FrancophonIA/ELRC3.0 huggingface dataset:
English: Use in children and adolescents under 18 years of age ARICLAIM should not be used in the treatment of children and adolescents under the age of 18 years.
Croatian: Primjena u djece i adolescenata mlađih od 18 godina ARICLAIM se ne smije primjenjivati u liječenju djece i adolescenata mlađih od 18 godina.
English: The pharmacokinetics of duloxetine demonstrate large intersubject variability (generally 50-60%), partly due to gender, age, smoking status and CYP2D6 metaboliser status.
Croatian: Farmakokinetika duloksetina pokazuje veliku interindividualnu varijabilnost (općenito 50-60%), dijelom zbog spola, dobi, pušenja i statusa metabolizatora za CYP2D6.
English: The European Medicines Agency has waived the obligation to submit the results of studies with ARICLAIM in all subsets of the paediatric population in the treatment of diabetic neuropathic pain.
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka ARICLAIM u svim podskupinama pedijatrijske populacije u liječenju boli kod dijabetičke neuropatije.
English: Patients should be instructed that if they experience sedation or dizziness they should avoid potentially hazardous tasks such as driving or operating machinery.
Croatian: Bolesnike se mora upozoriti da u slučaju osjećaja sedacije ili omaglice izbjegavaju moguće opasne poslove, poput upravljanja vozilima i rukovanja strojevima.
English: No clinically significant differences were observed for QT, PR, QRS, or QTcB measurements between duloxetine-treated and placebo-treated patients.
Croatian: Nisu bile opažene klinički značajne razlike u izmjerenim vrijednostima QT, PR, QRS ili QTcB između bolesnika liječenih duloksetinom i bolesnika koji su uzimali placebo.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive
English: • Stevens-Johnson syndrome (serious illness with blistering of the skin, mouth, eyes and genitals), serious allergic reaction which causes swelling of the face or throat (angioedema)
Croatian: • Stevens-Johnsonov sindrom (ozbiljna bolest sa stvaranjem mjehurića na koži, ustima, očima i genitalijama), ozbiljna alergijska reakcija koja uzrokuje oticanje lica ili grla (angioedem)
English: ARICLAIM may cause a sensation of restlessness or an inability to sit or stand still.
Croatian: ARICLAIM može uzrokovati osjećaj nemira ili nemogućnost mirnog sjedenja ili stajanja.
English: ARICLAIM increases the levels of serotonin and noradrenaline in the nervous system.
Croatian: ARICLAIM povećava razine serotonina i noradrenalina u živčanom sustavu.
English: • Tell your doctor if you become pregnant, or you are trying to become pregnant, while you are taking ARICLAIM.
Croatian: • Obavijestite svog liječnika ako zatrudnite ili pokušavate zatrudnjeti dok uzimate lijek ARICLAIM.
English: However, as with any medicine, caution should be exercised when treating the elderly (see section 5.2).
Croatian: Međutim, kao i kod svih drugih lijekova, mora se s oprezom liječiti starije osobe (vidjeti dio 5.2).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11 August 2004
Croatian: Datum prvog odobrenja: 11. kolovoza 2004.
English: Duloxetine was not genotoxic in a standard battery of tests and was not carcinogenic in rats.
Croatian: Duloksetin nije bio genotoksičan u standardnom kompletu testova i nije bio karcinogen u štakora.
English: Do not stop taking ARICLAIM, or change your dose, without talking to your doctor.
Croatian: Nemojte prekinuti uzimati ARICLAIM niti mijenjati dozu lijeka bez prethodnog razgovora sa svojim liječnikom.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim poremećajima nepodnošenja fruktoze, malapsorpcijom glukoze-galaktoze ili insuficijencijom saharoze-izomaltaze ne smiju uzimati ovaj lijek.
English: If you forget to take ARICLAIM
Croatian: Ako ste zaboravili uzeti ARICLAIM
English: − are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI) (see ‘Other medicines and ARICLAIM')
Croatian: − uzimate ili ste unutar zadnjih 14 dana uzimali drugi lijek koji je poznat kao inhibitor monoaminooksidaze (MAOI) (vidjeti ‘Drugi lijekovi i ARICLAIM')
English: Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal thoughts prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicidal behaviour, and should receive careful monitoring during treatment.
Croatian: Poznato je da bolesnici koji u anamnezi imaju događaje povezane sa samoubojstvom, ili oni koji su pokazivali značajan stupanj suicidalnih misli prije početka liječenja, imaju veći rizik od suicidalnih misli ili suicidalnog ponašanja te se moraju pažljivo pratiti tijekom liječenja.
