natgillin/translations-raw huggingface dataset:
There were un-confounded cases with no underlying history of cerebrovascular disorders, reporting cerebral infarction and cerebral artery occlusion; right cerebral occlusion and cerebral ischaemic event.
Obstajali so primeri brez vpliva begavih spremenljivk, ki so bili brez anamneze obstoječega cerebrovaskularnega obolenja ter z navedbami cerebralnega infarkta in okluzije cerebralne arterije; desne cerebralne okluzije in cerebralnega ishemijskega dogodka.
Methylphenidate is associated with the onset or exacerbation of motor and verbal tics.
Metilfenidat so povezovali z nastankom ali poslabšanjem motoričnih in verbalnih tikov.
Overall, the data relating to cardiovascular risks from all clinical trials of methylphenidate-containing products showed that the events of hypertension, heart rate increases or arrhythmias (mainly tachycardia) and QT prolongation were the main cardiovascular events reported.
Na splošno so podatki o tveganju srčno-žilnih obolenj iz vseh kliničnih preskušanj zdravil, ki vsebujejo metilfenidat, pokazali, da so najpogosteje poročani poglavitni srčno-žilni dogodki hipertenzija, pospešen srčni utrip ali aritmije (v glavnem tahikardija) ter podaljšanje QT.
Patients who develop symptoms such as palpitations, exertional chest pain, unexplained syncope, dyspnoea or other symptoms suggestive of cardiac disease during methylphenidate treatment should undergo a prompt specialist cardiac evaluation.
Pri bolnikih, ki med zdravljenjem z metilfenidatom dobijo simptome, kot so palpitacije, bolečine v prsih ob naporu, nepojasnjeno sinkopo, dispnejo ali kakšne druge simptome, ki kažejo na srčno bolezen, pa morate takoj opraviti specialistični pregled srca.
Longstanding abuse of methylphenidate can lead to marked tolerance, psychological dependence, abnormal behaviour, psychotic episodes.
Dolgotrajna zloraba metilfenidata lahko vodi v izrazito odpornost, psihološko odvisnost, neobičajno vedenje, psihotične epizode.
The MAHs should evaluate newly identified or potential risks, or new new/important information on existing identified or potential risks, in the RMP on an ongoing basis
Imetniki dovoljenj za promet z zdravilom morajo v načrtih obvladovanja tveganja redno vrednotiti novo ugotovljena ali možna tveganja ali nove/pomembne podatke o obstoječih ugotovljenih ali možnih tveganjih.
Furthermore, the MAHs committed to investigate the long term effect on children's development.
Ravno tako so se imetniki dovoljenj za promet z zdravilom zavezali k raziskovanju dolgoročnega učinka na razvoj otrok.
Efficacy of peritoneal dialysis or extracorporeal haemodialysis for overdose of methylphenidate has not been established.
Učinkovitost peritonealne dialize ali zunajtelesne hemodialize pri prevelikem odmerjanju metilfenidata še ni bila ugotovljena.
The MAHs should include, in the core safety specification, the final core table of identified and potential risks as requested by the CHMP.
Imetniki dovoljenj za promet z zdravilom morajo na zahtevo CHMP v osrednjo specifikacijo varnosti vključiti končno osrednjo preglednico ugotovljenih in možnih tveganj.
The synchronisation of the PSUR submission will facilitate a common assessment and harmonised response by the National Competent Authorities on updates of the SPC / PL and RMP.
Sinhronizacija predložitve rednih poročil o varnosti zdravila bo olajšala skupno vrednotenje in usklajen odziv nacionalnih pristojnih organov na posodobitve povzetka glavnih značilnosti zdravila / navodila za uporabo in načrta obvladovanja tveganja.
Not known: cerebrovascular disorders* (including vasculitis, cerebral haemorrhages, cerebrovascular accidents, cerebral arteritis, cerebral occlusion), grand mal convulsions*, migraine
Neznani: cerebrovaskularne motnje* (vključno z vaskulitisom, možganskimi krvavitvami, cerebrovaskularnimi poškodbami, možganskim arteritisom, zaporo možganske žile), generalizirani tonično-klonični krči*, migrena
Use with centrally acting alpha-2 agonists (e.g. clonidine) Serious, adverse events, including sudden death, have been reported in concomitant use with clonidine.
