. . . "4.8 \tNe\u017E\u00E1douc\u00ED \u00FA\u010Dinky"@cs . . . . . . . . . . . . . . . . . . . . . . . "Nej\u010Dast\u011Bj\u0161\u00EDm ne\u017E\u00E1douc\u00EDm \u00FA\u010Dinkem je nauzea. P\u0159i l\u00E9\u010Db\u011B soci\u00E1ln\u00ED \u00FAzkostn\u00E9 poruchy se u 14% mu\u017E\u016F l\u00E9\u010Den\u00FDch sertralinem vyskytla sexu\u00E1ln\u00ED dysfunkce (porucha ejakulace) v porovn\u00E1n\u00ED s 0% u placeba. Tyto ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky jsou z\u00E1visl\u00E9 na d\u00E1vce a s pokra\u010Duj\u00EDc\u00ED l\u00E9\u010Dbou \u010Dasto vymiz\u00ED.\nProfil ne\u017E\u00E1douc\u00EDch \u00FA\u010Dink\u016F b\u011B\u017En\u011B pozorovan\u00FD u dvojit\u011B slep\u00FDch placebem kontrolovan\u00FDch studi\u00ED p\u0159i l\u00E9\u010Db\u011B OCD, panick\u00E9 poruchy, PTSD a soci\u00E1ln\u00ED \u00FAzkostn\u00E9 poruchy byl podobn\u00FD profilu pozorovan\u00E9mu v klinick\u00FDch studi\u00EDch u pacient\u016F s depres\u00ED.\nTabulka 1 uv\u00E1d\u00ED ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky pozorovan\u00E9 po uveden\u00ED p\u0159\u00EDpravku na trh (\u010Detnost nezn\u00E1ma) a v placebem kontrolovan\u00FDch klinick\u00FDch studi\u00EDch (celkem 2542 pacient\u016F l\u00E9\u010Den\u00FDch sertralinem a 2145 dost\u00E1vaj\u00EDc\u00EDch placebo) p\u0159i l\u00E9\u010Db\u011B deprese, OCD, panick\u00E9 poruchy, PTSD a soci\u00E1ln\u00ED \u00FAzkostn\u00E9 poruchy.\nN\u011Bkter\u00E9 ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky mohou s pokra\u010Duj\u00EDc\u00ED l\u00E9\u010Dbou ztr\u00E1cet na intenzit\u011B a \u010Detnosti a obecn\u011B nevedou k ukon\u010Den\u00ED l\u00E9\u010Dby.\n\u010Cetnost ne\u017E\u00E1douc\u00EDch \u00FA\u010Dink\u016F pozorovan\u00FDch u placebem kontrolovan\u00FDch klinick\u00FDch studi\u00ED u deprese, OCD, panick\u00E9 poruchy, PTSD a soci\u00E1ln\u00ED \u00FAzkostn\u00E9 poruchy. Souhrnn\u00E1 anal\u00FDza a zku\u0161enosti po uveden\u00ED p\u0159\u00EDpravku na trh (\u010Detnost nezn\u00E1ma).\n Hodnocen\u00ED \u010Detnosti:\n\tVelmi \u010Dast\u00E9:\n\t\u2265 1/10\n\t\u010Cast\u00E9:\n\t\u2265 1/100, < 1/10\n\tM\u00E9n\u011B \u010Dast\u00E9:\n\t\u2265 1/1000, \u2264 1/100\n\tVz\u00E1cn\u00E9:\n\t\u2265 1/10000, \u2264 1/1000\n\tVelmi vz\u00E1cn\u00E9:\n\t\u2264 1/10000\n\tNen\u00ED zn\u00E1mo:\n\t(z dostupn\u00FDch \u00FAdaj\u016F nelze ur\u010Dit)\n\tT\u0159\u00EDdy org\u00E1nov\u00FDch syst\u00E9m\u016F\n\tVelmi \u010Dast\u00E9 (>1/10)\n\t\u010Cast\u00E9 (>1/100, <1/10)\n\tM\u00E9n\u011B \u010Dast\u00E9 (>1/1000, <1/100)\n\tVz\u00E1cn\u00E9 (>1/10000, <1/1000)\n\t\u010Cetnost nezn\u00E1ma (z dostupn\u00FDch \u00FAdaj\u016F nelze ur\u010Dit)\n\tInfekce a infestace\n\t\u2500\n\tfaryngitida\n\tinfekce horn\u00EDch cest d\u00FDchac\u00EDch, rinitida\n\tdivertikulitida, gastroenteritida, otitis media\n\t\u2500\n\tNovotvary benign\u00ED, malign\u00ED a bl\u00ED\u017Ee neur\u010Den\u00E9 (zahrnuj\u00EDc\u00ED cysty a polypy)\n\t\u2500\n\t\u2500\n\t\u2500\n\tnovotvar\u2020\n\t\u2500\n\tPoruchy krve a lymfatick\u00E9ho syst\u00E9mu\n\t\u2500\n\t\u2500\n\t\u2500\n\tlymphadenopatie\n\tleukopenie, trombocytopenie\n\tPoruchy imunitn\u00EDho syst\u00E9mu\n\t\u2500\n\t\u2500\n\t\u2500\n\t\u2500\n\tanafylaktick\u00E9 reakce, alergick\u00E9 reakce, alergie\n\tEndokrinn\u00ED poruchy\n\t\u2500\n\t\u2500\n\t\u2500\n\t\u2500\n\thyperprolactin\u00E9mie, hypothyroidismus, syndrom nep\u0159im\u011B\u0159en\u00E9 sekrece antidiuretick\u00E9ho hormonu\n\tPoruchy metabolismu a v\u00FD\u017Eivy\n\t\u2500\n\tanorexie, zv\u00FD\u0161en\u00E1 chu\u0165 k j\u00EDdlu*\n\t\u2500\n\thypercholesterol\u00E9mie, hypoglyk\u00E9mie\n\tHyponatr\u00E9mie\n\tPsychiatrick\u00E9 poruchy\n\tnespavost (19%)\n\tdeprese*, depersonalizace, no\u010Dn\u00ED m\u016Fry, \u00FAzkost *, agitovanost *, nervozita, pokles sexu\u00E1ln\u00ED touhy *, bruxismus\n\thalucinace *, euforick\u00E1 n\u00E1lada *, apatie, neobvykl\u00E9 my\u0161len\u00ED\n\tkonverzn\u00ED porucha, l\u00E9kov\u00E1 z\u00E1vislost, psychotick\u00E1 porucha *, agrese *, paranoia, sebevra\u017Eedn\u00E9 my\u0161lenky / chov\u00E1n\u00ED ***, n\u00E1m\u011Bs\u00ED\u010Dnost, p\u0159ed\u010Dasn\u00E1 ejakulace\n\td\u011Bsiv\u00E9 sny, sebevra\u017Eedn\u00E9 my\u0161lenky / chov\u00E1n\u00ED ***\n\tPoruchy nervov\u00E9ho syst\u00E9mu\n\tz\u00E1vrat\u011B (11%), somnolence (13%), bolest hlavy (21%) *.\n\tparest\u00E9zie *, t\u0159es, hypertonie, dysgeuzie, poruchy pozornosti\n\tk\u0159e\u010De *, nekontrolovateln\u00E9 svalov\u00E9 kontrakce *, poruchy koordinace, hyperkinezie, amnezie, hypest\u00E9zie *, poruchy \u0159e\u010Di, postur\u00E1ln\u00ED z\u00E1vra\u0165, migr\u00E9na *.\n\tk\u00F3ma *, choreoatet\u00F3za, dyskineze, hyperest\u00E9zie, poruchy smyslov\u00E9ho vn\u00EDm\u00E1n\u00ED.