FrancophonIA/ELRC3.0 huggingface dataset:
English: For those patients who have an acceptable tolerability profile but require greater symptom relief, the dose may be increased to 15 mg daily, based on individual response (see section 5.2).
Slovenian: Za bolnike, ki imajo sprejemljiv profil tolerabilnosti, a potrebujejo večje lajšanje simptomov, je odmerek mogoče povečati na 15 mg na dan na podlagi posameznikovega odziva (glejte poglavje 5.2).
English: Emselex reduces the activity of an overactive bladder.
Slovenian: Zdravilo Emselex zmanjša aktivnost čezmerno aktivnega sečnega mehurja.
English: Following administration of an oral dose of 14C-darifenacin solution to healthy volunteers, approximately 60% of the radioactivity was recovered in the urine and 40% in the faeces.
Slovenian: Ko so zdravim prostovoljcem dali peroralni odmerek raztopine 14C-darifenacina, so ugotovili približno 60 % radioaktivnosti v seču, 40 % pa v blatu.
English: Aspartate aminotransferase increased, alanine aminotransferase increased Injury, poisoning, and procedural complications Uncommon
Slovenian: Preiskave občasni povišane vrednosti aspartat-aminotransferaze, povišane vrednosti alanin-aminotransferaze Poškodbe in zastrupitve in zapleti pri posegih občasni poškodba
English: A small study of subjects (n=24) with varying degrees of renal impairment (creatinine clearance between 10 ml/min and 136 ml/min) given darifenacin 15 mg once daily to steady state demonstrated no relationship between renal function and darifenacin clearance (see section 4.2).
Slovenian: Študija na majhnem številu bolnikov (n=24) z različnimi stopnjami ledvične okvare (očistek kreatinina med 10 ml/min in 136 ml/min), ki so dobivali po 15 mg darifenacina enkrat na dan do stanja dinamičnega ravnovesja, ni pokazala zveze med ledvičnim delovanjem in očistkom darifenacina (glejte poglavje 4.2).
English: It is not known whether darifenacin is excreted in human milk.
Slovenian: Ni znano, ali se izloča tudi v materino mleko.
English: The recommended starting dose, including for patients aged over 65 years, is 7.5 mg daily.
Slovenian: Priporočeni začetni odmerek za odrasle, vključno z bolniki, ki so starejši od 65 let, je 7,5 mg na dan.
English: Potent P-glycoprotein inhibitors such as ciclosporin and verapamil should also be avoided.
Slovenian: Izogibati se moramo tudi močnim zaviralcem glikoproteina P, na primer ciklosporinu in verapamilu.
English: Treatment with Emselex administered at dosages of 7.5 mg and 15 mg daily has been investigated in four double-blind, Phase III, randomised, controlled clinical studies in male and female patients with symptoms of overactive bladder.
Slovenian: Zdravljenje z zdravilom Emselex v odmerkih po 7,5 mg in 15 mg na dan so raziskovali v štirih dvojno slepih, randomiziranih, kontroliranih kliničnih študijah faze III pri bolnikih in bolnicah s simptomi čezmerno aktivnega mehurja.
English: However, caution should be exercised when treating this population (see section 5.2).
Slovenian: Vendar je pri zdravljenju te skupine bolnikov potrebna previdnost (glejte poglavje 5.2).
English: Emselex is not recommended during pregnancy.
Slovenian: Zdravila Emselex v nosečnosti ne priporočamo.
English: However, the patient discontinuation rates due to these adverse reactions were low (dry mouth: 0%0.9% and constipation: 0.6% - 2.2% for darifenacin, depending on the dose; and 0% and 0.3% for placebo, for dry mouth and constipation, respectively).
Slovenian: Vendar je bil odstotek bolnikov, ki so zaradi navedenih neželenih učinkov prenehali jemati zdravilo, majhen (suha usta: 0 % - 0,9 % in zapeka: 0,6 % - 2,2 % ob darifenacinu v odvisnosti od odmerka, ob placebu pa 0 % zaradi suhih ust in 0,3 % zaradi zapeke).
