natgillin/translations-raw huggingface dataset:
Common Uncontrollable movements (hyperkinesias), being sick (vomiting), worsening of symptoms of Parkinson’ s disease, dizziness, diarrhoea, abdominal pain, constipation, dry mouth, hallucinations (seeing/ hearing/ feeling/ smelling things that are not really there), prolonged muscle contractions (dystonia), tiredness, increased sweating, sleeplessness, vivid dreams, fall and confusion.
Pogosti nehoteni gibi (hiperkinezije), slabost z bruhanjem, poslabšanje simptomov Parkinsonove bolezni, vrtoglavost, driska, bolečine v trebuhu, zapeka, suha usta, halucinacije (pri halucinacijah vidite/ slišite/ čutite/ vohate stvari, ki jih v resnici ni), podaljšano krčenje mišic (distonija), utrujenost, povečano znojenje, nespečnost, žive sanje, padci in zmedenost.
Rare Rashes and abnormal results in liver function test.
Redki izpuščaji in nenormalni izvidi testov jetrne funkcije.
Very rare Mental restlessness, decreased appetite, weight decrease, hives.
Zelo redki duševni nemir, zmanjšan tek, hujšanje, koprivnica.
Colitis (inflammation of the colon), hepatitis and skin, hair, beard and nail discolorations.
Natančna pogostnost naslednjih neželenih učinkov ni znana, podatki temeljijo na poročilih iz obdobja, odkar je zdravilo dostopno na trgu: kolitis (vnetje debelega črevesa), hepatitis (vnetje jeter) in sprememba barve kože, las, brade in nohtov.
The side effects are often caused by the increased effects of levodopa therapy and are most common at the start of treatment.
Neželene učinke pogosto povzroča povečani učinek zdravljenja z levodopo in so najpogostejši na začetku zdravljenja.
Some, such as uncontrollable movements, nausea and abdominal pain, may also be more common with higher doses (1,400 to 2,000 mg per day).
Nekateri od neželenih učinkov, na primer nehoteni gibi, slabost s siljenjem na bruhanje in bolečine v trebuhu, so lahko tudi pogostejši ob večjih odmerkih zdravila (1. 400 do 2. 000 mg na dan) kot ob manjših.
If you experience such effects at the start of treatment with Comtan you should contact your doctor, who may decide to adjust your dosage of levodopa.
Če opazite take učinke na začetku zdravljenja s Comtanom, se morate posvetovati s svojim zdravnikom, ki vam bo mogoče prilagodil odmerjanje levodope.
Excessive daytime drowsiness has been reported in rare cases in patients receiving Comtan with levodopa and there have been isolated cases of sudden sleep onset episodes.
V redkih primerih pri bolnikih, ki jemljejo Comtan z levodopo, poročajo o čezmerni zaspanosti podnevi, v posameznih primerih pa o nenadnih napadih spanja.
A few cases of neuroleptic malignant syndrome (NMS) and rhabdomyolysis have been reported.
V nekaj primerih so poročali o nevroleptičnem malignem sindromu (NMS) in o rabdomiolizi.
NMS is a rare severe reaction to medicines used to treat disorders of the central nervous system and 19 characterised by stiffness, muscle twitching, shaking, mental changes, coma, high body temperature, increased heart rate and unstable blood pressure.
Nevroleptični maligni sindrom je redka huda reakcija na zdravila za zdravljenje centralnega živčnega sistema, za katero so značilni okorelost, trzanje mišic, tresenje, spremembe duševnega stanja, koma, zvišana telesna temperatura, pospešen utrip srca in nestabilen krvni tlak.
Rhabdomyolysis is a rare severe muscle disorder.
Rabdomioliza je redka huda 20 bolezen mišic.
Behavioural changes such as urge to gamble (pathological gambling) or increased sexual desire and urges (increased libido and hypersexuality) have been reported in patients receiving dopaminergic medicines including Comtan with levodopa.
Pri bolnikih, ki so prejemali dopaminergična zdravila, ki vključujejo Comtan z levodopo, so opisovali spremembe vedenja, kot so potreba po igranju iger na srečo (patološko hazardiranje) ali povečana spolna sla in pretirana potreba po spolnosti (povečan libido in hiperseksualnost).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželen učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika.
