FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, medicinal products that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine, amantadine, mexiletine, zidovudine, cisplatin, quinine, and procainamide, may interact with pramipexole resulting in reduced clearance of pramipexole.
Croatian: Stoga lijekovi koji su inhibitori tog aktivnog renalnog puta eliminacije ili se tim putem odstranjuju, kao što su cimetidin, amantadin, meksiletin, zidovudin, cisplatin, kinin i prokainamid, mogu stupiti u interakciju s pramipeksolom, što može rezultirati smanjenim klirensom pramipeksola.
English: In the absence of human data, Oprymea should not be used during breast-feeding.
Croatian: U nedostatku podataka za ljude, Oprymea se ne bi trebao primjenjivati tijekom dojenja.
English: Patients and carers should be made aware that mania and delirium can occur in patients treated with pramipexole.
Croatian: Bolesnici i njihovi skrbnici moraju biti svjesni mogućnosti pojave manije i delirija u bolesnika koji se liječe pramipeksolom.
English: After 12 hours, the missed dose should be left out and the next dose should be taken on the following day at the next regularly scheduled time.
Croatian: Nakon 12 sati, propuštena doza se preskače, a sljedeća doza se uzima sljedeći dan prema režimu doziranja.
English: When Oprymea is given in combination with levodopa, it is recommended that the dose of levodopa is reduced and the dose of other anti-parkinsonian medicinal products is kept constant while increasing the dose of Oprymea.
Croatian: Kada se Oprymea primjenjuje u kombinaciji s levodopom, preporučuje se sniziti dozu levodope i ne mijenjati doze ostalih antiparkinsonika, dok se povisuje doza lijeka Oprymea.
English: Patients being treated with Oprymea and presenting with somnolence and/or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. operating machines) until such recurrent episodes and somnolence have resolved (see also sections 4.4, 4.5 and 4.8).
Croatian: Bolesnike koji su tijekom liječenja lijekom Oprymea imali somnolenciju i/ili epizode iznenadnog usnivanja potrebno je upozoriti da ne upravljaju motornim vozilima ili obavljaju nekakve druge aktivnosti gdje bi njihova smanjena mogućnost reagiranja ponekad mogla ugroziti vlastitu ili tuđu sigurnost te dovesti do rizika za tešku ozljedu ili smrt (npr. upravljanje strojevima), sve dok takve opetovane epizode i somnolencija ne prestanu (vidjeti također dijelove 4.4, 4.5 i 4.8).
English: Ophthalmologic monitoring Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Croatian: Oftalmološki pregled Preporučuje se oftalmološki pregled u redovitim intervalima ili ako se pojave poremećaji vida.
English: The use of Oprymea tablets should be considered.
Croatian: Potrebno je razmotriti primjenu Oprymea tableta.
English: Pramipexole alleviates Parkinsonian motor deficits by stimulation of dopamine receptors in the striatum.
Croatian: Pramipeksol reducira parkinsonske motorne deficite, stimulirajući dopaminske receptore u strijatumu.
English: The efficacy and tolerability of an overnight switch from pramipexole tablets to pramipexole prolonged-release tablets at the same daily dose were evaluated in a double-blind clinical study in patients with early Parkinson's disease.
Croatian: Djelotvornost i podnošljivost prijelaza „preko noći“ s pramipeksol tableta na pramipeksol tablete s produljenim oslobađanjem u jednakoj dnevnoj dozi ocjenjivane su u dvostruko-slijepom kliničkom ispitivanju na bolesnicima u ranom stadiju Parkinsonove bolesti.
English: 67% of patients on pramipexole and 54% of patients on placebo reported at least one adverse drug reaction.
Croatian: 67% bolesnika na pramipeksolu i 54% bolesnika na placebu prijavilo je najmanje jednu nuspojavu.
English: The treatment of patients with a creatinine clearance below 30 ml/min with Oprymea prolonged release tablets is not recommended as no data are available for this patient population.
