FrancophonIA/ELRC3.0 huggingface dataset:
English: Silodosin is highly selective for α1A-adrenoreceptors that are primarily located in the human prostate, bladder base, bladder neck, prostatic capsule and prostatic urethra.
Slovenian: Silodozin se visoko selektivno veže ne α1A adrenergične receptorje, ki se prvenstveno nahajajo v humani prostati, bazi mehurja, vratu mehurja, kapsuli prostate in prostatičnem delu sečnice.
English: If you have severe kidney problems, you should not take Silodosin Recordati.
Slovenian: Če imate hude težave z ledvicami, ne smete jemati zdravila Silodosin Recordati.
English: If you have taken more than one capsule, inform your doctor as soon as possible.
Slovenian: Če ste vzeli večji odmerek zdravila Silodosin Recordati, kot bi smeli Če ste vzeli več kot eno kapsulo, čimprej obvestite svojega zdravnika.
English: The dose-limiting adverse reaction was postural hypotension.
Slovenian: Odmerek omejujoč neželeni učinek je bila posturalna hipotenzija.
English: • medicines used for treating problems in getting or keeping an erection (such as sildenafil or tadalafil), since the concomitant use with Silodosin Recordati might lead to a slight decrease in blood pressure.
Slovenian: • zdravila za zdravljenje težav z nastankom ali ohranitvijo erekcije (kot sta sildenafil ali tadalafil), ker uporaba skupaj z zdravilom Silodosin Recordati lahko vodi v rahlo znižanje krvnega tlaka.
English: Treatment with silodosin leads to a decrease in the amount of semen released during orgasm that may temporarily affect male fertility.
Slovenian: Zdravljenje s silodozinom povzroča zmanjšanje količine ejakulata, ki se sprosti med orgazmom, kar lahko začasno prizadene moško plodnost.
English: • medicines which lower blood pressure (in particular, medicines called alpha1-blockers, such as prazosin or doxazosin) as there may be the potential risk that the effect of these medicines is increased whilst taking Silodosin Recordati.
Slovenian: • zdravila za zniževanje krvnega tlaka (zlasti zdravila, imenovana zaviralci alfa1 kot sta prazosin ali doksazosin), ker obstaja tveganje, da se ob jemanju zdravila Silodosin Recordati učinek teh zdravil okrepi.
English: A review of safety data of patients enrolled in all clinical studies does not indicate that mild renal impairment (n = 487) poses an additional safety risk during silodosin therapy (such as an increase in dizziness or orthostatic hypotension) as compared to patients with normal renal function (n = 955).
Slovenian: Pregled varnostnih podatkov bolnikov, vključenih v vse klinične študije, ne nakazuje, da bi blago okvarjeno delovanje ledvic (n = 487) v primerjavi z normalnim delovanjem ledvic (n = 955) pri zdravljenju s silodozinom predstavljalo dodatno varnostno tveganje (kot je npr. porast omotičnosti ali ortostatske hipotenzije).
English: Plasma level monitoring in a Phase III clinical study showed that levels of total silodosin after 4 weeks of treatment did not change in patients with mild impairment (n = 70), compared to patients with normal renal function (n = 155), while the levels were doubled on average in patients with moderate impairment (n = 7).
Slovenian: Spremljanje plazemskih ravni v klinični študiji Faze III je pokazalo, da se ravni celokupnega silodozina po 4 tednih zdravljenja pri bolnikih z blago okvarjenim delovanjem (n = 70) v primerjavi z bolniki z normalnim delovanjem ledvic (n = 155) niso spremenile, pri bolnikih z zmerno okvarjenim delovanjem (n = 7) pa so bile v povprečju podvojene.
English: In the active-controlled clinical study conducted in Europe, silodosin 8 mg once daily was shown to be non inferior to tamsulosin 0.4 mg once daily: the adjusted mean difference (95% CI) in the IPSS Total Score between treatments in the per-protocol population was 0.4 (-0.4 to 1.1).
Slovenian: V z učinkovino nadzorovani klinični študiji, izpeljani v Evropi, se je pokazalo, da 8 mg silodozina enkrat na dan ni dajalo slabših rezultatov od 0,4 mg tamsulozina enkrat na dan: prilagojena povprečna razlika (95% CI) v rezultatu vprašalnika IPSS med posameznimi s protokolom določenimi populacijami je znašala 0,4 (-0,4 do 1,1).
