Desloratadine Teva

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

Buy It Now

Patient Information leaflet Patient Information leaflet (PIL)
09-06-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
09-06-2022

Active ingredient:

dcsloratadin

Available from:

Teva B.V

ATC code:

R06AX27

INN (International Name):

desloratadine

Therapeutic group:

Antihistaminici za sistemsku primjenu,

Therapeutic area:

Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

Therapeutic indications:

Дезлоратадин Tewa je indiciran za olakšanje od simptoma vezanih uz:alergijski rinitis;osip.

Product summary:

Revision: 18

Authorization status:

odobren

Authorization date:

2011-11-24

Patient Information leaflet

                                18
B. UPUTA O LIJEKU
19
UPUTA O LIJEKU: INFORMACIJE ZA BOLESNIKA
DESLORATADIN TEVA 5 MG FILMOM OBLOŽENE TABLETE
desloratadin
PAŽLJIVO PROČITAJTE CIJELU UPUTU PRIJE NEGO POČNETE UZIMATI OVAJ
LIJEK JER SADRŽI VAMA VAŽNE
PODATKE.
-
Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.
-
Ako imate dodatnih pitanja, obratite se 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 Desloratadin Teva i za što se koristi
2.
Što morate znati prije nego počnete uzimati Desloratadin Teva
3.
Kako uzimati Desloratadin Teva
4.
Moguće nuspojave
5.
Kako čuvati Desloratadin Teva
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE DESLORATADIN TEVA I ZA ŠTO SE KORISTI
ŠTO JE DESLORATADIN TEVA
Desloratadin Teva sadrži desloratadin koji je antihistaminik.
KAKO DJELUJE DESLORATADIN TEVA
Desloratadin Teva je lijek protiv alergije koji ne izaziva pospanost.
Pomaže u kontroli alergijske
reakcije i njezinih simptoma.
KADA TREBA UZIMATI DESLORATADIN TEVA
Desloratadin Teva ublažava simptome povezane s alergijskim rinitisom
(upala nosnih puteva
uzrokovana alergijom, na primjer, kod peludne groznice ili alergije na
grinje) u odraslih osoba i
adolescenata u dobi od 12 ili više godina. Ti simptomi uključuju
kihanje, curenje ili svrbež nosa,
svrbež nepca te svrbež, crvenilo i suzenje očiju.
Desloratadin Teva se također koristi za ublažavanje simptoma
povezanih s urtikarijom (promjene na
koži uslijed alergije). Ovi simptomi uključuju svrbež i
koprivnjaču.
Simptomi su ublaženi tijekom čitavog dana, što Vam pomaže da
nastavite s uobičajenim dnevnim
aktivnostima i da normalno spavate.
2.
ŠTO MORATE ZNATI PRIJE NEGO POČNETE UZIMATI DESLORATADIN TEVA
NEMOJTE UZIMATI DESLO
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
Desloratadin Teva 5 mg filmom obložene tablete
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Jedna tableta sadrži 5 mg desloratadina.
Pomoćna(e) tvar(i) s poznatim učinkom:
Jedna filmom obložena tableta sadrži 1,2 mg laktoza hidrata (vidjeti
dio 4.4.)
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Filmom obložena tableta.
Plava, okrugla, bikonveksna filmom obložena tableta bez oznaka na
objema stranama.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Desloratadin Teva je indiciran u odraslih i adolescenata u dobi od 12
ili više godina za ublažavanje
simptoma povezanih s:
-
alergijskim rinitisom (vidjeti dio 5.1),
-
urtikarijom (vidjeti dio 5.1).
4.2
DOZIRANJE I NAČIN PRIMJENE
Doziranje
_Odrasli i adolescenti (u dobi od 12 godina i stariji) _
Preporučena doza lijeka Desloratadin Teva 5 mg filmom obložene
tablete je jedna tableta jedanput na
dan.
Intermitentni alergijski rinitis (simptomi su prisutni manje od 4 dana
u tjednu ili kraće od 4 tjedna)
potrebno je liječiti u skladu s procjenom povijesti bolesti
bolesnika, a liječenje se može prekinuti
nakon nestanka simptoma te ponovno započeti pri ponovnoj pojavi
simptoma.
Kod perzistentnog alergijskog rinitisa (simptomi su prisutni 4 ili
više dana u tjednu i duže od 4 tjedna),
bolesnicima se može preporučiti kontinuirano liječenje tijekom
razdoblja izloženosti alergenu.
_Pedijatrijska populacija _
Postoji ograničeno iskustvo iz kliničkih ispitivanja djelotvornosti
primjenom desloratadina u
adolescenata u dobi od 12 do 17 godina (vidjeti dijelove 4.8 i 5.1).
Sigurnost i djelotvornost lijeka Desloratadin Teva 5 mg filmom
obložene tablete u djece mlađe od
12 godina nisu ustanovljene.
Način primjene
Kroz usta.
Doza se može uzeti s hranom ili bez nje.
3
4.3
KONTRAINDIKACIJE
Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih
u dijelu 6.1 ili na loratadin.
4.4
POSEBNA UPOZORENJA I MJERE OPREZA PRI UPORABI
U slučaju teške insuficijencije bubrega,
                                