Croatian: U bolesnika s klirensom kreatinina manjim od 30 ml/min, ne preporučuje se liječenje Oprymea tabletama s produljenim oslobađanjem, s obzirom da nisu dostupni podaci za ovu skupinu bolesnika.
English: When prescribing Oprymea in a patient with Parkinson's disease with renal impairment a reduced dose is suggested in line with section 4.2.
Croatian: Kada se Oprymea propisuje bolesnicima s Parkinsonovom bolešću koji imaju oštećenje bubrega, preporučuje se snižena doza u skladu s dijelom 4.2.
English: Your doctor will then discuss with you if you should continue to take Oprymea.
Croatian: Liječnik će s Vama razmotriti je li potreban nastavak liječenja lijekom Oprymea.
English: Children and adolescents Oprymea is not recommended for use in children or adolescents under 18 years.
Croatian: Djeca i adolescenti Oprymea se ne preporučuje za primjenu u djece ili adolescenata mlađih od 18 godina.
English: Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2).
Croatian: Simptomi koji upućuju na maligni neuroleptički sindrom zabilježeni su uz nagli prekid dopaminergičke terapije (vidjeti dio 4.2).
English: Superiority of pramipexole prolonged-release tablets over placebo was demonstrated after 18 weeks of treatment on both the primary (UPDRS Parts II+III score) and the key secondary (CGI-I and PGI-I responder rates) efficacy endpoints in a double-blind placebo-controlled trial including a total of 539 patients with early Parkinson's disease.
Croatian: Veća djelotvornost pramipeksol tableta s produljenim oslobađanjem u odnosu na placebo pokazana je nakon 18 tjedana liječenja i u primarnim (rezultat prema UPDRS, dijelovima II+III) i ključnim sekundarnim (stopa odgovora prema CGI-I i PGI-I) mjerama ishoda za djelotvornost u dvostruko-slijepom, placebom kontroliranom ispitivanju koje je uključivalo ukupno 539 bolesnika s ranim stadijem Parkinsonove bolesti.
English: In a double-blind placebo-controlled trial including a total of 517 patients with advanced Parkinson's disease who were on concomitant levodopa therapy superiority of pramipexole prolonged-release tablets over placebo was demonstrated after 18 weeks of treatment on both the primary (UPDRS Parts II+III score) and the key secondary (off-time) efficacy endpoints.
Croatian: U dvostruko-slijepom, placebom kontroliranom ispitivanju, koje je uključivalo ukupno 517 bolesnika s uznapredovalom Parkinsonovom bolešću koji su bili na istodobnoj terapiji levodopom, pokazana je superiornost pramipeksol tableta s produljenim oslobađanjem u odnosu na placebo nakon 18 tjedana liječenja i za primarne (rezultat prema UPDRS dijelovima II+III) i ključne sekundarne (off-time) mjere ishoda za učinkovitost.
English: The excretion of pramipexole into breast milk has not been studied in women.
Croatian: Izlučivanje pramipeksola u majčinom mlijeku u žena nije ispitivano.
English: Decreases in diastolic and systolic pressure and heart rate were noted in the minipig, and a tendency to a hypotensive effect was discerned in the monkey.
Croatian: Smanjenje dijastoličkog i sistoličkog tlaka i broja otkucaja srca uočeno je u patuljastih svinja, kao i sklonost k hipotenzivnom učinku u majmuna.
English: Oprymea can be taken with or without food.
Croatian: Oprymea se može uzimati sa ili bez hrane.
English: Patients with kidney disease If you have severe kidney disease, Oprymea may not be a suitable treatment for you.
Croatian: Ako imate tešku bolest bubrega, Oprymea možda neće biti prikladna za Vaše liječenje.
English: Swallow whole, do not chew, divide or crush.
Croatian: Progutati cijelu tabletu, ne žvakati, dijeliti ili drobiti.
English: Further dose adjustments should be done based on the clinical response and the occurrence of adverse reactions.
Croatian: Dodatno prilagođavanje doze potrebno je provesti prema kliničkom odgovoru i pojavi nuspojava.
English: Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is seen in man.