HOW TO STORE COMTAN
SHRANJEVANJE ZDRAVILA COMTAN
Do not use Comtan after the expiry date which is stated on the carton and on the bottle label.
Zdravila Comtan ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki stekleničke.
- The active substance is entacapone.
- Zdravilna učinkovina je entakapon.
- The other ingredients are microcrystalline cellulose, mannitol, croscarmellose sodium,
- Pomožne snovi so mikrokristalna celuloza, manitol, premreženi natrijev karmelozat,
- The film-coating contains hypromellose, polysorbate 80, glycerol 85%, sucrose, yellow iron
- Filmska obloga vsebuje hipromelozo, polisorbat 80, glicerol 85%, saharozo, rumeni železov
oxide (E172), red iron oxide (E172) and titanium dioxide (E171).
oksid (E172), rdeči železov oksid (E172) in titanov dioksid (E171).
What Comtan looks like and contents of the pack Comtan 200 mg film-coated tablets are brownish-orange, oval tablets with “ Comtan ” engraved on one side.
Izgled zdravila Comtan in vsebina pakiranja Comtan 200 mg filmsko obložene tablete so rjavkastooranžne, ovalne tablete z vtisnjenim napisom “ Comtan ” na eni strani.
There are four different pack sizes (bottles containing 30, 60, 100 or 500 tablets).
Obstajajo štiri različne velikosti pakiranj (stekleničke, ki vsebujejo po 30, 60, 100 ali 500 tablet).
Marketing Authorisation Holder Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom
Imetnik dovoljenja za promet z zdravilom Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB Velika Britanija
Manufacturer Novartis Pharmaceuticals UK Ltd Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom
Izdelovalec Novartis Pharmaceuticals UK Ltd Wimblehurst Road Horsham West Sussex, RH12 5AB Velika Britanija
For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
21 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Comtess is used to treat patients with Parkinson’ s disease.
Zdravilo Comtess se uporablja za zdravljenje bolnikov s Parkinsonovo boleznijo.
Comtess is used together with levodopa (either a combination of levodopa and benserazide or a combination of levodopa and carbidopa) when the patient is having ‘ fluctuations ’ towards the end of the period between two doses of their medication.
Zdravilo Comtess se uporablja skupaj z levodopo (bodisi v kombinaciji z levodopo in benserazidom ali kombinaciji z levodopo in karbidopo), kadar bolnik doživlja „ nihanja “ proti koncu obdobja med dvema odmerkoma zdravil.
It should not be used with combinations that are ‘ modified release’ (when the levodopa is released slowly over a few hours).
Ne sme se ga uporabljati v kombinacijah s „ prilagojenim sproščanjem “ (kjer se levodopa počasi sprošča v obdobju več ur).
Entacapone blocks an enzyme that is involved in the breakdown of levodopa in the body called 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Entakapon blokira encim, imenovan katehol- O- metiltransferaza (COMT), ki 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Comtess has been studied in a total of 376 patients with Parkinson’ s disease, in two six-month studies that measured the effects of adding Comtess or placebo (a dummy medicine) to the patient’ s combination of levodopa and carbidopa or levodopa and benserazide.
Zdravilo Comtess so preučevali pri skupno 376 bolnikih s Parkinsonovo boleznijo v dveh šestmesečnih študijah, v katerih so merili učinke dodajanja zdravila Comtess ali placeba (zdravila brez zdravilne učinkovine) bolnikovi kombinaciji levodope in karbidope oziroma levodope in benserazida.
The main measure of effectiveness was the time spent in the ‘ on’ state (the time when levodopa is controlling the symptoms of Parkinson’ s disease) after the first levodopa dose of the morning in the first study, and over one day in the second study.
Glavno merilo učinkoitosti je bil čas, ko je bilo bolnikovo stanje dobro (stanje „ vklopa “, ko je levodopa nadzorovala simptome Parkinsonove bolezni), in sicer po prvem jutranjem odmerku levodope v prvi študiji in v teku celega dne v drugi študiji.
In the first study, adding Comtess increased the ‘ on’ time by 1 hour and 18 minutes more than adding placebo.
V prvi študiji je dodajanje zdravila Comtess podaljšalo trajanje stanja „ vklopa “ za 1 uro in 18 minut v primerjavi s placebom.
