natgillin/translations-raw huggingface dataset:
Irritability, Nervousness, Restlessness, Insomnia, Abnormal dreams
razdražljivost, nervoza, nemirnost, nespečnost, nenavadne sanje
Mood altered, Aggression, Agitation, Crying, Early morning awakening, Libido increased
nihanje v razpoloženju nasilnost, razburjenost, jokanje, zgodnje jutranje zbujanje, povečan libido
Migraine, Psychomotor hyperactivity, Dizziness, Somnolence
migrena, psihomotorična hiperaktivnost, vrtoglavica, zaspanost
Memory impairment, Disturbance in attention, Poor quality sleep
težave s spominom, motnje pozornosti, šibek spanec
Visual acuity reduced, Vision blurred, Lacrimation increased
zmanjšana ostrina vida, zamegljen vid, povečano izločanje solz
Vertigo positional
pozicijski vertigo
Vascular Disorders
Žilne bolezni
Abdominal pain, Constipation, Dry mouth
bolečine v trebuhu, zaprtost, suha usta
Gastrointestinal disorder, Gastrointestinal upset, Vomiting, Bowel sounds abnormal, Flatulence, Salivary hypersecretion, Halitosis
gastrointestinalne težave, gastrointestinalne motnje, bruhanje, nenormalni črevesni zvoki, napenjanje, povečano izločanje sline, ustni zadah
Hepatobiliary Disorders
Bolezni jeter, žolčnika in žolčevodov
Hepatic enzyme increased, Liver function test abnormal, laboratory test abnormal
povečani jetrni encimi, nenormalni testi jetrnih funkcij, nenormalni laboratorijski testi
Eczema, Erythema, Rash pruritic, Pruritus, Dry skin, Nail disorder, Night sweats,
ekcemi, eritem, srbečica z osipom, pruritus, suha koža, motnje nohtov, nočno potenje
Musculoskeletal and Connective Tissue Disorders
Bolezni mišično - skeletnega sistema in vezivnega tkiva
Muscle cramp, Neck pain
mišični krči, bolečine v vratu
Reproductive System and Breast Disorders
Motnje reprodukcije in dojk
Priapism
priapizem
5 No case of overdose has been reported.
Ni poročil o primerih prevelikega odmerjanja.
Circadin has been administered at 5 mg daily doses in clinical trials over 12 months without significantly changing the nature of the adverse reactions reported.
V kliničnih preskušanjih so Circadin dajali v 5 mg dnevnih odmerkih 12 mesecev brez pomembne spremembe v naravi sporočenih neželenih učinkov.
If overdose occurs, drowsiness is to be expected.
5 Pri prevelikem odmerku je treba pričakovati zaspanost.
Melatonin Receptor Agonists, ATC code:
Agonisti receptorjev melatonina, oznaka ATC:
Physiologically, melatonin secretion increases soon after the onset of darkness, peaks at 2-4 am and diminishes during the second half of the night.
Fiziološko se pojavi izločanje melatonina takoj, ko se začne temniti, in doseže vrhunec med 2- 4 uro zjutraj, v drugi polovici noči pa se količina manjša.
Mechanism of action The activity of melatonin at the MT1, MT2 and MT3 receptors is believed to contribute to its sleep- promoting properties, as these receptors (mainly MT1 and MT2) are involved in the regulation of circadian rhythms and sleep regulation.
Mehanizem delovanja Predvideva se, da aktivnost melatonina pri receptorjih MT1, MT2 in MT3 prispeva k lastnostim, ki spodbujajo spanje, saj ti receptorji (pretežno MT1 in MT2) sodelujejo pri uravnavanju cirkadianega ritma in uravnavanju spanja.
Rationale for use Because of the role of melatonin in sleep and circadian rhythm regulation, and the age related decrease in endogenous melatonin production, melatonin may effectively improve sleep quality particularly in patients who are over 55 with primary insomnia.
Smiselnost uporabe Zaradi vloge melatonina pri uravnavanju spanja in cirkadianega ritma in s starostjo povezanim zmanjšanjem proizvodnje endogenega melatonina, lahko melatonin učinkovito izboljša kakovost spanja, še zlasti pri bolnikih s primarno nespečnostjo, starih več kot 55 let.