Croatian: Pramipeksol se u vrlo maloj mjeri veže na proteine plazme (<20%), te se malo biotransformira u ljudi.
English: If use of Oprymea is unavoidable, breast-feeding should be stopped.
Croatian: Ako je primjena lijeka Oprymea neizbježna, potrebno je prekinuti dojenje.
English: Not known
Croatian: Nepoznato:
English: Oprymea is used to treat the symptoms of primary Parkinson's disease in adults.
Croatian: Oprymea se primjenjuje u liječenju simptoma primarne Parkinsonove bolesti u odraslih.
English: It is recommended that the dose of levodopa is reduced during both the dose escalation and the maintenance treatment with Oprymea, depending on reactions in individual patients (see section 4.5).
Croatian: Preporučuje se smanjiti dozu levodope za vrijeme postupnog povećanja doze, kao i za vrijeme terapije održavanja lijekom Oprymea, ovisno o reakcijama pojedinog bolesnika (vidjeti dio 4.5).
English: In a 26 week placebo controlled trial, rebound of RLS symptoms (worsening of symptom severity as compared to baseline) was observed in 10% of patients (14 out of 135) after abrupt discontinuation of treatment.
Croatian: U 26-tjednom placebom kontroliranom ispitivanju primijećen je “rebound” fenomen simptoma sindroma nemirnih nogu (pogoršanje težine simptoma u usporedbi s početnim vrijednostima) u 10% bolesnika (14 od 135) nakon naglog prekida liječenja.
English: CGI-I responder rates (improved, very much improved) were 51.2% and 72.0% for placebo and pramipexole, respectively (difference 20% CI 95%: 8.1%; 31.8%, p<0.0005).
Croatian: Stope bolesnika s odgovorom prema CGI-I (poboljšanje, poboljšanje u velikoj mjeri) bile su 51,2% za placebo i 72,0% za pramipeksol (razlika 20% CI 95%: 8,1%; 31,8%, p<0,0005).
English: Pramipexole is commonly associated with somnolence and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (see also section 4.4).
Croatian: Pramipeksol je često povezan sa somnolencijom te se manje često povezuje s pojavom prekomjerne dnevne somnolencije i epizodama iznenadnog usnivanja (vidjeti također dio 4.4).
English: Oprymea has been associated with sleepiness and episodes of suddenly falling asleep, particularly in patients with Parkinson's disease.
Croatian: Oprymea je povezana s pospanošću i epizodama iznenadnog usnivanja, osobito u bolesnika s Parkinsonovom bolešću.
English: Each pack of 21 prolonged-release tablets for a 3-week treatment schedule contains: 7 tablets of Oprymea 0.26 mg
Croatian: Svako pakiranje s 21 tabletom s produljenim oslobađanjem za plan liječenja za 3 tjedna sadrži: 7 Oprymea 0,26 mg tableta
English: Very common: - Nausea (sickness).
Croatian: Vrlo često: mučnina
English: Oprymea is used to: - treat the symptoms of primary Parkinson's disease in adults.
Croatian: Oprymea se primjenjuje u: liječenju simptoma primarne Parkinsonove bolesti u odraslih.
English: Pramipexole prolonged-release tablets were non-inferior to pramipexole immediate release tablets as assessed on the UPDRS Parts II+III score at week 33.
Croatian: Pramipeksol tablete s produljenim oslobađanjem nisu bile inferiorne pramipeksol tabletama s trenutnim oslobađanjem, ocjenjivano prema rezultatu UPDRS ljestvice, dijelovima II+III nakon 33 tjedna.
English: In patients pramipexole alleviates signs and symptoms of idiopathic Parkinson' s disease.
Croatian: U bolesnika pramipeksol otklanja znakove i simptome idiopatske Parkinsonove bolesti.
English: In patients with a creatinine clearance between 30 and 50 ml/min, treatment should be started with 0.26 mg Oprymea prolonged-release tablets every other day.
Croatian: U bolesnika s klirensom kreatinina između 30 i 50 ml/min, liječenje treba započeti s Oprymea 0,26 mg tabletom s produljenim oslobađanjem svaki drugi dan.