English: Other medicines and Emselex
Slovenian: Druga zdravila in zdravilo Emselex
English: • if you suffer from uncontrolled narrow-angle glaucoma (high pressure in the eyes with loss of eyesight that is not being adequately treated).
Slovenian: • če imate neobvladan glavkom z zaprtim zakotjem (zvišan tlak v očeh z izgubo vida, ki ni ustrezno zdravljen),
English: Eating food has no effect on Emselex.
Slovenian: Uživanje hrane ne vpliva na zdravilo Emselex.
English: • if you are taking medicinal products that can cause or worsen inflammation of the oesophagus such as oral bisphosphonates (a class of medicinal products that prevent the loss of bone mass and are used to treat osteoporosis).
Slovenian: • če jemljete zdravila, ki lahko povzročijo ali poslabšajo vnetje požiralnika, kot so peroralni difosfonati (skupina zdravil, ki preprečujejo izgubljanje kostne mase in jih uporabljamo pri zdravljenju osteoporoze),
English: • if you have severe ulcerative colitis or toxic megacolon (acute dilation of the colon due to complication of infection or inflammation).
Slovenian: • če imate hud ulcerozni kolitis ali toksični megakolon (akutna razširitev debelega črevesa kot zaplet okužbe ali vnetja),
English: A decision whether to avoid breast-feeding or to abstain from Emselex therapy during lactation should be based on a benefit and risk comparison.
Slovenian: Odločitev o tem, ali naj se ženska odpove dojenju ali zdravljenju z zdravilom Emselex, mora temeljiti na primerjavi med koristmi in tveganji.
English: Depending on your response to Emselex, your doctor may increase your dose to 15 mg daily, two weeks after starting therapy.
Slovenian: Odvisno od vašega odziva na zdravilo Emselex vam bo zdravnik dva tedna po začetku zdravljenja mogoče zvečal odmerek na 15 mg na dan.
English: As with any other antimuscarinic agents, concomitant use of medicinal products that possess antimuscarinic properties, such as oxybutynin, tolterodine and flavoxate, may result in more pronounced therapeutic and side effects.
Slovenian: Tako kot pri drugih antimuskarinskih sredstvih lahko sočasno zdravljenje z zdravili, ki imajo antimuskarinske lastnosti, na primer z oksibutininom, s tolterodinom in flavoksatom, povzroči izrazitejše terapevtske in neželene učinke.
English: There was considerable overlap between the ranges of exposures seen in these two populations (see section 4.2).
Slovenian: Obsega izpostavljenosti pri teh dveh skupinah sta se precej prekrivala (glejte poglavje 4.2).
English: Darifenacin pharmacokinetics were investigated in subjects with mild (Child Pugh A) or moderate (Child Pugh B) impairment of hepatic function given darifenacin 15 mg once daily to steady state.
Slovenian: Farmakokinetiko darifenacina so raziskali pri bolnikih z blago (Child Pugh A) ali zmerno (Child Pugh B) okvaro jetrnega delovanja, ki so dobivali po 15 mg darifenacina enkrat na dan do stanja dinamičnega ravnovesja.
English: For both doses of 7.5 mg and 15 mg, the percentage median reduction from baseline in the number of incontinence episodes per week was similar between males and females.
Slovenian: Pri obeh odmerkih, 7,5 mg in 15 mg, je bilo mediano odstotno zmanjšanje števila epizod inkontinence na teden glede na začetno stanje podobno pri moških in pri ženskah.
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.
Slovenian: Previdnost je potrebna pri sočasni uporabi darifenacina z zdravili, ki jih pretežno presnavlja CYP2D6 in ki imajo majhno terapevtsko širino, na primer s flekainidom, tioridazinom ali tricikličnimi antidepresivi, na primer z imipraminom.
