natgillin/translations-raw huggingface dataset:
If you experience any of the following serious side effects, stop taking the medicine and contact your doctor immediately: 
Če opazite katerega koli od naslednjih resnih neželenih učinkov, prenehajte jemati to zdravilo in se takoj posvetujte z zdravnikom:
- Smoking may make Circadin less effective, because the components of tobacco smoke can increase the breakdown of melatonin by the liver. 
• kajenje lahko zmanjša učinkovitost zdravila Circadin, ker sestavine tobačnega dima lahko povečajo razgradnjo melatonina v jetrih.
Physiologically, melatonin secretion increases soon after the onset of darkness, peaks at 2-4 am and diminishes during the second half of the night. 
Fiziološko se pojavi izločanje melatonina takoj, ko se začne temniti, in doseže vrhunec med 2-4 uro zjutraj, v drugi polovici noči pa se količina manjša.
No clinically significant pharmacokinetic interactions were found in each case. 
V nobenem primeru niso ugotovili klinično pomembnih farmakokinetičnih interakcij.
Hypersensitivity reaction, swelling of mouth or tongue, swelling of the skin and abnormal milk secretion. 
Preobčutljivnostne reakcije, oteklost ust ali jezika, oteklost kože in nenormalno izločanje mleka.
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. 
V kliničnih preskušanjih (v katerih je skupno 1931 bolnikov jemalo zdravilo Circadin in 1642 bolnikov placebo) je 48,8 % bolnikov, ki so prejemali zdravilo Circadin, poročalo o neželenih učinkih v primerjavi s 37,8 %, ki so jemali placebo.
Circadin is mainly bound to albumin, alpha1-acid glycoprotein and high density lipoprotein. 
Zdravilo Circadin se veže pretežno na albumin, alfa1 kisli glikoprotein in lipoprotein visoke gostote.
Crushing or chewing should not be used to facilitate swallowing. 
Ne sme se jih drobiti ali žvečiti zaradi lažjega požiranja.
• Circadin may enhance the sedative properties of benzodiazepines and non-benzodiazepine hypnotics, such as zaleplon, zolpidem and zopiclone. 
• Zdravilo Circadin lahko poveča pomirjevalne lastnosti benzodiazepinskih in ne-benzodiazepinskih hipnotikov kot so zaleplon, zolpidem in zopiklon.
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). 
Pri primerjavi razmerja bolnikov z neželenimi učinki s 100 tedni zdravljenja je bila stopnja za placebo višja od stopnje za zdravilo Circadin (5,743placebo v primerjavi s 3,013 - zdravilo Circadin).
If you experience any of the following non-serious side effects contact your doctor and/or seek medical advice: 
Če opazite katerega koli od naslednjih neželenih učinkov, ki niso resni, se posvetujte z zdravnikom in/ali poiščite zdravniški nasvet:
The pack consists of one blister strip containing 7, 20 or 21 tablets, or two blister strips containing 15 tablets each (30 tablets). 
Pakiranje vsebuje en pretisni omot z 7, 20 ali 21 tabletami ali dva dvojna traka, ki vsebujeta po 15 tablet (30 tablet).
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. 
Zdravilo Circadin lahko povzroči zaspanost, zato je treba zdravilo jemati previdno, če so učinki zaspanosti povezani s tveganjem za varnost.
Several cases of overdose have been reported post-marketing. 
V obdobju trženja so poročali o nekaj primerih prevelikega odmerjanja.
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). 
Prisotnost hrane upočasni absorpcijo melatonina, kar povzroči kasnejši (Tmax = 3,0 h v primerjavi s Tmax = 0,75 h) in nižji vrh plazemske koncentracije v stanju na poln želodec (Cmax = 1020 pg/ml v primerjavi s Cmax = 1176 pg/ml).
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. 
Najpogostejši neželeni učinki so bili glavobol, nazofaringitis, bolečine v hrbtu in artralgija, ki so bili, po opredelitvi MedDRA, pogosti v obeh skupinah, v skupini, ki je prejemala zdravilo Circadin in v skupini, ki je prejemala placebo.
White to off-white, round, biconvex tablets 
Bele do umazano bele, okrogle, bikonveksne tablete.
This leaflet was last revised in { month/YYYY}. 
Navodilo je bilo nazadnje revidirano dne (MM/LLLL)
The recommended dose is one Circadin tablet (2 mg) taken daily by mouth, after food, 1-2 hours before bedtime. 
