeni železov oksid (E172), etilceluloza, titanov dioksid (E171), triacetin, natrijev lavrilsulfat.
Tasmar is available in PVC/ PE/ PVDC blisters (pack sizes of 30 and 60 film-coated tablets) and in glass bottles (pack sizes of 30, 60 and 100 film-coated tablets).
Zdravilo Tasmar je na voljo v pretisnih omotih PVC/ PE/ PVDC (velikost pakiranja je 30 in 60 filmsko obloženih tablet) in stekleničkah (velikost pakiranja je 30, 60 in 100 filmsko obloženih tablet).
Not all pack sizes may be marketed
Na trgu ni na voljo vseh pakiranj.
11 6.6 Instructions for use and handling and disposal
11 6. 6 Navodila za pripravo in ravnanje z zdravilom in odlaganje
Tasmar 100 mg tablets:
Tasmar 100 mg tablete:
27 August 1997 / 31 october2004
27. avgust 1997 / 31. avgust 2004
Tasmar 200 mg film coated tablets.
Tasmar 200 mg filmsko obložena tableta
Tasmar 200 mg is an orange yellow to brown yellow, hexagonal, biconvex, film-coated tablet. “ TASMAR” and “ 200” are engraved on one side.
Na eni strani tablete je vgravirano “ TASMAR ” in “ 200 ”.
As Tasmar decreases the breakdown of levodopa in the body, side effects due to increased levodopa concentrations may occur when beginning Tasmar treatment.
13 Ker zdravilo Tasmar zmanjša razgradnjo levodope v telesu, se lahko ob začetku zdravljenja z zdravilom Tasmar zaradi zvišanih koncentracij levodope pojavijo neželeni učinki.
14 4.4 Special warnings and special precautions for use
14 4. 4 Posebna opozorila in previdnostni ukrepi
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
15 Pred začetkom zdravljenja: da bi zmanjšali tveganje za NMS, bolnikom s hudo diskinezijo in anamnezo NMS, vključno z rabdomiolizo ali hipertermijo, zdravila Tasmar ne predpisujemo (glejte 4. 3).
16 Catechols and other drugs metabolised by catechol-O-methyltransferase (COMT):
16 Kateholi in druga zdravila, ki se presnavljajo s katehol- O- metiltransferazo (COMT): tolkapon lahko vpliva na farmakokinetiko učinkovin, ki se presnavljajo s COMT.
17 4.7 Effects on ability to drive and use machines
17 Varnost tolkapona za dojenčke ni znana; zato naj ženske med zdravljenjem z zdravilom Tasmar ne dojijo.
Hospitalisation is advised.
19 Ukrepi pri prevelikem odmerjanju: priporoča se hospitalizacija.
20 Tab.
20 Preglednica 1.
21 5.3 Preclinical safety data
21 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 is available in PVC/ PE/ PVDC blisters (pack sizes of 30 and 60 film-coated tablets) and in glass bottles (pack sizes of 100 film-coated tablets).
Zdravilo Tasmar je na voljo v pretisnih omotih PVC/ PE/ PVDC (velikost pakiranja je 30 in 60 filmsko obloženih tablet) in stekleničkah (velikost pakiranja je 100 filmsko obloženih tablet).
22 6.6 Instructions for use and handling and disposal
22 6. 6 Navodila za pripravo in ravnanje z zdravilom in odlaganje
Tasmar 200 mg tablets:
Tasmar 200 mg tablete:
27 August 1997 / 31 October2004
2004
Przemysł owa 2 35-959 Rzeszów Poland
Przemysłowa 2 35- 959 Rzeszów Poljska
After the PSUR submitted in October 2004, in line with the international birth date, PSURs will be submitted according to the requirements for initial PSUR submissions after granting of a Marketing Authorisation as laid down in Council Regulation (EEC) 2309/ 93, Article 22 (2).
Po PSUR- u predloženemu v oktobru 2004, v skladu z datumom prve registracije, bodo PSUR- i predloženi glede na zahteve za prvotno oddajo PSUR- a po dodelitvi dovoljenja za promet, kot je opisano v Uredbi Sveta (EEC) 2309/ 93, člen 22 (2).
