FrancophonIA/ELRC3.0 huggingface dataset:
English: Emselex should be used with caution in patients with risk of decreased gastrointestinal motility, gastro-oesophageal reflux and/or who are concurrently taking medicinal products (such as oral bisphosphonates) that can cause or exacerbate oesophagitis.
Croatian: Emselex treba primjenjivati s oprezom u bolesnika s rizikom od smanjenog gastrointestinalnog motiliteta, gastro-ezofagealnog refluksa i/ili u bolesnika koji istodobno uzimaju lijekove koji mogu izazvati ili pogoršati ezofagitis (npr. oralni bisfosfonati).
English: It can therefore be concluded that darifenacin administration does not alter the pharmacokinetics of CYP3A4 substrates in vivo.
Croatian: Stoga se može zaključiti da primjena darifenacina ne mijenja farmakokinetiku CYP3A4 supstrata in vivo.
English: The most common adverse reactions seen were dry mouth, constipation, headache, dyspepsia and nasal dryness.
Croatian: Najčešće uočene nuspojave bile su suha usta, konstipacija, glavobolja, dispepsija i suhoća nosa.
English: Emselex should be used with caution in patients being treated for narrow-angle glaucoma (see section 4.3).
Croatian: Emselex treba primjenjivati s oprezom u bolesnika koji primaju lijekove protiv glaukoma zatvorenog kuta (vidjeti dio 4.3).
English: Emselex should be taken with caution while breast-feeding.
Croatian: Emselex se tijekom dojenja treba uzimati s oprezom.
English: What Emselex contains
Croatian: Što Emselex sadrži
English: Emselex should be administered with caution to patients with autonomic neuropathy, hiatus hernia, clinically significant bladder outflow obstruction, risk for urinary retention, severe constipation or gastrointestinal obstructive disorders, such as pyloric stenosis.
Croatian: Emselex treba primjenjivati s oprezom u bolesnika s neuropatijom autonomnog živčanog sustava, hijatalnom hernijom, klinički značajnom opstrukcijom pražnjenja mokraćnog mjehura, rizikom od retencije mokraće, teškom konstipacijom ili opstrukcijskim poremećajima gastrointestinalnog trakta, poput stenoze pilorusa.
English: Mild hepatic impairment had no effect on the pharmacokinetics of darifenacin.
Croatian: Blago oštećenje jetre nije utjecalo na farmakokinetiku darifenacina.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU SREDNJA KUTIJA VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA)
English: Depending on your response to Emselex, your doctor may increase your dose to 15 mg daily, two weeks after starting therapy.
Croatian: Ovisno o Vašem odgovoru na Emselex, dva tjedna nakon početka liječenja, liječnik može dozu povećati na 15 mg na dan.
English: The recommended starting dose is 7.5 mg daily.
Croatian: Preporučena početna doza je 7,5 mg dnevno.
English: • if you have severe constipation (less than or equal to 2 bowel movements per week).
Croatian: • ako patite od jakog zatvora (imate stolicu 2 puta na tjedan ili rjeđe).
English: Unbound darifenacin exposure was estimated to be 4.7-fold higher in subjects with moderate hepatic impairment than subjects with normal hepatic function (see section 4.2).
Croatian: Procijenjeno je da je izloženost nevezanom darifenacinu u osoba s umjerenim oštećenjem jetre bila 4,7 puta veća od one u osoba s normalnom funkcijom jetre (vidjeti dio 4.2).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF UNIT PACK
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA JEDINIČNOG PAKIRANJA
English: Most of the adverse reactions were of mild or moderate intensity and did not result in discontinuation in the majority of the patients.
Croatian: Većina nuspojava su bile blage do umjereno jake i u većine bolesnika nisu rezultirale prekidom liječenja.
English: Emselex 7.5 mg once daily Placebo
Croatian: Emselex 7,5 mg jednom na dan
English: INFORMATION IN BRAILLE Emselex 15 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Emselex 15 mg
English: Patients receiving concomitant treatment with substances that are potent inhibitors of CYP2D6 or moderate inhibitors of CYP3A4
Croatian: Bolesnici koji istodobno primaju tvari koje su snažni inhibitori CYP2D6 ili umjereno jaki inhibitori CYP3A4
English: However, there was no association between the occurrence of adverse events related to the biliary system in darifenacin-treated patients and increasing age.