Priporočeni odmerek je ena tableta zdravila Circadin (2 mg) dnevno, zaužita peroralno, po obroku, 1-2 uri pred spanjem.
Caution should be used when melatonin is administered to such patients. 
Pri dajanju melatonina takim bolnikom je potrebna previdnost.
• Alcohol should not be taken with Circadin, because it reduces the effectiveness of Circadin on sleep. 
• Z zdravilom Circadin naj ne bi uživali alkohola, saj slednji zmanjša učinkovitost zdravila Circadin na spanje.
Visual acuity reduced, vision blurred, lacrimation increased 
Očesne bolezni zmanjšana ostrina vida, zamegljen vid, povečano izločanje solz
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. 
Pri reproduktivni toksičnosti preoralno dajanje melatonina brejim samicam miši, podgan in kuncev ni pokazalo neželenih učinkov na mladiče, merjeno glede na zarodkovo sposobnost preživetja, okvar okostja in drobovja, razmerja med spoloma, porodne teže in naknadnega fizičnega, funkcionalnega in spolnega razvoja.
Therefore, interactions between melatonin and other active substances as a consequence of their effect on CYP1A enzymes is possible. 
Zato so možne interakcije med melatoninom in drugimi zdravilnimi učinkovinami, kot posledica njihovega učinka na encime CYP1A.
Endogenous melatonin was measured in human breast milk thus exogenous melatonin is probably secreted into human milk. 
V materinem mleku je bil izmerjen endogeni melatonin, iz česar se sklepa, da se eksogeni melatonin verjetno izloča v materino mleko.
Excipient with known effect: each prolonged-release tablet contains 80 mg lactose monohydrate. 
Pomožne snovi z znanim učinkom: ena tableta s podaljšanim sproščanjem vsebuje 80 mg laktoze monohidrata.
Circadin has been administered at 5 mg daily doses in clinical trials over 12 months without significantly changing the nature of the adverse reactions reported. 
V kliničnih preskušanjih so zdravilo Circadin dajali v 5 mg dnevnih odmerkih 12 mesecev brez pomembne spremembe v naravi sporočenih neželenih učinkov.
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. 
Zdravilo Circadin se uporablja samostojno za kratkotrajno zdravljenje primarne nespečnosti (težave zaspati ali ohraniti spanec, šibek spanec) pri bolnikih, starih 55 let ali starejših.
If overdose occurs, drowsiness is to be expected. 
Pri prevelikem odmerku je treba pričakovati zaspanost.
Therefore, breast-feeding is not recommended in women under treatment with melatonin. 
Zato se dojenje ženskam, ki se zdravijo z melatoninom, ne priporoča.
• 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. 
• V literaturi so na voljo številni podatki glede učinkov adrenergičnih agonistov/antagonistov, opiatnih agonistov/antagonistov, zdravil proti depresiji, zaviralcih prostaglandina, benzodiazepinih, triptofanu in alkoholu na endogeno izločanje melatonina.
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. 
Zdravilo Circadin se uporablja kot monoterapija za kratkotrajno zdravljenje primarne nespečnosti, za katero je značilna slaba kakovost spanca pri bolnikih, starih 55 ali več let.
Melatonin is a naturally occurring hormone produced by the pineal gland and is structurally related to serotonin. 
Melatonin je naraven hormon, ki ga proizvaja češarika in je po strukturi soroden serotoninu.
Experimental data suggest that isoenzymes CYP1A1, CYP1A2 and possibly CYP2C19 of the cytochrome P450 system are involved in melatonin metabolism. 
Eksperimentalni podatki nakazujejo, da pri presnovi melatonina sodelujejo izoencimi CYP1A1, CYP1A2 in morebiti CYP2C19 sistema citokroma P450.
• 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. 
• Previdnost je potrebna pri bolnikih, ki se zdravijo s fluvoksaminom, ki povišuje ravni melatonina (za 17-krat višji AUC in 12-krat višji serum Cmax) z zaviranjem njegove presnove preko izocimov jetrnega citokroma P450 (CYP) CYP1A2 in CYP2C19.
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. 
Študij o uporabi zdravila Circadin pri ljudeh z avtoimunskimi boleznimi niso izvedli; pred začetkom jemanja zdravila Circadin se zato posvetujte z zdravnikom, saj uporaba ni priporočljiva.
What Circadin contains - The active substance is melatonin. 