These PSURs will address cumulative data on hepatic reactions and NMS.
Ti PSUR- i bodo vključevali celostne podatke o jetrnih reakcijah in NMS.
27 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Bottle Packs and bottle label, 100 Film-Coated Tablets
Stekleničke, nalepka na steklenički, 100 filmsko obloženih tablet
1 film-coated tablet contains tolcapone 100 mg
Ena filmsko obložena tableta vsebuje 100 mg tolkapona
Colours (E171, E172), lactose monohydrate
Barvila (E171, E172), monohidrat laktoze
The tablets should be swallowed whole
Tablete morate pogoltniti cele
Read package leaflet before use
Pred uporabo preberite priloženo navodilo
29 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Bottle Packs and bottle label, 60 Film-Coated Tablets
Stekleničke, nalepka na steklenički, 60 filmsko obloženih tablet
31 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Bottle Packs and bottle label, 30 Film-Coated Tablets
Stekleničke, nalepka na steklenički, 30 filmsko obloženih tablet
33 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Blister Packs, 60 Film-Coated Tablets
Pretisni omot, 60 filmsko obloženih tablet
1 film-coated tablet contains tolcapone 100 mg
Filmsko obložena tableta vsebuje 100 mg tolkapona
35 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Blister packs, 30 Film-Coated Tablets
Pretisni omot, 30 filmsko obloženih tablet
Tasmar 100 mg Tolcapone
Tasmar 100 mg tolkapon
38 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
1 film-coated tablet contains tolcapone 200 mg
Ena filmsko obložena tableta vsebuje 200 mg tolkapona
40 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
1 film-coated tablet contains tolcapone 200 mg
Filmsko obložena tableta vsebuje 200 mg tolkapona
42 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Tasmar 200 mg Tolcapone
Tasmar 200 mg tolkapon
46 PACKAGE LEAFLET
46 NAVODILO ZA UPORABO
Read all of this leaflet carefully before you start taking this medicine.
Pred uporabo natančno preberite celotno navodilo!
What Tasmar is and what it is used for 2.
Kaj je zdravilo Tasmar in za kaj ga uporabljamo 2.
Before you take Tasmar 3.
Kaj morate vedeti, preden boste vzeli zdravilo Tasmar 3.
How to take Tasmar 4.
Kako jemati zdravilo Tasmar 4.
Storing Tasmar 6.
Možni neželeni učinki 5 Shranjevanje zdravila Tasmar 6.
Tasmar 100 mg film-coated tablet Tolcapone
Tasmar 100 mg filmsko obložena tableta tolkapon
- The active substance is tolcapone (100 mg in each film- coated tablet)
- Zdravilna učinkovina je tolkapon (100 mg v vsaki filmsko obloženi tableti).
Film-coat:
Jedro tablete: brezvodni kalcijev hidrogenfosfat, mikrokristalna celuloza, povidon K30, natrijev karboksimetilškrob, monohidrat laktoze, smukec, magnezijev stearat.
Methylhydroxypropylcellulose, Talc, Yellow iron oxide (E 172), Ethylcellulose, Titanium dioxide (E 171), Triacetin, Sodium lauryl sulfate.
Filmska obloga: hipromeloza, smukec, rumeni železov oksid (E172), etilceluloza, titanov dioksid (E171), triacetin, natrijev lavrilsulfat.
The manufacturer responsible for batch release is:
Izdelovalec, odgovoren za sproščanje zdravila na trg:
WHAT TASMAR IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO TASMAR IN ZA KAJ GA UPORABLJAMO
Tasmar is a pale to light yellow, oval shaped, film-coated tablet. “ TASMAR” and “ 100” is engraved on one side.
Na eni strani tablete je vgravirano “ TASMAR ” in “ 100 ”.
Tasmar is supplied as film coated tablets containing 100 mg tolcapone.
Zdravilo Tasmar je v obliki filmsko obložene tablete, ki vsebuje 100 mg tolkapona.
It is available in blisters in pack sizes of 30 and 60 tablets and in glass bottles in pack sizes of 30, 60 and 100 tablets.
