FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have problems with your liver or kidney, or if you are older than 65, and depending on the severity of your problems, your doctor may carefully consider whether this medicine is suitable for you or recommend that you take a different dose, and monitor you more closely for potential side effects.
Slovenian: Če imate težave z jetri ali ledvicami ali če ste starejši od 65 let, bo zdravnik glede na resnost težav skrbno presodil, ali je to zdravilo primerno za vas, ali vam priporočil, da jemljete drugačen odmerek, in vas natančneje spremljal zaradi morebitnih neželenih učinkov.
English: Mysimba is available in packs containing 28 or 112 tablets.
Slovenian: Zdravilo Mysimba je na voljo v pakiranjih, ki vsebujejo po 28, 112 tablet.
English: The tablets should not be cut, chewed, or crushed.
Slovenian: Tablete se ne smejo prerezati, žvečiti ali zdrobiti.
English: After you stop treatment with Mysimba you may be more sensitive to low doses of opiates (see “Do not take Mysimba”).
Slovenian: Ko boste prekinili zdravljenje z zdravilom Mysimba, boste morda bolj občutljivi na manjše odmerke opiatov (glejte “Ne jemljite zdravila Mysimba”).
English: Polska Valeant Pharma Poland sp. z o.o.
Slovenian: Valeant Pharma Poland sp. z o.o.
English: Fits are more likely if you take too much, if you take some other medicines or if you are at a higher than usual risk of fits (see section 2).
Slovenian: Pojav krčev je bolj verjeten, če vzamete prevelik odmerek, če vzamete nekatera druga zdravila ali če je tveganje krčev pri vas večje kot običajno (glejte poglavje 2).
English: However, studies on abuse liability in humans and extensive clinical experience show that bupropion has low abuse potential.
Slovenian: Vendar so študije o možnosti zlorabe pri človeku in obsežne klinične izkušnje pokazale, da je verjetnost zlorabe bupropiona majhna.
English: Post Authorisation Safety Study :
Slovenian: Študija o varnosti zdravila po pridobitvi dovoljenja za promet:
English: • Patients undergoing acute alcohol or benzodiazepine withdrawal
Slovenian: • Bolniki, ki prestajajo akutno odtegnitev alkohola ali benzodiazepinov
English: General supportive and symptomatic measures are also recommended.
Slovenian: Priporočeni ukrepi obsegajo splošno podporno in simptomatsko zdravljenje.
English: • Ticlopidine or clopidogrel, mainly used in the treatment of heart disease or stroke;
Slovenian: • tiklopidin ali klopidogrel, ki se v glavnem uporabljata za zdravljenje bolezni srca ali možganske kapi;
English: In the combined Phase 3 studies, the mean age was 46 years, 83% were female, and 77% were White, 18% were Black and 5% were other races.
Slovenian: V združenih podatkih študij 3. faze je bila povprečna starost 46 let, 83 % oseb je bilo žensk, 77 % oseb je bilo belcev, 18 % je bilo črncev, 5 % pa je bilo predstavnikov drugih ras.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Mysimba in one or more subsets of the paediatric population in obesity (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Mysimba za eno ali več podskupin pediatrične populacije glede debelosti (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: If a dose is missed, patients should not take an additional dose, but take the prescribed next dose at the usual time.
Slovenian: Če bolnik izpusti odmerek, ne sme vzeti dodatnega odmerka, ampak mora ob predvidenem času vzeti naslednji predpisani odmerek.
English: The MAH shall ensure that in each Member State where Mysimba is marketed, all healthcare professionals who are expected to prescribe Mysimba are provided with a prescriber guide.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da v vsaki državi članici, kjer se zdravilo Mysimba trži, vsi zdravstveni delavci, za katere se pričakuje, da bodo predpisovali zdravilo Mysimba,
English: The body mass index is calculated as the measured body weight (kg) divided by the measured height squared (m2).
Slovenian: Indeks telesne mase se izračuna z izmerjeno telesno maso (kg), deljeno z izmerjeno višino na kvadrat (m2).
English: Naltrexone and its metabolites are excreted primarily by the kidney (37 to 60% of the dose).
Slovenian: Naltrekson in njegovi presnovki se primarno izločajo skozi ledvice (37 do 60 % odmerka).
English: The maximum recommended daily dose of Mysimba is two tablets taken twice a day.
