natgillin/translations-raw huggingface dataset:
They may be active substance-induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. 
Lahko jih sproži zdravilna učinkovina, lahko nastanejo spontano ali pa kot posledica prikrite psihične ali telesne motnje.
Zaleplon binds selectively to the benzodiazepine type I receptor. 
Zaleplon se selektivno veže na benzodiazepinske receptorje tipa I.
Capsule, hard. 
Trda kapsula.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON, TEXT FOR SONATA 10 MG - PACK SIZES 7, 10 AND 14 CAPSULES 
PODATKI NA ZUNANJI OVOJNINI BESEDILO ZA SONATA 10 MG - VELIKOSTI PAKIRANJ 7, 10 IN 14 KAPSUL
How to take Sonata 
Kako jemati zdravilo Sonata
INFORMATION IN BRAILLE Sonata 10 mg 
PODATKI V BRAILLOVI PISAVI Sonata 10 mg
Patients who develop angioedema after treatment with zaleplon should not be rechallenged with the active substance. 
Bolniki, pri katerih se po zdravljenju z zaleplonom pojavi angioedem, te zdravilne učinkovine ne smejo več dobiti.
Do not try and catch up on the doses you have missed. 
Ne poskušajte nadomestiti izpuščenih odmerkov.
No dosage adjustment is required in patients with mild to moderate renal insufficiency, because Sonata pharmacokinetics is not altered in such patients. 
Pri bolnikih z blago do zmerno ledvično insuficienco ni potrebna prilagoditev odmerka, ker farmakokinetika zdravila Sonata pri teh bolnikih ni spremenjena.
INFORMATION IN BRAILLE Sonata 5 mg 
PODATKI V BRAILLOVI PISAVI Sonata 5 mg
10 hard capsules 
10 trdih kapsul
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. 
Kancerogenost Peroralno dajanje zaleplona podganam v obdobju 104 zaporednih tednov v odmerkih do 20 mg/kg/dan ni povzročilo tumorogenih učinkov, povezanih s to spojino.
• Do not use a second dose of Sonata within a single night. 
• Ne vzemite drugega odmerka v isti noči.
The most frequent reported adverse drug reactions are amnesia, paraesthesia, somnolence and dysmenorrhea. 
4.8 Neželeni učinki Najpogostejši neželeni učinki so amnezija, parestezija, somnolenca in dismenoreja.
• if you have sleep apnoea syndrome (stopping breathing for short periods while asleep). 
če med spanjem večkrat prenehate dihati za kratek čas).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON, TEXT FOR SONATA 5 MG - PACK SIZES 7, 10 AND 14 CAPSULES 
PODATKI NA ZUNANJI OVOJNINI BESEDILO ZA ZDRAVILO SONATA 5 MG - VELIKOSTI PAKIRANJ 7, 10 IN 14 KAPSUL
Oral use 
Peroralna uporaba
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. 
Pri bolnikih, ki jemljejo sedative/hipnotike, poročajo o oblikah kompleksnega vedenja, kakršna je “vožnja v polsnu” (tj., upravljanje motornega vozila v ne povsem budnem stanju po zaužitju sedativa-hipnotika in s poznejšo amnezijo za ta dogodek).
The remainder of the urinary recovery consists of minor metabolites. 
Preostali del izločanja zdravila s sečem je v obliki manj pomembnih presnovkov.
What you need to know before you take Sonata 
Kaj morate vedeti, preden boste vzeli zdravilo Sonata Ne jemljite zdravila Sonata
There is limited clinical experience with the effects of an acute overdose of Sonata, and overdose levels in humans have not been determined. 
Klinične izkušnje z učinki akutnega prevelikega odmerka zdravila Sonata so omejene.
Cimetidine, a non-specific moderate inhibitor of several hepatic enzymes including both aldehyde oxidase and CYP3A4, produced an 85% increase in plasma concentrations of zaleplon because it inhibited both the primary (aldehyde oxidase) and secondary (CYP3A4) enzymes responsible for zaleplon's metabolism. 
