Clopidogrel Qualimed

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
08-09-2014
Summary of Product characteristics Summary of Product characteristics (SPC)
08-09-2014
Public Assessment Report Public Assessment Report (PAR)
08-09-2014

Active ingredient:

clopidogrel (as hydrochloride)

Available from:

Qualimed

ATC code:

B01AC06

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 ta 'avvenimenti aterotrombotiċi f': Pazjenti li jbatu minn infart mijokardijaku (minn ftit jiem sa inqas minn 35 jum), puplesija iskemika (minn 7 ijiem sa inqas minn 6 xhur) jew mard arterjali periferali. Għall-aktar informazzjoni jekk jogħġbok irreferi għal sezzjoni 5.

Product summary:

Revision: 4

Authorization status:

Irtirat

Authorization date:

2009-09-23

Patient Information leaflet

                                B. FULJETT TA’ TAGĦRIF
23
Prodott mediċinali li m’għadux awtorizzat
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU
MINNU
CLOPIDOGREL QUALIMED 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 ġiet 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 Qualimed u għal xiex jintuża
2.
qabel ma tieħu Clopidogrel Qualimed
3.
Kif għandek tieħu Clopidogrel Qualimed
4.
Effetti sekondarji li jista’ jkollu
5.
Kif taħżen Clopidogrel Qualimed
6.
Aktar tagħrif
1.
X’INHU CLOPIDOGREL QUALIMED U GĦALXIEX JINTUŻA
Clopidogrel Qualimed jifforma parti minn grupp ta’ mediċini msejħa
prodotti mediċinali ta’ kontra l-
plejtlets. Plejtlets huma partijiet żgħar ħafna fid-demm, 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
ċapep tad-demm (proċess imsejjaħ trombożi).
Clopidogrel Qualimed jittieħed sabiex jevita li jiġu ffurmati emboli
tad-demm (trombi) b’vażi tad-demm li
qed jibbiesu (arterji), proċess magħruf bħala aterosklerosi, li
jista’ jwassal għal każijiet arterotrombotiċi
(bħal puplesija, attakk tal-qalb, jew mewt).
Inti ngħatatlek riċetta għal Clopidogrel Qualimed sabiex jiġi
evitat li jiffurmaw emboli tad-demm u jitnaqqas
ir-riskju ta’ dawn il-każijiet minħabba:
-
Għandek kundizzjoni fejn qed jibbiesu l-arterji (magħrufa wkoll
bħala atherosklerosi), u
-
Intikellek attakk f’qalbek
                                
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Summary of Product characteristics

                                ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
1
Prodott mediċinali li m’għadux awtorizzat
1.
ISEM TAL-PRODOTT MEDIĊINALI
Clopidogrel Qualimed 75 mg pilloli miksija b’rita
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Kull pillola miksija b’rita fiha 75 mg clopidogrel (bħala
hydrochloride)
Sustanzi mhux attivi:
Kull pillola miksija b’rita fiha 13 mg ta’ żejt ir-riġnu
idroġenat.
Għal-lista kompleta ta’ sustanzi mhux attivi, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Pillola miksija b’rita.
Pilloli miksija b’rita li huma ta’ lewn roża tondi u ftit
imbuzzata.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
_Il-prevenzjoni ta’ avvenimenti aterotrombotiċi_
Clopidogrel hu indikat
f’:
•
Pazjenti adulti 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
tal-arterji periferali.
Għal aktar tagħrif jekk jogħġbok irreferi għal sezzjoni 5.1
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
Pożoloġija
•
Adulti u anzjani
Clopidogrel ghandu jinghata darba kuljum bhala doza ta’ 75 mg.
Jekk tintesa doża:
-
F’anqas minn 12-il siegħa mill-ħin li normalment tittieħed:
il-pazjenti għandhom jieħdu d-doża
mill-ewwel imbagħad jieħdu d-doża li jmiss fil-ħin tas-soltu.
-
Għal aktar minn 12-il siegħa: il-pazjenti għandhom jieħdu d-doża
li jmiss fil-ħin tas-soltu u
m’għandhomx jieħdu doża doppja.
•
Popolazzjoni pedjatrika.
Clopidogrel m’għandux jintuża fit-tfal minħabba kwistjonijiet
ta’ effikaċja. (ara sezzjoni 5.1).
•
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 tal-fwied
moderat li jista’ jkollhom dijasteżi
emorraġika (ara sezzjoni 4.4)
Metodu ta’ kif għandu jingħata
Għall-użu orali
Jista’ jingħata mal-ikel jew fuq stonku vojt.
2
Prodott mediċinali li m’għadux awtorizzat
4.3
KONTRAINDIK
                                
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Active ingredient clopidogrel (as hydrochloride)

clopidogrel (as hydrochloride)

ATC code B01AC06

B01AC06

Marketed by Qualimed

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INN (International Name) clopidogrel

clopidogrel

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