Irbesartan Teva

Country: European Union

Language: Estonian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
05-09-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
05-09-2023
Public Assessment Report Public Assessment Report (PAR)
16-11-2009

Active ingredient:

irbesartaan

Available from:

Teva B.V.

ATC code:

C09CA04

INN (International Name):

irbesartan

Therapeutic group:

Reniini-angiotensiini süsteemi toimivad ained

Therapeutic area:

Hüpertensioon

Therapeutic indications:

Essentsiaalse hüpertensiooni ravi. Ravi neeruhaigusega patsientidel, kellel on hüpertensioon ja 2. tüüpi suhkurtõve osana hüperaktiivsuse vastased ravimi raviskeemi.

Product summary:

Revision: 16

Authorization status:

Volitatud

Authorization date:

2009-10-30

Patient Information leaflet

                                35
B. PAKENDI INFOLEHT
36
PAKENDI INFOLEHT: TEAVE KASUTAJALE
IRBESARTAN TEVA 75 MG ÕHUKESE POLÜMEERIKATTEGA TABLETID
Irbesartaan
ENNE RAVIMI VÕTMIST LUGEGE HOOLIKALT INFOLEHTE, SEST SIIN ON TEILE
VAJALIKKU TEAVET.
-
Hoidke infoleht alles, et seda vajadusel uuesti lugeda.
-
Kui teil on lisaküsimusi, pidage nõu oma arsti või apteekriga.
-
Ravim on välja kirjutatud üksnes teile. Ärge andke seda kellelegi
teisele. Ravim võib olla neile
kahjulik, isegi kui haigusnähud on sarnased.
-
Kui teil tekib ükskõik milline kõrvaltoime, pidage nõu oma arsti
või apteekriga. Kõrvaltoime
võib olla ka selline, mida selles infolehes ei ole nimetatud. Vt
lõik 4.
INFOLEHE
SISUKORD
1.
Mis ravim on Irbesartan Teva ja milleks seda kasutatakse
2.
Mida on vaja teada enne Irbesartan Teva võtmist
3.
Kuidas Irbesartan Teva’t võtta
4.
Võimalikud kõrvaltoimed
5.
Kuidas Irbesartan Teva’t säilitada
6.
Pakendi sisu ja muu teave
1.
MIS RAVIM ON IRBESARTAN TEVA JA MILLEKS SEDA KASUTATAKSE
Irbesartan Teva kuulub ravimite gruppi, mida tuntakse angiotensiin II
retseptori antagonistidena.
Angiotensiin II on organismis toodetav aine, mis seondub veresoontes
olevate retseptoritega
põhjustades nende ahenemist. Selle tulemusel tõuseb vererõhk.
Irbesartan Teva hoiab ära angiotensiin
II seondumise nende retseptoritega, põhjustades veresoonte
lõõgastumise ja vererõhu languse.
Kõrgvererõhutõve ja teist tüüpi suhkruhaigusega patsientidel
aeglustab Irbesartan Teva neerutalitluse
halvenemist.
Irbesartan Teva’t kasutatakse täiskasvanud patsientidel
-
kõrgvererõhutõve (essentsiaalse hüpertensiooni) raviks
-
neerude kaitsmiseks kõrgvererõhutõve, teist tüüpi suhruhaiguse ja
neerutalitluse laboratoorselt
tõestatud kahjustusega patsientidel.
2.
MIDA ON VAJA TEADA ENNE IRBESARTAN TEVA VÕTMIST
ÄRGE VÕTKE IRBESARTAN TEVA’T
-
kui olete irbesartaani või selle ravimi mis tahes koostisosade
(loetletud lõigus 6) suhtes
allergiline,
-
kui te olete rohkem kui 3 kuud rase (ka raseduse algul on parem
vältida Irbesartan Te
                                
