natgillin/translations-raw huggingface dataset:
What Avandamet contains 
Kaj vsebuje zdravilo Avandamet
Pruritis 
Presnova
Surgery 
Kirurgija
Increased monitoring of the patient is recommended if AVANDAMET is used in combination particularly with insulin but also with a sulphonylurea. 
Pri uporabi zdravila AVANDAMET v kombinaciji s sulfonilsečnino, še posebej pa v kombinaciji z insulinom, priporočamo skrben nadzor bolnika.
Your kidney function will be checked 
Preverjati je treba delovanje ledvic
Rare side effects 
Neželen učinek
INFORMATION IN BRAILLE avandamet 1 mg/500 mg 
PODATKI V BRAILLOVI PISAVI avandamet 1 mg/500 mg
Take your tablets around the same time every day and follow any dietary advice that your doctor has given you. 
Tablete jemljite vsak dan ob približno istem času.
Very rare side effects 
Zelo redki neželeni učinki
Patients experiencing an ACS have not been studied in rosiglitazone controlled clinical trials. 
V nadzorovanih kliničnih preskušanjih uporabe rosiglitazona pri bolnikih z AKS niso raziskovali.
• steroids (used to treat inflammation) such as prednisolone or dexamethasone 
• kortikosteroidi (uporabljamo jih pri zdravljenju vnetja), kot sta prednizolon ali deksametazon.
INFORMATION IN BRAILLE avandamet 4 mg/1000 mg 
PODATKI V BRAILLOVI PISAVI avandamet 4 mg/1000 mg
INFORMATION IN BRAILLE avandamet 2 mg/500 mg 
PODATKI V BRAILLOVI PISAVI avandamet 2 mg/500 mg
Multipack comprising 3 packs, each containing 56 film-coated tablets. 
Vsaka enota vsebuje 56 filmsko obloženih tablet.
A more pronounced glucose-lowering effect was observed in obese patients. 
Pri debelih bolnikih je bil učinek zniževanja glukoze še izrazitejši.
Always take Avandamet tablets exactly as your doctor has told you. 
Pri jemanju Avandamet tablet natančno upoštevajte zdravnikova navodila.
Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including rosiglitazone. 
Med spremljanjem tiazolindionov, vključno z rosiglitazonom, po pridobitvi dovoljenja za promet so poročali o primerih na novo nastalega diabetičnega edema makule z zmanjšano ostrino vida ali njegovega poslabšanja.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4 mg of rosiglitazone (as rosiglitazone maleate) and 1000 mg of metformin hydrochloride (corresponding to metformin free base 780 mg). 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka tableta vsebuje 4 mg rosiglitazona (kot rosiglitazonijev maleat) in 1000 mg metforminijevega klorida (kar ustreza 780 mg metformina).
Cationic medicinal products that are eliminated by renal tubular secretion (e.g. cimetidine) may interact with metformin by competing for common renal tubular transport systems. 
Zaradi kompeticije za ledvične tubulne transportne sisteme se lahko med kationskimi zdravilnimi učinkovinami, ki se izločajo preko ledvic s tubulno sekrecijo (npr. cimetidin) in metforminom pojavi medsebojno delovanje.
INFORMATION IN BRAILLE avandamet 2 mg/1000 mg 
PODATKI V BRAILLOVI PISAVI avandamet 2 mg/1000 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg of rosiglitazone (as rosiglitazone maleate) and 500 mg of metformin hydrochloride (corresponding to metformin free base 390 mg). 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka tableta vsebuje 2 mg rosiglitazona (kot rosiglitazonijev maleat) in 500 mg metforminijevega klorida (kar ustreza 390 mg metformina).
• if you are going to have an X-ray using an injected dye (see ‘While you take 
• če imate predvideno rentgensko preiskavo pri kateri vam bodo v žilo vbrizgali kontrastno sredstvo (glejte ‘Med jemanjem zdravila Avandamet morate obvestiti svojega zdravnika' v nadaljevanju poglavja 2).
Metformin may act via three mechanisms: - by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis - in muscle, by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation - by delaying intestinal glucose absorption. 
Metformin lahko deluje na tri načine: - zmanjšuje nastajanje glukoze v jetrih, tako da inhibira glukoneogenezo in glikogenolizo;
In addition to the adverse reactions identified from clinical trial data, the adverse reactions presented in Table 2 have been identified in post approval use of rosiglitazone. 
