FrancophonIA/ELRC3.0 huggingface dataset:
English: Rare: (may affect up to 1 in 1000 people)
Croatian: Rijetko: (može se javiti kod do 1 na 1000 osoba)
English: However, Circadin co-administration resulted in increased feelings of tranquility and difficulty in performing tasks compared to imipramine alone, and increased feelings of “muzzyheadedness” compared to thioridazine alone.
Croatian: Međutim, istodobna primjena Circadina pojačala je osjećaj smirenosti i izazvala poteškoće u obavljanju zadataka u usporedbi sa samim imipraminom te je pojačala osjećaj „smušenosti“ u usporedbi sa samim tioridazinom.
English: The recommended dose is one Circadin tablet (2 mg) taken daily by mouth, after food, 1-2 hours before bedtime.
Croatian: Preporučena doza je jedna tableta Circadina uzeta dnevno (2 mg) kroz usta nakon obroka 1-2 sata prije odlaska na spavanje.
English: If you experience any of the following non-serious side effects contact your doctor and/or seek medical advice:
Croatian: Ako primijetite bilo koju od sljedećih manje ozbiljnih nuspojava obavijestite svog liječnika i/ili zatražite medicinski savjet:
English: There are data in animal models including rodents, sheep, bovine and primates that indicate maternal transfer of melatonin to the foetus via the placenta or in the milk.
Croatian: Podaci iz ispitivanja na životinjama, uključujući glodavce, ovce, goveda i primate, ukazuju na prijenos melatonina s majke na fetus putem placente ili mlijeka.
English: Circadin may cause drowsiness.
Croatian: Circadin može uzrokovati pospanost.
English: • Disorientation
Croatian: • dezorijentacija
English: Cmax levels around 500 pg/ml in adults (18-45) versus 1200 pg/ml in elderly (55-69); AUC levels around 3,000 pg*h/mL in adults versus 5,000 pg*h/mL in the elderly.
Croatian: Cmax iznosila je oko 500 pg/ml u odraslih (18-45 godina) prema 1200 pg/ml u starijih osoba (55-69 godina); razina AUC iznosila je oko 3000 pg*h/ml u odraslih prema 5000 pg*h/ml u starijih.
English: If you have accidentally taken too much of your medicine, contact your doctor or pharmacist as soon as possible.
Croatian: Ako ste slučajno uzeli preveliku količinu lijeka, što je prije moguće se javite liječniku ili ljekarniku.
English: Melatonin is associated with the control of circadian rhythms and entrainment to the light-dark cycle.
Croatian: Melatonin je povezan s kontrolom cirkadijanog ritma i ciklusom izmjene svjetlosti i tame.
English: Elimination is by renal excretion of metabolites, 89% as sulphated and glucoronide conjugates of 6-hydroxymelatonin and 2% is excreted as melatonin (unchanged active substance).
Croatian: Eliminacija se odvija izlučivanjem metabolita putem bubrega, od čega se 89% izluči u obliku konjugata 6-hidroksimelatonina sa sulfatima ili glukuronidima, a 2% se izluči u obliku melatonina (neizmijenjena djelatna tvar).
English: Sími: +354 535 7000
Croatian: Simi: +354 535 7000
English: Experimental data suggest that isoenzymes CYP1A1, CYP1A2 and possibly CYP2C19 of the cytochrome P450 system are involved in melatonin metabolism.
Croatian: Eksperimentalni podaci pokazuju da su izoenzimi CYP1A1, CYP1A2 i moguće CYP2C19 sustava citokroma P450 uključeni u metabolizam melatonina.
English: If you stop taking Circadin
Croatian: Ako prestanete uzimati Circadin
English: In addition, there were fewer dropouts in the active treatment group (9 patients; 15.0%) compared to the placebo group (21 patients; 32.3%).
Croatian: Nadalje, bilo je manje bolesnika koji su odustali od ispitivanja u skupini koja je primala aktivno liječenje (9 bolesnika; 15,0 %) u usporedbi sa skupinom koja je primala placebo (21 bolesnik;
English: • Circadin may enhance the sedative properties of benzodiazepines and non-benzodiazepine hypnotics, such as zaleplon, zolpidem and zopiclone.