\n\tpohybov\u00E9 poruchy (zahrnuj\u00EDc\u00ED extrapyramidov\u00E9 p\u0159\u00EDznaky jako je hyperkineze, hypertonie, sk\u0159\u00EDp\u00E1n\u00ED zub\u016F nebo poruchy ch\u016Fze), synkopa\n\tD\u00E1le byly hl\u00E1\u0161eny zn\u00E1mky a p\u0159\u00EDznaky souvisej\u00EDc\u00ED se serotoninov\u00FDm syndromem nebo neuroleptick\u00FDm malign\u00EDm syndromem: v n\u011Bkter\u00FDch p\u0159\u00EDpadech souvisej\u00EDc\u00ED se soub\u011B\u017En\u00FDm u\u017Eit\u00EDm serotoninergn\u00EDch l\u00E9k\u016F zahrnuj\u00EDc\u00ED agitovanost, zmatenost, diafor\u00E9zu, pr\u016Fjem, hore\u010Dku, hypertenzi, strnulost a tachykardii. \nAkatizie a psychomotorick\u00FD neklid (viz bod 4.4).\n\tPoruchy oka\n\t\u2500\n\tporuchy zraku\n\t\u2500\n\tglaukom, porucha slzen\u00ED, skotom, diplopie, fotofobie, hyf\u00E9ma, mydri\u00E1za *\n\tporuchy vid\u011Bn\u00ED\n\tPoruchy ucha a labyrintu\n\t\u2500\n\ttinitus*\n\tbolest ucha\n\t\u2500\n\t\u2500\n\tSrde\u010Dn\u00ED poruchy\n\t\u2500\n\tpalpitace*\n\ttachykardie\n\tinfarkt myokardu, bradykardie, srde\u010Dn\u00ED poruchy\n\t\u2500\n\tC\u00E9vn\u00ED poruchy\n\t\u2500\n\tn\u00E1valy horka*\n\thypertenze*, n\u00E1valy\n\tperifern\u00ED ischemie \n\tneobvykl\u00E9 krv\u00E1cen\u00ED (jako je epistaxe, gastrointestin\u00E1ln\u00ED krv\u00E1cen\u00ED nebo hematurie)\n\tRespira\u010Dn\u00ED, hrudn\u00ED a mediastin\u00E1ln\u00ED poruchy\n\t\u2500\n\tz\u00EDv\u00E1n\u00ED*\n\tbronchospazmus*, dyspnoe, epistaxe\n\tlaryngospazmus, hyperventilace, hypoventilace, stridor, dysfonie, \u0161kytavka\n\t\u2500\n\tGastrointestin\u00E1ln\u00ED poruchy\n\tnauzea (24%), pr\u016Fjem (18%), sucho v \u00FAstech (14%)\n\tdyspepsie, z\u00E1cpa*, bolest b\u0159icha*, zvracen\u00ED*, flatulence\n\tesofagitida, dysfagie, hemoroidy, nadm\u011Brn\u00E1 produkce slin, porucha jazyka, eruktace\n\tmel\u00E9na, hematochezie, stomatitida, tvorba v\u0159ed\u016F na jazyku, poruchy zub\u016F, glositida, tvorba v\u0159ed\u016F v \u00FAstech\n\tpankreatitida\n\tPoruchy jater a \u017Elu\u010Dov\u00FDch cest\n\t\u2500\n\t\u2500\n\t\u2500\n\tporucha jatern\u00EDch funkc\u00ED\n\tz\u00E1va\u017En\u00E9 onemocn\u011Bn\u00ED jater (zahrnuj\u00EDc\u00ED hepatitidu, \u017Eloutenku a selh\u00E1n\u00ED jater).