FrancophonIA/ELRC3.0 huggingface dataset:
English: • You have severe or persistent diarrhoea; esomeprazole has been associated with a small increased risk of infectious diarrhoea.
Croatian: • Ako imate težak ili dugotrajan proljev; esomeprazol se povezuje s blago povećanim rizikom od zaraznog proljeva.
English: Effects of esomeprazole on the pharmacokinetics of other medicinal products As esomeprazole is one enantiomer of omeprazole it is reasonable to advise about interactions reported with omeprazole.
Croatian: Učinci esomeprazola na farmakokinetiku drugih lijekova Budući da je esomeprazol jedan enantiomer omeprazola, uputno je dati podatke o interakcijama koje su prijavljene kod primjene omeprazola.
English: Mean peak plasma concentrations were 60% higher.
Croatian: Prosječne vrijednosti vršne koncentracije u plazmi bile su 60% više.
English: In healthy volunteers, concomitant administration of 40 mg esomeprazole resulted in a 32% increase in area under the plasma concentration-time curve (AUC) and a 31% prolongation of elimination half-life(t1/2) but no significant increase in peak plasma levels of cisapride.
Croatian: U zdravih je dobrovoljaca istodobna primjena esomeprazola u dozi od 40 mg rezultirala povećanjem površine ispod krivulje koncentracija-vrijeme u plazmi (AUC) cisaprida za 32% i produljenjem poluvremena njegove eliminacije (t1/2) za 31%, no ne i značajnim povećanjem vršnih koncentracija cisaprida u plazmi.
English: Increased gastric pH during omeprazole treatment may change the absorption of the protease inhibitors.
Croatian: Povišenje želučanog pH tijekom liječenja omeprazolom može promijeniti apsorpciju inhibitora proteaze.
English: BOTTLE LABEL
Croatian: NALJEPNICA NA BOČICI
English: No other liquids should be used as the enteric coating may be dissolved.
Croatian: Ne smiju se koristiti nikakve druge tekućine jer može doći do otapanja želučanootporne ovojnice.
English: It is recommended to monitor the plasma concentrations of phenytoin when treatment with esomeprazole is introduced or withdrawn.
Croatian: Preporučuje se nadzirati koncentracije fenitoina u plazmi kada se uvodi ili prekida liječenje esomeprazolom.
English: • Skin rash on exposure to sunshine.
Croatian: • kožni osip pri izlaganju sunčevoj svjetlosti
English: Omeprazole has been reported to interact with some protease inhibitors.
Croatian: Prijavljeno je da omeprazol ulazi u interakcije s nekim inhibitorima proteaze.
English: A reinforced monitoring of tacrolimus concentrations as well as renal function (creatinine clearance) should be performed, and the dose of tacrolimus adjusted if needed.
Croatian: Potrebno je pojačano praćenje koncentracija takrolimusa kao i bubrežne funkcije (klirensa kreatinina) te po potrebi prilagodba doze takrolimusa.
English: • Eyesight problems such as blurred vision.
Croatian: • tegobe s vidom, poput zamagljenog vida
English: (Gasto-resistant capsule).
Croatian: (Želučanootporna kapsula)
English: Food intake both delays and decreases the absorption of esomeprazole although this has no significant influence on the effect of esomeprazole on intragastric acidity.
Croatian: Istodobno uzimanje hrane odgađa i smanjuje apsorpciju esomeprazola iako to ne utječe značajno na djelovanje esomeprazola na kiselost u želucu.
English: The bottle also contains a sealed container with silica gel desiccant.
Croatian: Bočica isto tako sadrži zatvoreni spremnik sa silikagelom kao sredstvom za sušenje.
English: Esomeprazole is the S-isomer of omeprazole and reduces gastric acid secretion through a specific targeted mechanism of action.
Croatian: Esomeprazol je S-izomer omeprazola koji smanjuje lučenje želučane kiseline specifičnim ciljanim mehanizmom djelovanja.
English: When starting or ending treatment with esomeprazole, the potential for interactions with medicinal products metabolised through CYP2C19 should be considered.
Croatian: Na početku i na kraju liječenja esomeprazolom treba u obzir uzeti mogućnost interakcije s lijekovima koji se metaboliziraju putem CYP2C19.