Na voljo je v pretisnih omotih v pakiranjih po 30 in 60 tablet in v steklenicah v pakiranju po 30, 60 in 100 tablet.
Tasmar is used together with levodopa/ benserazide or levodopa/ carbidopa when all other alternative medications cannot stabilise your Parkinson’ s disease.
Zdravilo Tasmar uporabljamo skupaj z levodopo/ benserazidom ali levodopo/ karbidopo, ko z drugimi zdravili ne moremo urediti vaše Parkinsonove bolezni.
Tasmar therapy should only be initiated by physicians experienced in the treatment of Parkinson’ s disease to ensure an appropriate risk-benefit assessment.
Terapijo z zdravilom Tasmar naj začnejo le zdravniki, izkušeni v zdravljenju Parkinsonove bolezni, da je zagotovljena primerna ocena razmerja med tveganjem in koristjo zdravljenja.
47 Catechol-O-methyltransferase (COMT) is a natural enzyme in your body that breaks down the levodopa medication used to treat your Parkinson’ s disease.
47 Katehol- O- metiltransferaza (COMT) je naravni encim v vašem telesu, ki razgrajuje zdravilo levodopo, namenjeno zdravljenju vaše Parkinsonove bolezni.
Tasmar blocks COMT and slows the breakdown of levodopa.
Zdravilo Tasmar zavira COMT in upočasni razgradnjo levodope.
This means when it is taken together with levodopa (as levodopa/ benserazide or levodopa/ carbidopa) you should have an improvement in your symptoms of Parkinson’ s disease.
To pomeni, da ko ga jemljete skupaj z levodopo (kot levodopa/ benserazid ali levodopa/ karbidopa), se morajo vaši simptomi Parkinsonove bolezni izboljšati.
BEFORE YOU TAKE TASMAR
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO TASMAR
You should not start taking Tasmar until your doctor has described the risks of treatment with Tasmar and measures necessary to minimise those risks, and answered any questions you may have.
Zdravila Tasmar ne smete začeti jemati, dokler vam vaš zdravnik ne opiše tveganj zdravljenja z zdravilom Tasmar, in ukrepov, potrebnih za zmanjšanje teh tveganj na najnižjo možno raven, ter vam odgovori na vprašanja, ki jih morda imate.
You should only receive Tasmar if your Parkinson’ s disease is not adequately controlled by the use of other therapies.
Zdravilo Tasmar naj bi prejemali le, če vaša Parkinsonova bolezen ni bila zadostno urejena z uporabo ostalih zdravil.
In addition, your doctor will stop Tasmar treatment if after 3 weeks you do not improve enough to justify the risks of continuing treatment.
Poleg tega bo vaš zdravnik zdravljenje z zdravilom Tasmar prekinil, če po 3 tednih ne napredujete dovolj, da bi nadaljnje zdravljenje upravičevalo tveganja.
Liver Injury:
Jetrna poškodba
Tasmar may cause rare but potentially fatal liver injury.
Zdravilo Tasmar lahko povzroči redko, a potencialno usodno jetrno poškodbo.
Liver injury has occurred most often after 1 month and before 6 months.
Jetrna poškodba se je najpogosteje pojavila med 1 mesecem in 6 meseci zdravljenja.
Injury occurring earlier or later is also possible.
Poškodba lahko nastane tudi prej ali pozneje.
It should also be noted that female patients may have a higher risk of liver injury.
Prav tako je treba omeniti, da utegne biti tveganje za jetrne poškodbe večje pri ženskah.
To reduce the risk of liver injury you should not use Tasmar if 1) you have liver disease or 2) blood tests done before starting treatment show any liver abnormality (tests of ALT, alanine amino transferase and AST, aspartate amino transferase).
Pred začetkom zdravljenja: da bi zmanjšali tveganje za jetrno poškodbo, zdravila Tasmar ne smete jemati, če 1) imate jetrno bolezen, ali 2) če krvne preiskave, narejene pred zdravljenjem, kažejo kakršnokoli nepravilnost jetrnega delovanja (testa ALT, alanin- aminotransferaza in AST, aspartat- aminotransferaza).