Uporaba s centralno delujočimi agonisti adrenergičnih receptorjev alfa-2 (npr. klonidin) Pri sočasni uporabi metilfenidata s klonidinom so poročali o resnih neželenih učinkih, vključno z nenadno smrtjo.
DE - Germany TAD Pharma GmbH Postfach 720
DE - Nemčija TAD Pharma GmbH Postfach 720
AT - Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75
AT - Avstrija Janssen-Cilag Pharma GmbH Pfarrgasse 75
• Phaeochromocytoma
• feokromocitom,
DK-Denmark Janssen-Cilag A/S Hammerbakken 19
DK - Danska Janssen-Cilag A/S Hammerbakken 19
Before performing gastric lavage, control agitation and seizures if present and protect the airway.
Preden opravite izpiranje želodca, nadzorujte bolnikovo vznemirjenost in epileptične napade, če so prisotni, in zavarujte dihalne poti.
Overall, cardiovascular events reported were mainly of cardiac arrhythmias (including tachycardia), hypertension, cardiac arrests, ischemia, QT prolongation, with some reports of sudden death.
Na splošno so bili poročani srčno-žilni dogodki v glavnem srčne aritmije (vključno s tahikardijo), hipertenzija, srčni zastoji, ishemija, podaljšanje QT ter nekaj poročil nenadne smrti.
Co-morbidity of psychiatric disorders in ADHD is common and should be taken into account when prescribing stimulant products.
Bolniki z ADHD imajo pogosto sočasno tudi druge psihiatrične motnje, kar je treba upoštevati pri predpisovanju stimulantov.
DE - Germany ratiopharm GmbH D-89070 Ulm
DE - Nemčija ratiopharm GmbH D-89070 Ulm
Like all medicines, methylphenidate can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi metilfenidat neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
• pre-existing cardiovascular disorders including severe hypertension, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias and channelopathies (disorders caused by the dysfunction of ion channels).
• obstoječe srčnožilne bolezni vključno s hudo hipertenzijo, srčnim popuščanjem, arterijsko okluzivno boleznijo, angino pektoris, hemodinamsko pomembno prirojeno srčno napako, kardiomiopatijami, miokardnim infarktom, potencialno življenje ogrožujočimi aritmijami in motnjami v delovanju ionskih kanalčkov,
Where analyses of medical history or concurrent medications were provided, these did not provide conclusive evidence of predictive risk factors for cardiovascular effects of methylphenidate.
Kadar so podatki vsebovali analize zdravstvene anamneze ali sočasno jemanih zdravil, ni bilo možno najti prepričljivih dokazov napovednih dejavnikov tveganja srčno-žilnih učinkov metilfenidata.
AT - Austria UCB Pharma GmbH Jaquingasse 16-18/3 A-1030 Wien
AT - Avstrija UCB Pharma GmbH Jaquingasse A-1030 Wien
The MAHs have committed to it.
Imetniki dovoljenj za promet z zdravilom so se zavezali k temu.
Methylphenidate can cause dizziness, drowsiness and visual disturbances including difficulties with accommodation, diplopia and blurred vision.
Metilfenidat lahko povzroči omotico, zaspanost in motnje vida, vključno s težavami z akomodacijo očesa, dvojnim in zameglenim vidom.
Your child should be monitored for the risk of diversion, misuse and abuse of methylphenidate.
Vašega otroka je treba spremljati za tveganje rekreativne uporabe, napačne uporabe in zlorabe metilfenidata.
Drug treatment is usually discontinued during or after puberty.
Zdravljenje z zdravili se običajno prekine med puberteto ali po njej.
Recent findings from a case-control study have indicated a potentially increased risk of lymphocytic leukaemia with methylphenidate, which the MAHs were required to further evaluate.
Nedavna odkritja v študiji primerov in kontrol so pokazala potencialno povečano tveganje limfocitne levkemije zaradi metilfenidata, zato je bilo od imetnikov dovoljenj za promet z zdravilom zahtevano dodatno vrednotenje.
The MAH review of post-marketing spontaneous data found that cerebrovascular events from spontaneous reports consisted mainly of the reported terms: cerebrovascular accident, stroke, cerebral infarction and cerebral ischemia as well as a few reports of other events.