Croatian: U bolesnika liječenih darifenacinom nije, međutim, uočena veza između štetnih događaja povezanih s bilijarnim sustavom i povećanja životne dobi.
English: The use of agents such as physostigmine can assist in reversing such symptoms.
Croatian: U ublažavanju tih simptoma može pomoći primjena tvari poput fizostigmina.
English: As seen in Table 2 below, a pooled analysis of 3 of the studies for the treatment with both Emselex 7.5 mg and 15 mg provided a statistically significant improvement in the primary endpoint, reduction in incontinence episodes, versus placebo.
Croatian: Kao što se vidi u tablici 2 danoj ispod, zajednička analiza rezultata triju ispitivanja pokazala je da se liječenjem Emselexom u dozi od 7,5 mg i 15 mg postiglo statistički značajno poboljšanje primarnog ishoda ispitivanja, tj. smanjenje broja epizoda inkontinencije u odnosu na placebo.
English: Common (may affect up to 1 in 10 people) Headache, abdominal pain, indigestion, feeling sick, dry eyes, nasal dryness.
Croatian: Često (mogu se javiti u do 1 na 10 osoba) Glavobolja, bol u trbuhu, probavne smetnje, osjećaj mučnine, suhoća očiju, suhoća nosne sluznice.
English: • if you have autonomic neuropathy (damage to the nerves that communicate between the brain and internal organs, muscles, skin, and blood vessels to regulate vital functions, including the heart rate, blood pressure and bowel function) - your doctor will have told you if you have this.
Croatian: • ako imate neuropatiju autonomnog živčanog sustava (oštećenje živaca koji komuniciraju između mozga i unutrašnjih organa, mišića, kože i krvnih žila radi održavanja životnih funkcija,
English: Due to extensive first-pass metabolism darifenacin has a bioavailability of approximately 15% and 19% after 7.5 mg and 15 mg daily doses at steady state.
Croatian: Zbog opsežnog metabolizma prvog prolaska, bioraspoloživost darifenacina u stanju dinamičke ravnoteže iznosi oko 15% nakon dnevne doze od 7,5 mg, a oko 19% nakon dnevne doze od 15 mg.
English: Dry eye
Croatian: Suhoća očiju
English: Due to genetic differences, about 7% of the Caucasians lack the CYP2D6 enzyme and are said to be poor metabolisers.
Croatian: Zbog genetskih razlika, enzim CYP2D6 nedostaje u oko 7% bijelaca te ih se stoga naziva osobama koje slabo metaboliziraju lijek.
English: INFORMATION IN BRAILLE Emselex 7.5 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Emselex 7,5 mg
English: It is not known whether darifenacin is excreted in human milk.
Croatian: Nije poznato izlučuje li se darifenacin u majčino mlijeko u ljudi.
English: Doubling the darifenacin dose from 7.5 mg to 15 mg result in a 150% increase in steady-state exposure.
Croatian: Udvostruči li se doza darifenacina sa 7,5 mg na 15 mg, izloženost u stanju dinamičke ravnoteže povećava se za 150%.
English: The incidence of adverse reactions with the doses of Emselex 7.5 mg and 15 mg decreased during the treatment period up to 6 months.
Croatian: Incidencija nuspojava pri dozama Emselexa od 7,5 mg i 15 mg smanjila se tijekom razdoblja liječenja od 6 mjeseci.
English: Substances that are inducers of CYP3A4, such as rifampicin, carbamazepine, barbiturates and St John´s wort (Hypericum perforatum) are likely to decrease the plasma concentrations of darifenacin.
Croatian: Tvari koje induciraju CYP3A4, poput rifampicina, karbamazepina, barbiturata i Gospine trave (Hypericum perforatum) vjerojatno će smanjiti koncentraciju darifenacina u plazmi.
English: If you forget to take Emselex
Croatian: Ako ste zaboravili uzeti Emselex
English: There were no effects on reproductive organs in either sex in dogs treated for 1 year at oral doses up to 6 mg/kg/day (82 times the AUC0-24h of free plasma concentration at MRHD).
Croatian: Nije bilo učinka na reproduktivne organe oba spola u pasa koji su 1 godinu primali oralne doze do 6 mg/kg/dan (što je 82 puta veće od AUC0-24h koncentracije slobodne tvari u plazmi kod najviše preporučene doze u ljudi).