English: − have liver disease
Croatian: − imate bolest jetre
English: Make sure your midwife and/or doctor knows you are on ARICLAIM.
Croatian: Budite sigurni da primalja i/ili liječnik znaju da uzimate lijek ARICLAIM.
English: • night sweats, hives, cold sweats, sensitivity to sunlight, increased tendency to bruise
Croatian: • noćno znojenje, koprivnjača, hladan znoj, osjetljivost na sunčevu svjetlost, povećana sklonost stvaranju modrica
English: Care should be taken if you drink alcohol while you are being treated with ARICLAIM.
Croatian: Budite oprezni ako pijete alkohol dok se liječite lijekom ARICLAIM.
English: Generally, for SSRIs and SNRIs, these events are mild to moderate and self-limiting, however, in some patients they may be severe and/or prolonged.
Croatian: U načelu su kod primjene SSRI i SNRI ovi događaji blagi do umjereni i samoograničavajući, no u nekih bolesnika mogu biti teški i/ili produljeni.
English: Based upon in vitro studies, the circulating metabolites of duloxetine are considered pharmacologically inactive.
Croatian: Na temelju rezultata in vitro ispitivanja, cirkulirajući metaboliti duloksetina smatraju se farmakološki neaktivnima.
English: How to take ARICLAIM
Croatian: Kako uzimati ARICLAIM
English: • feeling the heart pumping in the chest,
Croatian: • osjećaj lupanja srca u prsima
English: HbA1c was stable in both duloxetine-treated and placebo-treated patients.
Croatian: HbA1c bio je stabilan i u bolesnika liječenih duloksetinom i u bolesnika koji su uzimali placebo.
English: Talk with your doctor about how long you should keep taking ARICLAIM.
Croatian: Razgovarajte s liječnikom o tome koliko dugo trebate uzimati lijek ARICLAIM.
English: When stopping treatment with ARICLAIM the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 and 4.8).
Croatian: Kada se liječenje lijekom ARICLAIM prekida, doza se mora smanjivati postupno tijekom razdoblja od najmanje jednog do dva tjedna kako bi se smanjio rizik od reakcija prekida liječenja (vidjeti dijelove 4.4 i 4.8).
English: INFORMATION IN BRAILLE ARICLAIM 60 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU ARICLAIM 60 mg
English: Generally these symptoms are mild to moderate, however, in some patients they may be severe in intensity.
Croatian: Općenito su ti simptomi blagi do umjereni, međutim u nekih bolesnika mogu biti teški po intenzitetu.
English: ARICLAIM should normally not be used for children and adolescents under 18 years.
Croatian: ARICLAIM se u načelu ne smije primjenjivati u djece i adolescenata mlađih od 18 godina.
English: Your doctor should decide whether you can take ARICLAIM with other medicines.
Croatian: Vaš liječnik mora donijeti odluku o tome smijete li uzimati lijek ARICLAIM s drugim lijekovima.
English: • Ariclaim may cause effects that you may not be aware of, such as increases in liver enzymes or blood levels of potassium, creatine phosphokinase, sugar, or cholesterol
Croatian: • dobivanje tjelesne težine • ARICLAIM može uzrokovati učinke kojih možda i niste svjesni, poput povišenja jetrenih enzima ili povišenih razina kalija, kreatin fosfokinaze, šećera ili kolesterola u krvi
English: DO NOT stop taking your capsules without the advice of your doctor even if you feel better.
Croatian: Ako prestanete uzimati ARICLAIM NEMOJTE prekinuti uzimati kapsule bez prethodnog niste savjetovanja sa svojim liječnikom, čak i ako se osjećate bolje.
English: Capsule content:
Croatian: Ovojnica kapsule:
English: Although ARICLAIM is not indicated for the treatment of depression, its active ingredient (duloxetine) also exists as an antidepressant medicinal product.
Croatian: Iako ARICLAIM nije indiciran za liječenje depresije, njegov djelatni sastojak (duloksetin) također se koristi kao antidepresivni lijek.
English: Each capsule of ARICLAIM contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid.
Croatian: Jedna ARICLAIM kapsula sadrži granule duloksetinklorida s ovojnicom koja ih štiti od želučane kiseline.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim nadopunama Plana.
English: The primary outcome measure was the weekly mean of 24-hour average pain, which was collected in a daily diary by patients on an 11-point Likert scale.
Croatian: Primarna mjera ishoda bio je tjedni prosjek 24-satnih srednjih vrijednosti boli, koje su bolesnici svakodnevno bilježili u dnevnik prema Likertovoj ljestvici s 11 bodova.
