FrancophonIA/ELRC3.0 huggingface dataset:
English: This enables you to wait longer before you go to the toilet and it increases the amount of urine that your bladder can hold.
Slovenian: Omogoča, da lahko dalj časa počakate, preden greste na stranišče, in zveča količino seča, ki jo lahko drži vaš mehur.
English: 7 tablets 14 tablets 28 tablets 49 tablets 56 tablets 98 tablets
Slovenian: 7 tablet 14 tablet 28 tablet 49 tablet 56 tablet 98 tablet
English: Only a small percentage of the excreted dose was unchanged darifenacin (3%).
Slovenian: Le majhen odstotek izločenega odmerka je bil nespremenjeni darifenacin (3 %).
English: Differences from placebo1
Slovenian: razlike od placeba1
English: Multipack comprising 10 packs, each containing 14 tablets.
Slovenian: Skupno pakiranje obsega 10 škatel, od katerih vsaka vsebuje 14 tablet.
English: Patients experiencing these side effects should not drive or use machines.
Slovenian: Bolniki, ki imajo te stranske učinke, ne smejo voziti ali upravljati s stroji.
English: Therefore, it is important to keep taking Emselex correctly, as described above.
Slovenian: Zato je pomembno, da ves čas jemljete zdravilo Emselex pravilno, kot je opisano zgoraj.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 October 2004
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 22. oktober 2004
English: This is particularly important if you are taking any of the following as your doctor may need to adjust your dose of Emselex and/or the other medicine:
Slovenian: To je še posebno pomemebno, če jemljete katero od naslednjih zdravil, saj vam bo morda moral zdravnik spremeniti odmerek zdravila Emselex in/ali odmerek drugega zdravila:
English: Not known (frequency cannot be estimated from the available data) Depressed mood/mood alterations, hallucination.
Slovenian: Z neznano pogostnostjo (ni mogoče oceniti iz razpoložljivih podatkov) Depresivno razpoloženje/spremembe razpoloženja, halucinacije.
English: Date of latest renewal: 24 September 2009
Slovenian: Datum podaljšanja dovoljenja za promet: 24. september 2009
English: • Do not use this medicine after the expiry date which is stated on the carton and blister.
Slovenian: • Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu.
English: Children and adolescents Emselex is not recommended for use in children and adolescents (<18 years).
Slovenian: Otroci in mladostniki Uporaba zdravila Emselex pri otrocih in mladostnikih (<18 let) ni priporočljiva.
English: After 2 weeks of starting therapy, patients should be reassessed for efficacy and safety.
Slovenian: Dva tedna po začetku zdravljenja je treba bolnike ponovno oceniti glede učinkovitosti in varnosti zdravila.
English: Most of the adverse reactions were of mild or moderate intensity and did not result in discontinuation in the majority of the patients.
Slovenian: Večina je bila blagih ali zmernih in pri večini bolnikov ni povzročila prekinitve zdravljenja.
English: • if you are allergic to darifenacin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na darifenacin ali katerokoli sestavino tega zdravila (navedeno v poglavju 6),
English: Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with Emselex.
Slovenian: Druge vzroke pogostega mokrenja (popuščanje srca ali ledvične bolezni) je treba oceniti pred zdravljenjem z zdravilom Emselex.
English: It is not known whether this selectivity for the M3 receptor translates into any clinical advantage when treating symptoms of overactive bladder syndrome.
Slovenian: Ni znano, ali ta selektivnost za receptorje M3 pomeni pri zdravljenju simptomov sindroma čezmerno aktivnega sečnega mehurja kakšno prednost.
English: • if you have heart diseases.
Slovenian: • če imate srčno bolezen.
English: The adverse reactions are ranked under heading of frequency using the following convention: 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) and not known (cannot be estimated from the available data).
Slovenian: Pogostost neželenih učinkov: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: The steady-state volume of distribution (Vss) is estimated to be 163 litres.
Slovenian: Ocenjujejo, da je porazdelitveni volumen v stanju dinamičnega ravnovesja (Vss) 163 litrov.
English: Your doctor will tell you how long your treatment with Emselex will last.
