FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, prije uzimanja ovog lijeka, obratite se svom liječniku.
English: Zaleplon is lipophilic with a volume of distribution of about 1.4 ± 0.3 l/kg following intravenous administration.
Croatian: Raspodjela Zaleplon je lipofilna tvar s volumenom raspodjele od oko 1,4 ± 0,3 l/kg nakon intravenske primjene.
English: If for compelling medical reasons, the medicinal product is administered during the late phase of pregnancy, or during labour at high doses, effects on the neonate, such as hypothermia, hypotonia and moderate respiratory depression, can be expected, due to the pharmacological action of the compound.
Croatian: Ako su u kasnoj fazi trudnoće ili tijekom poroda zbog opravdanih medicinskih razloga primjenjivane veće doze lijeka, mogu se očekivati učinci na novorođenče kao što su hipotermija, hipotonija i umjerena respiratorna depresija uzrokovani farmakološkim djelovanjem tvari.
English: Warnings already exist in the zaleplon product information however based on the available information the PRAC considered it prudent within this procedure to strengthen the wording in SmPC and PL to ensure clear information is available for patients and healthcare professionals given the potentially serious consequences of next day psychomotor impairment.
Croatian: Međutim, temeljem dostupnih informacija PRAC smatra da je pametno u sklopu ovog postupka to još naglasiti u tekstu sažetka opisa svojstava lijeka i upute o lijeku kako bi se osigurala jasnoća informacija za bolesnike i zdravstvene djelatnike, s obzirom na potencijalno ozbiljne posljedice poremećene psihomotorne funkcije sljedeći dan.
English: If you stop taking Sonata
Croatian: Ako prestanete uzimati Sonatu
English: Zaleplon undergoes presystemic metabolism, resulting in an absolute bioavailability of approximately
Croatian: Zaleplon se podvrgava presistemskom metabolizmu što rezultira apsolutnom bioraspoloživosti od približno 30%.
English: The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data)
Croatian: Učestalost mogućih, dolje navedenih nuspojava definirana je kako slijedi: vrlo često (javlja se u više od 1 na 10 korisnika) često (javlja se u 1 do 10 na 100 korisnika) manje često (javlja se u 1 do 10 na 1 000 korisnika)
English: No adverse effects on embryofetal development were observed in rabbits.
Croatian: Kod kunića nisu uočeni štetni učinci na embriofetalni razvoj.
English: • if you have severe breathing or chest problems.
Croatian: • ako imate teške probleme s disanjem ili prsnim košem
English: No dosage adjustment is required in patients with mild to moderate renal insufficiency, because Sonata pharmacokinetics is not altered in such patients.
Croatian: Nije potrebno prilagođavati dozu u bolesnika s blagim do umjerenim zatajenjem bubrega jer u tih bolesnika farmakokinetika Sonate nije promijenjena.
English: • Do not use Sonata or any other sleeping medicine for longer than your doctor tells you to.
Croatian: • Sonatu ili bilo koji drugi lijek za spavanje nemojte upotrebljavajti dulje nego
English: In a pre- and postnatal development study in rats, increased stillbirth and postnatal mortality, and decreased growth and physical development, were observed in the offspring of females treated with doses of ≥7 mg/kg/day that did not elicit maternal toxicity.
Croatian: Tijekom ispitivanja pre- i postnatalnog razvoja štakora, uočeni su povećan broj mrtvorođene mladunčadi i postnatalni mortalitet, te smanjen rast i fizički razvoj mladunčadi ženki koje su primile doze ≥7 mg/kg/dan koje nisu izazvale toksičnost kod majke.
English: See also below under Amnesia Eye disorders
Croatian: Također vidjeti u nastavku pod Amnezija
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 March 1999
Croatian: Datum prvog odobrenja: 12. ožujka 1999.
English: Benzodiazepines and benzodiazepine-like agents should not be used alone to treat depression or anxiety associated with depression (suicide may be precipitated in such patients).
Croatian: Depresija Benzodiazepini i lijekovi srodni benzodiazepinima ne smiju se primjenjivati sami u liječenju depresije ili tjeskobe povezane s depresijom (u takvih bolesnika moguć je povećan rizik samoubojstva).
