. . . . . . . . "004.008" . "B\u011Bhem l\u00E9\u010Dby perindoprilem nebo amlodipinem byly pozorov\u00E1ny n\u00E1sleduj\u00EDc\u00ED ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky uveden\u00E9 odd\u011Blen\u011B a t\u0159\u00EDd\u011Bn\u00E9 podle klasifikace MedDRA podle t\u011Blesn\u00FDch syst\u00E9m\u016F a n\u00E1sleduj\u00EDc\u00ED frekvence:\n-\tVelmi \u010Dast\u00E9 ((1/10)\n-\t\u010Cast\u00E9 ((1/100 a\u017E <1/10)\n-\tM\u00E9n\u011B \u010Dast\u00E9 ((1/1\u00A0000 a\u017E <1/100)\n-\tVz\u00E1cn\u00E9 ((1/10 000 a\u017E <1/1\u00A0000)\n-\tVelmi vz\u00E1cn\u00E9 (<1/10 000)\n-\tNen\u00ED zn\u00E1mo (z dostupn\u00FDch \u00FAdaj\u016F nelze ur\u010Dit)\nP\u0159i seskupen\u00ED v r\u00E1mci ka\u017Ed\u00E9 frekvence se ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky uv\u00E1d\u011Bj\u00ED v po\u0159ad\u00ED jejich klesaj\u00EDc\u00ED z\u00E1va\u017Enosti.\n\tT\u0159\u00EDda org\u00E1nov\u00E9ho\nsyst\u00E9mu MedDRA\n\tNe\u017E\u00E1douc\u00ED \u00FA\u010Dinky\n\tFrekvence\n\t\n\t\n\tAmlodipin\n\tPerindopril\n\tPoruchy krve a\nlymfatick\u00E9ho syst\u00E9mu\n\tLeukopenie/neutropenie (viz bod 4.4)\n\tVelmi\nvz\u00E1cn\u00E9\n\tVelmi\nvz\u00E1cn\u00E9\n\t\n\tAgranulocyt\u00F3za nebo pancytopenie (viz bod 4.4)\n\t\n\tVelmi\nvz\u00E1cn\u00E9\n\t\n\tTrombocytopenie (viz bod 4.4)\n\tVelmi\nvz\u00E1cn\u00E9\n\tVelmi\nvz\u00E1cn\u00E9\n\t\n\tHemolytick\u00E1 an\u00E9mie u pacient\u016F s vrozenou\nnedostate\u010Dnost\u00ED G-6PDH (viz bod 4.4)\n\t-\n\tVelmi\nvz\u00E1cn\u00E9\n\t\n\tPokles hemoglobinu a hematokritu\n\t-\n\tVelmi\nvz\u00E1cn\u00E9\n\tPoruchy imunitn\u00EDho\nsyst\u00E9mu\n\tAlergick\u00E1 reakce: kop\u0159ivka\n\tVelmi\nvz\u00E1cn\u00E9\n\tM\u00E9n\u011B \u010Dast\u00E9\n\tPoruchy\nmetabolismu a v\u00FD\u017Eivy\n\tHyperglykemie\n\tVelmi\nvz\u00E1cn\u00E9\n\t-\n\t\n\tP\u0159\u00EDr\u016Fstek t\u011Blesn\u00E9 hmotnosti\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t-\n\t\n\tPokles t\u011Blesn\u00E9 hmotnosti\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t-\n\t\n\tHypoglykemie (viz bod 4.4 a 4.5)\n\t-\n\tNen\u00ED zn\u00E1mo\n\tPsychiatrick\u00E9\nporuchy\n\tInsomnie\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t-\n\t\n\tZm\u011Bny n\u00E1lad\n\tM\u00E9n\u011B \u010Dast\u00E9\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t\n\tPoruchy sp\u00E1nku\n\t-\n\tM\u00E9n\u011B \u010Dast\u00E9\n\tPoruchy nervov\u00E9ho\nsyst\u00E9mu\n\tSomnolence\n\t\u010Cast\u00E9\n\t-\n\t\n\tZ\u00E1vrat\u011B\n\t\u010Cast\u00E9\n\t\u010Cast\u00E9\n\t\n\tBolest hlavy\n\t\u010Cast\u00E9\n\t\u010Cast\u00E9\n\t\n\tT\u0159es\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t-\n\t\n\tHypestezie,\nParestezie\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t-\n\t\n\t\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t\u010Cast\u00E9\n\t\n\tHypertonie\n\tVelmi\nvz\u00E1cn\u00E9\n\t-\n\t\n\tPerifern\u00ED neuropatie\n\tVelmi\nvz\u00E1cn\u00E9\n\t-\n\t\n\tVertigo\n\t-\n\t\u010Cast\u00E9\n\t\n\tStavy zmatenosti\n\t-\n\tVelmi\nvz\u00E1cn\u00E9\n\tPoruchy oka\n\tPoruchy