\n\tPoruchy k\u016F\u017Ee a podko\u017En\u00ED tk\u00E1n\u011B\n\t\u2500\n\tvyr\u00E1\u017Eka*, hyperhidr\u00F3za \n\tperiorbit\u00E1ln\u00ED ed\u00E9m*, purpura*, alopecie*, studen\u00FD pot, such\u00E1 k\u016F\u017Ee, kop\u0159ivka* \n\tdermatitida, bul\u00F3zn\u00ED dermatitida, folikul\u00E1rn\u00ED vyr\u00E1\u017Eka, zm\u011Bna struktury vlasu, zm\u011Bna pachu k\u016F\u017Ee\n\tvz\u00E1cn\u00E9 p\u0159\u00EDpady z\u00E1va\u017En\u00FDch ko\u017En\u00EDch ne\u017E\u00E1douc\u00EDch \u00FA\u010Dink\u016F (SCAR): nap\u0159. Stevens-Johnson\u016Fv syndrom a epiderm\u00E1ln\u00ED nekrol\u00FDza, angioed\u00E9m, otok obli\u010Deje, fotosenzitivita, ko\u017En\u00ED reakce, pruritus\n\tPoruchy svalov\u00E9 a kostern\u00ED soustavy a pojivov\u00E9 tk\u00E1n\u011B\n\t\u2500\n\tmyalgie\n\tosteoartritida, svalov\u00E1 slabost, bolest zad, svalov\u00E9 z\u00E1\u0161kuby\n\tporuchy kost\u00ED\n\tartralgie, svalov\u00E9 k\u0159e\u010De\n\tPoruchy ledvin a mo\u010Dov\u00FDch cest\n\t\u2500\n\t\u2500\n\tnykturie, retence mo\u010Di *, polyurie, polakisurie, poruchy mikce\n\toligurie, mo\u010Dov\u00E1 inkontinence *, opo\u017Ed\u011Bn\u00FD za\u010D\u00E1tek mo\u010Den\u00ED\n\t\u2500\n\tPoruchy reproduk\u010Dn\u00EDho syst\u00E9mu a prsu**\n\tporucha ejakulace (14%)\n\tsexu\u00E1ln\u00ED dysfunkce, erektiln\u00ED dysfunkce\n\tvagin\u00E1ln\u00ED krv\u00E1cen\u00ED, \u017Eensk\u00E1 sexu\u00E1ln\u00ED dysfunkce\n\tmenoragie, atrofick\u00E1 vulvovaginitida, balanopostitida, v\u00FDtok z genit\u00E1lu, priapismus *, galaktorea *.\n\tgynekomastie, nepravideln\u00E1 menstruace\n\tCelkov\u00E9 poruchy a reakce v m\u00EDst\u011B aplikace\n\t\u00FAnava (10%)* \n\tbolest na hrudi*\n\tmal\u00E1tnost *, t\u0159esavka, pyrexie *, ast\u00E9nie*, \u017E\u00EDze\u0148\n\thernie, fibr\u00F3za v m\u00EDst\u011B vpichu, sn\u00ED\u017Een\u00E1 l\u00E9kov\u00E1 tolerance, poruchy ch\u016Fze, nevyhodnotiteln\u00E1 p\u0159\u00EDhoda\n\tperifern\u00ED ed\u00E9m\n\tVy\u0161et\u0159en\u00ED\n\t\u2500\n\t\u2500\n\tsn\u00ED\u017Een\u00ED t\u011Blesn\u00E9 hmotnosti *, zv\u00FD\u0161en\u00ED t\u011Blesn\u00E9 hmotnosti *\n\tzv\u00FD\u0161en\u00ED alanin- aminotransfer\u00E1zy*, zv\u00FD\u0161en\u00ED aspart\u00E1t-aminotransfer\u00E1zy*, poruchy spermatu\n\tabnorm\u00E1ln\u00ED klinick\u00E9 laboratorn\u00ED n\u00E1lezy, zm\u011Bn\u011Bn\u00E1 funkce krevn\u00EDch desti\u010Dek, zv\u00FD\u0161en\u00E1 hladina cholesterolu v s\u00E9ru\n\tPoran\u011Bn\u00ED, otravy a procedur\u00E1ln\u00ED komplikace\n\t\u2500\n\t\u2500\n\t\u2500\n\tzran\u011Bn\u00ED\n\t\u2500\n\tChirurgick\u00E9 a l\u00E9\u010Debn\u00E9 postupy\n\t\u2500\n\t\u2500\n\t\u2500\n\tvazodilata\u010Dn\u00ED l\u00E9\u010Dba\n\t\u2500\nPokud se ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky vyskytly p\u0159i l\u00E9\u010Db\u011B deprese, OCD, panick\u00E9 poruchy, PTSD a soci\u00E1ln\u00ED \u00FAzkostn\u00E9 poruchy, byly n\u00E1zvy org\u00E1n\u016F reklasifikov\u00E1ny podle n\u00E1zv\u016F org\u00E1n\u016F u\u017E\u00EDvan\u00FDch ve studi\u00EDch deprese.