natgillin/translations-raw huggingface dataset:
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).
Če se zdravilo uporablja v kombinaciji z alkoholom, se lahko poveča sedativni učinek, kar lahko vpliva na sposobnost vožnje ali upravljanja s stroji naslednji dan (glejte poglavje 4.7).
The single dose pharmacokinetics of zaleplon were studied in patients with mild (creatinine clearance 40 to 89 ml/min) and moderate (20 to 39 ml/min) renal impairment, and in patients on dialysis.
Farmakokinetiko enkratnega odmerka zaleplona so preučevali pri bolnikih z blago (očistek kreatinina 40 do 89 ml/min) in zmerno (20 do 39 ml/min) ledvično okvaro ter pri bolnikih na dializi.
Repeated dose toxicity
Toksičnost pri ponavljajočih odmerkih
Caution should be observed when prescribing sedative medicinal products to patients with chronic respiratory insufficiency.
Pri predpisovanju sedativnih zdravil bolnikom s kronično respiratorno insuficienco je potrebna previdnost.
As administration after food delays the time to maximal plasma concentration by approximately 2 hours no food should be eaten with or shortly before intake of Sonata.
Ker jemanje zdravila po hrani zadrži nastop maksimalne koncentracije v plazmi za približno 2 uri, ne uživajte hrane ob jemanju ali neposredno pred jemanjem zdravila Sonata.
Consequently, the oral clearance of zaleplon was reduced by 70% and 87% in compensated and decompensated cirrhotic patients, respectively, leading to marked increases in mean Cmax and AUC (up to 4-fold and 7-fold in compensated and decompensated patients, respectively) relative to healthy subjects.
Zaradi tega je bil peroralni očistek zaleplona zmanjšan za 70% oziroma 87% pri bolnikih s kompenzirano in dekompenzirano cirozo ter je povzročil izrazito povečanje povprečne vrednosti Cmax in AUC (do 4-kratno povečanje oz. 7kratno povečanje pri bolnikih s kompenzirano oziroma dekompenzirano cirozo) glede na zdrave preiskovance.
In mild cases, symptoms include drowsiness, mental confusion, and lethargy, in more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, rarely coma and very rarely death.
V blagih primerih so med simptomi zaspanost, mentalna zmedenost in letargija, v resnejših primerih pa ataksija, hipotonija, hipotenzija, depresija dihanja, redko koma in zelo redko smrt.
In severe cases the following symptoms may occur: unreality, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.
V hudih primerih se lahko pojavijo naslednji simptomi: neresničnost, depersonalizacija, hiperakuzija, otopelost in mravljinci v okončinah, preobčutljivost za svetlobo, hrup in telesni stik, halucinacije ali epileptični napadi.
Therefore, caution is advisable in co-administering cimetidine and Sonata.
Zato svetujemo previdnost pri sočasnem dajanju cimetidina in zdravila Sonata.
This leaflet was last approved in
Navodilo je bilo nazadnje revidirano dne
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.
Pri bolnikih s šibko do zmerno jetrno insuficienco je biološka uporabnost zaleplona povečana zaradi zmanjšanega očistka in zato je treba pri teh bolnikih odmerek prilagoditi.
If you forget to take Sonata
Če ste pozabili vzeti zdravilo Sonata
If you stop taking Sonata
Če ste prenehali jemati zdravilo Sonata
• if you have severe kidney or liver problems.
• če imate hudo ledvično ali jetrno okvaro.
If an overdose has been taken you may become increasingly drowsy very quickly, with high doses probably leading to a coma.
Če ste vzeli prevelik odmerek, se omotičnost lahko zelo hitro poveča, pri velikih odmerkih lahko privede celo do kome.
• There is a chance that you may experience a certain type of temporary memory loss (amnesia) and lack of coordination when taking sleep medicines.
• Obstaja možnost, da boste zaradi jemanja uspaval imeli določeno vrsto izgube spomina (amnezijo) in slabo koordinacijo gibov.
If affected do not drive or operate machinery.
Če opazite take znake, ne vozite avtomobila in ne upravljajte strojev.
Should this occur, use of this product should be discontinued.
V primeru, da do njih pride, mora bolnik prenehati z uporabo tega zdravila.
Pre-and postnatal growth of rats was reduced at the maternally toxic dose of 100 mg/kg/day.
Pred- in poporodna rast podgan je bila zmanjšana pri odmerku 100 mg/kg/dan, ki je toksičen za mater.
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.
Sočasna uporaba zdravila Sonata z enkratnim 800 mg odmerkom eritromicina, močnega, selektivnega zaviralca CYP3A4, je povzročila 34% povečanje koncentracije zaleplona v plazmi.
What Sonata looks like and contents of the pack
Izgled zdravila Sonata in vsebina pakiranja
Animal studies suggest that flumazenil is an antagonist to zaleplon and should be considered in the management of Sonata overdose.