English: As the safety of duloxetine in infants is not known, the use of ARICLAIM while breast-feeding is not recommended.
Croatian: Budući da sigurnost duloksetina u dojenčadi nije poznata, ne preporučuje se primjena lijeka ARICLAIM u dojilja.
English: Patients not demonstrating a pain reduction of 30% within 60 days of treatment were unlikely to reach this level during further treatment.
Croatian: 30% unutar 60 dana liječenja nije bilo vjerojatno da će se to ostvariti daljnjim liječenjem.
English: The safety and efficacy of duloxetine for the treatment of diabetic peripheral neuropathic pain has not been studied.
Croatian: Sigurnost i djelotvornost duloksetina za liječenje boli kod dijabetičke periferne neuropatije nisu ispitane.
English: Monoamine oxidase inhibitors (MAOIs): You should not take ARICLAIM if you are taking, or have recently taken (within the last 14 days) an antidepressant medicine called a monoamine oxidase inhibitor (MAOI).
Croatian: Inhibitore monoamino-oksidaze (MAOI): ne smijete uzimati lijek ARICLAIM ako uzimate ili ste nedavno (unutar zadnjih 14 dana) uzimali antidepresivni lijek koji se zove inhibitor monoamino oksidaze (MAOI).
English: Elimination: The elimination half-life of duloxetine ranges from 8 to 17 hours (mean of 12 hours).
Croatian: Eliminacija: poluvijek eliminacije duloksetina kreće se u rasponu od 8 do 17 sati (srednja vrijednost 12 sati).
English: ARICLAIM is used in adults to treat a condition called diabetic neuropathic pain (often described as burning, stabbing, stinging, shooting or aching or like an electric shock.
Croatian: ARICLAIM se primjenjuje u odraslih za liječenje stanja koje se zove bol kod dijabetičke neuropatije (često se opisuje kao goruća, probadajuća, žareća, sijevajuća ili tupa bol ili kao bol nalik elektrošoku.
English: A meta-analysis of placebo-controlled clinical trials of antidepressant medicinal products in psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Croatian: Metaanaliza placebom kontroliranih kliničkih ispitivanja antidepresivnih lijekova u liječenju psihijatrijskih poremećaja pokazala je povećan rizik od suicidalnog ponašanja kod primjene antidepresiva u usporedbi s placebom u bolesnika mlađih od 25 godina.
English: • falls (mostly in elderly people), fatigue
Croatian: • padovi (najčešće u starijih ljudi), umor
English: Inducers of CYP1A2: Population pharmacokinetic analyses have shown that smokers have almost 50% lower plasma concentrations of duloxetine compared with non-smokers.
Croatian: Induktori CYP1A2: populacijske farmakokinetičke analize ispitivanja pokazale su da su u pušača koncentracije duloksetina u plazmi gotovo 50% niže u usporedbi s nepušačima.
English: Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with
Croatian: Informacije iz kliničkih ispitivanja pokazale su povećan rizik od samoubilačkog ponašanja u odraslih koji su mlađi od 25 godina, a zbog psihijatrijskih stanja su liječeni antidepresivom.
English: Hyponatraemia has been reported when administering ARICLAIM, including cases with serum sodium lower than 110 mmol/l.
Croatian: Prijavljeni su slučajevi hiponatrijemije kod primjene lijeka ARICLAIM, uključujući slučajeve sa serumskim natrijem nižim od 110 mmol/l.
English: You should use ARICLAIM only after discussing the potential benefits and any potential risks to your unborn child with your doctor.
Croatian: Smijete uzimati lijek ARICLAIM tek nakon što razgovarate s liječnikom o mogućim koristima i mogućim rizicima za nerođeno dijete.
English: Female rats receiving duloxetine (45 mg/kg/day) before and during mating and early pregnancy had a decrease in maternal food consumption and body weight, oestrous cycle disruption, decreased live birth indices and progeny survival, and progeny growth retardation at systemic exposure levels estimated to be at the most at maximum clinical exposure (AUC).
Croatian: Ženke štakora koje su primale duloksetin (45 mg/kg/dan) prije i tijekom parenja i rane trudnoće imale su smanjenje unosa hrane i tjelesne težine, prekid estrusnog ciklusa, smanjen indeks živookoćene mladunčadi, smanjeno preživljenje mladunčadi te zaostajanje u rastu mladunčadi pri razinama sistemske izloženosti koja je odgovarala maksimalnoj kliničkoj izloženosti (AUC).