Imetniki dovoljenj za promet z zdravilom so pregledali podatke iz spontanih poročil v času trženja zdravil ter ugotovili, da cerebrovaskularni dogodki v teh poročilih obsegajo zlasti izraze: cerebrovaskularni insult, možganska kap, cerebralni infarkt in cerebralna ishemija ter nekaj poročil o drugih dogodkih.
Treatment must be under the supervision of a specialist in childhood behavioural disorders.
Zdravljenje mora potekati pod nadzorom specialista za motnje vedenja v otroštvu.
• pre-existing cerebrovascular disorders cerebral aneurysm, vascular abnormalities including vasculitis or stroke
• obstoječe cerebrovaskularne motnje, možganska anevrizma, žilne bolezni, vključno z vaskulitisom ali kapjo.
Common: anorexia, decreased appetite, moderately reduced weight and height gain during prolonged use in children*
Pogosti: anoreksija, zmanjšan tek, zmerno zmanjšano pridobivanje telesne mase in višine pri daljši uporabi pri otrocih*
Pregnancy-embryonal/foetal development
Nosečnost- razvoj embria/ploda
Common: arrhythmia, tachycardia palpitations
Pogosti: aritmija, tahikardija, palpitacije
The MAHs submitted data supporting the position that there is no preclinical or clinical evidence for a significant carcinogenic risk associated with methylphenidate.
Imetniki dovoljenj za promet z zdravilom so predložili podatke, ki podpirajo stališče, da ni predkliničnih ali kliničnih dokazov za zadostno tveganje kancerogenosti, povezane z metilfenidatom.
Novartis s.r.o.
CS - Češka Novartis s.r.o.
As a consequence, the CHMP has recommended the maintenance of the Marketing Authorisations for the medicinal products referred to in Annex I for which the amendments to the relevant sections of the Summary of Product Characteristics and Package Leaflet are set out in Annex III
Posledično je CHMP priporočil ohranitev dovoljenj za promet z zdravili iz Dodatka I, katerih dopolnila zadevnih poglavij povzetkov glavnih značilnosti zdravila in navodil za uporabo so navedena v Dodatku III.
Your doctor will decide whether you or your daughter should use methylphenidate.
Zato bo zdravnik odločil, ali naj vi ali vaša hči med jemanjem metilfenidata dojita.
Methylphenidate is indicated as a part of a comprehensive treatment programme for ADHD in children over 6 years of age where remedial measures alone prove insufficient.
Metilfenidat je indiciran kot del celovitega programa zdravljenja motnje ADHD pri otrocih, starejših od 6 let, kjer so zgolj ukrepi za odpravo stanja nezadostni.
There was no evidence from pre-clinical or clinical trial data of an increased risk of cyanosis with methylphenidate.
V predkliničnih podatkih in podatkih kliničnih preskušanj ni bilo dokazov o zvišanem tveganju cianoze zaradi metilfenidata.
Metabolism and nutritional disorders*
Presnovne in prehranske motnje*
Methylphenidate is used to treat attention deficit hyperactivity disorder (ADHD) in adolescents and children 6 years of age and over when other non pharmaceutical measures alone have proven insufficient.
Metilfenidat se uporablja za zdravljenje motnje pozornosti s hiperaktivnostjo (ADHD) pri mladostnikih in otrocih, starejših od 6 let, ko so se drugi nefarmacevtski ukrepi sami izkazali za nezadostne.
Reproductive system and breast disorders Rare: Gynaecomastia
Motnje reprodukcije in dojk Redki: ginekomastija
Careful supervision is required during withdrawal from abusive use since severe depression may occur.
Tudi med ukinitvijo zdravila zaradi njegove zlorabe je potreben skrben nadzor, ker lahko nastopi huda depresija.
Common: anorexia, affect lability, aggression*, agitation*, anxiety*, depression*, irritability, abnormal behaviour
Pogosti: anoreksija, čustvena labilnost, napadalnost*, vznemirjenje*, anksioznost*, depresija*, razdražljivost, neobičajno vedenje
If seizure frequency increases or new-onset seizures occur, methylphenidate should be discontinued.
Če se poveča pogostnost epileptičnih napadov ali se pojavijo novi napadi, je treba metilfenidat ukiniti.
