natgillin/translations-raw huggingface dataset:
Caution is advised if YENTREVE is co-administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone and metoprolol).
Savjetuje se oprez ako se YENTREVE primjenjuje istodobno s lijekovima koji se metaboliziraju prvenstveno pomoću CYP2D6 (risperidon, triciklički antidepresivi poput nortriptilina, amitriptilina i imipramina), naročito ako imaju uzak terapijski indeks (poput flekainida, propafenona i metoprolola).
The pharmacokinetics of duloxetine and its metabolites have not been studied in patients with mild or severe hepatic insufficiency.
Farmakokinetika duloksetina i njegovih metabolita nije ispitivana u bolesnica s blagom ni u bolesnica s teškom insuficijencijom jetre.
Each capsule may contain up to 37 mg sucrose.
Jedna kapsula može sadržavati do 37 mg saharoze.
The primary efficacy measures were Incontinence Episode Frequency (IEF) from diaries and an incontinence specific quality of life questionnaire score (I-QOL).
Primarne mjere ishoda djelotvornosti bile su učestalost epizoda inkontinencije (UEI) iz dnevnika i rezultat prema upitniku za procjenu kvalitete života uz inkontinenciju (engl.
If you have further questions on the use of this medicine, ask your doctor or pharmacist.
U slučaju bilo pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili ljekarniku.
CNS medicinal products: Caution is advised when YENTREVE is taken in combination with other centrally acting medicinal products or substances, including alcohol and sedative medicinal products (e.g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Lijekovi koji djeluju na središnji živčani sustav (SŽS): savjetuje se oprez kada se YENTREVE primjenjuje u kombinaciji s drugim lijekovima ili tvarima koje djeluju na SŽS, uključujući alkohol i sedative (npr. benzodiazepine, morfinomimetike, antipsihotike, fenobarbital, sedativne antihistaminike).
Duloxetine should be used with caution in patients treated with other medicinal products associated with hepatic injury.
Duloksetin se mora primjenjivati s oprezom u bolesnica koje se liječe drugim lijekovima koji mogu uzrokovati oštećenje jetre.
Cases of suicidal thoughts and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.8).
Prijavljeni su slučajevi suicidalnih misli i suicidalnog ponašanja tijekom terapije duloksetinom ili ubrzo nakon prekida liječenja (vidjeti dio 4.8).
YENTREVE hard gastro-resistant capsules contain sucrose.
YENTREVE tvrde želučanootporne kapsule sadrže saharozu.
Combined therapy (duloxetine + PFMT) showed greater improvement in both pad use and condition-specific quality of life measures than YENTREVE alone or PFMT alone.
Kombinirana terapija (duloksetin + jačanje mišića donjeg dijela zdjelice) pokazala je veće poboljšanje i u korištenju uložaka i u mjerama kvalitete života specifičnima za to stanje, nego liječenjem samo lijekom YENTREVE ili samo jačanjem mišića donjeg dijela zdjelice.
The initiation of treatment with YENTREVE is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis (see sections 4.4 and
Kontraindicirano je započeti liječenje lijekom YENTREVE u bolesnica s nekontroliranom hipertenzijom koje bolesnice može izložiti potencijalnom riziku od hipertenzivne krize (vidjeti dijelove 4.4 i 4.8).
6 Estimated frequency of post-marketing surveillance reported adverse reactions; not observed in placebo-controlled clinical trials.
6 Procijenjena učestalost nuspojava prijavljenih tijekom postmarketinškog praćenja, nisu uočene u placebom kontroliranim kliničkim ispitivanjima.
YENTREVE 40 mg is available in packs of 28, 56, 98 and 140 hard gastro-resistant capsules and in a multipack containing 196 (2 packs of 98) hard gastro-resistant capsules.
YENTREVE 40 mg dostupan je u pakiranjima od 28, 56, 98 i 140 tvrdih želučanootpornih kapsula te u višestrukom pakiranju koje sadrži 196 (2 pakiranja od 98) tvrdih želučanootpornih kapsula.
These symptoms may include floppy muscles, trembling, jitteriness, not feeding properly, trouble with breathing and fits.
Ovi simptomi mogu uključivati mlohave mišiće, drhtanje, nervozne pokrete, nepravilno hranjenje, teškoće pri disanju i napadaje.
How to take YENTREVE
Kako uzimati YENTREVE
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS (40 mg hard gastroresistant capsules)
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP (40 mg tvrde želučanootporne kapsule)
Symptoms of overdose include sleepiness, coma, serotonin syndrome (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits, vomiting and fast heart rate.
Simptomi predoziranja uključuju pospanost, komu, serotoninski sindrom (rijetka reakcija koja može uzrokovati osjećaj velike sreće, omamljenost, nespretnost, nemir, osjećaj poput opijenosti, vrućicu, znojenje ili ukočene mišiće), napadaje, povraćanje i ubrzan rad srca.
Discontinuation symptoms seen with duloxetine may include hypotonia, tremor, jitteriness, feeding difficulty, respiratory distress and seizures.
Simptomi prekida primjene lijeka primijećeni s duloksetinom mogu uključivati hipotoniju, tremor, nervozne pokrete, teškoće pri hranjenju, respiratorni distres i napadaje.
Combining YENTREVE with a pelvic floor muscle training (PFMT) programme may be more effective than either treatment alone.
Kombiniranje lijeka YENTREVE i programa vježbi za jačanje mišića donjeg dijela zdjelice moglo bi biti učinkovitije nego svako od tih dvaju liječenja zasebno.
Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing duloxetine in patients with increased intraocular pressure, or those at risk of acute narrowangle glaucoma.
Prijavljeni su slučajevi midrijaze povezani s duloksetinom te se stoga duloksetin mora s oprezom propisivati bolesnicama s povišenim intraokularnim tlakom i onima s rizikom od akutnog glaukoma uskog kuta.
98 hard gastro-resistant capsules.
98 tvrdih želučanootpornih kapsula.
• passing bright red blood in your stools, inflammation of the large intestine (leading to diarrhoea)
• svjetlocrvena krv u stolici, upala debelog crijeva (što dovodi do proljeva)
Gastric lavage may be indicated if performed soon after ingestion or in symptomatic patients.
Ispiranje želuca može biti indicirano ako se provede ubrzo nakon uzimanja lijeka ili u simptomatskih bolesnica.
What you need to know before you take YENTREVE DO NOT take YENTREVE if you:
Što morate znati prije nego počnete uzimati YENTREVE
Multipack: 196 (2 packs of 98 hard gastro-resistant capsules)
OBLIK I SADRŽAJ Višestruko pakiranje: 196 (2 pakiranja od 98) tvrdih želučanootpornih kapsula.
After an intravenous dose the plasma clearance of duloxetine ranges from 22 l/hr to 46 l/hr (mean of 36 l/hr).
Klirens duloksetina iz plazme nakon intravenske doze kreće se u rasponu od 22 l/h do 46 l/h (srednja vrijednost 36 l/h).
The use of YENTREVE while breastfeeding is not recommended.
Ne preporučuje se uzimanje lijeka YENTREVE za vrijeme dojenja.
YENTREVE 40 mg is available in packs of 28, 56, 98, 140 and 196 (2 x 98) capsules.
YENTREVE 40 mg dostupan je u pakiranjima od 28, 56, 98, 140 i 196 (2 x 98) kapsula.
After an oral dose the apparent plasma clearance of duloxetine ranges from 33 to 261 l/hr (mean 101 l/hr).
Prividni klirens duloksetina iz plazme nakon peroralne doze kreće se u rasponu od 33 do 261 l/h (srednja vrijednost 101 l/h).
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.
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
The efficacy of duloxetine 40 mg given twice daily in the treatment of SUI was established in four double-blind, placebo-controlled studies that randomised 1913 women (22 to 83 years) with SUI; of these, 958 patients were randomised to duloxetine and 955 to placebo.
Klinička djelotvornost i sigurnost Djelotvornost duloksetina danog 40 mg dvaput dnevno u liječenju SUI utvrđena je u četiri dvostruko slijepa, placebom kontrolirana ispitivanja u kojima je randomizirano 1913 žena (22 do 83 godina) sa SUI.
Medicinal products metabolised by CYP1A2: The pharmacokinetics of theophylline, a CYP1A2 substrate, were not significantly affected by co-administration with duloxetine (60 mg twice daily).
Lijekovi koji se metaboliziraju pomoću CYP1A2: nije bilo znatnijeg utjecaja na farmakokinetiku teofilina, koji je supstrat CYP1A2, prilikom istodobne primjene s duloksetinom (60 mg dva puta dnevno).
Elevated liver enzymes (ALT, AST, alkaline phosphatase) Acute liver injury
Poremećaji jetre i žuči hepatitis3 povišeni jetreni enzimi (ALT, AST, alkalna fosfataza)
pricking or tingling of the skin
uključujući obamrlost, bockanje ili trnci na koži
YENTREVE must not be used in women with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
Oštećenje jetrene funkcije YENTREVE se ne smije primjenjivati u žena s bolešću jetre čija je posljedica oštećenje jetrene funkcije (vidjeti dijelove 4.3 i 5.2).
These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with YENTREVE, you should see your doctor.
Ako primijetite bilo koji neuobičajen simptom dok uzimate neki od tih lijekova zajedno s lijekom YENTREVE, morate se javiti svom liječniku.
YENTREVE contains sucrose
YENTREVE sadrži saharozu
Quality of Life: Incontinence Quality of Life (I-QOL) questionnaire scores were significantly improved in the duloxetine-treated patient group compared with the placebo-treated group (9.2 versus 5.9 score improvement, p<0.001).
značajno su se poboljšali u skupini bolesnica liječenoj duloksetinom u usporedbi sa skupinom koja je primala placebo (poboljšanje od 9,2 naspram 5,9 bodova, p<0,001).
Talk to your doctor before you take Yentreve if you: - are taking medicines to treat depression (see ‘Other medicines and YENTREVE') - are taking St. John's Wort, a herbal treatment (Hypericum perforatum) - have kidney disease - have had seizures (fits) - have had mania - suffer from bipolar disorder - have eye problems, such as certain kinds of glaucoma (increased pressure in the eye) - have a history of bleeding disorders (tendency to develop bruises), especially if you are pregnant (see ‘Pregnancy and breast-feeding‘) - are at risk of low sodium levels (for example if you are taking diuretics, especially if you are elderly) - are currently being treated with another medicine which may cause liver damage.
- ako patite od bipolarnog poremećaja - ako imate probleme s očima poput određenih vrsta glaukoma (povišen očni tlak) - ako u povijesti bolesti imate poremećaje krvarenja (sklonost pojavi modrica), osobito ako ste trudni (pogledajte dio „Trudnoća i dojenje“) - ako imate rizik od pojave niskih razina natrija (na primjer, ako uzimate diuretike, osobito ako ste starija osoba)
YENTREVE 20 mg is available in packs of 28, 56 and 98 capsules.
YENTREVE 20 mg dostupan je u pakiranjima od 28, 56 i 98 kapsula.
How to store YENTREVE
Kako čuvati YENTREVE
Medicines that increase the level of serotonin: Triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), SNRIs (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, St John's Wort and MAOIs (such as moclobemide and linezolid).
Lijekovi koji povećavaju razinu serotonina: triptani, tramadol, triptofan, SSRI (poput paroksetina i fluoksetina), inhibitori ponovne pohrane serotonina i noradrenalina (poput venlafaksina) triciklički antidepresivi (poput klomipramina, amitriptilina), petidin, gospina trava i inhibitori MAO (poput moklobemida i linezolida).
clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits, sudden involuntary jerks or twitches of the muscles, sensation of restlessness or an inability to sit or stand still, difficulty controlling movement e.g. lack of coordination or involuntary movements of the muscles, restless legs syndrome
napadaji, iznenadno nevoljno treperenje ili trzaji mišića, osjećaj nemira ili nemogućnost mirnog sjedenja ili stajanja, teškoće pri kontroliranju pokreta npr. nedostatak koordinacije ili nevoljni pokreti mišića, sindrom nemirnih nogu
In pre/postnatal toxicity study in the rat, duloxetine induced adverse behavioural effects in the offspring at systemic exposure levels below maximum clinical exposure (AUC).
U ispitivanju pre/postnatalne toksičnosti u štakora duloksetin je izazvao štetne bihevioralne učinke u mladunčadi pri razinama sistemske izloženosti manjima od maksimalne kliničke izloženosti (AUC).
EU/1/04/280/001 (56 hard gastro-resistant capsules) EU/1/04/280/007 (28 hard gastro-resistant capsules) EU/1/04/280/008 (98 hard gastro-resistant capsules)
EU/1/04/280/001 (56 tvrdih želučanootpornih kapsula) EU/1/04/280/007 (28 tvrdih želučanootpornih kapsula) EU/1/04/280/008 (98 tvrdih želučanootpornih kapsula)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK INNER CARTON FOR 40 MG HARD GASTRO-RESISTANT CAPSULES (WITHOUT BLUE BOX)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA VIŠESTRUKOG PAKIRANJA TVRDIH ŽELUČANOOTPORNIH KAPSULA OD 40 MG (BEZ PLAVOG OKVIRA)
Edible ink: synthetic black iron oxide (E172), propylene glycol, shellac.
Jestiva tinta: sintetski crni željezov oksid (E172), propilenglikol, šelak.
Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).
Depresija je povezana s povećanim rizikom od suicidalnih misli,
No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/min).
U bolesnica s blagom ili umjerenom disfunkcijom bubrežne funkcije (klirens kreatinina 30 do 80 ml/min) nije potrebna prilagodba doze.
• vomiting blood, or black tarry stools (faeces), gastroenteritis, inflammation of the mouth, burping, difficulty swallowing, breaking wind, bad breath
• pojačano zijevanje • povraćanje krvi ili crna katranasta stolica (feces), gastroenteritis, upala usta, podrigivanje,
• difficulty to start urinating, painful urination, needing to pass urine during the night, frequent urination, abnormal urine odour
• otežan početak mokrenja, bolno mokrenje, potreba za mokrenjem tijekom noći, često mokrenje,
Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of YENTREVE in this age group have not yet been demonstrated.
YENTREVE na rast, sazrijevanje te intelektualni razvoj i razvoj ponašanja nisu još dokazani u ovoj dobnoj skupini.
If a decision to initiate antidepressant pharmacological therapy is taken, the gradual discontinuation of YENTREVE is recommended (see section 4.2).
Ako se donese odluka o uvođenju antidepresivne farmakološke terapije, preporučuje se postupan prekid liječenja lijekom YENTREVE
Capsule shell: gelatin, sodium lauryl sulfate, titanium dioxide (E171), indigo carmine (E132), red iron oxide and yellow iron oxide, edible black ink.
Ovojnica kapsule: želatina, natrijev laurilsulfat, titanijev dioksid (E171), indigo karmin (E132), crveni željezov oksid i žuti željezov oksid, jestiva crna tinta.
28 hard gastro-resistant capsules 56 hard gastro-resistant capsules 98 hard gastro-resistant capsules 140 hard gastro-resistant capsules
28 tvrdih želučanootpornih kapsula 56 tvrdih želučanootpornih kapsula 98 tvrdih želučanootpornih kapsula 140 tvrdih želučanootpornih kapsula
YENTREVE 20 mg YENTREVE 20 mg is available in packs of 28, 56 and 98 hard gastro-resistant capsules.
YENTREVE 20 mg YENTREVE 20 mg dostupan je u pakiranjima od 28, 56 i 98 tvrdih želučanootpornih kapsula.
YENTREVE contains sucrose.
YENTREVE sadrži saharozu.
• headache, dizziness, feeling sluggish, feeling sleepy, tremor, numbness, including numbness,
• glavobolja, omaglica, osjećaj tromosti, osjećaj pospanosti, nevoljno drhtanje, utrnulost,
YENTREVE and Pelvic Floor Muscle Training (PFMT): During a 12-week blinded, randomised, controlled study, YENTREVE demonstrated greater reductions in IEF compared with either placebo treatment or with PFMT alone.
YENTREVE i vježbe za jačanje mišića donjeg dijela zdjelice: tijekom 12-tjednog slijepog randomiziranog kontroliranog ispitivanja YENTREVE je doveo do većih smanjenja UEI-a u usporedbi s primjenom placeba ili primjenom samo jačanja mišića donjeg dijela zdjelice.
Multinucleated cells were seen in the liver in the absence of other histopathological changes in the rat carcinogenicity study.
ispitivanju kancerogenosti u štakora primijećene su multinuklearne stanice u jetri, ali ne i druge histopatološke promjene.
• excessive vaginal bleeding shortly after birth (postpartum haemorrhage)
• prekomjerno vaginalno krvarenje ubrzo nakon poroda (poslijeporođajno krvarenje) • padovi (najčešće u starijih ljudi), poremećen hod.
Food delays the time to reach the peak concentration from 6 to 10 hours and it marginally decreases the extent of absorption (approximately 11 %).
Hrana odgađa vrijeme do postizanja vršne koncentracije sa 6
The 40 mg capsules are orange and blue and are printed with '40 mg' and the code ‘9545'.
Kapsule od 40 mg su narančaste i plave boje s otisnutom oznakom „40 mg“ i oznakom „9545“.
56 hard gastro-resistant capsules 28 hard gastro-resistant capsules 98 hard gastro-resistant capsules
56 tvrdih želučanootpornih kapsula 28 tvrdih želučanootpornih kapsula 98 tvrdih želučanootpornih kapsula
Caution is advisable if YENTREVE is used concomitantly with serotonergic agents like SSRIs, SNRIs, tricyclic antidepressants like clomipramine or amitriptyline, MAOIs like moclobemide or linezolid, St John's wort (Hypericum perforatum) or triptans, tramadol, pethidine and tryptophan (see section 4.4).
YENTREVE primjenjuje istodobno sa serotoninergičkim lijekovima poput SSRI-ja, SNRI-ja, tricikličkih antidepresiva poput klomipramina ili amitriptilina, inhibitora MAO poput moklobemida ili linezolida, gospine trave (Hypericum perforatum) ili triptana, tramadola, petidina i triptofana (vidjeti dio 4.4).
The 20 mg capsules are blue and are printed with '20 mg' and the code ‘9544'.
Kapsule od 20 mg su plave boje s otisnutom oznakom „20 mg“ i oznakom „9544“.
Pharmacokinetic data on duloxetine is limited in patients with mild or moderate renal impairment.
Podaci o farmakokinetici duloksetina u bolesnica s blagim ili umjerenim oštećenjem bubrežne funkcije su ograničeni.
• Stevens-Johnson syndrome (serious illness with blistering of the skin, mouth, eyes and genitals),
• zatajenje jetre, žutilo kože ili bjeloočnica (žutica) • Stevens-Johnsonov sindrom (ozbiljna bolest sa stvaranjem mjehurića na koži, ustima, očima i genitalijama), ozbiljna alergijska reakcija koja uzrokuje oticanje lica ili grla (angioedem),
The efficacy of YENTREVE is reinforced when combined with a training program called Pelvic Floor Muscle Training (PFMT).
Djelotvornost lijeka YENTREVE dodatno se pospješuje u kombinaciji s programom vježbi za jačanje mišića donjeg dijela zdjelice.
Absorption: Duloxetine is well absorbed after oral administration with a Cmax occurring 6 hours post dose.
Apsorpcija: duloksetin se nakon peroralne primjene dobro apsorbira, pri čemu se Cmax postiže
Feeling abnormal Feeling cold Thirst
neuobičajeno osjećanje osjećaj hladnoće žeđ malaksalost osjećaj vrućine smetnje hoda
• suicidal behaviour, suicidal thoughts, mania (over activity, racing thoughts and decreased need for sleep), hallucinations, aggression and anger
• samoubilačko ponašanje, samoubilačke misli, manija (prekomjerna aktivnost, brze misli i smanjena potreba za spavanjem), halucinacije, agresivnost i bijes • "serotoninski sindrom" (rijetka reakcija koja može uzrokovati osjećaj velike sreće,
• weakness, shivering
• slabost, drhtanje
Black iron oxide - synthetic (E172) Propylene glycol
Jestiva tinta: željezov oksid, crni - sintetski (E172) propilenglikol šelak
Musculoskeletal and connective tissue disorders Musculo-skeletal pain
Poremećaji mišićno-koštanog sustava i vezivnog tkiva mišićno-koštana bol stezanje mišića spazam mišića trizmus trzanje mišića
The clinical benefit of YENTREVE compared with placebo has not been demonstrated in women with mild SUI, defined in randomised trials as those with IEF < 14 per week.
Klinička korist lijeka YENTREVE u usporedbi s placebom nije pokazana u žena s blagom
• muscle pain, muscle tightness, muscle spasm, contraction of the jaw muscle
• bol u mišićima, stezanje mišića, grčevi mišića, stezanje mišića čeljusti
EU/1/04/280/002(28 hard gastro-resistant capsules) EU/1/04/280/003 (56 hard gastro-resistant capsules) EU/1/04/280/004 (98 hard gastro-resistant capsules) EU/1/04/280/005 (140 hard gastro-resistant capsules)
EU/1/04/280/004 (98 tvrdih želučanootpornih kapsula) EU/1/04/280/005 (140 tvrdih želučanootpornih kapsula)
• decreased thyroid gland activity which can cause tiredness or weight gain
• smanjena aktivnost štitnjače koja može uzrokovati umor ili dobivanje na tjelesnoj težini
It is recommended that consideration be given to concomitant PFMT.
Preporučuje se razmotriti istodobno uvođenje programa jačanja mišića donjeg dijela zdjelice.
The efficacy of YENTREVE has not been evaluated for longer than 3 months in placebo-controlled studies.
U placebom kontroliranim ispitivanjima djelotvornost lijeka YENTREVE nije ocijenjena za razdoblje dulje od 3 mjeseca.
The pharmacokinetics of duloxetine demonstrate large intersubject variability (generally 50-60%), partly due to gender, age, smoking status and CYP2D6 metaboliser status.
Farmakokinetika duloksetina pokazuje veliku interindividualnu varijabilnost (općenito 50-60%),
Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on haemodialysis (creatinine clearance <30 ml/min).
Oštećenje bubrežne funkcije U bolesnica s teškim oštećenjem bubrežne funkcije (klirens kreatinina < 30 ml/min) koje su na hemodijalizi koncentracije duloksetina u plazmi su povećane.
• abnormal periods, including heavy, painful, irregular or prolonged periods, unusually light or missed periods, abnormal production of breast milk
• nenormalne mjesečnice, uključujući obilne, bolne, neredovite ili produljene mjesečnice,
Dizziness, sensory disturbances (including paraesthesia or electric shock-like sensations, particularly in the head), sleep disturbances (including insomnia and intense dreams), fatigue, somnolence, agitation or anxiety, nausea and/or vomiting, tremor, headache, myalgia, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions.
Najčešće prijavljene reakcije su omaglica, senzorni poremećaji (uključujući paresteziju ili osjete nalik elektrošoku, osobito u glavi), poremećaji spavanja (uključujući nesanicu i intenzivne snove), umor, somnolencija, agitacija ili anksioznost, mučnina i/ili povraćanje, tremor, glavobolja,
• difficulty or inability to pass urine, needing to pass more urine than normal, having a decreased urine flow
• otežano ili nemogućnost mokrenja, pojačana potreba za mokrenjem, smanjen protok mokraće
Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN).
Epidemiološki podaci pokazali su da primjena SSRI-a u trudnoći, osobito u visokom stupnju trudnoće,
No malformations were observed in another study testing a higher dose of a different salt of duloxetine.
U drugom ispitivanju u kojem se ispitivala viša doza različite soli duloksetina nisu uočene malformacije.
See section 4.2 for information on patients with mild or moderate renal dysfunction.
Za bolesnice s teškim oštećenjem bubrežne funkcije vidjeti dio 4.3. Vidjeti dio 4.2 za informacije o bolesnicama s blagim ili umjerenim poremećajem bubrežne funkcije.
YENTREVE 20 mg hard gastro-resistant capsules Duloxetine
YENTREVE 20 mg tvrde želučanootporne kapsule duloksetin