English: Some patients have reported the occurrence of remnants in faeces which may resemble intact Oprymea prolonged-release tablets.
Croatian: Neki su bolesnici prijavili pojavu ostataka u stolici koji bi mogli nalikovati čitavim Oprymea tabletama s produljenim oslobađanjem.
English: Boxes of 10, 30, 90 and 100 tablets in blisters of 10 tablets are available.
Croatian: Dostupne su kutije od 10, 30, 90 i 100 tableta u blisterima od 10 tableta.
English: Oprymea prolonged-release tablets are a once-a-day oral formulation of pramipexole.
Croatian: Oprymea tablete s produljenim oslobađanjem su jednokratna dnevna oralna formulacija pramipeksola.
English: Blister (OPA/Alu/desiccant/PE-Alu foil): 10, 30, 90 or 100 prolonged-release tablets, in a box.
Croatian: Blister (OPA/Al/desikant/PE-Al folija): 10, 30, 90 ili 100 tableta s produljenim oslobađanjem, u kutiji.
English: Only one patient switched to pramipexole prolonged-release tablets experienced a drug-related adverse event leading to withdrawal.
Croatian: Samo je jedan bolesnik koji je prešao na pramipeksol tablete s produljenim oslobađanjem imao nuspojavu povezanu s lijekom koja je dovela do prekida terapije.
English: During the first week, the usual dose is 1 tablet Oprymea 0.088 mg three times a day (equivalent to 0.264 mg daily):
Croatian: Tijekom prvog tjedna, uobičajena doza je 1 tableta lijeka Oprymea od 0,088 mg tri puta dnevno (što odgovara 0,264 mg dnevno):
English: (eating more food than normal and more than is needed to satisfy your hunger)* - Mania (agitation, feeling elated or over-excited)* - Delirium (decreased awareness, confusion, loss of reality)*
Croatian: (jedenje veće količine hrane nego što je normalno i više nego je potrebno za utaženje gladi)* manija (agitacija, osjećaj ushita ili pretjeranog uzbuđenja)* delirij (poremećaj svijesti, konfuzija, gubitak osjećaja za stvarnost)*
English: If you experience these side effects, you must not drive or operate machinery.
Croatian: Ako primijetite takve nuspojave, ne smijete upravljati vozilima ili strojevima.
English: Since the daily dose for the treatment of Restless Legs Syndrome will not exceed 0.54 mg of base (0.75 mg of salt) Oprymea can be discontinued without tapering off.
Croatian: S obzirom da dnevna doza u liječenju sindroma nemirnih nogu neće prelaziti 0,54 mg baze (0,75 mg soli), liječenje lijekom Oprymea se može prekinuti bez postupnog snižavanja doze.
English: The primary endpoint was change from baseline on the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS).
Croatian: Total Tic Score) u tzv. Yale Global Tic Severity Scale (YGTSS) u odnosu na početne vrijednosti.
English: There is no relevant use of Oprymea in the paediatric population for the indication of Parkinson's Disease.
Croatian: Nema relevantne primjene lijeka Oprymea u pedijatrijskoj populaciji za indikaciju Parkinsonove bolesti.
English: A lower maintenance dose of three Oprymea 0.088 mg tablets a day is also possible.
Croatian: Također je moguća niža doza održavanja od tri Oprymea 0,088 mg tablete dnevno.
English: - Vision impairment.
Croatian: Oštećenje vida.
English: - The other ingredients are mannitol, maize starch, pregelatinised maize starch, povidone K25, colloidal anhydrous silica and magnesium stearate.
Croatian: Drugi sastojci su manitol, kukuruzni škrob, prethodno geliran kukuruzni škrob, povidon K25, koloidni bezvodni silicijev dioksid i magnezijev stearat.