Clinical efficacy In clinical trials, where patients suffering from primary insomnia received Circadin 2 mg every evening for 3 weeks, benefits were shown in treated patients compared to placebo in sleep latency (as measured by objective and subjective means) and in subjective quality of sleep and daytime functioning (restorative sleep) with no impairment of vigilance during the day.
Klinična učinkovitost V kliničnih preskušanjih, kjer so bolniki s primarno nespečnostjo 3 tedne vsak večer prejemali Circadin 2 mg, so se pokazale prednosti pri zdravljenih bolnikih v primerjavi s tistimi, ki so jemali placebo, pri latentnosti uspavanja (merjeno z objektivnimi in subjektivnimi sredstvi), subjektivni kakovosti spanja in funkcioniranjem čez dan (krepčilni spanec) brez vpliva na budnost čez dan.
In a polysomnographic (PSG) study with a run-in of 2 weeks (single-blind with placebo treatment), followed by a treatment period of 3 weeks (double-blind, placebo-controlled, parallel group design) and a 3-week withdrawal period, sleep latency (SL) was shortened by 9 minutes compared to placebo.
V polisomnografični (PSG) študiji, ki je trajala 2 tedna (enojno slepa, s placebom), ki ji je sledilo 3 - tedensko obdobje zdravljenja (dvojno slepa, s placebom kontrolirana študija, zasnovana kot paralelna skupina) in 3- tedensko obdobje odtegnitve, je bila latentnost uspavanja krajša za 9 minut, v primerjavi s placebom.
In an outpatient study with 2 week run-in baseline period with placebo, a randomised, double blind, placebo controlled, parallel group treatment period of 3 weeks and 2 week withdrawal period with placebo, the rate of patients who showed a clinically significant improvement in both quality of sleep and morning alertness was 47% in the Circadin group as compared to 27% in the placebo group.
V ambulantni študiji primerjave s placebom, randomizirani, dvojno slepi, s placebom kontrolirani, z dvotedenskim uvajalnim obdobjem, s 3- tedenskim trajanjem in dvotedenskim obdobjem odtegnitve, je bil odstotek bolnikov, ki so pokazali klinično pomembno izboljšanje tako v kakovosti spanja kot jutranji budnosti 47% v skupini, ki je jemala Circadin, v primerjavi s 27% v skupini, ki je jemala placebo.
Sleep variables gradually returned to baseline with no rebound, no increase in adverse events and no increase in withdrawal symptoms.
Spremenljivke spanja so se postopoma vrnile k izhodišču brez povratnega učinka (rebound), povečanih neželenih učinkov in brez povečanih odtegnitvenih simptomov.
In a second outpatient study with two week run in baseline period with placebo and a randomised, double blind, placebo controlled, parallel group treatment period of 3 weeks, the rate of patients who showed a clinically significant improvement in both quality of sleep and morning alertness was 26% in the Circadin group as compared to 15% in the placebo group.
6 V drugi ambulantni študiji z dvotedenskim uvajalnim obdobjem s placebom, randomizirani, dvojno slepi, s placebom kontrolirani s 3- tedenskim trajanjem paralelni skupini je bila stopnja bolnikov, ki so kazali klinično pomembno izboljšanje v kakovosti spanja in budnosti zjutraj 26% v skupini z zdravilom Circadin v primerjavi s 15% v skupini s placebom.
Circadin shortened patients’ reported
Bolniki, ki so jim zmanjšali odmerek zdravila Circadin, so poročali o latentnosti uspavanja 24, 3 minute v primerjavi z 12, 9 minutami s placebom.
6 sleep latency by 24.3 minutes vs 12.9 minutes with placebo.
Poleg tega poročila bolnikov kažejo na pomembno izboljšavo kakovosti spanja in jutranje budnosti v skupini z zdravilom Circadin v primerjavi s tisto s placebom.
In addition, patients’ self-reported quality of sleep, number of awakenings and morning alertness significantly improved with Circadin compared to placebo.
V skupini, ki je jemala Circadin 2 mg se je kakovost življenja pomembno izboljšala v primerjavi s tisto, ki je jemala placebo.
Quality of life was improved significantly with Circadin 2 mg compared to placebo.
5. 2 Farmakokinetične lastnosti
Absorption The absorption of orally ingested melatonin is complete in adults and may be decreased by up to 50% in the elderly.