Po pridobitvi dovoljenja za uporabo rosiglitazona so poleg neželenih učinkov, odkritih med kliničnimi preskušanji poročali še o neželenih učinkih, ki so navedene v preglednici 2.
The decision whether to continue the patient on therapy with AVANDAMET should be guided by clinical judgement pending laboratory evaluations. 
Dokler ne razpolagamo z rezultati laboratorijskih preiskav, je klinična presoja tista, ki vodi do odločitve o nadaljevanju zdravljenja z zdravilom AVANDAMET.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Component of a multipack comprising 3 packs, each containing 112 film-coated tablets. 
Vsaka enota vsebuje 112 filmsko obloženih tablet.
Use only as directed by your doctor. 
Pri uporabi zdravila natančno upoštevajte zdravnikova navodila.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/258/016 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/258/016
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (WITH BLUE BOX) (EXCLUDING MULTIPACKS) 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA ( Z BLUE BOX) (NI ZA PAKIRANJE PO VEČ ENOT)
Pink film-coated tablets marked "gsk" on one side and "4/1000" on the other. 
Filmsko obložena tableta Rožnate filmsko obložene tablete z oznako "gsk" na eni strani in "4/1000" na drugi strani.
NAME OF THE MEDICINAL PRODUCT AVANDAMET 4 mg/1000 mg film-coated tablets 
IME ZDRAVILA AVANDAMET 4 mg/1000 mg filmsko obložene tablete
Lactose monohydrate Povidone (E1201) Magnesium stearate. 
Jedro tablete: natrijev karboksimetilškrob hipromeloza (E464) mikrokristalna celuloza (E460) laktoza monohidrat povidon (E1201) magnezijev stearat
NAME OF THE MEDICINAL PRODUCT AVANDAMET 1 mg/500 mg film-coated tablets 
IME ZDRAVILA AVANDAMET 1 mg/500 mg filmsko obložene tablete
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (WITHOUT BLUE BOX) MULTIPACKS ONLY (56 TABLETS) 
PODATKI NA ZUNANJI OVOJNINI VMESNA ŠKATLA (BREZ BLUE BOX) SAMO ZA PAKIRANJE PO VEČ ENOT (56 TABLET)
An increased incidence of cardiac failure has been observed in clinical trials when rosiglitazone is used in combination with insulin. 
V kliničnih preskušanjih so pri uporabi rosiglitazona v kombinaciji z insulinom poročali o večji pojavnosti srčnega popuščanja.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/258/015 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/258/015
NAME OF THE MEDICINAL PRODUCT AVANDAMET 2 mg/500 mg film-coated tablets 
IME ZDRAVILA AVANDAMET 2 mg/500 mg filmsko obložene tablete
This risk was increased when rosiglitazone was added to established insulin and in patients receiving nitrates for known ischaemic heart disease. 
Pri bolnikih, ki so se že zdravili z insulinom, in bolnikih, ki so prejemali nitrate zaradi znane ishemične bolezni srca, se je to tveganje po dodatni uvedbi rosiglitazona povečalo.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (WITHOUT BLUE BOX) MULTIPACKS ONLY (3x112 TABLETS) 
PODATKI NA ZUNANJI OVOJNINI VMESNA ŠKATLA (BREZ BLUE BOX) SAMO ZA PAKIRANJE PO VEČ ENOT (3 x 112 TABLET)
EU/1/03/258/010 14 tablets EU/1/03/258/011 28 tablets EU/1/03/258/012 56 tablets EU/1/03/258/022 180 tablets 
EU/1/03/258/010 14 tablet EU/1/03/258/011 28 tablet EU/1/03/258/012 56 tablet EU/1/03/258/022 180 tablet
Yellow film-coated tablets marked "gsk" on one side and "1/500" on the other. 
Filmsko obložena tableta Rumene filmsko obložene tablete z oznako "gsk" na eni strani in "1/500" na drugi strani.