English: Orthostatic hypotension2
Croatian: ortostatska hipotenzija2
English: In the extension phase of these studies, which lasted up to 52 weeks, there was an increase in HbA1c in both the duloxetine and routine care groups, but the mean increase was 0.3% greater in the duloxetinetreated group.
Croatian: U produženoj fazi tih ispitivanja, koje je trajalo do 52 tjedna, HbA1c se povećao i u skupini liječenoj duloksetinom i u skupinama bolesnika na standardnom liječenju, ali je srednja vrijednost bila za 0,3% veća u skupini liječenoj duloksetinom.
English: Do not take more than the daily amount of ARICLAIM that has been prescribed for you in one day.
Croatian: Nemojte u jednome danu uzeti više od propisane dnevne doze lijeka ARICLAIM.
English: Therefore ARICLAIM should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Croatian: Stoga se ARICLAIM ne smije primjenjivati u kombinaciji s potentnim inhibitorima CYP1A2 poput fluvoksamina (vidjeti dio 4.3).
English: - If you have any further questions, ask your doctor or pharmacist.
Croatian: - Ako imate dodatnih pitanja, obratite se svome liječniku ili ljekarniku.
English: Medicines that cause sleepiness: These include medicines prescribed by your doctor including benzodiazepines, strong painkillers, antipsychotics, phenobarbital and antihistamines.
Croatian: Lijekovi koji uzrokuju pospanost: to uključuje lijekove koje Vam je propisao liječnik, uključujući benzodiazepine, jake lijekove protiv bolova, antipsihotike, fenobarbital i antihistaminike.
English: In the 12 week acute phase of three clinical trials of duloxetine in patients with diabetic neuropathic pain, small but statistically significant increases in fasting blood glucose were observed in duloxetinetreated patients.
Croatian: U 12-tjednoj akutnoj fazi triju kliničkih ispitivanja duloksetina u bolesnika s boli kod dijabetičke neuropatije primijećena su mala, ali statistički značajna povećanja glukoze u krvi natašte u bolesnika liječenih duloksetinom.
English: Monoamine oxidase inhibitors (MAOIs): Due to the risk of serotonin syndrome, duloxetine should not be used in combination with non-selective irreversible monoamine oxidase inhibitors (MAOIs), or within at least 14 days of discontinuing treatment with an MAOI.
Croatian: Inhibitori monoaminooksidaze (MAO): zbog rizika od serotoninskog sindroma duloksetin se ne smije primjenjivati u kombinaciji s neselektivnim ireverzibilnim inhibitorima monoaminooksidaze (MAOI) ili unutar najmanje 14 dana nakon prekida liječenja nekim od MAOI.
English: The most commonly reported adverse reactions in patients treated with ARICLAIM were nausea, headache, dry mouth, somnolence, and dizziness.
Croatian: Najčešće prijavljene nuspojave u bolesnika liječenih lijekom ARICLAIM bile su mučnina, glavobolja, suha usta, somnolencija i omaglica.
English: Inhibitors of CYP1A2: Because CYP1A2 is involved in duloxetine metabolism, concomitant use of duloxetine with potent inhibitors of CYP1A2 is likely to result in higher concentrations of duloxetine.
Croatian: Inhibitori CYP1A2: budući da je CYP1A2 uključen u metabolizam duloksetina, istodobna primjena duloksetina s potentnim inhibitorima CYP1A2 vjerojatno će rezultirati povišenim koncentracijama duloksetina.
English: Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines.
Croatian: Također, morate znati da bolesnici mlađi od 18 godina koji se liječe ovom skupinom lijekova imaju povećan rizik od nuspojava poput pokušaja samoubojstva, misli o samoubojstvu i neprijateljskog ponašanja (prvenstveno agresivnost, protivljenje i bijes).
English: Fluvoxamine (100 mg once daily), a potent inhibitor of CYP1A2, decreased the apparent plasma clearance of duloxetine by about 77% and increased AUCo-t 6-fold.
Croatian: Fluvoksamin (100 mg jednom dnevno), potentni inhibitor CYP1A2, smanjio je prividni klirens duloksetina iz plazme za oko 77% i 6 puta povećao AUCo-t.
English: ARICLAIM should not be used in combination with fluvoxamine, ciprofloxacin or enoxacin (i.e. potent CYP1A2 inhibitors) since the combination results in elevated plasma concentrations of duloxetine (see section 4.5).
Croatian: ARICLAIM se ne smije primjenjivati u kombinaciji s fluvoksaminom, ciprofloksacinom ili enoksacinom (tj. potentnim inhibitorima CYP1A2) jer ta kombinacija rezultira povišenim koncentracijama duloksetina u plazmi (vidjeti dio 4.5).