English: These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability.
Croatian: Oni mogu obuhvaćati glavobolju, bolove u mišićima, izrazitu tjeskobu, napetost, nemir, smetenost i razdražljivost.
English: Metabolism and nutrition disorders Uncommon:
Croatian: Poremećaji metabolizma i prehrane Manje često:
English: Psychosis
Croatian: Psihoza
English: If you forget to take Sonata
Croatian: Ako ste zaboravili uzeti Sonatu
English: In severe cases, use of activated charcoal or gastric lavage may be useful when performed soon after ingestion.
Croatian: U teškim slučajevima može biti korisno odmah nakon ingestije primijeniti aktivni ugljen ili ispiranje želuca.
English: The CHMP recommends that the terms of the Marketing Authorisation should be varied.
Croatian: CHMP predlaže izmjenu uvjeta odobrenja za stavljanje lijeka u promet.
English: Scientific conclusions and grounds recommending the variation to the terms of the Marketing
Croatian: Znanstveni zaključci i razlozi za preporuku izmjene uvjeta odobrenja za stavljanje lijeka u
English: Benzodiazepine and benzodiazepine-like agents are not indicated to treat patients with severe hepatic insufficiency as they may precipitate encephalopathy (see section 4.2).
Croatian: Benzodiazepini i lijekovi srodni benzodiazepinima nisu indicirani za liječenje bolesnika s teškim oštećenjem funkcije jetre jer mogu pospješiti encefalopatiju (vidjeti dio 4.2).
English: Diphenhydramine is reported to be a weak inhibitor of aldehyde oxidase in rat liver, but its inhibitory effects in human liver are not known.
Croatian: Zabilježeno je da je difenhidramin slab inhibitor aldehid-oksidaze u jetri štakora, ali nisu poznati njegovi inhibitorni učinci u jetri ljudi.
English: In a fertility and reproductive performance study in rats, mortality and decreased fertility were observed in males and females at an oral zaleplon dose of 100 mg/kg/day (equivalent to 49-times the maximum recommended human dose (MRHD) of 20 mg on a mg/m2 basis).
Croatian: Tijekom ispitivanja plodnosti i reproduktivne sposobnosti kod štakora, uočen je mortalitet i smanjenje plodnosti u mužjaka i ženki kod primjene peroralne doze zaleplona od 100 mg/kg/dan (odgovara 49 puta većoj dozi od maksimalne preporučene doze kod ljudi (engl. maximum recommended human dose, MRHD) od 20 mg, na osnovu mg/m2).
English: Zaleplon has not been adequately studied in patients with severe renal impairment.
Croatian: Zaleplon nije dovoljno ispitan u bolesnika s teškim oštećenjem funkcije bubrega.
English: Co-administration of Sonata with a single 800 mg dose of erythromycin, a strong, selective CYP3A4 inhibitor, produced a 34% increase in zaleplon's plasma concentrations.
Croatian: Istodobna primjena Sonate s jednokratnom dozom eritromicina od 800 mg, jakog, selektivnog inhibitora CYP3A4, uzrokovala je povećanje koncentracije zaleplona u plazmi za 34%.
English: Benzodiazepine and benzodiazepine-like agents should be used with extreme caution in patients with a history of alcohol or medicinal product abuse.
Croatian: Benzodiazepini i lijekovi srodni benzodiazepinima moraju se primjenjivati uz krajnji oprez u bolesnika s anamnezom zloupotrebe alkohola ili lijekova.
English: Furthermore, the co-administration of zaleplon with alcohol and other CNS depressants increases this risk (see section 4.5).
Croatian: Osim toga, istodobna primjena zaleplona sa alkoholom i drugim depresorima SŽS-a povećava taj rizik (vidjeti dio 4.5.).
English: An allergic reaction may also include a rash, itching, or swelling of the face, lips, throat or tongue.
Croatian: Alergijska reakcija može obuhvaćati osip, svrbež ili oticanje lica, usana, grla ili jezika.