English: TREATMENT INITIATION PACK ONLY PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Croatian: PAKIRANJE SAMO ZA POČETNO LIJEČENJE PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
English: 21 prolonged-release tablets: EU/1/08/469/054
Croatian: 21 tableta s produljenim oslobađanjem: EU/1/08/469/054
English: TREATMENT INITIATION PACK ONLY MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Croatian: PAKIRANJE SAMO ZA POČETNO LIJEČENJE PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP
English: Oprymea is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Croatian: Primjena lijeka Oprymea se ne preporučuje u djece i adolescenata u dobi do 18 godina zbog nedostatnih podataka o sigurnosti i djelotvornosti.
English: In a Phase I trial, where pramipexole immediate release and prolonged-release tablets were assessed in fasted state, the minimum and peak plasma concentration (Cmin, Cmax) and exposure (AUC) of the same daily dose of pramipexole prolonged-release tablets given once daily and pramipexole tablets given three times a day were equivalent.
Croatian: U ispitivanju faze I, u kojem su ocjenjivane pramipeksol tablete s trenutnim oslobađanjem i pramipeksol tablete s produljenim oslobađanjem natašte, minimalne i maksimalne koncentracije u plazmi (Cmin, Cmax) i ekspozicija (AUC) jednakoj dnevnoj dozi pramipeksol tableta s produljenim oslobađanjem, primjenjivanih jedanput dnevno i pramipeksol tableta primjenjivanih tri puta dnevno, bile su jednake.
English: For patients requiring additional symptomatic relief, the dose may be increased every 4-7 days to a maximum of 0.54 mg of base (0.75 mg of salt) per day (as shown in the table below).
Croatian: Za bolesnike kojima je potrebno dodatno ublažavanje simptoma doza se može povećavati svakih 4-7 dana, maksimalno do 0,54 mg baze (0,75 mg soli) dnevno, kao što je prikazano u donjoj tabeli.
English: During the first week, the usual daily dose is 0.26 mg pramipexole.
Croatian: Tijekom prvog tjedna uobičajena dnevna doza je 0,26 mg pramipeksola.
English: Warnings and precautions Talk to your doctor before taking Oprymea.
Croatian: Obratite se svom liječniku prije nego uzmete lijek Oprymea.
English: Boxes of 20, 30, 60, 90 and 100 tablets in blisters of 10 tablets are available.
Croatian: Dostupne su kutije od 20, 30, 60, 90 i 100 tableta u blisterima od 10 tableta.
English: The most commonly (≥ 5%) reported adverse drug reactions in patients with Parkinson's disease more frequent with pramipexole treatment than with placebo were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
Croatian: Najčešće (≥5%) prijavljene nuspojave u bolesnika s Parkinsonovom bolešću, češće kod liječenja pramipeksolom nego placebom, bile su mučnina, diskinezija, hipotenzija, omaglica, somnolencija, nesanica, konstipacija, halucinacija, glavobolja i umor.
English: Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole (see sections 4.4, 4.7 and 4.8).
Croatian: Zbog mogućih dodatnih učinaka, oprez je potreban u bolesnika koji uzimaju sedative ili alkohol u kombinaciji s pramipeksolom (vidjeti dijelove 4.4, 4.7 i 4.8).
English: You can take Oprymea with or without food.
Croatian: Možete uzimati lijek Oprymea sa ili bez hrane.
English: In advanced Parkinson's disease, pramipexole doses higher than 1.1 mg of base (1.5 mg of salt) per day can be useful in patients where a reduction of the levodopa therapy is intended.
Croatian: U uznapredovaloj Parkinsonovoj bolesti, dnevne doze više od 1,1 mg baze (1,5 mg soli) mogu biti korisne u bolesnika kojima se namjerava sniziti terapija levodope.
English: Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data .
Croatian: U klasifikaciji prema organskim sustavima, nuspojave su navedene prema učestalosti (broj bolesnika u kojih se očekuje nuspojava), uz uporabu sljedećih kategorija: vrlo često (≥1/10); često (≥1/100 do <1/10); manje često (≥1/1000 do <1/100); rijetko (≥1/10 000 do <1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: In advanced Parkinson's disease, pramipexole doses higher than 1.05 mg of base (1.5 mg of salt) per day can be useful in patients where a reduction of the levodopa therapy is intended.