Comtess should not be used in patients with: • liver disease; • phaeochromocytoma (a tumour of the adrenal gland); • a history of neuroleptic malignant syndrome (a dangerous nervous system disorder usually caused by antipsychotic medicines) or rhabdomyolysis (breakdown of muscle fibres).
Zdravila Comtess ne smejo uporabljati bolniki: • z obolenji jeter, • s feokromocitomom (tumorjem nadledvične žleze), • ki so imeli v preteklosti nevroleptični maligni sindrom (nevarno obolenje živčnega sistema, ki ga običajno povzročijo antipsihotična zdravila) ali rabdomiolizo (razgradnjo mišičnih vlaken).
Comtess should not be used together with other medicines that belong to the group ‘ monoamine oxidase inhibitors ’ (a type of antidepressant).
Zdravilo Comtess se ne sme jemati hkrati z drugimi zdravili, ki spadajo v skupino zaviralcev monoaminooksidaze (vrste antidepresivov).
The Committee for Medicinal Products for Human Use (CHMP) decided that Comtess’ s benefits are greater than its risks as an adjunct to standard preparations of levodopa/ benserazide or levodopa/ carbidopa for use in patients with Parkinson’ s disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Comtess kot dodatka k standardnima kombinacijama levodope/ benserazida oziroma levodope/ karbidope za zdravljenje bolnikov s Parkinsonovo boleznijo in motoričnimi nihanji ob koncu delovanja odmerka, ki jih ne moremo stabilizirati z navedenimi kombinacijami, večje od z njim povezanih tveganj.
Bottle (HDPE) Bottle (HDPE) Bottle (HDPE) Bottle (HDPE)
steklenica (HDPE) steklenica (HDPE) steklenica (HDPE) steklenica (HDPE)
Brownish-orange, oval, biconvex film-coated tablet with "COMT" engraved on one side.
Rjavkastooranžna, ovalna, bikonveksna filmsko obložena tableta z vtisnjenim napisom “ COMT ” na eni strani.
One 200 mg tablet is taken with each levodopa/ dopa decarboxylase inhibitor dose.
Odmerjanje Ena tableta po 200 mg se vzame z vsakim odmerkom levodope/ zaviralca dopa- dekarboksilaze.
The daily dose of levodopa should be reduced by about 10-30% by extending the dosing intervals and/ or by reducing the amount of levodopa per dose, according to the clinical condition of the patient.
Glede na bolnikovo klinično stanje je treba dnevni odmerek levodope zmanjšati za približno 10 – 30%, in sicer s podaljšanjem časovnega presledka med posameznimi odmerki in/ ali z zmanjšanjem količine levodope na odmerek.
Entacapone increases the bioavailability of levodopa from standard levodopa/ benserazide preparations slightly (5-10%) more than from standard levodopa/ carbidopa preparations.
Entakapon nekoliko bolj (za 5– 10%) poveča biološko uporabnost levodope iz standardnih pripravkov levodope/ benserazida kot iz standardnih pripravkov levodope/ karbidope.
Renal impairment:
Okvare ledvic:
However, for patients who are receiving dialysis therapy, a longer dosing interval may be considered (see section 5.2).
Vendar je pri bolnikih, zdravljenih z dializo, včasih treba podaljšati časovni razmik med posameznimi odmerki (glejte poglavje 5. 2).
2 Hepatic impairment: see section 4.3.
2 Okvare jeter: glejte poglavje 4. 3.
Comtess is not recommended for use in children below age 18 due to lack of data of safety and efficacy.
Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba zdravila Comtess pri otrocih pod 18 let ni priporočljiva.
Entacapone is administered orally and simultaneously with each levodopa/ carbidopa or levodopa/ benserazide dose.
Način uporabe Entakapon se uporablja peroralno in sočasno z vsakim odmerkom levodope/ karbidope ali levodope/ benserazida.
- Concomitant use of a selective MAO-A inhibitor plus a selective MAO-B inhibitor and entacapone
- Sočasna uporaba selektivnega zaviralca MAO- A in selektivnega zaviralca MAO- B ter
(see section 4.5).
entakapona (glejte poglavje 4. 5).
