Ipreziv

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Download Patient Information leaflet (PIL)
19-12-2014
Download Summary of Product characteristics (SPC)
19-12-2014
Download 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:

Sredstva, ki delujejo na sistem renin-angiotenzin

Therapeutic area:

Hipertenzija

Therapeutic indications:

Zdravilo Ipreziv je indicirano za zdravljenje esencialne hipertenzije pri odraslih.

Product summary:

Revision: 4

Authorization status:

Umaknjeno

Authorization date:

2011-12-07

Patient Information leaflet

                                43
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
_ _
Takeda Pharma A/S
Dybendal Alle 10
2630 Taastrup
Danska
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/11/735/001 14 tablet
EU/1/11/735/002 28 tablet
EU/1/11/735/012 30 tablet
EU/1/11/735/003 56 tablet
EU/1/11/735/013 90 tablet
EU/1/11/735/004 98 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_ _
_ _
Ipreziv 20 mg
Zdravilo nima veā dovoljenja za promet
44
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA STIČNI OVOJNINI
PRETISNI OMOT
1.
IME ZDRAVILA
_ _
Ipreziv 20 mg tablete
medoksomilazilsartanat
2.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Takeda Logo
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
_ _
EXP
4.
ŠTEVILKA SERIJE
_ _
Lot
5.
DRUGI PODATKI
Zdravilo nima veā dovoljenja za promet
45
PODATKI NA ZUNANJI OVOJNINI
ŠKATLA
1.
IME ZDRAVILA
Ipreziv 40 mg tablete
medoksomilazilsartanat
2.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN
Ena tableta vsebuje 40 mg medoksomilazilsartanata (v obliki kalijeve
soli).
3.
SEZNAM POMOŽNIH SNOVI
_ _
4.
FARMACEVTSKA OBLIKA IN VSEBINA
14 tablet
28 tablet
30 tablet
56 tablet
90 tablet
98 tablet
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
Pred uporabo preberite priloženo navodilo!
peroralna uporaba
6.
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN
POGLEDA OTROK
Zdravilo shranjujte nedosegljivo otrokom!
7.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
8.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
_ _
EXP
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
_ _
Shranjujte v originalni ovojnini za zagotovitev zaščite pred
svetlobo in vlago.
Zdravilo nima veā dovoljenja za promet
46
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
_ _
Takeda Pharma A/S

                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Zdravilo nima veā dovoljenja za promet
2
Za to zdravilo se izvaja dodatno spremljanje varnosti. Tako bodo
hitreje na voljo nove informacije
o njegovi varnosti. Zdravstvene delavce naprošamo, da poročajo o
katerem koli domnevnem
neželenem učinku zdravila. Glejte poglavje 4.8, kako poročati o
neželenih učinkih.
1.
IME ZDRAVILA
Ipreziv 20 mg tablete
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Ena tableta vsebuje 20 mg medoksomilazilsartanata (v obliki kalijeve
soli).
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
tableta
Bele do skoraj bele okrogle tablete, premera 6,0 mm, z vtisnjeno
oznako “ASL” na eni in oznako “20”
na drugi strani.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravilo Ipreziv je indicirano za zdravljenje esencialne hipertenzije
pri odraslih.
4.2
ODMERJANJE IN NAČIN UPORABE
Odmerjanje
Priporočeni začetni odmerek je 40 mg enkrat na dan. Odmerek se lahko
poveča do največ 80 mg
enkrat na dan za bolnike, pri katerih krvni tlak ni ustrezno urejen z
nižjimi odmerki.
Skoraj najvišji antihipertenzivni učinek se pokaže v 2 tednih,
največji učinki pa so doseženi po
4 tednih.
Če zdravilo Ipreziv samo ne zagotovi ustreznega uravnavanja krvnega
tlaka, se lahko dodatno znižanje
krvnega tlaka doseže tako, da se zdravilo Ipreziv daje skupaj z
drugimi antihipertenzivi, vključno z
diuretiki (kot sta klortalidon in hidroklorotiazid) in zaviralci
kalcijevih kanalčkov (glejte poglavja 4.3,
4.4, 4.5 in 5.1).
_ _
Posebne populacije
_Starejši (65 let in starejši) _
Pri starejših bolnikih ni potrebna prilagoditev začetnega odmerka
(glejte poglavje 5.2). Pri zelo starih
bolnikih (≥ 75 let), pri katerih obstaja nevarnost hipotenzije,
lahko začnete z začetnim odmerkom
20 mg.
Zdravilo nima veā dovoljenja za promet
3
_Ledvična okvara _
Pri hipertenzivnih bolnikih s hudo ledvično okvaro in končno stopnjo
ledvične bolezni je potrebna
previdnost, ker ni izkušenj z uporabo zdravila Ipreziv pri teh
bolnikih 
                                
                                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

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