EU/1/03/258/007-009 EU/1/03/258/013 EU/1/03/258/017 EU/1/03/258/021 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/258/007-009, EU/1/03/258/013, EU/1/03/258/017, EU/1/03/258/021
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX) MULTIPACKS ONLY (3x112 TABLETS) 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (Z BLUE BOX) SAMO ZA PAKIRANJE PO VEČ ENOT (3 x 112 TABLET)
Check with your doctor or pharmacist if you are not sure. 
Če ste negotovi, se posvetujte z zdravnikom ali s farmacevtom.
NAME OF THE MEDICINAL PRODUCT AVANDAMET 1 mg/500 mg tablets rosiglitazone/metformin HCl 
IME ZDRAVILA AVANDAMET 1 mg/500 mg tablete rosiglitazon/metforminijev klorid
NAME OF THE MEDICINAL PRODUCT AVANDAMET 2 mg/500 mg tablets rosiglitazone/metformin HCl 
IME ZDRAVILA AVANDAMET 2 mg/500 mg tablete rosiglitazon/metforminijev klorid
However, the risk of both fluid related adverse events and hypoglycaemia are increased when AVANDAMET is used in combination with insulin. 
Vendar pa pri uporabi zdravila AVANDAMET v kombinaciji z insulinom obstaja večje tveganje tako za pojav neželenih dogodkov povezanih z zastajanjem tekočine, kot za pojav hipoglikemije.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (WITHOUT BLUE BOX) MULTIPACKS ONLY (112 TABLETS) 
PODATKI NA ZUNANJI OVOJNINI VMESNA ŠKATLA (BREZ BLUE BOX) - SAMO ZA PAKIRANJE PO VEČ ENOT (112 TABLET)
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 4 mg of rosiglitazone (as maleate) and 1000 mg of metformin hydrochloride. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta vsebuje 4 mg rosiglitazona (kot maleat) in 1000 mg metforminijevega klorida.
Pale pink film-coated tablets marked "gsk" on one side and "2/500" on the other. 
Filmsko obložena tableta Bledo rožnate filmsko obložene tablete z oznako "gsk" na eni strani in "2/500" na drugi strani.
If you get side effects 
V primeru pojava neželenih učinkov
NAME OF THE MEDICINAL PRODUCT AVANDAMET 2 mg/1000 mg film-coated tablets 
IME ZDRAVILA AVANDAMET 2 mg/1000 mg filmsko obložene tablete
EU/1/03/258/007 14 tablets EU/1/03/258/008 28 tablets EU/1/03/258/009 56 tablets EU/1/03/258/021 180 tablets 
EU/1/03/258/007 14 tablet EU/1/03/258/008 28 tablet EU/1/03/258/009 56 tablet EU/1/03/258/021 180 tablet
Yellow film-coated tablets marked "gsk" on one side and "2/1000" on the other. 
Filmsko obložena tableta Rumene filmsko obložene tablete z oznako "gsk" na eni strani in "2/1000" na drugi strani.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2 mg of rosiglitazone (as maleate) and 500 mg of metformin hydrochloride. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta vsebuje 2 mg rosiglitazona (kot maleat) in 500 mg metforminijevega klorida.
EU/1/03/258/017, 56 tablets, component of a 168 tablet multipack. 
EU/1/03/258/013, 56 tablet, sestavni del pakiranja po več enot s 112 tabletami EU/1/03/258/017, 56 tablet, sestavni del pakiranja po več enot s 168 tabletami
EU/1/03/258/004 28 tablets EU/1/03/258/005 56 tablets EU/1/03/258/006 112 tablets EU/1/03/258/020 360 tablets 
EU/1/03/258/004 28 tablet EU/1/03/258/005 56 tablet EU/1/03/258/006 112 tablet EU/1/03/258/020 360 tablet
Within each system organ class, adverse reactions are presented in the table by decreasing frequency for the rosiglitazone monotherapy treatment regimen. 
Za režim zdravljenja z rosiglitazonom kot samostojnim zdravilom so neželeni učinki v preglednici, znotraj vsakega organskega sistema, navedeni po padajoči pogostnosti.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2 mg of rosiglitazone (as maleate) and 1000 mg of metformin hydrochloride. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta vsebuje 2 mg rosiglitazona (kot maleat) in 1000 mg metforminijevega klorida.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 1 mg of rosiglitazone (as maleate) and 500 mg of metformin hydrochloride. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta vsebuje 1 mg rosiglitazona (kot maleat) in 500 mg metforminijevega klorida.