English: Darifenacin had no effect on male or female fertility in rats or any effect in the reproductive organs of either sex in rats and dogs (for details, see section 5.3).
Slovenian: Podatkov o vplivu darifenacina na plodnost pri ljudeh ni. Darifenacin ni vplival na plodnost samcev in samic pri podganah, prav tako ni vplival na spolne organe pri nobenem od obeh spolov pri podganah in psih (za podrobnosti glejte poglavje 5.3).
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).
Slovenian: Ocenili so, da je bila izpostavljenost nevezanemu darifenacinu 4,7-krat večja pri osebah z zmerno jetrno okvaro kot pri osebah z normalnim jetrnim delovanjem (glejte poglavje 4.2).
English: For those patients requiring greater symptom relief, the dose may be increased to 15 mg daily, based on individual response.
Slovenian: Za bolnike, ki potrebujejo večje lajšanje simptomov, je odmerek mogoče povečati na 15 mg na dan na podlagi posameznikovega odziva.
English: • certain antibiotics (e.g. erythromycin, clarithromycin and rifampicin),
Slovenian: • določene antibiotike (na primer eritromicin, klaritromicin in rifampicin),
English: Safety and efficacy have not yet been established in patients with a neurogenic cause for detrusor over activity.
Slovenian: Pri bolnikih z nevrogenim vzrokom čezmerne aktivnosti detruzorja varnosti in učinkovitosti še niso dokazali.
English: Darifenacin is excreted in the milk of rats.
Slovenian: Pri podganah darifenacin prehaja v mleko.
English: Due to genetic differences, about 7% of the Caucasians lack the CYP2D6 enzyme and are said to be poor metabolisers.
Slovenian: Zaradi genetskih razlik okrog 7 % belcev nima encima s CYP2D6 in zanje pravimo, da so osebe z upočasnjeno presnovo.
English: At steady state, peak-to-trough fluctuations in darifenacin concentrations are small (PTF: 0.87 for 7.5 mg and 0.76 for 15 mg), thereby maintaining therapeutic plasma levels over the dosing interval.
Slovenian: V stanju dinamičnega ravnovesja so nihanja med maksimalnimi in minimalnimi koncentracijami (PTF: peak-to-trough fluctuations) majhna (PTF: 0,87 pri 7,5 mg in 0,76 pri 15 mg), s čimer se vzdržuje terapevtska raven zdravila v plazmi v presledku med jemanjem posameznih odmerkov.
English: Emselex has been administered in clinical trials at doses up to 75 mg (five times maximum therapeutic dose).
Slovenian: V kliničnih preskušanjih so zdravilo Emselex uporabljali v odmerkih do 75 mg (ta odmerek je petkrat večji od največjega terapevtskega odmerka).
English: Treatment with Emselex may possibly mask symptoms associated with gallbladder disease.
Slovenian: Zdravljenje z zdravilom Emselex lahko včasih prikrije simptome, povezane z boleznimi žolčnika.
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.
Slovenian: Zdravilo Emselex je treba previdno uporabljati pri bolnikih s tveganjem za zmanjšano motiliteto prebavnega trakta, z gastroezofagealnim refluksom in/ali pri tistih, ki sočasno jemljejo zdravila (na primer peroralne difosfonate), ki lahko povzročijo ali poslabšajo ezofagitis.
English: The recommended starting dose is 7.5 mg daily.
Slovenian: Priporočeni začetni odmerek je 7,5 mg na dan.
English: • if you have severe constipation (less than or equal to 2 bowel movements per week).
Slovenian: • če ste zelo zaprti (če greste na blato največ dvakrat na teden),
English: INFORMATION IN BRAILLE Emselex 15 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Emselex 15 mg
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.
Slovenian: Kot kaže preglednica 2 spodaj, je združena analiza 3 od teh študij za zdravljenje z odmerki zdravila Emselex tako 7,5 mg kot 15 mg pokazala v primerjavi s placebom statistično značilno izboljšanje primarnega cilja opazovanja, to je zmanjšanje števila inkontinenčnih epizod.
English: Due to a greater contribution of CYP3A4 after higher darifenacin doses, the magnitude of the effect is expected to be even more pronounced when combining ketoconazole with darifenacin 15 mg.
Slovenian: Zaradi višjega prispevka CYP3A4 se pri odmerkih 15 mg darifenacina pričakuje še izrazitejši učinek le-tega v kombinaciji s ketokonazolom.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX)
Slovenian: PODATKI NA ZUNANJI OVOJNINI VMESNA ŠKATLA SKUPNEGA PAKIRANJA (BREZ “BLUE BOX” PODATKOV)
English: Doubling the darifenacin dose from 7.5 mg to 15 mg result in a 150% increase in steady-state exposure.
Slovenian: Podvojitev odmerka darifenacina s 7,5 mg na 15 mg je povzročila 150-odstotno zvečanje izpostavljenosti v stanju dinamičnega ravnovesja.
English: The interaction with midazolam lacks clinical relevance, and therefore no dose adjustment is needed for CYP3A4 substrates.
Slovenian: Medsebojno delovanje z midazolamom ni klinično pomembno, zato prilagajanje odmerkov substratov CYP3A4.
English: Emselex 7.5 mg once daily Placebo
Slovenian: Emselex 7,5 mg enkrat na dan placebo
English: Paediatric patients The pharmacokinetics of darifenacin have not been established in the paediatric population.
Slovenian: Pediatrični bolniki V pediatrični populaciji farmakokinetike darifenacina niso ugotavljali.
English: What Emselex is and what it is used for 2.
Slovenian: Kaj je zdravilo Emselex in za kaj ga uporabljamo 2.
English: Special patient population
Slovenian: Posebne skupine bolnikov
English: Table 2: Pooled analysis of data from three Phase III clinical studies assessing fixed doses of 7.5 mg and 15 mg Emselex
Slovenian: Preglednica 2: Združena analiza podatkov iz treh kliničnih študij faze III, s katerimi so ocenjevali stalne odmerke po 7,5 ali 15 mg zdravila Emselex odmerek
English: Darifenacin treatment resulted in a modest increase in the exposure of the CYP3A4 substrate midazolam.
Slovenian: Zdravljenje z darifenacinom je povzročilo zmerno zvečanje izpostavljenosti substratu CYP3A4 midazolamu.
English: Common (may affect up to 1 in 10 people) Headache, abdominal pain, indigestion, feeling sick, dry eyes, nasal dryness.
Slovenian: Pogosti (lahko se pojavijo pri največ 1 od 10 ljudi) Glavobol, bolečine v trebuhu, prebavne motnje, slabo počutje, suhe oči, suha nosna sluznica.
English: Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with overactive bladder syndrome.
Slovenian: Simptomatsko zdravljenje urgentne inkontinence in zvečane pogostnosti mokrenja ali obeh ter urgence (nenadne močne nuje po mokrenju) pri odraslih bolnikih s sindromom čezmerno aktivnega sečnega mehurja.
English: INFORMATION IN BRAILLE Emselex 7.5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Emselex 7,5 mg
English: What you need to know before you take Emselex 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Emselex 3.
English: However, a population pharmacokinetic analyses of Phase III data indicated that on average steady-state exposure is 66% higher in poor metabolisers than in extensive metabolisers.
Slovenian: Populacijska farmakokinetična analiza podatkov faze III je pokazala, da je izpostavljenost v stanju dinamičnega ravnovesja pri osebah z upočasnjeno presnovo povprečno za 66 % večja kot pri onih z obsežno presnovo.
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.