Entacapone increases the bioavailability of levodopa from standard levodopa/ benserazide preparations 5-10% more than from standard levodopa/ carbidopa preparations.
Entakapon poveča biološko uporabnost levodope v standardnih pripravkih levodope/ benserazida za 5– 10% bolj kot v standardnih pripravkih levodope/ karbidope.
To reduce levodopa-related dopaminergic adverse reactions, it is often necessary to adjust levodopa
Za zmanjšanje dopaminergičnih neželenih učinkov, povezanih z levodopo, je v prvih dnevih ali prvih tednih po uvedbi zdravljenja z entakaponom glede na bolnikovo klinično stanje pogosto potrebno
3 dosage within the first days to first weeks after initiating entacapone treatment, according to the clinical condition of the patient (see sections 4.2 and 4.8).
3 prilagoditi odmerjanje levodope (glejte poglavji 4. 2 in 4. 8).
In clinical studies, undesirable dopaminergic effects, e. g. dyskinesia, were more common in patients who received entacapone and dopamine agonists (such as bromocriptine), selegiline or amantadine compared to those who received placebo with this combination.
V kliničnih študijah so bili neželeni dopaminergični učinki, na primer diskinezija, pogostejši pri bolnikih, ki so dobivali entakapon in agoniste dopamina (na primer bromokriptin), selegilin ali amantadin, kot pri tistih, ki so skupaj s to kombinacijo dobivali placebo.
However, the experience of the clinical use of entacapone with several medicinal products, including MAO-A inhibitors, tricyclic antidepressants, noradrenaline reuptake inhibitors such as desipramine, maprotiline and venlafaxine, and medicinal products that are metabolised by COMT (e. g. catechol-structured compounds: rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha- methyldopa, apomorphine, and paroxetine) is still limited.
Vendar so izkušnje s klinično uporabo entakapona z več zdravili, med drugim z zaviralci MAO- A, tricikličnimi antidepresivi, zaviralci ponovnega privzema noradrenalina, kot so desipramin, maprotilin in venlafaksin, in zdravili, ki jih presnavlja COMT (na primer spojine s kateholno skupino: rimiterol, izoprenalin, adrenalin, noradrenalin, dopamin, dobutamin, alfa- metildopa, apomorfin in paroksetin), še omejene.
Caution should be exercised when these medicinal products are used concomitantly with entacapone (see also sections 4.3 and section 4.4).
Pri sočasni uporabi teh zdravil z entakaponom je potrebna previdnost (glejte tudi poglavji 4. 3 in 4. 4).
Entacapone and iron preparations should be taken at least 2-3 hours apart (see section 4.8).
Entakapon in pripravke železa je treba jemati s časovnim presledkom vsaj 2– 3 ur (glejte poglavje 4. 8).
The INR
Vendar v študiji medsebojnega delovanja na zdravih prostovoljcih entakapon ni spremenil plazemskih koncentracij S- varfarina, medtem ko se je AUC za R- varfarin povečala povprečno za 18% [IZ90
4 values increased on average by 13% [CI90 6– 19%].
Vrednosti INR so se povečale povprečno za 13% [IZ90 6- 19%].
Comtess in association with levodopa may have major influence on the ability to drive and use machines.
Comtess ima skupaj z levodopo pomemben vpliv na sposobnost vožnje in upravljanja s stroji.
The following adverse drug reactions, listed below in Table 1, have been accumulated both from clinical studies with entacapone and since the introduction of entacapone into the market.
Neželeni učinki zdravila, ki so navedeni spodaj v preglednici 1, so bili opaženi v kliničnih študijah z entakaponom in po prihodu entakapona na trg.
