Ipreziv

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
19-12-2014
Summary of Product characteristics Summary of Product characteristics (SPC)
19-12-2014
Public Assessment Report Public Assessment Report (PAR)
19-12-2014

Active ingredient:

Azilsartan medoxomil

Available from:

Takeda Pharma A/S

ATC code:

C09CA09

INN (International Name):

azilsartan medoxomil

Therapeutic group:

Aġenti li jaġixxu fuq is-sistema renin-angiotensin

Therapeutic area:

Pressjoni għolja

Therapeutic indications:

Ipreziv huwa indikat għat-trattament tal-ipertensjoni essenzjali fl-adulti.

Product summary:

Revision: 4

Authorization status:

Irtirat

Authorization date:

2011-12-07

Patient Information leaflet

                                B. FULJETT TA’ TAGĦRIF
51
Prodott mediċinali li m’għadux awtorizzat
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU
MINNU
IPREZIV 20 MG PILLOLI
IPREZIV 40 MG PILLOLI
IPREZIV 80 MG PILLOLI
azilsartan medoxomil
Dan il-prodott mediċinali huwa suġġett għal monitoraġġ
addizzjonali. Dan ser jippermetti
identifikazzjoni ta’ malajr ta’ informazzjoni ġdida dwar
is-sigurtà. Inti tista’ tgħin billi tirrapporta
kwalunkwe effett sekondarju li jista’ jkollok. Ara t-tmiem ta’
sezzjoni 4 biex tara kif għandek
tirrapporta effetti sekondarji.
AQRA SEW DAN IL-FULJETT KOLLU QABEL TIBDA TIEĦU 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, anki jekk ikollhom 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 Ipreziv u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tieħu Ipreziv
3.
Kif għandek tieħu Ipreziv
4.
Effetti sekondarji li jista’ jkollu
5.
Kif taħżen Ipreziv
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU IPREZIV U GĦALXIEX JINTUŻA
Ipreziv fih is-sustanza attiva li jisimgħa azilsartan medoxomil u
tappartieni lill-klassi ta’ mediċini li
jisimhom antagonisti tar-riċetturi ta’ anġjotensina II (AIIRAs).
Anġjotensina II hi sustanza li teżisti
b’mod naturali fil-ġisem u li tikkawza l-issikkar tal-vini u
l-arterji, u b’hekk tgħolli l-pressjoni. Ipreziv
jibblokkja dan l-effett sabiex jirrilassaw il-vini u l-arterji, li
jgħin biex tniżżel il-pressjoni.
Din il-mediċina hi użata biex tikkura pressjoni għolja
(ipertensjoni essenzjali) f’pazjenti adulti (ta’ 
                                
                                Read the complete document

Summary of Product characteristics

                                _ _
_ _
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
1
Prodott mediċinali li m’għadux awtorizzat
Dan il-prodott mediċinali huwa suġġett għal monitoraġġ
addizzjonali. Dan ser jippermetti
identifikazzjoni ta’ malajr ta’ informazzjoni ġdida dwar
is-sigurtà. Il-professjonisti dwar il-kura tas-
saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa
suspettata. Ara sezzjoni 4.8 dwar kif
għandhom jiġu rappurtati reazzjonijiet avversi.
_ _
1.
ISEM IL-PRODOTT MEDIĊINALI
Ipreziv 20 mg pilloli
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Kull pillola fiha 20 mg ta’ azilsartan medoxomil (bħala potassju).
Għal lista kompleta ta’ sustanzi mhux attivi, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Pillola.
Pilloli bojod għal kważi bojod tondi, b’dijametru ta’ 6.0 mm,
b’ “ASL” debuzzat fuq naħa waħda u
“20” fuq in-naħa l-oħra.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Ipreziv hu indikat għal kura ta’ pressjoni għolja essenzjali
f’adulti.
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
Pożoloġija
Id-doża rrikmandata fil-bidu hi ta’ 40 mg darba kuljum. Id-doża
tista' tiġi miżjuda għal massimu ta' 80
mg darba kuljum għal pazjenti li l-pressjoni tad-demm tagħhom ma
tkunx ikkontrollata b'mod adegwat
b’doża aktar baxxa.
Effett kważi massimu anti-ipertensiv hu evidenti wara ġimgħatejn,
bl-effetti massimi milħuqa sa 4
ġimgħat.
Jekk il-pressjoni tad-demm ma tkunx ikkontrollata b'mod adegwat
b’Ipreziv biss, tnaqqis miżjud fil-
pressjoni tad-demm jista' jintlaħaq meta Ipreziv jingħata flimkien
ma’ prodotti oħra mediċinali anti-
ipertensivi, inklużi dijuretiċi (bħal klortalidon u
idroklorotijazide) u imblokkaturi tal-kanali tal-kalċju
(ara sezzjonijiet 4.3, 4.4, 4.5 u 5.1).
Popolazzjonijiet speċjali
_Persuni aktar anzjani (65 sena u akbar) _
M’hemmx bżonn ta’ aġġustament inizjali fid-doża b’Ipreziv
f'pazjenti anzjani (ara sezzjoni 5.2),
għalkemm konsiderazzjoni tista' tingħata sa 20 mg bħala doża
tal-bidu fl-anzjani akbar
                                
