natgillin/translations-raw huggingface dataset:
Multiple dosing of perampanel 12 mg/day also enhanced the effects of alcohol on vigilance and alertness, and increased levels of anger, confusion and depression as assessed using the Profile of Mood State 5-point rating scale. 
Višekratna primjena perampanela u dozi od 12 mg na dan također je pojačala učinke alkohola na pozornost i budnost i povisila razinu ljutnje, smetenosti i depresije, kako je procijenjeno pomoću ocjenske ljestvice za procjenu stanja raspoloženja s 5 stupnjeva.
The pharmacokinetics of perampanel following a single 1 mg dose were evaluated in 12 subjects with mild and moderate hepatic impairment (Child-Pugh A and B, respectively) compared with 12 healthy, demographically matched subjects. 
Farmakokinetika perampanela nakon jednokratne doze od 1 mg bila je procijenjena u 12 ispitanika s blagim (Child-Pugh A) i umjerenim oštećenjem jetre (Child-Pugh B) u usporedbi s 12 zdravih, demografski sličnih ispitanika.
Two studies (studies 304 and 305) compared doses of perampanel 8 and 12 mg/day with placebo and the third study (study 306) compared doses of perampanel 2, 4 and 8 mg/day with placebo. 
Dva ispitivanja (ispitivanja 304 i 305) uspoređivala su doze perampanela od 8 i 12 mg na dan s placebom, dok je treće ispitivanje (ispitivanje 306) uspoređivalo doze perampanela od 2, 4 i 8 mg na dan s placebom.
- Felbamate (a medicine used to treat epilepsy) may also affect Fycompa. 
- Felbamat (lijek koji se uzima za liječenje epilepsije) također može utjecati na Fycompu.
In vitro studies show that perampanel is not a substrate or significant inhibitor of organic anion transporting polypeptides (OATP) 1B1 and 1B3, organic anion transporters (OAT) 1, 2, 3, and 4, organic cation transporters (OCT) 1, 2, and 3, and the efflux transporters P-glycoprotein and Breast Cancer Resistance Protein (BCRP). 
In vitro ispitivanja pokazuju da perampanel nije supstrat ili značajni inhibitor polipeptida za prijenos organskih aniona 1B1 i 1B3, prijenosnika organskih aniona (OAT) 1, 2, 3 i 4, prijenosnika organskih kationa (OCT) 1, 2, i 3, te efluksnih prijenosnika P-glikoproteina i proteina rezistencije na rak dojke (BCRP).
The 50% responder rate was 22.2% in combination with enzyme-inducing anti-epileptic medicinal products and was 69.4% when perampanel was given in combination with non-enzyme-inducing anti-epileptic medicinal products. 
Stopa ispitanika s 50% odgovora iznosila je 22,2% u kombinaciji s antiepileptičkim lijekovima koji induciraju enzime, a 69,4% kad se perampanel davao u kombinaciji s antiepileptičkim lijekovima koji ne induciraju enzime.
The metabolism of perampanel is mediated primarily by CYP3A based on clinical study results in healthy subjects administered radiolabeled perampanel and supported by in vitro studies using recombinant human CYPs and human liver microsomes. 
Metabolizam perampanela posredovan je primarno enzimom CYP3A na temelju rezultata kliničkih ispitivanja u zdravih ispitanika kojima je bio primijenjen radioaktivno označen perampanel te potkrijepljenih in vitro ispitivanjima upotrebom rekombinantnih ljudskih enzima CYP i mikrosoma ljudske jetre.
The adverse reactions most commonly (≥ 1% in the total perampanel group and greater than placebo) leading to discontinuation were dizziness and somnolence. 
Nuspojave koje su najčešće (≥1% u cijeloj skupini koja je uzimala perampanel i više nego placebo) dovele do prekida liječenja bile su omaglica i pospanost.
Multiple dosing of perampanel 12 mg/day increased levels of anger, confusion, and depression as assessed using the Profile of Mood State 5-point rating scale (see section 5.1). 
Višekratne doze perampanela od 12 mg na dan povisile su razine ljutnje, smetenosti i depresije, kako se procijenilo pomoću ocjenske ljestvice profila stanja raspoloženja s 5 stupnjeva (vidjeti dio 5.1).
There is limited clinical experience with perampanel overdose in humans. 