Cimetidin, nespecifičen zmerni zaviralec nekaterih jetrnih encimov, vključno z aldehidno oksidazo in CYP3A4, je povzročil 85% povečanje koncentracije zaleplona v plazmi, ker je zaviral tako primarni encim
Uncommon side effects include: dizziness; weakness; reduced coordination of movements; unsteadiness and/or falls (ataxia); decreased concentration; apathy; restlessness; depression; agitation; irritability; confusion; abnormal thinking and behaviour (extroversion that seems out of character, decreased inhibition, aggressiveness, rages, delusion, depersonalisation, psychosis); nightmares; hallucinations; double vision or other sight problems; increased sensitivity to noise (hyperacusis); smell disorder (parosmia); speech disorders, including slurred speech; numbness, e.g. in the extremities (hypoaesthesia); nausea; decreased appetite; increased sensitivity to light (sunlight, UV light); feeling vaguely ill (malaise). 
Občasni neželeni učinki: omotičnost, šibkost, zmanjšana koordinacija gibov, negotovost in/ali padci (ataksija), zmanjšana koncentracija, apatija, nemir, depresija, vznemirjenos, razdražljivost, zmedenost, nenormalno mišljenje in obnašanje (ekstrovertnost, ki se zdi pretirana, popustitev zavor, agresivnost, bes, prividi, depersonalizacija, psihoza), nočne more, halucinacije, dvojni vid ali druge motnje vida, povečana občutljivost za zvok (hiperakuzija), motnje voha (parosmija), motnje govora, vključno z nerazločnim izgovarjanjem,,otopelost, npr. v okončinah (hipoestezija), slabost, zmanjšan apetit, povečana občutljivost za svetlobo (sončno svetlobo, UV svetlobo), slabo počutje (občutek bolehnosti).
In a subsequent cross-fostering study, adverse effects on offspring viability and growth appeared to result from both in utero and lactational exposure to zaleplon. 
V nadaljnji t.i. cross-fostering študiji (v kateri so prenesli mladiče iz enega legla v drugega) se je zdelo, da so neželeni učinki na sposobnost za preživetje mladičev in njihovo rast posledica izpostavljenosti zaleplonu tako v maternici kot med laktacijo.
Depression Pre-existing depression may be unmasked during benzodiazepine or benzodiazepine-like agent use. 
Obstoječa latentna depresija lahko postane vidna med uporabo benzodiazepinov ali njim sorodnih učinkovin.
Capsules have an opaque white hard shell with the strength “10 mg”. 
Kapsule imajo neprozorno belo trdo ovojnico z jakostjo »10 mg«.
PVC / PVDC aluminium blister packages of 7, 10, 14 capsules in perforated unit-dose blisters. 
Pretisni omoti iz PVC/PVDC in aluminija s po 7, 10 ali 14 kapsulami.
Use of benzodiazepines and benzodiazepine-like agents may lead to physical and psychic dependence. 
Uporaba benzodiazepinov in njim sorodnih učinkovin lahko privede do telesne in duševne odvisnosti.
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) 
pogosti (pojavijo se lahko pri 1 do 10 bolnikov od 100 bolnikov) občasni (pojavijo se lahko pri 1 do 10 bolnikov od 1000 bolnikov) redki (pojavijo se lahko pri 1 do 10 bolnikov od 10.000 bolnikov) zelo redki (pojavijo se lahko pri manj kot 1 bolniku od 10.000 bolnikov)
Capsules have an opaque white and opaque light brown hard shell with the strength “5 mg”. 
Kapsule imajo neprozorno belo in neprozorno svetlo rjavo trdo ovojnico z jakostjo »5 mg«.
Severe renal impairment is contraindicated (see section 4.3. 
Pri hudi ledvični okvari je kontraindicirano (glejte poglavje
Pregnancy and breast-feeding 
Nosečnost, dojenje in plodnost
These medicines include: substances used in the treatment of mental conditions (antipsychotics, hypnotics, anxiolytics/sedatives, antidepressants), medicines used for strong pain relief (narcotic analgesics), medicines used for the treatment of seizures/convulsions (antiepileptic medicines), medicines used for loss of feeling/ insensibility (anaesthetics), and medicines used in the treatment of allergies (sedative antihistamines). 
