Clopidogrel Sandoz

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
26-10-2011
Summary of Product characteristics Summary of Product characteristics (SPC)
26-10-2011
Public Assessment Report Public Assessment Report (PAR)
26-10-2011

Active ingredient:

clopidogrel

Available from:

Acino Pharma GmbH

ATC code:

B01AC04

INN (International Name):

clopidogrel

Therapeutic group:

Aġenti antitrombotiċi

Therapeutic area:

Peripheral Vascular Diseases; Stroke; Myocardial Infarction

Therapeutic indications:

Clopidogrel huwa indikat fl-adulti għall-prevenzjoni tal-ġrajjiet atherothrombotic f: * pazjenti li jsofru minn myocardial infarzjoni (minn ftit ġranet sa inqas minn 35 jum), ischaemic stroke (minn 7 ijiem sa inqas minn 6 xhur) jew stabbilit periferali mard arterjali. Għall-aktar informazzjoni jekk jogħġbok irreferi għal sezzjoni 5.

Product summary:

Revision: 2

Authorization status:

Irtirat

Authorization date:

2009-09-21

Patient Information leaflet

                                B. FULJETT TA’ TAGĦRIF
20
Prodott mediċinali li m’għadux awtorizzat
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU
MINNU
CLOPIDOGREL SANDOZ 75 MG PILLOLI MIKSIJA B’RITA
Clopidogrel
AQRA SEW DAN IL-FULJETT KOLLU QABEL TIBDA TIEĦU DIN IL-MEDIĊINA.
-
Żomm dan il-fuljett. Jista’ jkollok bżonn terġa’ taqrah.
-
Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib jew lill-ispiżjar
tiegħek.
-
Din il-mediċina giet mogħtija lilek M’għandekx tgħaddiha lil
persuni oħra. Tista’
tagħmlilhom il-ħsara, anki jekk ikollhom l-istess sintomi bħal
tiegħek.
-
Jekk xi wieħed mill-effetti sekondarji jiggrava jew jekk tinnota xi
effetti sekondarji li
m’humiex imsemmijin f’dan il-fuljett, jekk jogħġbok, għid
lit-tabib jew lill-ispiżjar
tiegħek.
F’DAN IL-FULJETT:
1.
X’inhu Clopidogrel Sandoz u għalxiex jintuża
2.
Qabel ma tieħu Clopidogrel Sandoz
3.
Kif għandek tieħu Clopidogrel Sandoz
4.
Effetti sekondarju li jista jkollu
5.
Kif taħżen Clopidogrel Sandoz
6.
Aktar tagħrif
1.
X’INHU CLOPIDOGREL SANDOZ U GĦALXIEX JINTUŻA
Clopidogrel Sandoz fih is-sustanza attiva Clopidogrel li tifforma
parti minn grupp ta’ mediċini msejħa
prodotti mediċinali ta’ antiplejtlets. Plejtlets (hekk imsejħa
tromboċiti) huma partijiet żgħar ħafna, li
jinġemġħu flimkien waqt li jkun qed jagħqad id-demm. Il-prodotti
mediċinali ta’ kontra l-plejtlets
jilqgħu għal dan u jnaqqsu l-possibbiltajiet li jiffurmaw emboli
tad-demm (proċess imsejjaħ trombożi).
Clopidogrel Sandoz jittieħed biex inaqqas ir-riskju li emboli
tad-demm (trombi) jifformaw fl-arterji
mwebbsin (arterji), proċess imsejjaħ aterotrombosi, li jista’
jwassal għal konsegwenzi aterotrombotiċi
(bħal puplesija, attakk tal-qalb, jew mewt).
Ingħatajt Clopidogrel Sandoz biex inaqqas ir-riskju ta’ emboli
tad-demm u l-konsegwenzi severi
tagħhom għaliex:
-
Għandek kundizzjoni fejn l-arterji tiegħek qegħdin jibbiesu
(magħrufa wkoll bħala
aterosklerożi), u
-
Kellek attakk tal-qalb, puplesija jew kundizz
                                
                                Read the complete document

Summary of Product characteristics

                                ANNESS I
SOMMARJU TAL-KARATTERISTIĊI T
AL-PRODOTT
1
Prodott mediċinali li m’għadux awtorizzat
1.
ISEM TAL-PRODOTT MEDIĊINALI
Clopidogrel Sandoz 75 mg pilloli miksija b’rita
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Kull pillola miksija b'rita fiha 75 mg ta’ clopidogrel (bħala
besilate).
Sustanzi mhux attivi: kull pillola fiha 3.80 mg ta’ castor oil
idroġenat.
Għal-lista kompleta ta’ sustanzi mhux attivi, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Pillola miksija b’rita
Pilloli miksija b’rita, bojod sa bojod jagħtu fil-griż, qishom
irħam, tondi u bikonvessi.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Clopidogrel huwa indikat fl-adulti għall-prevenzjoni ta’
avvenimenti aterotrombotiċi f’:

Pazjenti li għandhom infart mijokardijaku (minn ftit jiem sa inqas
minn 35 jum),
puplesija iskemika (minn 7 ijiem sa inqas minn 6 xhur) jew mard
stabbilit ta’ l-arterji
periferali.
Għal aktar informazzjoni jekk jogħġbok irreferi għal sezzjoni 5.1.
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA

Adulti u anzjani
Clopidogrel għandu jingħata darba kuljum bħala doża ta’ 75 mg
ma’ l-ikel jew mingħajru.

Farmakoġenetika
L-istatus ta’ CYP2C19 f’metaboliżżatur dgħajjef huwa assoċjat
mal-rispons mnaqqas tal-
clopidogrel. L-aħjar siste
ma tad-dożaġġ għall-me
taboliżżaturi dgħajfa għadhom ma ġewx
determinati (ara sezzjoni 5.2)

Pazjenti pedjatriċi
Is-sigurtà u l-effikaċja ta' clopidogrel fit-tfal u fl-adolexxenti
għadhom ma ġewx
stabbiliti.

Indeboliment renali
L-esperjenza terapewtika hija limitata f’pazjenti b’indeboliment
renali (ara sezzjoni 4.4).

Indeboliment epatiku
L-esperjenza terapewtika hija limitata f’pazjenti b’mard epatiku
moderat li jista’ jkollhom
dijateżi emorraġika (ara sezzjoni 4.4).
4.3
KONTRA-INDIKAZZJONIJIET

Sensittività eċċessiva għas-sustanza attiva jew għal xi sustanzi
mhux attivi.

Indeboliment sever tal-fwied.

Dmija qawwija patoloġika bħal f’ulċera peptika jew emorraġija
fil-kra
                                
                                Read the complete document

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Active ingredient clopidogrel

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ATC code B01AC04

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INN (International Name) clopidogrel

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Patient Information leaflet Patient Information leaflet Bulgarian 26-10-2011
Summary of Product characteristics Summary of Product characteristics Bulgarian 26-10-2011
Public Assessment Report Public Assessment Report Bulgarian 26-10-2011
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