Adverse drug reactions*
5 Preglednica 1 * Neželeni učinki zdravila
Nervous system disorders Very common:
Bolezni živčevja Bolezni prebavil
Parkinsonism aggravated, dizziness, dystonia, hyperkinesia
diskinezija poslabšanje parkinsonizma, vrtoglavost, distonija, hiperkinezija
Gastrointestinal disorders Very common:
zelo pogosti: pogosti: zelo redki: pogostnost
Nausea
navzea driska, bolečine v trebuhu, suha usta, zapeka, bruhanje anoreksija
Very rare:
Bolezni sečil
Diarrhoea, abdominal pain, dry mouth, constipation, vomiting Anorexia Colitis
kolitis
Renal and urinary disorders Very common:
zelo pogosti:
Very rare:
sprememba barve urina
Not known:
Bolezni kože in podkožja
Erythematous or maculopapular rash Urticaria Skin, hair, beard and nail discolorations
redki: zelo redki: pogostnost
General disorders and administration site conditions
eritematozen ali makulopapularen izpuščaj urtikarija
Very rare:
neznana:
Fatigue, sweating increased, fall Weight decrease
sprememba barve kože, las, brade in nohtov
Hepatobiliary disorders
pogosti: zelo redki:
Not known:
utrujenost, povečano znojenje, padci zmanjšanje telesne mase
Hepatic function tests abnormal Hepatitis with mainly cholestatic features (see section 4.4.)
Bolezni jeter, žolčnika in žolčevodov
Psychiatric disorders
redki: pogostnost
Common:
neznana:
Insomnia, hallucinations, confusion, paroniria
hepatitis s prevladujočimi znaki holestaze (glejte poglavje 4. 4)
Very rare:
Psihiatrične motnje
Agitation
pogosti: zelo redki:
Entacapone belongs to a new therapeutic class, catechol-O-methyl transferase (COMT) inhibitors.
Entakapon pripada novi skupini zdravil, zaviralcem katehol- O- metiltransferaze (COMT).
Table 2.
Preglednica 2:
Daily ON time (Mean ±SD)
Dnevno obdobje ‘ ON ’ (povprečje ± S. D.)
Daily On time (h)
Dnevno obdobje ‘ ON ’ (ure) izhodišče
Entacapone (n=85)
entakapon (n=85) 9, 3 ± 2, 2
Placebo (n=86)
placebo (n=86) 9, 2 ± 2, 5
9.2±2.5
razlika
Week 8-24
teden 8– 24
1 h 20 min (8.3%) CI95% 45 min, 1 h 56 min
1 h 20 min (8, 3%) IZ95% 45 min, 1h 56 min
Absorption There are large intra- and interindividual variations in the absorption of entacapone.
Splošne značilnosti zdravilne učinkovine Absorpcija V absorpciji entakapona so velike intra - in interindividualne variacije.
7 Distribution After absorption from the gastrointestinal tract, entacapone is rapidly distributed to the peripheral tissues with a distribution volume of 20 litres at steady state (Vdss).
7 Porazdelitev Po absorpciji iz prebavil se entakapon hitro porazdeli v periferna tkiva s porazdelitvenim volumnom 20 litrov v stanju dinamičnega ravnovesja (Vdss).
At therapeutic concentrations, entacapone does not displace other extensively bound substances (e. g. warfarin, salicylic acid, phenylbutazone, or diazepam), nor is it displaced to any significant extent by any of these substances at therapeutic or higher concentrations.
Entakapon v terapevtskih koncentracijah ne izriva drugih učinkovin, ki se v veliki meri vežejo na beljakovine (na primer varfarin, salicilna kislina, fenilbutazon ali diazepam), pa tudi nobena od teh učinkovin v terapevtskih ali višjih koncentracijah ne izriva entakapona v velikem obsegu.
It is estimated that 80- 90% of the dose is excreted in faeces, although this has not been confirmed in man.
Ocenjeno je, da se 80– 90% odmerka izloči z blatom, čeprav to pri človeku ni potrjeno.
Approximately 10- 20% is excreted in urine.
Približno 10– 20% odmerka se izloča z urinom.
Characteristics in patients
Od presnovkov, ki so v urinu, jih le okrog 1% nastane z oksidacijo.
Microcrystalline cellulose Croscarmellose sodium Povidone Magnesium stearate
Jedro tablete mikrokristalna celuloza natrijev karmelozat, premreženi povidon magnezijev stearat
8 Polyvinyl alcohol, partly hydrolysed Talc Macrogol Soybean lecithin Yellow iron oxide (E 172) Red iron oxide (E 172) Titanium dioxide (E 171)
8 polivinil alkohol, delno hidroliziran smukec makrogol sojin lecitin rumeni železov oksid (E172) rdeči železov oksid (E172) titanov dioksid (E171)
6.3 Shelf- life
6. 3 Rok uporabnosti
Orion Corporation Orionintie 1 FI-02200 Espoo Finland
Orion Corporation Orionintie 1 FI- 02200 Espoo Finska
17.10.2003
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET
DATE OF REVISION OF THE TEXT
EU/ 1/ 98/ 082/ 001- 003 EU/ 1/ 98/ 082/ 005
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
17/ 10/ 2003
CONDITIONS OF THE MARKETING AUTHORISATION
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu
Comtess 200 mg film-coated tablets Entacapone
Comtess 200 mg filmsko obložene tablete entakapon
What Comtess is and what it is used for 2.