English: Use of benzodiazepines and benzodiazepine-like agents may lead to physical and psychic dependence.
Croatian: Primjena benzodiazepina i lijekova srodnih benzodiazepinima može dovesti do fizičke i psihičke ovisnosti.
English: Sonata 10 mg hard capsules, which contain a light blue powder, have a white cap and white body, with pink imprint “10 mg”.
Croatian: Sonata 10 mg tvrde kapsule koje sadrže svijetloplavi prašak imaju bijelu kapicu i bijelo tijelo sa ružičastom utisnutom oznakom “10 mg”.
English: Skin and subcutaneous tissue disorders Uncommon:
Croatian: Poremećaji kože i potkožnog tkiva Manje često:
English: In Sonata studies using objective PSG measures, Sonata 10 mg was superior to placebo in decreasing sleep latency and increasing sleep duration during the first half of the night.
Croatian: U ispitivanjima Sonate u kojima su se koristila objektivna polisomnografska mjerenja, Sonata 10 mg je u odnosu na placebo bila bolja u smanjivanju vremena do usnivanja i povećavanju trajanja sna tijekom prve polovice noći.
English: Some patients taking sedative-hypnotics have had additional symptoms such as dyspnoea, throat closing, or nausea and vomiting.
Croatian: nekih bolesnika koji su uzimali sedative-hipnotike postojali su i dodatni simptomi poput dispneje, stezanja grla ili mučnine i povraćanja.
English: Sonata 5 mg hard capsules, which contain a light blue powder, have a light brown cap and white body, with gold imprint “5 mg”.
Croatian: Sonata 5 mg tvrde kapsule koje sadrže svijetloplavi prašak imaju svijetlosmeđu kapicu i bijelo tijelo sa zlatnom utisnutom oznakom “5 mg”.
English: Because zaleplon is excreted in the breast milk, Sonata should not be administered to breast-feeding mothers.
Croatian: Budući da se zaleplon izlučuje u majčino mlijeko, dojilje ne smiju primjenjivati Sonatu.
English: hyperacusis
Croatian: hiperakuzija
English: Marketing Authorisation holder: Meda AB
Croatian: Nositelj odobrenja za stavljanje u promet lijeka: Meda AB
English: Animal studies suggest that flumazenil is an antagonist to zaleplon and should be considered in the management of Sonata overdose.
Croatian: Ispitivanja na životinjama upućuju na to da je flumazenil antagonist zaleplona te se njegova primjena tijekom liječenja predoziranja Sonatom mora razmotriti.
English: Meda Pharmaceuticals Sp. z o.o.
Croatian: Polska Meda Pharmaceuticals Sp. z o.o.
English: These reactions may be active substance-induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder.
Croatian: Ove reakcije mogu biti izazvane djelatnom tvari, biti spontanog porijekla ili biti rezultat podležećeg psihičkog ili fizičkog poremećaja.
English: amnesia, paraesthesia, somnolence ataxia/coordination abnormal, dizziness, disturbance in attention, parosmia, speech disorder (dysarthria, slurred speech), hypoaesthesia
Croatian: amnezija, parestezija, somnolencija ataksija/poremećena koordinacija, omaglica, poremećaj pažnje, parosmija, poremećaj govora (dizartrija, nerazgovjetan govor), hipoestezija
English: If you experience these events, contact your doctor immediately.
Croatian: Ako doživite ove događaje, odmah se javite svom liječniku.
English: If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal.
Croatian: Ako angioedem zahvaća jezik, glotis ili grkljan može doći do opstrukcije dišnih puteva koja može biti smrtonosna.
English: If you are in any doubt about whether you have any of these conditions, do ask your doctor.
Croatian: Ako niste sigurni imate li neko od ovih stanja, posavjetujte se sa svojim liječnikom.
English: Overdose of benzodiazepine or benzodiazepine-like agents is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma.
Croatian: Simptomi predoziranja Predoziranje benzodiazepinima ili lijekovima srodnim benzodiazepinima obično se manifestira stupnjevima depresije središnjeg živčanog sustava od omamljenosti do kome.