English: It is therefore advised that duloxetine should be gradually tapered when discontinuing treatment over a period of no less than 2 weeks, according to the patient's needs (see section 4.2).
Croatian: Stoga se savjetuje da se kod prekida liječenja duloksetinom doza postupno smanjuje tijekom razdoblja od ne manje od 2 tjedna, sukladno potrebama bolesnika (vidjeti dio 4.2).
English: Cases of liver injury, including severe elevations of liver enzymes (>10 times upper limit of normal), hepatitis and jaundice have been reported with duloxetine (see section 4.8).
Croatian: Kod primjene duloksetina prijavljeni su slučajevi oštećenja jetre, uključujući velika povišenja jetrenih enzima (> 10 puta iznad gornje granice normale), hepatitis i žuticu (vidjeti dio 4.8).
English: The heart rate-corrected QT interval in duloxetine-treated patients did not differ from that seen in placebo-treated patients.
Croatian: QT-interval korigiran za srčanu frekvenciju u bolesnika liječenih duloksetinom nije se razlikovao od onog viđenog u bolesnika koji su primali placebo.
English: • weight loss
Croatian: • gubljenje tjelesne težine
English: The use of duloxetine has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still.
Croatian: Akatizija/psihomotorni nemir Primjena duloksetina povezana je s razvojem akatizije, koju karakterizira subjektivno neugodan ili uznemirujući nemir i potreba za kretanjem, često praćena nesposobnošću mirnog sjedenja ili stajanja.
English: CNS medicinal products: The risk of using duloxetine in combination with other CNS-active medicinal products has not been systematically evaluated, except in the cases described in this section.
Croatian: Lijekovi koji djeluju na središnji živčani sustav (SŽS): rizici pri uzimanju duloksetina u kombinaciji s drugim lijekovima koji djeluju na SŽS nisu sustavno ocijenjeni, osim u slučajevima opisanima u ovom dijelu.
English: Keep out of the reach sight and reach sight of children.
Croatian: Čuvati izvan pogleda i dohvata djece.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit risk profile or as the result of an important (pharmacovililance or risk minimisation) milestone being reached.
Croatian: • uoči svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
English: Serotonergic agents: In rare cases, serotonin syndrome has been reported in patients using SSRIs/SNRIs concomitantly with serotonergic agents.
Croatian: Serotoninergički lijekovi: u rijetkim je slučajevima prijavljen serotoninski sindrom u bolesnika koji su uzimali SSRI-je/SNRI-je istodobno sa serotoninergičkim lijekovima.
English: Duloxetine should be used with caution in patients whose conditions could be compromised by an increased heart rate or by an increase in blood pressure.
Croatian: Duloksetin se mora primjenjivati s oprezom u bolesnika čija stanja mogu biti kompromitirana ubrzanjem srčane frekvencije ili povišenjem krvnog tlaka.
English: For patients who experience a sustained increase in blood pressure while receiving duloxetine either dose reduction or gradual discontinuation should be considered (see section 4.8).
Croatian: U bolesnika koji imaju stalno povišeni krvni tlak za vrijeme uzimanja duloksetina mora se razmotriti ili smanjenje doze ili postupan prekid uzimanja lijeka (vidjeti dio 4.8).
English: Furthermore, increases in INR values have been reported when duloxetine was co-administered to patients treated with warfarin.
Croatian: Nadalje, prijavljena su povišenja vrijednosti INR-a kada se duloksetin primjenjivao istodobno u bolesnika liječenih varfarinom.
English: In an embryotoxicity study in the rabbit, a higher incidence of cardiovascular and skeletal malformations was observed at systemic exposure levels below the maximum clinical exposure (AUC).
Croatian: U istraživanju embriotoksičnosti u kunića uočena je viša incidencija kardiovaskularnih i skeletnih malformacija pri razinama sistemske izloženosti manjima od maksimalne kliničke izloženosti (AUC).
English: Suicide-related behaviours (suicide attempts and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger), were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
Croatian: kliničkim su ispitivanjima suicidalno ponašanje (pokušaji samoubojstva i suicidalne misli) i neprijateljsko ponašanje (prvenstveno agresija, protivljenje i bijes) uočeni češće u djece i adolescenata liječenih antidepresivima u usporedbi s onima koji su dobivali placebo.
English: EU/1/04/283/012 (98 hard gastro-resistant capsules)
Croatian: EU/1/04/283/012 (98 tvrdih želučanootpornih kapsula)