English: In one pharmacokinetic study the steady-state exposure in poor metabolisers was 164% and 99% higher during treatment with 7.5 mg and 15 mg once daily, respectively.
Croatian: U jednom farmakokinetičkom ispitivanju, izloženost darifenacinu u stanju dinamičke ravnoteže u osoba koje slabo metaboliziraju lijek bila je 164%, odnosno 99% veća tijekom liječenja sa 7,5 mg, odnosno 15 mg dnevno.
English: Emselex may cause effects such as dizziness, blurred vision, trouble sleeping or drowsiness.
Croatian: Emselex može izazvati omaglicu, zamućen vid, nesanicu ili pospanost.
English: • antiviral medicines (e.g. nelfinavir and ritonavir),
Croatian: • antivirusni lijekovi (npr. nelfinavir i ritonavir),
English: If you stop taking Emselex
Croatian: Ako prestanete uzimati Emselex
English: The other ingredients are calcium hydrogen phosphate (anhydrous), hypromellose, magnesium stearate, polyethylene glycol, talc, titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172).
Croatian: Pomoćne tvari su kalcijev hidrogenfosfat (bezvodni), hipromeloza, magnezijev stearat, polietilenglikol, talk, titanijev dioksid (E171), željezov oksid, crveni (E172) i željezov oksid, žuti (E172).
English: The other ingredients are calcium hydrogen phosphate (anhydrous), hypromellose, magnesium stearate, polyethylene glycol, titanium dioxide (E171) and talc.
Croatian: Pomoćne tvari su kalcijev hidrogenfosfat (bezvodni), hipromeloza, magnezijev stearat, polietilenglikol, titanijev dioksid (E171) i talk.
English: Psychiatric disorders Uncommon
Croatian: Psihijatrijski poremećaji Manje često
English: • if you have a digestive motility disorder.
Croatian: • ako imate poremećaj probavne pokretljivosti.
English: Emselex 7.5 mg and 15 mg doses significantly reduced both the severity and number of urinary urgency episodes and the number of micturitions, while significantly increasing the mean volume voided from baseline.
Croatian: Emselex je u dozama od 7,5 mg i 15 mg značajno smanjio i težinu i broj epizoda u kojima se javljala hitnost za mokrenjem, kao i broj mokrenja, a znatno je povećao srednju vrijednost izmokrenog volumena u odnosu na početnu vrijednost.
English: P value2
Croatian: P vrijednost2
English: For those patients requiring greater symptom relief, the dose may be increased to 15 mg daily, based on individual response.
Croatian: Bolesnicima kojima je potrebno izrazitije ublažavanje simptoma, doza se može povećati na 15 mg dnevno, ovisno o individualnom odgovoru.
English: For Emselex, these side effects have been reported to be uncommon (see section 4).
Croatian: Te nuspojave su za Emselex prijavljene kao manje česte (pogledajte dio 4).
English: Darifenacin AUC24 and Cmax from 30 mg once daily dosing in subjects who are extensive metabolisers were 95% and 128% higher when erythromycin (moderate CYP3A4 inhibitor) was co-administered with darifenacin than when darifenacin was taken alone.
Croatian: U osoba koje darifenacin opsežno metaboliziraju, AUC24 i Cmax darifenacina pri dozi od 30 mg jednom na dan bili su za 95%, odnosno za 128% veći kada se uz darifenacin primjenjivao i eritromicin (umjereno jaki inhibitor CYP3A4), nego kada se darifenacin primjenjivao sam.
English: Darifenacin treatment resulted in a modest increase in the exposure of the CYP3A4 substrate midazolam.
Croatian: Liječenje darifenacinom rezultiralo je umjerenim povećanjem izloženosti midazolamu, koji je supstrat CYP3A4.
English: • other antimuscarinic medicines (e.g. tolterodine, oxybutynin and flavoxate).
Croatian: • drugi antimuskarinski lijekovi (npr. tolterodin, oksibutinin i flavoksat).
English: Emselex 7.5 mg and 15 mg were associated with statistically significant improvements over placebo in some aspects of quality of life as measured by the Kings Health Questionnaire including incontinence impact, role limitations, social limitations and severity measures.