EU/1/03/258/001 28 tablets EU/1/03/258/002 56 tablets EU/1/03/258/003 112 tablets EU/1/03/258/019 360 tablets 
EU/1/03/258/001 28 tablet EU/1/03/258/002 56 tablet EU/1/03/258/003 112 tablet EU/1/03/258/019 360 tablet
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX) 
ZUNANJA NALEPKA (Z BLUE BOX)
EU/1/03/258/018, 56 tablets, component of a 168 tablet multipack. 
EU/1/03/258/014, 56 tablet, sestavni del pakiranja po več enot s 112 tabletami EU/1/03/258/018, 56 tablet, sestavni del pakiranja po več enot s 168 tabletami
and your dose of Avandamet may need to be changed. 
Zdravnik bo preveril vrednost krvnega sladkorja, odmerek zdravila Avandamet pa bo morda moral spremeniti.
Hepatobiliary disorders liver function disorders 
Bolezni jeter, žolčnika in žolčevodov motnje v delovanju jeter
HOW TO STORE AVANDAMET Keep out of the reach and sight of children. 
SHRANJEVANJE ZDRAVILA AVANDAMET Zdravilo shranjujte nedosegljivo otrokom!
New or worse cases of macular oedema have occurred on rare occasions in people taking Avandamet and similar medicines. 
V redkih primerih so pri bolnikih, ki so se zdravili z zdravilom Avandamet in podobnimi zdravili poročali o novem pojavu ali poslabšanju že obstoječega makularnega edema.
Each tablet contains 2 mg of rosiglitazone (as rosiglitazone maleate) and 1000 mg of metformin hydrochloride (corresponding to metformin free base 780 mg). 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka tableta vsebuje 2 mg rosiglitazona (kot rosiglitazonijev maleat) in 1000 mg metforminijevega klorida (kar ustreza 780 mg metformina).
Each tablet contains 1 mg of rosiglitazone (as rosiglitazone maleate) and 500 mg of metformin hydrochloride (corresponding to metformin free base 390 mg). 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka tableta vsebuje 1 mg rosiglitazona (kot rosiglitazonijev maleat) in 500 mg metforminijevega klorida (kar ustreza 390 mg metformina).
NAME OF THE MEDICINAL PRODUCT AVANDAMET 4 mg/1000 mg film-coated tablets rosiglitazone/metformin HCl 
AVANDAMET 4 mg/1000 mg filmsko obložene tablete rosiglitazon/metforminijev klorid
Therefore, close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic medicinal products that are eliminated by renal tubular secretion are co-administered (see section 4.4). 
Pri sočasnem dajanju kationskih zdravilnih učinkovin, ki se izločajo preko ledvic s tubulno sekrecijo je torej treba skrbno nadzirati urejenost glikemije, skrbeti za prilagoditev odmerka znotraj priporočenega odmernega intervala in razmisliti o morebitnih spremembah pri zdravljenju sladkorne bolezni.
NAME OF THE MEDICINAL PRODUCT AVANDAMET 4 mg/1000 mg tablets rosiglitazone/metformin HCl 
AVANDAMET 4 mg/1000 mg tablete rosiglitazon/metforminijev klorid
The protein binding of the major metabolite (a para-hydroxy-sulphate) is very high 
Stopnja vezave glavnega metabolita (parahidroksisulfata) na proteine je zelo visoka (> 99,99 %).
NAME OF THE MEDICINAL PRODUCT AVANDAMET 2 mg/1000 mg film-coated tablets rosiglitazone/metformin HCl 
AVANDAMET 2 mg/1000 mg filmsko obložene tablete rosiglitazon/metforminijev klorid
EU/1/03/258/010-012 EU/1/03/258/014 EU/1/03/258/018 EU/1/03/258/022 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/258/010-012, EU/1/03/258/014, EU/1/03/258/018, EU/1/03/258/022
HOW TO TAKE AVANDAMET 
Zdravilo Avandamet
Excipients: 
Pomožne snovi:
NAME OF THE MEDICINAL PRODUCT AVANDAMET 2 mg/1000 mg tablets rosiglitazone/metformin HCl 
AVANDAMET 2 mg/1000 mg tablete rosiglitazon/metforminijev klorid
Titanium dioxide (E171) 
Filmska obloga: hipromeloza (E464) titanov dioksid (E171) makrogol rumeni železov oksid (E172)
PHARMACEUTICAL FORM AND CONTENTS Multipack comprising 3 packs, each containing 112 film-coated tablets. 
