COMPOSICIÓN CUALICUANTITATIVA
Cada comprimido recubierto de 5mg contiene:
7DGDODÀORPJ
H[FLSLHQWHVFVSFRPSULPLGRUHFXELHUWR
Cada comprimido recubierto de 20 mg contiene:
7DGDODÀORPJ
H[FLSLHQWHVFVSFRPSULPLGRUHFXELHUWR
FORMA FARMACÉUTICA
Comprimido recubierto
INDICACIONES TERAPÉUTICAS
Caste 5mg y 20mg
7UDWDPLHQWRGHODGLVIXQFLyQHUpFWLOHQKRPEUHVDGXOWRV
3DUDTXHWDGDODÀORVHDHIHFWLYRSDUDHOWUDWDPLHQWRGHODGLVIXQFLyQHUpFWLOHVQHFHVDULDODHVWLPXODFLyQVH[XDO
Caste 5mg
7UDWDPLHQWRGHORVVLJQRV\VtQWRPDVGHODKLSHUSODVLDEHQLJQDGHSUyVWDWDHQKRPEUHVDGXOWRV
(OXVRGHWDGDODÀORQRHVWiLQGLFDGRHQPXMHUHV
POSOLOGÍA Y FORMA DE ADMINISTRACIÓN
Disfunción eréctil en hombres adultos
(QJHQHUDOODGRVLVUHFRPHQGDGDHVGHPJWRPDGRVDQWHVGHODDFWLYLGDGVH[XDOSUHYLVWDFRQRVLQDOLPHQWRV
(QDTXHOORVSDFLHQWHVHQORVTXHPJGH7DGDODÀORQRSURGX]FDHOHIHFWRDGHFXDGRVHSXHGHSUREDUFRQOD
GRVLVGHPJ6HSXHGHWRPDUGHVGHDOPHQRVPLQXWRVDQWHVGHODDFWLYLGDGVH[XDO
/DIUHFXHQFLDPi[LPDGHGRVLÀFDFLyQHVGHXQFRPSULPLGRXQDYH]DOGtD
8QDGRVLVGH\PJGH7DGDODÀORVHXWLOL]DUiQDQWHVGHODDFWLYLGDGVH[XDOSUHYLVWD\QRVHUHFRPLHQGDVX
XVRGLDULRFRQWLQXR
(QSDFLHQWHVTXHSUHYHDQXQXVRIUHFXHQWHGHWDGDODÀORHVGHFLUSRUORPHQRVGRVYHFHVSRUVHPDQDSXHGH
VHUDGHFXDGRHOXVRGLDULRGHODVGRVLVPiVEDMDVGHWDGDODÀORWHQLHQGRHQFXHQWDWDQWRODHOHFFLyQGHOSDFLHQWH
FRPRHOMXLFLRFOtQLFRGHOPpGLFR(QHVWRVSDFLHQWHVODGRVLVUHFRPHQGDGDHVGHPJWRPDGRVXQDYH]DOGtD
DSUR[LPDGDPHQWHDODPLVPDKRUD6HGHEHUHHYDOXDUSHULyGLFDPHQWHODLGRQHLGDGGHOXVRFRQWLQXDGRGHHVWH
UpJLPHQGHDGPLQLVWUDFLyQGLDULD
Hiperplasia benigna de próstata en hombres adultos
/DGRVLVUHFRPHQGDGDHVGHPJWRPDGRVXQDYH]DOGtDDSUR[LPDGDPHQWHDODPLVPDKRUDFRQRVLQDOLPHQWRV
La dosis recomendada para hombres adultos que estén siendo tratados tanto para la hiperplasia benigna de
SUyVWDWDFRPRSDUDODGLVIXQFLyQHUpFWLOHVWDPELpQGHPJWRPDGRVXQDYH]DOGtDDSUR[LPDGDPHQWHDOD
PLVPDKRUD
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SDUDHOWUDWDPLHQWRGHKLSHUSODVLD%HQLJQDGH3UyVWDWD
Poblaciones especiales
Hombres de edad avanzada
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+RPEUHVFRQLQVXÀFLHQFLDUHQDO
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Caste®
4ADALAlLO
-EDICAMENTOUSADOENDISFUNCIØNERÏCTIL
Uso oral
Comprimidos recubiertos
USO EN ADULTOS MAYORES DE 18 AÑOS