Absorpcija Absorpcija peroralno zaužitega melatonina pri odraslih je popolna in se lahko zmanjša za do 50% pri starejših.
The kinetics of melatonin are linear over the range of 2-8 mg.
Kinetika melatonina je linearna v razponu med 2- 8 mg.
Bioavailability is in the order of 15%.
Biološka uporabnost je približno 15%.
There is a significant first pass effect with an estimated first pass metabolism of 85%.
Učinek prvega prehoda je pomemben z oceno presnove prvega prehoda 85%.
The presence of food delayed the absorption of the melatonin resulting in a later (Tmax=3.0 h versus Tmax=0.75 h) and lower peak plasma concentration in the fed state (Cmax=1020pg/ ml versus Cmax=1176 pg/ ml).
Prisotnost hrane upočasni absorpcijo melatonina, kar povzroči kasnejši (Tmax = 3, 0 h v primerjavi s Tmax = 0, 75 h) in nižji vrh plazemske koncentracije v stanju na poln želodec (Cmax = 1020 pg/ ml v primerjavi s Cmax = 1176 pg/ ml).
Distribution The in vitro plasma protein binding of melatonin is approximately 60%.
Porazdelitev In vitro vezava melatonina na proteine plazme je približno 60%.
Circadin is mainly bound to albumin, alpha1-acid glycoprotein and high density lipoprotein.
Circadin se veže pretežno na albumin, alfa1 kisli glikoprotein in lipoprotein visoke gostote.
Biotransformation Experimental data suggest that isoenzymes CYP1A1, CYP1A2 and possibly CYP2C19 of the cytochrome P450 system are involved in melatonin metabolism.
Biološka transformacija Eksperimentalni podatki nakazujejo, da pri presnovi melatonina sodelujejo izoencimi CYP1A1, CYP1A2 in morebiti CYP2C19 sistema citokroma P450.
The principal metabolite is 6- sulphatoxy-melatonin (6-S-MT), which is inactive.
Najpomembnejši metabolit je 6- sulfatoksi - melatonin (6- S- MT), ki ni aktiven.
The site of biotransformation is the liver.
Biološka transformacija poteka v jetrih.
Elimination Terminal half life (t½) is 3.5-4 hours.
Izločanje Končna razpolovna doba (t½) je 3, 5- 4 ure.
Elimination is by renal excretion of metabolites, 89% as sulphated and glucoronide conjugates of 6-hydroxymelatonin and 2% is excreted as melatonin (unchanged drug).
Izločanje poteka z izločanjem metabolitov skozi ledvice, 89% kot sulfatni in glukoronidni konjugati 6- hidroksimelatonina in 2% se izloča kot melatonin (nespremenjeno zdravilo).
Gender A 3-4-fold increase in Cmax is apparent for women compared to men.
Spol Pri ženskah je povečanje Cmax 3- 4- kratno v primerjavi z moškimi.
Elderly Melatonin metabolism is known to decline with age.
Starejši Znano je, da z leti presnova melatonina upada.
Cmax levels around 500 pg/ ml in adults (18-45) versus 1200 pg/ ml in elderly (55-69); AUC levels around 3,000 pg*h/ mL in adults versus 5,000 pg*h/ mL in the elderly.
Med različnimi razponi odmerkov poročajo o višjih ravneh AUC and Cmax pri starejših posameznikih v primerjavi z mlajšimi, kar kaže na nižjo presnovo melatonina pri starejših: ravni Cmax okoli 500 pg/ ml pri odraslih (18- 45) v primerjavi z 1200 pg/ ml pri starejših (55- 69); ravni AUC okoli 3. 000 pg* h/ ml pri odraslih, v primerjavi s 5. 000 pg* h/ ml pri starejših.
Renal impairment Company data indicates that there is no accumulation of melatonin after repeated dosing.
Okvarjeno delovanje ledvic Podatki družbe kažejo, da se melatonin ne akumulira s ponavljajočimi odmerki.
The levels assessed in the blood of the patients at 23:00 (2 hours after administration) following 1 and 3 weeks of daily administration were 411.4 ± 56.5 and 432.00 ± 83.2 pg/ ml respectively, and are similar to those found in in healthy volunteers following a single dose of Circadin 2 mg.