English: Total plasma clearance is about 17 l/h after a single dose and about 9 l/h after repeated administration.
Croatian: Ukupan klirens esomeprazola iz plazme iznosi oko 17 l/h nakon jedne doze i oko 9 l/h nakon ponovljene primjene.
English: • Severe liver problems leading to liver failure and inflammation of the brain.
Croatian: • teške tegobe s jetrom koje uzrokuju zatajenje jetre i upalu mozga
English: • You are aged over 55 years and have new or recently changed reflux symptoms or need to take a non-prescription indigestion or heartburn remedy treatment every day.
Croatian: • Ako ste stariji od 55 godina i nedavno su Vam se pojavili novi ili izmijenili postojeći simptomi refluksa, ili imate potrebu svakodnevno uzimati bezreceptne lijekove za probavne smetnje ili liječenje žgaravice.
English: • Disturbed sleep (insomnia), feeling sleepy.
Croatian: • poremećaj spavanja (nesanica), pospanost
English: Other possible interaction mechanisms are via inhibition of CYP2C19.
Croatian: Drugi mogući mehanizmi interakcije su putem inhibicije CYP2C19.
English: Patients with long-term recurrent symptoms of indigestion or heartburn should see their doctor at regular intervals.
Croatian: Bolesnici s dugotrajnim rekurentnim simptomima indigestije ili žgaravice moraju redovito odlaziti liječniku.
English: What Nexium Control contains
Croatian: Što Nexium Control sadrži
English: If you are overweight or smoke you increase the probability of suffering from heartburn.
Croatian: Prekomjerna težina i pušenje povećavaju vjerojatnost pojave žgaravice.
English: Esomeprazole 20 mg has been demonstrated to effectively treat frequent heartburn in subjects receiving one dose per 24 hours over 2 weeks.
Croatian: Dokazano je da 20 mg esomeprazola učinkovito liječi čestu žgaravicu u bolesnika koji su primili jednu dozu tijekom 24 sata tijekom 2 tjedna.
English: Talk to your doctor before taking Nexium Control if:
Croatian: Obratite se svom liječniku prije nego uzmete Nexium Control:
English: In these individuals the metabolism of esomeprazole is probably mainly catalysed by CYP3A4.
Croatian: U tih se osoba metabolizam esomeprazola vjerojatno katalizira putem CYP3A4.
English: Skin and subcutaneous tissue disorders dermatitis, pruritus, rash urticaria alopecia, photosensitivity erythema multiforme, StevensJohnson syndrome, toxic epidermal necrolysis (TEN)
Croatian: Poremećaji kože i potkožnog tkiva dermatitis, pruritus, osip, urtikarija alopecija, fotoosjetljivost multiformni eritem, StevensJohnsonov sindrom, toksična epidermalna nekroliza (TEN)
English: Excipient(s) with known effect Each gastro-resistant hard capsule contains 11.5 mg sucrose.
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom Jedna želučanootporna tvrda kapsula sadrži 11,5 mg saharoze.
English: Esomeprazole is completely eliminated from plasma between doses with no tendency for accumulation during once-daily administration.
Croatian: Esomeprazol se u potpunosti eliminira iz plazme između dviju doza i nije sklon akumulaciji kod primjene jedanput na dan.
English: • To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink it.
Croatian: • Kako biste bili sigurni da ste popili sav lijek, napunite čašu do pola vodom ispirući stijenke čaše i popijte sadržaj.
English: If you have an infection with symptoms such as fever with a severely reduced general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in urinating, you must consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test.
Croatian: Ako imate infekciju sa simptomima poput vrućice i jako pogoršanog općeg stanja ili vrućicu i simptome lokalne infekcije, poput boli u vratu, grlu ili ustima te otežanog mokrenja, morate se što prije obratiti liječniku kako bi se krvnim pretragama isključio nedostatak bijelih krvnih stanica (agranulocitoza).
English: • Tacrolimus (in cases of organ transplantation)
Croatian: • Takrolimus (u slučaju presađivanja organa)
English: • Swelling of the feet and ankles.
Croatian: • oticanje stopala ili gležnjeva
English: Nexium Control has a low likelihood of affecting your ability to drive or use machines.