English: In embryofetal development studies, oral administration of zaleplon up to 100 mg/kg/day and 50 mg/kg/day to pregnant rats and rabbits, respectively, produced no evidence of teratogenicity (equivalent to 49- (rat) and 48-(rabbit) times the MRHD on a mg/m2 basis).
Croatian: Tijekom ispitivanja embriofetalnog razvoja, peroralna primjena zaleplona do 100 mg/kg/dan kod gravidnih štakora, odnosno 50 mg/kg/dan kod gravidnih kunića, nije dokazala teratogenost (odgovara primjeni 49 puta (štakor) i 48 puta (kunić) veće doze od MRHD, na osnovu mg/m2).
English: Zaleplon is metabolised primarily by the liver and undergoes significant presystemic metabolism.
Croatian: Zaleplon se primarno metabolizira putem jetre i podliježe značajnom predsistemskom metabolizmu.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON, TEXT FOR SONATA 5 MG - PACK SIZES 7, 10 AND 14 CAPSULES
Croatian: PODACI KOJI SE MORAJU NALAZITI NA KUTIJI KAO VANJSKOM PAKIRANJU, TEKST ZA SONATU OD 5 MG - VELIČINE PAKIRANJA OD 7, 10 I 14 KAPSULA
English: Benzodiazepines and benzodiazepine-like agents may induce anterograde amnesia and psychomotor impairment.
Croatian: Benzodiazepini i lijekovi srodni benzodiazepinima mogu izazvati anterogradnu amneziju i psihomotorni poremećaj.
English: In patients with mild to moderate hepatic insufficiency, the bioavailability of zaleplon is increased because of reduced clearance, and the dose will therefore need to be modified in these patients.
Croatian: U bolesnika s blagim do umjerenim oštećenjem funkcije jetre, bioraspoloživost zaleplona je povećana zbog smanjenog klirensa, stoga je u ovih bolesnika potrebna prilagodba doze.
English: Dr. Franje Tudmana 3 10431 Sveta Nedelja Tel: +385 1 3374 010
Croatian: Medical Intertrade d.o.o. Dr. Franje Tuđmana 3 10431 Sveta Nedelja Tel: +385 1 3374 010
English: Concomitant use of zaleplon with these drugs may increase the risk of next day drowsiness, including impaired driving ability (see section 4.7).
Croatian: Istodobna primjena zaleplona s tim lijekovima može povećati rizik od omamljenosti sljedeći dan, uključujući i poremećaj sposobnosti upravljanja vozilima (vidjeti dio 4.7).
English: They may be active substance-induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder.
Croatian: One mogu biti izazvane djelatnom tvari, biti spontanog porijekla ili biti rezultat podležećeg psihičkog ili fizičkog poremećaja.
English: Severe renal impairment is contraindicated (see section 4.3.
Croatian: Primjena kod teškog oštećenja funkcije bubrega je kontraindicirana (vidjeti dio 4.3.).
English: Zaleplon is primarily metabolised by aldehyde oxidase to form 5-oxo-zaleplon.
Croatian: Zaleplon se primarno metabolizira putem aldehid-oksidaze u 5-okso-zaleplon.
English: An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue, or nausea and vomiting.
Croatian: Alergijska reakcija može uključivati osip, svrbež, otežano disanje ili oticanje lica, usana, grla ili jezika ili mučninu i povraćanje.
English: United Kingdom Meda Pharmaceuticals Ltd. Skyway House Parsonage Road Takeley
Croatian: Skyway House Parsonage Road Takeley
English: LIST OF EXCIPIENTS Also contains: lactose monohydrate See leaflet for further information.
Croatian: Također sadrži: laktozu hidrat Vidjeti Uputu o lijeku za dodatne informacije.
English: How to take Sonata
Croatian: Kako uzimati Sonatu
English: Oral administration of zaleplon to rats for 104 consecutive weeks at dosage levels up to 20 mg/kg/day did not result in compound-related tumorigenicity.
Croatian: Perralna primjena zaleplona kod štakora tijekom 104 uzastopna tjedna pri razini doze do 20 mg/kg/dan nije rezultirala tumorogenošću vezanom uz lijek.