                                Read the complete document

Similar products

Active ingredient Azilsartan medoxomil

Azilsartan medoxomil

ATC code C09CA09

C09CA09

Marketed by Takeda Pharma A/S

Takeda Pharma A/S

INN (International Name) azilsartan medoxomil

azilsartan medoxomil

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 19-12-2014
Summary of Product characteristics Summary of Product characteristics Bulgarian 19-12-2014
Public Assessment Report Public Assessment Report Bulgarian 19-12-2014
Patient Information leaflet Patient Information leaflet Spanish 19-12-2014
Summary of Product characteristics Summary of Product characteristics Spanish 19-12-2014
Public Assessment Report Public Assessment Report Spanish 19-12-2014
Patient Information leaflet Patient Information leaflet Czech 19-12-2014
Summary of Product characteristics Summary of Product characteristics Czech 19-12-2014
Public Assessment Report Public Assessment Report Czech 19-12-2014
Patient Information leaflet Patient Information leaflet Danish 19-12-2014
Summary of Product characteristics Summary of Product characteristics Danish 19-12-2014
Public Assessment Report Public Assessment Report Danish 19-12-2014
Patient Information leaflet Patient Information leaflet German 19-12-2014
Summary of Product characteristics Summary of Product characteristics German 19-12-2014
Public Assessment Report Public Assessment Report German 19-12-2014
Patient Information leaflet Patient Information leaflet Estonian 19-12-2014
Summary of Product characteristics Summary of Product characteristics Estonian 19-12-2014
Public Assessment Report Public Assessment Report Estonian 19-12-2014
Patient Information leaflet Patient Information leaflet Greek 19-12-2014
Summary of Product characteristics Summary of Product characteristics Greek 19-12-2014
Public Assessment Report Public Assessment Report Greek 19-12-2014
Patient Information leaflet Patient Information leaflet English 19-12-2014
Summary of Product characteristics Summary of Product characteristics English 19-12-2014
Public Assessment Report Public Assessment Report English 19-12-2014
Patient Information leaflet Patient Information leaflet French 19-12-2014
Summary of Product characteristics Summary of Product characteristics French 19-12-2014
Public Assessment Report Public Assessment Report French 19-12-2014
Patient Information leaflet Patient Information leaflet Italian 19-12-2014
Summary of Product characteristics Summary of Product characteristics Italian 19-12-2014
Public Assessment Report Public Assessment Report Italian 19-12-2014
Patient Information leaflet Patient Information leaflet Latvian 19-12-2014
Summary of Product characteristics Summary of Product characteristics Latvian 19-12-2014
Public Assessment Report Public Assessment Report Latvian 19-12-2014
Patient Information leaflet Patient Information leaflet Lithuanian 19-12-2014
Summary of Product characteristics Summary of Product characteristics Lithuanian 19-12-2014
Public Assessment Report Public Assessment Report Lithuanian 19-12-2014
Patient Information leaflet Patient Information leaflet Hungarian 19-12-2014
Summary of Product characteristics Summary of Product characteristics Hungarian 19-12-2014
Public Assessment Report Public Assessment Report Hungarian 19-12-2014
Patient Information leaflet Patient Information leaflet Dutch 19-12-2014
Summary of Product characteristics Summary of Product characteristics Dutch 19-12-2014
Public Assessment Report Public Assessment Report Dutch 19-12-2014
Patient Information leaflet Patient Information leaflet Polish 19-12-2014
Summary of Product characteristics Summary of Product characteristics Polish 19-12-2014
Public Assessment Report Public Assessment Report Polish 19-12-2014
Patient Information leaflet Patient Information leaflet Portuguese 19-12-2014
Summary of Product characteristics Summary of Product characteristics Portuguese 19-12-2014
Public Assessment Report Public Assessment Report Portuguese 19-12-2014
Patient Information leaflet Patient Information leaflet Romanian 19-12-2014
Summary of Product characteristics Summary of Product characteristics Romanian 19-12-2014
Public Assessment Report Public Assessment Report Romanian 19-12-2014
Patient Information leaflet Patient Information leaflet Slovak 19-12-2014
Summary of Product characteristics Summary of Product characteristics Slovak 19-12-2014
Public Assessment Report Public Assessment Report Slovak 19-12-2014
Patient Information leaflet Patient Information leaflet Slovenian 19-12-2014
Summary of Product characteristics Summary of Product characteristics Slovenian 19-12-2014
Public Assessment Report Public Assessment Report Slovenian 19-12-2014
Patient Information leaflet Patient Information leaflet Finnish 19-12-2014
Summary of Product characteristics Summary of Product characteristics Finnish 19-12-2014
Public Assessment Report Public Assessment Report Finnish 19-12-2014
Patient Information leaflet Patient Information leaflet Swedish 19-12-2014
Summary of Product characteristics Summary of Product characteristics Swedish 19-12-2014
Public Assessment Report Public Assessment Report Swedish 19-12-2014
Patient Information leaflet Patient Information leaflet Norwegian 19-12-2014
Summary of Product characteristics Summary of Product characteristics Norwegian 19-12-2014
Patient Information leaflet Patient Information leaflet Icelandic 19-12-2014
Summary of Product characteristics Summary of Product characteristics Icelandic 19-12-2014
Patient Information leaflet Patient Information leaflet Croatian 19-12-2014
Summary of Product characteristics Summary of Product characteristics Croatian 19-12-2014

Search alerts related to this product

Alerts Ipreziv Azilsartan medoxomil

Ipreziv Azilsartan medoxomil

View documents history

Documents history Documents history

Ipreziv