Croatian: Malo je vjerojatno da bi Nexium Control mogao utjecati na sposobnost upravljanja vozilima ili rukovanja strojevima.
English: Studies evaluating concomitant administration of esomeprazole and either naproxen or rofecoxib did not identify any clinically relevant pharmacokinetic interactions during short-term studies.
Croatian: U ispitivanjima u kojima se ocjenjivala istodobna primjena esomeprazola s naproksenom ili rofekoksibom nisu utvrđene klinički značajne farmakokinetičke interakcije tijekom kratkoročnih kliničkih ispitivanja.
English: The metabolism of esomeprazole in patients with mild to moderate liver dysfunction may be impaired.
Croatian: Metabolizam esomeprazola u bolesnika s blagim do umjerenim oštećenjem jetre može biti poremećen.
English: This increase is dose-dependent and results in a more than dose proportional increase in AUC after repeated administration.
Croatian: To je povećanje ovisno o dozi, a nakon ponovljene primjene dovodi do povećanja AUC-a koje je veće od povećanja proporcionalnog dozi.
English: The major metabolites of esomeprazole have no effect on gastric acid secretion.
Croatian: Glavni metaboliti esomeprazola ne utječu na lučenje želučane kiseline.
English: It is unknown whether esomeprazole/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se esomeprazol/njegovi metaboliti u majčino mlijeko.
English: Monitoring is recommended when initiating and ending concomitant esomeprazole treatment during treatment with warfarin or other coumarine derivatives.
Croatian: Preporučuje se nadzor kada se liječenje esomeprazolom započinje ili prekida istodobno s liječenjem varfarinom ili drugim kumarinskim derivatima.
English: • If you experience any of the symptoms detailed in Section 2 of this leaflet and it advises you to talk to your doctor or pharmacist.
Croatian: • Ako osjetite bilo koje simptome opisane u dijelu 2. ove upute, za koje postoji napomena da se obratite liječniku ili ljekarniku.
English: For short-term treatment of reflux symptoms (heartburn, acid regurgitation) in adults, aged 18 or over.
Croatian: Za kratkotrajno liječenje simptoma refluksa (žgaravice, vraćanje kiseline iz želuca) u odraslih u dobi od 18 godina ili više.
English: Approximately 78% of the subjects on 20 mg esomeprazole reported first resolution of heartburn within the first week of treatment compared to 52 - 58% for placebo.
Croatian: Približno 78% ispitanika liječenih s 20 mg esomeprazola prijavilo je prvo povlačenje žgaravice unutar prvoga tjedna liječenja u usporedbi s 52-58% bolesnika koji su primali placebo.
English: You may also notice that when you lie down, that your heartburn gets worse.
Croatian: Također možda primijetite pogoršanje žgaravice nakon što legnete.
English: • You get stomach pain or signs of indigestion such as nausea, fullness, bloating especially after food intake.
Croatian: • Ako Vas boli želudac ili imate znakove probavnih smetnji, poput mučnine, osjećaja punoće ili nadutosti, osobito nakon unosa hrane.
English: • You have jaundice (yellowing of skin or eyes) or severe liver problems.
Croatian: • Ako imate žuticu (koža ili oči postaju žuti) ili teške probleme s jetrom.
English: In two multicenter, randomized, double-blind, placebo-controlled pivotal studies 234 subjects with a recent history of frequent heartburn were treated with 20 mg esomeprazole for 4 weeks.
Croatian: U dva multicentrična, randomizirana, dvostruko slijepa, placebom kontrolirana pivotalna ispitivanja, 234 ispitanika s nedavnim učestalim žgaravicama u anamnezi liječena su esomeprazolom u dozi od 20 mg tijekom 4 tjedna.
English: The investigators' assessments of heartburn resolution were consistent with the subjects' assessments, showing statistically significant differences between esomeprazole (34.7% - 41.8%) compared to placebo (8.0% - 11.4%).
Croatian: Ispitivačeve procjene povlačenja žgaravice bile su dosljedne ispitanikovim procjenama pokazujući statistički značajne razlike između esomeprazola (34,7%-41,8%) u usporedbi s placebom (8,0%-11,4%).