English: Additionally, zaleplon is metabolised by CYP3A4 to form desethylzaleplon which is further metabolised by aldehyde oxidase to form 5-oxo-desethylzaleplon.
Croatian: Pored toga, zaleplon se metabolizira i putem CYP3A4 u dezetilzaleplon, koji se dalje metabolizira putem aldehid-oksidaze u 5-okso-dezetilzaleplon.
English: The no-effect dose for postnatal development was 1 mg/kg/day (equivalent to 0.5-times the MRHD on a mg/m2 basis).
Croatian: Doza koja nije imala učinak na postnatalni razvoj iznosila je 1 mg/kg/dan (odgovara 0,5 puta većoj dozi od MRHD, na osnovu mg/m2).
English: Sleep latency in outpatient studies was decreased for up to 4 weeks in non-elderly patients with Sonata 10 mg.
Croatian: Vrijeme do usnivanja u ispitivanjima ambulantnih bolesnika bilo je smanjeno tijekom do 4 tjedna primjene Sonate od 10 mg u bolesnika koji nisu bili stariji.
English: Due to zaleplon's short plasma half-life, alternative therapy should be considered if early morning awakening is experienced.
Croatian: Zbog kratkog poluvijeka zaleplona u plazmi, u slučaju ranog jutarnjeg buđenja potrebno je razmotriti primjenu drugog lijeka.
English: Grounds recommending the variation to the terms of the Marketing Authorisation On the basis of the scientific conclusions for zaleplon the CHMP is of the opinion that the benefit-risk balance of the medicinal product containing zaleplon is favourable subject to the proposed changes to the product information
Croatian: Na temelju znanstvenih zaključaka za zaleplon, CHMP smatra da je omjer koristi i rizika za lijek koji sadrži djelatnu tvar zaleplon povoljan, uz predložene izmjene informacija o lijeku.
English: INFORMATION IN BRAILLE Sonata 10 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Sonata 10 mg
English: In contrast, rifampicin, a strong inducer of several hepatic enzymes, including CYP3A4 resulted in a four fold reduction in zaleplon plasma concentration.
Croatian: Suprotno tome, rifampicin, snažni induktor nekoliko jetrenih enzima, uključujući CYP3A4, doveo je do četverostrukog smanjenjem koncentracije zaleplona u plazmi.
English: If affected do not drive or operate machinery.
Croatian: Ako ste pod utjecajem lijeka, nemojte upravljati vozilima niti raditi sa strojevima.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU
English: If the medicinal product is prescribed to a woman of child-bearing potential, she should be warned to contact her physician regarding discontinuance of the medicinal product if she intends to become or suspects that she is pregnant.
Croatian: Ako se lijek propiše ženi u reproduktivnoj dobi, potrebno ju je upozoriti da se, ako ima namjeru ostati trudna ili u slučaju sumnje na trudnoću, obrati svom liječniku zbog prekida primjene lijeka.
English: dysmenorrhea
Croatian: dismenoreja
English: Nervous system disorders Common:
Croatian: Poremećaji živčanog sustava Često:
English: Talk to your doctor or pharmacist before taking Sonata.
Croatian: Obratite se svojem liječniku ili ljekarniku prije nego uzmete Sonatu • Tijekom liječenja Sonatom nikad ne konzumirajte alkohol.
English: In elderly patients, sleep latency was often significantly decreased with Sonata 5 mg and was consistently decreased with Sonata 10 mg compared with placebo in 2-week studies.
Croatian: U ispitivanjima starijih bolesnika u trajanju od 2 tjedna, vrijeme do usnivanja često je bilo znatno smanjeno kod primjene Sonate od 5 mg te se konzistentno smanjivalo kod primjene Sonate od 10 mg u usporedbi s placebom.
English: If you suffer from these symptoms, ask your doctor for advice.
Croatian: Ako imate ove simptome, posavjetujte se sa svojim liječnikom.
English: Once physical dependence has developed, abrupt termination of treatment may be accompanied by withdrawal symptoms.
Croatian: Nakon razvijanja fizičke ovisnosti, nagli prekid liječenja može biti popraćen simptomima apstinencije.
