Skip to Content

HEMINEVRIN 31.5 MG/ML SYRUP

Active substance(s): CLOMETHIAZOLE EDISILATE

View full screen / Print PDF » Download PDF ⇩
Transcript
koepcke.publishing
stand (datum): 23.09.2013
format: 297 x 210 mm, DIN A4
farben: 1/1-farbig schwarz
schriftgröße: 9 pt
mat.-nr.: 9000555/11 Behörde Varinate 1
code: 835

PACKAGE LEAFLET: INFORMATION FOR THE USER

Clomethiazole 31.5 mg/ml Syrup
clomethiazole
(as clomethiazole edisilate)
5HDGDOORIWKLVOHDÁHWFDUHIXOO\EHIRUH\RXVWDUWWDNLQJ
WKLVPHGLFLQH
‡.HHSWKLVOHDÁHW ‡,I\RXKDYHDQ\IXUWKHUTXHVWLRQVDVN\RXUGRFWRURU
SKDUPDFLVW

‡7KLVPHGLFLQHKDVEHHQSUHVFULEHGIRU\RX'RQRWSDVVLWRQ
WRRWKHUVOWPD\KDUPWKHPHYHQLIWKHLUV\PSWRPVDUHWKH
VDPHDV\RXUV

‡,IDQ\RIWKHVLGHHIIHFWVJHWVHULRXVRULI\RXQRWLFHDQ\
VLGHHIIHFWVQRWOLVWHGLQWKLVOHDÁHWSOHDVHWHOO\RXUGRFWRURU
SKDUPDFLVW
,QWKLVOHDÁHW
:KDW&ORPHWKLD]ROH6\UXSLVDQGZKDWLWLVXVHGIRU
%HIRUH\RXWDNH&ORPHWKLD]ROH6\UXS
+RZWRWDNH&ORPHWKLD]ROH6\UXS
3RVVLEOHVLGHHIIHFWV

+RZWRVWRUH&ORPHWKLD]ROH6\UXS
)XUWKHULQIRUPDWLRQ

1. :KDW&ORPHWKLD]ROH6\UXSLVDQGZKDWLWLVXVHGIRU
&ORPHWKLD]ROH6\UXSFRQWDLQVDPHGLFLQHFDOOHGFORPHWKLD]ROH
7KLVEHORQJVWRDJURXSRIPHGLFLQHVFDOOHGK\SQRWLFVDQG
VHGDWLYHVOWKDVDFDOPLQJ VHGDWLYH HIIHFWRQ\RXUQHUYRXV
V\VWHP
&ORPHWKLD]ROH6\UXSLVXVHGWR
‡7UHDWIHHOLQJVRIUHVWOHVVQHVVDQGDJLWDWLRQ

‡+HOS\RXLI\RXDUHXQDEOHWRVOHHS VKRUWWHUPWUHDWPHQW 
‡5HOLHYHWKHV\PSWRPVRIDOFRKROZLWKGUDZDO

2.
%HIRUH\RXWDNH&ORPHWKLD]ROH6\UXS
'RQRWWDNH&ORPHWKLD]ROH6\UXSLI
‡ RWKHULQJUHGLHQWVLQ&ORPHWKLD]ROH6\UXS VHH6HFWLRQ)XUWKHU
LQIRUPDWLRQ 