                                Read the complete document

Summary of Product characteristics

                                1
I LISA
RAVIMI OMADUSTE KOKKUVÕTE
2
1.
RAVIMPREPARAADI NIMETUS
Irbesartan Teva 75 mg õhukese polümeerikattega tabletid
Irbesartan Teva 150 mg õhukese polümeerikattega tabletid
Irbesartan Teva 300 mg õhukese polümeerikattega tabletid
2.
KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS
Irbesartan Teva 75 mg õhukese polümeerikattega tabletid
Üks õhukese polümeerikattega tablett sisaldab 75 mg irbesartaani.
Irbesartan Teva 150 mg õhukese polümeerikattega tabletid
Üks õhukese polümeerikattega tablett sisaldab 150 mg irbesartaani.
Irbesartan Teva 300 mg õhukese polümeerikattega tabletid
Üks õhukese polümeerikattega tablett sisaldab 300 mg irbesartaani.
Abiainete täielik loetelu vt lõik 6.1.
3.
RAVIMVORM
Õhukese polümeerikattega tablett.
Irbesartan Teva 75 mg õhukese polümeerikattega tabletid
Valge kuni valkjas kapslikujuline õhukese polümeerikattega tablett.
Tableti ühele küljele on pressitud
number „93“. Tableti teisele küljele on pressitud number
„7464“.
Irbesartan Teva 150 mg õhukese polümeerikattega tabletid
Valge kuni valkjas kapslikujuline õhukese polümeerikattega tablett.
Tableti ühele küljele on pressitud
number „93“. Tableti teisele küljele on pressitud number
„7465“.
Irbesartan Teva 300 mg õhukese polümeerikattega tabletid
Valge kuni valkjas kapslikujuline õhukese polümeerikattega tablett.
Tableti ühele küljele on pressitud
number „93“. Tableti teisele küljele on pressitud number
„7466“.
4.
KLIINILISED ANDMED
4.1
NÄIDUSTUSED
Irbesartan Teva on näidustatud essentsiaalse hüpertensiooni raviks
täiskasvanutel.
Näidustuseks on ka kasutamine neeruhaiguse ravi ühe osana
antihüpertensiivse ravi skeemist
hüpertensiooni ja teist tüüpi diabeediga täiskasvanud patsientidel
(vt lõigud 4.3, 4.4, 4.5 ja 5.1).
4.2
ANNUSTAMINE JA MANUSTAMISVIIS
Annustamine
Tavaline soovitatav alg- ja säilitusannus on 150 mg 1 kord
ööpäevas, koos toiduga või ilma.
Irbesartaan annuses 150 mg üks kord ööpäevas annab üldiselt
parema 24-tunnise kontrolli vererõhu
                                
                                Read the complete document

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Active ingredient irbesartaan

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ATC code C09CA04

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INN (International Name) irbesartan