English: The most common side effect is a decrease in the amount of semen released during sex.
Slovenian: Najpogostejši neželeni učinek je zmanjšanje količine sperme, izločene pri spolnem odnosu.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Recordati Ireland Ltd.
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Recordati Ireland Ltd.
English: Silodosin Recordati does not treat prostate cancer.
Slovenian: Zdravilo Silodosin Recordati ne zdravi raka prostate.
English: The responder rate (i.e. improvement in the IPSS total score by at least 25%) was significantly higher in the silodosin (68%) and tamsulosin group (65%), as compared to placebo (53%).
Slovenian: izboljšanje rezultata vprašalnika IPSS za vsaj 25%) v skupini, ki je prejemala silodozin (68%) oziroma tamsulozin (65%) statistično značilno višja.
English: • Since a benign enlargement of the prostate and prostate cancer may present the same symptoms, your doctor will check you for prostate cancer before starting treatment with Silodosin Recordati.
Slovenian: • Ker imata nenevarno povečanje prostate in rak prostate lahko enake simptome, vas bo zdravnik pred pričetkom zdravljenja z zdravilom Silodosin Recordati poslal na kontrolni pregled za raka prostate.
English: Following oral administration of 14C-labelled silodosin, the recovery of radioactivity after 7 days was approximately 33.5% in urine and 54.9% in faeces.
Slovenian: Po peroralnem vnosu s 14C-označenega silodozina je bilo po 7 dneh v urinu zaznane približno 33,5%
English: Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men.
Slovenian: 4.1 Terapevtske indikacije Zdravljenje znakov in simptomov benigne hiperplazije prostate (BHP) pri odraslih moških.
English: In patients with orthostatic hypotension, treatment with silodosin is not recommended.
Slovenian: Pri bolnikih z ortostatsko hipotenzijo zdravljenje s silodozinom ni priporočljivo.
English: Silodosin Tamsulosin Placebo
Slovenian: Evropa silodozin tamsulozi n placebo
English: Dizziness, including dizziness when standing up, and occasionally fainting, may occur.
Slovenian: Pojavita se lahko omotica, vključno z omotico ob vstajanju v pokončni položaj, in občasno ome dle vica.
English: The pharmacokinetics of silodosin in patients with severe hepatic impairment has not been studied.
Slovenian: Farmakokinetika silodozina pri bolnikih s hudo okvaro delovanja jeter ni bila raziskana.
English: PDE-5 inhibitors
Slovenian: Zaviralci PDE-5
English: • Runny or blocked nose
Slovenian: • izcedek iz nosu ali zamašen nos • driska
English: Patients with kidney problems
Slovenian: Bolniki s težavami z delovanjem ledvic
English: In a Phase II dose-finding, double-blind, placebo-controlled clinical study with silodosin 4 or 8 mg once daily, a greater improvement in American Urologic Association (AUA) symptom index score was observed with silodosin 8 mg (-6.8 ± 5.8, n = 90; p = 0.0018) and silodosin 4 mg (-5.7 ± 5.5, n = 88; p = 0.0355) as compared to placebo (-4.0 ± 5.5, n = 83).
Slovenian: Klinična učinkovitost in varnost V dvojno slepi s placebom nadzorovani klinični študiji Faze II za določanje odmerka s 4 ali 8 mg silodozinom enkrat na dan je bilo v primerjavi s placebom (-4,0 ± 5,5, n = 83) pri uporabi 8 mg silodozina (-6,8 ± 5,8, n = 90; p = 0,0018) in 4 mg silodozina (-5,7 ± 5,5, n = 88; p = 0,0355) opaženo večje izboljšanje točkovnega rezultata po vprašalniku Ameriškega urološkega združenja (AUA - American Urologic Association).
English: There is no relevant use of Silodosin Recordati in the paediatric population for the indication of benign prostatic hyperplasia (BPH).
Slovenian: Pediatrična populacija Zdravilo Silodosin Recordati ni namenjeno za uporabo pri pediatrični populaciji za indikacijo benigne hiperplazije prostate (BHP).
English: This effect disappears after discontinuation of Silodosin Recordati.
Slovenian: Ta učinek izzveni po prekinitvi zdravljenja z zdravilom Silodosin Recordati.