Kaj vsebuje zdravilo Circadin - Zdravilna učinkovina je melatonin.
− Fluvoxamine (used for the treatment of depression and obsessive compulsive disorder), psoralens (used in the treatment of skin disorders e.g. psoriasis), cimetidine (used in the treatment of stomach problems such as ulcers), quinolones and rifampicin (used in the treatment of bacterial infections), oestrogens (used in contraceptives or hormone replacement therapy) and carbamazepine (used in the treatment of epilepsy). 
- fluvoksamin (uporablja se za zdravljenje depresije in obsesivne kompulzivne motnje), psoraleni (za zdravljenje kožnih bolezni, npr. luskavice), cimetidin (za zdravljenje želodčnih težav, kot so razjede), kinoloni in rifampicin (za zdravljenje bakterijskih okužb), estrogeni (v kontracepcijskih sredstvih in nadomestnem hormonskem zdravljenju) ter karbamazepini (za zdravljenje epilepsije).
• Severe chest pain due to angina 
• huda bolečina v prsih zaradi angine pektoris
Uncommon: (may affect up to 1 in 100 people) • Chest pain 
Občasni: (lahko se pojavijo pri največ 1 od 100 bolnikov) • Bolečine v prsih
In clinical trials, where patients suffering from primary insomnia received Circadin 2 mg every evening for 3 weeks, benefits were shown in treated patients compared to placebo in sleep latency (as measured by objective and subjective means) and in subjective quality of sleep and daytime functioning (restorative sleep) with no impairment of vigilance during the day. 
V kliničnih preskušanjih, kjer so bolniki s primarno nespečnostjo 3 tedne vsak večer prejemali zdravilo Circadin 2 mg, so se pokazale prednosti pri zdravljenih bolnikih v primerjavi s tistimi, ki so jemali placebo, pri latentnosti uspavanja (merjeno z objektivnimi in subjektivnimi sredstvi), subjektivni kakovosti spanja in funkcioniranjem čez dan (krepčilni spanec) brez vpliva na budnost čez dan.
Rationale for use 
Smiselnost uporabe
In view of the lack of clinical data, use in pregnant women and by women intending to become pregnant is not recommended. 
Uporaba zdravila pri nosečnicah in ženskam, ki načrtujejo nosečnost, ni priporočljiva zaradi pomanjkanja kliničnih podatkov.
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. 
Študij o uporabi zdravila Circadin pri ljudeh z boleznimi jeter ali ledvic niso izvedli; pred začetkom jemanja zdravila Circadin se zato posvetujte z zdravnikom, saj uporaba ni priporočljiva.
• CYP1A2 inducers such as carbamazepine and rifampicin may give rise to reduced plasma concentrations of melatonin. 
• Snovi, ki inducirajo CYP1A2, kot sta karbamazepin in rifampicin, lahko povzročijo znižane koncentracije melatonina v plazmi.
Blood and lymphatic system disorders 
Bolezni krvi in limfatičnega sistema levkopenija,
Administration of daily doses of up to 300 mg of melatonin without causing clinically significant adverse reactions have been reported in the literature. 
V literaturi poročajo o dajanju dnevnih odmerkov do 300 mg melatonina brez klinično pomembnih neželenih učinkov.
There was also a reduction in sleep latency with active treatment (61 minutes) compared to placebo (77 minutes) after 13 weeks of double-blind treatment, without causing earlier wake-up time. 
Pri aktivnem zdravljenju so po 13 tednih dvojno slepega zdravljenja opazili tudi zmanjšanje latence spanja (61 minut) v primerjavi s placebom (77 minut), brez zgodnejšega časa prebujanja.
• Circadin has been co-administered in studies with thioridazine and imipramine, active substances which affect the central nervous system. 
• V študijah so zdravilo Circadin dajali hkrati s tioridazinom in imipraminom, zdravilnima učinkovinama, ki vplivata na centralni živčni sistem.
What Circadin is and what it is used for What you need to know before you take Circadin How to take Circadin 
Kaj je zdravilo Circadin in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Circadin Kako jemati zdravilo Circadin Možni neželeni učinki
− Adrenergic agonists/antagonists (such as certain types of medicines used to control blood pressure by constricting blood vessels, nasal decongestants, blood pressure lowering medicines), opiate agonists/antagonists (such as medicinal products used in the treatment of drug addiction), prostaglandin inhibitors (such as nonsteroidal anti-inflammatory medicines), antidepressant medication, tryptophan and alcohol. 