Croatian: Prema procjeni Kingsovog upitnika o zdravstvenom stanju (Kings Health Questionnaire), Emselex 7,5 mg i 15 mg su bili, u odnosu na placebo, povezani sa statistički značajnim poboljšanjem određenih pokazatelja kakvoće života, uključujući učinak inkontinencije, ograničenja u aktivnostima, ograničenja u društvenom životu i pokazatelje težine stanja.
English: The recommended starting dose for the elderly is 7.5 mg daily.
Croatian: Preporučena početna doza u starijih osoba je 7,5 mg dnevno.
English: How long to take Emselex
Croatian: Koliko dugo uzimati Emselex
English: People who have taken an overdose may have dry mouth, constipation, headache, indigestion and nasal dryness.
Croatian: Osobe koje su se predozirale mogu imati suha usta, zatvor, glavobolju, probavne smetnje i suhoću nosa.
English: There were no effects on fertility in male and female rats treated at oral doses up to 50 mg/kg/day (78 times the AUC0-24h of free plasma concentration at maximum recommended human dose [MRHD]).
Croatian: Nije bilo učinka na plodnost u mužjaka i ženki štakora koji su primali oralne doze do 50 mg/kg/dan (što je 78 puta veće od AUC0-24h koncentracije slobodne tvari u plazmi kod najviše preporučene doze u ljudi).
English: The effects of darifenacin on the metabolism of CYP2D6 substrates are mainly clinically relevant for CYP2D6 substrates which are individually dose titrated.
Croatian: Učinak darifenacina na metabolizam supstrata CYP2D6 je klinički značajan kada je riječ o supstratima CYP2D6 čije se doze individualno prilagođavaju.
English: Darifenacin is a moderate inhibitor of the enzyme CYP2D6.
Croatian: Darifenacin je umjereno jak inhibitor enzima CYP2D6.
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Croatian: Neklinički podaci dobiveni konvencionalnim ispitivanjima farmakološke sigurnosti primjene, toksičnosti ponovljenih doza, genotoksičnosti i karcinogenog potencijala nisu ukazali na nikakvu posebnu opasnost za ljude.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA VIŠESTRUKOG PAKIRANJA (S PLAVIM OKVIROM)
English: This dose-dependency is probably caused by saturation of the CYP2D6 catalysed metabolism possibly together with some saturation of CYP3A4-mediated gut wall metabolism.
Croatian: Ta je ovisnost o dozi vjerojatno uzrokovana zasićenjem metabolizma posredovanog enzimom CYP2D6, vjerojatno u kombinaciji sa zasićenjem metabolizma posredovanog enzimom CYP3A4 u stijenci crijeva.
English: Standard therapeutic prothrombin time monitoring for warfarin should be continued.
Croatian: Kod primjene varfarina potrebno je nastaviti sa standardnim praćenjem protrombinskog vremena.
English: What you need to know before you take Emselex
Croatian: Što morate znati prije nego počnete uzimati Emselex
English: • antifungal medicines (e.g. ketoconazole and itraconazole),
Croatian: • lijekovi protiv gljivica (npr. ketokonazol i itrakonazol),
English: Table 1: Adverse reactions with Emselex 7.5 mg and 15 mg prolonged-release tablets
Croatian: Tablica 1: Nuspojave s Emselex 7,5 mg i 15 mg tabletama s produljenim oslobađanjem
English: Emselex is for oral use.
Croatian: Emselex se primjenjuje peroralno.
English: What Emselex can be used for
Croatian: Za što se Emselex može koristiti
English: At the dose of 30 mg/kg/day in rabbits (28 times the AUC0-24h of free plasma concentration at MRHD), maternal toxicity and foetotoxicity (increased post implantation loss and decreased number of viable foetuses per litter) were observed.
Croatian: Pri dozi od 30 mg/kg/dan u kunića (što je 28 puta veće od AUC0-24h koncentracije slobodne tvari u plazmi kod najviše preporučene doze u ljudi), uočeni su toksičnost za majku i fetotoksičnost (povećani postimplantacijski gubitak i smanjeni broj vitalnih fetusa po litri).
English: Titanium dioxide (E171)
Croatian: Film-ovojnica polietilenglikol hipromeloza titanijev dioksid (E171) talk
English: Co-administration of darifenacin 7.5 mg with the potent CYP3A4 inhibitor ketoconazole 400 mg resulted in a 5-fold increase in steady-state darifenacin AUC.