English: In the table below, adverse reactions reported in all clinical studies and in the worldwide post-marketing experience for which a reasonable causal relationship exists are listed by MedDRA system organ class and frequency: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from available data).
Slovenian: < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: Since BPH and prostate carcinoma may present the same symptoms and can co-exist, patients thought to have BPH should be examined prior to starting therapy with silodosin, to rule out the presence of carcinoma of the prostate.
Slovenian: Ker imata BHP in karcinom prostate lahko enake simptome in ima bolnik lahko sočasno obe bolezni, je treba pred pričetkom zdravljenja s silodozinom bolnike s sumom na BHP pregledati in izključiti karcinom prostate.
English: If you stop treatment, your symptoms may re-appear.
Slovenian: Če ste prenehali jemati zdravilo Silodosin Recordati Če ste prenehali z zdravljenjem, se vaši simptomi lahko ponovno pojavijo.
English: Silodosin undergoes extensive metabolism through glucuronidation (UGT2B7), alcohol and aldehyde dehydrogenase and oxidative pathways, mainly CYP3A4.
Slovenian: Silodozin se obsežno presnavlja z glukuronidacijo (UGT2B7), alkohol- in aldehid-dehidrogenazo in po oksidativnih poteh, predvsem z encimom CYP3A4.
English: How to store Silodosin Recordati Contents of the pack and other information
Slovenian: Shranjevanje zdravila Silodosin Recordati Vsebina pakiranja in dodatne informacije
English: The incidence of orthostatic effects with silodosin is very low.
Slovenian: Pogostnost ortostatskih učinkov je ob uporabi silodozina zelo nizka.
English: Allergictype reactions including facial swelling, swollen tongue and pharyngeal oedema1
Slovenian: vključno z oteklostjo obraza, oteklostjo jezika in faringealnim edemom1
English: In a single-dose study, the pharmacokinetics of silodosin was not altered in nine patients with moderate hepatic impairment (Child-Pugh scores 7 to 9), compared to nine healthy subjects.
Slovenian: V študiji enkratnega odmerka farmakokinetika silodozina pri devetih bolnikih z zmerno okvarjenim delovanjem jeter (7 do 9 po lestvici Child-Pugh) v primerjavi z devetimi zdravimi prostovoljci ni bila spremenjena.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PVC/PVDC/ALUMINIUM FOIL BLISTERS
Slovenian: PRETISNI OMOTI IZ PVC/PVDC/ALUMINIJASTE FOLIJE
English: The safety of silodosin has been evaluated in four Phase II-III double-blind controlled clinical studies (with 931 patients receiving silodosin 8 mg once daily and 733 patients receiving placebo) and in two long-term open-label extension phase studies.
Slovenian: II-III Faze (z 931 bolniki, ki so prejemali 8 mg silodozina enkrat na dan in 733 bolniki, ki so prejemali placebo) in v dveh dolgoročnih odprtih podaljšanih študijah.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, carcinogenic, mutagenic and teratogenic potential.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, kancerogenega, mutagenega in teratogenega potenciala ne kažejo posebnega tveganja za človeka.
English: Accordingly, no dose adjustment is required in patients with mild renal impairment.
Slovenian: V skladu s tem prilagoditev odmerka pri bolnikih z blago okvarjenim delovanjem ledvic ni potrebna.
English: The pharmacokinetics of silodosin and its main metabolites have been evaluated in adult male subjects with and without BPH after single and multiple administrations with doses ranging from 0.1 mg to 48 mg per day.
Slovenian: Farmakokinetika silodozina in njegovih glavnih presnovkov je bila ovrednotena pri odraslih osebah moškega spola z BHP ali brez nje po enkratnem in večkratnem odmerjanju v odmerkih od 0,1 mg do 48 mg na dan. Farmakokinetika silodozina je v celotnem navedenem odmernem intervalu linearna.
English: Other medicines and Silodosin Recordati
Slovenian: Druga zdravila in zdravilo Silodosin Recordati
English: The other ingredients are pregelatinised maize starch, mannitol (E421), magnesium stearate, sodium laurilsulfate, gelatin, titanium dioxide (E171), yellow iron oxide (E172).