Med tovrstna zdravila sodijo: substance, ki se uporabljajo pri zdravljenju duševnih bolezni (antipsihotiki, hipnotiki, anksiolitiki/sedativi, antidepresivi), močna protibolečinska zdravila (narkotični analgetiki), zdravila za zdravljenje epileptičnih napadov oz. konvulzij (antiepileptična zdravila), anestetiki in zdravila za zdravljenje alergij (sedativni antihistaminiki).
The no-effect dose for postnatal development was 1 mg/kg/day (equivalent to 0.5-times the MRHD on a mg/m2 basis). 
Odmerek brez učinka na poporodni razvoj je bil 1 mg/kg/dan (kar ustreza 0,5-kratniku MRHD, izračunano v mg/m2).
The no-effect dose for growth of rat offspring was 10 mg/kg (equivalent to 5-times the MRHD on a mg/m2 basis). 
Odmerek brez učinka na rast podganjih mladičev je bil 10 mg/kg (kar ustreza 5-kratniku MRHD, izračunano v mg/m2).
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE
NAME OF THE MARKETING AUTHORISATION HOLDER Meda AB 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Meda AB
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 the available data) 
Pogostnosti so definirane kot: Zelo pogosti (≥1/10) Pogosti (≥1/100 do <1/10) Občasni (≥1/1.000 do <1/100) Redki (≥1/10.000 do <1/1.000) Zelo redki (<1/10.000)
Printing inks on the shell contain the following (gold ink SB-3002): shellac, ammonium hydroxide, yellow iron oxide (E172). 
Tiskarska črnila na ovojnici kapsule vsebujejo naslednje snovi (zlato črnilo SB-3002): šelak, amonijev hidroksid, rumeni železov oksid (E172).
What Sonata contains 
Kaj vsebuje zdravilo Sonata
C. OTHER CONDITIONS AND REQUIREMENTS OF THE D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE 
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z
Attention to airway patency and supportive management of ventilation and haemodynamics are usually sufficient. 
Običajno zadošča skrb za prehodnost dihalnih poti in zagotavljanje podpore dihanju in hemodinamiki.
Sonata 5 mg hard capsules, which contain a light blue powder, have a light brown cap and white body, with gold imprint “5 mg”. 
Izgled zdravila Sonata in vsebina pakiranja Sonata 5 mg trde kapsule, ki vsebujejo svetlo moder prašek, imajo svetlo rjav pokrovček in belo telo z zlatim odtisom »5 mg«.
The other ingredients are microcrystalline cellulose, pregelatinised starch, silicon dioxide, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide (E171). 
Druge sestavine so mikrokristalna celuloza, predgeliran škrob, silicijev dioksid, natrijev lavrilsulfat, magnezijev stearat, laktoza monohidrat, indigo karmin (E132), titanov dioksid (E171).
Talk to your doctor or pharmacist before taking Sonata. 
Pred začetkom jemanja zdravila Sonata se posvetujte z zdravnikom ali farmacevtom.
Reproductive system and breast disorders Common: 
Motnje reprodukcije in dojk Pogosto:
Zaleplon has not been adequately studied in patients with severe renal impairment. 
Zaleplona niso ustrezno testirali pri bolnikih s hudo ledvično okvaro.
anaphylactic/anaphylactoid reactions 
anafilaktične / anafilaktoidne reakcije
The majority of the faecal recovery consists of 5-oxo-zaleplon. 
Večino količine zdravila, izločene v blato, sestavlja 5-okso-zaleplon.
Once physical dependence has developed, abrupt termination of treatment may be accompanied by withdrawal symptoms. 
Če se razvije odvisnost, se lahko pri nenadni prekinitvi zdravljenja pojavijo odtegnitveni simptomi.
In patients with mild to moderate renal impairment, the pharmacokinetic profile of zaleplon is not significantly different than that in healthy subjects. 
Pri bolnikih z blago do zmerno ledvično okvaro farmakokinetski profil zaleplona ni pomembno drugačen kot pri zdravih osebah, zato pri teh bolnikih odmerka ni treba prilagajati.