Slovenian: • če imate avtonomno nevropatijo (prizadetost živcev, ki prenašajo signale med možgani in notranjimi organi, mišicami, kožo in krvnimi žilami ter omogočajo regulacijo vitalnih funkcij,
English: Mild hepatic impairment had no effect on the pharmacokinetics of darifenacin.
Slovenian: Blaga jetrna okvara ni vplivala na farmakokinetiko darifenacina.
English: As with other antimuscarinics, patients should be instructed to discontinue Emselex and seek immediate medical attention if they experience oedema of the tongue or laropharynx, or difficulty breathing (see section 4.8).
Slovenian: Tako kot pri ostalih antimuskarinskih zdravilih je treba bolnike poučiti, naj v primeru otekanja jezika ali laringofarinksa ali težav pri dihanju (glejte poglavje 4.8) prenehajo jemati zdravilo Emselex in takoj poiščejo zdravniško pomoč.
English: The active substance is darifenacin.
Slovenian: Učinkovina je darifenacin.
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.
Slovenian: Zdravilo Emselex je v odmerkih 7,5 mg in 15 mg signifikantno zmanjšalo tako izraženost kot število urgentnih epizod in število mokrenj, medtem ko je signifikantno zvečalo povprečni izločeni volumen na mokrenje od začetnega stanja.
English: It is used in adults for the treatment of the symptoms of overactive bladder conditions - such as a sudden urge to rush to the toilet, needing to go to the toilet frequently and/or not getting to the toilet in time and wetting yourself (urge incontinence).
Slovenian: Z njim pri odraslih zdravimo simptome čezmerno aktivnega sečnega mehurja, kot so nenadna močna nuja po mokrenju, potreba po pogostem mokrenju ali urgentna urinska inkontinenca, pri kateri se pomočite, ker ne pridete pravočasno do stranišča.
English: • if you have an obstructive gastrointestinal disorder (any obstruction of the passage of intestinal or gastric contents, such as narrowing of the pylorus, the lower part of the stomach) - your doctor will have told you if you have this.
Slovenian: • če imate obstruktivno bolezen prebavil (kakršnokoli zaporo prehoda črevesne ali želodčne vsebine, na primer zoženje želodčnega vratarja v končnem delu želodca), za katero vam je že povedal vaš zdravnik,
English: The recommended starting dose for the elderly is 7.5 mg daily.
Slovenian: Priporočeni začetni odmerek za starejše je 7,5 mg na dan.
English: The effects of darifenacin on the metabolism of CYP2D6 substrates are mainly clinically relevant for CYP2D6 substrates which are individually dose titrated.
Slovenian: Učinki darifenacina na presnovo substratov CYP2D6 so v glavnem klinično pomembni za substrate CYP2D6, katerih odmerjanje je treba titrirati individualno.
English: 26-28, rue Edward Steichen L-2540 Luxembourg Tel: +352 26 37 58 78
Slovenian: Tel: +352 26 37 58 78
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.
Slovenian: Snovi, ki so induktorji CYP3A4, na primer rifampicin, karbamazepin, barbiturati in šentjanževka (Hypericum perforatum), bodo verjetno znižale plazemske koncentracije darifenacina.
English: Merus Labs Netherlands B.V., Alexander Battalaan 37
Slovenian: Merus Labs Netherlands B.V.
English: Emselex is not recommended for use in children below 18 years of age due to a lack of data on safety and efficacy.
Slovenian: Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Emselex pri otrocih pod 18 let ni priporočljiva.
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.
Slovenian: Sočasna uporaba darifenacina v odmerku 7,5 mg z močnim zaviralcem CYP3A4 ketokonazolom v odmerku 400 mg je povzročila petkratno zvečanje AUC darifenacina v stanju dinamičnega ravnovesja.
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.
Slovenian: To odvisnost od odmerka je verjetno povzročilo nasičenje presnove, katalizirane s CYP2D6, mogoče skupaj z delnim nasičenjem presnove v črevesni steni, posredovane s CYP3A4.
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
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.