Slovenian: Druge sestavine zdravila so predgelirani koruzni škrob, manitol (E421), magnezijev stearat, natrijev lavrilsulfat, želatina, titanov dioksid (E171), rumeni železov oksid (E172).
English: Pregnancy and breast-feeding Not applicable as silodosin is intended for male patients only.
Slovenian: Navedba smiselno ni potrebna, saj je silodozin namenjen samo bolnikom moškega spola.
English: Orthostatic effects
Slovenian: Ortostatski učinki
English: The other ingredients are pregelatinised maize starch, mannitol (E421), magnesium stearate, sodium laurilsulfate, gelatin, titanium dioxide (E171).
Slovenian: Druge sestavine zdravila so predgelirani koruzni škrob, manitol (E421), magnezijev stearat, natrijev lavrilsulfat, želatina, titanov dioksid (E171).
English: Ejaculatory disorders, including retrograde ejaculation, anejaculation
Slovenian: vključno z retrogradno ejakulacijo, anejakulacijo erektilna disfunkcija
English: In a single-dose study, exposure to silodosin (unbound) in subjects with mild (n = 8) and moderate renal impairment (n = 8) resulted, on average, in an increase of Cmax (1.6-fold) and AUC (1.7-fold) relative to subjects with normal renal function (n = 8).
Slovenian: V študiji enkratnega odmerka je izpostavitev silodozinu (nevezanemu) pri bolnikih z blago (n = 8) in zmerno (n = 8) okvaro delovanja ledvic v primerjavi z bolniki z normalnim delovanjem ledvic (n = 8) v povprečju vodila v povečanje Cmax (1,6-krat) in AUC (1,7-krat).
English: Since no data are available in patients with severe hepatic impairment, the use of silodosin in these patients is not recommended (see sections 4.2 and 5.2).
Slovenian: Zaradi pomanjkanja podatkov o bolnikih s hudo okvaro delovanja jeter uporaba silodozina pri teh bolnikih ni priporočljiva (glejte poglavji 4.2 in 5.2).
English: • Dizziness, including dizziness when standing up (see also above, in this section)
Slovenian: • ohlapna šarenica med operacijo sive mrene (glejte tudi zgoraj v tem poglavju)
English: The use in patients with severe renal impairment (CLCR < 30 mL/min) is not recommended (see sections 4.4 and 5.2).
Slovenian: Uporaba pri bolnikih s hudo okvaro delovanja ledvic (CLCR < 30 ml/min) ni priporočljiva (glejte poglavji 4.4 in 5.2).
English: No significant reduction in supine blood pressure was observed in all clinical studies conducted with silodosin.
Slovenian: V vseh kliničnih študijah s silodozinom v ležečem položaju niso opazili pomembnega znižanja krvnega tlaka.
English: No dose adjustment is required for patients with mild renal impairment (CLCR ≥ 50 to ≤ 80 mL/min).
Slovenian: Pri bolnikih z blago okvaro delovanja ledvic (CLCR ≥ 50 do ≤80 ml/min) prilagoditev odmerka ni potrebna.
English: If ingestion is recent, induction of vomiting or gastric lavage may be considered.
Slovenian: Če je do zaužitja prišlo pred kratkim, lahko pride v poštev izzvano bruhanje ali izpiranje želodca.
English: What Silodosin Recordati is and what it is used for
Slovenian: Kaj je zdravilo Silodosin Recordati in za kaj ga uporabljamo
English: In clinical studies, the occurrence of ejaculation with reduced or no semen has been observed during treatment with silodosin (see section 4.8), due to the pharmacodynamic properties of silodosin.
Slovenian: V kliničnih študijah so med zdravljenjem s silodozinom, zaradi farmakodinamičnih lastnosti silodozina, opazili pojavljanje ejakulacije z zmanjšano količino ejakulata ali brez njega (glejte poglavje 4.8).
English: The use of silodosin in patients with severe renal impairment (CLCR < 30 mL/min) is not recommended (see sections 4.2 and 5.2).
Slovenian: Uporaba silodozina pri bolnikih s hudo okvaro delovanja ledvic (CLCR < 30 ml/min) ni priporočljiva (glejte poglavji 4.2 in 5.2).
English: Silodosin Recordati is selective for the receptors located in the prostate, bladder and urethra.
Slovenian: Zdravilo Silodosin Recordati se selektivno veže na receptorje, ki se nahajajo v prostati, mehurju in sečnici.
