. . . . . . . "P\u0159i p\u0159edeps\u00E1n\u00ED tablet MEDOPEXOL pacientovi s po\u0161kozen\u00EDm funkce ledvin p\u0159i Parkinsonov\u011B nemoci se doporu\u010Duje sn\u00ED\u017Een\u00ED d\u00E1vky v souladu s bodem 4.2.\nHalucinace\nHalucinace jsou zn\u00E1m\u00E9 jako ne\u017E\u00E1douc\u00ED \u00FA\u010Dinek l\u00E9\u010Dby agonisty dopaminu a levodopou. Pacienti mus\u00ED b\u00FDt informov\u00E1ni o mo\u017Enosti v\u00FDskytu halucinac\u00ED (v\u011Bt\u0161inou zrakov\u00FDch).\nDyskineze\nU pokro\u010Dil\u00E9 Parkinsonovy nemoci se p\u0159i kombinovan\u00E9 l\u00E9\u010Db\u011B s levodopou mohou v pr\u016Fb\u011Bhu po\u010D\u00E1te\u010Dn\u00ED titrace p\u0159\u00EDpravku MEDOPEXOL objevit dyskineze. Pokud k tomu dojde, je t\u0159eba sn\u00ED\u017Eit d\u00E1vku levodopy.\nEpizody n\u00E1hl\u00E9ho n\u00E1stupu sp\u00E1nku a somnolence\nMEDOPEXOL je spojov\u00E1n s v\u00FDskytem somnolence a epizodami n\u00E1hl\u00E9ho n\u00E1stupu sp\u00E1nku, a to zejm\u00E9na u pacient\u016F s Parkinsonovou nemoc\u00ED. M\u00E9n\u011B \u010Dasto byl hl\u00E1\u0161en n\u00E1hl\u00FD n\u00E1stup sp\u00E1nku b\u011Bhem denn\u00EDch aktivit, v n\u011Bkter\u00FDch p\u0159\u00EDpadech bez upozorn\u011Bn\u00ED \u010Di p\u0159edch\u00E1zej\u00EDc\u00EDch varovn\u00FDch p\u0159\u00EDznak\u016F. Pacienti mus\u00ED b\u00FDt o t\u00E9to skute\u010Dnosti informov\u00E1ni a upozorn\u011Bni na nutnou opatrnost p\u0159i \u0159\u00EDzen\u00ED vozidla nebo obsluze stroj\u016F b\u011Bhem l\u00E9\u010Dby p\u0159\u00EDpravkem MEDOPEXOL. Pacienti, kte\u0159\u00ED zaznamenali spavost a/nebo epizody n\u00E1hl\u00E9ho n\u00E1stupu sp\u00E1nku, nesm\u00ED \u0159\u00EDdit vozidla a obsluhovat stroje. D\u00E1le je nutno zv\u00E1\u017Eit sn\u00ED\u017Een\u00ED d\u00E1vek nebo ukon\u010Den\u00ED l\u00E9\u010Dby. Vzhledem k mo\u017En\u00FDm aditivn\u00EDm \u00FA\u010Dink\u016Fm je nutn\u00E1 opatrnost v p\u0159\u00EDpadech, kdy pacienti u\u017E\u00EDvaj\u00ED jin\u00E9 l\u00E9ky se sedativn\u00EDm \u00FA\u010Dinkem nebo alkohol v kombinaci s pramipexolem (viz bod 4.7 a bod 4.8).\nPoruchy kontroly impulzivity a nutkav\u00E9 chov\u00E1n\u00ED\nU pacient\u016F s Parkinsonovou nemoc\u00ED l\u00E9\u010Den\u00FDch agonisty dopaminu, v\u010Detn\u011B p\u0159\u00EDpravku MEDOPEXOL byly hl\u00E1\u0161eny patologick\u00E9 hr\u00E1\u010Dstv\u00ED, zv\u00FD\u0161en\u00E9 libido a hypersexualita. Pacienti a jejich o\u0161et\u0159ovatel\u00E9 by m\u011Bli b\u00FDt upozorn\u011Bni na skute\u010Dnost, \u017Ee se mohou objevit dal\u0161\u00ED symptomy poruch kontroly impulzivity a nutkav\u00E9 chov\u00E1n\u00ED, jako je z\u00E1chvatovit\u00E9 p\u0159ej\u00EDd\u00E1n\u00ED a nutkav\u00E9 nakupov\u00E1n\u00ED. Je t\u0159eba zv\u00E1\u017Eit sn\u00ED\u017Een\u00ED d\u00E1vky/postupn\u00E9 vysazen\u00ED l\u00E9\u010Dby.