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(QSDFLHQWHVFRQLQVXÀFLHQFLDUHQDOJUDYHQRVHUHFRPLHQGDODDGPLQLVWUDFLyQGLDULDGHPJSDUDHOWUDWDPLHQWR
GHODGLVIXQFLyQHUpFWLORGHODKLSHUSODVLDEHQLJQDGHSUyVWDWDYHUVHFFLRQHVDGYHUWHQFLDV\SUHFDXFLRQHV
HVSHFLDOHV\SURSLHGDGHVIDUPDFRFLQpWLFDV
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/D GRVLV UHFRPHQGDGD SDUD HO WUDWDPLHQWR GH OD GLVIXQFLyQ HUpFWLO FRQ WDGDODÀOR D GHPDQGD HV GH PJ
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VHJXULGDGGHWDGDODÀORHQSDFLHQWHVFRQLQVXÀFLHQFLDKHSiWLFDJUDYHFODVLÀFDFLyQ&KLOG3XJKJUDGR&(Q
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VXSHULRUHVDPJHQSDFLHQWHVFRQLQVXÀFLHQFLDKHSiWLFD
1RVHKDHVWXGLDGRHOUpJLPHQGHDGPLQLVWUDFLyQGLDULDGHWDGDODÀORSDUDHOWUDWDPLHQWRWDQWRGHODGLVIXQFLyQ
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YHUVHFFLRQHVDGYHUWHQFLDV\SUHFDXFLRQHVHVSHFLDOHV\SURSLHGDGHVIDUPDFRFLQpWLFDV
Hombres diabéticos
1RVHUHTXLHUHDMXVWHGHODGRVLVHQSDFLHQWHVGLDEpWLFRV
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Forma de administración
7DGDODÀORHVWiGLVSRQLEOHHQFRPSULPLGRVUHFXELHUWRVPJ\PJSDUDDGPLQLVWUDFLyQSRUYtDRUDO
CONTRAINDICACIONES
+LSHUVHQVLELOLGDGDOSULQFLSLRDFWLYRRDDOJXQRGHORVH[FLSLHQWHVLQFOXLGRVHQODVHFFLyQ/LVWDGHH[FLSLHQWHV
'XUDQWHORVHQVD\RVFOtQLFRVVHREVHUYyTXHWDGDODÀORLQFUHPHQWDEDHOHIHFWRKLSRWHQVRUGHORVQLWUDWRV6H
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*03F3RUHOORWDGDODÀORHVWiFRQWUDLQGLFDGRHQSDFLHQWHVTXHHVWpQWRPDQGRFXDOTXLHUIRUPDGHQLWUDWR
RUJiQLFRYHUVHFFLyQ,QWHUDFFLyQFRQRWURVPHGLFDPHQWRV\RWUDVIRUPDVGHLQWHUDFFLyQ
7DGDODÀORQRVHGHEHXWLOL]DUHQKRPEUHVFRQHQIHUPHGDGHVFDUGLDFDVHQORVTXHODDFWLYLGDGVH[XDOHVWi
GHVDFRQVHMDGD(OPpGLFRGHEHFRQVLGHUDUHOULHVJRFDUGLDFRSRWHQFLDOGHODDFWLYLGDGVH[XDOHQSDFLHQWHVFRQ
DQWHFHGHQWHVGHHQIHUPHGDGFDUGLRYDVFXODU
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\SRUWDQWRHOXVRGHWDGDODÀORHVWiFRQWUDLQGLFDGRHQ
• Pacientes que hubieran sufrido infarto de miocardio en los últimos 90 días,
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Association en los últimos 6 meses,
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FRQWUDLQGLFDFLRQHV
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LQWHUDFFLyQFRQRWURVPHGLFDPHQWRV\RWUDVIRUPDVGHLQWHUDFFLyQ
ADVERTENCIAS Y PRECAUCIONES