112 tablet Sestavni del pakiranja po več enot, ki vsebuje 3 enote.
NAME OF THE MEDICINAL PRODUCT AVANDAMET 2 mg/500 mg film-coated tablets rosiglitazone/metformin HCl 
AVANDAMET 2 mg/500 mg filmsko obložene tablete rosiglitazon/metforminijev klorid
The maximum dose is 4 mg rosiglitazone and 1000 mg metformin, taken twice a day. 
Največji odmerek je 4 mg rosiglitazona in 1.000 mg metformina dvakrat na dan. (Takšen odmerek lahko vzamete tudi v obliki dveh 2 mg/500 mg tablet dvakrat na dan.)
Insulin and rosiglitazone are both associated with fluid retention, concomitant administration may increase the risk of oedema and could increase the risk of ischaemic heart disease. 
Pri njuni sočasni uporabi se lahko poveča tveganje za pojav edemov in ishemično bolezen srca.
Metabolism and nutrition disorders hypercholesterolaemia1 Common hypertriglyceridaemia Common hyperlipaemia weight increase increased appetite hypoglycaemia 
Pogosti hipertrigliceridemija Pogosti hiperlipemija
NAME OF THE MEDICINAL PRODUCT AVANDAMET 1 mg/500 mg film-coated tablets rosiglitazone/metformin HCl 
AVANDAMET 1 mg/500 mg filmsko obložene tablete rosiglitazon/metforminijev klorid
What Avandamet looks like and contents of the pack Avandamet 1 mg/500 mg tablets are yellow and marked "gsk" on one side and "1/500" on the other. 
Izgled zdravila Avandamet in vsebina pakiranja Avandamet 1 mg/500 mg tablete so rumene barve.
In another long-term study, there was an increased incidence of bone fracture for subjects in the combined rosiglitazone group compared to active control [8.3% vs 5.3%, Risk ratio 1.57 (95% CI 1.26 - 1.97)]. 
s 5,3 %, razmerje tveganj 1,57 (95 % IZ 1,26-1,97)].
Strength Pharmaceutical Form 
Farmacevtska oblika
1 vial + 1 syringe + 1 needle + 1 adaptor + 2 alcohol pads 
1 viala + 1 injekcijska brizga + 1 igla + 1 adapter + 2 alkoholna zloženca napolnjena injekcijska brizga (steklo)
(Invented) name 
Številka EU Izmišljeno ime Jakost
EU/1/19/1356/001 IDACIO 40 mg/0.8 ml 
40 mg/0,8 ml raztopina za injiciranje viala (steklo)
Pack size 
Ovojnina
This summary was last updated in 07-2015. 
Povzetek je bil nazadnje posodobljen 07-2015.
As a result, patients fall asleep and wake up at unusual times. 
Posledično bolniki zaspijo in se zbujajo ob neobičajnih urah.
However, continued treatment would be necessary to maintain the beneficial effects. 
Vendar je za vzdrževanje koristnih učinkov nujno potrebno neprekinjeno zdravljenje.
The European Commission granted a marketing authorisation valid throughout the European Union for Hetlioz on 3 July 2015. 
Evropska komisija je dovoljenje za promet z zdravilom Hetlioz, veljavno po vsej Evropski uniji, izdala 3. julija 2015.
The recommended dose is one capsule per day, taken one hour before bedtime, at the same time every night. 
Priporočeni odmerek je ena kapsula na dan, ki jo je treba vsak večer ob istem času vzeti eno uro pred spanjem.
What measures are being taken to ensure the safe and effective use of Hetlioz? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Hetlioz?
Improved results were seen in a subset of patients after 7 months of treatment, which indicate that patients may take weeks or months to respond. 
Boljše rezultate so opazili pri podskupini bolnikov po sedmih mesecih zdravljenja, kar kaže na to, da lahko včasih traja več tednov ali mesecev, da se bolniki odzovejo.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Hetlioz's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Hetlioz večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
This is a summary of the European public assessment report (EPAR) for Hetlioz. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Hetlioz.