,QSDUWLFXODUWHOO\RXUGRFWRURUSKDUPDFLVWLI\RXDUHWDNLQJDQ\
RIWKHIROORZLQJ
‡3URSUDQRORO IRUKLJKEORRGSUHVVXUH 
‡'LD]R[LGH IRUORZEORRGSUHVVXUHRUORZEORRGVXJDU 
‡&LPHWLGLQH IRUVWRPDFKXOFHUVRUKHDUWEXUQ 
‡&DUEDPD]HSLQH IRUDQ[LHW\HSLOHSV\PRRGVZLQJVRUD
SDLQIXOFRQGLWLRQRIWKHIDFHFDOOHG·WULJHPLQDOQHXUDOJLDҊ 
7DNLQJ&ORPHWKLD]ROH6\UXSZLWKIRRGDQGGULQN
‡'RQRWGULQNDOFRKROZKLOH\RXDUHWDNLQJ&ORPHWKLD]ROH6\UXS
‡,I\RXDUHWDNLQJ&ORPHWKLD]ROH6\UXSWRKHOSZLWKDOFRKRO
SUREOHPV\RXPXVWWHOO\RXUGRFWRULI\RXKDYHUHFHQWO\KDGD
GULQNFRQWDLQLQJDOFRKRO
3UHJQDQF\DQGEUHDVWIHHGLQJ
7DONWR\RXUGRFWRUEHIRUHWDNLQJ&ORPHWKLD]ROH6\UXSLI\RXDUH
SUHJQDQWPD\EHFRPHSUHJQDQWRUDUHEUHDVWIHHGLQJ GRFWRUZLOOGHFLGHZKHWKHU\RXFDQWDNH&ORPHWKLD]ROH6\UXS
GXULQJWKLVWLPH
,I\RXDUHSUHJQDQWRUEUHDVWIHHGLQJDQG\RXDUHDOUHDG\WDNLQJ
GLD]R[LGH DPHGLFLQHWRWUHDWORZEORRGSUHVVXUHRUORZEORRG
VXJDU GRQRWWDNH&ORPHWKLD]ROH6\UXS
'ULYLQJDQGXVLQJPDFKLQHV
'RQRWGULYHRUXVHDQ\WRROVRUPDFKLQHVZKLOHWDNLQJ
&ORPHWKLD]ROH6\UXS7KLVLVEHFDXVHWKHPHGLFLQHFDQPDNH\RX
IHHOGURZV\ VOHHS\ 
,PSRUWDQWLQIRUPDWLRQDERXWVRPHRIWKHLQJUHGLHQWVRI
Clomethiazole Syrup
‡&ORPHWKLD]ROH6\UXSFRQWDLQVVPDOODPRXQWVRIDOFRKRO HWKDQRO 
OWFRQWDLQVOHVVWKDQPJSHUGRVH
‡&ORPHWKLD]ROH6\UXSFRQWDLQVVRUELWRO,I\RXKDYHEHHQWROGE\
\RXUGRFWRUWKDW\RXFDQQRWWROHUDWHRUGLJHVWVRPHVXJDUV
KDYHDQLQWROHUDQFHWRVRPHVXJDUV WDONWR\RXUGRFWRU
EHIRUHWDNLQJWKLVPHGLFLQH2QHPORI&ORPHWKLD]ROH6\UXS
FRQWDLQVPJRIVRUELWRO:KHQWDNHQDVUHFRPPHQGHG
HDFKGRVHFRQWDLQVXSWRJRIVRUELWROOWFDQFDXVHVWRPDFK
XSVHWDQGGLDUUKRHD

‡ JRWZRUVH

3.
+RZWRWDNH&ORPHWKLD]ROH6\UXS

7DNHVSHFLDOFDUHZLWK&ORPHWKLD]ROH6\UXS
&KHFNZLWK\RXUGRFWRURUSKDUPDFLVWEHIRUHWDNLQJ&ORPHWKLD]ROH
6\UXSLI
‡
7KHLQVWUXFWLRQVRQWKHODEHOZLOOUHPLQG\RXRIZKDWWKHGRFWRU
VDLG7KH\ZLOOWHOO\RXKRZPXFKV\UXSWRWDNHDQGKRZRIWHQ
'RQRWWDNHPRUHWKDQ\RXKDYHEHHQWROGWR

‡
‡7RKHOS\RXWRVOHHSDWQLJKWWKHXVXDOGRVHLVRQHWRWZR
POVSRRQIXOVEHIRUHEHG PHGLFLQHIRUDVKRUWSHULRGRIWLPH

7DNLQJRWKHUPHGLFLQHV
3OHDVHWHOO\RXUGRFWRURUSKDUPDFLVWLI\RXDUHWDNLQJRUKDYH
UHFHQWO\WDNHQDQ\RWKHUPHGLFLQHV7KLVLQFOXGHVPHGLFLQHV
WKDW\RXEX\ZLWKRXWDSUHVFULSWLRQDQGKHUEDOPHGLFLQHV
7KLVLVEHFDXVH&ORPHWKLD]ROH6\UXSFDQDIIHFWWKHZD\VRPH
PHGLFLQHVZRUNDQGVRPHPHGLFLQHVFDQKDYHDQHIIHFWRQ
&ORPHWKLD]ROH6\UXS

‡7RVWRS\RXIHHOLQJUHVWOHVVRUDJLWDWHGWKHXVXDOGRVHLV
RQHPOVSRRQIXOWKUHHWLPHVDGD\

'RQRWWDNH&ORPHWKLD]ROH6\UXSLIDQ\RIWKHDERYHDSSO\WR\RX
,I\RXDUHQRWVXUHWDONWR\RXUGRFWRURUSKDUPDFLVWEHIRUHWDNLQJ
&ORPHWKLD]ROH6\UXS