Slovenian: Pogostnost neželenih učinkov se je pri odmerkih 7,5 mg in 15 mg zdravila Emselex med zdravljenjem, ki je trajalo do 6 mesecev, zmanjševala.
English: • if you have gastric retention (problems emptying the contents of the stomach).
Slovenian: • če imate zastoj v želodcu (težave pri praznjenju želodčne vsebine),
English: In the pivotal clinical trials with doses of Emselex 7.5 mg and 15 mg, adverse reactions were reported as presented in the table above.
Slovenian: V ključnih kliničnih preskušanjih z odmerki 7,5 mg in 15 mg zdravila Emselex so poročali o neželenih učinkih, kot so predstavljeni v zgornji preglednici.
English: • if you have difficulties in passing urine and a weak stream of urine.
Slovenian: • če imate težave pri odvajanju vode in šibek curek seča,
English: • antifungal medicines (e.g. ketoconazole and itraconazole),
Slovenian: • antimikotike (na primer ketokonazol in itrakonazol),
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.
Slovenian: Zdravilo Emselex je treba previdno dajati bolnikom z avtonomno nevropatijo, s hiatusno kilo, klinično pomembno zaporo odtekanja seča iz sečnega mehurja, s tveganjem za zastoj seča, s hudo zapeko ali z obstruktivnimi boleznimi prebavil, na primer s pilorično stenozo.
English: No dose adjustment is required in patients with impaired renal function.
Slovenian: Za bolnike z zmanjšanim ledvičnim delovanjem ni potrebno prilagajanje odmerjanja.
English: SPECIAL STORAGE CONDITIONS Keep the blister packs in the outer carton in order to protect from light.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Pretisne omote shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: How much Emselex to take
Slovenian: Koliko zdravila Emselex jemati
English: • certain antidepressants (e.g. imipramine),
Slovenian: • določene antidepresive (na primer imipramin),
English: Emselex should be used with caution in patients being treated for narrow-angle glaucoma (see section 4.3).
Slovenian: Zdravilo Emselex je treba previdno uporabljati pri bolnikih, ki se zdravijo zaradi glavkoma z zaprtim zakotjem (glejte poglavje 4.3).
English: The information below applies to subjects who have normal CYP2D6 activity (extensive metabolisers) unless otherwise stated.
Slovenian: Kjer ni navedeno drugače, veljajo spodnji podatki za osebe, ki imajo normalno aktivnost CYP2D6 (osebe z obsežno presnovo).
English: Calcium hydrogen phosphate, anhydrous
Slovenian: Jedro tablete brezvodni kalcijev hidrogenfosfat hipromeloza magnezijev stearat
English: If you forget to take Emselex
Slovenian: Če ste pozabili vzeti zdravilo Emselex
English: • Keep the blister packs in the outer carton in order to protect from light.
Slovenian: • Pretisne omote shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: The most common adverse reactions seen were dry mouth, constipation, headache, dyspepsia and nasal dryness.
Slovenian: Najpogostejši neželeni učinki, ki so jih opazili, so bili suha usta, zapeka, glavobol, dispepsija in izsušitev nosne sluznice.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF UNIT PACK
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA POSAMIČNEGA PAKIRANJA
English: How to take Emselex 4.
Slovenian: Kako jemati zdravilo Emselex 4.
English: Emselex may cause effects such as dizziness, blurred vision, trouble sleeping or drowsiness.
Slovenian: Zdravilo Emselex lahko povzroča učinke, kot so vrtoglavica, zamegljen vid, nespečnost ali zaspanost.
English: The other ingredients are calcium hydrogen phosphate (anhydrous), hypromellose, magnesium stearate, polyethylene glycol, titanium dioxide (E171) and talc.
Slovenian: Pomožne snovi so: brezvodni kalcijev hidrogenfosfat, hipromeloza, magnezijev stearat, polietilenglikol, titanov dioksid (E171) in smukec.