vid\u011Bn\u00ED\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t\u010Cast\u00E9\n\tPoruchy ucha a\nlabyrintu\n\tTinitus\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t\u010Cast\u00E9\n\tSrde\u010Dn\u00ED poruchy\n\tPalpitace\n\t\u010Cast\u00E9\n\t-\n\t\n\tSynkopa\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t-\n\t\n\tAngin\u00F3zn\u00ED bolest\n\tVz\u00E1cn\u00E9\n\t-\n\t\n\tAngina pectoris\n\t-\n\tVelmi\nvz\u00E1cn\u00E9\n\t\n\tInfarkt myokardu, p\u0159\u00EDpadn\u011B sekund\u00E1rn\u011B u\npacient\u016F s nadm\u011Brn\u011B vysok\u00FDm rizikem hypotenze\n(viz bod 4.4)\n\tVelmi\nvz\u00E1cn\u00E9\n\tVelmi\nvz\u00E1cn\u00E9\n\t\n\tArytmie (v\u010Detn\u011B bradykardie, ventrikul\u00E1rn\u00ED\ntachykardie a atri\u00E1ln\u00ED fibrilace)\n\tVelmi\nvz\u00E1cn\u00E9\n\tVelmi\nvz\u00E1cn\u00E9\n\tC\u00E9vn\u00ED poruchy\n\tZrudnut\u00ED k\u016F\u017Ee\n\t\u010Cast\u00E9\n\t-\n\t\n\tHypotenze (a \u00FA\u010Dinky vztahuj\u00EDc\u00ED se k hypotenzi)\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t\u010Cast\u00E9\n\t\n\tMozkov\u00E1 p\u0159\u00EDhoda p\u0159\u00EDpadn\u011B sekund\u00E1rn\u011B u pacient\u016F\ns vysok\u00FDm rizikem nadm\u011Brn\u00E9 hypotenze (viz bod\n4.4)\n\t-\n\tVelmi\nvz\u00E1cn\u00E9\n\t\n\tVaskulitida\n\tVelmi\nvz\u00E1cn\u00E9\n\tNen\u00ED zn\u00E1mo\n\tRespira\u010Dn\u00ED, hrudn\u00ED a\nmediastin\u00E1ln\u00ED poruchy\n\tDyspnoe\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t\u010Cast\u00E9\n\t\n\tRinitida\n\tM\u00E9n\u011B \u010Dast\u00E9\n\tVelmi\nvz\u00E1cn\u00E9\n\t\n\tKa\u0161el\n\tVelmi\nvz\u00E1cn\u00E9\n\t\u010Cast\u00E9\n\t\n\tBronchospasmus\n\t-\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t\n\tEosinofiln\u00ED pneumonie\n\t-\n\tVelmi\nvz\u00E1cn\u00E9\n\tGastrointestin\u00E1ln\u00ED\nporuchy\n\tHyperplazie d\u00E1sn\u00ED\n\tVelmi\nvz\u00E1cn\u00E9\n\t-\n\t\n\tBolest b\u0159icha, nevolnost\n\t\u010Cast\u00E9\n\t\u010Cast\u00E9\n\t\n\tZvracen\u00ED\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t\u010Cast\u00E9\n\t\n\tDyspepsie\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t\u010Cast\u00E9\n\t\n\tZm\u011Bna chov\u00E1n\u00ED st\u0159ev\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t-\n\t\n\tSucho v \u00FAstech\n\tM\u00E9n\u011B \u010Dast\u00E9\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t\n\tPorucha chuti\n\t-\n\t\u010Cast\u00E9\n\t\n\tZm\u011Bna chuti\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t-\n\t\n\tPr\u016Fjem, z\u00E1cpa\n\t-\n\t\u010Cast\u00E9\n\t\n\tPankreatitida\n\tVelmi\nvz\u00E1cn\u00E9\n\tVelmi\nvz\u00E1cn\u00E9\n\t\n\tGastritida\n\tVelmi\nvz\u00E1cn\u00E9\n\t-\n\tPoruchy jater a\n\u017Elu\u010Dov\u00FDch cest\n\tHepatitida, cholestatick\u00E1 \u017Eloutenka\n\tVelmi\nvz\u00E1cn\u00E9\n\t-\n\t\n\tHepatitida bu\u010F cytolytick\u00E1 nebo cholestatick\u00E1\n(viz bod 4.4)\n\t-\n\tVelmi\nvz\u00E1cn\u00E9\n\tPoruchy k\u016F\u017Ee a\npodko\u017En\u00ED tk\u00E1n\u011B\n\tQuinckeho ed\u00E9m\n\tVelmi\nvz\u00E1cn\u00E9\n\t-\n\t\n\tAngioed\u00E9m