Kliničko iskustvo s predoziranjam perampanela u ljudi je ograničeno.
The mean apparent clearance of unbound perampanel in mildly impaired subjects was 188 ml/min vs. 338 ml/min in matched controls, and in moderately impaired subjects was 120 ml/min vs. 392 ml/min in matched controls. 
Prosječni prividni klirens nevezanog perampanela u ispitanika s blagim oštećenjem iznosio je 188 ml/min naspram 338 ml/min u sličnih kontrolnih ispitanika, a u ispitanika s umjerenim oštećenjem iznosio je 120 ml/min nasuprot 392 ml/min u sličnih kontrolnih ispitanika.
Following administration of radiolabeled perampanel, only trace amounts of perampanel metabolites were observed in plasma. 
Nakon primjene radiološki označenog perampanela, u plazmi su bili pronađeni metaboliti perampanela samo u tragovima.
During the Titration Phase in all three trials, treatment was initiated at 2 mg/day and increased in weekly increments of 2 mg/day to the target dose. 
Tijekom faze titracije u sva tri ispitivanja, liječenje je bilo započeto dozom od 2 mg na dan koja se povisivala za 2 mg na dan do ciljne doze.
The doctor will weigh up the benefit and risks to your baby of taking Fycompa while you are breast-feeding. 
Liječnik će odvagnuti koristi u odnosu na rizike uzimanja Fycompe za Vaše dijete u razdoblju dojenja.
It should not be chewed, crushed or split. 
Tabletu se ne smije žvakati, drobiti niti lomiti.
A 19-week, randomised, double-blind, placebo-controlled study with an open-label extension phase (Study 235) was performed to assess the short-term effects on cognition of Fycompa (target dose range of 8 to 12 mg once daily) as adjunctive therapy in 133 (Fycompa n = 85, placebo n = 48) adolescent patients, ages 12 to less than 18 years old, with inadequately controlled partial-onset seizures. 
Provedeno je 19-tjedno randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje s fazom otvorenog produžetka (ispitivanje 235) kako bi se procijenili kratkotrajni učinci Fycompe na kognitivne sposobnosti (ciljni raspon doza od 8 do 12 mg jedanput na dan) kao dodatna terapija u 133 (Fycompa n=85, placebo n=48) adolescentna bolesnika u dobi od 12 do manje od 18 godina, s nezadovoljavajuće kontroliranim parcijalnim napadajima.
1 bottle (340 ml) contains 170 mg perampanel. 
Jedna boca (340 ml) sadrži 170 mg perampanela.
Response rates after addition of perampanel at fixed doses were less when patients received concomitant CYP3A enzyme-inducing anti-epileptic medicinal products (carbamazepine, phenytoin, oxcarbazepine) as compared to response rates in patient who received concomitant non-enzyme-inducing anti-epileptic medicinal products. 
Stope odgovora nakon dodavanja fiksnih doza perampanela bile su manje u bolesnika koji su istovremeno primali antiepileptičke lijekove koji induciraju enzim CYP3A (karbamazepin, fenitoin, okskarbazepin) u usporedbi sa stopama odgovora u bolesnika koji su istovremeno primali antiepileptičke lijekove koji ne induciraju enzime.
The effect of perampanel on human fertility has not been established. 
Učinak perampanela na plodnost u ljudi nije ustanovljen.
Perampanel is dosed to clinical effect regardless of other AEDs. 
Perampanel se dozira do postizanja kliničkog učinka bez obzira na druge antiepileptike.
Talk to your doctor or pharmacist before taking Fycompa if you have liver problems or moderate or severe kidney problems. 
Obratite se svom liječniku ili ljekarniku prije nego uzmete Fycompu ako imate tegobe s jetrom ili umjerene do teške tegobe s bubrezima.
The active substance is perampanel. 
Djelatna tvar je perampanel.
In healthy subjects, Fycompa (6 mg once daily for 20 days) decreased midazolam AUC by 13%. 
U zdravih je ispitanika Fycompa (6 mg jedanput na dan tijekom 20 dana) smanjio AUC midazolama za 13%.