\n(+) Byl hl\u00E1\u0161en 1 p\u0159\u00EDpad novotvaru u 1 pacienta u\u017E\u00EDvaj\u00EDc\u00EDho sertralin v porovn\u00E1n\u00ED s \u017E\u00E1dn\u00FDm p\u0159\u00EDpadem ve skupin\u011B u\u017E\u00EDvaj\u00EDc\u00ED placebo.\n* tyto ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky se vyskytly i po uveden\u00ED p\u0159\u00EDpravku na trh.\n** po\u010Det pacient\u016F ve skupin\u011B zahrnuj\u00EDc\u00ED ob\u011B pohlav\u00ED: sertralin (1118 mu\u017E\u016F, 1424 \u017Een), placebo (926 mu\u017E\u016F, 1219 \u017Een).\nPouze studie OCD, kr\u00E1tkodob\u00E9, 1-12t\u00FDdenn\u00ED.\n*** B\u011Bhem l\u00E9\u010Dby sertralinem nebo brzy po ukon\u010Den\u00ED l\u00E9\u010Dby byly hl\u00E1\u0161eny p\u0159\u00EDpady sebevra\u017Eedn\u00FDch my\u0161lenek a sebevra\u017Eedn\u00E9ho chov\u00E1n\u00ED (viz bod 4.4).\nP\u0159\u00EDznaky z vysazen\u00ED pozorovan\u00E9 po p\u0159eru\u0161en\u00ED l\u00E9\u010Dby sertralinem:\nP\u0159eru\u0161en\u00ED l\u00E9\u010Dby sertralinem (zvl\u00E1\u0161t\u00E9 n\u00E1hl\u00E9) obecn\u011B vede k\u00A0p\u0159\u00EDznak\u016Fm z\u00A0vysazen\u00ED l\u00E9ku. Nej\u010Dast\u011Bji hl\u00E1\u0161en\u00E9 \u00FA\u010Dinky jsou z\u00E1vrat\u011B, smyslov\u00E9 poruchy (v\u010Detn\u011B parest\u00E9zie), poruchy sp\u00E1nku (v\u010Detn\u011B nespavosti a neobvykl\u00FDch sn\u016F), agitovanost nebo \u00FAzkost, nevolnost a/nebo zvracen\u00ED, t\u0159es a bolesti hlavy. Obvykle jsou tyto p\u0159\u00EDznaky m\u00EDrn\u00E9 a\u017E st\u0159edn\u011B z\u00E1va\u017En\u00E9 a miz\u00ED samy od sebe, i kdy\u017E u n\u011Bkter\u00FDch nemocn\u00FDch mohou b\u00FDt z\u00E1va\u017En\u00E9 a/nebo prodlou\u017Een\u00E9. P\u0159i ukon\u010Dov\u00E1n\u00ED l\u00E9\u010Dby sertralinem se proto doporu\u010Duje postupn\u00E9 sni\u017Eov\u00E1n\u00ED d\u00E1vky (viz body 4.2 a 4.4).\nStar\u0161\u00ED pacienti\nL\u00E9ky ze skupin SSRI nebo SNRI v\u010Detn\u011B sertralinu byly spojeny s p\u0159\u00EDpady klinicky v\u00FDznamn\u00E9 hyponatr\u00E9mie u star\u0161\u00EDch pacient\u016F, kte\u0159\u00ED mohou b\u00FDt vystaveni vy\u0161\u0161\u00EDmu riziku tohoto ne\u017E\u00E1douc\u00EDho \u00FA\u010Dinku (viz bod 4.4).