$QWHVGHLQLFLDUHOWUDWDPLHQWRFRQWDGDODÀOR
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físico para diagnosticar la disfunción eréctil o la hiperplasia benigna de próstata y determinar las potenciales
FDXVDVVXE\DFHQWHV
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Visión
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Disminución o pérdida súbita de audición
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diaria para el tratamiento bien de la disfunción eréctil o de la hiperplasia benigna de próstata en pacientes con
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Priapismo y deformación anatómica del pene
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Por excipientes:
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INTERACCIONES MEDICAMENTOSAS Y OTRAS FORMAS DE INTERACCIÓN
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Inhibidores del citocromo P450
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Transportadores
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Inductores del citocromo P450
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Nitratos
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GHPP+JUHVSHFWLYDPHQWHFRPRHQELSHGHVWDFLyQGLVPLQXFLyQPHGLDPi[LPDGHPP+J
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(QXQHVWXGLRSDUDHYDOXDUORVHIHFWRVGHWDGDODÀORVREUHODYLVLyQQRVHGHWHFWyGHWHULRURGHODGLVFULPLQDFLyQ
GHORVFRORUHVD]XOYHUGHXVDQGRODSUXHEDGH)DUQVZRUWK0XQVHOOKXH(VWHKHFKRHVFRQVLVWHQWHFRQ
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QRWLÀFDFLRQHVGHFDPELRVHQHOFRORUGHODYLVLyQIXHURQUDUDV
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PJXQHVWXGLRGHPHVHV\PJXQHVWXGLRGHPHVHV\RWURGHPHVHVDGPLQLVWUDGRVGLDULDPHQWH(Q
GRVGHHVWRVHQVD\RVVHREVHUYDURQGLVPLQXFLRQHVHQHOUHFXHQWRHVSHUPiWLFR\HQODFRQFHQWUDFLyQGHHVSHUPD
DVRFLDGDVDOWUDWDPLHQWRFRQWDGDODÀORTXHQRSDUHFHQWHQHUUHOHYDQFLDFOtQLFD(VWRVHIHFWRVQRHVWXYLHURQ
DVRFLDGRVDDOWHUDFLRQHVGHRWURVSDUiPHWURVWDOHVFRPRPRWLOLGDGPRUIRORJtD\)6+
Disfunción eréctil
6HUHDOL]DURQWUHVHQVD\RVFOtQLFRVSDUDWDGDODÀORDGHPDQGDHQSDFLHQWHVHQXQHQWRUQRGRPLFLOLDULRSDUD
GHÀQLUHOSHUtRGRGHUHVSXHVWDDWDGDODÀOR7DGDODÀORGHPRVWUyXQDPHMRUtDHVWDGtVWLFDPHQWHVLJQLÀFDWLYDIUHQWH
DSODFHERWDQWRHQODIXQFLyQHUpFWLO\ODFDSDFLGDGSDUDPDQWHQHUXQDUHODFLyQVH[XDOVDWLVIDFWRULDKDVWD