obli\u010Deje, kon\u010Detin, rt\u016F, sliznic,\njazyka, hlasivkov\u00E9 \u0161t\u011Brbiny a/nebo hrtanu (viz\nbod 4.4)\n\t-\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t\n\tErythema multiforme\n\tVelmi\nvz\u00E1cn\u00E9\n\tVelmi\nvz\u00E1cn\u00E9\n\t\n\tAlopecie\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t-\n\t\n\tPurpura\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t-\n\t\n\tZm\u011Bna zbarven\u00ED k\u016F\u017Ee\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t-\n\t\n\tZv\u00FD\u0161en\u00E9 pocen\u00ED\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t-\n\t\n\tPocen\u00ED\n\t-\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t\n\tPruritus\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t\u010Cast\u00E9\n\t\n\tVyr\u00E1\u017Eka\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t\u010Cast\u00E9\n\t\n\tStevens\u016Fv-Johnson\u016Fv syndrom\n\tVelmi\nvz\u00E1cn\u00E9\n\t-\n\tPoruchy svalov\u00E9 a\nkostern\u00ED soustavy a pojivov\u00E9 tk\u00E1n\u011B\n\tArtralgie, myalgie\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t-\n\t\n\tSvalov\u00E9 k\u0159e\u010De\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t\u010Cast\u00E9\n\t\n\tBolest v z\u00E1dech\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t-\n\tPoruchy mo\u010Den\u00ED\n\tPoruchy mo\u010Den\u00ED, nykturie, zv\u00FD\u0161en\u00E1 frekvence\nmo\u010Den\u00ED\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t-\n\t\n\tZhor\u0161en\u00ED funkce ledvin\n\t-\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t\n\tAkutn\u00ED ren\u00E1ln\u00ED selh\u00E1n\u00ED\n\t-\n\tVelmi\nvz\u00E1cn\u00E9\n\tPoruchy\nreproduk\u010Dn\u00EDho syst\u00E9mu a prsu\n\tImpotence\n\tM\u00E9n\u011B \u010Dast\u00E9\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t\n\tGynekomastie\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t\n\tCelkov\u00E9 poruchy a\nreakce v m\u00EDst\u011B aplikace\n\tEd\u00E9m, perifern\u00ED ed\u00E9m\n\t\u010Cast\u00E9\n\t-\n\t\n\t\u00DAnava\n\t\u010Cast\u00E9\n\t-\n\t\n\tBolest na hrudn\u00EDku\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t-\n\t\n\tAstenie\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t\u010Cast\u00E9\n\t\n\tBolest\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t-\n\t\n\tCelkov\u00E1 nevolnost\n\tM\u00E9n\u011B \u010Dast\u00E9\n\t-\n\tVy\u0161et\u0159en\u00ED\n\tZv\u00FD\u0161en\u00ED jatern\u00EDch enzym\u016F: ALT, AST (v\u011Bt\u0161inou\nkonzistentn\u011B s cholest\u00E1zou)\n\tVelmi\nvz\u00E1cn\u00E9\n\t-\n\t\n\tZv\u00FD\u0161en\u00ED hladin bilirubinu a jatern\u00EDch enzym\u016F v s\u00E9ru\n\t-\n\tVz\u00E1cn\u00E9\n\t\n\tZv\u00FD\u0161en\u00ED hladin mo\u010Doviny v krvi a kreatininu v\u00A0krevn\u00EDm s\u00E9ru, hyperkalemie (viz bod 4.4)\n\t-\n\tNen\u00ED zn\u00E1mo\nDal\u0161\u00ED informace v\u00A0souvislosti s\u00A0amlodipinem\nV\u00FDjime\u010Dn\u00E9 p\u0159\u00EDpady extrapyramidov\u00E9ho syndromu byly hl\u00E1\u0161eny u blok\u00E1tor\u016F kalciov\u00FDch kan\u00E1l\u016F.\n"@cs . . "4.8\tNe\u017E\u00E1douc\u00ED \u00FA\u010Dinky"@cs . . . . .