Blood tests will be done every 2 weeks for the first year of therapy, every 4 weeks for the next 6 months and every 8 weeks thereafter and treatment will be stopped if they become abnormal.
Med zdravljenjem: krvne preiskave boste opravljali vsake 2 tedna v prvem letu zdravljenja, vsake 4 tedne naslednjih 6 mesecev ter vsakih 8 tednov zatem in zdravljenje bo prekinjeno, če bodo izvidi patološki.
The following symptoms may indicate liver injury and you should report them to your doctor immediately: jaundice (yellowing of the skin or eyes), darkening of your urine, pain in your stomach (particularly over the liver in the right upper area), worsening of nausea or vomiting, loss of appetite, if you tire more easily than usual or feel weak.
Naslednji simptomi lahko nakazujejo jetrno poškodbo, zato morate o njih takoj poročati svojemu zdravniku: zlatenica (porumenenje kože in oči), temnenje urina, bolečine v trebuhu (posebno nad jetri v desnem zgornjem predelu), poslabšanje slabosti ali bruhanje, izguba apetita, če se utrudite hitreje kot ponavadi in se počutite šibki.
NMS (Neuroleptic Malignant Syndrome):
NMS (maligni nevroleptični sindrom)
NMS (Neuroleptic Malignant Syndrome) consists of some or all of the following: severe muscle stiffness, jerking movements of muscles, arms or legs, and soreness of muscles.
NMS (maligni nevroleptični sindrom) sestavlja nekaj ali vse od naštetega: huda mišična togost, trzajoči premiki mišic, rok ali nog in bolečina v mišicah.
Other important symptoms are high fever and mental confusion.
Ostala pomembna simptoma sta visoka telesna temperatura in duševna zmedenost.
Very rarely, after abruptly reducing or stopping Tasmar or other antiparkinsonian drugs, you may experience severe symptoms of muscle stiffening, fever or mental confusion.
Zelo redko, potem ko nenadno zelo zmanjšamo odmerek ali prekinemo zdravljenje z zdravilom Tasmar ali drugimi antiparkinsoniki, lahko izkusite hude simptome togosti mišic, visoko telesno temperaturo ali duševno zmedenost.
Symptoms may also occur during Tasmar treatment.
Simptomi se lahko pojavijo tudi med zdravljenjem z zdravilom Tasmar.
To reduce the risk of NMS you should not use Tasmar if your doctor says you have severe dyskinesia (involuntary movement) or a previous illness that may have been NMS.
Pred zdravljenjem: da bi zmanjšali tveganje za NMS, ne smete jemati zdravila Tasmar, če vaš zdravnik pravi, da imate resno diskinezijo (nehoteno gibanje), ali ste v preteklosti imeli bolezen, ki bi lahko bila NMS.
Inform your doctor of all prescription and non-prescription medications as the risk of NMS may be increased if you are taking medications that may alter the effects of the brain messenger molecules of dopamine and serotonin.
Povejte zdravniku za vsa zdravila, ki ste jih prejeli na recept ali brez recepta, saj se lahko tveganje za NMS poveča, če jemljete zdravila, ki lahko spremenijo delovanje možganskih prenašalcev dopamina in serotonina.
If you develop symptoms as described above, that you think may be NMS, you should report them to your doctor immediately.
Med zdravljenjem: če se pri vas pojavijo zgoraj opisani simptomi in menite, da bi lahko bil NMS, to nemudoma sporočite svojemu zdravniku.
Do not stop Tasmar or any other Parkinson’ s medications without telling your doctor as this may increase the risk of NMS.
Ne prekinite jemanja zdravila Tasmar ali katerega drugega zdravila za zdravljenje Parkinsonove bolezni, ne da bi se posvetovali z zdravnikom, saj to lahko poveča tveganje za NMS.
Do not take Tasmar:
Ne jemljite zdravila Tasmar:
- if you have severe dyskinesia (involuntary movement)
- če imate jetrno bolezen ali povečane jetrne encime;
- if you are hypersensitive (allergic) to tolcapone or to any of the other ingredients of Tasmar.
- če imate hudo diskinezijo (nehoteno gibanje);
- if you have Phaeochromocytoma
- če ste v preteklosti imeli kompleks simptomov malignega nevroleptičnega sindroma (NMS)
Take special care with Tasmar:
- če imate feokromocitom.