English: Thus, when esomeprazole is combined with medicinal products metabolised by CYP2C19, such as warfarin, phenytoin, citalopram, imipramine, clomipramine, diazepam, etc., the plasma concentrations of these medicinal products may be increased and a dose reduction could be needed.
Croatian: Stoga, kada se esomeprazol kombinira s lijekovima koji se metaboliziraju putem CYP2C19, kao što su varfarin, fenitoin, citalopram, imipramin, klomipramin, diazepam itd., može doći do povećanja plazmatske koncentracije navedenih lijekova te može biti potrebno smanjiti dozu navedenih lijekova.
English: Do not take this medicine if you are also taking a medicine containing nelfinavir (used to treat HIV infection).
Croatian: Nemojte uzimati ovaj lijek ako također uzimate lijek koji sadrži nelfinavir (koristi se za liječenje HIV infekcije).
English: Česká republika Pfizer PFE, spol.
Croatian: Česká republika Pfizer PFE, spol. s.r.o.
English: Concomitant administration of 40 mg esomeprazole to warfarin-treated patients in a clinical study showed that coagulation times were within the accepted range.
Croatian: U jednom je kliničkom ispitivanju istodobna primjena 40 mg esomeprazola u bolesnika liječenih varfarinom pokazala da su vremena koagulacije unutar prihvatljivoga raspona.
English: Common Uncommon Rare
Croatian: Vrlo rijetko Nepoznato
English: As a precaution, concomitant use of esomeprazole and clopidogrel should be discouraged.
Croatian: Kao mjeru opreza treba izbjegavati istodobno uzimanje esomeprazola i klopidogrela.
English: In high-dose methotrexate administration a temporary withdrawal of esomeprazole may need to be considered.
Croatian: U slučaju primjene visokih doza metotreksata možda će trebati razmotriti privremeni prekid liječenja esomeprazolom.
English: • Tacrolimus (in cases of organ transplantation).
Croatian: • Takrolimus (u slučaju presađivanja organa).
English: Inconsistent data on the clinical implications of this PK/PD interaction in terms of major cardiovascular events have been reported from both observational and clinical studies.
Croatian: I u opservacijskim i u kliničkim ispitivanjima prijavljeni su neujednačeni podaci o kliničkom značaju ove PK/PD interakcije u smislu ozbiljnih kardiovaskularnih događaja.
English: The glass should be rinsed with half a glass of water and the water drunk.
Croatian: Čašu treba isprati s pola čaše vode, a zatim tu vodu popiti.
English: These findings have no implications for the posology of esomeprazole.
Croatian: Ovi nalazi nemaju utjecaja na doziranje esomeprazola.
English: The major part of the metabolism of esomeprazole is dependent on the polymorphic CYP2C19, responsible for the formation of the hydroxy- and desmethyl metabolites of esomeprazole.
Croatian: Glavni dio metabolizma esomeprazola ovisi o polimorfno izraženom CYP2C19, koji je odgovoran za stvaranje hidroksi- i dezmetilnih metabolita esomeprazola.
English: • You lose a lot of weight for no reason.
Croatian: • Ako bezrazložno gubite na tjelesnoj težini.
English: Results from studies in healthy subjects have shown a pharmacokinetic (PK)/pharmacodynamic (PD) interaction between clopidogrel (300 mg loading dose/75 mg daily maintenance dose) and esomeprazole (40 mg orally daily) resulting in decreased exposure to the active metabolite of clopidogrel by an average of 40%, and resulting in decreased maximum inhibition of (ADP induced) platelet aggregation by an average of 14%.
Croatian: Rezultati ispitivanja u zdravih ispitanika pokazali su da postoji farmakokinetička (PK)/farmakodinamička (PD) interakcija između klopidogrela (udarna doza od 300 mg/doza održavanja od 75 mg na dan) i esomeprazola (40 mg peroralno na dan), koja smanjuje izloženost aktivnom metabolitu klopidogrela za prosječno 40%, a maksimalnu inhibiciju agregacije trombocita (potaknute ADP-om) smanjuje za prosječno 14%.
English: lansoprazole, rabeprazole or omeprazole).
Croatian: lanzoprazol, rabeprazol ili omeprazol).