KRUDVGHVSXpVGHODGRVLÀFDFLyQFRPRHQODFDSDFLGDGGHDOFDQ]DU\PDQWHQHUHUHFFLRQHVSDUDORJUDUUHODFLRQHV
VH[XDOHVVDWLVIDFWRULDVHQXQSHULRGRGHWLHPSRWDQFRUWRFRPRPLQXWRVGHVSXpVGHODGRVLÀFDFLyQ
6HHYDOXDURQGRVLVGHDPJGHWDGDODÀORDGHPDQGDHQHQVD\RVFOtQLFRVTXHLQFOX\HURQSDFLHQWHV
LQFOX\HQGRSDFLHQWHVFRQGLVIXQFLyQHUpFWLOGHGLYHUVDVJUDYHGDGHVOHYHPRGHUDGDJUDYHHWLRORJtDVHGDGHV
UDQJRGHDDxRV\HWQLDV/DPD\RUtDGHORVSDFLHQWHVUHSRUWDURQGLVIXQFLyQHUpFWLOGHDOPHQRVDxR
GHGXUDFLyQ(QORVHVWXGLRVGHHÀFDFLDSULPDULDGHSREODFLyQJHQHUDOHOGHORVSDFLHQWHVUHSRUWDURQTXH
WDGDODÀORPHMRUyVXVHUHFFLRQHVFRPSDUDGRFRQHOWUDWDGRFRQSODFHER7DPELpQSDFLHQWHVFRQGLVIXQFLyQ
HUpFWLOHQWRGDVODVFDWHJRUtDVGHJUDYHGDGUHSRUWDURQHUHFFLRQHVPHMRUDGDVPLHQWUDVWRPDEDQWDGDODÀOR
\SDUDOHYHPRGHUDGD\JUDYHUHVSHFWLYDPHQWHFRPSDUDGRFRQ\FRQSODFHER(Q
ORVHVWXGLRVGHHÀFDFLDSULPDULDHOGHORVLQWHQWRVGHFRLWRIXHURQVDWLVIDFWRULRVHQORVSDFLHQWHVWUDWDGRV
FRQWDGDODÀORFRPSDUDGRVFRQHOWUDWDGRFRQSODFHER
(QXQHQVD\RGHVHPDQDVGHGXUDFLyQTXHLQFOX\ySDFLHQWHVWUDWDGRVFRQWDGDODÀOR\FRQ
SODFHERFRQGLVIXQFLyQHUpFWLOFDXVDGDSRUOHVLyQHQODPpGXODHVSLQDOWDGDODÀORPHMRUyVLJQLÀFDWLYDPHQWHOD
IXQFLyQHUpFWLODOFDQ]DQGRXQSRUFHQWDMHPHGLRSRUSDFLHQWHGHWHQWDWLYDVGHFRLWRVDWLVIDFWRULDVGHXQHQ
ORVSDFLHQWHVWUDWDGRVFRQWDGDODÀORPJyPJGRVLVÁH[LEOHDGHPDQGDHQFRPSDUDFLyQFRQXQHQ
ORVSDFLHQWHVGHOJUXSRSODFHER
3DUDODHYDOXDFLyQGHODDGPLQLVWUDFLyQGLDULDGHWDGDODÀORHQGRVLVGH\PJLQLFLDOPHQWHVHOOHYDURQ
DFDERHQVD\RVFOtQLFRVHQORVTXHVHLQFOX\HURQXQWRWDOGHSDFLHQWHVFRQGLIHUHQWHVHGDGHVUDQJR
DxRV\UD]DVGLVIXQFLyQHUpFWLOGHGLIHUHQWHVJUDGRVGHJUDYHGDGOHYHPRGHUDGDJUDYH\HWLRORJtDV(QORVGRV
HVWXGLRVSULQFLSDOHVGHHÀFDFLDHQSREODFLyQJHQHUDOFRQGLVIXQFLyQHUpFWLOHOSRUFHQWDMHPHGLRSRUSDFLHQWHGH
WHQWDWLYDVGHFRLWRVDWLVIDFWRULDVIXHGHXQHQORVSDFLHQWHVWUDWDGRVFRQWDGDODÀORPJ\GHXQHQ
ORVSDFLHQWHVWUDWDGRVFRQWDGDODÀORPJHQFRPSDUDFLyQFRQXQHQORVSDFLHQWHVGHOJUXSRSODFHER
(QHOHQVD\RHQSDFLHQWHVGLDEpWLFRVFRQGLVIXQFLyQHUpFWLOHOSRUFHQWDMHPHGLRSRUSDFLHQWHGHWHQWDWLYDV
GHFRLWRVDWLVIDFWRULDVIXHGHXQ\GHXQHQORVSDFLHQWHVWUDWDGRVFRQWDGDODÀORPJ\PJ
UHVSHFWLYDPHQWHHQFRPSDUDFLyQFRQXQHQORVSDFLHQWHVGHOJUXSRSODFHER/DPD\RUtDGHORVSDFLHQWHV
HQORVWUHVHQVD\RVKDEtDQUHVSRQGLGRSUHYLDPHQWHDXQWUDWDPLHQWRDGHPDQGDFRQLQKLELGRUHVGHOD3'((Q
XQHVWXGLRSRVWHULRUSDFLHQWHVTXHQRKDEtDQVLGRWUDWDGRVSUHYLDPHQWHFRQLQKLELGRUHVGH3'(IXHURQ