Slovenian: Zdravnik vam bo povedal, kako dolgo naj traja vaše zdravljenje z zdravilom Emselex.
English: Do not stop treatment early because you do not see an immediate effect.
Slovenian: Ne prekinite ga prezgodaj, če ne boste opazili takojšnjega učinka.
English: However, no studies involving the interaction with antiparkinson agents and tricyclic antidepressants have been performed.
Slovenian: Vendar študij, ki bi obravnavale interakcije z antiparkinsoniki in tricikličnimi antidepresivi, niso opravili.
English: If you have not noticed any effect by then, discuss it with your doctor.
Slovenian: Če do tedaj ne boste opazili nikakršnega učinka, se o tem pogovorite z zdravnikom.
English: The observed differences from placebo for males in terms of percentage and absolute reductions in incontinence episodes was lower than for females.
Slovenian: Razlike glede na placebo, ki so jih našli pri moških, tako med odstotnim in absolutnim zmanjšanjem inkontinenčnih epizod, so bile manjše kot pri ženskah.
English: Anticholinergic effects, in general, are dose-dependent.
Slovenian: Antiholinergični učinki so na splošno odvisni od odmerka.
English: Component of a multipack, not to be sold separately.
Slovenian: Del skupnega pakiranja, ni namenjeno izdajanju posamično.
English: These doses are suitable for people with mild liver problems or people with kidney problems.
Slovenian: Navedeni odmerki so primerni za ljudi z blagimi jetrnimi težavami in za bolnike z ledvičnimi težavami.
English: When seeking medical advice, make sure that you take this leaflet and your remaining tablets with you to show them to the doctor.
Slovenian: Če potrebujete zdravniško pomoč, vzemite s seboj to navodilo in preostale tablete in jih pokažite zdravniku.
English: Estimated darifenacin clearance is 40 litres/hour.
Slovenian: Ocenjeni očistek darifenacina je 40 l/h.
English: Emselex with food and drink
Slovenian: Zdravilo Emselex skupaj s hrano in pijačo
English: Standard therapeutic prothrombin time monitoring for warfarin should be continued.
Slovenian: Nadaljevati je treba s standardnim terapevtskim spremljanjem protrombinskega časa.
English: Please also inform your doctor if you are taking products containing St John's wort.
Slovenian: Zdravniku povejte tudi, če jemljete pripravke, ki vsebujejo šentjanževko.
English: Darifenacin is a selective muscarinic M3 receptor antagonist (M3 SRA) in vitro.
Slovenian: Darifenacin je selektiven antagonist muskarinskih receptorjev M3 (M3 SRA) in vitro.
English: Finish the course of treatment prescribed by your doctor.
Slovenian: Dokončajte zdravilno kuro, ki vam jo je predpisal zdravnik.
English: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: Studies in animals have shown toxicity to parturition (for details, see section 5.3).
Slovenian: Študije na živalih so pokazale toksičnost za kotitev (za podrobnosti glejte poglavje 5.3).
English: Darifenacin is a lipophilic base and is 98% bound to plasma proteins (primarily to alpha-1-acidglycoprotein).
Slovenian: Darifenacin je lipofilna baza in se ga 98 % veže na plazemske beljakovine (predvsem na alfa-1-kisliglikoprotein).
English: Very common (may affect more than 1 in 10 people) Dry mouth, constipation.
Slovenian: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 ljudi) Suha usta, zapeka.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: If you have the impression that the effect of Emselex is too strong or too weak, talk to your doctor or pharmacist.
Slovenian: Če menite, da je učinek zdravila Emselex premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
English: If urinary tract infection is present, an appropriate antibacterial therapy should be started.
Slovenian: Če je prisotna okužba sečil, je treba uvesti ustrezno protibakterijsko zdravljenje.
English: • Do not use if the pack is damaged or shows signs of tampering.
Slovenian: • Ne uporabite zdravila, če je ovojnina poškodovana ali kaže znake, da jo je nekdo že odprl.
English: Caution should be used when prescribing antimuscarinics to patients with pre-existing cardiac diseases.
Slovenian: Previdnost je potrebna pri predpisovanju antimuskarinskih zdravil bolnikom, ki že imajo srčne bolezni.
English: Some side effects could be serious Serious allergic reactions including swelling, mainly of the face and throat.
Slovenian: Nekateri neželeni učinki so lahko resni Resne alergijske reakcije vključno z otekanjem, predvsem obraza in grla oziroma žrela.
English: The tablets are available in blister packs containing 7, 14, 28, 49, 56 or 98 tablets or in multipacks containing 140 (10x14) tablets.
Slovenian: Tablete so na voljo v pretisnih omotih po 7, 14, 28, 49, 56 ali 98 tablet ali v skupnem pakiranju, ki vsebuje 140 (10x14) tablet.
English: If any of these apply to you, tell your doctor before you take Emselex.
Slovenian: Če kaj od navedenega velja za vas, povejte to zdravniku, še preden boste vzeli zdravilo Emselex.
English: Therapeutic drug monitoring for digoxin should be performed when initiating and ending darifenacin treatment as well as changing the darifenacin dose.
Slovenian: Terapevtsko spremljanje digoksina je potrebno v začetku in ob koncu zdravljenja z darifenacinom, pa tudi ob spremembi odmerka darifenacina.
English: Therapeutic and supra-therapeutic doses of darifenacin resulted in no increase in QT/QTc interval prolongation from baseline compared to placebo at maximum darifenacin exposure.
Slovenian: Terapevtski in supraterapevtski odmerki darifenacina niso povzročili nikakršnega podaljšanja intervala QT/QTc od izhodišča v primerjavi s placebom pri maksimalni izpostavljenosti darifenacinu.
English: However, overdose with darifenacin can potentially lead to severe anticholinergic effects and should be treated accordingly.
Slovenian: Vendar lahko preveliki odmerki darifenacina potencialno povzročijo hude antiholinergične učinke, ki jih je treba ustrezno zdraviti.
English: 95% CI
Slovenian: 95 %-ni interval zaupanja vrednost
English: Patients with moderate hepatic impairment (Child Pugh B) should only be treated if the benefit outweighs the risk, and the dose should be restricted to 7.5 mg daily (see section 5.2).
Slovenian: Bolnike z zmernimi okvarami jeter (Child Pugh B) smemo zdraviti le, če korist odtehta tveganje, odmerek pa je treba omejiti na 7,5 mg na dan (glejte poglavje 5.2).
English: Pharmacotherapeutic group: Urologicals, drugs for urinary frequency and incontinence; ATC code: G04BD10.
Slovenian: Farmakoterapevtska skupina: Urološke snovi, zdravila za povečano pogostost uriniranja in inkontinenco, oznaka ATC: G04BD10
English: PHARMACEUTICAL FORM AND CONTENTS 140 tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 140 tablet
English: N-dealkylation of the pyrrolidine nitrogen.
Slovenian: N-dealkilacija pirolidinskega dušika.
English: The side effects caused by Emselex are usually mild and temporary.
Slovenian: Neželeni učinki, ki jih povzroča zdravilo Emselex, so navadno blagi in začasni.
English: After 2 weeks of starting therapy, patients should be reassessed.
Slovenian: Dva tedna po začetku zdravljenja je treba ponovno oceniti bolnikovo stanje.
English: Enzyme inducers
Slovenian: Encimski induktorji
English: A population pharmacokinetic analysis of patient data indicated that darifenacin exposure was 23% lower in males than females (see section 5.1).
Slovenian: Analiza populacijske farmakokinetike podatkov o bolnikih je pokazala, da je bila izpostavljenost darifenacinu pri moških za 23 % manjša kot pri ženskah (glejte poglavje 5.1).
English: Overdose with Emselex may lead to severe symptoms requiring emergency treatment in hospital.
Slovenian: Zaradi prevelikega odmerjanja zdravila Emselex lahko pride do resnih simptomov, zaradi katerih je potrebno urgentno zdravljenje v bolnišnici.
English: 6221 CB Maastricht The Netherlands
Slovenian: Alexander Battalaan 37 6221 CB Maastricht Nizozemska
English: A population pharmacokinetic analysis of patient data indicated a trend for clearance to decrease with age (19% per decade based on Phase III population pharmacokinetic analysis of patients aged 6089 years), see section 4.2.
Slovenian: Analiza populacijske farmakokinetike podatkov o bolnikih je pokazala trend zmanjševanja očistka s starostjo (19 % na dekado, na podlagi populacijske farmakokinetične analize faze III, bolnikov, starih 60-89 let), glejte poglavje 4.2.
English: The following events have been reported in association with darifenacin use in worldwide postmarketing experience: generalised hypersensitivity reactions including angioedema, depressed mood/mood alterations, hallucination.
Slovenian: V okviru postmarketinških izkušenj širom sveta so v povezavi z uporabo darifenacina poročali o naslednjih dogodkih: generalizirane preobčutljivostne reakcije vključno z angioedemom, z depresivnim razpoloženjem/spremembami razpoloženja in s halucinacijami.
English: The initial products of the hydroxylation and N-dealkylation pathways are major circulating metabolites but none contribute significantly to the overall clinical effect of darifenacin.
Slovenian: Začetni produkti hidroksilacije in N-dealkilacije so poglavitni presnovki, ki krožijo v krvi, od katerih pa nobeden pomembno ne prispeva k celotnemu kliničnemu učinku darifenacina.
English: Do not take Emselex:
Slovenian: Ne jemljite zdravila Emselex:
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Slovenian: V razvrstitvah pogostosti so neželeni učinki navedeni po padajoči resnosti.
English: Do not chew, split or crush it.
Slovenian: Tableto pogoltnite celo in je ne žvečite, ne delite niti ne drobite.
English: Maximum plasma levels are reached approximately 7 hours after administration of the prolonged-release tablets and steady-state plasma levels are achieved by the sixth day of administration.
Slovenian: Maksimalne plazemske koncentracije doseže približno 7 ur po zaužitju tablet s podaljšanim sproščanjem, ravnovesne plazemske koncentracije pa do šestega dne jemanja.
English: The effect of treatment with 15 mg and 75 mg of darifenacin on QT/QTc interval was evaluated in a study in 179 healthy adults (44% male: 56% females) aged 18 to 65 for 6 days (to steady state).
Slovenian: Učinek zdravljenja s 15 mg in 75 mg darifenacina na interval QT/QTc so ovrednotili v študiji, ki je trajala 6 dni (do stanja dinamičnega ravnovesja) in je vključevala 179 zdravih odraslih (44 % moških : 56 % žensk), starih od 18 do 65 let.
English: If you have any of these symptoms whilst taking Emselex, consult your doctor for advice on changing the dose or considering an alternative treatment.
Slovenian: Če imate v času jemanja zdravila Emselex katerega od teh simptomov, se z zdravnikom posvetujte o spremembi odmerka ali drugih možnostih zdravljenja.
English: • There are some medicines such as ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g. rheumatoid arthritis or atopic dermatitis), verapamil (a medicine used to lower blood pressure, to correct heart rhythm or to treat angina pectoris), antifungal medicines (e.g. ketoconazole and itraconazole) and some antiviral medicines (e.g. ritonavir) that must not be taken with Emselex.
Slovenian: • nekaterih zdravil, na primer ciklosporina (zdravila, ki ga uporabljamo po presaditvi za preprečevanje zavrnitve presadka in pri drugih boleznih, na primer pri revmatoidnem artritisu ali atopijskem dermatitisu), verapamila (zdravila, ki ga uporabljamo za zniževanje krvnega tlaka, za zdravljenje motenj srčnega ritma ali za zdravljenje angine pektoris), protiglivičnih zdravil (npr. ketokonazola in itrakonazola) in nekaterih protivirusnih zdravil (npr. ritonavirja) ne smete jemati z zdravilom Emselex.
English: If you have taken more tablets than you have been told to take, or if someone else accidentally takes your tablets, go to your doctor or hospital for advice immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Emselex, kot bi smeli Če ste vzeli več tablet, kot so vam naročili, ali če kdo drug nehote vzame vaše tablete, nemudoma odidite po nasvet k zdravniku ali v bolnišnico.
English: The elimination half-life of darifenacin following chronic dosing is approximately 13-19 hours.
Slovenian: Po kronični uporabi je razpolovni čas izločanja darifenacina približno 13-19 ur.
English: Cystometric studies performed with darifenacin in patients with involuntary bladder contractions showed increased bladder capacity, increased volume threshold for unstable contractions and diminished frequency of unstable detrusor contractions.
Slovenian: Cistometrične študije, ki so jih opravili z darifenacinom pri bolnikih z nehotenimi kontrakcijami sečnega mehurja, so po zdravljenju z njim pokazale zvečano zmogljivost sečnega mehurja, zvišan volumski prag za nestabilne kontrakcije in zmanjšano frekvenco nestabilnih kontrakcij detruzorja.
English: A similar trend is also seen for the discontinuation rates.
Slovenian: Podobno težnjo so ugotovili tudi za pogostnost prekinitve zdravljenja.
English: Women of child bearing potential should be made aware of the lack of fertility data, and Emselex should only be given after consideration of individual risks and benefits.
Slovenian: Ženske v rodnem obdobju je treba opozoriti, da podatkov o vplivu na plodnost ni in da se sme zdravilo Emselex jemati šele po razmisleku o tveganjih in koristih za posamezno bolnico.
English: The M3 receptor is the major subtype that controls urinary bladder muscle contraction.
Slovenian: Receptor M3 je poglavitna podvrsta, ki nadzira krčenje mišic sečnega mehurja.
English: Fatigue, accidental injury, facial swelling, high blood pressure, diarrhoea, flatulence, inflammation of the mucous membrane of the mouth, increased liver enzymes, swelling, dizziness, sleeplessness, drowsiness, abnormal thinking, runny nose (rhinitis), cough, shortness of breath, dry skin, itching, rash, sweating, visual disturbance including blurred vision, taste disturbance, urinary tract disorder or infection, impotence, discharge and itching in the vagina, bladder pain, inability to empty your bladder.
Slovenian: Občasni (lahko se pojavijo se pri največ 1 od 100 ljudi) Utrujenost, nezgodne poškodbe, otekanje obraza, visok krvni tlak, driska, vetrovi, vnetje ustne sluznice, zvišana raven jetrnih encimov, otekanje, vrtoglavost, nespečnost, zaspanost, motnje mišljenja, nahod (rinitis), kašelj, kratka sapa, suha koža, srbenje, izpuščaj, znojenje, motnje vida vključno z zamegljenim vidom, motnje čuta za okus, bolezen ali okužba sečil, impotenca, izcedek iz nožnice in srbenje v nožnici, bolečina v sečnem mehurju, nezmožnost praznjenja mehurja.
English: Emselex belongs to a class of medicines which relax the muscles of the bladder.
Slovenian: Zdravilo Emselex spada v skupino zdravil, ki sproščajo mišice sečnega mehurja.
English: 1 Hodges Lehmann estimate: median difference from placebo in change from baseline 2 Stratified Wilcoxon test for difference from placebo.
Slovenian: 1 Hodges-Lehmannova ocena: mediana razlika od placeba v spremembi od začetnega stanja 2 Stratificirani Wilcoxonov test za razliko od placeba.
English: In subjects who are poor metabolisers, darifenacin exposure increased approximately 10-fold.
Slovenian: Pri osebah z upočasnjeno presnovo se je izpostavljenost darifenacinu povečala približno desetkrat.
English: They can be taken with or without food, and must be swallowed whole and not chewed, divided or crushed.
Slovenian: Jemati jih je treba enkrat na dan s tekočino, lahko s hrano ali brez nje, bolnik jih mora pogoltniti cele, ne da bi jih žvečil, razdelil na več delov ali zdrobil.
English: Darifenacin was not teratogenic in rats and rabbits at doses up to 50 and 30 mg/kg/day, respectively.