- adrenergični agonisti/antagonisti (kot so nekatere vrste zdravil za obvladovanje krvnega tlaka, ki delujejo tako, da ožijo krvne žile, nazalni dekongestivi, zdravila za zniževanje krvnega tlaka), opioidni agonisti/antagonisti (kot so zdravila za zdravljenje odvisnosti od mamil), zaviralci sinteze prostaglandina (kot so nesteroidna protivnetna zdravila), antidepresivi, triptofan in alkohol.
patients in the active group and by 77% in the placebo group. 
O neželenih učinkih zaradi zdravljenja je poročalo 85 % bolnikov v aktivni skupini in 77 % v skupini s placebom.
• 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. 
• Previdnost je potrebna pri bolnikih, ki jemljejo estrogen (npr. kontracepcijska sredstva ali nadomestno hormonsko terapijo), saj ta zvišuje raven melatonina z zaviranjem njegove presnove s CYP1A1 in CYP1A2.
Warnings and precautions Talk to your doctor or pharmacist before taking Circadin. 
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Circadin se posvetujte z zdravnikom ali farmacevtom,
In addition, quality of sleep and morning alertness significantly improved with Circadin compared to placebo. 
Poleg tega se je kakovost spanja in jutranje budnosti v skupini z zdravilom Circadin pomembno izboljšala v primerjavi s tisto s placebom.
• CYP1A2 inhibitors such as quinolones may give rise to increased melatonin exposure. 
• Zaviralci CYP1A2, kot so kinoloni, lahko povzročijo povečano izpostavljenost melatoninu.
• Caution should be exercised in patients on 5- or 8-methoxypsoralen (5 and 8-MOP), which increases melatonin levels by inhibiting its metabolism. 
• Pri bolnikih, ki se zdravijo s 5- ali 8-metoksipsoralenom (5 in 8-MOP) je potrebna previdnost, saj dviguje ravni melatonina z zaviranjem njegove presnove.
The following adverse reactions were reported in clinical trials and from post-marketing spontaneous reporting. 
V kliničnih preskušanjih in spontanih poročilih iz obdobja trženja so poročali o naslednjih neželenih učinkih.
Angina pectoris, palpitations 
Srčne bolezni angina pektoris,
Most were mild to moderate in severity. 
Ta je bila v večini primerov blaga do zmerna.
Patients had a significantly decreased total excretion of 6-sulfatoxymelatonin compared with controls. 
V primerjavi s kontrolnimi skupinami je bil skupni izloček 6-sulfatoksimelatonin pri teh bolnikih znatno manjši.
There are no known harmful effects if treatment is interrupted or ended early. 
V zvezi s prekinitvijo ali predčasnim prenehanjem jemanja tega zdravila ni znanih škodljivih učinkov.
- Circadin can make you feel drowsy, you should be careful if the drowsiness affects you as it may impair your ability on tasks such as driving. 
• Zdravilo Circadin lahko povzroča zaspanost; če postanete zaspani, morate biti previdni, saj lahko to vpliva na vašo sposobnost upravljanja vozil.
- The other ingredients are ammonio methacrylate copolymer type B, calcium hydrogen phosphate dihydrate, lactose monohydrate, silica (colloidal anhydrous), talc and magnesium stearate. 
- Druge sestavine (pomožne snovi) so kopolimer amonijevega metakrilata (vrsta B), kalcijev hidrogenfosfat dihidrat, laktoza monohidrat, silicijev dioksid (brezvoden koloiden), smukec in magnezijev stearat.
If you are affected, you should not drive or operate machinery. 
Ne vozite in ne upravljajte s stroji, če čutite vpliv zdravila.
Circadin may cause drowsiness. 
Zdravilo Circadin lahko povzroči zaspanost.
If you have accidentally taken too much of your medicine, contact your doctor or pharmacist as soon as possible. 
Če ste vzeli večji odmerek zdravila Circadin, kot bi smeli Če ste pomotoma vzeli preveč zdravila, se čim prej posvetujte z zdravnikom ali s farmacevtom.
RAD Neurim Pharmaceuticals EEC SARL 4 rue de Marivaux 
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM RAD Neurim Pharmaceuticals EEC SARL 4 rue de Marivaux
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). 
Ena škatla vsebuje pretisni omot z 7, 20 ali 21 tabletami ali škatlo z dvema dvojnima trakovoma, ki vsebujeta po 15 tablet (30 tablet na pakiranje).
If you suffer from continued drowsiness, then you should consult your doctor. 
Če je zaspanost trajna, se posvetujte z zdravnikom.
If you forget to take Circadin 
Če ste pozabili vzeti zdravilo Circadin
• Melatonin does not induce CYP1A enzymes in vitro at supra-therapeutic concentrations. 
• Melatonin ne inducira CYP1A encimov in vitro pri koncentracijah, višjih kot so terapevtske.
• Melatonin's metabolism is mainly mediated by CYP1A enzymes. 
• Melatonin v glavnem presnavljajo CYP1A encimi.
PHARMACEUTICAL FORM Prolonged-release tablet. 
FARMACEVTSKA OBLIKA Tableta s podaljšanim sproščanjem.
Rare: (may affect up to 1 in 1000 people) 
Redki: (lahko se pojavijo pri največ 1 od 1000 bolnikov)
• Caution should be exercised in patients on cimetidine a CYP2D inhibitor, which increases plasma melatonin levels, by inhibiting its metabolism. 
• Previdnost je potrebna pri bolnikih, ki se zdravijo s cimetidinom, zaviralcem CYP2D, ki povečuje ravni melatonina v plazmi z zaviranjem njegove presnove.
Clearance of the active substance is expected within 12 hours after ingestion. 
Očistek zdravilne učinkovine se pričakuje v 12 urah po zaužitju.
The rate of melatonin absorption and Cmax following Circadin 2 mg oral administration is affected by food. 
Hrana vpliva na stopnjo absorpcije melatonina in Cmax po peroralnem jemanju zdravila Circadin 2 mg.
The liver is the primary site of melatonin metabolism and therefore, hepatic impairment results in higher endogenous melatonin levels. 
Okvara jeter Presnova melatonina poteka pretežno v jetrih, zato so posledica okvare jeter višje ravni endogenega melatonina.
• Melatonin has been observed to induce CYP3A in vitro at supra-therapeutic concentrations. 
• Opazili so, da melatonin inducira CYP3A in vitro pri koncentracijah, višjih kot so terapevtske.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 2 mg melatonin. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta s podaljšanim sproščanjem vsebuje 2 mg melatonina.
Each prolonged-release tablet contains 2 mg melatonin. 
Ena tableta s podaljšanim sproščanjem vsebuje 2 mg melatonina.
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. 
Med različnimi razponi odmerkov poročajo o višjih ravneh AUC and Cmax pri starejših bolnikih v primerjavi z mlajšimi, kar kaže na nižjo presnovo melatonina pri starejših: ravni Cmax okoli 500 pg/ml pri odraslih (18-45) v primerjavi z 1200 pg/ml pri starejših (55-69); ravni AUC okoli 3.000 pg*h/ml pri odraslih, v primerjavi s 5.000 pg*h/ml pri starejših.
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 
Pediatrična študija (n = 125) z odmerki 2 mg, 5 mg ali 10 mg melatonina s podaljšanim sproščanjem v večkratni količini 1-mg mini tablet (starosti primerna farmacevtska oblika), z dvotedenskim uvajanjem placeba v izhodiščnem obdobju in z randomiziranim, dvojno slepim, s placebom nadzorovanim, 13-tedenskim obdobjem zdravljenja z vzporedno skupino, je po 13 tednih dvojno slepega zdravljenja pokazala izboljšanje skupnega časa spanja (TST, total sleep time).
Therefore, interactions between melatonin and other active substances as a consequence of melatonin's effect on CYP1A enzymes are not likely to be significant. 
Zato je manj verjetno, da so interakcije med melatoninom in drugimi zdravilnimi učinkovinami, kot posledica učinkovanja melatonina na CYP1A encime,
In a polysomnographic (PSG) study with a run-in of 2 weeks (single-blind with placebo treatment), followed by a treatment period of 3 weeks (double-blind, placebo-controlled, parallel group design) and a 3-week withdrawal period, sleep latency (SL) was shortened by 9 minutes compared to placebo. 
V polisomnografični (PSG) študiji, ki je trajala 2 tedna (enojno slepa, s placebom), ki ji je sledilo 3-tedensko obdobje zdravljenja (dvojno slepa, s placebom kontrolirana študija, zasnovana kot paralelna skupina) in 3-tedensko obdobje odtegnitve, je bila latentnost uspavanja krajša za 9 minut, v primerjavi s placebom.