Common (may affect more than 1 user in 100) are: - increased or decreased appetite, weight gain - feeling aggressive, angry, irritable, anxious or confused - difficulty with walking or other balance problems (ataxia, gait disturbance, balance disorder) - slow speech (dysarthria) - blurred vision or double vision (diplopia) - spinning sensation (vertigo) - feeling sick (nausea) - back pain - feeling very tired (fatigue) - falling down 
Česte nuspojave (mogu se javiti u više od 1 korisnika na 100): - pojačan ili oslabljen apetit, povećanje tjelesne težine - osjećaj agresivnosti, ljutnje, razdraženosti, tjeskobe ili smetenosti - poteškoće s hodanjem ili druge poteškoće s ravnotežom (ataksija, poremećen hod, poremećaj ravnoteže) - usporen govor (dizartrija) - zamagljen vid ili dvostruki vid (diplopija) - osjećaj vrtnje (vrtoglavica) - mučnina - bol u leđima - jak umor (iscrpljenost) - padanje
A decrease in PGTC seizure frequency of at least 50% was seen in 65.9% of subjects after 1 year of treatment during the Extension Phase (relative to their pre-perampanel baseline seizure frequency). 
Smanjenje učestalosti primarno generaliziranih toničko-kloničkih napadaja za najmanje 50% bilo je opaženo u 65,9% ispitanika nakon 1 godine liječenja tijekom faze produžetka ispitivanja (u odnosu na njihovu početnu učestalost napadaja prije perampanela).
You can take Fycompa with or without food and should always take it the same way. 
Fycompu možete uzeti s hranom ili bez nje, ali je uzimajte uvijek na isti način.
Caution should be exercised in patients with a history of substance abuse and the patient should be monitored for symptoms of perampanel abuse. 
Potreban je oprez u bolesnika koji u anamnezi imaju zloporabu droga i takvog bolesnika treba pratiti zbog simptoma zloporabe perampanela.
Perampanel may cause dizziness and somnolence and therefore may influence the ability to drive or use machines (see section 4.7). 
Perampanel može prouzročiti omaglicu i pospanost te stoga može utjecati na sposobnost upravljanja vozilima i rukovanja strojevima (vidjeti dio 4.7).
In the controlled and uncontrolled trial in patients with primary generalised tonic-clonic seizures, 114 subjects have received perampanel of whom 68 have been treated for 6 months and 36 for longer than 12 months. 
U kontroliranim i nekontroliranim ispitivanjima u bolesnika s primarno generaliziranim toničko-kloničkim napadajima, od 114 ispitanika koji su primali perampanel, njih 68 bilo je liječeno 6 mjeseci, a 36 dulje od 12 mjeseci.
These studies show that once-daily administration of perampanel at doses of 4 mg to 12 mg was significantly more efficacious than placebo as adjunctive treatment in this population. 
Ova ispitivanja pokazuju da je primjena perampanela jedanput na dan u dozi od 4 mg do 12 mg bila značajno djelotvornija kao dodatno liječenje u ove populacije nego što je to bio placebo.
When coadministered with a high fat meal, Cmax and AUC0-inf of a single 12-mg dose of perampanel oral suspension were approximately 22% and 13%, respectively, lower compared to fasted conditions. 
Kada se primjenjuje uz obrok s visokim udjelom masti, vrijednosti za Cmax i AUC0-inf jedne doze oralne suspenzije perampanela od 12 mg bile su približno 22% odnosno 13% niže u usporedbi s onima dobivenim mjerenjem natašte.
Perampanel at a dose up to 8 mg/day has been shown to be effective in primary generalised tonic-clonic seizures. 
Perampanel u dozi do 8 mg na dan pokazao se učinkovit kod primarno generaliziranih toničko-kloničkih napadaja.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Fycompa. 
Ako Vam je liječnik rekao da ne podnosite neke šećere, savjetujte se s liječnikom prije uzimanja Fycompe.
Thirty four (34) patients were followed up for at least 6 months and, of these, 24 patients (71%) remained on perampanel monotherapy for at least 6 months. 
Od 34 bolesnika koja su praćena najmanje 6 mjeseci, 24 bolesnika (71%) ostalo je na monoterapiji perampanelom najmanje 6 mjeseci.