‡  LQWHUUXSWHGEUHDWKLQJZKHQ\RXDUHDVOHHS 

,I\RXDUHQRWVXUHLIDQ\RIWKHDERYHDSSO\WR\RXWDONWR\RXU
GRFWRURUSKDUPDFLVWEHIRUHWDNLQJ&ORPHWKLD]ROH6\UXS

$OZD\VWDNH&ORPHWKLD]ROH6\UXSH[DFWO\DV\RXUGRFWRUKDVWROG
\RX QRWVXUH

Adults
7KHXVXDOGRVHRI&ORPHWKLD]ROH6\UXSGHSHQGVRQZKDW\RXDUH
WDNLQJLWIRU

‡7RKHOS\RXWRZLWKGUDZIURPDOFRKRO\RXUGRFWRUZLOOVWDUW
\RXRQDKLJKGRVH WKHGRVH'RQRWWDNH&ORPHWKLD]ROH6\UXSIRUORQJHUWKDQ\RXU
GRFWRUKDVWROG\RXWR7KHPD[LPXPDPRXQWRIWLPHLVXVXDOO\
GD\V

,I\RXKDYHOLYHURUNLGQH\SUREOHPVWKHGRVHGHSHQGVRQ
KRZZHOO\RXUNLGQH\VDUHZRUNLQJ DORZGRVHDQGJUDGXDOO\LQFUHDVHLW
XVXDOWLPHSHULRG:LWKORQJHUWHUPXVH\RXUGRFWRUPD\QHHG
WRLQFUHDVH\RXUGRVHWRJHWWKHVDPHHIIHFW,I\RXWDNHPRUH
WKDQWKHXVXDOGRVHIRUDORQJSHULRGRIWLPHZKHQ\RXVWRS
WDNLQJWKHPHGLFLQH\RXPD\JHWZLWKGUDZDOV\PSWRPVVXFKDV
VKDNLQJ WUHPRUV RUÀWV
&KLOGUHQ
&ORPHWKLD]ROH6\UXSVKRXOGQRWEHWDNHQE\FKLOGUHQ
,I\RXWDNHPRUH&ORPHWKLD]ROH6\UXSWKDQ\RXVKRXOG
,I\RXWDNHWRRPXFK&ORPHWKLD]ROH6\UXSWDONWRDGRFWRURUJR
WRDKRVSLWDOVWUDLJKWDZD\7DNHWKHPHGLFLQHERWWOHRUFDUWRQ
ZLWK\RXVRWKDWLWFDQEHLGHQWLÀHG7KHIROORZLQJHIIHFWVPD\
KDSSHQVKDOORZEUHDWKLQJORZEORRGSUHVVXUH WKLVPD\PDNH
\RXIHHOGL]]\RUIDLQW ORZERG\WHPSHUDWXUHDQGFRPD EHLQJ
XQFRQVFLRXV 
,I\RXIRUJHWWRWDNH&ORPHWKLD]ROH6\UXS
,I\RXIRUJHWWRWDNHDGRVHWDNHLWDVVRRQDV\RXUHPHPEHULW
+RZHYHULILWLVQHDUO\WLPHIRUWKHQH[WGRVHVNLSWKHPLVVHG
GRVH'RQRWWDNHDGRXEOHGRVH WZRGRVHVDWWKHVDPHWLPH
WRPDNHXSIRUDIRUJRWWHQGRVH

4.
3RVVLEOHVLGHHIIHFWV
/LNHDOOPHGLFLQHV&ORPHWKLD]ROH6\UXSFDQFDXVHVLGHHIIHFWV
DOWKRXJKQRWHYHU\ERG\JHWVWKHP
6HYHUHDOOHUJLFUHDFWLRQV WKHVHDUHUDUHDIIHFWLQJOHVVWKDQ
LQSHRSOH
,I\RXKDYHDVHYHUHDOOHUJLFUHDFWLRQVWRSWDNLQJ Clomethiazole
6\UXSDQGVHHDGRFWRUVWUDLJKWDZD\ PHGLFDOWUHDWPHQW7KHVLJQVPD\LQFOXGHDVXGGHQRQVHWRI
‡5DVKLWFKLQJRUKLYHVRQWKHVNLQ
‡%OLVWHULQJRIWKHVNLQ
‡6ZHOOLQJRIWKHIDFHOLSVWRQJXHRURWKHUSDUWVRIWKHERG\