English: INFORMATION IN BRAILLE Sonata 5 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Sonata 5 mg
English: These events can occur in sedative-hypnotic-naive as well as in sedative-hypnotic experienced persons.
Croatian: Navedeno se može dogoditi u osoba koje prvi put uzimaju sedativ-hipnotik kao i u osoba koje su se već liječile sedativom-hipnotikom.
English: Complex behaviours such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported in patients taking sedativehypnotics.
Croatian: U bolesnika koji su uzimali sedative-hipnotike zabilježena su kompleksna ponašanja kao što su “vožnja u snu” (tj. vožnja u stanju nepotpune budnosti nakon uzimanja sedativa-hipnotika, s amnezijom o događaju).
English: The sedative effect may be enhanced when the product is used in combination with alcohol which may affect the ability to drive or use machines the next day (see section 4.7).
Croatian: Kada se lijek uzima u kombinaciji s alkoholom sedativni učinak se može pojačati što može utjecati na sposobnost upravljanja vozilima ili rada sa strojevima sljedeći dan (vidjeti dio 4.7).
English: The no-effect dose for growth of rat offspring was 10 mg/kg (equivalent to 5-times the MRHD on a mg/m2 basis).
Croatian: Doza koja nije imala učinak na rast mladunčadi štakora iznosila je 10 mg/kg (odgovara 5 puta većoj dozi od MRHD, na osnovu mg/m2).
English: Zaleplon plasma concentrations increased linearly with dose, and zaleplon showed no signs of accumulation following administration of up to 30 mg/day.
Croatian: Koncentracije zaleplona u plazmi linearno se povećavaju s dozom, a nakon primjene do 30 mg/dnevno, zaleplon nije pokazao znakove akumulacije.
English: Caution should be observed when prescribing sedative medicinal products to patients with chronic respiratory insufficiency.
Croatian: Kod propisivanja sedativnih lijekova bolesnicima s kroničnom respiratornom insuficijencijom potreban je oprez.
English: A transient syndrome whereby the symptoms that led to the treatment with a benzodiazepine or benzodiazepine-like agent recur in an enhanced form, may occur on withdrawal of treatment.
Croatian: Kod ustezanja liječenja može doći do prolaznog sindroma kod kojeg se simptomi koji su doveli do liječenja benzodiazepinima ili lijekova srodnih benzodiazepinima vraćaju u pojačanom obliku.
English: Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms.
Croatian: Nakon razvijanja fizičke ovisnosti, nagli prekid liječenja popratit će simptomi ustezanja.
English: There have been post-marketing reports of dependence associated with zaleplon, predominantly in combination with other psychotropic agents.
Croatian: Nakon stavljanja lijeka u promet zabilježeni su slučajevi ovisnosti povezani s primjenom zaleplona, pretežno kada se kombinira s drugim psihotropnim tvarima.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 5 mg of zaleplon.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka kapsula sadrži 5 mg zaleplona.
English: Patients who develop angioedema after treatment with zaleplon should not be rechallenged with the active substance.
Croatian: U bolesnika u kojih se nakon liječenja zaleplonom razvio angioedem, djelatna tvar se ne smije ponovno primjenjivati.
English: The majority of the faecal recovery consists of 5-oxo-zaleplon.
Croatian: Većinu lijeka izlučenog u stolici čini 5-okso-zaleplon.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 10 mg of zaleplon.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka kapsula sadrži 10 mg zaleplona.
English: If you have any further questions, please consult your doctor or pharmacist.
Croatian: Ako imate bilo kakvih dodatnih pitanja, molimo obratite se svom liječniku ili ljekarniku.
English: Therefore, no dose adjustment is necessary in patients with mild to moderate renal impairment.
Croatian: Stoga nije potrebna prilagodba doze u bolesnika s blagim do umjerenim oštećenjem funkcije bubrega.
English: Abuse of benzodiazepines and benzodiazepine-like active substances has been reported.
Croatian: Zabilježena je zloupotreba benzodiazepina i lijekova srodnih benzodiazepinima.