FrancophonIA/ELRC3.0 huggingface dataset:
English: Silodosin Recordati may cause complications during a cataract surgery (eye surgery because of cloudiness of the lens, see section “Warnings and precautions”).
Croatian: Silodozin Recordati može prouzročiti komplikacije tijekom operacije katarakte (operacija oka zbog zamućenosti leće, pogledajte dio „Upozorenja i mjere opreza“).
English: PDE-5 inhibitors
Croatian: Inhibitori PDE-5
English: During pre-operative assessment, eye surgeons and ophthalmic teams should consider whether patients scheduled for cataract surgery are being or have been treated with silodosin, in order to ensure that appropriate measures will be in place to manage IFIS during surgery.
Croatian: Za vrijeme predoperacijske procjene, očni kirurzi i oftalmološki timovi trebaju razmotriti liječe li se bolesnici predbilježeni za operaciju katarakte ili jesu li bili liječeni silodozinom, kako bi mogli osigurati primjenu odgovarajućih mjera za zbrinjavanje IFIS-a tijekom operacije.
English: Nevertheless, caution should be exercised when starting concomitant use with antihypertensives and patients should be monitored for possible adverse reactions.
Croatian: Ipak, potreban je oprez kad se započinje istovremena primjena s antihipertenzivima, a bolesnici trebaju biti pod nadzorom zbog mogućih nuspojava.
English: Silodosin Recordati does not treat prostate cancer.
Croatian: Silodozin Recordati ne liječi rak prostate.
English: Europe
Croatian: Europa
English: Do not use this medicine if you notice that is damaged or shows signs of tampering.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da je pakiranje oštećeno ili su vidljivi znakovi neovlaštenog otvaranja.
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.
Croatian: Kako BHP i karcinom prostate mogu imati iste simptome i postojati istovremeno, bolesnike za koje se misli da imaju BHP potrebno je pregledati prije početka terapije silodozinom, kako bi se isključila prisutnost karcinoma prostate.
English: Substances that inhibit (such as ketoconazole, itraconazole, ritonavir or cyclosporine) or induce (such as rifampicin, barbiturates, carbamazepine, phenytoin) these enzymes and transporters may affect the plasma concentrations of silodosin and its active metabolite.
Croatian: Tvari koje inhibiraju (kao što su ketokonazol, itrakonazol, ritonavir ili ciklosporin) ili induciraju (kao što su rifampicin, barbiturati, karbamazepin, fenitoin) ove enzime i transportne proteine mogu utjecati na koncentracije silodozina i njegovog djelatnog metabolita u plazmi.
English: Silodosin has a substantially lower affinity for the α1B-adrenoreceptors that are primarily located in the cardiovascular system.
Croatian: Silodozin ima znatno slabiji afinitet prema α1B-adrenergičkim receptorima koji se primarno nalaze u kardiovaskularnom sustavu.
English: It is reversible within a few days upon discontinuation of treatment (see section 4.4).
Croatian: Pojava je reverzibilna i prestaje u roku od nekoliko dana nakon prestanka liječenja (vidjeti dio 4.4).
English: The initiation of therapy with silodosin is not recommended in patients for whom cataract surgery is scheduled.
Croatian: Uvođenje terapije silodozinom ne preporučuje se u bolesnika u kojih se planira operacija katarakte.
English: • If you have severe liver problems, you should not take Silodosin Recordati, as it was not tested in this condition.
Croatian: • Ako imate teških tegoba s jetrom, ne biste smjeli uzimati Silodozin Recordati, jer nije ispitan kod takvog stanja.
English: Silodosin Recordati belongs to a group of medicines called alpha1A-adrenoreceptor blockers.
Croatian: Silodozin Recordati pripada skupini lijekova koji se zovu blokatori alfa1A-adrenergičkih receptora.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „Rok valjanosti / EXP“.
English: Talk to your doctor or pharmacist before taking Silodosin Recordati
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Silodozin Recordati.
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.
Croatian: Razlog tome je taj što tijekom ove operacije kod nekih bolesnika koji su se liječili tom vrstom lijeka nastane gubitak tonusa mišića u šarenici (obojeni kružni dio u oku).
English: The incidence of orthostatic effects with silodosin is very low.
Croatian: Incidencija ortostatskih učinaka silodozina vrlo je niska.
English: The pharmacokinetics of silodosin is linear throughout this dose range.
Croatian: Farmakokinetika silodozina bila je linearna u cijelom ovom rasponu doza.