DVLJQDGRVDOHDWRULDPHQWHDWDGDODÀORPJXQDYH]DOGtDIUHQWHDSODFHER(OSRUFHQWDMHPHGLRSRUSDFLHQWHGH
WHQWDWLYDVGHFRLWRVDWLVIDFWRULDVIXHGHXQHQORVSDFLHQWHVWUDWDGRVFRQWDGDODÀORHQFRPSDUDFLyQFRQXQ
HQORVSDFLHQWHVWUDWDGRVFRQSODFHER
Hiperplasia benigna de próstata
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HVFDODLQWHUQDFLRQDOGHVtQWRPDVSURVWiWLFRVFRQWDGDODÀORHQORVFXDWURHQVD\RVIXH\
FRPSDUDGRFRQ\FRQSODFHER/DVPHMRUtDVHQODSXQWXDFLyQWRWDOGHODHVFDODLQWHUQDFLRQDO
GHVtQWRPDVSURVWiWLFRVRFXUULHURQHQXQSHULRGRGHWLHPSRWDQFRUWRFRPRVHPDQD(QXQRGHORVHQVD\RV
TXHLQFOX\yWDPELpQWDPVXORVLQDPJFRPRXQFRPSDUDGRUDFWLYRODPHMRUtDHQODSXQWXDFLyQWRWDOGHOD
HVFDODLQWHUQDFLRQDOGHVtQWRPDVSURVWiWLFRVFRQWDGDODÀORPJWDPVXORVLQD\SODFHERIXH\
UHVSHFWLYDPHQWH
8QRGHHVWRVHQVD\RVHYDOXyODVPHMRUtDVHQGLVIXQFLyQHUpFWLO\VLJQRV\VtQWRPDVGHODKLSHUSODVLDEHQLJQD
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HVWHHVWXGLRIXHURQ\FRQWDGDODÀORPJFRPSDUDGRFRQ\FRQSODFHERUHVSHFWLYDPHQWH
(OSRUFHQWDMHPHGLRSRUSDFLHQWHGHWHQWDWLYDVGHFRLWRVDWLVIDFWRULDVIXHGHXQFRQWDGDODÀORPJ
FRPSDUDGRFRQXQFRQSODFHER
/DVRVWHQLELOLGDGGHOHIHFWRIXHHYDOXDGDHQXQHVWXGLRDELHUWRGHH[WHQVLyQGHXQRGHORVHQVD\RVHOFXDO
PRVWUyTXHODPHMRUtDHQODSXQWXDFLyQWRWDOGHODHVFDODLQWHUQDFLRQDOGHVtQWRPDVSURVWiWLFRVREVHUYDGDDODV
VHPDQDVVHPDQWXYRKDVWDDxRPiVFRQHOWUDWDPLHQWRFRQWDGDODÀORPJ
3REODFLyQSHGLiWULFD
6HKDUHDOL]DGRXQ~QLFRHVWXGLRHQSDFLHQWHVSHGLiWULFRVFRQ'LVWURItD0XVFXODUGH'XFKHQQH'0'HQORV
TXHQRVHREVHUYyHYLGHQFLDGHHÀFDFLD(OHVWXGLRGHWDGDODÀORGHJUXSRVGHWUDWDPLHQWRDOHDWRUL]DGRGREOH
FLHJRFRQWURODGRFRQSODFHER\SDUDOHORVHUHDOL]yHQQLxRVGHHGDGHVFRPSUHQGLGDVHQWUH\DxRVFRQ
'0'TXHUHFLELHURQGHIRUPDVLPXOWiQHDWUDWDPLHQWRFRQFRUWLFRVWHURULGHV(OHVWXGLRLQFOX\yXQSHUtRGRGH
VHPDQDVGREOHFLHJRHQHOTXHORVSDFLHQWHVIXHURQDVLJQDGRVDOD]DUDWDGDODÀORPJNJWDGDODÀORPJNJ
RSODFHERGLDULR7DGDODÀORQRGHPRVWUyHÀFDFLDHQHOUHWUDVRGHODGLVPLQXFLyQGHODGHDPEXODFLyQPHGLGDSRU
ODYDULDEOHSULQFLSDOGHGLVWDQFLDUHFRUULGDDSLHHQPLQXWRV'50HOFDPELRPHGLRSRUPtQLPRVFXDGUDGRV
0&SDUDOD'50DODVVHPDQDVIXHGH²PHWURVPHQHOJUXSRSODFHERFRPSDUDGRFRQP
HQHOJUXSRGHWDGDODÀORPJNJS \PHQHOJUXSRGHORVDQiOLVLVVHFXQGDULRVUHDOL]DGRVHQ
HVWHHVWXGLR/RVUHVXOWDGRVJOREDOHVGHVHJXULGDGGHHVWHHVWXGLRIXHURQGHIRUPDJHQHUDOFRQVLVWHQWHVFRQHO