Slovenian: Največji priporočeni dnevni odmerek zdravila Mysimba je po dve tableti dvakrat dnevno.
English: Opioid analgesics
Slovenian: Opioidni analgetiki
English: In case of doubt, check with your doctor, who might consider to interrupt the treatment depending on your situation.
Slovenian: Če ste v dvomih, se posvetujte z zdravnikom, ki bo na podlagi ocene vaše situacije razmislil o prekinitvi zdravljenja.
English: Rare - may affect up to 1 in 1,000 people taking Mysimba with risk of having a fit.
Slovenian: redki - pojavijo se lahko pri največ 1 od 1.000 bolnikov, ki jemljejo zdravilo Mysimba, s tveganjem za krče.
English: The tablets should preferably be taken with food (see section 5.2).
Slovenian: Priporoča se, da se tablete jemljejo skupaj s hrano (glejte poglavje 5.2).
English: • Patients with a current or previous diagnosis of bulimia or anorexia nervosa
Slovenian: • Bolniki, ki imajo trenutno ali so imeli v preteklosti diagnozo bulimije ali anoreksije nervoze
English: Your doctor may test your blood before initiating treatment with Mysimba if you have high blood sugar (diabetes) or if you are older than 65, so that your doctor can decide if you should take this medicine or if you need to take a different dose.
Slovenian: Zdravnik bo morda pred uvedbo zdravljenja z zdravilom Mysimba pri vas izvedel krvni test, če imate visoko raven sladkorja v krvi (sladkorno bolezen) ali če ste stari več kot 65 let, tako da bo lahko presodil, ali smete jemati to zdravilo ali če potrebujete drugačen odmerek.
English: EU/1/14/988/002 28 tablets
Slovenian: EU/1/14/988/002 28 tablet
English: Naltrexone blocks the effects of opiates; if you take higher doses of opiates to overcome these effects of naltrexone, you may suffer from an acute opiate intoxication which may be life threatening.
Slovenian: Naltrekson blokira učinke opiatov; če vzamete večje odmerke opiatov, da bi premostili te učinke naltreksona, se bo morda pri vas pojavila akutna zastrupitev z opiati, ki je smrtno nevarna.
English: • if you are currently dependent on or addicted to cocaine or other stimulating products;
Slovenian: • če ste trenutno odvisni od kokaina ali drugih stimulativnih sredstev oziroma ste zasvojeni z njimi;
English: What Mysimba is and what it is used for
Slovenian: Kaj je zdravilo Mysimba in za kaj ga uporabljamo
English: Naltrexone is primarily metabolized to 6-beta-naltrexol by the dihydrodiol dehydrogenases (DD1, DD2 and DD4).
Slovenian: Naltrekson se primarno presnavlja v 6-beta-naltreksol prek dihidrodiol dehidrogenaz (DD1, DD2 in DD4).
English: Seizure was reported in approximately one third of these overdose cases.
Slovenian: Pri približno eni tretjini teh primerov prevelikega odmerjanja so poročali o epileptičnih napadih.
English: • you already have or have had a condition affecting the circulation of blood in the brain (cerebrovascular disease).
Slovenian: • če imate ali ste imeli bolezen, ki vpliva na obtok krvi v možganih (cerebrovaskularno bolezen);
English: Metabolites of bupropion (and to a lesser extent unmetabolised bupropion) accumulate and reach steady state concentrations in approximately one week.
Slovenian: Presnovki bupropiona (in v manjši meri nepresnovljen bupropion) pa se akumulirajo in dosežejo koncentracije v stanju dinamičnega ravnovesja v približno enem tednu.
English: 6.5 Nature and contents of container PVC/PCTFE/PVC/Aluminium blisters.
Slovenian: 6.5 Vrsta ovojnine in vsebina Pretisni omoti PVC/PCTFE/PVC/aluminij.
English: In clinical practice with other bupropion containing products, hypertension, in some cases severe and requiring acute treatment, has been reported.
Slovenian: V klinični praksi so pri uporabi drugih zdravil, ki vsebujejo bupropion, poročali o hipertenziji, ki je bila v nekaterih primerih huda in je zahtevala akutno zdravljenje.