Croatian: • Circadin može pojačati sedativna svojstva benzodiazepinskih i nebenzodiazepinskih hipnotika, kao što su zaleplon, zolpidem i zopiklon.
English: • There is a large amount of data in the literature regarding the effect of adrenergic agonists/antagonists, opiate agonists/antagonists, antidepressant medicinal products, prostaglandin inhibitors, benzodiazepines, tryptophan and alcohol, on endogenous melatonin secretion.
Croatian: • U literaturi postoji mnogo podataka o učinku adrenergičkih agonista/antagonista, opijatskih agonista/antagonista, antidepresiva, inhibitora prostaglandina, benzodiazepina, triptofana i alkohola na sekreciju endogenog melatonina.
English: The tablets are packed in PVC/PVDC opaque blister strips with aluminium foil backing.
Croatian: Tablete su pakirane u neprozirnim PVC/PVDC blisterima, presvučenim aluminijskom folijom.
English: • Circadin has been co-administered in studies with thioridazine and imipramine, active substances which affect the central nervous system.
Croatian: • Circadin se u ispitivanjima primjenjivao zajedno s tioridazinom i imipraminom, djelatnim tvarima koje utječu na središnji živčani sustav.
English: • Cigarette smoking may decrease melatonin levels due to induction of CYP1A2.
Croatian: • Pušenje može smanjiti razinu melatonina zbog indukcije CYP1A2.
English: Most were mild to moderate in severity.
Croatian: U većini slučajeva bila je blage do umjerene težine.
English: Circadin is mainly bound to albumin, alpha1-acid glycoprotein and high density lipoprotein.
Croatian: Circadin se uglavnom veže za albumin, alfa1-kiseli glikoprotein i lipoproteine visoke gustoće.
English: − Benzodiazepines and non-benzodiazepine hypnotics (medicines used to induce sleep such as zaleplon, zolpidem and zopiclone)
Croatian: - Benzodiazepinski i nebenzodiazepinski hipnotici (lijekovi koji se primjenjuju za izazivanje sna, kao što su zaleplon, zolpidem i zopiklon).
English: Hypersensitivity reaction, swelling of mouth or tongue, swelling of the skin and abnormal milk secretion.
Croatian: Reakcija preosjetljivosti, oticanje usta ili jezika, oticanje kože i neuobičajeno izlučivanje majčinog mlijeka.
English: Comparing the rate of patients with adverse reactions per 100 patient weeks, the rate was higher for placebo than Circadin (5.743- placebo vs. 3.013- Circadin).
Croatian: Uspoređujući stopu bolesnika s nuspojavama na 100 bolesnik-tjedana, stopa je bila veća za placebo nego za Circadin (5743 za placebo prema 3013 za Circadin).
English: In clinical trials a total of 9.5% of patients receiving Circadin reported an adverse reaction compared with 7.4% of patients taking placebo.
Croatian: U kliničkim ispitivanjima ukupno je 9,5% bolesnika koji su primali Circadin prijavilo nuspojavu, u usporedbi s 7,4% bolesnika koji su uzimali placebo.
English: If you experience any of the following serious side effects, stop taking the medicine and contact your doctor immediately:
Croatian: Ako primijetite bilo koju od sljedećih nuspojava, prekinite s upotrebom lijeka i odmah obavijestite svog liječnika:
English: Priapism, prostatitis Galactorrhoea
Croatian: prostatitis galaktoreja
English: The study demonstrated improvements in sleep latency, quality of sleep and morning alertness, with no withdrawal symptoms and rebound insomnia.
Croatian: Ispitivanje je pokazalo skraćenje vremena do usnivanja, poboljšanje kvalitete sna i jutarnje budnosti, bez simptoma ustezanja i povratne nesanice.
English: Sleep variables gradually returned to baseline with no rebound, no increase in adverse reactions and no increase in withdrawal symptoms.
Croatian: Varijable sna postupno su se vratile na početne vrijednosti bez vraćanja na prvotno stanje, pogoršanja nuspojava niti pojačanja simptoma ustezanja.
English: White to off-white, round, biconvex tablets
Croatian: Bijele do gotovo bijele, okrugle, bikonveksne tablete.
