Riprazo HCT

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
20-09-2012
Summary of Product characteristics Summary of Product characteristics (SPC)
20-09-2012
Public Assessment Report Public Assessment Report (PAR)
20-09-2012

Active ingredient:

aliskiren, għall-idroklorotijażide

Available from:

Novartis Europharm Ltd.

ATC code:

C09XA52

INN (International Name):

aliskiren, hydrochlorothiazide

Therapeutic group:

Aġenti li jaġixxu fuq is-sistema renin-angiotensin

Therapeutic area:

Pressjoni għolja

Therapeutic indications:

Trattament ta 'pressjoni għolja essenzjali fl-adulti. Riprazo HCT huwa indikat f'pazjenti li l-pressjoni tad-demm ma tkunx ikkontrollata sew b'aliskiren jew hydrochlorothiazide użati waħidhom. Rirpozo HCT huwa indikat bħala terapija ta 'sostituzzjoni f'pazjenti li jkunu kontrollati sew b'aliskiren u hydrochlorothiazide, mogħtija flimkien, bl-istess livell ta' doża tat - taħlita.

Authorization status:

Irtirat

Authorization date:

2011-04-13

Patient Information leaflet

                                139
B. FULJETT TA’ TAGĦRIF
Prodott mediċinali li m’għadux awtorizzat
140
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU
MINNU
RIPRAZO HCT 150 MG/12.5 MG PILLOLI MIKSIJIN B’RITA
RIPRAZO HCT 150 MG/25 MG PILLOLI MIKSIJIN B’RITA
RIPRAZO HCT 300 MG/12.5 MG PILLOLI MIKSIJIN B’RITA
RIPRAZO HCT 300 MG/25 MG PILLOLI MIKSIJIN B’RITA
Aliskiren/hydrochlorothiazide
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 mhumiex
imsemmijin f’dan il-fuljett, jekk jogħġbok, għid lit-tabib jew
lill-ispiżjar tiegħek.
F’DAN IL-FULJETT:
1.
X’inhu Riprazo HCT u għalxiex jintuża
2.
Qabel ma tieħu Riprazo HCT
3.
Kif għandek tieħu Riprazo HCT
4.
Effetti sekondarji li jista’ jkollu
5.
Kif taħżen Riprazo HCT
6.
Aktar tagħrif
1.
X’INHU RIPRAZO HCT U GĦALXIEX JINTUŻA
Il-pilloli ta’ Riprazo HCT fihom żewġ sustanzi attivi, li jisimhom
aliskiren u hydrochlorothiazide. It-
tnejn li huma jgħinu sabiex tikkontrolla il-pressjoni għolja
(ipertensjoni).
Aliskiren huwa sustanza li tagħmel parti minn klassi ġdida ta’
mediċini li jissejjħu inibituri ta’ renin.
Dawn inaqqsu l-ammont ta’ angiotensin II li l-ġisem jista’
jipproduċi. B’angiotensin II il-vini tad-
demm jidjiequ u l-pressjoni tad-demm togħla. Bit-tnaqqis ta’
angiotensin II, il-vini tad-demm jistrieħu,
u l-pressjoni tad-demm titbaxxa.
Hydrochlorothiazide jagħmel parti minn grupp ta’ mediċini li
jissejħu dijuretiċi thiazide.
Hydrochlorothiazide iżid l-ammont ta’ awrina li tgħaddi, li ukoll
tbaxxi il-pressjoni tad-demm.
Pressjoni tad-demm għolja iżżid l-ammont ta’ xogħol fuq il-qa
                                
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Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
Prodott mediċinali li m’għadux awtorizzat
2
1.
ISEM IL-PRODOTT MEDIĊINALI
Riprazo HCT 150 mg/12.5 mg pilloli miksijin b’rita
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Kull pillola miksija b’rita fiha 150 mg aliskiren (bħala
hemifumarate) u 12.5 mg hydrochlorothiazide.
Sustanzi mhux attivi: Kull pillola fiha 25 mg lactose monohydrate u
24.5 mg wheat starch.
Għal-lista kompleta ta’ sustanzi mhux attivi, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Pillola miksija b’rita
Pillola bajda, konvessa miż-żewġ naħat, b’għamla ovali miksija
b’rita stampata b’ “LCI” fuq naħa u
“NVR” fuq l-oħra.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Għall-kura ta’ pressjoni għolja naturali f’adulti.
Riprazo HCT huwa indikat f’pazjenti li jkollhom pressjoni tad-demm
li ma tkunx qed tiġi
ikkontrollata sew b’aliskiren jew hydrochlorothiazide użati
waħidhom.
Riprazo HCT huwa indikat bħala terapija ta’ sostituzzjoni
f’pazjenti li jkunu kontrollati sew
b’aliskiren u hydrochlorothiazide, mogħtija flimkien, bl-istess
livell ta’ doża tat-taħlita.
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
Id-doża irrikkmandata ta’ Riprazo HCT hija pillola waħda kuljum.
Riprazo HCT għandu jittieħed ma’
ikla ħafifa darba kuljum, l-aħjar fl-istess ħin tal-ġurnata.
Il-meraq tal-grejpfrut m’għandux jittieħed
flimkien ma’ Riprazo HCT.
L-effett kontra l-pressjoni għolja jidher l-aktar fi żmien ġimgħa
u l-akbar effett ġeneralment jidher fi
żmien 4 ġimgħat.
Pożoloġija f’pazjenti li ma jkunux ikkontrollati sew
b’monoterapija ta’ aliskeren jew
hydrochlorothiazide
Jista’ jkun irrikkmandat li d-doża taż-żewġ komponenti
individwali tiġi miżjuda bil-mod b’mod
individwali qabel ma’ jkunu maqluba għat-taħlita fissa. Meta jkun
xieraq fis-sens kliniku, bidla diretta
mill-monoterapija għat-taħlita fissa tista’ tiġi ikkunsidrata.
Riprazo HCT 150 mg/12.5 mg jista’ jingħata f’pazjenti li jkollhom
il-
                                
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Active ingredient aliskiren, għall-idroklorotijażide

aliskiren, għall-idroklorotijażide

ATC code C09XA52

C09XA52

Marketed by Novartis Europharm Ltd.

Novartis Europharm Ltd.

INN (International Name) aliskiren, hydrochlorothiazide

aliskiren, hydrochlorothiazide

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