• Hyperthyroidism or Thyrotoxicosis
• hipertireoza ali tirotoksikoza,
Common: abdominal pain, diarrhoea, nausea, stomach discomfort, and vomiting - {for inclusion in PL for non-modified release formulations :} “these usually occur at the beginning of treatment and may be alleviated by concomitant food intake”, Dry mouth.
Pogosti: bolečine v trebuhu, driska, navzeja, nelagodje v želodcu in bruhanje {vključiti v navodilo za uporabo nespremenjenih formulacij za sproščanje :} „ti se najpogosteje pojavijo na začetku zdravljenja in jih lahko olajšamo s sočasnim zaužitjem hrane“, suha usta.
Because the {Invented name} tablet is nondeformable and does not appreciably change in shape in the gastrointestinal (GI) tract, it should not ordinarily be administered to patients with pre-existing severe GI narrowing (pathologic or iatrogenic) or in patients with dysphagia or significant difficulty in swallowing tablets.
Potencialna verjetnost zapore prebavnega trakta [izpolni država članica kot je primerno] Ker se tableta {zaščiteno ime zdravila} ne spremeni in v prebavilih bistveno ne spremeni svoje oblike, je običajno ne smemo predpisovati bolnikom z obstoječimi hudimi zožitvami v prebavilih (patološkimi ali iatrogenimi) ali bolnikom z disfagijo ali večjimi težavami pri požiranju tablet.
Uncommon: myalgia, muscle twitching Very rare: muscle cramps
Občasni: mialgija, trzanje mišic Zelo redki: mišični krči
ES - Spain Medice Arznemitel Putter GMBH Kuhloweg, 37 D 58638
ES - Španija Medice Arznemitel Putter GMBH Kuhloweg, 37 D 58638
Musculoskeletal, connective tissue and bone disorders Common: arthralgia
Bolezni mišično-skeletnega sistema, vezivnega tkiva in kosti Pogosti: artralgija
The physician who elects to use methylphenidate for extended periods (over 12 months) in children and adolescents with ADHD should periodically re-evaluate the long term usefulness of the drug for the individual patient with trial periods off medication to assess the patient's functioning without pharmacotherapy.
Zdravnik, ki se odloči za dolgotrajno zdravljenje (dlje kot 12 mesecev) z metilfenidatom pri otroku ali mladostniku z ADHD, mora periodično s poskusnimi obdobji, ko bolnik ne jemlje zdravila, ocenjevati korist dolgotrajne uporabe zdravila za posameznega bolnika da oceni stanje bolnika, kadar ne jemlje farmakoterapije.
Because of possible hypertensive crisis, methylphenidate is contraindicated in patients being treated (currently or within the preceding 2 weeks) with non-selective, irreversible MAO-inhibitors (see section 4.3 Contraindications).
Zaradi nevarnosti nastanka hipertenzivne krize je metilfenidat kontraindiciran pri bolnikih, ki se sočasno zdravijo z neselektivnimi, ireverzibilnimi zaviralci MAO oziroma so se z njimi zdravili 2 tedna pred tem (glejte poglavje 4.3).
Very rare: Anaemia, leukopenia, thrombocytopenia, thrombocytopenic purpura Unknown: Pancytopenia
Zelo redki: anemija, levkopenija, trombocitopenija, trombocitopenična purpura Neznani: pancitopenija
The text differed among MAHs, but the recommendation of baseline assessment and monitoring of growth was common to most products.
Besedila se razlikujejo med imetniki dovoljenj za promet z zdravilom, vendar je pri večini zdravil prisotno priporočilo o izhodiščnem vrednotenju ter spremljanju rasti.
Dose titration
Titracija odmerka
Long-term use (more than 12 months) in children and adolescents The safety and efficacy of long term use of methylphenidate has not been systematically evaluated in controlled trials.
Dolgotrajna uporaba (več kot 12 mesecev) pri otrocih in mladostnikih Varnosti in učinkovitosti dolgotrajne uporabe metilfenidata niso sistematično ovrednotili v nadzorovanih preskušanjih.
5, 10, 20 mg - tablet 10, 20, 30, 40 - prolongedrelease capsule, hard
5, 10, 20 mg - tableta 10, 20, 30, 40 - kapsula s prirejenim sproščanjem, trda
The medication is contained within a nonabsorbable shell designed to release the drug at a controlled rate.