Kaj je zdravilo Comtess in za kaj ga uporabljamo 2.
Before you take Comtess 3.
Kaj morate vedeti, preden boste uporabili zdravilo Comtess 3.
How to take Comtess 4.
Kako jemati zdravilo Comtess 4.
How to store Comtess 6.
Shranjevanje zdravila Comtess 6.
WHAT COMTESS IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO COMTESS IN ZA KAJ GA UPORABLJAMO
Comtess is used together with levodopa to treat Parkinson’ s disease.
Comtess se uporablja skupaj z levodopo za zdravljenje Parkinsonove bolezni.
Comtess improves the therapeutic effect of levodopa in relieving the symptoms of Parkinson's disease.
Comtess izboljša terapevtski učinek levodope pri lajšanju simptomov Parkinsonove bolezni.
Comtess has no antiparkinsonian activity without levodopa.
Comtess brez levodope nima nikakršnega antiparkinsonskega učinka.
BEFORE YOU TAKE COMTESS
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO COMTESS
Do not take Comtess – if you are allergic (hypersensitive) to entacapone or any of the other ingredients of Comtess; – if you have a tumour of the adrenal gland (known as pheochromocytoma; this may increase the risk of severe high blood pressure); – if you are taking certain antidepressants (ask your doctor or pharmacist whether your antidepressive medicine can be taken together with Comtess); – if you have liver disease; – if you have ever suffered from a rare reaction to antipsychotic medicines called neuroleptic malignant syndrome (NMS) and/ or a rare muscle disorder called non-traumatic rhabdomyolysis.
Ne uporabljajte zdravila Comtess
Take special care with Comtess
- če ste alergični na (preobčutljivi za) entakapon ali katerokoli sestavino zdravila Comtess;
- if you are taking a medicine which may cause low blood pressure when rising from a chair or
- če imate tumor nadledvičnice (ti. feokromocitom, ki lahko poveča tveganje za zelo visok krvni
bed;
tlak);
- if you experience diarrhoea, monitoring of your weight is recommended in order to avoid
- če jemljete določene antidepresive (povprašajte svojega zdravnika ali farmacevta, ali lahko
potentially excessive weight loss;
- če imate bolezen jeter;
- if you experience excessive gambling or excessive sexual activity.
sindrom (NMS) in/ ali redko bolezen mišic, ki se imenuje netravmatska rabdomioliza.
The dose of other antiparkinsonian medicines may need to be adjusted when you start taking Comtess.
Morda bo ob uvedbi zdravila Comtess potrebno prilagoditi odmerke drugih zdravil za Parkinsonovo bolezen.
If this happens, you should not drive or use any tools or machines (see section ” Driving and using machines”).
Če se vam to dogaja, ne smete voziti ali uporabljati naprav ali strojev (glejte poglavje “ Vpliv na sposobnost upravljanja vozil in strojev ”).
Children Experience with Comtess in patients under 18 years is limited.
Otroci Pri bolnikih, starih manj kot 18 let, so izkušnje z zdravilom Comtess omejene.
Therefore, the use of Comtess in children cannot be recommended.
Zato uporaba zdravila Comtess pri otrocih ni priporočljiva.
Taking other medicines Comtess may increase the effects of other medicinal products (e. g. those containing rimiterol, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa, and apomorphine).
Jemanje drugih zdravil Zdravilo Comtess lahko poveča učinke drugih zdravil (na primer tistih, ki vsebujejo rimiterol, izoprenalin, adrenalin, noradrenalin, dopamin, dobutamin, alfametildopo in apomorfin).
Comtess may make it harder for you to digest iron.
Zdravilo Comtess lahko oteži prebavo železa.