. . . . "4.8 Ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky "@cs . . . . . "004.008" . "Kombinace irbesartan/hydrochlorothiazid: \nZ 898 pacient\u016F s hypertenz\u00ED, kter\u00FDm byly pod\u00E1ny r\u016Fzn\u00E9 d\u00E1vky irbesartanu/hydrochlorothiazidu (rozsah: 37,5 mg/6,25 mg a\u017E 300 mg/25 mg) ve studi\u00EDch kontrolovan\u00FDch placebem, do\u0161lo u 29,5\u00A0% pacient\u016F k ne\u017E\u00E1douc\u00EDm reakc\u00EDm. Nej\u010Dast\u011Bji hl\u00E1\u0161en\u00FDmi ne\u017E\u00E1douc\u00EDmi reakcemi byly z\u00E1vrat\u011B (5,6\u00A0%), \u00FAnava (4,9\u00A0%), nausea/zvracen\u00ED (1,8\u00A0%) a abnorm\u00E1ln\u00ED mo\u010Den\u00ED (1,4\u00A0%). Nav\u00EDc byly ve stud\u00ED\u00EDch tak\u00E9 obvykle pozorov\u00E1ny n\u00E1r\u016Fsty dus\u00EDku mo\u010Doviny v krvi (BUN) (2,3\u00A0%), kreatinkin\u00E1zy (1,7\u00A0%) a kreatininu (1,1\u00A0%).\nV tabulce 1 jsou uvedeny reakce pozorovan\u00E9 ze spont\u00E1nn\u00EDch hl\u00E1\u0161en\u00ED a z klinick\u00FDch studi\u00ED kontrolovan\u00FDch placebem.\nFrekvence ne\u017E\u00E1douc\u00EDch reakc\u00ED uveden\u00FDch n\u00ED\u017Ee je definov\u00E1na s pou\u017Eit\u00EDm n\u00E1sleduj\u00EDc\u00ED konvence:\nvelmi \u010Dast\u00E9 (\u2265 1/10); \u010Dast\u00E9 (\u2265 1/100 a\u017E < 1/10); m\u00E9n\u011B \u010Dast\u00E9 (\u2265 1/1 000 a\u017E < 1/100); vz\u00E1cn\u00E9 (\u2265 1/10 000 a\u017E < 1/1 000); velmi vz\u00E1cn\u00E9 (< 1/10 000). K ka\u017Ed\u00E9 ze skupin podle frekvence jsou ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky uvedeny v po\u0159ad\u00ED s klesaj\u00EDc\u00ED z\u00E1va\u017Enost\u00ED.\n\tTabulka \u010D.1: Ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky v placebem kontrolovan\u00FDch studi\u00EDch a ze spont\u00E1nn\u00EDch hl\u00E1\u0161en\u00ED*\n\tV\u00EDcen\u00E1sobn\u00E1 vy\u0161et\u0159en\u00ED:\n\t\u010Cast\u00E9:\nM\u00E9n\u011B \u010Dast\u00E9:\n\tvzestup BUN, kreatininu a kreatinkin\u00E1zy\npokles drasl\u00EDku a sod\u00EDku v s\u00E9ru\n\tSrde\u010Dn\u00ED poruchy:\n\tM\u00E9n\u011B \u010Dast\u00E9:\n\tsynkopa, hypotenze, tachykardie, ed\u00E9m\n\tPoruchy nervov\u00E9ho syst\u00E9mu:\n\t\u010Cast\u00E9:\nM\u00E9n\u011B \u010Dast\u00E9: \nNen\u00ED zn\u00E1mo: \n\tz\u00E1vrat\u011B \nortostatick\u00E9 z\u00E1vrat\u011B\nbolesti hlavy\n\tPoruchy ucha a labyrintu:\n\tNen\u00ED zn\u00E1mo: \n\ttinnitus\n\tRespira\u010Dn\u00ED, hrudn\u00ED a\nmediastin\u00E1ln\u00ED poruchy:\n\tNen\u00ED zn\u00E1mo: \n\tka\u0161el\n\tGastrointestin\u00E1ln\u00ED poruchy: \n\t\u010Cast\u00E9:\nM\u00E9n\u011B \u010Dast\u00E9: \nNen\u00ED zn\u00E1mo: \n\tnauzea/zvracen\u00ED\npr\u016Fjem \ndyspepsie, dysgeusie\n\tPoruchy ledvin a mo\u010Dov\u00FDch cest:\n\t\u010Cast\u00E9:\nNen\u00ED zn\u00E1mo: \n\tabnorm\u00E1ln\u00ED mo\u010Den\u00ED \nporucha funkce ledvin v\u010Detn\u011B\nizolovan\u00FDch p\u0159\u00EDpad\u016F ren\u00E1ln\u00EDho selh\u00E1n\u00ED u\nrizikov\u00FDch pacient\u016F (viz bod 4.4)\n\tPoruchy svalov\u00E9 a kostern\u00ED soustavy a pojivov\u00E9 tk\u00E1n\u011B:\n\tM\u00E9n\u011B \u010Dast\u00E9: \nNen\u00ED zn\u00E1mo: \n\totoky kon\u010Detin \narthralgie, myalgie\n\tPoruchy metabolismu a v\u00FD\u017Eivy::\n\tNen\u00ED zn\u00E1mo: \n\thyperkal\u00E9mie\n\tC\u00E9vn\u00ED poruchy:\n\tM\u00E9n\u011B \u010Dast\u00E9:\n\tn\u00E1valy horka \n\tCelkov\u00E9 poruchy a reakce v\nm\u00EDst\u011B aplikace:\n\t\u010Cast\u00E9:\n\t\u00FAnava \n\tPoruchy imunitn\u00EDho syst\u00E9mu:\n\tNen\u00ED zn\u00E1mo:\n\tp\u0159\u00EDpady hypersenzitivn\u00ED reakce, jako je\nangioed\u00E9m, vyr\u00E1\u017Eka a kop\u0159ivka\n\tPoruchy jater a \u017Elu\u010Dov\u00FDch cest:\n\tNen\u00ED zn\u00E1mo:\n\thepatitida, abnorm\u00E1ln\u00ED jatern\u00ED funkce\n\tPoruchy reproduk\u010Dn\u00EDho syst\u00E9mu\na prsu:\n\tM\u00E9n\u011B \u010Dast\u00E9:\n\tsexu\u00E1ln\u00ED dysfunkce, zm\u011Bny libida \n* \u010Cetnost pro ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky zaznamenan\u00E9 u spont\u00E1nn\u00EDch hl\u00E1\u0161en\u00ED je udan\u00E1 jako \u201Cnen\u00ED zn\u00E1mo\u201D\nDal\u0161\u00ED informace k jednotliv\u00FDm slo\u017Ek\u00E1m: k ne\u017E\u00E1douc\u00EDm \u00FA\u010Dink\u016Fm kombinovan\u00E9ho p\u0159\u00EDpravku, kter\u00E9 jsou uvedeny v\u00FD\u0161e, nav\u00EDc pat\u0159\u00ED ne\u017E\u00E1douc\u00ED reakce ji\u017E d\u0159\u00EDve hl\u00E1\u0161en\u00E9 u jednotliv\u00FDch slo\u017Eek p\u0159\u00EDpravku. Tyto ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky jsou i potenci\u00E1ln\u00EDmi ne\u017E\u00E1douc\u00EDmi reakcemi p\u0159\u00EDpravku Lartokaz. Tabulky \u010D.2 a \u010D.3 viz n\u00ED\u017Ee, detailn\u011B ud\u00E1vaj\u00ED ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky zaznamenan\u00E9 pro jednotliv\u00E9 slo\u017Eky p\u0159\u00EDpravku Lartokaz. \n\tTabulka \u010D.2: Ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky hl\u00E1\u0161en\u00E9 p\u0159i u\u017Eit\u00ED samotn\u00E9ho irbesartanu\n\tCelkov\u00E9 poruchy a reakce v\nm\u00EDst\u011B aplikace:\n\tM\u00E9n\u011B \u010Dast\u00E9:\n\tbolest na hrudi \n\t\n\tTabulka \u010D.3: Ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky pozorovan\u00E9 p\u0159i pod\u00E1v\u00E1n\u00ED samotn\u00E9ho hydrochlorthiazidu (bez ohledu na vztah k l\u00E9\u010Div\u00E9mu