Furthermore, the co-administration of zaleplon with alcohol and other CNS depressants increases this risk (see section 4.5). 
To tveganje povečuje tudi sočasna uporaba zaleplona z alkoholom in drugimi zaviralci osrednjega živčevja (glejte poglavje 4.5).
If you experience these events, contact your doctor immediately. 
Če se vam zgodi kaj takega, se nemudoma posvetujte z zdravnikom.
If you are in any doubt about whether you have any of these conditions, do ask your doctor. 
Če sumite, da imate morda katero izmed zgoraj navedenih bolezni, se posvetujte s svojim zdravnikom.
Cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including zaleplon. 
Po zaužitju prvega ali kakšnega poznejšega odmerka sedativov/hipnotikov, vključno z zaleplonom, so poročali o primerih angioedema jezika, glotisa ali larinksa.
Printing inks on the shell contain the following (pink ink SW-1105): shellac, titanium dioxide (E171), ammonium hydroxide, red iron oxide (E172), yellow iron oxide (E172). 
Tiskarska črnila na ovojnici kapsule vsebujejo naslednje snovi (rožnato črnilo SW-1105): šelak, titanov dioksid (E171), amonijev hidroksid, rdeči železov oksid (E172), rumeni železov oksid (E172).
Side effects that may occur commonly: drowsiness; memory difficulties; sensations like tingling, e.g. in the extremities (paraesthesia); painful menstruation. 
neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) Pogosti neželeni učinki: dremavost/zaspanost, težave s spominom, občutki kot so mravljinci, npr. v okončinah (parestezije), boleča menstruacija.
MARKETING AUTHORISATION NUMBERS EU/1/99/102/001-003 
ŠTEVILKE DOVOLJENJ ZA PROMET Z ZDRAVILOM EU/1/99/102/001-003
These events can occur in sedative-hypnotic-naive as well as in sedative-hypnotic experienced persons. 
Ti dogodki se lahko pojavijo tako pri bolnikih, ki sedativa/hipnotika prej še nikoli niso vzeli, kot tudi pri tistih, ki ga že jemljejo.
In line with effects observed with other compounds binding to benzodiazepine receptors, reversible increases in liver and adrenal weights in rats and dogs were only noted upon repeated oral administration of high multiples of the maximum human therapeutic dose. 
Reverzibilno povečanje mase jeter in nadledvičnih žlez pri podganah in psih je bilo opaženo šele po večkratni peroralni uporabi visokih večkratnikov največjega terapevtskega odmerka za ljudi, kar je v skladu z učinki drugih zdravil, ki se vežejo na benzodiazepinske receptorje.
MARKETING AUTHORISATION NUMBERS EU/1/99/102/004-006 
ŠTEVILKE DOVOLJENJ ZA PROMET Z ZDRAVILOM EU/1/99/102/004-006
If you have any further questions, please consult your doctor or pharmacist. 
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
S-170 73 Solna 
S-170 09 Solna Švedska
This medicine has been prescribed for you. 
- Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
Co-administration of Sonata with medicinal products known to influence CYP3A4 is expected to result in changes in zaleplon's plasma concentrations. 
Sočasno odmerjanje zdravila Sonata z zdravili, ki vplivajo na izoencim CYP3A4, lahko povzroči spremembe koncentracije zaleplona v plazmi (glejte poglavje 4.5).
Severe renal impairment 
Huda ledvična okvara
Uncommon: 
Pogosto:
Sonata has been shown to preserve sleep stages in controlled studies that measured the percentage of sleep time spent in each sleep stage. 
V kontroliranih raziskavah za merjenje odstotka trajanja spanja v posameznih fazah spanja se je izkazalo, da zdravilo Sonata ohrani faze spanja.
Ingredients of the capsule shell: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172) and sodium lauryl sulphate. 
Sestavine ovojnice kapsule: želatina, titanov dioksid (E171), rdeči železov oksid (E172), rumeni železov oksid (E172), črni železov oksid (E172) in natrijev lavrilsulfat.
Psychiatric disorders Uncommon: 
Psihiatrične motnje Občasno:
How to store Sonata 
Shranjevanje zdravila Sonata
The active substance in each Sonata hard capsule is zaleplon 10 mg. 