Študije na živalih kažejo, da je flumazenil antagonist zaleplona in se lahko uporablja pri zdravljenju prevelikega odmerjanja zdravila Sonata.
Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms.
Ko se pojavi telesna odvisnost, nenadno prekinitev zdravljenja spremljajo odtegnitveni sindromi.
Combination with other CNS-acting compounds should be taken into account.
Upoštevati je treba tudi kombinacijo z drugimi sestavinami, ki vplivajo na osrednje živčevje.
photosensitivity reaction angioedema
fotosenzitivnost angioedem
Zaleplon plasma concentrations increased linearly with dose, and zaleplon showed no signs of accumulation following administration of up to 30 mg/day.
Koncentracije zaleplona v plazmi so rasle linearno z odmerkom in zaleplon ni pokazal znakov kopičenja po odmerkih do 30 mg/dan.
Abuse of benzodiazepines and benzodiazepine-like active substances has been reported.
Poročali so o zlorabi benzodiazepinov in njim podobnih zdravilnih učinkovin.
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).
Benzodiazepini in njim sorodne učinkovine se ne smejo uporabljati samostojno pri zdravljenju depresije ali tesnobe, povezane z depresijo (pri teh bolnikih obstaja nevarnost samomora).
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).
V študiji plodnosti in sposobnosti razmnoževanja pri podganah so opazovali smrtnost in zmanjšano plodnost pri samcih in samicah pri peroralnem odmerku zaleplona 100 mg/kg/dan (kar ustreza 49-kratniku najvišjega priporočenega odmerka za človeka (MRHD), ki je 20 mg, izračunano v mg/m2).
At these doses, a significant reduction in the weight of both prostate and testes was apparent in a three month study in prepubescent dogs.
Pri teh odmerkih so v trimesečni študiji pri predpubertetnih psih opazili očitno zmanjšanje mase tako prostate kot mod.
Concomitant use of zaleplon with these drugs may increase the risk of next day drowsiness, including impaired driving ability (see section 4.7).
Sočasna uporaba zaleplona s temi zdravili lahko poveča tveganje za zaspanost, ki se pojavi naslednji dan, vključno z zmanjšano sposobnostjo vožnje (glejte poglavje 4.7).
In the case of narcotic analgesics enhancement of the euphoria may occur leading to an increase in physiological dependence.
V primeru povečanja evforije zaradi sočasne uporabe narkotičnih analgetikov lahko pride do večje fiziološke odvisnosti od zdravila.
Sonata 10 mg hard capsules, which contain a light blue powder, have a white cap and white body, with pink imprint “10 mg”.
Sonata 10 mg trde kapsule, ki vsebujejo svetlo moder prašek, imajo bel pokrovček in belo telo z roza odtisom »10 mg«.
Coadministration of a single zaleplon 10 mg dose and venlafaxine (extended release) 75 mg or 150 mg daily did not produce any interaction on memory (immediate and delayed word recall) or psychomotor performance (digit symbol substitution test).
Sočasna uporaba enkratnega 10 mg odmerka zaleplona in venlafaksina (s podaljšanim sproščanjem) 75 mg ali 150 mg na dan ni vplivala na spomin (takojšnji in zapozneli priklic besed) ali psihomotorično sposobnost (test zamenjave številčnih simbolov).
Zaleplon undergoes presystemic metabolism, resulting in an absolute bioavailability of approximately
Zaleplon je podvržen predsistemski presnovi, katere rezultat je približno 30% absolutna biološka uporabnost.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.Ne jemljite nobenih drugih zdravil, ne da bi se prej posvetovali s svojim zdravnikom ali farmacevtom.
Scientific conclusions and grounds recommending the variation to the terms of the Marketing
Znanstveni zaključki in podlaga za spremembo pogojev dovoljenja za promet z zdravilom
As with other benzodiazepines or benzodiazepine-like agents, overdose should not present a threat to life unless combined with other CNS depressants (including alcohol).
Kot pri drugih benzodiazepinih ali njim sorodnih učinkovin prevelik odmerek ne bi smel biti smrtno nevaren, razen če zdravilo kombinirate z uporabo drugih zdravil, ki povzročajo depresijo osrednjega živčevja (vključno z alkoholom).
In contrast, rifampicin, a strong inducer of several hepatic enzymes, including CYP3A4 resulted in a four fold reduction in zaleplon plasma concentration.
Nasprotno pa je rifampicin močan induktor nekaterih jetrnih encimov, vključno s CYP3A4, privedel do štirikratnega zmanjšanja koncentracije zaleplona v plazmi.
Insomnia may represent an underlying physical or psychiatric disorder.
Nespečnost lahko predstavlja skrito telesno ali duševno motnjo.
Sonata has major influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Sonata ima velik vpliv na sposobnost vožnje in upravljanja s stroji.
14 hard capsules
14 trdih kapsul
In the management of overdose with any medicinal product, it should be borne in mind that multiple agents may have been taken.
Pri zdravljenju prevelikega odmerjanja s katerim koli zdravilom morate upoštevati, da je bolnik lahko zaužil več zdravil naenkrat.
