ANEKS I

CHARAKTERYSTYKA PRODUKTU LECZNICZEGO

1

1. NAZWA PRODUKTU LECZNICZEGO

Aripiprazole Zentiva 5 mg tabletkiAripiprazole Zentiva 10 mg tabletkiAripiprazole Zentiva 15 mg tabletkiAripiprazole Zentiva 30 mg tabletki

2. 6.à$'-$.2ĝ&,2:<,,/2ĝ&,2WY

Aripiprazole Zentiva 5 mg tabletki

.DĪGDWDEOHWND]DZLHUD mg arypiprazolu.

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(MHGQRZRGQHM).

Aripiprazole Zentiva 10 mg tabletki

.DĪGDWDEOHWND]DZLHUD10 mg arypiprazolu.

6XEVWDQFMDSRPRFQLF]DR]QDQ\PG]LDáDQLX NDĪGDWDEOHWND]DZLHUD

PJODNWR]\MHGQRZRGQHM

Aripiprazole Zentiva 15 mg tabletki

.DĪGDWDEOHWND]DZLHUD mg arypiprazolu.

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PJODNWR]\MHGQRZRGQHM

Aripiprazole Zentiva 30 mg tabletki

.DĪGDWDEOHWND]DZLHUDmgarypiprazolu.

6XEVWDQFMDSRPRFQLF]DR]QDQ\PG]LDáDQLXNDĪGDWDEOHWND]DZLHUD

PJODNWR]\MHGQRZRGQHM

3HáQ\Z\ND]VXEVWDQFMLSRPRFQLF]\FKSDWU]SXQNW

3. 3267$û)$50$&(87<&=1A

Tabletka

Aripiprazole Zentiva 5 mg tabletki

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Aripiprazole Zentiva 10 mg tabletki

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AripiprazoleZentiva15mgtabletki

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Aripiprazole Zentiva 30 mg tabletki

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2

/LQLDSRG]LDáXQDWDEOHWFHQLHMHVWSU]H]QDF]RQDGRSU]HáDP\ZDQLDWDEOHWNL

4. 6=&=(*Ïà2:('$1(./,NICZNE

4.1 Wskazania do stosowania

Aripiprazole Zentiva MHVWZVND]DQ\GROHF]HQLDVFKL]RIUHQLLXGRURVá\FKLXPáRG]LHĪ\ZZLHNXODW i starszej.

Aripiprazole Zentiva MHVWZVND]DQ\ZOHF]HQLXHSL]RGyZPDQLDNDOQ\FKRQDVLOHQLXXPLDUNRZDQ\PGRFLĊĪNLHJRZSU]HELHJX]DEXU]HQLDDIHNW\ZQHJRGZXELHJXQRZHJRW\SX,RUD]Z]DSRELHJDQLXQRZ\PHSL]RGRPPDQLDNDOQ\PXGRURVá\FKXNWyU\FKZ\VWĊSXMąJáyZQLHHSL]RG\PDQLDNDOQHLNWyU]\

RGSRZLDGDMąQDOHF]HQLHDU\SLSUD]ROHPSDWU]SXQNW

Aripiprazole Zentiva MHVWZVND]DQ\ZOHF]HQLXHSL]RGyZPDQLDNDOQ\FKRQDVLOHQLXXPLDUNRZDQ\PGR FLĊĪNLHJRZSU]HELHJX]DEXU]HQLDDIHNW\ZQHJRGZXELHJXQRZHJRW\SX,XPáRG]LHĪ\ZZLHNXODWi

VWDUV]HMZOHF]HQLXWUZDMąF\PGRW\JRGQLSDWU]SXQNW

4.2 Dawkowanie i sposób podawania

'DZNRZDQLH

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6FKL]RIUHQLD

=DOHFDQDGDZNDSRF]ąWNRZDSURGXNWX$ULSLSUD]ROH=HQWLYDWRPJOXE na GREĊ]GDZNąSRGWU]\PXMąFąmg na GREĊ/HNQDOHĪ\SRGDZDüUD]QDGREĊRVWDáHMSRU]HQLH]DOHĪQLHRG SRVLáNyZ

$ULSLSUD]ROH=HQWLYDMHVWVNXWHF]Q\ZGDZNDFKRGGRmgnaGREĊ&KRFLDĪQLHSRWZLHUG]RQRZLĊNV]HMVNXWHF]QRĞFLGDZHNZLĊNV]\FKQLĪGDZNDGRERZD PJMHGQDNXSRV]F]HJyOQ\FK SDFMHQWyZZLĊNV]DGDZNDPRĪHE\üNRU]\VWQD0DNV\PDOQDGDZNDGRERZDQLHPRĪHE\üZLĊNV]DQLĪ 30 mg.

(SL]RG\PDQLDNDOQHZ]DEXU]HQLXDIHNW\ZQ\PGZXELHJXQRZ\PW\SX,

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3

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4

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7DEOHWNLXOHJDMąFHUR]SDGRZLZMDPLHXVWQHMPRJąE\üVWRVRZDQHDOWHUQDW\ZQLHGRWDEOHWHNAripiprazole Zentiva XSDFMHQWyZNWyU]\PDMąWUXGQRĞFLZSRá\NDQLXWDEOHWHNAripiprazole Zentiva SDWU]WDNĪHSXQNW

4.3 Przeciwwskazania

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4.4 6SHFMDOQHRVWU]HĪHQLDLĞURGNLRVWURĪQRĞFLGRW\F]ąFHVWRVRZDQLD

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5

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11

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12

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13

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14

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4.9 Przedawkowanie

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DOPUSZCZENIE DO OBROTU

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