English: Modifications in diurnal functioning did not occur with Circadin 2 mg.
Croatian: Nije bilo promjena u dnevnom funkcioniranju uz dozu Circadina od 2 mg.
English: The active substance of Circadin, melatonin, belongs to a natural group of hormones produced by the body.
Croatian: Djelatna tvar u Circadinu je melatonin, koji pripada skupini hormona koji se prirodno stvaraju u tijelu.
English: There were no modifications of sleep architecture and no effect on REM sleep duration by Circadin.
Croatian: Nije bilo promjena u strukturi sna, niti je Circadin utjecao na trajanje REM faze.
English: The pack consists of one blister strip containing 7, 20 or 21 tablets, or two blister strips containing 15 tablets each (30 tablets).
Croatian: Pakiranje sadrži jedan blister s 7, 20 ili 21 tabletom ili dva blistera od kojih svaki sadrži 15 tableta (30 tableta).
English: Do not use this medicine after the expiry date which is stated on the carton (EXP).
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza (Rok valjanosti).
English: Circadin is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.
Croatian: Circadin je indiciran kao monoterapija za kratkoročno liječenje primarne insomnije, koju karakterizira loša kvaliteta sna, u bolesnika u dobi od 55 ili više godina.
English: In reproductive toxicology, oral administration of melatonin in pregnant female mice, rats or rabbits did not result in adverse effects on their offspring, measured in terms of foetal viability, skeletal and visceral abnormalities, sex ratio, birthweight and subsequent physical, functional and sexual development.
Croatian: U ispitivanjima reproduktivne toksičnosti, oralna primjena melatonina u skotnih ženki miševa, štakora ili kunića nije imala štetne učinke na njihovo potomstvo u smislu preživljavanja fetusa, promjena na kostima i unutarnjim organima, omjera ženskog i muškog potomstva, porođajne težine te kasnijeg fizičkog, funkcionalnog i spolnog razvoja.
English: The most common adverse reactions were headache, nasopharyngitis, back pain, and arthralgia, which were common, by MedDRA definition, in both the Circadin and placebo treated groups.
Croatian: Najčešće nuspojave bile su glavobolja, nazofaringitis, bol u leđima i artralgija, koje su prema MedDRA definiciji bile česte, kako u skupini koja je uzimala Circadin, tako i u skupini koja je uzimala placebo.
English: If you forget to take Circadin
Croatian: Ako ste zaboravili uzeti Circadin
English: No studies on the use of Circadin in people with auto-immune diseases have been performed; therefore, you should speak to your doctor before taking Circadin as its use is not recommended.
Croatian: Nisu provedena ispitivanja o primjeni Circadina u osoba s autoimunim bolestima, stoga biste trebali razgovarati sa svojim liječnikom prije uzimanja Circadina jer njegova upotreba nije preporučena.
English: Therefore, interactions between melatonin and other active substances as a consequence of their effect on CYP1A enzymes is possible.
Croatian: Stoga su moguće interakcije između melatonina i drugih djelatnih tvari zbog posljedica njihova učinka na enzime CYP1A.
English: Circadin contains lactose.
Croatian: Circadin sadrži laktozu.
English: The levels assessed in the blood of the patients at 23:00 (2 hours after administration) following 1 and 3 weeks of daily administration were 411.4 ± 56.5 and 432.00 ± 83.2 pg/ml respectively, and are similar to those found in in healthy volunteers following a single dose of Circadin 2 mg.
Croatian: Koncentracija u krvi bolesnika u 23:00 sata (2 sata nakon primjene) iznosila je 411,4 ± 56,5 pg/ml nakon jednog tjedna odnosno 432,00 ± 83,2 pg/ml nakon 3 tjedna svakodnevne primjene te je bila slična onima pronađenim kod zdravih dobrovoljaca nakon jedne doze Circadina od 2 mg.
English: • Caution should be exercised in patients on 5- or 8-methoxypsoralen (5 and 8-MOP), which increases melatonin levels by inhibiting its metabolism.
Croatian: • Potreban je oprez u bolesnika koji uzimaju 5- ili 8-metoksipsoralen (5- i 8-MOP), koji povećava razinu melatonina tako što inhibira njegov metabolizam.
