Riprazo HCT

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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

Active ingredient:

aliskiren, hydrochlorothiazide

Available from:

Novartis Europharm Ltd.

ATC code:

C09XA52

INN (International Name):

aliskiren, hydrochlorothiazide

Therapeutic group:

Sredstva, ki delujejo na sistem renin-angiotenzin

Therapeutic area:

Hipertenzija

Therapeutic indications:

Zdravljenje esencialne hipertenzije pri odraslih. Riprazo HCT je indicirana pri bolnikih, katerih krvni tlak ni ustrezno nadzorovan na aliskiren ali hydrochlorothiazide uporablja samostojno. Rirpozo HCT je označen kot nadomestno zdravljenje pri bolnikih ustrezno nadzorovana z aliskiren in hydrochlorothiazide, saj hkrati, na isti ravni odmerka, kot je v kombinaciji.

Authorization status:

Umaknjeno

Authorization date:

2011-04-13

Patient Information leaflet

                                88
8.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Uporabno do
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Shranjujte pri temperaturi do 30 °C.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
Velika Britanija
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/11/680/010
7 filmsko obloženih tablet
EU/1/11/680/011
14 filmsko obloženih tablet
EU/1/11/680/012
28 filmsko obloženih tablet
EU/1/11/680/013
30 filmsko obloženih tablet
EU/1/11/680/014
50 filmsko obloženih tablet
EU/1/11/680/015
56 filmsko obloženih tablet
EU/1/11/680/016
56 filmsko obloženih tablet (56x1; perforirani pretisni omoti za
posamične odmerke)
EU/1/11/680/017
90 filmsko obloženih tablet
EU/1/11/680/018
98 filmsko obloženih tablet
13.
ŠTEVILKA SERIJE
Lot
14.
NAČIN IZDAJANJA ZDRAVILA
Predpisovanje in izdaja zdravila je le na recept.
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Riprazo HCT 150 mg/12,5 mg
Zdravilo nima veā dovoljenja za promet
89
PODATKI NA ZUNANJI OVOJNINI
ŠKATLA ZA POSAMIČNO PAKIRANJE, KI VSEBUJE PRETISNE OMOTE IZ
PA/ALU/PVC
1.
IME ZDRAVILA
Riprazo HCT 150 mg/12,5 mg filmsko obložene tablete
aliskiren/hidroklorotiazid
2.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN
Ena filmsko obložena tableta vsebuje 150 mg aliskirena (v obliki
hemifumarata) in 12,5 mg
hidroklorotiazida.
3.
SEZNAM POMOŢNIH SNOVI
Vsebuje laktozo in pšenični škrob.
Za več podatkov glejte priložena navodila.
4.
FARMACEVTSKA OBLIKA IN VSEBINA
7 filmsko obloženih tablet
14 filmsko obloženih tablet
28 filmsko obloženih tablet
30 filmsko obloženih tablet
50 filmsko obloženih tablet
56 filmsko obloženih tablet
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
Peroralna uporaba.
Pred uporabo preberite priloženo navodilo.
6.
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA I
                                
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Summary of Product characteristics

                                1
DODATEK I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Zdravilo nima veā dovoljenja za promet
2
1.
IME ZDRAVILA
Riprazo HCT 150 mg/12,5 mg filmsko obložene tablete
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Ena filmsko obložena tableta vsebuje 150 mg aliskirena (v obliki
hemifumarata) in 12,5 mg
hidroklorotiazida.
Pomožne snovi: Ena tabeta vsebuje 25 mg laktoze monohidrata in 24,5
mg pšeničnega škroba.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
filmsko obložena tableta
Bela, bikonveksna ovalna filmsko obložena tableta z vtisnjeno oznako
“LCI” na eni strani in “NVR”
na drugi.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravljenje esencialne hipertenzije pri odraslih.
Zdravilo Riprazo HCT je indicirano za bolnike, katerih krvni tlak ni
ustrezno urejen, če uporabljajo
samo aliskiren ali samo hidroklorotiazid.
Zdravilo Riprazo HCT je kot nadomestno zdravljenje indicirano za
bolnike, katerih krvni tlak je
ustrezno urejen s sočasno uporabo aliskirena in hidroklorotiazida v
odmerkih, ki so enaki kot v
kombiniranem zdravilu.
4.2
ODMERJANJE IN NAČIN UPORABE
Priporočeni odmerek zdravila Riprazo HCT je ena tableta na dan.
Zdravilo Riprazo HCT je treba
jemati z lahkim obrokom enkrat na dan, najbolje vsak dan ob istem
času. Zdravila Riprazo HCT se ne
sme jemati skupaj z grenivkinim sokom.
Antihipertenzivni učinek se večinoma pokaže v 1 tednu, največji
učinek pa je večinoma mogoče
opaziti v 4 tednih.
Odmerjanje pri bolnikih, katerih krvni tlak ni ustrezno urejen z
uporabo monoterapije z aliskirenom
ali s hidroklorotiazidom
Pred prehodom na že pripravljeno kombinacijo zdravila je lahko
priporočeno ločeno titriranje
odmerkov vsake od posameznih sestavin. Kadar je to klinično primerno,
velja razmisliti tudi o
neposrednem prehodu z monoterapije na že pripravljeno kombinacijo
zdravila.
Zdravilo Riprazo HCT 150 mg/12,5 mg je mogoče uporabljati pri
bolnikih, katerih krvni tlak ni
ustrezno urejen, če uporabljajo samo aliskiren v odmerku 150 mg ali
samo hidroklorotiazid 
                                
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Similar products

Active ingredient aliskiren, hydrochlorothiazide

aliskiren, hydrochlorothiazide

ATC code C09XA52

C09XA52

Marketed by Novartis Europharm Ltd.

Novartis Europharm Ltd.

INN (International Name) aliskiren, hydrochlorothiazide

aliskiren, hydrochlorothiazide

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Summary of Product characteristics Summary of Product characteristics Bulgarian 20-09-2012
Public Assessment Report Public Assessment Report Bulgarian 20-09-2012
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Riprazo HCT