Učinkovina se nahaja v ovojnici, ki se ne absorbira in je namenjena zagotavljanju nadzorovane hitrosti sproščanja učinkovine.
Caution is advised in patients being treated with methylphenidate with any other drug that can also elevate blood pressure (see also sections on cardiovascular and cerebrovascular conditions in Section 4.4 Warnings and Precautions for use)
Uporaba metilfenidata z zdravili, ki zvišajo krvni tlak Pri bolnikih, ki se zdravijo z metilfenidatom in katerimkoli zdravilom, ki lahko tudi zviša krvni tlak, je potrebna previdnost (glejte tudi poglavja o srčnožilnih in možganskožilnih boleznih v poglavju 4.4).
Patients with additional risk factors (such as a history of cardiovascular disease, concomitant medications that elevate blood pressure) should be assessed at every visit for neurological signs and symptoms after initiating treatment with methylphenidate.
Pri tistih, ki imajo dodatne dejavnike tveganja (kot so srčnožilne bolezni v pretekli anamnezi ali sočasno jemanje drugih zdravil, ki zvišajo krvni tlak), pa je treba pri vsakem obisku po uvedbi zdravljenja z metilfenidatom opraviti pregled, da ugotovite morebitne nevrološke znake ali simptome.
Most frequently reported psychiatric adverse events of interest from spontaneous reports were abnormal behaviour, abnormal thinking, anger, hostility, aggression, agitation, tic, irritability, anxiety, crying, depression, somnolence, aggravated ADHD, psychomotor hyperactivity, emotional disorder, anger, nervousness, psychotic disorder, mood swings, morbid thoughts, obsessive-compulsive disorder, personality change/disorder, restlessness, confusional state, hallucinations, lethargy, paranoia and suicidality.
Najpogosteje poročani zanimivi psihiatrični neželeni učinki v spontanih poročilih so bili nenormalno vedenje, nenormalne misli, jeza, sovražnost, nasilje, agitiranost, tik, razdražljivost, anksioznost, jok, depresija, nespečnost, poslabšanje motnje ADHD, psihomotorična hiperaktivnost, čustvena motnja, jeza, živčnost, psihotična motnja, spremembe razpoloženja, morbidne misli, obsesivno-kompulzivna motnja, sprememba/motnja osebnosti, nemirnost, zmedenost, halucinacije, letargija, paranoja in samomorilnost.
Patients on long-term therapy (i.e. over 12 months) must have careful ongoing monitoring according to the guidance in sections 4.2 and 4.4. for cardiovascular status, growth, appetite, development of de novo or worsening of pre-existing psychiatric disorders.
Bolnike na dolgoročni terapiji (tj. več kot 12 mesecev) je treba skrbno neprekinjeno spremljati, zlasti srčnožilno stanje, rast, tek, razvoj de novo ali poslabšanje predhodno obstoječih psihiatričnih simptomov.
On going studies on sex maturation will also provide new data in this aspect.
Nove podatke s tega področja bodo dale tudi tekoče raziskave o spolnem zorenju.
CONDITIONS OF THE MARKETING AUTHORISATIONS
POGOJI DOVOLJENJ ZA PROMET Z ZDRAVILOM
{The MA Holder should describe the dose conversion (between formulations) and the dose titration steps that are relevant to the formulation and strength of their own methylphenidate product, in each methylphenidate SPC in the EU}
[Imetnik dovoljenja za promet mora opisati postopke zamenjave (med farmacevtskimi oblikami ) in titracije odmerkov, ki so pomembni pri farmacevtskih oblikah in jakostih njegovega zdravila z metilfenidatom, v vsakem SmPC z metilfenidatom v EU]
Methylphenidate may lower the convulsive threshold in patient with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and rarely in patients without a history of convulsions and no EEG abnormalities.
Metilfenidat je treba uporabljati previdno pri bolnikih z epilepsijo, saj bi lahko znižal prag za nastanek konvulzij pri bolnikih, ki imajo epileptične napade v anamnezi, pri tistih s predhodnimi motnjami EEG brez epileptičnih napadov, in redko tudi pri tistih, ki v anamnezi nimajo konvulzij ali motenj v EEG.