Fycompa 2 mg film-coated tablets Fycompa 4 mg film-coated tablets Fycompa 6 mg film-coated tablets Fycompa 8 mg film-coated tablets Fycompa 10 mg film-coated tablets Fycompa 12 mg film-coated tablets 
Fycompa 2 mg filmom obložene tablete Fycompa 4 mg filmom obložene tablete Fycompa 6 mg filmom obložene tablete Fycompa 8 mg filmom obložene tablete Fycompa 10 mg filmom obložene tablete Fycompa 12 mg filmom obložene tablete
Fycompa may make certain hormonal contraceptives such as levonorgestrel less effective. 
Fycompa može smanjiti djelotvornost nekih hormonskih kontraceptiva, kao što je levonorgestrel.
The 50% responder rates in the 4 mg, 8 mg and 12 mg groups were respectively 23.0%, 31.5%, and 30.0% in combination with enzyme-inducing anti-epileptic medicinal products and were 33.3%, 46.5% and 50.0% when perampanel was given in combination with non-enzyme-inducing anti-epileptic medicinal products. 
Stope bolesnika s 50%-tnim odgovorom u skupinama koje su primale doze od 4 mg, 8 mg i 12 mg iznosile su 23,0%, 31,5% odnosno 30,0% kad se perampanel davao u kombinaciji s antiepileptičkim lijekovima koji induciraju enzime te 33,3%, 46,5% odnosno 50,0% kad se perampanel davao u kombinaciji s antiepileptičkim lijekovima koji ne induciraju enzime.
Not known (the frequency of this side effect cannot be estimated from the available data) are: - widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome). 
Nepoznato (učestalost ovih nuspojava ne može se procijeniti iz dostupnih podataka): - široko rasprostranjeni osip, visoka tjelesna temperatura, povišenje jetrenih enzima, abnormalnosti u krvi (eozinofilija), povećani limfni čvorovi s uključenošću drugih tjelesnih organa (reakcija na lijek s eozinofilijom i sustavnim simptomima poznata i pod nazivom DRESS ili sindrom preosjetljivosti na lijek).
- Your doctor may increase this in 2 mg steps to a maintenance dose between 4 mg and 12 mg depending on your response. 
- Liječnik je može povećavati po 2 mg do doze održavanja između 4 mg i 12 mg - ovisno o
Other concomitant (non- anti-epileptic) cytochrome P450 inducing or inhibiting medicinal products 
Istovremena primjena drugih lijekova (ne antiepileptičkih) koji induciraju ili inhibiraju citokrom P450
Some anti-epileptic drugs known as CYP450 3A enzyme inducers (carbamazepine, phenytoin, oxcarbazepine) have been shown to increase perampanel clearance and consequently to decrease plasma concentrations of perampanel. 
Pokazalo se da neki antiepileptički lijekovi koji su poznati kao induktori enzima CYP450 3A (karbamazepin, fenitoin, okskarbazepin), povećavaju klirens perampanela i posljedično snizuju koncentracije perampanela u plazmi.
Perampanel is a first-in-class selective, non-competitive antagonist of the ionotropic α-amino-3hydroxy-5-methyl-4-isoxazolepopionic acid (AMPA) glutamate receptor on post-synaptic neurons. 
Perampanel je prvi u klasi selektivnih, nekompetitivnih antagonista ionotropnog glutamatnog receptora α-amino-3-hidroksi-5-metil-4-izoksazolpropionatne kiseline (AMPA) na postsinaptičkim neuronima.
Perampanel is extensively metabolised via primary oxidation and sequential glucuronidation. 
Perampanel se opsežno metabolizira putem primarne oksidacije te potom glukuronidacije.
If at any time you have these thoughts, contact your doctor straight away. 
Ako Vam se ikad pojave takve misli, odmah se obratite svom liječniku.
The efficacy of perampanel in partial-onset seizures was established in three adjunctive therapy 19 week, randomised, double-blind, placebo-controlled, multicentre trials in adult and adolescent patients. 
Djelotvornost perampanela u parcijalnim napadajima bila je ustanovljena u tri randomizirana, dvostruko slijepa, placebom kontrolirana, multicentrična ispitivanja dodatne terapije u trajanju od 19 tjedana u odraslih i adolescentnih bolesnika.
Perampanel as adjunctive therapy in patients 12 years of age and older with idiopathic generalised epilepsy experiencing primary generalised tonic-clonic seizures was established in a multicenter, randomised, double-blind, placebo-controlled study (Study 332). 