English: An in vitro study with Caco-2 cells showed that silodosin is a substrate for P-glycoprotein.
Croatian: U in vitro ispitivanju na Caco-2 stanicama pokazalo se da je silodozin supstrat P-glikoproteina.
English: • Fast or irregular heart beats (called palpitations)
Croatian: • brzi ili nepravilni otkucaji srca (zvani palpitacije) • nesvjestica / gubitak svijesti
English: Dizziness when standing up and occasionally fainting may occur when taking Silodosin Recordati, particularly when starting treatment or if you are taking other medicines that lower blood pressure.
Croatian: Za vrijeme uzimanja lijeka Silodozin Recordati mogu nastati omaglica pri ustajanju i povremeno nesvjestica, osobito na početku liječenja ili ako uzimate druge lijekove koji snižavaju krvni tlak.
English: • Dry mouth
Croatian: suha usta
English: It has been demonstrated in vitro that the α1A:α1B binding ratio of silodosin (162:1) is extremely high.
Croatian: Pokazalo se in vitro da je omjer vezanja silodozina za α1A:α1B (162:1)
English: Protein binding of silodosin glucuronide is 91%.
Croatian: Vezanje silodozin glukuronida na proteine plazme je 91%.
English: How to store Silodosin Recordati Contents of the pack and other information
Croatian: Kako čuvati Silodozin Recordati Sadržaj pakiranja i druge informacije
English: A starting dose of 4 mg once daily is recommended in patients with moderate renal impairment (CLCR 30 to < 50 mL/min), which may be increased to 8 mg once daily after one week of treatment, depending on the individual patient's response.
Croatian: U bolesnika s umjerenim oštećenjem bubrega (CLcr ≥30 do < 50 ml/min) preporučuje se početna doza od 4 mg jedanput na dan, koja se može povećati na 8 mg jedanput na dan nakon jednog tjedna liječenja, ovisno o odgovoru pojedinog bolesnika.
English: Within each frequency grouping the observed adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine po učestalosti, primijećene nuspojave prikazane su u padajućem redoslijedu s obzirom na ozbiljnost.
English: • If you have ever fainted or felt dizzy when suddenly standing up, please inform your doctor before taking Silodosin Recordati.
Croatian: • Ako ste ikad izgubili svijest ili osjetili omaglicu pri naglom ustajanju, obavijestite o tome svog liječnika prije nego što počnete uzimati Silodozin Recordati.
English: In subjects with severe renal impairment (n = 5) increase of exposure was 2.2-fold for Cmax and 3.7-fold for AUC.
Croatian: ispitanika s teškim oštećenjem funkcije bubrega (n = 5) izloženost se povećala 2,2 puta za Cmax i 3,7 puta za AUC.
English: The dose-limiting adverse reaction was postural hypotension.
Croatian: Nuspojava koja ograničuje dozu bila je posturalna hipotenzija.
English: Titanium dioxide (E171) Yellow iron oxide (E172) (4 mg capsules only)
Croatian: Ovojnica kapsule želatina titanijev dioksid (E171) željezov oksid, žuti (E172) (samo kapsule od 4 mg)
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).
Croatian: Pregled podataka o sigurnosti primjene u bolesnika uključenih u sva klinička ispitivanja ne pokazuje da blago oštećenje funkcije bubrega (n = 487) predstavlja dodatni sigurnosni rizik tijekom terapije silodozinom (kao što je povećanje omaglice ili ortostatske hipotenzije) u usporedbi s bolesnicima s normalnom funkcijom bubrega (n = 955).
English: There is no relevant use of Silodosin Recordati in the paediatric population for the indication of benign prostatic hyperplasia (BPH).
Croatian: Nema relevantne primjene lijeka Silodozin Recordati u pedijatrijskoj populaciji za indikaciju benigne hiperplazije prostate (BPH).
English: Carcinoma of the prostate
Croatian: Karcinom prostate
English: If you take more Silodosin Recordati than you should
Croatian: Ako uzmete više Silodozin Recordati nego što ste trebali
English: Silodosin is metabolised extensively, mainly via CYP3A4, alcohol dehydrogenase and UGT2B7.
Croatian: Silodozin se opsežno metabolizira, uglavnom putem CYP3A4, alkoholne dehidrogenaze i UGT2B7.
English: It is important that you immediately inform your eye specialist if you are using or have previously used Silodosin Recordati.
Croatian: Važno je da odmah obavijestite svog specijalistu za očne bolesti ako uzimate ili ste prethodno uzimali Silodozin Recordati.
