Desloratadine Teva

Country: European Union

Language: Icelandic

Source: EMA (European Medicines Agency)

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

Active ingredient:

desloratadin

Available from:

Teva B.V

ATC code:

R06AX27

INN (International Name):

desloratadine

Therapeutic group:

Andhistamín fyrir almenn nota,

Therapeutic area:

Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

Therapeutic indications:

Upplýsa Mg er ætlað til að draga af einkennum:ofnæmi nefi;ofsakláða.

Product summary:

Revision: 18

Authorization status:

Leyfilegt

Authorization date:

2011-11-24

Patient Information leaflet

                                18
B. FYLGISEÐILL
19
FYLGISEÐILL: UPPLÝSINGAR FYRIR SJÚKLING
DESLORATADINE TEVA 5 MG FILMUHÚÐAÐAR TÖFLUR
desloratadin
LESIÐ ALLAN FYLGISEÐILINN VANDLEGA ÁÐUR EN BYRJAÐ ER AÐ NOTA
LYFIÐ. Í HONUM ERU MIKILVÆGAR
UPPLÝSINGAR.
-
Geymið fylgiseðilinn. Nauðsynlegt getur verið að lesa hann
síðar.
-
Leitið til læknisins eða lyfjafræðings ef þörf er á frekari
upplýsingum.
-
Þessu lyfi hefur verið ávísað til persónulegra nota. Ekki má
gefa það öðrum. Það getur valdið
þeim skaða, jafnvel þótt um sömu sjúkdómseinkenni sé að
ræða.
-
Látið lækninn eða lyfjafræðing vita um allar aukaverkanir.
Þetta gildir einnig um aukaverkanir
sem ekki er minnst á í þessum fylgiseðli. Sjá kafla 4.
Í FYLGISEÐLINUM ERU EFTIRFARANDI KAFLAR
:
1.
Upplýsingar um Desloratadine Teva og við hverju það er notað
2.
Áður en byrjað er að nota Desloratadine Teva
3.
Hvernig nota á Desloratadine Teva
4.
Hugsanlegar aukaverkanir
5.
Hvernig geyma á Desloratadine Teva
6.
Pakkningar og aðrar upplýsingar
1.
UPPLÝSINGAR UM DESLORATADINE TEVA OG VIÐ HVERJU ÞAÐ ER NOTAÐ
UPPLÝSINGAR UM DESLORATADINE TEVA
Desloratadine Teva inniheldur desloratadin sem er andhistamín sem
veldur ekki syfju. Það hjálpar við
að hafa hemil á ofnæmisverkunum og einkennum þeirra.
HVERNIG VIRKAR DESLORATADINE TEVA
Desloratadine Teva er ofnæmislyf sem dregur úr einkennum
ofnæmisnefkvefs (bólga í nefgöngum
vegna ofnæmis, t.d. heymæði eða ofnæmi fyrir rykmaurum).
Einkennin eru hnerri, nefrennsli og kláði
í nefi, kláði í efri góm, kláði í augum, rauð eða tárvot
augu.
HVENÆR Á AÐ NOTA DESLORATADINE TEVA
Desloratadine Teva er einnig notað til að draga úr einkennum
ofsakláða (einkenni í húð vegna
ofnæmis) hjá fullorðnum og unglingum, 12 ára og eldri. Einkennin
eru kláði og ofsakláði.
Léttir þessara einkenna varir allan daginn og hjálpar þér við
að endurheimta eðlilega starfsgetu og
eðlilegan svefn.
2.
ÁÐUR EN BYRJAÐ ER AÐ NOTA DESLORATADINE TEVA
E
                                
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Summary of Product characteristics

                                1
VIÐAUKI I
SAMANTEKT Á EIGINLEIKUM LYFS
2
1.
HEITI LYFS
Desloratadine Teva 5 mg filmuhúðaðar töflur
2.
INNIHALDSLÝSING
Hver tafla inniheldur 5 mg desloratadin.
Hjálparefni með þekkta verkun:
Hver filmuhúðuð tafla inniheldur 1,2 mg af laktósaeinhýdrati
(sjá kafla 4.4).
Sjá lista yfir öll hjálparefni í kafla 6.1.
3.
LYFJAFORM
Filmuhúðuð tafla
Blá, kringlótt, tvíkúpt, filmuhúðuð tafla, án áletrunar á
báðum hliðum.
4.
KLÍNÍSKAR UPPLÝSINGAR
4.1
ÁBENDINGAR
Desloratadine Teva er ætlað fullorðnum og unglingum, 12 ára og
eldri, til að draga úr einkennum:
-
ofnæmisnefkvefs (sjá kafla 5.1)
-
ofsakláða (sjá kafla 5.1)
4.2
SKAMMTAR OG LYFJAGJÖF
Skammtar
_Fullorðnir og unglingar (12 ára og eldri) _
Ráðlagður skammtur af Desloratadine Teva 5 mg filmuhúðuðum
töflum er ein tafla einu sinni á dag.
Skammvinnt ofnæmiskvef (einkenni vara skemur en 4 daga í viku eða
skemur en 4 vikur) skal
meðhöndla í samræmi við sjúkrasögu sjúklingsins og hætta má
meðferð þegar einkenni hverfa og hefja
hana að nýju þegar einkenni koma aftur.
Við þrálátt ofnæmiskvef (einkenni vara í 4 daga eða meira í
viku og lengur en í 4 vikur) gæti
sjúklingurinn þurft á áframhaldandi meðferð að halda meðan
ofnæmistíminn varir.
_Börn _
Takmörkuð reynsla er af verkun úr klínískum rannsóknum við
notkun desloratadins hjá unglingum á
aldrinum 12 til 17 ára (sjá kafla 4.8 og 5.1).
Ekki hefur verið sýnt fram á öryggi og verkun Desloratadine Teva 5
mg filmuhúðaðra taflna hjá
börnum yngri en 12 ára.
Lyfjagjöf
Til inntöku.
Skammtinn má taka með eða án matar.
4.3
FRÁBENDINGAR
Ofnæmi fyrir virka efninu eða einhverju hjálparefnanna sem talin
eru upp í kafla 6.1 eða fyrir
loratadini.
3
4.4
SÉRSTÖK VARNAÐARORÐ OG VARÚÐARREGLUR VIÐ NOTKUN
Desloratadine Teva 5 mg filmuhúðaðar töflur ætti að nota með
varúð í tilfellum alvarlega skertrar
nýrnastarfsemi (sjá kafla 5.2).
Gæta skal varúðar við gjöf deslóratadíns hjá sjúklingu
                                
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Active ingredient desloratadin

desloratadin

ATC code R06AX27

R06AX27

Marketed by Teva B.V

Teva B.V

INN (International Name) desloratadine

desloratadine

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