Oral administration of zaleplon to mice for 65 or 104 consecutive weeks at high dosage levels (≥100 mg/kg/day) elicited a statistically significant increase in benign but not in malignant liver tumors.
Peroralno dajanje zaleplona mišim v obdobju 65 ali 104 zaporednih tednov v visokih odmerkih (≥100 mg/kg/dan) je privedlo do statistično značilnega povečanja pogostnosti benignih, ne pa tudi malignih tumorjev.
These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability.
Le-ti vključujejo glavobole, bolečino v mišicah, izredno tesnobo, napetost, nemir, zmedenost in razdražljivost.
Elderly patients may be sensitive to the effects of hypnotics; therefore, 5 mg is the recommended dose of Sonata.
Starejši bolniki so lahko občutljivi za učinke uspaval, zato je zanje priporočeni odmerek zdravila Sonata 5
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V. 4.9 Preveliko odmerjanje
Benzodiazepine and benzodiazepine-like agents are not recommended for the primary treatment of psychotic illness.
Benzodiazepini in njim sorodne učinkovine niso priporočljive za primarno zdravljenje psihotičnih motenj.
Zaleplon is primarily metabolised by aldehyde oxidase to form 5-oxo-zaleplon.
Zaleplon se primarno presnavlja s pomočjo aldehidne oksidaze in tvori 5-okso-zaleplon.
Enhancement of the central sedation may occur in cases of concomitant use with antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, anti-epileptic medicinal products, anaesthetics, and sedative antihistamines.
Povečanje centralne sedacije lahko nastopi v primerih sočasne uporabe z antipsihotiki (nevroleptiki), hipnotiki, anksiolitiki/sedativi, antidepresivnimi sredstvi, narkotičnimi analgetiki, antiepileptiki, anestetiki in sedativnimi antihistaminiki.
Extension beyond these periods should not take place without clinical re-evaluation of the patient.
Pred podaljšanjem tega roka morate bolnika ponovno klinično pregledati.
Sonata belongs to a class of substances called benzodiazepine-related medicinal products, which consists of preparations with hypnotic actions.
Zdravilo Sonata sodi v skupino zdravil, ki jih imenujemo benzodiazepinom sorodna zdravila oz. zdravila z uspavalnim delovanjem.
Contact a doctor immediately and say how many capsules you have taken.
Če ste vzeli večji odmerek zdravila Sonata, kot bi smeli Nemudoma pokličite zdravnika in mu povejte, koliko kapsul ste vzeli.
These reactions may be active substance-induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder.
Te reakcije lahko povzroči zdravilna učinkovina, lahko so spontane ali pa so posledica prikrite psihične ali telesne motnje.
You should not take a second dose within a single night.
V isti noči ne smete vzeti drugega odmerka.
If you suffer from these symptoms, ask your doctor for advice.
Če imate te simptome, se posvetujte z zdravnikom.
Taking into account the PRAC Assessment Report on the PSUR for zaleplon, the scientific conclusions of CHMP are as follows:
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za zaleplon, je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
There have been post-marketing reports of dependence associated with zaleplon, predominantly in combination with other psychotropic agents.
V obdobju spremljanja zdravila na tržišču so o odvisnosti, povezani z zaleplonom, poročali predvsem v kombinaciji z drugimi psihoaktivnimi snovmi.
Common (1/100 to <1/10)
Pogosti (≥1/100 do <1/10)
Additionally, zaleplon is metabolised by CYP3A4 to form desethylzaleplon which is further metabolised by aldehyde oxidase to form 5-oxo-desethylzaleplon.
Poleg tega se zaleplon presnavlja s pomočjo encima CYP3A4 in tvori desetilzaleplon, ki se naprej presnovi s pomočjo aldehidne oksidaze in tvori 5-okso-desetilzaleplon.
Due to zaleplon's short plasma half-life, alternative therapy should be considered if early morning awakening is experienced.
Zaradi kratke razpolovne dobe zaleplona morate premisliti o uporabi drugega načina zdravljenja v primeru zgodnjega jutranjega zbujanja bolnika.
Zaleplon is metabolised primarily by the liver and undergoes significant presystemic metabolism.
Jetrna okvara Zaleplon se presnavlja predvsem v jetrih in je podvržen pomembni predsistemski presnovi.
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
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).
Študije embriofetalnega razvoja po peroralni uporabi aleplona v odmerku do 100 mg/kg/dan in 50 mg/kg/dan, ki so ga prejele breje podgane oziroma kunci, niso pokazale teratogenosti (odmerek ustreza 49-kratniku (podgane) in 48-kratniku (kunci) MRHD, izračunano v mg/m2).
Benzodiazepines and benzodiazepine-like agents may induce anterograde amnesia and psychomotor impairment.
Benzodiazepini in njim podobne snovi lahko sprožijo anterogradno amnezijo in psihomotorične motnje.
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
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