FRQRFLGRSHUÀOGHVHJXULGDGGHWDGDODÀOR\FRQORVHIHFWRVDGYHUVRV($HVSHUDGRVHQXQDSREODFLyQSHGLiWULFD
GH'0'TXHUHFLEtDFRUWLFRVWHURLGHV
La Agencia Europea de Medicamentos ha eximido al titular de la obligación de presentar los resultados de los
HQVD\RVUHDOL]DGRVFRQWDGDODÀORHQORVGLIHUHQWHVJUXSRVGHODSREODFLyQSHGLiWULFDHQHOWUDWDPLHQWRGHOD
GLVIXQFLyQHUpFWLOYHUVHFFLyQ3RVRORJtD\IRUPDGHDGPLQLVWUDFLyQSDUDFRQVXOWDUODLQIRUPDFLyQVREUHHOXVR
HQSREODFLyQSHGLiWULFD
Propiedades Farmacocinéticas
Absorción
7DGDODÀORVHDEVRUEHLQPHGLDWDPHQWHWUDVODDGPLQLVWUDFLyQSRUYtDRUDO\ODFRQFHQWUDFLyQSODVPiWLFDPi[LPD
PHGLD&PD[VHDOFDQ]DHQXQWLHPSRPHGLRGHKRUDVGHVSXpVGHODGRVLÀFDFLyQ1RVHKDGHWHUPLQDGROD
ELRGLVSRQLELOLGDGDEVROXWDGHWDGDODÀORGHVSXpVGHODDGPLQLVWUDFLyQRUDO
1LODYHORFLGDGQLODPDJQLWXGGHDEVRUFLyQGHWDGDODÀORVHYHQLQÁXLGRVSRUODLQJHVWDSRUORTXHWDGDODÀORVH
SXHGHWRPDUFRQRVLQDOLPHQWRV/DKRUDGHGRVLÀFDFLyQPDxDQDRWDUGHQRWXYRHIHFWRVFOtQLFRVUHOHYDQWHVHQ
ODYHORFLGDG\ODPDJQLWXGGHDEVRUFLyQ
Distribución
(OYROXPHQPHGLRGHGLVWULEXFLyQHVDSUR[LPDGDPHQWHOLQGLFDQGRTXHWDGDODÀORVHGLVWULEX\HHQORVWHMLGRV
$FRQFHQWUDFLRQHVWHUDSpXWLFDVHOGHWDGDODÀORHQSODVPDVHHQFXHQWUDXQLGRDSURWHtQDVSODVPiWLFDV/D
XQLyQDSURWHtQDVQRVHYHDIHFWDGDSRUODIXQFLyQUHQDODOWHUDGD
(QHOVHPHQGHYROXQWDULRVVDQRVVHGHWHFWyPHQRVGHOGHODGRVLVDGPLQLVWUDGD
Biotransformación
7DGDODÀORVHPHWDEROL]DSULQFLSDOPHQWHSRUODLVRIRUPD$GHOFLWRFURPR&<3(OPHWDEROLWRSULQFLSDO
FLUFXODQWH HV HO PHWLOFDWHFRO JOXFXUyQLGR (VWH PHWDEROLWR HV DO PHQRV YHFHV PHQRV VHOHFWLYR TXH
WDGDODÀORSDUDOD3'(3RUFRQVLJXLHQWHQRVHHVSHUDTXHVHDFOtQLFDPHQWHDFWLYRDODVFRQFHQWUDFLRQHVGH
PHWDEROLWRREVHUYDGDV
Eliminación
(O DFODUDPLHQWR PHGLR GH WDGDODÀOR HV GH OK \ OD VHPLYLGD SODVPiWLFD HV KRUDV HQ LQGLYLGXRV
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DSUR[LPDGDPHQWHHOGHODGRVLVDGPLQLVWUDGD\HQPHQRUPHGLGDHQODRULQDDSUR[LPDGDPHQWHHO
GHODGRVLV
Linealidad/No linealidad
/DIDUPDFRFLQpWLFDGHWDGDODÀORHQLQGLYLGXRVVDQRVHVOLQHDOUHVSHFWRDOWLHPSR\DODGRVLV(QHOUDQJRGH
GRVLVGHKDVWDPJODH[SRVLFLyQ$8&DXPHQWDSURSRUFLRQDOPHQWHFRQODGRVLVDGPLQLVWUDGD(OHVWDGR
HVWDFLRQDULRVHDOFDQ]DDORVGtDVFRQXQDGRVLV~QLFDGLDULD
La farmacocinética determinada en un grupo de pacientes con disfunción eréctil es similar a la farmacocinética
HQLQGLYLGXRVVLQGLVIXQFLyQHUpFWLO
Poblaciones especiales
Pacientes de edad avanzada.