Perampanel kao dodatna terapija u bolesnika u dobi od 12 i više godina s idiopatskom generaliziranom epilepsijom koji su imali primarno generalizirane toničko-kloničke napadaje bila je ustanovljena u multicentričnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju (ispitivanje 332).
<10% decrease 
<10% sniženje klobazam nema utjecaja
Potential interactions between Fycompa (up to 12 mg once daily) and other anti-epileptic drugs (AEDs) were assessed in clinical studies and evaluated in the population PK analysis of four pooled Phase 3 studies including patients with partial-onset seizures and primary generalised tonic-clonic seizures. 
Moguće interakcije između Fycompe (u dozi do 12 mg jedanput na dan) i drugih antiepileptičkih lijekova bile su procijenjene u kliničkim ispitivanjima i pomoću populacijske farmakokinetičke analize objedinjenih podataka iz četiri ispitivanja faze 3 koja su uključila bolesnike s parcijalnim napadajima i primarno generaliziranim toničko-kloničkim napadajima.
The dosage of perampanel should be reduced if such symptoms occur and should be discontinued immediately if symptoms are severe. 
Ako se takvi simptomi pojave dozu perampanela treba smanjiti, a ako su simptomi teški, liječenje treba odmah prekinuti.
In healthy subjects, plasma concentrations of perampanel increased in direct proportion to administered doses over the range of 2 to 12 mg. 
Koncentracije perampanela u plazmi zdravih ispitanika povećavale su se proporcionalno primijenjenim dozama u rasponu od 2 do 12 mg.
You should not take Fycompa if you have serious liver problems or moderate or serious kidney problems. 
Ne smijete uzimati Fycompu ako imate ozbiljne tegobe s jetrom ili umjerene ili ozbiljne tegobe s bubrezima.
Tell your doctor if you are taking midazolam as your dose may need to be adjusted. 
Obavijestite svog liječnika ako uzimate midazolam jer će Vam možda trebati prilagoditi dozu.
Patients from the randomised trial were converted to perampanel over 16 weeks followed by a long term maintenance period (≥ 1 year). 
Bolesnici iz randomiziranih ispitivanja bili su prebačeni na perampanel u roku od 16 tjedana, a potom je slijedilo dugo razdoblje održavanja (≥1 godine).
What Fycompa contains 
Što Fycompa sadrži
In a population pharmacokinetic analysis of the adolescent patients pooled from the Phase 2 and 3 clinical studies, there were no notable differences between this population and the overall population. 
U populacijskoj farmakokinetičkoj analizi objedinjenih podataka za adolescentne bolesnike iz kliničkih ispitivanja faze 2 i 3 nije bilo primjetnih razlika između ove populacije i ukupne populacije.
Very common (may affect more than 1 user in 10) are: - feeling dizzy - feeling sleepy (drowsiness or somnolence) 
Vrlo česte nuspojave (mogu se javiti u više od 1 korisnika na 10): - omaglica - pospanost (omamljenost ili pospanost)
In a population pharmacokinetic analysis of patients with partial-onset seizures receiving Fycompa up to 12 mg/day in placebo-controlled clinical trials, Fycompa did not affect to a clinically relevant manner the clearance of clonazepam, levetiracetam, phenobarbital, phenytoin, topiramate, zonisamide, carbamazepine, clobazam, lamotrigine and valproic acid, at the highest perampanel dose evaluated (12 mg/day). 
U populacijskoj farmakokinetičkoj analizi bolesnika s parcijalnim napadajima koji su primali Fycompu u dozi do 12 mg na dan u placebom kontroliranim kliničkim ispitivanjima, Fycompa nije imala klinički važan utjecaj na klirens klonazepama, levetiracetama, fenobarbitala, fenitoina, topiramata, zonisamida, karbamazepina, klobazama, lamotrigina i valproatne kiseline pri najvišim ispitanim dozama perampanela (12 mg na dan).
Uncommon (may affect more than 1 user in 1000) are: - thoughts about harming yourself or ending your own life (suicidal thoughts), tried to end your own life (attempted suicide) 
Manje česte nuspojave (mogu se javiti u više od 1 korisnika na 1000): - misli o samoozljeđivanju ili samoubojstvu (suicidalne misli), pokušaj samoubojstva (pokušaj suicida).