English: Syncope Loss of consciousness1
Slovenian: Bolezni živčevja omotica sinkopa izguba zavesti1
English: Orthostatic hypotension may occasionally lead to syncope (see section 4.4).
Slovenian: Ortostatska hipotenzija občasno lahko vodi v sinkopo
English: In all studies, patients treated with silodosin had a greater decrease in both storage (irritative) and voiding (obstructive) symptoms of BPH as compared to placebo as assessed after 12 weeks of treatment.
Slovenian: V vseh študijah so imeli bolniki, zdravljeni s silodozinom, v primerjavi s placebom bolj izraženo izboljšanje iritacijskih in obstrukcijskih simptomov BHP, kar so ocenili po
English: Silodosin has not been evaluated in patients less than 18 years of age.
Slovenian: Uporaba silodozina pri bolnikih, mlajših od 18 let, ni bila ovrednotena.
English: This is because some patients treated with this kind of medicine experienced a loss of muscle tone in the iris (the coloured circular part of the eye) during such a surgery.
Slovenian: ki so bili zdravljeni s to vrsto zdravil, med takšno operacijo izgubili mišični tonus v šarenici
English: Discontinuing treatment with an α1-blocker 1-2 weeks prior to cataract surgery has been recommended, but the benefit and duration of stopping the therapy prior to cataract surgery has not yet been established.
Slovenian: Prekinitev zdravljenja z zaviralcem α1 receptorjev 1-2 tedna pred operacijo sive mrene je priporočljiva,
English: Silodosin Recordati is used in adult men to treat the urinary symptoms associated with benign enlargement of the prostate (prostatic hyperplasia), such as:
Slovenian: Za kaj uporabljamo zdravilo Silodosin Recordati Zdravilo Silodosin Recordati se pri odraslih moških uporablja za zdravljenje simptomov mokrenja, ki so povezani z nenevarnim povečanjem prostate (hiperplazijo prostate), kot na primer:
English: In patients with severe renal impairment administration of Silodosin Recordati is not recommended.
Slovenian: Pri bolnikih s hudo okvaro delovanja ledvic uporaba zdravila Silodosin Recordati ni priporočljiva.
English: Libido decreased
Slovenian: Psihiatrične motnje zmanjšan libido
English: Tachycardia1 Palpitations1
Slovenian: Srčne bolezni tahikardija1
English: The capsule should not be broken or chewed but swallowed whole, preferably with a glass of water.
Slovenian: treba je pogoltniti celo, najbolje s kozarcem vode.
English: The exposure to the main metabolite in plasma, silodosin glucuronide (KMD-3213G), at steady-state is about 3-fold that of the parent substance.
Slovenian: Izpostavitev glavnemu presnovku v plazmi, glukuronidnemo konjugatu silodozina (KMD-3213G), je v stanju dinamičnega ravnotežja približno trikrat večja od izpostavitve izhodiščni učinkovini.
English: Do not break or chew the capsule, but swallow it whole, preferably with a glass of water.
Slovenian: ampak pogoltnite celo, najbolje s kozarcem vode.
English: IFIS has been reported during cataract surgery (see section 4.4).
Slovenian: Medoperacijski sindrom ohlapne šarenice (IFIS) Poročali so, da je pri operacijah sive mrene prišlo do sindroma IFIS (glejte poglavje 4.4).
English: When silodosin was co-administered with a CYP3A4 inhibitor of moderate potency such as diltiazem, an increase in silodosin AUC of approximately 30% was observed, but Cmax and half-life were not affected.
Slovenian: Ob sočasni uporabi silodozina in zmernih zaviralcev CYP3A4 kot je diltiazem so opazili približno 30% porast AUC silodozina, Cmax in razpolovna doba pa se nista spremenila.
English: In an interaction study, a 3.7-fold increase in maximum silodosin plasma concentrations and a 3.1-fold increase in silodosin exposure (i.e. AUC) were observed with concurrent administration of a potent CYP3A4 inhibitor (ketoconazole 400 mg).
Slovenian: V študiji medsebojnega delovanja so ob sočasni uporabi močnega zaviralca CYP3A4 (ketokonazol 400 mg) opazili 3,7-kratno zvečanje najvišjih plazemskih koncentracij silodozina in 3,1-kratno zvišanje izpostavljenosti silodozinu (tj. AUC).