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HQWUH\DxRV(VWDLQÁXHQFLDGHODHGDGQRHVFOtQLFDPHQWHVLJQLÀFDWLYD\QRUHTXLHUHDMXVWHGHODGRVLV
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HQSDFLHQWHVFRQLQVXÀFLHQFLDKHSiWLFD6LWDGDODÀORVHSUHVFULEHXQDYH]DOGtDHOPpGLFRGHEHUHDOL]DUXQD
HYDOXDFLyQFXLGDGRVDGHODUHODFLyQEHQHÀFLRULHVJR
Pacientes con diabetes
/DH[SRVLFLyQDWDGDODÀOR$8&HQSDFLHQWHVFRQGLDEHWHVIXHDSUR[LPDGDPHQWHXQLQIHULRUFRQUHVSHFWR
DOYDORUGH$8&HQLQGLYLGXRVVDQRV(VWDGLIHUHQFLDHQODH[SRVLFLyQQRUHTXLHUHXQDMXVWHGHODGRVLV
Datos preclínicos
Los datos en los estudios no clínicos no muestran riesgos especiales para los seres humanos según los estudios
FRQYHQFLRQDOHV VREUH IDUPDFRORJtD GH VHJXULGDG WR[LFLGDG D GRVLV UHSHWLGDV JHQRWR[LFLGDG SRWHQFLDO
FDUFLQRJpQLFR\WR[LFLGDGSDUDODUHSURGXFFLyQ
1RKXERHYLGHQFLDGHWHUDWRJHQLFLGDGHPEULRWR[LFLGDGRIHWRWR[LFLGDGHQUDWDVRUDWRQHVTXHUHFLELHURQKDVWD
PJNJGtDGHWDGDODÀOR(QXQHVWXGLRGHGHVDUUROORSUHQDWDO\SRVWQDWDOHQUDWDVODGRVLVDODTXHQRVH
REVHUYyHIHFWRIXHGHPJNJGtD(O$8&SDUDHOSULQFLSLRDFWLYROLEUHHQUDWDVSUHxDGDVDHVWDGRVLVIXH
DSUR[LPDGDPHQWHYHFHVHO$8&KXPDQDSDUDXQDGRVLVGHPJ
1R VH SURGXMR DOWHUDFLyQ GH OD IHUWLOLGDG HQ UDWDV PDFKRV QL KHPEUDV (Q SHUURV D ORV TXH VH DGPLQLVWUy
GLDULDPHQWHWDGDODÀORGXUDQWHDPHVHVDGRVLVGHPJNJGtDUHVXOWDQGRHQXQDH[SRVLFLyQDOPHQRV
YHFHVVXSHULRU>LQWHUYDORGH@DODREVHUYDGDHQKXPDQRVFRQXQDGRVLV~QLFDGHPJ\VXSHULRUHV
VHSURGXMRUHJUHVLyQHQHOHSLWHOLRVHPLQtIHURWXEXODUTXHVXSXVRXQDGLVPLQXFLyQGHODHVSHUPDWRJpQHVLVHQ
DOJXQRVSHUURV9HUVHFFLyQSURSLHGDGHVIDUPDFRGLQiPLFDV
DATOS FARMACÉUTICOS
Lista de excipientes
Celulosa microcristalina, croscarmelosa sódica, dióxido de silicio, estearato de magnesio, hiprolosa, lactosa
0ODXULOVXOIDWRGHVRGLRODFWRVDPRQRKLGUDWDGDKLSURPHORVDWULDFHWLQDGLy[LGRGHWLWDQLRFL
y[LGRGHKLHUURDPDULOORFLDJXDGHVLRQL]DGD
Incompatibilidades
1RSURFHGH
Periodo de validez
DxRV
Precauciones especiales de conservación
&RQVHUYDUHQWHPSHUDWXUDDPELHQWHPHQRUD&
Naturaleza y contenido del envase
1DWXUDOH]D%OtVWHUGH$OXPLQLR39&
Para la dosis de 5 mg:
&RQWHQLGR\FRPSULPLGRVUHFXELHUWRV
0XHVWUDPHGLFDFRPSULPLGRVUHFXELHUWRV
Para la dosis de 20 mg:
&RQWHQLGRFRPSULPLGRVUHFXELHUWRV
0XHVWUDPHGLFDFRPSULPLGRUHFXELHUWR
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