- if during the treatment you suffer from a liver condition.
- če imate med zdravljenjem težave z jetri.
The treatment with Tasmar may
Zdravljenje z zdravilom Tasmar lahko včasih vodi v
sometimes lead to disturbances in the way the liver works.
motnje delovanja jeter.
Therefore, if you experience symptoms such as nausea, vomiting, abdominal pain, loss of appetite, weakness, fever, darkening of urine or jaundice you should contact your doctor immediately
Če imate simptome, kot so slabost, bruhanje, bolečina v trebuhu, izguba apetita, šibkost, visoka telesna temperatura, temnenje urina ali zlatenica, takoj obvestite svojega zdravnika;
- if you have any illnesses other than Parkinson’ s disease.
- če imate katero drugo bolezen poleg Parkinsonove;
- if you are allergic to other medicines, foods and dyes.
- če ste alergični na druga zdravila, hrano ali barvila;
- if you are taking other medicines, including those you can obtain without a prescription.
- če jemljete druga zdravila, vključno s tistimi, ki jih lahko dobite brez recepta;
- If you have taken already Tasmar and developed acute liver injury while on Tasmar, it should
- če ste že jemali zdravilo Tasmar in med zdravljenjem dobili akutno poškodbo jeter, zdravila
not be re-introduced again.
Tasmar ne bi smeli ponovno jemati.
Swallow Tasmar with water.
Jemanje zdravila Tasmar skupaj s hrano in pijačo Zdravilo Tasmar pogoltnite z vodo.
Tasmar can be taken with or without food.
Zdravilo Tasmar se lahko jemlje s hrano ali brez nje.
Pregnancy You must tell your doctor if you are pregnant or intend to become pregnant.
Nosečnost Zdravniku morate povedati, če ste noseči ali nameravate zanositi.
Breast-feeding The effects of Tasmar have not been studied in infants.
Dojenje Učinkov zdravila Tasmar na dojenčke niso proučevali.
Tasmar has an effect on your symptoms of Parkinson’ s disease.
Vpliv na sposobnost upravljanja vozil in strojev Tasmar ima učinek na simptome vaše Parkinsonove bolezni.
Since your ability to drive a car or operate machinery may be affected by Parkinson’ s disease, you should discuss this with your doctor.
Ker ima Parkinsonova bolezen lahko vpliv na vašo sposobnost vožnje avtomobila ali upravljanja orodij ali strojev, se o tem pogovorite z zdravnikom.
Tasmar used with your other Parkinson medication can cause somnolence (excessive drowsiness) and sudden sleep onset episodes.
Tasmar lahko z uporabo ostalih vaših zdravil za Parkinsonovo bolezen povzroči somnolenco (povečano zaspanost) in obdobja nenadnega uspavanja.
Therefore you must refrain from driving or engaging in activities where impaired alertness may put yourself or others at risk of serious injury or death (e. g. operating machines) until such recurrent episodes and somnolence have resolved.
Dokler taka ponavljajoča se obdobja in zaspanost ne minejo, opustite vožnjo ali vključevanje v dejavnosti, kjer bi zaradi zmanjšane pozornosti sebe ali druge izpostavili tveganju za resne poškodbe ali smrt (npr. upravljanje strojev).
Soon after beginning and during your treatment with Tasmar, you may have symptoms caused by levodopa such as dyskinesia (involuntary movement) and nausea.
Pomembne informacije o nekaterih neželenih učinkih zdravila Tasmar Kmalu po začetku zdravljenja in med zdravljenjem z zdravilom Tasmar, lahko izkusite simptome, povzročene z levodopo, kot sta diskinezija (nehoteno gibanje) in slabost.
If you feel unwell, you should contact your doctor because you may need to take less levodopa.
Če se ne počutite dobro, morate stopiti v stik s svojim zdravnikom, ker bo morda treba zmanjšati vaš odmerek levodope.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Če vam je vaš zdravnik povedal, da imate zmanjšano toleranco za nekatere sladkorje, se z njim posvetujte preden začnete jemati to zdravilo..