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Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 05-09-2023
Summary of Product characteristics Summary of Product characteristics Bulgarian 05-09-2023
Public Assessment Report Public Assessment Report Bulgarian 16-11-2009
Patient Information leaflet Patient Information leaflet Spanish 05-09-2023
Summary of Product characteristics Summary of Product characteristics Spanish 05-09-2023
Public Assessment Report Public Assessment Report Spanish 16-11-2009
Patient Information leaflet Patient Information leaflet Czech 05-09-2023
Summary of Product characteristics Summary of Product characteristics Czech 05-09-2023
Public Assessment Report Public Assessment Report Czech 16-11-2009
Patient Information leaflet Patient Information leaflet Danish 05-09-2023
Summary of Product characteristics Summary of Product characteristics Danish 05-09-2023
Public Assessment Report Public Assessment Report Danish 16-11-2009
Patient Information leaflet Patient Information leaflet German 05-09-2023
Summary of Product characteristics Summary of Product characteristics German 05-09-2023
Public Assessment Report Public Assessment Report German 16-11-2009
Patient Information leaflet Patient Information leaflet Greek 05-09-2023
Summary of Product characteristics Summary of Product characteristics Greek 05-09-2023
Public Assessment Report Public Assessment Report Greek 16-11-2009
Patient Information leaflet Patient Information leaflet English 05-09-2023
Summary of Product characteristics Summary of Product characteristics English 05-09-2023
Public Assessment Report Public Assessment Report English 16-11-2009
Patient Information leaflet Patient Information leaflet French 05-09-2023
Summary of Product characteristics Summary of Product characteristics French 05-09-2023
Public Assessment Report Public Assessment Report French 16-11-2009
Patient Information leaflet Patient Information leaflet Italian 05-09-2023
Summary of Product characteristics Summary of Product characteristics Italian 05-09-2023
Public Assessment Report Public Assessment Report Italian 16-11-2009
Patient Information leaflet Patient Information leaflet Latvian 05-09-2023
Summary of Product characteristics Summary of Product characteristics Latvian 05-09-2023
Public Assessment Report Public Assessment Report Latvian 16-11-2009
Patient Information leaflet Patient Information leaflet Lithuanian 05-09-2023
Summary of Product characteristics Summary of Product characteristics Lithuanian 05-09-2023
Public Assessment Report Public Assessment Report Lithuanian 16-11-2009
Patient Information leaflet Patient Information leaflet Hungarian 05-09-2023
Summary of Product characteristics Summary of Product characteristics Hungarian 05-09-2023
Public Assessment Report Public Assessment Report Hungarian 16-11-2009
Patient Information leaflet Patient Information leaflet Maltese 05-09-2023
Summary of Product characteristics Summary of Product characteristics Maltese 05-09-2023
Public Assessment Report Public Assessment Report Maltese 16-11-2009
Patient Information leaflet Patient Information leaflet Dutch 05-09-2023
Summary of Product characteristics Summary of Product characteristics Dutch 05-09-2023
Public Assessment Report Public Assessment Report Dutch 16-11-2009
Patient Information leaflet Patient Information leaflet Polish 05-09-2023
Summary of Product characteristics Summary of Product characteristics Polish 05-09-2023
Public Assessment Report Public Assessment Report Polish 16-11-2009
Patient Information leaflet Patient Information leaflet Portuguese 05-09-2023
Summary of Product characteristics Summary of Product characteristics Portuguese 05-09-2023
Public Assessment Report Public Assessment Report Portuguese 16-11-2009
Patient Information leaflet Patient Information leaflet Romanian 05-09-2023
Summary of Product characteristics Summary of Product characteristics Romanian 05-09-2023
Public Assessment Report Public Assessment Report Romanian 16-11-2009
Patient Information leaflet Patient Information leaflet Slovak 05-09-2023
Summary of Product characteristics Summary of Product characteristics Slovak 05-09-2023
Public Assessment Report Public Assessment Report Slovak 16-11-2009
Patient Information leaflet Patient Information leaflet Slovenian 05-09-2023
Summary of Product characteristics Summary of Product characteristics Slovenian 05-09-2023
Public Assessment Report Public Assessment Report Slovenian 16-11-2009
Patient Information leaflet Patient Information leaflet Finnish 05-09-2023
Summary of Product characteristics Summary of Product characteristics Finnish 05-09-2023
Public Assessment Report Public Assessment Report Finnish 16-11-2009
Patient Information leaflet Patient Information leaflet Swedish 05-09-2023
Summary of Product characteristics Summary of Product characteristics Swedish 05-09-2023
Public Assessment Report Public Assessment Report Swedish 16-11-2009
Patient Information leaflet Patient Information leaflet Norwegian 05-09-2023
Summary of Product characteristics Summary of Product characteristics Norwegian 05-09-2023
Patient Information leaflet Patient Information leaflet Icelandic 05-09-2023
Summary of Product characteristics Summary of Product characteristics Icelandic 05-09-2023
Patient Information leaflet Patient Information leaflet Croatian 05-09-2023
Summary of Product characteristics Summary of Product characteristics Croatian 05-09-2023

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