p\u0159\u00EDpravku)\n\tV\u00EDcen\u00E1sobn\u00E1 vy\u0161et\u0159en\u00ED\n\tNen\u00ED zn\u00E1mo:\n\telektrolytov\u00E1 dysbalance (v\u010Detn\u011B\nhypokal\u00E9mie a hyponatr\u00E9mie, viz\nbod 4.4), hyperurik\u00E9mie, glykosurie,\nhyperglyk\u00E9mie, vzestup hladiny\ncholesterolu a triacylglycerol\u016F\n\tSrde\u010Dn\u00ED poruchy:\n\tNen\u00ED zn\u00E1mo:\n\tsrde\u010Dn\u00ED arytmie\n\tPoruchy krve a lymfatick\u00E9ho\nsyst\u00E9mu:\n\tNen\u00ED zn\u00E1mo:\n\taplastick\u00E1 an\u00E9mie, \u00FAtlum kostn\u00ED d\u0159en\u011B,\nneutrop\u00E9nie/agranulocyt\u00F3za,\nhemolytick\u00E1 an\u00E9mie, leukop\u00E9nie,\ntrombocytop\u00E9nie\n\tPoruchy nervov\u00E9ho syst\u00E9mu:\n\tNen\u00ED zn\u00E1mo:\n\tz\u00E1vrat\u011B, parest\u00E9zie, pocit na omdlen\u00ED,neklid\n\tPoruchy oka:\n\tNen\u00ED zn\u00E1mo:\n\tp\u0159echodn\u00E9 poruchy vid\u011Bn\u00ED, \u017Elut\u00E9 vid\u011Bn\u00ED\n\tRespira\u010Dn\u00ED, hrudn\u00ED a\nmediastin\u00E1ln\u00ED poruchy:\n\tNen\u00ED zn\u00E1mo:\n\tdechov\u00E1 t\u00EDse\u0148 (v\u010Detn\u011B pneumonitidy a\nplicn\u00EDho ed\u00E9mu)\n\tGastrointestin\u00E1ln\u00ED poruchy:\n\tNen\u00ED zn\u00E1mo:\n\tpankreatitida, anorexie, pr\u016Fjem, z\u00E1cpa,podr\u00E1\u017Ed\u011Bn\u00ED \u017Ealude\u010Dn\u00ED sliznice,\nsialoadenitida, ztr\u00E1ta chuti\n\tPoruchy ledvin a mo\u010Dov\u00FDch cest:\n\tNen\u00ED zn\u00E1mo:\n\tinterstici\u00E1ln\u00ED nefritida, ren\u00E1ln\u00ED\ndysfunkce\n\tPoruchy k\u016F\u017Ee a podko\u017En\u00ED tk\u00E1n\u011B:\n\tNen\u00ED zn\u00E1mo:\n\tanafylaktick\u00E9 reakce, toxick\u00E1\nepiderm\u00E1ln\u00ED nekrol\u00FDza, nekrotizuj\u00EDc\u00ED\nangiitida (vaskulitida, ko\u017En\u00ED\nvaskulitida), reakce podobn\u00E9 ko\u017En\u00EDmu\nlupus erytematodes, reaktivace\nko\u017En\u00EDho lupus erytematodes,\nfotosenzitivn\u00ED reakce, vyr\u00E1\u017Eka,\nkop\u0159ivka\n\tPoruchy svalov\u00E9 a kostern\u00ED\nsoustavy a pojivov\u00E9 tk\u00E1n\u011B:\n\tNen\u00ED zn\u00E1mo:\n\tslabost, svalov\u00FD spasmus \n\tC\u00E9vn\u00ED poruchy:\n\tNen\u00ED zn\u00E1mo:\n\tpostur\u00E1ln\u00ED hypotenze\n\tCelkov\u00E9 poruchy a reakce v\nm\u00EDst\u011B aplikace:\n\tNen\u00ED zn\u00E1mo:\n\thore\u010Dka \n\tPoruchy jater a \u017Elu\u010Dov\u00FDch cest:\n\tNen\u00ED zn\u00E1mo:\n\t\u017Eloutenka (intrahepat\u00E1ln\u00ED cholestatick\u00E1\n\u017Eloutenka)\n\tPsychiatric disorders:\n\tNen\u00ED zn\u00E1mo:\n\tdeprese, poruchy sp\u00E1nku\nNa d\u00E1vce z\u00E1visl\u00E9 ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky hydrochlorothiazidu (zejm\u00E9na poruchy elektrolyt\u016F) se mohou p\u0159i titraci hydrochlorothiazidu zvy\u0161ovat.\n"@cs . .