English: After repeated administration with 20 mg esomeprazole once daily for five days, mean peak acid output after pentagastrin stimulation is decreased 90% when measured 6-7 hours after dosing on day five.
Croatian: Nakon višekratne primjene 20 mg esomeprazola jednom na dan tijekom pet dana, prosječne vršne vrijednosti lučenja kiseline nakon stimulacije pentagastrinom smanjile su se za 90%, mjereno petoga dana 6-7 sati nakon uzimanja doze.
English: The parameters below reflect mainly the pharmacokinetics in individuals with a functional CYP2C19 enzyme, extensive metabolisers.
Croatian: Niže navedeni parametri većinom odražavaju farmakokinetiku u osoba u kojih je funkcionalan enzim CYP2C19, tj. koje su brzi metabolizatori.
English: • Feeling agitated, confused or depressed.
Croatian: • uznemirenost, smetenost ili depresija
English: However, side effects such as dizziness and visual disturbances may uncommonly occur (see section 4).
Croatian: Međutim, nuspojave poput omaglice i smetnji vida mogu se manje često javiti (pogledajte dio 4.).
English: Patients should not take Nexium Control as a long term preventive medicinal product.
Croatian: Bolesnici ne smiju dugotrajno uzimati Nexium Control u preventivne svrhe.
English: Effects of other medicinal products on the pharmacokinetics of esomeprazole Medicinal products which inhibit CYP2C19 and/or CYP3A4
Croatian: Učinci drugih lijekova na farmakokinetiku esomeprazola Lijekovi koji inhibiraju CYP2C19 i/ili CYP3A4
English: • Yellow skin, dark urine and tiredness, which can be symptoms of liver problems, seen rarely.
Croatian: • žuta koža, tamna mokraća i umor, koji mogu biti simptomi jetrenih tegoba, javljaju se rijetko.
English: The CYP2C19 and CYP3A4 inhibitor voriconazole increased omeprazole AUCt by 280%.
Croatian: Inhibitor CYP2C19 i CYP3A4, vorikonazol, povećao je AUCt omeprazola za 280%.
English: As a precautionary measure, you should preferably avoid the use of Nexium Control during pregnancy.
Croatian: Kao mjera opreza, trebali biste izbjegavati primjenu lijeka Nexium Control tijekom trudnoće.
English: Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours.
Croatian: Povišena koncentracija kromogranina A (CgA) može utjecati na pretrage za neuroendokrine tumore.
English: What you need to know before you take Nexium Control
Croatian: Što morate znati prije nego počnete uzimati Nexium Control
English: The area under the plasma concentration-time curve increases with repeated administration of esomeprazole.
Croatian: Površina ispod krivulje koncentracija-vrijeme u plazmi povećava se s ponovljenom primjenom esomeprazola.
English: Immune system disorders hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/shock
Croatian: Poremećaji imunološkog sustava reakcije preosjetljivosti, npr. vrućica, angioedem i anafilaktička reakcija/šok
English: If you take more Nexium Control than you should If you take more Nexium Control than recommended, talk to your doctor or pharmacist straight away.
Croatian: Ako uzmete više lijeka Nexium Control od preporučenog, odmah se obratite svom liječniku ili ljekarniku.
English: A dose adjustment of esomeprazole is not regularly required in either of these situations.
Croatian: Niti u jednom od tih slučajeva obično nije potrebno prilagođavati dozu esomeprazola.
English: • You have been taking treatment continuously for reflux or heartburn for 4 or more weeks.
Croatian: • Ako uzimate lijekove za refluks ili žgaravicu neprekidno 4 tjedna ili dulje.
English: After oral dosing with esomeprazole 20 mg and 40 mg the onset of effect occurs within one hour.
Croatian: Nakon peroralne primjene 20 mg ili 40 mg esomeprazola djelovanje započinje unutar jednoga sata.
English: Esomeprazole has been shown to have no clinically relevant effects on the pharmacokinetics of amoxicillin and quinidine.
Croatian: Pokazalo se da esomeprazol nema klinički značajnih učinaka na farmakokinetiku amoksicilina ni kinidina.
English: Nexium Control is available in a pack size of 14 gastro-resistant hard capsules in high-density polyethylene (HDPE) bottles with an induction seal closure and child resistant closure.