Croatian: U uznapredovaloj Parkinsonovoj bolesti, dnevne doze pramipeksola više od 1,05 mg baze (1,5 mg soli) mogu biti korisne u bolesnika kojima se namjerava sniziti doza levodope.
English: In patients with a creatinine clearance between 20 and 50 ml/min, the initial daily dose of Oprymea should be administered in two divided doses, starting at 0.088 mg of base (0.125 mg of salt) twice a day (0.176 mg of base/0.25 mg of salt daily).
Croatian: U bolesnika s klirensom kreatinina između 20 i 50 ml/min, početna dnevna doza lijeka Oprymea treba se podijeliti u dvije odvojene doze, počevši od 0,088 mg baze (0,125 mg soli) dva puta dnevno (0,176 mg baze/0,25 mg soli dnevno).
English: Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Croatian: U klasifikaciji prema organskim sustavima, nuspojave su navedene prema učestalosti (broj bolesnika u kojih se očekuje nuspojava), uz uporabu sljedećih kategorija: vrlo često (≥ 1/10); često (≥ 1/100, do < 1/10); manje često (≥ 1/1000 do < 1/100); rijetko (≥ 1/10 000 do < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Dose adjustment in patients with hepatic failure is probably not necessary, as approx. 90% of absorbed active substance is excreted through the kidneys.
Croatian: Prilagođavanje doze u bolesnika s oštećenom funkcijom jetre vjerojatno nije potrebno jer se oko 90% apsorbirane djelatne tvari izlučuje putem bubrega.
English: Blister (week 1)
Croatian: Blister (1. tjedan)
English: Oprymea should not be used during breast-feeding.
Croatian: Oprymea se ne smije primjenjivati tijekom dojenja.
English: Oprymea can have a major influence on the ability to drive and use machines.
Croatian: Oprymea može značajno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: There is no relevant use of Oprymea prolonged-release tablets in the paediatric population for the indication of Parkinson's Disease.
Croatian: Nema relevantne primjene Oprymea tableta s produljenim oslobađanjem u pedijatrijskoj populaciji za indikaciju Parkinsonove bolesti.
English: Based on the analysis of pooled placebo-controlled trials, comprising a total of 1,778 Parkinson's disease patients on pramipexole and 1,297 patients on placebo, adverse drug reactions were frequently reported for both groups.
Croatian: Na temelju analize zbirnih podataka iz placebom kontroliranih ispitivanja, koja su obuhvatila 1778 bolesnika s Parkinsonovom bolešću na pramipeksolu i 1297 bolesnika na placebu, nuspojave su se često prijavljivale za obje grupe.
English: Blister (week 2)
Croatian: Blister (2. tjedan)
English: Uncommon (≥1/1,000 to
Croatian: Manje često (≥1/1000 i
English: Pramipexole was not teratogenic in rats and rabbits but was embryotoxic in the rat at maternally toxic doses.
Croatian: Pramipeksol nije bio teratogen u štakora i zečeva, ali je bio embriotoksičan u štakora primijenjen u dozama toksičnim za majku.
English: The recommended starting dose of Oprymea is 0.088 mg of base (0.125 mg of salt) taken once daily 2-3 hours before bedtime.
Croatian: Preporučena početna doza lijeka Oprymea je 0,088 mg baze (0,125 mg soli) jedanput dnevno 2-3 sata prije spavanja.
English: Hallucinations are known as a side-effect of treatment with dopamine agonists and levodopa.
Croatian: Halucinacije su poznata nuspojava liječenja agonistima dopamina i levodopom.
English: Blister (week 3)
Croatian: Blister (3. tjedan)
English: Oprymea is not recommended for use in children and adolescents below 18 years since the efficacy and safety has not been established in this population.
Croatian: Primjena lijeka Oprymea se ne preporučuje u djece i adolescenata u dobi do 18 godina jer njihova sigurnost i djelotvornost nisu ustanovljene za ovu populaciju.
English: No studies on the effect on human fertility have been conducted.
Croatian: Nisu dostupni podaci o plodnosti u ljudi.