                                Read the complete document

Similar products

Active ingredient dcsloratadin

dcsloratadin

ATC code R06AX27

R06AX27

Marketed by Teva B.V

Teva B.V

INN (International Name) desloratadine

desloratadine

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 09-06-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 09-06-2022
Public Assessment Report Public Assessment Report Bulgarian 08-12-2011
Patient Information leaflet Patient Information leaflet Spanish 09-06-2022
Summary of Product characteristics Summary of Product characteristics Spanish 09-06-2022
Public Assessment Report Public Assessment Report Spanish 08-12-2011
Patient Information leaflet Patient Information leaflet Czech 09-06-2022
Summary of Product characteristics Summary of Product characteristics Czech 09-06-2022
Public Assessment Report Public Assessment Report Czech 08-12-2011
Patient Information leaflet Patient Information leaflet Danish 09-06-2022
Summary of Product characteristics Summary of Product characteristics Danish 09-06-2022
Public Assessment Report Public Assessment Report Danish 08-12-2011
Patient Information leaflet Patient Information leaflet German 09-06-2022
Summary of Product characteristics Summary of Product characteristics German 09-06-2022
Public Assessment Report Public Assessment Report German 08-12-2011
Patient Information leaflet Patient Information leaflet Estonian 09-06-2022
Summary of Product characteristics Summary of Product characteristics Estonian 09-06-2022
Public Assessment Report Public Assessment Report Estonian 08-12-2011
Patient Information leaflet Patient Information leaflet Greek 09-06-2022
Summary of Product characteristics Summary of Product characteristics Greek 09-06-2022
Public Assessment Report Public Assessment Report Greek 08-12-2011
Patient Information leaflet Patient Information leaflet English 09-06-2022
Summary of Product characteristics Summary of Product characteristics English 09-06-2022
Public Assessment Report Public Assessment Report English 08-12-2011
Patient Information leaflet Patient Information leaflet French 09-06-2022
Summary of Product characteristics Summary of Product characteristics French 09-06-2022
Public Assessment Report Public Assessment Report French 08-12-2011
Patient Information leaflet Patient Information leaflet Italian 09-06-2022
Summary of Product characteristics Summary of Product characteristics Italian 09-06-2022
Public Assessment Report Public Assessment Report Italian 08-12-2011
Patient Information leaflet Patient Information leaflet Latvian 09-06-2022
Summary of Product characteristics Summary of Product characteristics Latvian 09-06-2022
Public Assessment Report Public Assessment Report Latvian 08-12-2011
Patient Information leaflet Patient Information leaflet Lithuanian 09-06-2022
Summary of Product characteristics Summary of Product characteristics Lithuanian 09-06-2022
Public Assessment Report Public Assessment Report Lithuanian 08-12-2011
Patient Information leaflet Patient Information leaflet Hungarian 09-06-2022
Summary of Product characteristics Summary of Product characteristics Hungarian 09-06-2022
Public Assessment Report Public Assessment Report Hungarian 08-12-2011
Patient Information leaflet Patient Information leaflet Maltese 09-06-2022
Summary of Product characteristics Summary of Product characteristics Maltese 09-06-2022
Public Assessment Report Public Assessment Report Maltese 08-12-2011
Patient Information leaflet Patient Information leaflet Dutch 09-06-2022
Summary of Product characteristics Summary of Product characteristics Dutch 09-06-2022
Public Assessment Report Public Assessment Report Dutch 08-12-2011
Patient Information leaflet Patient Information leaflet Polish 09-06-2022
Summary of Product characteristics Summary of Product characteristics Polish 09-06-2022
Public Assessment Report Public Assessment Report Polish 08-12-2011
Patient Information leaflet Patient Information leaflet Portuguese 09-06-2022
Summary of Product characteristics Summary of Product characteristics Portuguese 09-06-2022
Public Assessment Report Public Assessment Report Portuguese 08-12-2011
Patient Information leaflet Patient Information leaflet Romanian 09-06-2022
Summary of Product characteristics Summary of Product characteristics Romanian 09-06-2022
Public Assessment Report Public Assessment Report Romanian 08-12-2011
Patient Information leaflet Patient Information leaflet Slovak 09-06-2022
Summary of Product characteristics Summary of Product characteristics Slovak 09-06-2022
Public Assessment Report Public Assessment Report Slovak 08-12-2011
Patient Information leaflet Patient Information leaflet Slovenian 09-06-2022
Summary of Product characteristics Summary of Product characteristics Slovenian 09-06-2022
Public Assessment Report Public Assessment Report Slovenian 08-12-2011
Patient Information leaflet Patient Information leaflet Finnish 09-06-2022
Summary of Product characteristics Summary of Product characteristics Finnish 09-06-2022
Public Assessment Report Public Assessment Report Finnish 08-12-2011
Patient Information leaflet Patient Information leaflet Swedish 09-06-2022
Summary of Product characteristics Summary of Product characteristics Swedish 09-06-2022
Public Assessment Report Public Assessment Report Swedish 08-12-2011
Patient Information leaflet Patient Information leaflet Norwegian 09-06-2022
Summary of Product characteristics Summary of Product characteristics Norwegian 09-06-2022
Patient Information leaflet Patient Information leaflet Icelandic 09-06-2022
Summary of Product characteristics Summary of Product characteristics Icelandic 09-06-2022

Search alerts related to this product

Alerts Desloratadine Teva dcsloratadin

Desloratadine Teva dcsloratadin

View documents history

Documents history Documents history

Desloratadine Teva