English: Circadin may cause drowsiness, therefore the product should be used with caution if the effects of drowsiness are likely to be associated with a risk to safety.
Croatian: Circadin može uzrokovati pospanost, stoga se lijek mora koristiti s oprezom u slučaju kada bi učinci pospanosti mogli ugroziti sigurnost osobe.
English: Plasma melatonin levels in patients with cirrhosis were significantly increased during daylight hours.
Croatian: Razine melatonina u plazmi u bolesnika s cirozom jetre bile su značajno povišene tijekom dana.
English: Vertigo positional, vertigo
Croatian: Poremećaji uha i labirinta pozicijski vertigo, vertigo
English: Circadin shortened patients' reported sleep latency by 24.3 minutes vs 12.9 minutes with placebo.
Croatian: Circadin je skratio vrijeme do usnivanja, prema navodima ispitanika, za 24,3 minute u odnosu na 12,9 minuta u ispitanika koji su primali placebo.
English: Quality of life was improved significantly with Circadin 2 mg compared to placebo.
Croatian: Kvaliteta života značajno se poboljšala u ispitanika koji su primali Circadin u dozi od 2 mg u usporedbi s onima koji su uzimali placebo.
English: Therefore, breast-feeding is not recommended in women under treatment with melatonin.
Croatian: Stoga se ne preporučuje dojenje ženama koje se liječe melatoninom.
English: The effect of any stage of renal impairment on melatonin pharmacokinetics has not been studied.
Croatian: Nije ispitan učinak bilo kojeg stupnja oštećenja bubrega na farmakokinetiku melatonina.
English: Across a range of doses, higher AUC and Cmax levels have been reported in older patients compared to younger patients, reflecting the lower metabolism of melatonin in the elderly.
Croatian: Pri primjeni različitih doza, stariji bolesnici imali su veće vrijednosti AUC i Cmax nego mlađi bolesnici, što ukazuje na slabiji metabolizam melatonina u starijih osoba.
English: • CYP1A2 inducers such as carbamazepine and rifampicin may give rise to reduced plasma concentrations of melatonin.
Croatian: • Induktori CYP1A2, kao što su karbamazepin i rifampicin, mogu prouzročiti sniženje koncentracije melatonina u plazmi.
English: Therefore the product should be used with caution if the effects of drowsiness are likely to be associated with a risk to safety.
Croatian: Stoga se lijek mora koristiti s oprezom u slučaju kada bi učinci pospanosti mogli ugroziti sigurnost osobe.
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, potražite savjet svog liječnika prije uzimanja ovog lijeka.
English: Melatonin is a naturally occurring hormone produced by the pineal gland and is structurally related to serotonin.
Croatian: Melatonin je hormon koji se prirodno proizvodi u hipofizi i strukturom je sličan serotoninu.
English: Circadin is used on its own for the short-term treatment of primary insomnia (persistent difficulty in getting to sleep or staying asleep, or poor quality of sleep) in patients aged 55 years and older.
Croatian: Circadin se koristi kao samostalna terapija za kratkoročno liječenje primarne nesanice (ustrajne poteškoće s usnivanjem ili održavanjem sna ili slaba kvaliteta sna), u bolesnika u dobi od 55 ili više godina.
English: • Melatonin's metabolism is mainly mediated by CYP1A enzymes.
Croatian: • Metabolizam melatonina uglavnom se odvija putem enzima CYP1A.
English: Nervous system disorders were more common in the active group with 42% patients, compared to 23% in the placebo group, mainly driven by somnolence and headache more frequent in the active group.
Croatian: Poremećaji živčanog sustava bili su češći u skupini koja je primala aktivno liječenje i pojavili su se u 42 % bolesnika, u usporedbi s 23 % bolesnika u skupini koja je primala placebo, te su uglavnom bili izazvani somnolencijom i glavoboljom koje su se pojavljivale češće u skupini koja je primala aktivno liječenje.
English: • Caution should be exercised in patients on fluvoxamine, which increases melatonin levels (by 17-fold higher AUC and a 12-fold higher serum Cmax) by inhibiting its metabolism by hepatic cytochrome P450 (CYP) isozymes CYP1A2 and CYP2C19.
