Silodyx

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
10-10-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
10-10-2022
Public Assessment Report Public Assessment Report (PAR)
09-10-2014

Active ingredient:

silodozin

Available from:

Recordati Ireland Ltd

ATC code:

G04CA04

INN (International Name):

silodosin

Therapeutic group:

Urološki

Therapeutic area:

Hiperplazija prostate

Therapeutic indications:

Zdravljenje znakov in simptomov benigne hiperplazije prostate (BPH).

Product summary:

Revision: 16

Authorization status:

Pooblaščeni

Authorization date:

2010-01-29

Patient Information leaflet

                                17
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Shranjujte pri temperaturi do 30 °C.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred
svetlobo in vlago.
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
Recordati Ireland Ltd.
Raheens East
Ringaskiddy Co. Cork
Irska
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/09/607/001
EU/1/09/607/002
EU/1/09/607/003
EU/1/09/607/004
EU/1/09/607/005
EU/1/09/607/006
EU/1/09/607/007
13.
ŠTEVILKA SERIJE
_ _
Lot
14.
NAČIN IZDAJANJA ZDRAVILA
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Silodyx 4 mg
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA_ _
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako
18
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI_ _
PC:
SN:
NN:
19
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI
DVOJNEM TRAKU
PRETISNI OMOTI IZ PVC/PVDC/ALUMINIJASTE FOLIJE
1.
IME ZDRAVILA
Silodyx 4 mg trde kapsule
silodozin
2.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Recordati Ireland Ltd.
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
_ _
EXP
4.
ŠTEVILKA SERIJE
Lot
5.
DRUGI PODATKI
20
PODATKI NA ZUNANJI OVOJNINI
ŠKATLA
1.
IME ZDRAVILA
Silodyx 8 mg trde kapsule
silodozin
2.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN
Ena trda kapsula vsebuje 8 mg silodozina.
3.
SEZNAM POMOŽNIH SNOVI
_ _
4.
FARMACEVTSKA OBLIKA IN VSEBINA
5 trdih kapsul
10 trdih kapsul
20 trdih kapsul
30 trdih kapsul
50 trdih kapsul
90 trdih kapsul
100 trdih kapsul
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
21
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Shranjujte pri temperaturi do 30 °C.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred
svetlobo in vlago.
10.
POSEBN
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA
Silodyx 4 mg trde kapsule
Silodyx 8 mg trde kapsule
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Silodyx 4 mg trde kapsule
Ena trda kapsula vsebuje 4 mg silodozina.
Silodyx 8 mg trde kapsule
Ena trda kapsula vsebuje 8 mg silodozina.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
Trda kapsula
_ _
Silodyx 4 mg trde kapsule
Rumena, neprozorna, trda želatinska kapsula velikosti 3 (približno
15,9 mm x 5,8 mm).
Silodyx 8 mg trde kapsule
Bela, neprozorna, trda želatinska kapsula velikosti 0 (približno
21,7 mm x 7,6 mm).
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravljenje znakov in simptomov benigne hiperplazije prostate (BHP)
pri odraslih moških.
4.2
ODMERJANJE IN NAČIN UPORABE
Odmerjanje
Priporočeni odmerek je ena kapsula zdravila Silodyx 8 mg na dan. Pri
posebnih skupinah bolnikov je
priporočena ena kapsula zdravila Silodyx 4 mg na dan (glejte spodaj).
_Starejši _
Pri starejših bolnikih prilagajanje odmerka ni potrebno (glejte
poglavje 5.2).
_Okvarjeno delovanje ledvic _
Pri bolnikih z blago okvaro delovanja ledvic (CL
CR
≥ 50 do ≤ 80 ml/min) prilagoditev odmerka ni
potrebna. Pri bolnikih z zmerno okvaro delovanja ledvic (CL
CR
≥ 30 do < 50 ml/min) je priporočljivo
uporabiti začetni odmerek 4 mg enkrat na dan, ki se ga glede na odziv
posameznega bolnika po enem
tednu zdravljenja lahko poveča na 8 mg enkrat na dan. Uporaba pri
bolnikih s hudo okvaro delovanja
ledvic (CL
CR
< 30 ml/min) ni priporočljiva (glejte poglavji 4.4 in 5.2).
_ _
_Okvarjeno delovanje jeter _
Pri bolnikih z blago do zmerno okvaro delovanja jeter prilagoditev
odmerka ni potrebna.
Zaradi pomanjkanja podatkov uporaba pri bolnikih s hudo okvaro
delovanja jeter ni priporočljiva
(glejte poglavji 4.4 in 5.2).
3
_Pediatrična populacija_
Zdravilo Silodyx ni namenjeno za uporabo pri pediatrični populaciji
za navedeno benigne hiperplazije
prostate (BHP).
Način uporabe
Peroralna uporaba.
Kapsulo je treba vzeti s hrano, najbolje vsak dan 
                                
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Similar products

Active ingredient silodozin

silodozin

ATC code G04CA04

G04CA04

Marketed by Recordati Ireland Ltd

Recordati Ireland Ltd

INN (International Name) silodosin

silodosin

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