Treatment must be stopped if the symptoms do not improve after appropriate dosage adjustment over a one-month period.
Če se v času enega meseca po ustrezni prilagoditvi odmerka simptomi ne izboljšajo, je treba zdravljenje s tem zdravilom ukiniti.
A comprehensive treatment programme typically includes psychological, educational and social measures as well as pharmacotherapy and is aimed at stabilising children with ADHD with symptoms that may include chronic history of short attention span, distractibility, emotional lability, impulsivity, moderate to severe hyperactivity, minor neurological signs and abnormal electoencephalograpy (EEG).
Program celovitega zdravljenja navadno vključuje psihološke, izobraževalne in socialne ukrepe ter tudi zdravljenje z zdravili in je usmerjen k uravnoteženju otrok, ki imajo motnje pozornosti s hiperaktivnostjo in simptome, ki lahko vključujejo kronično anamnezo kratkotrajne pozornosti, raztresenosti, čustvene labilnosti, impulzivnosti, zmerne do hude hiperaktivnosti, blagih nevroloških znakov in neobičajne elektroencefalografije (EEG).
DE - Germany Alfred E.Tiefenbacher GmbH & Co.KG Van-der-Smissen-Str. 1
DE - Nemčija Alfred E.Tiefenbacher GmbH & Co.KG
Methylphenidate is not licensed for use in adults in ADHD.
Metilfenidat ni indiciran za uporabo pri odraslih z ADHD.
Methylphenidate treatment does not need to be indefinite.
Ni potrebe, da je zdravljenje z metilfenidatom neomejeno.
DE - Germany Novartis Pharma GmbH D-90327 Nuernberg
DE - Nemčija Novartis Pharma GmbH D-90327 Nuernberg
There is little evidence to suggest that patients at higher risk can be identified and the initial onset of symptoms may be the first indication of an underlying clinical problem.
Pogosto je lahko šele začetni pojav simptomov prvi znak obstoječih kliničnih težav.
Pharmacokinetic interaction
Farmakokinetične interakcije
This medicinal product contains sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine
To zdravilo vsebuje saharozo in ga ne smejo jemati bolniki z redkimi dednimi motnjami fruktozne intolerance, malabsorpcije glukoze in galaktoze ter pomanjkanja saharaze oz. izomaltaze.
Signs of overdose may include: vomiting, agitation, shaking, increased uncontrolled movements, muscle twitching, fits (may be followed by coma), feeling of extreme happiness, confusion (severe confusion), hallucinations (seeing, feeling or hearing things that are not real), sweating, flushing, headache, high fever, changes in heart beat (slow, fast or irregular), high blood pressure, dilated pupils and dry nose and mouth.
Znaki prevelikega odmerjanja so lahko: bruhanje, vznemirjenost, tresavica, povečani neobvladljivi gibi, trzanje mišic, napadi (lahko jim sledi koma), občutek pretirane sreče, zmedenost (huda zmedenost), halucinacije (videti, čutiti ali slišati stvari, ki niso resnične), znojenje, rdečica, glavobol, povišana telesna temperatura, spremembe v bitju srca (počasno, hitro ali neredno), visok krvni tlak, razširjene zenice, suha usta in nos.
Renal or hepatic insufficiency There is no experience with the use of methylphenidate in patients with renal or hepatic insufficiency.
Ledvična ali jetrna insuficienca Pri bolnikih z ledvično ali jetrno insuficienco ni izkušenj z uporabo metilfenidata.
Psychiatric disorders to monitor for are described below, and include (but are not limited to) motor or vocal tics, aggressive or hostile behaviour, agitation, anxiety, depression, psychosis, mania, delusions, irritability, lack of spontaneity, withdrawal and excessive perseveration.
Psihiatrične motnje, na katere je treba biti pozoren, so navedene spodaj in vključujejo na primer motorične ali govorne tike, nasilno ali sovražno vedenje, razdražljivost, tesnobo, depresijo, psihozo, manijo, privide, pomanjkanje spontanosti, umik vase in pretirano perseveracijo.
Careful supervision is required during drug withdrawal, since this may unmask depression as well as chronic over-activity.
Ob odtegnitvi zdravila je potreben skrben nadzor, saj se ob tem lahko razkrijeta depresija in tudi dolgotrajna prevelika aktivnost.