Croatian: • Potreban je oprez u bolesnika koji uzimaju fluvoksamin, koji povećava razinu melatonina (17 puta veća AUC i 12 puta veća serumska Cmax) tako što inhibira njegov metabolizam putem izoenzima CYP1A2 i CYP2C19 jetrenog citokroma P450 (CYP).
English: The rate of melatonin absorption and Cmax following Circadin 2 mg oral administration is affected by food.
Croatian: Brzina apsorpcije melatonina i Cmax nakon peroralne primjene Circadina u dozi od 2 mg mijenja se pod utjecajem hrane.
English: Uncommon: (may affect up to 1 in 100 people)
Croatian: Manje često: (može se javiti kod do 1 na 100 osoba)
English: Excipient with known effect: each prolonged-release tablet contains 80 mg lactose monohydrate.
Croatian: Pomoćna tvar s poznatim učinkom: jedna tableta s produljenim oslobađanjem sadrži 80 mg laktoze hidrata.
English: Crushing or chewing should not be used to facilitate swallowing.
Croatian: Gutanje se ne smije olakšavati drobljenjem ili žvakanjem.
English: • CYP1A2 inhibitors such as quinolones may give rise to increased melatonin exposure.
Croatian: • Inhibitori CYP1A2, poput kinolona, mogu dovesti do povećane ekspozicije melatoninu.
English: Only those adverse reactions reported during clinical trials occurring in patients at an equivalent or greater rate than placebo have been included below.
Croatian: U dolje navedenoj tablici prikazane su samo nuspojave prijavljene tijekom kliničkih ispitivanja koje su se u bolesnika javile u jednakoj ili većoj stopi od one uz placebo.
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava leukopenija,
English: No clinical data exist concerning the use of Circadin in individuals with autoimmune diseases.
Croatian: Nema kliničkih podataka o primjeni Circadina u osoba s autoimunim bolestima.
English: No studies on the use of Circadin in people with liver or kidney diseases have been performed, you should speak to your doctor before taking Circadin as its use is not recommended.
Croatian: Nisu provedena ispitivanja o primjeni Circadina u osoba s bolestima jetre ili bubrega, trebali biste razgovarati sa svojim liječnikom prije uzimanja Circadina jer njegova primjena nije preporučena.
English: Endogenous melatonin was measured in human breast milk thus exogenous melatonin is probably secreted into human milk.
Croatian: Endogeni melatonin je ustanovljen u majčinom mlijeku u ljudi, pa se u majčino mlijeko vjerojatno izlučuje i egzogeni melatonin.
English: Hypertriglyceridaemia, hypocalcaemia, hyponatraemia
Croatian: Hipertrigliceridemija, hipokalcemija,
English: In clinical trials (in which a total of 1,931 patients were taking Circadin and 1,642 patients were taking placebo), 48.8% of patients receiving Circadin reported an adverse reaction compared with 37.8% taking placebo.
Croatian: U kliničkim je ispitivanjima (u kojima je ukupno 1931 bolesnik uzimao Circadin, dok su 1642 uzimala placebo) nuspojavu prijavilo 48,8% bolesnika koji su primali Circadin i 37,8% onih koji su uzimali placebo.
English: Somnolence was the most reported adverse event.
Croatian: Najčešće prijavljena nuspojava bila je somnolencija.
English: Several cases of overdose have been reported post-marketing.
Croatian: Nakon što je lijek stavljen u promet, prijavljeno je nekoliko slučaja predoziranja.
English: Clearance of the active substance is expected within 12 hours after ingestion.
Croatian: Klirens djelatne tvari očekuje se unutar 12 sati nakon uzimanja.