7 Ravni, izmerjene v krvi bolnikov ob 23: 00 (2 uri po zaužitju) po 1 in 3 tednih vsakodnevnega jemanja so bile 411, 4 ± 56, 5 oziroma 432, 00 ± 83, 2 pg/ ml in so bile podobne tistim, ki so jih izmerili pri zdravih prostovoljcih po enojnem odmerku zdravila Circadin 2 mg.
Hepatic impairment The liver is the primary site of melatonin metabolism and therefore, hepatic impairment results in higher endogenous melatonin levels.
Okvarjeno delovanje jeter Presnova melatonina poteka pretežno v jetrih, zato so posledica okvarjenega delovanja jeter višje ravni endogenega melatonina.
7 Plasma melatonin levels in patients with cirrhosis were significantly increased during daylight hours.
Ravni melatonina v plazmi pri bolnikih s cirozo so bile v svetlih urah dneva znatno povečane.
Patients had a significantly decreased total excretion of 6-sulfatoxymelatonin compared with controls.
V primerjavi s kontrolnimi skupinami je bil skupni izloček 6- sulfatoksimelatonin pri teh bolnikih znatno manjši.
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti.
The No Observed Adverse Effect Level (NOAEL) at 15 mg/ kg/ day in rats, is equivalent to an AUC which is considerably higher (x 15000) than the human exposure after ingestion of Circadin 2 mg.
Stopnja brez opaznih neželenih učinkov (NOAEL) s 15 mg/ kg/ dnevno pri podganah ustreza AUC, ki je znatno višji (x 15000), kot izpostavljenost ljudi po zaužitju zdravila Circadin 2 mg.
A slight effect on post-natal growth and viability was found in rats only at very high doses, equivalent to approximately 2000 mg/ day in humans.
Rahel učinek na rast in sposobnost preživetja po rojstvu se je pokazal pri podganah samo pri zelo visokih odmerkih, ki ustrezajo približno 2000 mg/ dni pri ljudeh.
Ammonio methacrylate copolymer type B Calcium hydrogen phosphate dihydrate Lactose monohydrate Silica, colloidal anhydrous Talc Magnesium stearate
amonijev metakrilat kopolimer vrste B kalcijev hidrogen fosfat, dihidrat laktoza monohidrat brezvoden koloiden silicijev dioksid smukec magnezijev stearat
Do not store above 25°C.
Shranjujte pri temperature do 25 °C.
6.5 Nature and contents of container
8 6. 5 Vrsta ovojnine in vsebina
The tablets are packed in PVC/ PVDC opaque blister strips with aluminium foil backing.
Tablete so pakirane v neprozorne pretisne omote PVC/ PVDC s hrbtno stranjo iz aluminija.
The pack consists of one blister strip containing 20 or 21 tablets.
Pakiranje vsebuje en pretisni omot z 20 ali 21 tabletami.
8 Medicines no longer required should not be disposed of via wastewater or the municipal sewage system.
Zdravila, ki ga ne potrebujete več, ne zavrzite v vodovod ali kanalizacijo.
Return them to a pharmacy or ask your pharmacist how to dispose of them in accordance with the national regulations.
Neuporabljeno zdravilo ali odpadni material vrnite v lekarno ali vprašajte farmacevta, kako jih zavreči v skladu z lokalnimi predpisi.
RAD Neurim Pharmaceuticals EEC Limited One Forbury Square The Forbury Reading Berkshire RG1 3EB United Kingdom e-mail: neurim@neurim. com
RAD Neurim Pharmaceuticals EEC Limited One Forbury Square The Forbury Reading Berkshire RG1 3EB
Penn Pharmaceutical Services Ltd Units 23-24 Tafarnaubach Industrial Estate Tredegar Gwent NP22 3AA UK
Penn Pharmaceutical Services Ltd Units 23- 24 Tafarnaubach Industrial Estate Tredegar Gwent NP22 3AA Velika Britanija
The MAH must ensure that the system of pharmacovigilance is in place and functioning prior to placing the product on the market.
Imetnik dovoljenja za promet mora zagotoviti delujoči sistem farmakovigilance pred dajanjem zdravila v promet.
Risk Management System
Sistem obvladovanja tveganj
The MAH commits to performing the study detailed in the Pharmacovigilance Plan.