Croatian: Nexium Control dostupan je u pakiranju od 14 želučanootpornih tvrdih kapsula u bočicama od polietilena visoke gustoće (HDPE) sa zaštitnom folijom na otvoru i sigurnosnim zatvaračem za djecu.
English: You must talk to a doctor if you do not feel better or if you feel worse after 14 days.
Croatian: Obavezno se obratite liječniku ako se ne osjećate bolje ili ako se osjećate lošije nakon 14 dana.
English: Hepatobiliary disorders increased liver enzymes hepatitis with or without jaundice hepatic failure, hepatic encephalopathy in patients with pre-existing liver disease
Croatian: Poremećaji jetre i žuči povišene vrijednosti jetrenih enzima hepatitis sa žuticom ili bez nje zatajenje jetre, hepatička encefalopatija u bolesnika s postojećom bolešću jetre
English: Adverse reactions such as dizziness and visual disturbances are uncommon (see section 4.8).
Croatian: Nuspojave poput omaglice i smetnji vida javljaju se manje često (vidjeti dio 4.8).
English: Esomeprazole is extensively plasma protein bound and is therefore not readily dialysable.
Croatian: Esomeprazol se u velikoj mjeri veže na proteine u plazmi pa se stoga teško uklanja dijalizom.
English: Esomeprazole should not be used during breast-feeding.
Croatian: Esomeprazol se ne smije primjenjivati tijekom dojenja.
English: • Low numbers of red blood cells, white blood cells, and platelets (a condition called pancytopenia)
Croatian: • nizak broj crvenih i bijelih krvnih stanica te krvnih pločica (stanje koje se naziva pancitopenijom)
English: Treatment with proton pump inhibitors (PPIs) may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and in hospitalised patients, also possibly Clostridium difficile (see section 5.1).
Croatian: Liječenje inhibitorima protonske pumpe može dovesti do blago povećanog rizika od gastrointestinalnih infekcija, poput infekcija bakterijama Salmonella i Campylobacter, a u hospitaliziranih bolesnika i do moguće infekcije s Clostridium difficile (vidjeti dio 5.1).
English: As a precautionary measure, it is preferable to avoid the use of Nexium Control during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka Nexium Control tijekom trudnoće.
English: High-density polyethylene (HDPE) bottle with an induction seal closure and child resistant closure containing 14 gastro-resistant capsules.
Croatian: Bočica od polietilena visoke gustoće (engl. high-density polyethylene, HDPE) sa zaštitnom folijom na otvoru i sigurnosnim zatvaračem za djecu koja sadrži 14 želučanootpornih kapsula.
English: The investigators also found esomeprazole to be significantly more effective than placebo in resolving acid regurgitation (58.5% - 63.6% vs placebo 28.3% - 37.4%) during the week 2 evaluation.
Croatian: Ispitivači su također pronašli da je esomeprazol značajno djelotvorniji od placeba u liječenju regurgitacije kiseline (58,5%-63,6% u odnosu na 28,3%-37,4% u bolesnika koji su primali placebo) tijekom procjene u 2. tjednu.
English: If you forget to take Nexium Control
Croatian: Ako ste zaboravili uzeti Nexium Control
English: (Cyprus Pharmaceutical Organization Ltd.)
Croatian: Pfizer Ελλάς Α.Ε. (Cyprus Pharmaceutical Organization Ltd.)
English: Other secondary endpoints were supportive of the primary endpoint, including relief of heartburn at week 1 and week 2, percentage of 24 hour days without heartburn at week 1 and week 2, mean heartburn severity at week 1 and week 2, and time to initial and sustained resolution of heartburn over a 24 hour period and during the night compared to placebo.
Croatian: Druge sekundarne mjere ishoda podržavale su primarne, uključujući osjećaj olakšanja bez žgaravice u 1. tjednu i 2. tjednu, te postotak 24-satnih dana bez žgaravice u 1. tjednu i 2. tjednu, prosječnu težinu žgaravice u 1. tjednu i 2. tjednu i vrijeme do početnog i održanog povlačenja žgaravice tijekom razdoblja od 24 sata te tijekom noći, u usporedbi s placebom.