Croatian: Pri istodobnoj primjeni 7,5 mg darifenacina i 400 mg ketokonazola, snažnog inhibitora CYP3A4, AUC darifenacina u stanju dinamičke ravnoteže povećao se 5 puta.
English: • if you have severe liver problems.
Croatian: • ako imate teških problema s jetrom.
English: The pharmacokinetics of darifenacin at steady state are dose-dependent, due to saturation of the CYP2D6 enzyme.
Croatian: Farmakokinetika darifenacina u stanju dinamičke ravnoteže je ovisna o dozi, zbog zasićenja enzima CYP2D6.
English: Metabolism Darifenacin is extensively metabolised by the liver following oral administration.
Croatian: Darifenacin se nakon oralne primjene opsežno metabolizira u jetri.
English: How much Emselex to take
Croatian: Koliko Emselexa uzeti
English: SPECIAL STORAGE CONDITIONS Keep the blister packs in the outer carton in order to protect from light.
Croatian: POSEBNE MJERE ČUVANJA Blistere čuvati u kutiji radi zaštite od svjetlosti.
English: Darifenacin is metabolised by CYP3A4 and CYP2D6.
Croatian: Darifenacin se metabolizira putem CYP3A4 i CYP2D6.
English: Caution should be exercised when darifenacin is used concomitantly with medicinal products that are predominantly metabolised by CYP2D6 and which have a narrow therapeutic window, such as flecainide, thioridazine, or tricyclic antidepressants such as imipramine.
Croatian: Kada se darifenacin primjenjuje istodobno s lijekovima uske terapijske širine, koji se pretežno metaboliziraju putem CYP2D6, poput flekainida, tioridazina ili tricikličkih antidepresiva, poput imipramina, nužan je oprez.
English: Urinary retention.
Croatian: S retencijom mokraće.
English: • Keep the blister packs in the outer carton in order to protect from light.
Croatian: • Blistere čuvati u kutiji radi zaštite od svjetlosti.
English: • certain antidepressants (e.g. imipramine),
Croatian: • neki antidepresivi (npr. imipramin),
English: At the dose of 50 mg/kg/day in rats (59 times the AUC0-24h of free plasma concentration at MRHD), delay in the ossification of the sacral and caudal vertebrae was observed.
Croatian: Pri dozi od 50 mg/kg/dan u štakora (što je 59 puta veće od AUC0-24h koncentracije slobodne tvari u plazmi kod najviše preporučene doze u ljudi), uočen je zastoj u okoštavanju sakralnih i kaudalnih kralježaka.
English: Keep the blister packs in the outer carton in order to protect from light.
Croatian: Blistere čuvati u kutiji radi zaštite od svjetlosti.
English: N
Croatian: C.
English: Do not stop taking Emselex until your doctor tells you to. You should not experience any effects when you stop treatment.
Croatian: Emselex nemojte prestati uzimati dok Vam to liječnik ne odredi.
English: How Emselex works
Croatian: Kako Emselex djeluje
English: There are no human fertility data for darifenacin.
Croatian: Nema podataka o učinku darifenacina na plodnost u ljudi.
English: What Emselex looks like and contents of the pack Emselex 7.5 mg prolonged-release tablets are round, convex white tablets and are debossed with “DF” on one side and “7.5” on the other.
Croatian: Emselex 7,5 mg tablete s produljenim oslobađanjem su okrugle, konveksne tablete bijele boje, s utisnutom oznakom „DF“ na jednoj strani i oznakom „7.5“ na drugoj strani.
English: How to take Emselex
Croatian: Kako uzimati Emselex
English: When co-administered with moderate CYP3A4 inhibitors such as erythromycin, clarithromycin, telithromycin, fluconazole and grapefruit juice, the recommended starting dose of darifenacin should be 7.5 mg daily.
Croatian: Kod istodobne primjene s umjereno jakim inhibitorima CYP3A4, poput eritromicina, klaritromicina, telitromicina, flukonazola i soka od grejpa, preporučena početna doza darifenacina iznosi 7,5 mg na dan.
English: In patients receiving substances that are potent CYP2D6 inhibitors, such as paroxetine, terbinafine, quinidine and cimetidine, treatment should start with the 7.5 mg dose.
Croatian: U bolesnika koji primaju tvari koje su snažni inhibitori CYP2D6, npr. paroksetin, terbinafin, kinidin i cimetidin, liječenje treba započeti dozom od 7,5 mg.
