Ipreziv

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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

Active ingredient:

Azilsartan medoxomil

Available from:

Takeda Pharma A/S

ATC code:

C09CA09

INN (International Name):

azilsartan medoxomil

Therapeutic group:

Sredstva koja djeluju na sustav renin-angiotenzina

Therapeutic area:

Hipertenzija

Therapeutic indications:

Ipreziv je indiciran za liječenje esencijalne hipertenzije kod odraslih osoba.

Product summary:

Revision: 4

Authorization status:

povučen

Authorization date:

2011-12-07

Patient Information leaflet

                                51
B. UPUTA O LIJEKU
52
UPUTA O LIJEKU: INFORMACIJA ZA KORISNIKA
_ _
IPREZIV 20 MG TABLETE
IPREZIV 40 MG TABLETE
IPREZIV 80 MG TABLETE
azilsartanmedoksomil
Ovaj je lijek pod dodatnim praćenjem. Time se omogućuje brzo
otkrivanje novih sigurnosnih
informacija. Prijavom svih sumnji na nuspojavu i Vi možete pomoći.
Za postupak prijavljivanja
nuspojava, pogledajte dio 4.
PAŽLJIVO PROČITAJTE CIJELU UPUTU PRIJE NEGO POČNETE UZIMATI OVAJ
LIJEK JER SADRŽI VAMA VAŽNE
PODATKE.
-
Sačuvajte ovu uputu. Možda ćete je trebati ponovo pročitati.
-
Ako imate dodatnih pitanja, obratite se svom liječniku ili
ljekarniku.
-
Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im
naškoditi, čak i ako su
njihovi znakovi bolesti jednaki Vašima.
-
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti
liječnika ili ljekarnika. To
uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi.
Pogledajte dio 4.
ŠTO SE NALAZI U OVOJ UPUTI
:
1.
Što je Ipreziv i za što se koristi
2.
Što morate znati prije nego počnete uzimati Ipreziv
3.
Kako uzimati Ipreziv
4.
Moguće nuspojave
5.
Kako čuvati Ipreziv
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE IPREZIV I ZA ŠTO SE KORISTI
Ipreziv sadrži djelatnu tvar po nazivu azilsartanmedoksomil i pripada
skupini lijekova koji se zovu
antagonisti receptora angiotenzina II . Angiotenzin II je tvar koja se
prirodno nalazi u tijelu i uzrokuje
stezanje krvnih žila te tako povisuje krvni tlak. Ipreziv blokira taj
učinak tako da se krvne žile
opuštaju, što pridonosi sniženju krvnog tlaka.
Ovaj se lijek primjenjuje za liječenje povišenog krvnog tlaka
(esencijalna hipertenzija) u odraslih
bolesnika (u dobi iznad 18 godina).
2.
ŠTO MORATE ZNATI PRIJE NEGO POČNETE UZIMATI IPREZIV
NEMOJTE UZIMATI IPREZIV AKO STE
-
ALERGIČNI
(preosjetljivi) na azilsartanmedoksomil ili bilo koji drugi sastojak
lijeka Ipreziv
(vidjeti dio 6).
-
TRUDNI VIŠE OD 3 MJESECA.
(Bolje je izbjegavati Ipreziv i u ranoj trudnoći – vidjeti dio o
trudnoći).
-
imate šećernu 
                                
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Summary of Product characteristics

                                1
_ _
DODATAK I
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
Ovaj je lijek pod dodatnim praćenjem. Time se omogućuje brzo
otkrivanje novih sigurnosnih
informacija. Od zdravstvenih djelatnika se traži da prijave svaku
sumnju na nuspojavu za ovaj lijek.
Za postupak prijavljivanja nuspojava vidjeti dio 4.8.
_ _
_ _
1.
NAZIV LIJEKA
Ipreziv 20 mg tablete
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Jedna tableta sadrži 20 mg azilsartanmedoksomila (u obliku kalijeve
soli).
Za cjeloviti popis pomoćnih tvari, vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Tableta.
Bijele do gotovo bijele okrugle tablete promjera 6,0 mm, s utisnutim
“ASL” na jednoj strani i “20” na
drugoj strani.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Ipreziv je indiciran za liječenje esencijalne hipertenzije u
odraslih.
4.2
DOZIRANJE I NAČIN PRIMJENE
Doziranje
Preporučena početna doza je 40 mg jedanput na dan. Doza se može
povisiti na najviše 80 mg jedanput
na dan u bolesnika čiji se krvni tlak ne može kontrolirati nižom
dozom na odgovarajući način.
Gotovo najjači antihipertenzivni učinak postaje vidljiv nakon 2
tjedna, a najjači učinci postižu se
nakon 4 tjedna.
Ako se krvni tlak ne može na odgovarajući način kontrolirati samo
Iprezivom, dodatno sniženje
krvnog tlaka može se postići istovremenom primjenom Ipreziva s
drugim antihipertenzivnim
lijekovima, uključujući diuretike (kao što su klortalidon i
hidroklorotiazid) i blokatore kalcijevih
kanala (vidjeti dijelove 4.3, 4.4, 4.5 i 5.1).
_ _
Posebne populacije
_Starije osobe (u dobi od 65 ili više godina) _
Nije potrebna prilagodba doze Ipreziva u početku liječenja starijih
bolesnika (vidjeti dio 5.2), iako se
u vrlo starih bolesnika (≥ 75 godina) u kojih može postojati rizik
od hipotenzije može razmotriti
20 mg kao početna doza.
_ _
3
_Oštećenje funkcije bubrega _
Potreban je oprez u bolesnika s hipertenzijom i teškim oštećenjem
funkcije bubrega ili završnim
stadijem bubrežne bolesti, jer nema iskustva s primjenom Ipreziva u
tih bolesnika (vidjeti dio 4.4
i 5.2). Hemod
                                
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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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