Zdravilna učinkovina: v eni trdi kapsuli Sonata je 10 mg zaleplona.
Use (even at therapeutic doses) may lead to the development of physical dependence: discontinuation of therapy may result in withdrawal or rebound phenomena (see section 4.4). 
prekinitev terapije lahko povzroči odtegnitvene simptome ali povratni fenomen (glejte poglavje 4.4).
If you experience any of these events, contact your doctor immediately. 
Če pri sebi opazite kaj od naštetega, se nemudoma posvetujte z zdravnikom.
The active substance in each Sonata hard capsule is zaleplon 5 mg. 
Zdravilna učinkovina: v eni trdi kapsuli Sonata je 5 mg zaleplona.
As clearance is reduced, patients with mild to moderate hepatic impairment should be treated with Sonata 5 mg. For severe hepatic impairment see section 4.3. 
Ker je očistek zdravila zmanjšan, morate bolnike z blago do zmerno jetrno okvaro zdraviti z zdravilom Sonata
MARKETING AUTHORISATION NUMBER(S) EU/1/99/102/004 7 capsules 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/99/102/004 7 kapsul
amnesia, paraesthesia, somnolence ataxia/coordination abnormal, dizziness, disturbance in attention, parosmia, speech disorder (dysarthria, slurred speech), hypoaesthesia 
Glejte tudi spodaj pod amnezijo amnezija, parestezije, zaspanost ataksija/nekoordiniranost gibov, vrtoglavica, zmanjšana koncentracija, parosmija; motnje govora (dizartrija,
Excipient with known effect: Lactose monohydrate 54 mg. For the full list of excipients, see section 6.1. 
Pomožne snovi z znanim učinkom: 54 mg laktoze monohidrata
An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue, or nausea and vomiting. 
Alergijska reakcija lahko obsega izpuščaj, srbenje, oteženo dihanje ali otekanje obraza, ustnic, žrela ali jezika ali slabost in bruhanje Če pri sebi opazite kaj od naštetega, se nemudoma posvetujte z zdravnikom.
Chromaturia (bluegreen urine discolouration) has been reported with zaleplon overdose. 
Pri prevelikem odmerjanju zaleplona so poročali o kromaturiji (modro-zelena obarvanost urina).
Sonata 5 mg hard capsules zaleplon 
Sonata 5 mg trde kapsule zaleplon
Other complex behaviours (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. 
Pri bolnikih, ki po tistem, ko vzamejo sedativ/hipnotik, niso povsem budni, so poročali še o drugih vrstah kompleksnega vedenja (npr. priprava in uživanje hrane, telefoniranje ali spolno občevanje).
Reactions like restlessness, agitation, irritability, decreased inhibition, aggressiveness, abnormal thinking, delusions, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour, extroversion that seems out of character, and other adverse behavioural reactions are known to occur when using benzodiazepines or benzodiazepine-like agents. 
Reakcije kot so nemir, vznemirjenost, razdražljivost, popustitev zavor, agresivnost, nenormalno mišljenje, zablode, bes, nočne more, občutki depersonalizacije, halucinacije, psihoza, neprimerno vedenje, ekstrovertnost, ki se zdi pretirana, ter druge neželene vedenjske reakcije se lahko pojavijo ob uporabi benzodiazepinov ali njim sorodnih učinkovin.
Some loss of efficacy to the hypnotic effects of short-acting benzodiazepines and benzodiazepine-like agents may develop after repeated use for a few weeks. 
Po nekajtedenski zaporedni uporabi lahko nastopi zmanjšanje uspavalnega učinka kratkotrajno delujočih benzodiazepinov in njim sorodnih učinkovin.
MARKETING AUTHORISATION NUMBER(S) EU/1/99/102/001 7 capsules 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/99/102/001 7 kapsul
Ingredients of the capsule shell: gelatin, titanium dioxide (E171) and sodium lauryl sulphate. 
Sestavine ovojnice kapsule: želatina, titanov dioksid (E171) in natrijev lavrilsulfat.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.V tem primeru ne smete jemati zdravila Sonata, saj ni na voljo dovolj kliničnih podatkov za oceno varnosti jemanja zdravila Sonata med nosečnostjo.
