Fareston

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
03-12-2021
Summary of Product characteristics Summary of Product characteristics (SPC)
03-12-2021
Public Assessment Report Public Assessment Report (PAR)
02-04-2009

Active ingredient:

toremifene

Available from:

Orion Corporation

ATC code:

L02BA02

INN (International Name):

toremifene

Therapeutic group:

Terapija endokrinali

Therapeutic area:

Neoplażmi tas-Sider

Therapeutic indications:

Trattament ta 'ormon l-ewwel linja ta' kanċer tas-sider metastatiku li jiddependi mill-ormoni f'pazjenti wara l-menopawsa. Fareston mhux rakkomandat għal pazjenti b'-riċettur tal-estroġenu tumuri negattivi.

Product summary:

Revision: 25

Authorization status:

Awtorizzat

Authorization date:

1996-02-14

Patient Information leaflet

                                17
B. FULJETT TA’ TAGĦRIF
18
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-UTENT
FARESTON 60 MG PILLOLI
toremifene
AQRA SEW DAN IL-FULJETT KOLLU QABEL TIBDA TUŻA DIN IL-MEDIĊINA
PERESS LI FIH INFORMAZZJONI
IMPORTANTI GĦALIK.
-
Żomm dan il-fuljett. Jista’ jkollok bżonn terġa’ taqrah.
-
Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib jew lill-ispiżjar
tiegħek.
-
Din il-mediċina ġiet mogħtija lilek biss. M’għandekx tgħaddiha
lil persuni oħra. Tista’
tagħmlilhom il-ħsara anke jekk għandhom l-istess sinjali ta’ mard
bħal tiegħek.
-
Jekk ikollok xi effett sekondarju kellem lit-tabib jew lill-ispiżjar
tiegħek. Dan jinkludi xi effett
sekondarju possibbli li mhuwiex elenkat f’dan il-fuljett. Ara
sezzjoni 4.
F’DAN IL-FULJETT
1.
X’inhu Fareston u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tieħu Fareston
3.
Kif għandek tieħu Fareston
4.
Effetti sekondarji possibbli
5.
Kif taħżen Fareston
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU FARESTON U GĦALXIEX JINTUŻA
Fareston fih is-sustanza attiva toremifene, li hija anti-estroġenu.
Fareston jintuża għall-kura ta’ ċertu
tip ta’ tumur fis-sider f’nisa li jkunu għaddew mill-menopawsa.
2.
X’GĦANDEK TKUN TAF QABEL MA TIEĦU FARESTON
TIĦUX FARESTON
-
jekk inti allerġika għal toremifene jew għal xi sustanza oħra
ta’ din il-mediċina (imniżżla fis-
sezzjoni 6).
-
jekk għandek tħaxxin tal-inforra tal-utru
-
jekk għandek problemi gravi fil-fwied
-
jekk twelidt bi jew għandek xi kondizzjoni li tikkawża ċerti
bidliet anormali fl-irrekordjar
elettriku tal-qalb (elettrokardjogramm jew ECG)
-
jekk għandek żbilanċ ta’ melħ fid-demm, speċjalment
konċentrazzjonijiet baxxi ta’ potassium
fid-demm (ipokalimja) li fil-preżent mhumiex irranġati bil-kura
-
jekk għandek ritmu tal-qalb bil-mod ħafna (bradikardija)
-
jekk għandek insuffiċjenza tal-qalb
-
jekk għandek storja ta’ ritmi tal-qalb anormali (arritmiji)
-
jekk qed tieħu mediċini oħra li jista’ jkollhom effett fuq qalbek
(ara 
                                
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Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
1.
ISEM IL-PRODOTT MEDIĊINALI
Fareston pilloli ta’ 60 mg
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Kull pillola fiha 60 mg ta’ toremifene (bħala citrate).
Eċċipjent b’effett magħruf
Pillola waħda fiha 28.5 mg ta’ lactose (bħala monohydrate).
Għal-lista sħiħa ta’ eċċipjenti, ara
sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Pillola.
Pillola bajda, tonda, ċatta, bit-tarf imżerżaq u bil-kitba TO 60
fuq naħa waħda.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Kura preferita ormonali f’pazjenti li għaddew mill-menopawsa
b’kanċer metastatiku tas-sider
dipendenti fuq l-ormoni.
Fareston mhux irrakkomandat għall-pazjenti b’tumuri li jkunu
negattivi għar-riċetturi tal-estroġeni.
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
Pożoloġija
Id-doża rakkomandata hi ta’ 60 mg kuljum.
_Indeboliment renali_
Mhux meħtieġ tibdil fid-dożaġġ f’pazjenti li għandhom
insuffiċjenza renali.
_Indeboliment tal-fwied_
Toremifene għandu jintuża b’attenzjoni f’pazjenti
b’indeboliment tal-fwied (ara sezzjoni 5.2).
_Popolazzjoni pedjatrika_
M’hemm l-ebda użu rilevanti ta’ Fareston fil-popolazzjoni
pedjatrika.
Metodu ta’ kif għandu jingħata
Toremifene jingħata mill-ħalq. Toremifene jista’ jittieħed
mal-ikel jew fuq stonku vojt.
4.3
KONTRAINDIKAZZJONIJIET
-
Toremifene huwa kontraindikat għal użu fit-tul f’pazjenti li
għandhom iperplasja endometrijali
jew li għandhom insuffiċjenza gravi tal-fwied.
-
Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe
sustanza mhux attiva elenkata
fis-sezzjoni 6.1.
-
Kemm fl-investigazzjonijiet ta’ qabel l-użu kliniku kif ukoll
fil-bnedmin, ġew osservati bidliet
fl-elettrofiżjoloġija kardijaka wara esponiment għal toremifene,
fil-forma ta’ titwil ta’ QT. Għal
raġunijiet ta’ sigurtà tal-mediċina, toremifene għalhekk huwa
kontraindikat f’pazjenti b’:
3
-
Titwil konġenitali jew akkwistat dokumentat fil-QT
-
Disturbi fl-elettroliti, b’mod pa
                                
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