English: Data observed in the Intent-to-treat populations of each study are shown below:
Croatian: Intent-to-treat) u pojedinom ispitivanju prikazani su ispod:
English: Silodosin Recordati may reduce the amount of sperm, and so could temporarily affect your ability to father a child.
Croatian: Silodozin Recordati može smanjiti količinu sperme, stoga bi mogao privremeno utjecati na vašu sposobnost začeća.
English: Silodosin Recordati is not intended for use by women.
Croatian: Lijek Silodozin Recordati nije namijenjen za primjenu u žena.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PVC/PVDC/ALUMINIUM FOIL BLISTERS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTERI OD PVC/PVDC/ALUMINIJSKE FOLIJE
English: Dizziness, including dizziness when standing up, and occasionally fainting, may occur.
Croatian: Može se javiti omaglica, uključujući omaglicu pri ustajanju, i povremeno nesvjestica.
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.
Croatian: U ispitivanju jednokratne doze, farmakokinetika silodozina nije bila izmijenjena u devet bolesnika s umjerenim oštećenjem funkcije jetre (Child-Pugh bodovi 7 do 9) u usporedbi s devet zdravih ispitanika.
English: Silodosin is also a substrate for P-glycoprotein.
Croatian: Silodozin je i supstrat P-glikoproteina.
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.
Croatian: Kad se silodozin primjenjivao istovremeno s inibitorom CYP3A4 umjerene jakosti, kao što je diltiazem, primijećeno je povećanje AUC silodozina za približno 30%, ali Cmax i poluvijek nisu bili promijenjeni.
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.
Croatian: • Kako dobroćudno povećanje prostate i rak prostate mogu imati iste simptome, liječnik će Vas pregledati na rak prostate prije nego što počnete uzimati Silodozin Recordati.
English: In patients with orthostatic hypotension, treatment with silodosin is not recommended.
Croatian: U bolesnika s ortostatskom hipotenzijom ne preporučuje se liječenje silodozinom.
English: If ingestion is recent, induction of vomiting or gastric lavage may be considered.
Croatian: Ukoliko nije prošlo puno vremena od ingestije, može se razmotriti izazivanje povraćanja i ispiranje želuca.
English: This causes an improvement of both storage (irritative) and voiding (obstructive) symptoms (Lower urinary tract symptoms, LUTS) associated with benign prostatic hyperplasia.
Croatian: To uzrokuje poboljšanje simptoma i kod zadržavanja mokraće (iritativnih) i mokrenja (opstruktivnih) (simptomi donjeg dijela mokraćnog trakta) povezanih s benignom hiperplazijom prostate.
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.
Croatian: • lijekove koji snižavaju krvni tlak (osobito lijekove koji se zovu blokatori alfa1-receptora, kao što su prazosin ili doksazosin), jer postoji mogući rizik od pojačanog učinka tih lijekova za vrijeme uzimanja lijeka Silodozin Recordati.
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.
Croatian: Više od 800 bolesnika s umjerenim do jakim simptomima BHP (Međunarodni indeks simptoma prostate, IPSS; početna vrijednost ≥ 13) primilo je silodozin od 8 mg jedanput na dan, u dva placebom kontrolirana klinička ispitivanja Faze III koja su se provela u Sjedinjenim Američkim Državama i jednom kliničkom ispitivanju s placebom i aktivnom kontrolom provedenima u Europi.
English: If you become dizzy or feel weak, tell your doctor straight away.
Croatian: Ako osjetite omaglicu ili slabost, odmah se javite liječniku.
English: In a Phase IV clinical trial performed in Europe, with a mean baseline IPSS total score of 18.9 points, 77.1%were responders to silodosin (as assessed by a change from baseline in the IPSS total score of at least 25%).
Croatian: U kliničkom ispitivanju Faze IV provedenom u Europi, s prosječnim početnim ukupnim IPSS rezultatom od 18,9 bodova, 77,1% bolesnika odgovorilo je na terapiju silodozinom (što je procijenjeno na temelju promjene ukupnog IPSS rezultata od najmanje 25% od početne vrijednosti).
English: The main metabolite in plasma, the glucuronide conjugate of silodosin (KMD-3213G), that has been shown to be active in vitro, has an extended half-life (approximately 24 hours) and reaches plasma concentrations approximately four times higher than those of silodosin.
Croatian: Glavni metabolit u plazmi, konjugat silodozina s glukuronidom (KMD-3213G), koji se pokazao djelatan in vitro, ima produljeni poluvijek (približno 24 sata) i postiže koncentracije u plazmi približno četiri puta veće od onih koje postiže silodozin.
English: Intraoperative Floppy Iris Syndrome (IFIS)
Croatian: Intraoperacijski sindrom meke šarenice (IFIS)
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).
Croatian: U ispitivanju interakcija primijećeno je 3,7-struko povećanje maksimalnih koncentracija silodozina u plazmi i 3,1-struko povećanje izloženosti silodozinu (tj. AUC) kad se istovremeno primjenjivao jaki inhibitor CYP3A4 (ketokonazol 400 mg).
English: If you have severe kidney problems, you should not take Silodosin Recordati.
Croatian: Ako imate teške tegobe s bubrezima, ne biste smjeli uzimati Silodozin Recordati.
English: • Runny or blocked nose
Croatian: • curenje iz nosa ili začepljen nos
English: If dizziness when standing up or fainting occurs, please inform your doctor as soon as possible.
Croatian: Ako nastane omaglica ili nesvjestica kod ustajanja, molimo čim prije obavijestite liječnika.
English: This effect disappears after discontinuation of silodosin (see section 4.8).
Croatian: Ovaj učinak nestaje nakon prestanka uzimanja silodozina (vidjeti dio 4.8).
English: What Silodosin Recordati is and what it is used for What you need to know before you take Silodosin Recordati How to take Silodosin Recordati Possible side effects
Croatian: Što je Silodozin Recordati i za što se koristi Što morate znati prije nego počnete uzimati Silodozin Recordati Kako uzimati Silodozin Recordati
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.
Croatian: Silodozin je visoko selektivan prema α1A-adrenergičkim receptorima koji se primarno nalaze u ljudskoj prostati, dnu mokraćnog mjehura, vratu mokraćnog mjehura, kapsuli prostate i prostatičnom dijelu uretre.
English: For special patient populations, one capsule of Silodosin Recordati 4 mg daily is recommended (see below).
Croatian: Kod posebnih populacija bolesnika, preporučuje se jedna kapsula lijeka Silodozin Recordati 4 mg na dan (vidjeti niže).
English: Other medicines and Silodosin Recordati
Croatian: Drugi lijekovi i Silodozin Recordati
English: The most frequent adverse reactions reported with silodosin in placebo controlled clinical studies and during long-term use were ejaculatory disorders such as retrograde ejaculation and anejaculation (ejaculatory volume reduced or absent), with a frequency of 23%.
Croatian: Najčešće nuspojave zabilježene uz silodozin u placebom kontroliranim kliničkim ispitivanjima i za vrijeme dugotrajnog uzimanja bile su poremećaji ejakulacije, kao što je retrogradna ejakulacija i izostanak ejakulacije (smanjen volumen ejakulata ili izostanak ejakulata) s učestalosti od 23%.
English: • medicines for epilepsy or rifampicin (a medicine to treat tubercolosis), since the effect of Silodosin Recordati may be reduced.
Croatian: • lijekove protiv epilepsije ili rifampicin (lijek za liječenje tuberkuloze), budući da mogu smanjiti učinak lijeka Silodozin Recordati.
English: In all studies, patients who did not respond to placebo during a 4-week placebo run-in phase were randomised to receive the study treatment.
Croatian: U svim ispitivanjima, bolesnici koji nisu imali odgovor na placebo tijekom uvodne placebo faze u trajanju od
English: • antifungal medicines (such as ketoconazole or itraconazole), medicines used for HIV-AIDS (such as ritonavir) or medicines used after transplants to prevent organ rejection (such as cyclosporin) because these medicines can increase the blood concentration of Silodosin Recordati.
Croatian: • lijekove protiv gljivica (kao što su ketokonazol ili itrakonazol), lijekove koji se primjenjuju kod HIV-a/SIDA-e (kao što je ritonavir) ili lijekove koji se koriste nakon presađivanja organa da bi se spriječilo njegovo odbacivanje (kao što je ciklosporin), zato što ti lijekovi mogu povećati koncentraciju lijeka Silodozin Recordati u krvi.
English: In healthy male subjects of the target age range (n = 16, mean age 55 ± 8 years) after once-a-day oral administration of 8 mg immediately after breakfast for 7 days, the following pharmacokinetic parameters were obtained: Cmax 87 ± 51 ng/mL (sd), tmax 2.5 hours (range 1.0-3.0), AUC 433 ± 286 ng • h/mL.