EU/1/99/102/002 10 capsules EU/1/99/102/003 14 capsules 
EU/1/99/102/003 14 kapsul
• Reactions like restlessness, agitation, irritability, aggressiveness, abnormal thinking, delusion, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour, extroversion that seems out of character and other behavioural effects have been reported following use of any medicines belonging to the sleep inducing group, including Sonata. 
besnost, nočne more, depersonalizacija, halucinacije, psihoze, neprimerno vedenje, ekstrovertiranost, ki se zdi pretirana, in drugi vedenjski učinki pri uporabi katerih koli zdravil, ki spadajo med uspavala, tudi zdravila Sonata.
EU/1/99/102/005 10 capsules EU/1/99/102/006 14 capsules 
EU/1/99/102/006 14 kapsul
Severe respiratory insufficiency 
Hude težave z dihanjem
Therefore, no dose adjustment is necessary in patients with mild to moderate renal impairment. 
Pri bolnikih z blago do zmerno ledvično okvaro torej ni treba prilagajati odmerka.
NAME OF THE MEDICINAL PRODUCT Sonata 10 mg hard capsules 
IME ZDRAVILA Sonata 10 mg trde kapsule
NAME OF THE MEDICINAL PRODUCT Sonata 5 mg hard capsules 
IME ZDRAVILA Sonata 5 mg trde kapsule
Therapy of overdose 
Zdravljenje prevelikega odmerjanja
Sonata 10 mg hard capsules zaleplon 
Sonata 10 mg trde kapsule zaleplon
Capsule shell gelatin, titanium dioxide (E171), sodium lauryl sulphate, 
Ovojnica kapsule: želatina titanov dioksid (E171) natrijev lavrilsulfat
Sleep apnoea syndrome 
Sindrom apneje v spanju
Microcrystalline cellulose, pregelatinised starch, silicon dioxide, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide (E171). 
Jedro kapsule: mikrokristalna celuloza predgeliran škrob silicijev dioksid natrijev lavrilsulfat magnezijev stearat laktoza monohidrat indigo karmin (E132) titanov dioksid (E171)
Do not go unaccompanied to seek medical help. 
Če rabite zdravniško pomoč, obiščite zdravnika s spremstvom.
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. 
V študiji prenatalnega in postnatalnega razvoja pri podganah so pri potomcih samic, zdravljenih z odmerkom
QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 5 mg of zaleplon. 
Vsaka kapsula vsebuje 5 mg zaleplona.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 10 mg of zaleplon. 
Vsaka kapsula vsebuje 10 mg zaleplona.
Rebound insomnia and anxiety 
Povrnitev nespečnosti in tesnoba
Excipient with known effect: Lactose monohydrate 49 mg. For the full list of excipients, see section 6.1. 
Pomožne snovi z znanim učinkom: 49 mg laktzoze monohidrata
NAME OF THE MEDICINAL PRODUCT Sonata 5 mg hard capsules zaleplon 
IME ZDRAVILA Sonata 5 mg trde kapsule zaleplon
NAME OF THE MEDICINAL PRODUCT Sonata 10 mg hard capsules zaleplon 
IME ZDRAVILA Sonata 10 mg trde kapsule zaleplon
Hepatic impairment 
Očesne bolezni
If you have any further questions, ask your doctor or pharmacist. 
V primeru dodatnih vprašanj se posvetujte z zdravnikom ali farmacevtom.
Capsule shell gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), sodium lauryl sulphate, 
Ovojnica kapsule: želatina titanov dioksid (E171) rdeči železov oksid (E172) rumeni železov oksid (E172)
Severe anaphylactic/anaphylactoid reactions have been reported with the use of sedative-hypnotics, including zaleplon. 
Pri jemanju sedativov/hipnotikov, vključno z zaleplonom, so poročali o hudih anafilaktičnih/anafilaktoidnih reakcijah.
Ear and labyrinth disorders Uncommon: 
Ušesne bolezni,vključno z motnjami labirinta Občasno: