natgillin/translations-raw huggingface dataset:
The pattern of liver damage is predominantly hepatocellular with increased serum transaminases, which usually return to normal levels on cessation of agomelatine.
Pojav poškodb jeter je večinoma hepatocelularen, pri čemer se zvišane aminotransferaze v serumu običajno vrnejo na normalne vrednosti ob ukinitvi agomelatina.
Calendar packs of 100 film-coated tablets for hospital use.
Koledarska pakiranja s 100 filmsko obloženimi tabletami za bolnišnično uporabo.
Agomelatine was not compared directly with paroxetine and fluoxetine as these comparators where added in order to ensure assay sensitivity of the trials.
Agomelatina niso primerjali neposredno s paroksetinom ali fluoksetinom, ker sta bili ti primerjalni zdravili dodani zaradi zagotavljanja občutljivosti analize v preskušanjih.
No effect of agomelatine is documented in patients ≥75 years, therefore agomelatine should not be used by patients in this age group (see also sections 4.2 and 5.1).
Pri bolnikih ≥ 75 let učinka agomelatina niso dokazali, zato se agomelatin pri bolnikih v tej starostni skupini ne sme uporabljati (glejte tudi poglavji 4.2 in 5.1).
If Valdoxan is initiated while tapering the dosage of the previous medicine, possible discontinuation symptoms should not be confounded with a lack of early effect of Valdoxan.
Če vam bodo zdravilo Valdoxan uvedli že v času zmanjševanja odmerka prejšnjega zdravila, možnih odtegnitvenih simptomov ne smete zamenjati z odsotnostjo zgodnjega učinka zdravila Valdoxan.
There is no relevant use of agomelatine in children from birth to 2 years for treatment of major depressive episodes.
Agomelatin ni primeren za uporabo pri otrocih, od rojstva do starosti 2 let, za zdravljenje velikih depresivnih epizod.
Other medicines and Valdoxan
Druga zdravila in zdravilo Valdoxan
Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free of symptoms.
Bolnike z depresijo morate zdraviti dovolj časa, to je najmanj 6 mesecev, da se zagotovi odsotnost simptomov.
Be vigilant about signs and symptoms that your liver may not be working properly - If you observe any of these signs and symptoms of liver problems: unusual darkening of the urine, light coloured stools, yellow skin/eyes, pain in the upper right belly, unusual fatigue (especially associated with other symptoms listed above), seek urgent advice from a doctor who may advise you to stop taking Valdoxan.
Bodite pozorni na znake in simptome, ki kažejo na morebitno nepravilno delovanje vaših jeter - Če opazite katere koli znake in simptome težav z jetri: neobičajno temen urin, svetlo obarvanje blata, rumena koža/oči, bolečina v zgornjem desnem delu trebuha, neobičajna utrujenost (še posebno, če je povezana z drugimi simptomi, navedenimi zgoraj), nujno poiščite pomoč zdravnika, ki vam bo morda svetoval prenehanje zdravljenja z zdravilom Valdoxan.
Ethnic groups
Etnična pripadnost
Agomelatine has no abuse potential as measured in healthy volunteer studies on a specific visual analogue scale or the Addiction Research Center Inventory (ARCI) 49 check-list.
Agomelatin nima potenciala za zlorabo, kar so dokazali v študijah pri zdravih prostovoljcih z namensko vizualno analogno lestvico ali vprašalnikom Centra za raziskave odvisnosti (ARCI-49).
At higher doses, a saturation of the first-pass effect occurs.
Ob večjih odmerkih se pojavi zasičenost učinka prvega prehoda preko jeter.
Any patient who develops increased serum transaminases should have his/her liver function tests repeated within 48 hours.
Če pri kateremkoli bolniku opazite zvišanje aminotransferaz v serumu, je treba pregled delovanja jeter ponoviti v 48 urah.
Therefore, agomelatine should not be used by patients in this age group (see sections 4.4 and 5.1).
Agomelatin se zato v tej starostni skupini bolnikov ne sme uporabljati (glejte poglavji 4.4 in 5.1).
Treatment discontinuation No dosage tapering is needed on treatment discontinuation.
Prekinitev zdravljenja Ob prekinitvi zdravljenja odmerka ni potrebno postopoma zmanjševati.
Therefore, agomelatine will not modify exposure to medicinal products metabolised by CYP 450.
Agomelatin zato ne vpliva na izpostavljenost zdravilom, ki se presnavljajo preko CYP450.
During treatment transaminases should be monitored periodically after around three weeks, six weeks (end of acute phase), twelve weeks and twenty four weeks (end of maintenance phase) and thereafter when clinically indicated (see also section 4.4).
Med zdravljenjem je treba redno spremljati vrednosti aminotransferaz, po približno 3 tednih, 6 tednih (na koncu akutne faze), 12 tednih in 24 tednih (na koncu vzdrževalne faze) ter pozneje, ko je to klinično indicirano (glejte tudi poglavje 4.4).
Agomelatine has shown an antidepressant-like effect in animal models of depression (learned helplessness test, despair test, chronic mild stress) as well as in models with circadian rhythm desynchronisation and in models related to stress and anxiety.
Agomelatin je imel antidepresivom soroden učinek pri živalskih modelih depresije (test priučene nebogljenosti, test obupanosti, kroničen blag stres), desinhronizacije cirkadianega ritma ter stresa in anksioznosti.
- If you have increased levels of liver enzymes before treatment, your doctor will decide if Valdoxan is right for you.
- Če imate pred zdravljenjem zvišane vrednosti jetrnih encimov, bo vaš zdravnik odločil, ali je zdravilo Valdoxan primerno za vas.
Some patients may get increased levels of liver enzymes in their blood during treatment with Valdoxan.
Pri nekaterih bolnikih se lahko vrednosti jetrnih encimov med jemanjem zdravila Valdoxan zvišajo.
Hallucinations*
redki halucinacije*
Following discontinuation of Valdoxan therapy liver function tests should be repeated until serum transaminases return to normal.
Po prekinitvi zdravljenja z zdravilom Valdoxan morate delovanje jeter pregledovati dokler se aminotransferaze v serumu ne vrnejo na normalne vrednosti.
Adverse reactions are listed below 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
Neželeni učinki so našteti po naslednji razvrstitvi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100, < 1/10),
It is not known whether agomelatine/metabolites are excreted in human milk.
Dojenje Ni znano, ali se agomelatin/presnovki izločajo v materino mleko.
INFORMATION IN BRAILLE Valdoxan 25 mg
PODATKI V BRAILLOVI PISAVI Valdoxan 25 mg
The recommended dose is 25 mg once daily taken orally at bedtime.
Odmerjanje Priporočeni odmerek je 25 mg enkrat na dan peroralno pred spanjem.
5 How to store Valdoxan Contents of the pack and other information
Shranjevanje zdravila Valdoxan Vsebina pakiranja in dodatne informacije
Valdoxan starts to act on symptoms of depression in most depressed people within two weeks of starting treatment.
Pri večini bolnikov zdravilo Valdoxan začne zmanjševati simptome depresije v dveh tednih po začetku zdravljenja.
Valdoxan should not be used for the treatment of major depressive episodes in elderly patients with dementia since the safety and efficacy of Valdoxan have not been established in these patients.
Uporaba pri starejših z demenco Zdravila Valdoxan ne smete predpisovati za zdravljenje velikih depresivnih epizod pri starejših bolnikih z demenco, ker varnosti in učinkovitosti zdravila Valdoxan pri tovrstnih bolnikih niso proučevali.
The variability is increased with high fat food.
Ob živilih z veliko maščobami se zveča variabilnost.
If your doctor changes your previous antidepressant medicine from an SSRI or SNRI to Valdoxan, he/she will advise you on how you should discontinue your previous medicine when starting Valdoxan.
Če vam bo zdravnik zamenjal vaš prejšnji antidepresiv iz skupine SSRI ali SNRI z zdravilom Valdoxan, vam bo ob uvedbi zdravila Valdoxan svetoval o ustreznem načinu prenehanja zdravljenja s prejšnjim zdravilom.
Increased ALT and/or AST (in clinical trials, increases >3 times the upper limit of the normal range for ALT and/or AST were seen in 1.2% of patients on agomelatine 25 mg daily and 2.6 % on agomelatine 50 mg daily vs. 0.5% on placebo).
Bolezni jeter, žolčnika in žolčevodov pogosti zvišani ALT in/ali AST (v kliničnih preskušanjih so zvišanja za > 3-kratno zgornjo mejo normalnih vrednosti ALT in/ali AST opazili pri 1,2 % bolnikov, zdravljenih s 25 mg agomelatina, ter 2,6 % bolnikov, zdravljenih s 50 mg agomelatina, v primerjavi z 0,5 % bolnikov, ki so prejemali placebo)
No improvement was observed in very elderly patients (≥75 years, N= 69, of which 48 on agomelatine).
Pri najstarejših bolnikih (≥ 75 let, N=69, 48 od bolnikov je prejemalo agomelatin) ni bilo opaznega izboljšanja.
- obesity/overweight/non-alcoholic fatty liver disease, diabetes
- debelost/prekomerna telesna masa/zamaščenost jeter nealkoholnega izvora, sladkorna bolezen,
The symptoms of depression vary from one person to another, but often include deep sadness, feelings of worthlessness, loss of interest in favourite activities, sleep disturbances, feeling of being slowed down, feelings of anxiety, changes in weight.
Simptomi depresije se razlikujejo od bolnika do bolnika, pogosto pa zajemajo globoko žalost, občutek ničvrednosti, izgubo zanimanja za priljubljene dejavnosti, motnje spanja, občutek upočasnjenosti, občutek tesnobe in spremembe telesne mase.
After two weeks of treatment, if there is no improvement of symptoms, the dose may be increased to 50 mg once daily, i.e. two 25 mg tablets, taken together at bedtime.
Če se simptomi ne izboljšajo, lahko po 2 tednih zdravljenja odmerek zvečate na 50 mg enkrat na dan,
In depressed patients, treatment with agomelatine 25 mg increased slow wave sleep without modification of REM (Rapid Eye Movement) sleep amount or REM latency.
Pri bolnikih z depresijo je zdravljenje z agomelatinom v odmerku 25 mg podaljšalo spanje s počasnimi valovi, brez vpliva na fazo spanja REM (Rapid Eye Movement) ali na čas do njenega nastopa.
Binding studies indicate that agomelatine has no effect on monoamine uptake and no affinity for α, β adrenergic, histaminergic, cholinergic, dopaminergic and benzodiazepine receptors.
Študije o vezavi so pokazale, da agomelatin nima učinka na privzem monoaminov niti afinitete za α-adrenergične, β-adrenergične, histaminske, holinergične, dopaminergične ali benzodiazepinske receptorje.
Effect of Valdoxan is not documented in patients aged 75 years and older.
Učinka zdravila Valdoxan pri bolnikih starih 75 let in več niso dokazali.
The below table gives the adverse reactions observed from placebo-controlled and active-controlled clinical trials.
V spodnji preglednici so navedeni neželeni učinki, ki so jih opažali v kliničnih preskušanjih, nadzorovanih s placebom ali učinkovino.
Caution should be exercised before starting treatment and close surveillance should be performed throughout the treatment period in all patients, especially if hepatic injury risk factors or concomitant medicinal products associated with risk of hepatic injury are present.
Pred uvedbo zdravljenja je potrebna previdnost, med zdravljenjem pa morate posebej skrbno nadzirati vse bolnike, zlasti tiste, ki imajo prisotne dejavnike tveganja za poškodbo jeter ali sočasno jemljejo zdravila, ki jih spremlja tveganje za poškodbe jeter.
Agomelatine passes into the placenta and foetuses of pregnant rats.
Agomelatin prehaja v placento in fetuse pri brejih podganah.
You might experience dizziness or sleepiness which could affect your ability to drive or operate machines.
Vpliv na sposobnost upravljanja vozil in strojev Morda boste občutili omotico ali zaspanost, ki lahko vplivata na vašo sposobnost upravljanja vozil in strojev.
Medicinal products that interact with these isoenzymes may decrease or increase the bioavailability of agomelatine.
Zdravila, ki medsebojno delujejo z naštetimi izoencimi, lahko zvečujejo ali zmanjšujejo biološko uporabnost agomelatina.
No effect of agomelatine on juvenile animals behavioural performances, visual and reproductive function were observed.
Vpliva agomelatina na vedenjsko sposobnost, vidno in razmnoževalno funkcijo pri živalih v juvenilnem obdobju niso opazili.
Responder rate analysis favoured agomelatine.
Analiza stopenj odziva je pokazala prednost agomelatina.
Valdoxan with alcohol
Zdravilo Valdoxan skupaj z alkoholom
Hepatic impairment Agomelatine is contraindicated in patients with hepatic impairment (see sections 4.3, 4.4 and 5.2).
Agomelatin je pri bolnikih z jetrno okvaro kontraindiciran (glejte poglavja 4.3, 4.4 in 5.2).
• lactose monohydrate, maize starch, povidone (K30), sodium starch glycolate type A, stearic acid, magnesium stearate, colloidal anhydrous silica,hypromellose, glycerol, macrogol (6000), yellow iron oxide (E172) and titanium dioxide (E171).
- Pomožne snovi so: - laktoza monohidrat, koruzni škrob, povidon (K30), natrijev karboksimetilškrob (vrsta A), stearinska kislina, magnezijev stearat, brezvoden koloidni silicijev dioksid, hipromeloza, glicerol, makrogol (6000), rumeni železov oksid (E172) in titanov dioksid (E171);
While there was no specific safety signal in the 800 patients treated in combination with oestrogens, caution should be exercised when prescribing agomelatine with other moderate CYP1A2 inhibitors (e.g. propranolol, enoxacin) until more experience has been gained (see section 4.4).
Čeprav pri 800 bolnikih, ki so sočasno jemali estrogene, niso zasledili specifičnih varnostnih opozoril, morate biti previdni, ko predpisujete agomelatin z drugimi zmernimi zaviralci CYP1A2 (npr. propranololom, enoksacinom), dokler ne bo na voljo več izkušenj
No evidence of pharmacokinetic or pharmacodynamic interaction with medicinal products which could be prescribed concomitantly with Valdoxan in the target population was found in phase I clinical trials: benzodiazepines, lithium, paroxetine, fluconazole and theophylline.
V kliničnih preskušanjih faze I niso opazili dokazov o farmakokinetičnem ali famakodinamičnem medsebojnem delovanju zdravila Valdoxan z zdravili, ki jih sočasno predpisujemo pri ciljni skupini bolnikov: benzodiazepini, litijem, paroksetinom, flukonazolom in teofilinom.
Weight decreased* * Frequency estimated from clinical trials for adverse reactions detected from spontaneous report (1) Few cases were exceptionally reported with fatal outcome or liver transplantation in patients with hepatic risk factors.
*frekvenca neželenih učinkov spontanih poročil ocenjena na podlagi kliničnih preskušanj (1) pri bolnikih s prisotnimi dejavniki tveganja za poškodbo jeter so izjemoma poročali o nekaj primerih s smrtnim izidom ali transplantacijo jeter.
Do not take Valdoxan - if you are allergic to agomelatine or any of the other ingredients of this medicine (listed in section
Kaj morate vedeti, preden boste vzeli zdravilo Valdoxan Ne jemljite zdravila Valdoxan - če ste alergični na agomelatin ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
Valdoxan is indicated for the treatment of major depressive episodes in adults.
4.1 Terapevtske indikacije Zdravilo Valdoxan je indicirano za zdravljenje velikih depresivnih epizod pri odraslih.
Each film-coated tablet contains 25 mg of agomelatine.
Ena filmsko obložena tableta vsebuje 25 mg agomelatina.
In vivo, agomelatine does not induce CYP450 isoenzymes.
In vivo, agomelatin ne spodbuja izoencimov CYP450.
Primary endpoint was change in HAMD-17 score from baseline.
Primarni izid je bila sprememba izhodiščnega seštevka po Hamiltonovi ocenjevalni lestvici za depresijo HAMD-17.
Reproduction studies in the rat and the rabbit showed no effect of agomelatine on fertility, embryofoetal development and pre- and post natal development.
Študije o razmnoževanju pri podganah in kuncih niso pokazale učinka agomelatina na plodnost, razvoj zarodka ali ploda in predporodni ter poporodni razvoj.
When treatment was switched from these antidepressants to agomelatine, discontinuation symptoms arose after cessation of the SSRI or SNRI treatment, either after abrupt cessation or gradual cessation of the previous treatment.
Ob menjavi zdravljenja z omenjenih antidepresivov na agomelatin, so se po prenehanju zdravljenja s SSRI ali SNRI pojavili odtegnitveni simptomi, ki so se pojavili bodisi po nenadnem bodisi po postopnem prenehanju zdravljenja s prejšnjim zdravilom.
Confusional state*
stanje zmedenosti*
4.4 Special warnings and precautions for use
4.4 Posebna opozorila in previdnostni ukrepi Spremljanje delovanja jeter
Agomelatine 25 mg also induced an advance of the time of sleep onset and of minimum heart rate.
Agomelatin v odmerku 25 mg je tudi premaknil nastop spanja in najmanjše srčne frekvence na zgodnejšo uro.
Superiority (2 trials) or non-inferiority (4 trials) has been shown in six out of seven efficacy trials in heterogeneous populations of depressed adult patients versus SSRI/SNRI (sertraline, escitalopram, fluoxetine, venlafaxine or duloxetine) The anti-depressive effect was assessed with the HAMD-17 score either as primary or secondary endpoint.
Superiornost (2 preskušanji) ali neinferiornost (4 preskušanja) napram SSRI/SNRI (setralinu, escitalopramu, fluoksetinu, venlafaksinu ali duloksetinu) je bila dokazana v šestih od sedmih preskušanj učinkovitosti v heterogeni populaciji odraslih bolnikov z depresijo.
In a specific sexual dysfunction comparative trial with remitted depressed patients, there was a numerical trend (not statistically significant) towards less sexual emergent dysfunction than venlafaxine for Sex Effects Scale (SEXFX) drive arousal or orgasm scores on agomelatine.
Pri bolnikih z remisijo depresije je specifično primerjalno preskušanje o spolni disfunkciji pokazala težnjo, ki sicer ni bila statistično značilna, k manjšemu številu novonastalih spolnih motenj pri agomelatinu v primerjavi z venlafaksinom pri seštevkih točk, povezanih z libidom, vzburjenjem in orgazmi, merjenih po lestvici spolnih učinkov (SEXFX - Sex Effects Scale).
Ten placebo controlled trials have been performed to investigate the short term efficacy of agomelatine in major depressive disorder in adults, with fixed dose and/or dose up-titration.
Da bi proučili kratkoročno učinkovitost agomelatina pri velikih depresivnih epizodah, so izvedli deset s placebom nadzorovanih preskušanj pri odraslih, s stalnimi odmerki in/ali povečevanjem odmerka.
Baseline liver function tests should be undertaken in all patients and treatment should not be initiated in patients with baseline values of ALT and/or AST >3 X upper limit of normal (see section 4.3).
Pred začetkom zdravljenja je treba pri vseh bolnikih pregledati delovanje jeter, zdravljenja pa ne smete uvesti bolnikom z izhodiščnimi vrednostmi ALT in/ali AST > 3-kratno zgornjo mejo normalnih vrednosti (glejte poglavje 4.3).
A battery of in vitro and in vivo standard genotoxicity assays concludes to no mutagenic or clastogenic potential of agomelatine.
Serija standardnih genotoksičnih analiz in vitro ter in vivo je dokazala, da agomelatin nima mutagenega ali klastogenega potenciala.
The Summary of Product Characteristics;
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Smoking induces CYP1A2 and has been shown to decrease the bioavailability of agomelatine, especially in heavy smokers (> 15 cigarettes/day) (see section 5.2).
Pokazali so, da zmanjša biološko uporabnost agomelatina, še posebno pri težkih kadilcih (≥ 15 cigaret/dan) (glejte poglavje 5.2).
In a trial designed to assess discontinuation symptoms by the Discontinuation Emergent Signs and Symptoms (DESS) check-list in patients with remitted depression, agomelatine did not induce discontinuation syndrome after abrupt treatment cessation.
(DESS - Discontinuation Emergent Signs and Symptoms) ocenjevali odtegnitvene simptome pri bolnikih z remisijo depresije, agomelatin ni povzročal odtegnitvenega sindroma po nenadni prekinitvi zdravljenja.
What Valdoxan contains - The active substance is agomelatine.
Kaj vsebuje zdravilo Valdoxan - Učinkovina je agomelatin.
- When increasing the dosage, liver function tests should again be performed at the same frequency as when initiating treatment.
- Ob povečanju odmerka je treba jetrne teste znova izvajati v enakih razmakih kot ob uvedbi zdravljenja.
(<1/10,000), not known (cannot be estimated from the available data).
občasni (≥ 1/1.000, < 1/100), redki (≥ 1/10.000, < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Available pharmacodynamic/toxicological data in animals have shown excretion of agomelatine/metabolites in milk (see section 5.3).
toksikološki podatki pri živalih kažejo na izločanje agomelatina/presnovkov v mleko (glejte poglavje 5.3).
Rifampicin an inducer of all three cytochromes involved in the metabolism of agomelatine may decrease the bioavailability of agomelatine.
Rifampicin kot spodbujevalec vseh treh citokromov, ki so vpleteni v presnovo agomelatina, lahko zmanjša biološko uporabnost agomelatina.
Hepatic impairment (i.e. cirrhosis or active liver disease) or transaminases exceeding 3 X upper limit of normal (see sections 4.2 and 4.4).
Jetrna okvara (na primer ciroza ali aktivna bolezen jeter) ali zvišanje aminotransferaz nad 3-kratno zgornjo mejo normalnih vrednosti (glejte poglavji 4.2 in 4.4).
Fluvoxamine, a potent CYP1A2 and moderate CYP2C9 inhibitor markedly inhibits the metabolism of agomelatine resulting in a 60-fold (range 12-412) increase of agomelatine exposure.
Fluvoksamin, močan zaviralec CYP1A2 in zmeren zaviralec CYP2C9, izrazito zavira presnovo agomelatina, zaradi česar se izpostavljenost agomelatinu zveča za 60-krat (razpon: 12-krat do
Your doctor will run laboratory tests to check that your liver is working properly before starting treatment and then periodically during treatment, usually after 3 weeks, 6 weeks, 12 weeks and 24 weeks.
Spremljanje delovanja jeter (glejte tudi poglavje 2) Zdravnik bo opravil laboratorijske preiskave, da bi preveril, ali jetra delujejo pravilno, in sicer pred uvedbo zdravljenja ter redno med njim, običajno po 3 tednih, 6 tednih, 12 tednih in 24 tednih.
The Physician's guide to prescribing, including a liver monitoring scheme.
• povzetek glavnih značilnosti zdravila; • priročnik o predpisovanju za zdravnike, vključno s shemo spremljanja delovanja jeter.
When increasing the dosage, liver function tests should again be performed at the same frequency as when initiating treatment.
Ob povečanju odmerka je treba jetrne teste spet izvajati v enakih razmakih kot ob uvedbi zdravljenja.
The percentage of patients with at least one discontinuation symptom one week after the SSRI/SNRI treatment stop, was lower in the long tapering group (gradual cessation of the previous SSRI/SNRI within 2 weeks) than in the short tapering group (gradual cessation of the previous SSRI/SNRI within 1 week) and in the abrupt substitution group (abrupt cessation): 56.1%, 62.6 % and 79.8% respectively.
(postopno prenehanje predhodnega zdravljenja s SSRI/SNRI v 2 tednih) v primerjavi s skupino s hitrim zmanjševanjem odmerka (62,6 %) (postopno prenehanje predhodnega zdravljenja s SSRI/SNRI v 1 tednu) in v primerjavi s skupino z nenadno menjavo zdravila (79,8 %) (nenadno prenehanje predhodnega zdravljenja).
Valdoxan should be used with caution in patients with a history of bipolar disorder, mania or hypomania and should be discontinued if a patient develops manic symptoms (see section 4.8).
Bipolarna motnja / manija / hipomanija Pri bolnikih z bipolarno motnjo, manijo ali hipomanijo v anamnezi morate zdravilo Valdoxan uporabljati previdno in zdravljenje prekiniti, če se pri bolniku razvijejo simptomi manije (glejte poglavje 4.8).
Anxiety Abnormal dreams*
Psihiatrične motnje pogosti anksioznost nenormalne sanje*
The most common adverse reactions were headache, nausea and dizziness.
Najpogostejši neželeni učinki so bili glavobol, navzea in omotica.
If you have any further questions on the use of this product, please ask your doctor or pharmacist.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte s svojim zdravnikom ali farmacevtom.
In two other trials, it was not possible to draw any conclusions because the active controls, paroxetine or fluoxetine, failed to differentiate from placebo.
V drugih dveh preskušanjih ni bilo mogoče postaviti zaključkov, ker se od skupine, ki je prejemala placebo, nista razlikovali skupini, ki sta prejemali paroksetin ali fluoksetin.