Imetnik dovoljenja za promet se zavezuje izdelati študijo, opredeljeno v načrtu farmakovigilance.
An updated Risk Management Plan should be provided as per the CHMP Guideline on Risk Management System for medicinal products for human use.
Zagotoviti je treba posodobljen načrt upravljanja tveganj v skladu s CHMP Smernicami o sistemih za obvladovanje tveganj za zdravila za humano uporabo.
Each tablet contains 2 mg melatonin.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN
Contains lactose monohydrate See leaflet for further information
Za nadaljnje informacije glejte navodilo.
Prolonged-release tablets 20 tablets 21 tablets
Tablete s podaljšanim sproščanjem 20 tablet 21 tablet
RAD Neurim Pharmaceuticals EEC Limited One Forbury Square The Forbury Reading Berkshire RG1 3EB United Kingdom e-mail: neurim@neurim. com
RAD Neurim Pharmaceuticals EEC Limited One Forbury Square The Forbury Reading Berkshire RG1 3EB Velika Britanija e- pošta: neurim@ neurim. com
EU/ 1/ 07/ 392/ 001 21 tablets EU/ 1/ 07/ 392/ 002 20 tablets
EU/ 1/ 07/ 392/ 001 21 tablet EU/ 1/ 07/ 392/ 002 20 tablet
17 PACKAGE LEAFLET:
17 NAVODILO ZA UPORABO:
Circadin 2 mg prolonged-release tablets Melatonin
Circadin 2 mg tablete s podaljšanim sproščanjem melatonin
What Circadin is and what it is used for 2.
Kaj je zdravilo Circadin in za kaj ga uporabljamo 2.
Before you take Circadin 3.
Kaj morate vedeti, preden boste vzeli zdravilo Circadin 3.
How to take Circadin 4.
Kako jemati zdravilo Circadin 4.
How to store Circadin 6.
Shranjevanje zdravila Circadin 6.
WHAT CIRCADIN IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO CIRCADIN IN ZA KAJ GA UPORABLJAMO
Circadin is used as monotherapy for the short-term treatment of primary insomnia (difficulty in getting to sleep or staying asleep, or poor quality of sleep for at least one month), characterised by poor quality of sleep in patients aged 55 years and older.
Circadin se uporablja kot monoterapija za kratkotrajno zdravljenje primarne nespečnosti (težave zaspati ali ohraniti spanec, šibek spanec, ki traja vsaj en mesec), za katero je značilna slaba kakovost spanca pri bolnikih, starih 55 let ali starejših.
BEFORE YOU TAKE CIRCADIN
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO CIRCADIN
Do not take Circadin
Ne jemljite zdravila Circadin
- if you are allergic (hypersensitive) to melatonin or any of the other ingredients of Circadin.
- če ste alergični na (preobčutljivi za) melatonin ali katerokoli drugo sestavilo zdravila Circadin.
Take special care with Circadin
Bodite posebno pozorni pri uporabi zdravila Circadin
- if drowsiness is likely to cause a risk to your safety;
- če lahko zaspanost ogrozi vašo varnost;
- if you suffer from any liver problems;
- če imate kakršnokoli težave z jetri;
- if you suffer from kidney problems;
- če imate kakršnekoli težave z ledvicami;
- if you suffer from any autoimmune disease (where the body is ‘ attacked’ by its own
- če imate kakršnokoli avtoimuno bolezen (kjer telo » napada « lasten imunski sistem).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription BEFORE you start the treatment as they may affect the action of Circadin.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta PREDEN začnete z zdravljenjem, saj lahko vplivajo na delovanje zdravila Circadin.
These medicines include hypnotics and tranquilisers (e. g. benzodiazepines), fluvoxamine, thioridazine and imipramine (used to treat depression or psychiatric problems), oestrogen (contraceptives or hormone replacement therapy), cimetidine and psoralens (used to treat skin problems e. g. psoriasis).
Ta zdravila zajemajo hipnotike in pomirjevala (npr. benzodiazepine), fluvoksamin, tioridazin in imipramin (uporabljajo se za zdravljenje depresije ali psihiatričnih težav), estrogen (kontracepcijska sredstva ali nadomestna hormonska terapija), cimetidin in psoralene (uporabljajo se za zdravljenje kožnih bolezni, na primer luskavice).