English: The recommended dose is one capsule of Silodosin Recordati 8 mg daily.
Slovenian: Priporočeni odmerek je ena kapsula zdravila Silodosin Recordati 8 mg na dan.
English: Skin rash1, Pruritus1
Slovenian: Bolezni kože in podkožja kožni izpuščaj1, pruritus1
English: Hypotension1
Slovenian: palpitacije1
English: • Abnormal results of liver function tests
Slovenian: • nenormalni rezultati jetrnih testov • nizek krvni tlak
English: What Silodosin Recordati looks like and contents of the pack
Slovenian: Izgled zdravila Silodosin Recordati in vsebina pakiranja
English: Very common
Slovenian: izjemno visoko.
English: No dose adjustment is required for patients with mild to moderate hepatic impairment.
Slovenian: Pri bolnikih z blago do zmerno okvaro delovanja jeter prilagoditev odmerka ni potrebna.
English: Silodosin was evaluated at doses of up to 48 mg/day in healthy male subjects.
Slovenian: 4.9 Preveliko odmerjanje Uporaba silodozina je bila pri zdravih moških ovrednotena vse do odmerka 48 mg/dan.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalneg a prostora nosna kongestija
English: Very common side effects (may affect more than 1 in 10 people)
Slovenian: Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov)
English: You may take your capsule later the same day if you have forgotten to take it earlier.
Slovenian: Če ste pozabili vzeti zdravilo Silodosin Recordati Če ste tekom dneva pozabili vzeti kapsulo, jo vzemite pozneje istega dne.
English: Over 800 patients with moderate to severe symptoms of BPH (International Prostate Symptom Score, IPSS, baseline value ≥ 13) received silodosin 8 mg once daily in two Phase III placebo-controlled clinical studies conducted in the United States and in one placebo- and active-controlled clinical study conducted in Europe.
Slovenian: Score; izhodiščna vrednost ≥ 13) je v dveh s placebom nadzorovanih kliničnih študijah Faze III v Združenih državah Amerike in v eni s placebom in z učinkovino nadzorovani klinični študiji, izpeljani v Evropi, prejemalo 8 mg silodozin enkrat na dan.
English: • Nausea
Slovenian: • slabost
English: INFORMATION IN BRAILLE silodosin recordati 4 mg
Slovenian: PODATKI V BRAILLOVI PISAVI silodosin recordati 4 mg
English: The initiation of therapy with silodosin is not recommended in patients for whom cataract surgery is scheduled.
Slovenian: Uvajanje zdravljenja s silodozinom pri bolnikih, ki čakajo na operacijo sive mrene, ni priporočljivo.
English: INFORMATION IN BRAILLE silodosin recordati 8 mg
Slovenian: PODATKI V BRAILLOVI PISAVI silodosin recordati 8 mg
English: Silodosin Recordati 8 mg hard capsules Each hard capsule contains 8 mg silodosin.
Slovenian: Silodosin Recordati 8 mg trde kapsule Ena trda kapsula vsebuje 8 mg silodozina.
English: Very rare side effects (may affect up to 1 in 10,000 people) • Other allergic reactions with swelling of the face or throat
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) • hiter ali nereden srčni utrip (imenovan palpitacije)
English: Silodosin Recordati 4 mg are yellow, opaque, hard gelatin capsules, size 3 (approximately 15.9 x 5.8 mm).
Slovenian: Zdravilo Silodosin Recordati 4 mg so rumene, neprozorne, trde želatinske kapsule, velikost 3 (približno 15,9 mm x 5,8 mm).
English: Each capsule contains 4 mg of silodosin.
Slovenian: Ena kapsula vsebuje 4 mg silodozina.
English: The recommended dose is one capsule of Silodosin Recordati 8 mg per day by oral administration.
Slovenian: Priporočeni odmerek je ena kapsula zdravila Silodosin Recordati 8 mg enkrat na dan peroralno (zaužita skozi usta).
English: Silodosin Recordati 8 mg are white, opaque, hard gelatin capsules, size 0 (approximately 21.7 x 7.6 mm).
Slovenian: Zdravilo Silodosin Recordati 8 mg so bele, neprozorne, trde želatinske kapsule, velikost 0 (približno 21,7 mm x 7,6 mm).