Fycompa is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in adult and adolescent patients from 12 years of age with epilepsy. 
Fycompa je indicirana za dodatno liječenje parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih bolesnika i adolescenata u dobi iznad 12 godina s epilepsijom.
For patients with perampanel in the open label extension (n = 112), the mean change (SD) from baseline to end of open-label treatment (52 weeks) in CDR System Global Cognition t-Score was (minus) -1.0 (9.91). 
Za bolesnike koji su u otvorenom produžetku ispitivanja primali perampanel (n=112), srednja vrijednost promjene (SD) od početka ispitivanja do kraja otvorenog liječenja (52 tjedna) prema t-rezultatu za opće kognitivno funkcioniranje dobivenom sustavom CDR testova bila je (minus) -1,0 (9,91).
Take Fycompa for as long as your doctor recommends. 
Uzimajte Fycompu onoliko dugo koliko je to preporučio liječnik.
Switching between the tablet and suspension formulation should be done with caution (see section 5.2). 
Potreban je oprez kad se prelazi s tableta na primjenu suspenzije i obrnuto (vidjeti dio 5.2).
1) Active metabolite monohydroxycarbazepine was not assessed. 
Aktivni metabolit monohidroksikarbazepin nije bio procijenjen.
Patients from the randomised trial were converted to perampanel over 6 weeks followed by a long term maintenance period (≥ 1 year). 
Bolesnici iz randomiziranog ispitivanja bili su prebačeni na perampanel tijekom 6 tjedana nakon čega je uslijedilo dugotrajno razdoblje terapije održavanja (≥1 godine).
Freedom from all seizures was achieved in 23.5% (19/81) of patients on perampanel compared to 4.9% (4/81) of patients on placebo. 
Prestanak svih napadaja postignut je u 23,5% (19/81) bolesnika koji su uzimali perampanel u usporedbi s 4,9% (4/81) bolesnika koji su uzimali placebo.
Fycompa is for oral use. 
Fycompa je namijenjena za oralnu primjenu.
Conversely, withdrawal of a concomitant CYP450 3A enzyme inducer can be expected to increase plasma concentrations of perampanel and dose reduction may be required. 
Suprotne tome, očekuje se da će se ukidanjem istovremene primjene induktora enzima CYP450 3A koncentracije perampanela u plazmi povećati, pa može biti potrebno smanjenje doze.
Taking Fycompa with other anti-epileptic medicine, which contains sorbitol, may affect how much they work. 
Uzimanje Fycompe s drugim lijekom protiv epilepsije koji sadrži sorbitol, može utjecati na njihovo djelovanje.
Patients should be closely monitored for tolerability and clinical response when adding or removing cytochrome P450 inducers or inhibitors, since perampanel plasma levels can be decreased or increased; the dose of perampanel may need to be adjusted accordingly. 
Kad se dodaju ili ukidaju lijekovi koji induciraju ili inhibiraju citokrom P450, bolesnike treba pažljivo pratiti zbog podnošljivosti i kliničkog odgovora, budući da razine perampanela u plazmi mogu biti snižene ili povišene; može biti potrebno prilagoditi dozu perampanela sukladno tome.
It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. 
Važno je napomenuti da je moguća rana pojava reakcija preosjetljivosti, primjerice vrućice ili limfadenopatije, iako osip nije vidljiv.
You should continue doing this for one month after stopping treatment. 
Kontracepciju trebate nastaviti uzimati i jedan mjesec nakon prestanka liječenja.
Influence of AED on Fycompa concentration 
Utjecaj antiepileptika na koncentraciju Fycompe
In all three trials, following a 6-week Baseline Phase to establish baseline seizure frequency prior to randomisation, subjects were randomised and titrated to the randomised dose. 
U sva tri ispitivanja, nakon 6-tjednog početnog razdoblja tijekom kojeg se odredila osnovna učestalost napadaja prije randomizacije, ispitanici su bili randomizirani i titrirani do nasumično dodijeljene doze.
- Drinking alcohol while taking Fycompa can make you less alert and affect your ability to drive or use tools or machines. 
- Konzumiranje alkohola za vrijeme uzimanja Fycompe može Vam smanjiti budnost i utjecati na Vašu sposobnost upravljanja vozilima i rukovanja alatima i strojevima.