6. )XUWKHULQIRUPDWLRQ
:KDW&ORPHWKLD]ROH6\UXSFRQWDLQV
7KHDFWLYHVXEVWDQFHLVFORPHWKLD]ROH DVFORPHWKLD]ROH
HGLVLODWH 7KHUHLVPJRIFORPHWKLD]ROHLQHDFKPLOOLOLWUH
PO RIV\UXS
7KHRWKHULQJUHGLHQWVDUHSXULÀHGZDWHUOLTXLGVRUELWRO QRQ
FU\VWDOOLVLQJ  ( HWKDQROFLQHROHVRGLXPK\GUR[LGHDQG
OHYRPHQWKRO
:KDW&ORPHWKLD]ROH6\UXSORRNVOLNHDQGFRQWHQWVRIWKHSDFN
&ORPHWKLD]ROH6\UXSLVDFOHDUFRORXUOHVVVROXWLRQOWLVDYDLODEOH
LQPOERWWOHV
0DUNHWLQJ$XWKRULVDWLRQ+ROGHUDQG0DQXIDFWXUHU
&+(3/$3+$50$U]QHLPLWWHO*PE+%DKQKRIVWUD
0HVHNHQKDJHQ*HUPDQ\
&ORPHWKLD]ROH6\UXSLVGLVWULEXWHGE\,QWUDSKDUP/DERUDWRULHV/WG
7KH&RXUW\DUG%DUQV&KRNH/DQH&RRNKDP'HDQ0DLGHQKHDG
%HUNV6/378QLWHG.LQJGRP

7ROLVWHQWRRUUHTXHVWDFRS\RIWKLVOHDÁHWLQ
%UDLOOHODUJHSULQWRUDXGLRSOHDVHFDOOIUHHRI
FKDUJH
 8.RQO\
3OHDVHEHUHDG\WRJLYHWKHIROORZLQJLQIRUPDWLRQ
3URGXFWQDPHClomethiazole Syrup
5HIHUHQFHQXPEHU
7KLVLVDVHUYLFHSURYLGHGE\WKH5R\DO1DWLRQDO
,QVWLWXWHRIWKH%OLQG
7KLVOHDÁHWZDVODVWUHYLVHGLQ6HSWHPEHU

‡6KRUWQHVVRIEUHDWKZKHH]LQJRUWURXEOHEUHDWKLQJ
2WKHUSRVVLEOHVLGHHIIHFWV
‡7LQJOLQJRUEORFNHGQRVH7KLVFDQRFFXUZLWKLQWR
PLQXWHVRIWDNLQJDGRVHRI&ORPHWKLD]ROH6\UXS
‡6RUHH\HVDQGKHDGDFKH
‡5XQQ\QRVHDQGFKHVWSKOHJP
‡5DVKZKLFKPD\EHLWFK\
‡6WRPDFKXSVHW
‡&KDQJHVLQKRZ\RXUOLYHULVZRUNLQJ VKRZQE\EORRGWHVWV 
‡)HHOLQJRYHUH[FLWHGRUFRQIXVHG
‡)HHOLQJYHU\VOHHS\7KLVLVPRUHOLNHO\LI\RXDUHWDNLQJDKLJK
GRVHRIWKHPHGLFLQHRULI\RXDUHHOGHUO\DQG\RXDUHWDNLQJ
WKHPHGLFLQHGXULQJWKHGD\
‡·+DQJRYHUҊHIIHFWVPD\RFFXULQWKHHOGHUO\
'RQRWEHFRQFHUQHGE\WKLVOLVWRIVLGHHIIHFWV DQ\RIWKHP,IDQ\RIWKHVLGHHIIHFWVJHWVHULRXVRULI\RXQRWLFH
DQ\VLGHHIIHFWVQRWOLVWHGLQWKLVOHDÁHWSOHDVHWHOO\RXUGRFWRU
RUSKDUPDFLVW

5.
+RZWRVWRUH&ORPHWKLD]ROH6\UXS
‡.HHSRXWRIWKHUHDFKDQGVLJKWRIFKLOGUHQ

‡6WRUHEHWZHHQDQGƒ&LQWKHIULGJHEXWQRWIUR]HQ

‡'RQRWXVH&ORPHWKLD]ROH6\UXSDIWHUWKHH[SLU\GDWHZKLFKLV
VWDWHGRQWKHSDFNDJLQJ
0HGLFLQHVVKRXOGQRWEHGLVSRVHGRIYLDZDVWHZDWHURU
KRXVHKROGZDVWH$VN\RXUSKDUPDFLVWKRZWRGLVSRVHRI
PHGLFLQHVWKDWDUHQRORQJHUUHTXLUHG7KLVZLOOKHOSWRSURWHFW
WKHHQYLURQPHQW




Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide