FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: 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.
English: Therefore, interactions between melatonin and other active substances as a consequence of their effect on CYP1A enzymes is possible.
Slovenian: Zato so možne interakcije med melatoninom in drugimi zdravilnimi učinkovinami, kot posledica njihovega učinka na encime CYP1A.
English: Endogenous melatonin was measured in human breast milk thus exogenous melatonin is probably secreted into human milk.
Slovenian: V materinem mleku je bil izmerjen endogeni melatonin, iz česar se sklepa, da se eksogeni melatonin verjetno izloča v materino mleko.
English: Excipient with known effect: each prolonged-release tablet contains 80 mg lactose monohydrate.
Slovenian: Pomožne snovi z znanim učinkom: ena tableta s podaljšanim sproščanjem vsebuje 80 mg laktoze monohidrata.
English: 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.
Slovenian: V kliničnih preskušanjih so zdravilo Circadin dajali v 5 mg dnevnih odmerkih 12 mesecev brez pomembne spremembe v naravi sporočenih neželenih učinkov.
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.
Slovenian: Zdravilo Circadin se uporablja samostojno za kratkotrajno zdravljenje primarne nespečnosti (težave zaspati ali ohraniti spanec, šibek spanec) pri bolnikih, starih 55 let ali starejših.
English: If overdose occurs, drowsiness is to be expected.
Slovenian: Pri prevelikem odmerku je treba pričakovati zaspanost.
English: Therefore, breast-feeding is not recommended in women under treatment with melatonin.
Slovenian: Zato se dojenje ženskam, ki se zdravijo z melatoninom, ne priporoča.
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.
Slovenian: • 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.
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.
Slovenian: 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.
English: Melatonin is a naturally occurring hormone produced by the pineal gland and is structurally related to serotonin.
Slovenian: Melatonin je naraven hormon, ki ga proizvaja češarika in je po strukturi soroden serotoninu.
English: Experimental data suggest that isoenzymes CYP1A1, CYP1A2 and possibly CYP2C19 of the cytochrome P450 system are involved in melatonin metabolism.
Slovenian: Eksperimentalni podatki nakazujejo, da pri presnovi melatonina sodelujejo izoencimi CYP1A1, CYP1A2 in morebiti CYP2C19 sistema citokroma P450.
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.
Slovenian: • 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.
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.
Slovenian: 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.
English: What Circadin contains - The active substance is melatonin.
Slovenian: Kaj vsebuje zdravilo Circadin - Zdravilna učinkovina je melatonin.
English: − 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).
Slovenian: - 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).
English: • Severe chest pain due to angina
Slovenian: • huda bolečina v prsih zaradi angine pektoris
English: Uncommon: (may affect up to 1 in 100 people) • Chest pain
Slovenian: Občasni: (lahko se pojavijo pri največ 1 od 100 bolnikov) • Bolečine v prsih
English: 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.
Slovenian: 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.
English: Rationale for use
Slovenian: Smiselnost uporabe
English: In view of the lack of clinical data, use in pregnant women and by women intending to become pregnant is not recommended.
Slovenian: Uporaba zdravila pri nosečnicah in ženskam, ki načrtujejo nosečnost, ni priporočljiva zaradi pomanjkanja kliničnih podatkov.
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.
Slovenian: 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.
English: • CYP1A2 inducers such as carbamazepine and rifampicin may give rise to reduced plasma concentrations of melatonin.
Slovenian: • Snovi, ki inducirajo CYP1A2, kot sta karbamazepin in rifampicin, lahko povzročijo znižane koncentracije melatonina v plazmi.
English: INFORMATION IN BRAILLE Circadin 2 mg
Slovenian: Circadin 2 mg
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema levkopenija,
English: Administration of daily doses of up to 300 mg of melatonin without causing clinically significant adverse reactions have been reported in the literature.
Slovenian: V literaturi poročajo o dajanju dnevnih odmerkov do 300 mg melatonina brez klinično pomembnih neželenih učinkov.
English: 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.
Slovenian: 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.
English: • Circadin has been co-administered in studies with thioridazine and imipramine, active substances which affect the central nervous system.
Slovenian: • V študijah so zdravilo Circadin dajali hkrati s tioridazinom in imipraminom, zdravilnima učinkovinama, ki vplivata na centralni živčni sistem.
English: What Circadin is and what it is used for What you need to know before you take Circadin How to take Circadin
Slovenian: Kaj je zdravilo Circadin in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Circadin Kako jemati zdravilo Circadin Možni neželeni učinki
English: − 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.
Slovenian: - 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.
English: patients in the active group and by 77% in the placebo group.
Slovenian: O neželenih učinkih zaradi zdravljenja je poročalo 85 % bolnikov v aktivni skupini in 77 % v skupini s placebom.
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.
Slovenian: • 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.
English: Warnings and precautions Talk to your doctor or pharmacist before taking Circadin.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Circadin se posvetujte z zdravnikom ali farmacevtom,
English: In addition, quality of sleep and morning alertness significantly improved with Circadin compared to placebo.
Slovenian: Poleg tega se je kakovost spanja in jutranje budnosti v skupini z zdravilom Circadin pomembno izboljšala v primerjavi s tisto s placebom.
English: • CYP1A2 inhibitors such as quinolones may give rise to increased melatonin exposure.
Slovenian: • Zaviralci CYP1A2, kot so kinoloni, lahko povzročijo povečano izpostavljenost melatoninu.
English: • Caution should be exercised in patients on 5- or 8-methoxypsoralen (5 and 8-MOP), which increases melatonin levels by inhibiting its metabolism.
Slovenian: • 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.
English: The following adverse reactions were reported in clinical trials and from post-marketing spontaneous reporting.
Slovenian: V kliničnih preskušanjih in spontanih poročilih iz obdobja trženja so poročali o naslednjih neželenih učinkih.
English: Angina pectoris, palpitations
Slovenian: Srčne bolezni angina pektoris,
English: Most were mild to moderate in severity.
Slovenian: Ta je bila v večini primerov blaga do zmerna.
English: Patients had a significantly decreased total excretion of 6-sulfatoxymelatonin compared with controls.
Slovenian: V primerjavi s kontrolnimi skupinami je bil skupni izloček 6-sulfatoksimelatonin pri teh bolnikih znatno manjši.
English: There are no known harmful effects if treatment is interrupted or ended early.
Slovenian: V zvezi s prekinitvijo ali predčasnim prenehanjem jemanja tega zdravila ni znanih škodljivih učinkov.
English: - 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.
Slovenian: • Zdravilo Circadin lahko povzroča zaspanost; če postanete zaspani, morate biti previdni, saj lahko to vpliva na vašo sposobnost upravljanja vozil.
English: - The other ingredients are ammonio methacrylate copolymer type B, calcium hydrogen phosphate dihydrate, lactose monohydrate, silica (colloidal anhydrous), talc and magnesium stearate.
Slovenian: - Druge sestavine (pomožne snovi) so kopolimer amonijevega metakrilata (vrsta B), kalcijev hidrogenfosfat dihidrat, laktoza monohidrat, silicijev dioksid (brezvoden koloiden), smukec in magnezijev stearat.
English: If you are affected, you should not drive or operate machinery.
Slovenian: Ne vozite in ne upravljajte s stroji, če čutite vpliv zdravila.
English: Circadin may cause drowsiness.
Slovenian: Zdravilo Circadin lahko povzroči zaspanost.
English: If you have accidentally taken too much of your medicine, contact your doctor or pharmacist as soon as possible.
Slovenian: 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.
English: RAD Neurim Pharmaceuticals EEC SARL 4 rue de Marivaux
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM RAD Neurim Pharmaceuticals EEC SARL 4 rue de Marivaux
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).
Slovenian: 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).
English: If you suffer from continued drowsiness, then you should consult your doctor.
Slovenian: Če je zaspanost trajna, se posvetujte z zdravnikom.
English: If you forget to take Circadin
Slovenian: Če ste pozabili vzeti zdravilo Circadin
English: • Melatonin does not induce CYP1A enzymes in vitro at supra-therapeutic concentrations.
Slovenian: • Melatonin ne inducira CYP1A encimov in vitro pri koncentracijah, višjih kot so terapevtske.
English: • Melatonin's metabolism is mainly mediated by CYP1A enzymes.
Slovenian: • Melatonin v glavnem presnavljajo CYP1A encimi.
English: MEDICE Arzneimittel Pütter GmbH & Co. KG Tel.: + 48-(0)22 642 2673 e-mail: office@medice.pl
Slovenian: KG Tel.: + 48-(0)22 642 2673 e-mail: office@medice.pl
English: PHARMACEUTICAL FORM Prolonged-release tablet.
Slovenian: FARMACEVTSKA OBLIKA Tableta s podaljšanim sproščanjem.
English: Rare: (may affect up to 1 in 1000 people)
Slovenian: Redki: (lahko se pojavijo pri največ 1 od 1000 bolnikov)
English: • Caution should be exercised in patients on cimetidine a CYP2D inhibitor, which increases plasma melatonin levels, by inhibiting its metabolism.
Slovenian: • Previdnost je potrebna pri bolnikih, ki se zdravijo s cimetidinom, zaviralcem CYP2D, ki povečuje ravni melatonina v plazmi z zaviranjem njegove presnove.
English: Clearance of the active substance is expected within 12 hours after ingestion.
Slovenian: Očistek zdravilne učinkovine se pričakuje v 12 urah po zaužitju.
English: The rate of melatonin absorption and Cmax following Circadin 2 mg oral administration is affected by food.
Slovenian: Hrana vpliva na stopnjo absorpcije melatonina in Cmax po peroralnem jemanju zdravila Circadin 2 mg.
English: The liver is the primary site of melatonin metabolism and therefore, hepatic impairment results in higher endogenous melatonin levels.
Slovenian: Okvara jeter Presnova melatonina poteka pretežno v jetrih, zato so posledica okvare jeter višje ravni endogenega melatonina.
English: • Melatonin has been observed to induce CYP3A in vitro at supra-therapeutic concentrations.
Slovenian: • Opazili so, da melatonin inducira CYP3A in vitro pri koncentracijah, višjih kot so terapevtske.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 2 mg melatonin.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta s podaljšanim sproščanjem vsebuje 2 mg melatonina.
English: Each prolonged-release tablet contains 2 mg melatonin.
Slovenian: Ena tableta s podaljšanim sproščanjem vsebuje 2 mg melatonina.
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.
Slovenian: 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.
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
Slovenian: 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).
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.
Slovenian: Zato je manj verjetno, da so interakcije med melatoninom in drugimi zdravilnimi učinkovinami, kot posledica učinkovanja melatonina na CYP1A encime,
English: 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.
Slovenian: 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.
English: Shingles, high level of fatty molecules in the blood, low serum calcium levels in the blood, low sodium levels in the blood, altered mood, aggression, agitation, crying, stress symptoms, early morning awakening, increased sex drive, depressed mood, memory impairment, disturbance in attention, dreamy state, restless legs syndrome, poor quality sleep, ‘pins and needles' feeling, watery eyes, dizziness when standing or sitting, hot flushes, acid reflux, stomach disorder, blistering in the mouth, tongue ulceration, stomach upset, vomiting, abnormal bowel sounds, wind, excess saliva production, bad breath, abdominal discomfort, gastric disorder, inflammation of the stomach lining, eczema, skin rash, hand dermatitis, itchy rash, nail disorder, arthritis, muscle spasms, neck pain, night cramps, prolonged erection that might be painful, inflammation of the prostate gland, tiredness, pain, thirst, passing large volumes of urine, urinating during the night, increased liver enzymes, abnormal blood electrolytes and abnormal laboratory tests.
Slovenian: Herpes Zoster (pasasti izpuščaj), visoka raven maščobnih molekul v krvi, nizke ravni serumskega kalcija v krvi, nizke ravni natrija v krvi, nihanja v razpoloženju, nasilnost, nemir, jokanje, simptomi stresa, zgodnje jutranje zbujanje, povečan libido (povečana spolna sla), depresivno razpoloženje, težave s spominom, motnje pozornosti, zaspanost, sindrom nemirnih nog, šibek spanec, zbadanje in mravljinčenje, povečano solzenje (solzne oči), omotica pri stanju ali sedenju, vročinski vali, refluks kisline, želodčne motnje, mehurji v ustih, razjede jezika, razdražen želodec, bruhanje, nenormalni črevesni zvoki, vetrovi, povečano izločanje sline, neprijeten ustni zadah, nelagodje v trebuhu, želodčne motnje, vnetje trebušne stene, ekcem, kožni osip, dermatitis rok, srbenje, motnje nohtov, artritis, mišični spazmi, bolečine v vratu, nočni krči, podaljšanje erekcije, ki je lahko boleče, vnetje prostate, utrujenost, bolečina, žeja, izločanje velikih količin urina, uriniranje ponoči, povečani jetrni encimi, nenormalni elektroliti v krvi in nenormalni laboratorijski testi.
English: Pharmacodynamic interactions
Slovenian: Farmakodinamične interakcije:
English: Only those adverse reactions reported during clinical trials occurring in patients at an equivalent or greater rate than placebo have been included below.
Slovenian: V nadaljevanju so vključeni le neželeni učinki, ki so se med kliničnimi preskušanji pojavili v enaki ali večji pogostnosti pri bolnikih, ki so prejemali zdravilo, glede na tiste, ki so prejemali placebo.
English: Circadin contains lactose.
Slovenian: Zdravilo Circadin vsebuje laktozo.
English: Vertigo positional, vertigo
Slovenian: Ušesne bolezni, vključno z motnjami labirinta pozicijski vertigo, vertigo
English: Irritability, nervousness, restlessness, insomnia, abnormal dreams, nightmares, anxiety, migraine, headache, lethargy (tiredness, lack of energy), restlessness associated with increased activity, dizziness, tiredness, high blood pressure, upper abdominal pain, indigestion, mouth ulceration, dry mouth, nausea, changes in the composition of your blood which could cause yellowing of the skin or eyes, inflammation of the skin, night sweats, itching, rash, dry skin, pain in extremities, menopausal symptoms, feeling of weakness, excretion of glucose in the urine, excess proteins in the urine, abnormal liver function and weight increase.
Slovenian: Razdražljivost, živčnost, nemirnost, nespečnost, nenavadne sanje, nočne more, anksioznost, migrena, glavobol, letargija (utrujenost, pomanjkanje energije), nemirnost, povezana s povečano aktivnostjo, omotičnost, utrujenost, visok krvni tlak, bolečine v zgornjem delu trebuhu, prebavne motnje, razjede v ustih, suha usta, navzea (siljenje na bruhanje), spremembe v sestavi krvi, ki povzročajo rumenost kože ali oči, vnetje kože, nočno potenje, srbečica, osip, suha koža, bolečina v okončinah, menopavzni simptomi, občutek šibkosti, izločanje glukoze v urinu, preveč beljakovin v urinu, nenormalno delovanje jeter in povečana telesna masa.
English: In a second outpatient study with two week run in baseline period with placebo and a randomised, double blind, placebo controlled, parallel group treatment period of 3 weeks, the rate of patients who showed a clinically significant improvement in both quality of sleep and morning alertness was 26% in the Circadin group as compared to 15% in the placebo group.
Slovenian: V drugi ambulantni študiji z dvotedenskim uvajalnim obdobjem s placebom, randomizirani, dvojno slepi, s placebom kontrolirani s 3-tedenskim trajanjem paralelni skupini je bila stopnja bolnikov, ki so kazali klinično pomembno izboljšanje v kakovosti spanja in budnosti zjutraj 26% v skupini z zdravilom Circadin v primerjavi s 15% v skupini s placebom.
English: Uncommon: (may affect up to 1 in 100 people)
Slovenian: Občasni: (lahko se pojavijo pri največ 1 od 100 bolnikov)