In the second study, 57 patients first received Hetlioz for around 11 weeks. 
V drugi študiji je 57 bolnikov sprva prejemalo zdravilo Hetlioz približno 11 tednov.
The medicine should be taken without food. 
Zdravilo Hetlioz je treba jemati brez hrane.
Hetlioz is intended for long-term use. 
Zdravilo Hetlioz je namenjeno dolgotrajni uporabi.
These are usually mild or moderate in severity and temporary. 
Ti neželeni učinki so po resnosti navadno blagi ali zmerni in so prehodni.
The most common side effects with Hetlioz (which may affect more than 3 in 100 people) are headache, somnolence, nausea (feeling sick) and dizziness. 
Najpogostejši neželeni učinki zdravila Hetlioz (ki lahko prizadenejo več kot 3 osebe od 100) so glavobol, somnolenca (bolezenska zaspanost), navzeja (slabost) in omotica.
The main measure of effectiveness was the percentage of patients who were able to adjust to the 24-hour clock, which was calculated by looking at how the amount of melatonin breakdown products changed in the patient's urine over time. 
Glavno merilo učinkovitosti je bil odstotek bolnikov, ki so se uspeli prilagoditi na 24-urni dan, kar so izračunali s pomočjo določanja, kako se je količina produktov razgradnje melatonina v urinu bolnikov spreminjala s časom.
The summary of the opinion of the Committee for Orphan Medicinal Products for Hetlioz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Povzetek mnenja Odbora za zdravila sirote o zdravilu Hetlioz je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Hetlioz is available as 20 mg capsules and can only be obtained with a prescription. 
Zdravilo Hetlioz je na voljo v obliki 20-miligramskih kapsul in se izdaja le na recept.
Other information about Hetlioz 
Druge informacije o zdravilu Hetlioz
What benefits of Hetlioz have been shown in studies? 
Kakšne koristi je zdravilo Hetlioz izkazalo v študijah?
The CHMP noted that only around 20% of patients would be able to benefit from treatment with Hetlioz, but in view of the lack of approved treatments for non-24-hour sleep-wake disorder, which is a debilitating condition, this modest response was still considered important. 
Odbor CHMP je izpostavil, da bi imelo od zdravljenja z zdravilom Hetlioz korist le približno 20 % bolnikov, vendar pa je z vidika pomanjkanja odobrenih zdravljenj za motnjo ne-24-urnega cikla spanja in budnosti, ki je izčrpavajoča motnja, ta skromen odziv še vedno pomemben.
A risk management plan has been developed to ensure that Hetlioz is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Hetlioz je bil pripravljen načrt obvladovanja tveganj.
In people with normal perception of light and dark, melatonin is produced in hours of darkness and promotes sleep by acting on melatonin receptors in specific areas of the brain. 
Pri osebah z normalnim zaznavanjem svetlobe in teme se melatonin tvori v času teme in spodbuja spanje z delovanjem na melatoninske receptorje v določenih delih možganov.
Non-24hour sleep-wake disorder is a condition that occurs almost exclusively in people who are completely blind, where patients have sleep patterns that are not synchronised with day and night and often follow a cycle that is longer than the standard 24-hour clock. 
Ne-24-urni cikel spanja in budnosti je motnja, ki se pojavlja skoraj izključno pri popolnoma slepih osebah in pri kateri imajo bolniki vzorce spanja, ki niso usklajeni z dnevom in nočjo ter pogosto sledijo ciklu, daljšemu od standardnega 24-urnega dneva.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Hetlioz, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
What are the risks associated with Hetlioz? 
Kakšna tveganja so povezana z zdravilom Hetlioz?
A hormone called melatonin plays a key role in co-ordinating the body's sleep-wake cycle. 
Hormon, imenovan melatonin, ima ključno vlogo pri usklajevanju cikla spanja in budnosti v telesu.
For more information about treatment with Hetlioz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Hetlioz preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Regarding safety, Hetlioz was shown to be well tolerated, causing only few mild side effects. 
V zvezi z varnostjo se je izkazalo, da bolniki zdravilo Hetlioz dobro prenašajo in da je povzročilo le nekaj blagih neželenih učinkov.