\nPacienti s psychotick\u00FDmi poruchami\nPacienti s psychotick\u00FDm onemocn\u011Bn\u00EDm by m\u011Bli b\u00FDt l\u00E9\u010Deni agonisty dopaminu pouze tehdy, pokud potenci\u00E1ln\u00ED p\u0159\u00EDnos p\u0159ev\u00E1\u017E\u00ED rizika.\nJe t\u0159eba se vyhnout sou\u010Dasn\u00E9mu pod\u00E1v\u00E1n\u00ED antipsychotick\u00FDch l\u00E9k\u016F s pramipexolem (viz bod 4.5).\nOftalmologick\u00E9 kontroly\nV pravideln\u00FDch intervalech nebo v p\u0159\u00EDpad\u011B poruchy zraku se doporu\u010Duj\u00ED oftalmologick\u00E9 kontroly.\nZ\u00E1va\u017En\u00E9 kardiovaskul\u00E1rn\u00ED onemocn\u011Bn\u00ED\nV p\u0159\u00EDpad\u011B z\u00E1va\u017En\u00E9ho kardiovaskul\u00E1rn\u00EDho onemocn\u011Bn\u00ED je t\u0159eba opatrnost. Z d\u016Fvodu obecn\u00E9ho rizika postur\u00E1ln\u00ED hypotenze spojen\u00E9 s dopaminergn\u00ED l\u00E9\u010Dbou, a to zejm\u00E9na na po\u010D\u00E1tku l\u00E9\u010Dby, se doporu\u010Duje monitorovat krevn\u00ED tlak.\nNeuroleptick\u00FD malign\u00ED syndrom\nP\u0159i n\u00E1hl\u00E9m p\u0159eru\u0161en\u00ED dopaminergn\u00ED l\u00E9\u010Dby byly hl\u00E1\u0161eny p\u0159\u00EDznaky p\u0159ipom\u00EDnaj\u00EDc\u00ED neuroleptick\u00FD malign\u00ED syndrom (viz bod 4.2).\nAugmentace\nZpr\u00E1vy z literatury nazna\u010Duj\u00ED, \u017Ee p\u0159i l\u00E9\u010Db\u011B syndromu neklidn\u00FDch nohou dopaminergn\u00EDmi l\u00E9\u010Div\u00FDmi p\u0159\u00EDpravky m\u016F\u017Ee doj\u00EDt k augmentaci. Augmentace se t\u00FDk\u00E1 \u010Dasn\u011Bj\u0161\u00EDho n\u00E1stupu symptom\u016F ve\u010Der (nebo dokonce odpoledne), zv\u00FD\u0161en\u00ED intenzity symptom\u016F a roz\u0161\u00ED\u0159en\u00ED symptom\u016F na dal\u0161\u00ED kon\u010Detiny. Frekvence augmentac\u00ED po del\u0161\u00EDm u\u017E\u00EDv\u00E1n\u00ED p\u0159\u00EDpravku MEDOPEXOL a vhodn\u00E9 o\u0161et\u0159en\u00ED t\u011Bchto ud\u00E1lost\u00ED nebylo hodnoceno v kontrolovan\u00FDch klinick\u00FDch studi\u00EDch.\n"@cs . . . . . . . . . "Zvl\u00E1\u0161tn\u00ED upozorn\u011Bn\u00ED a opat\u0159en\u00ED pro pou\u017Eit\u00ED"@cs . . . "004.004" .