\n\u00DA\u010Dinky skupiny l\u00E9\u010Div\nEpidemiologick\u00E9 studie - p\u0159edev\u0161\u00EDm ty, kter\u00E9 byly proveden\u00E9 u pacient\u016F ve v\u011Bku 50 let a v\u00FD\u0161e - uk\u00E1zaly zv\u00FD\u0161en\u00E9 riziko fraktur kost\u00ED u t\u011Bch pacient\u016F, kte\u0159\u00ED u\u017E\u00EDvaj\u00ED selektivn\u00ED inhibitory zp\u011Btn\u00E9ho vychyt\u00E1v\u00E1n\u00ED serotoninu (SSRI) nebo tricyklick\u00E1 (TCA) antidepresiva. Mechanismus vzniku tohoto rizika nen\u00ED zn\u00E1m.\nPediatrick\u00E1 populace\nU v\u00EDce ne\u017E 600 pediatrick\u00FDch pacient\u016F l\u00E9\u010Den\u00FDch sertralinem byl celkov\u00FD profil ne\u017E\u00E1douc\u00EDch \u00FA\u010Dink\u016F podobn\u00FD t\u011Bm u dosp\u011Bl\u00FDch. N\u00E1sleduj\u00EDc\u00ED ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky byly hl\u00E1\u0161eny z kontrolovan\u00FDch studi\u00ED (n=281 pacient\u016F l\u00E9\u010Den\u00FDch sertralinem):\nVelmi \u010Dast\u00E9 (\u22651/10): bolest hlavy (22%), nespavost (21%), pr\u016Fjem (11%) a nevolnost (15%).\n\u010Cast\u00E9 (\u22651/100 a\u017E <1/10): bolest na hrudi, m\u00E1nie, hore\u010Dka, zvracen\u00ED, anorexie, labiln\u00ED chov\u00E1n\u00ED, agrese, agitovanost, nervozita, poruchy pozornosti, z\u00E1vra\u0165, hyperkineze, migr\u00E9na, somnolence, t\u0159es, poruchy zraku, sucho v \u00FAstech, dyspepsie, no\u010Dn\u00ED m\u016Fry, \u00FAnava, mo\u010Dov\u00E1 inkontinence, vyr\u00E1\u017Eka, akn\u00E9, epistaxe, flatulence.\nM\u00E9n\u011B \u010Dast\u00E9 (\u22651/1000 a\u017E <1/100): prodlou\u017Een\u00ED QT intervalu na EKG, pokus o sebevra\u017Edu, k\u0159e\u010De, extrapyramidov\u00E9 poruchy, parest\u00E9zie, deprese, halucinace, purpura, hyperventilace, an\u00E9mie, porucha funkce jater, zv\u00FD\u0161en\u00ED alaninaminotransfer\u00E1zy, cystitida, herpes simplex, otitis externa, bolest ucha, bolest oka, mydri\u00E1za, nevolnost, hematurie, v\u0159\u00EDdkovit\u00E1 vyr\u00E1\u017Eka, rinitida, zran\u011Bn\u00ED, pokles t\u011Blesn\u00E9 hmotnosti, svalov\u00E9 z\u00E1\u0161kuby, neobvykl\u00E9 sny, apatie, albuminurie, polakisurie, polyurie, bolest prs\u016F, menstrua\u010Dn\u00ED poruchy, alopecie, dermatitida, poruchy k\u016F\u017Ee, zm\u011Bna pachu k\u016F\u017Ee, urtikarie, bruxismus, n\u00E1valy.\n\u010Cetnost nezn\u00E1ma: enur\u00E9za.\n"@cs . . . "004.008" . . . . . . . . . . . . . .