English: Emselex 15 mg prolonged-release tablets Darifenacin
Croatian: Emselex 15 mg tablete s produljenim oslobađanjem darifenacin
English: (PVC/PVDC/alu blisters)
Croatian: (PVC/PVDC/alu blisteri)
English: Therapeutic drug monitoring for digoxin should be performed when initiating and ending darifenacin treatment as well as changing the darifenacin dose.
Croatian: Na početku i na kraju liječenja darifenacinom, kao i pri promjeni doze darifenacina, nužno je terapijsko praćenje digoksina.
English: White round, convex tablet, debossed with “DF” on one side and “7.5” on the reverse.
Croatian: Okrugla, konveksna tableta bijele boje, s utisnutom oznakom „DF“ na jednoj strani i oznakom „7.5“ na drugoj strani.
English: • antipsychotic medicines (e.g. thioridazine),
Croatian: • antipsihotici (npr. tioridazin),
English: No dose adjustment is required in patients with mild hepatic impairment (Child Pugh A).
Croatian: U bolesnika s blagim oštećenjem jetre (Child Pugh A) dozu ne treba prilagođavati.
English: In patients receiving substances that are moderate CYP3A4 inhibitors, such as fluconazole, grapefruit juice and erythromycin, the recommended starting dose is 7.5 mg daily.
Croatian: U bolesnika koji uzimaju tvari koje su umjereno jaki inhibitori CYP3A4, npr. flukonazol, sok od grejpa i eritromicin, preporučena početna doza je 7,5 mg dnevno.
English: Calcium hydrogen phosphate, anhydrous
Croatian: Jezgra tablete kalcijev hidrogenfosfat, bezvodni hipromeloza magnezijev stearat
English: (PVC/CTFE/alu blisters)
Croatian: (PVC/CTFE/alu blisteri)
English: Darifenacin undergoes significant metabolism by cytochrome CYP3A4 and CYP2D6 in the liver and by CYP3A4 in the gut wall.
Croatian: Darifenacin se značajno metabolizira u jetri putem citokroma CYP3A4 i CYP2D6, a u stijenci crijeva putem CYP3A4.
English: No dose adjustment is required in patients with impaired renal function.
Croatian: U bolesnika s oštećenom funkcijom bubrega dozu ne treba prilagođavati.
English: Skin and subcutaneous tissue disorders Uncommon
Croatian: Poremećaji kože i potkožnog sustava Manje često
English: The metabolism of darifenacin in CYP2D6 poor metabolisers is principally mediated by CYP3A4.
Croatian: Metabolizam darifenacina u osoba koje slabo metaboliziraju lijek putem CYP2D6, uglavnom je posredovan enzimom CYP3A4.
English: What Emselex looks like and contents of the pack Emselex 15 mg prolonged-release tablets are round, convex light peach tablets and are debossed with “DF” on one side and “15” on the other.
Croatian: Emselex 15 mg tablete s produljenim oslobađanjem su okrugle, konveksne tablete boje breskve, s utisnutom oznakom „DF“ na jednoj strani i oznakom „15“ na drugoj strani.
English: In patients receiving substances that are potent CYP2D6 inhibitors (e.g. paroxetine, terbinafine, cimetidine and quinidine) the recommended starting dose should be 7.5 mg daily.
Croatian: U bolesnika koji primaju tvari koje su snažni inhibitori CYP2D6 (npr. paroksetin, terbinafin, cimetidin i kinidin) preporučuje se početna doza od 7,5 mg na dan.
English: Emselex 7.5 mg prolonged-release tablets Darifenacin
Croatian: Emselex 7,5 mg tablete s produljenim oslobađanjem darifenacin
English: Change from baseline (median)
Croatian: Promjena u odnosu na početnu vrijednost (medijan)
English: The dose may be titrated to 15 mg daily to obtain an improved clinical response provided the dose is well tolerated.
Croatian: Radi postizanja boljeg kliničkog odgovora, doza se može povećati do 15 mg dnevno, pod uvjetom da se lijek u toj dozi dobro podnosi.
English: Insomnia, thinking abnormal
Croatian: Nesanica, poremećaj tijeka misli
English: Each tablet contains 7.5 mg darifenacin (as hydrobromide).
Croatian: Svaka tableta sadrži 7,5 mg darifenacina (u obliku darifenacinbromida).