Slovenian: Darifenacin ni bil teratogen pri podganah in pri kuncih, ki so jim dajali odmerke do 50 oziroma do 30 mg/kg/dan.
English: Clear PVC/CTFE/aluminium or PVC/PVDC/aluminium blisters in cartons containing 7, 14, 28, 49, 56 or 98 tablets as unit pack or in multipacks containing 140 (10x14) tablets.
Slovenian: Prozorni PVC/CTFE/aluminijevi ali PVC/PVDC/aluminijevi pretisni omoti v kartonskih škatlah, ki vsebujejo po 7, 14, 28, 49, 56 ali 98 tablet kot posamezno pakiranje ali skupno pakiranje, ki vsebuje 140 (10x14) tablet.
English: There are limited amount of data from the use of darifenacin in pregnant women.
Slovenian: O uporabi darifenacina pri nosečnicah je zelo malo podatkov.
English: Darifenacin 30 mg once daily (two times greater than the recommended daily dose) co-administered with digoxin at steady state resulted in a small increase in digoxin exposure (AUC: 16% and Cmax: 20%).
Slovenian: Darifenacin 30 mg enkrat na dan (to je dvakrat več od priporočenega dnevnega odmerka), dan sočasno z digoksinom, je v stanju dinamičnega ravnovesja povzročil majhno povečanje izpostavljenosti digoksinu (AUC: 16 % in Cmax: 20 %).
English: The three main metabolic routes are as follows: monohydroxylation in the dihydrobenzofuran ring; dihydrobenzofuran ring opening and
Slovenian: Tri poglavitne presnovne poti so: monohidroksilacija v dihidrobenzofuranskem obroču; odprtje dihidrobenzofuranskega obroča in
English: • certain medicines used to treat heart problems (e.g. flecainide, verapamil and digoxin),
Slovenian: • določena zdravila, ki se uporabljajo za zdravljenje težav s srcem (na primer flekainid, verapamil in digoksin),
English: • if you have myasthenia gravis (a disease marked by abnormal tiredness and weakness of selected muscles).
Slovenian: • če imate miastenijo gravis (bolezen, za katero sta značilni nenormalna utrujenost in šibkost nekaterih mišic),
English: A few percent of the population have increased CYP2D6 enzyme levels (ultrafast metabolisers).
Slovenian: Nekaj odstotkov prebivalstva ima zvišano raven encima s CYP2D6 (osebe z ultrahitro presnovo).
English: However, there is a risk of increased exposure in this population (see section 5.2).
Slovenian: Vendar obstaja pri tej skupini tveganje za večjo izpostavljenost zdravilu (glejte poglavje 5.2).
English: Darifenacin should not be used together with potent CYP3A4 inhibitors (see section 4.3) such as protease inhibitors (e.g. ritonavir), ketoconazole and itraconazole.
Slovenian: Darifenacin se ne sme uporabljati skupaj z močnimi zaviralci CYP3A4 (glejte poglavje 4.3), na primer s proteaznimi inhibitorji (npr. z ritonavirjem), s ketokonazolom in z itrakonazolom.
English: PHARMACEUTICAL FORM AND CONTENTS 14 tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 14 tablet
English: Consistent with the pharmacological profile, the most commonly reported adverse reactions were dry mouth (20.2% and 35% for the 7.5 mg and 15 mg dose, respectively, 18.7% after flexible dose titration, and 8% - 9% for placebo) and constipation (14.8% and 21% for the 7.5 mg and 15 mg dose, respectively, 20.9% after flexible dose titration, and 5.4% - 7.9% for placebo).
Slovenian: Skladno s farmakološkim profilom so bili neželeni učinki, o katerih so najpogosteje poročali, suha usta (20,2 % oziroma 35 % ob 7,5-miligramskem oziroma 15-miligramskem odmerku, 18,7 % ob prilagodljivem titriranju odmerka in 8 % - 9 % ob placebu) in zapeka (14,8 % oziroma 21 % ob 7,5-miligramskem oziroma 15-miligramskem odmerku, 20,9 % ob prilagodljivem titriranju odmerka in 5,4 % - 7,9 % ob placebu).