English: A Paediatric study (n=125) with doses of 2, 5 or 10 mg prolonged-release melatonin in multiples of 1 mg minitablets (age-appropriate pharmaceutical form), with two week run in baseline period on placebo and a randomised, double blind, placebo controlled, parallel group treatment period of 13 weeks, demonstrated an improvement in total sleep time (TST) after 13 weeks of double-blind treatment; participants slept more with active treatment (508 minutes), compared to placebo
Croatian: Pedijatrijsko ispitivanje (n=125) s dozama od 2, 5 ili 10 mg melatonina s produljenim oslobađanjem u višestrukim mini tabletama od 1 mg (farmaceutski oblik primjeren dobnoj skupini), koje se sastojalo od dva tjedna uvodnog liječenja placebom i 13 tjedana randomiziranog, dvostruko slijepog, placebom kontroliranog ispitivanja na usporednim skupinama, pokazalo je poboljšanje u ukupnom vremenu spavanja nakon 13 tjedana dvostruko slijepog liječenja; sudionici koji su primali aktivno liječenje spavali su dulje (508 minuta) od sudionika koji su primali placebo (488 minuta).
English: INFORMATION IN BRAILLE Circadin 2 mg
Croatian: Circadin 2 mg
English: The presence of food delayed the absorption of the melatonin resulting in a later (Tmax=3.0 h versus Tmax=0.75 h) and lower peak plasma concentration in the fed state (Cmax=1020pg/ml versus Cmax=1176 pg/ml).
Croatian: Prisutnost hrane odgađa apsorpciju melatonina, pa vršna koncentracija melatonina u plazmi u stanju sitosti nastupa kasnije (Tmax = 3,0 h prema Tmax = 0,75 h) i ima nižu vrijednost (Cmax = 1020 pg/ml prema Cmax = 1176 pg/ml).
English: Each carton of tablets contains one blister strip of 7, 20 or 21 tablets, or alternatively in a carton containing two blister strips of 15 tablets each (30 tablet pack).
Croatian: Jedna kutija tableta sadrži jedan blister s 7, 20 ili 21 tabletom ili se u kutiji nalaze dva blistera koji svaki sadrži 15 tableta (30 tableta).
English: Angina pectoris, palpitations
Croatian: Srčani poremećaji angina pektoris,
English: The liver is the primary site of melatonin metabolism and therefore, hepatic impairment results in higher endogenous melatonin levels.
Croatian: Budući da je jetra primarno mjesto metabolizma melatonina, oštećenje jetre dovodi do povećanja razine endogenog melatonina.
English: However, no pharmacodynamic differences between males and females were found despite differences in blood levels.
Croatian: Međutim, usprkos razlikama u koncentraciji u krvi, farmakodinamičke razlike između muškaraca i žena nisu pronađene.
English: • Caution should be exercised in patients on oestrogens (e.g. contraceptive or hormone replacement therapy), which increase melatonin levels by inhibiting its metabolism by CYP1A1 and CYP1A2.
Croatian: • Potreban je oprez u bolesnica koje uzimaju estrogene (npr. kontracepcijske tablete ili hormonsku nadomjesnu terapiju) jer estrogeni povisuju razinu melatonina tako što inhibiraju njegovo metaboliziranje putem CYP1A1 i CYP1A2.
English: Administration of daily doses of up to 300 mg of melatonin without causing clinically significant adverse reactions have been reported in the literature.
Croatian: U literaturi je navedena primjena dnevnih doza melatonina do najviše 300 mg koja nije prouzročila klinički značajne nuspojave.
English: • Caution should be exercised in patients on cimetidine a CYP2D inhibitor, which increases plasma melatonin levels, by inhibiting its metabolism.
Croatian: • Potreban je oprez u bolesnika koji uzimaju cimetidin, inhibitor CYP2D, koji povećava razine melatonina u plazmi tako što inhibira njegov metabolizam.
English: Therefore, interactions between melatonin and other active substances as a consequence of melatonin's effect on CYP1A enzymes are not likely to be significant.
Croatian: Stoga vjerojatno neće biti značajnih interakcija između melatonina i drugih djelatnih tvari zbog učinka melatonina na enzime CYP1A.
English: MEDICE Arzneimittel Pütter GmbH & Co. KG Tel.: + 48-(0)22 642 2673 e-mail: office@medice.pl
Croatian: KG Tel.: + 48-(0)22 642 2673 e-mail: office@medice.pl
English: Syncope, memory impairment, disturbance in attention, dreamy state, restless legs syndrome, poor quality sleep, paraesthesia
Croatian: somnolencija sinkopa, narušeno pamćenje, poremećaj pozornosti, sanjivo stanje, sindrom nemirnih nogu, loša kvaliteta sna,