18 Taking Circadin with food and drink Take Circadin after you have eaten.
Jemanje zdravila Circadin skupaj s hrano in pijačo Circadin vzemite po tem, ko ste zaužili hrano.
Do not drink alcohol before, during or after taking Circadin.
Pred, med ali po jemanju zdravila Circadin ne pijte alkohola.
Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
18 Nosečnost in dojenje Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo.
It is not recommended to take Circadin if you are pregnant or suspect that you may be pregnant.
Jemanje zdravila Circadin se ne priporoča, če ste noseči ali mislite, da ste morda noseči.
It is not recommended to take Circadin if you are breast feeding.
Jemanje zdravila Circadin se ne priporoča, če dojite.
Driving and using machines Circadin may cause drowsiness.
Vpliv na sposobnost upravljanja vozil in strojev Circadin lahko povzroči zaspanost.
Important information about some of the ingredients of Circadin Each prolonged-release tablet contains 80 mg of lactose-monohydrate.
Pomembne informacije o nekaterih sestavinah zdravila Circadin Vsaka tableta s podaljšanim sproščanjem vsebuje 80 mg laktoze monohidrata.
HOW TO TAKE CIRCADIN
KAKO JEMATI ZDRAVILO CIRCADIN
Always take Circadin exactly as your doctor has told you.
Pri jemanju zdravila Circadin natančno upoštevajte zdravnikova navodila.
The dose is one Circadin tablet taken daily by mouth, after food, 1-2 hours before bedtime, for 3 weeks.
Običajen odmerek je ena tableta zdravila Circadin dnevno, zaužita peroralno, po obroku, 1- 2 uri pred spanjem, 3 tedne.
If you take more Circadin than you should If you have accidentally taken too much of your medicine, contact your doctor or pharmacist as soon as possible.
Če ste vzeli večji odmerek zdravila Circadin, kot bi smeli Če ste pomotoma vzeli preveč zdravila, se čimprej posvetujte z zdravnikom ali s farmacevtom.
If you forget to take Circadin If you forget to take your tablet, take another as soon as you remember, before going to sleep, or wait until it is time to take your next dose, then go on as before.
Če ste pozabili vzeti zdravilo Circadin Če ste pozabili vzeti tableto, jo vzemite takoj, ko se spomnite, preden greste spat, ali pa počakajte do naslednjega odmerka, nato pa nadaljujte kot običajno.
If you stop taking Circadin There are no known harmful effects if treatment is interrupted or ended early.
Če ste prenehali jemati Circadin V zvezi s prekinitvijo ali predčasnim prenehanjem jemanja tega zdravila ni znanih škodljivih učinkov.
Like all medicines, Circadin can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Circadin neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The following events are considered to be uncommon (i. e. likely to occur in fewer than 1 in 100 patients):
Učinki, našteti v nadaljevanju, veljajo za občasne (tj. verjetno se bodo pojavili pri manj kot 1 od 100 bolnikov):
Irritability, nervousness, restlessness, insomnia, abnormal dreams, migraine, psychomotor hyperactivity (restlessness associated with increased activity), dizziness, somnolence (tiredness), abdominal pain, constipation, dry mouth, hyperbilirubinaemia (changes in the composition of your blood which could cause yellowing of the skin or eyes (jaundice), hyperhidrosis (excessive sweating), asthenia (feeling of weakness) and weight increase.
Razdražljivost, živčnost, nemirnost, nespečnost, nenavadne sanje, migrena, psihomotorična hiperaktivnost (nemirnost, povezana s povečano aktivnostjo), omotičnost, dremavica (utrujenost), bolečine v trebuhu, zaprtost, suha usta, hiperbilirubinemija (spremembe v sestavi krvi, ki povzročajo rumenost kože ali oči (zlatenica)), nenavadne sanje, nespečnost, razdražljivost, živčnost, nemirnost, hiperhidroza (prekomerno potenje), astenija (občutek šibkosti) in povečana telesna teža.
The following events are considered to be rare (i. e., likely to occur in fewer than 1 in 1,000 patients):
Učinki v nadaljevanju veljajo za redke (tj. verjetno se bodo pojavili pri manj kot 1 od 1. 000 bolnikov):