Croatian: U zdravih muških ispitanika u ciljnom dobnom rasponu (n = 16, srednja vrijednost dobi 55 ± 8 godina) nakon peroralne primjene 8 mg jedanput na dan neposredno nakon doručka tijekom 7 dana, dobili su se sljedeći farmakokinetički parametri: Cmax 87 ± 51 ng/ml (sd), tmax 2,5 sati
English: • If you are undergoing eye surgery because of cloudiness of the lens (cataract surgery), it is important that you immediately inform your eye specialist that you are using or have previously used Silodosin Recordati.
Croatian: • Ako idete na operaciju oka zbog zamućenja leće (operacija katarakte), važno je da odmah obavijestite svog specijalistu za liječenje očnih bolesti da uzimate ili da ste prije uzimali
English: Silodosin undergoes extensive metabolism through glucuronidation (UGT2B7), alcohol and aldehyde dehydrogenase and oxidative pathways, mainly CYP3A4.
Croatian: Biotransformacija Silodozin se opsežno metabolizira glukuronidacijom (UGT2B7), alkoholnom i aldehidnom dehidrogenazom i oksidativnim metaboličkim putevima, uglavnom putem CYP3A4.
English: Do not take Silodosin Recordati if you are allergic to silodosin or any of the other ingredients of this medicine (listed in section 6).
Croatian: Što morate znati prije nego počnete uzimati Silodozin Recordati Nemojte uzimati Silodozin Recordati ako ste alergični na silodozin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: • The treatment with Silodosin Recordati may lead to an abnormal ejaculation (decrease in the amount of semen released during sex) that may temporarily affect male fertility.
Croatian: • Liječenje lijekom Silodozin Recordati može dovesti do poremećaja ejakulacije (smanjenja količine sjemena koje se oslobađa u spolnom odnosu), što može privremeno narušiti plodnost u muškarca.
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).
Croatian: Praćenje razine u plazmi u Fazi III kliničkog ispitivanja pokazalo je da se razine ukupnog silodozina nakon 4 tjedna liječenja nisu promijenile u bolesnika s blagim oštećenjem funkcije bubrega (n = 70) u usporedbi s bolesnicima s normalnom funkcijom bubrega (n = 155), dok su razine u prosjeku bile udvostručene u bolesnika s umjerenim oštećenjem funkcije bubrega (n = 7).
English: This effect disappears after discontinuation of Silodosin Recordati.
Croatian: Ovaj učinak nestaje nakon prestanka uzimanja lijeka Silodozin Recordati.
English: Silodosin is excreted mainly as metabolites, very low amounts of unchanged drug are recovered in urine.
Croatian: Silodozin se uglavnom izlučuje u obliku metabolita, dok se neizmijenjeni lijek može pronaći u mokraći u vrlo malim količinama.
English: Do not drive or operate machines if you feel faint, dizzy, drowsy or have blurred vision.
Croatian: Nemojte upravljati vozilima niti raditi sa strojevima ako Vam prijeti nesvjestica, osjećate omaglicu,
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.
Croatian: U kliničkim je ispitivanjima za vrijeme liječenja silodozinom primijećena pojava ejakulacije sa smanjenom količinom sjemena ili bez sjemena (vidjeti dio 4.8) zbog farmakodinamičkih svojstava silodozina.
English: By blocking these receptors, it causes smooth muscle in these tissues to relax.
Croatian: Blokiranjem ovih receptora, Silodozin Recordati uzrokuje opuštanje glatkih mišića u tim tkivima.
English: The most common side effect is a decrease in the amount of semen released during sex.
Croatian: Najčešća nuspojava je smanjena količina sperme koje se oslobađa kod spolnog odnosa.
English: What Silodosin Recordati looks like and contents of the pack
Croatian: Kako Silodozin Recordati izgleda i sadržaj pakiranja
English: Silodosin Recordati has minor or moderate influence on the ability to drive and use machines.
Croatian: Silodozin Recordati malo do umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Treatment with silodosin leads to a decrease in the amount of semen released during orgasm that may temporarily affect male fertility.
Croatian: Liječenje silodozinom dovodi do smanjenja količine sperme koja se oslobađa tijekom orgazma, što može privremeno smanjiti plodnost kod muškarca.
English: The terminal half-life of parent drug and its glucuronide is approximately 11 hours and 18 hours, respectively.
Croatian: Terminalni poluvijek prekursora iznosi približno 11 sati,
English: Patients with kidney problems
Croatian: Bolesnici koji imaju tegobe s bubrezima