English: • tramadol (a painkiller belonging to the class of opiates);
Slovenian: • tramadol (zdravilo za lajšanje bolečin, ki spada v razred opiatov);
English: • if you regularly use medicines to help you to sleep (sedatives);
Slovenian: • če redno jemljete zdravila za uspavanje (pomirjevala);
English: Obesity in adults over 18 years of age is defined as a body mass index of greater than or equal to 30 and overweight in adults over 18 years of age is defined as a body mass index greater than or equal to 27 and less than 30.
Slovenian: Debelost pri odraslih, starejših od 18 let, je opredeljena z indeksom telesne mase, ki je večji ali enak 30, odrasli, ki so starejši od 18 let in imajo čezmerno telesno maso, pa so opredeljeni z indeksom telesne mase, ki je večji ali enak 27 in manjši od 30.
English: If you experience fainting, muscle weakness or fits during treatment, do not drive or use machines.
Slovenian: Če se med zdravljenjem pojavijo omedlevica, mišična šibkost ali krči, ne vozite ali upravljajte strojev.
English: Symptoms include severe muscle cramps, muscle pain or muscle weakness.
Slovenian: Simptomi vključujejo hude mišične krče, bolečine v mišicah in šibkost mišic.
English: Rhabdomyolysis is an abnormal breakdown of muscle tissue which can lead to kidney problems.
Slovenian: Rabdomioliza je nenormalna razgradnja mišičnega tkiva, ki lahko povzroči težave z ledvicami.
English: If you have thoughts about harming yourself or other distressing thoughts, or if you are depressed and notice that you feel worse or develop new symptoms, contact your doctor or go to a hospital straight away.
Slovenian: Če razmišljate o tem, da bi se poškodovali, ali imate druge obremenjujoče misli, ste depresivni in opazite, da se počutite slabše ali pa se razvijejo novi simptomi, se takoj obrnite na zdravnika ali pojdite v bolnišnico.
English: The metabolites have longer elimination half-lives than bupropion and accumulate to a greater extent.
Slovenian: Presnovki imajo daljše razpolovne čase izločanja kot bupropion in se akumulirajo v večji meri.
English: Excessive use of alcohol while being treated with Mysimba might increase the risk for fits (seizures), mental disorder events or might reduce alcohol tolerance.
Slovenian: Čezmerna uporaba alkohola med zdravljenjem z zdravilom Mysimba lahko poveča tveganje krčev (epileptičnih napadov) ali duševnih motenj oziroma zmanjša toleranco za alkohol.
English: When feasible, the option of therapeutic drug monitoring should be considered for medicinal products with a narrow therapeutic index, such as tricyclic antidepressants.
Slovenian: Če je to izvedljivo, je treba razmisliti o možnosti spremljanja koncentracije zdravil z ozkim terapevtskim indeksom, kot so triciklični antidepresivi.
English: However, only Caucasian and Black subjects were investigated to a significant extent.
Slovenian: Vendar so bili v večjem obsegu v raziskave vključeni samo preiskovanci bele in črne rase.
English: A decrease in the pregnancy rate of mated female rats also occurred.
Slovenian: Prišlo je tudi do zmanjšanja stopnje brejosti pri samicah podgan, ki so se parile.
English: Genotoxicity data indicate that bupropion is a weak bacterial mutagen, but not a mammalian mutagen, and therefore is of no concern as a human genotoxic agent.
Slovenian: Podatki o genotoksičnosti kažejo, da je bupropion šibek bakterijski mutagen, toda ne mutagen sesalcev, zato kot genotoksično zdravilo pri človeku ni relevanten.
English: Based on its half-life, 6-beta-naltrexol is estimated to reach steady state concentrations in approximately 3 days.
Slovenian: Na podlagi razpolovnega časa se ocenjuje, da 6-beta-naltreksol doseže koncentracije v stanju dinamičnega ravnovesja v približno 3 dneh.
English: Frequency of the side effects suicide attempts, suicidal behavior, suicidal thoughts and feeling depressed are not known and cannot be estimated from the available data in people taking Mysimba.
Slovenian: pogostnost neželenih učinkov, kot so poskusi samomora, samomorilno vedenje, samomorilne misli in občutek depresije, ni znana in je ni mogoče oceniti iz razpoložljivih podatkov za bolnike, ki jemljejo zdravilo Mysimba.
English: Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Slovenian: Bolnike (in skrbnike bolnikov) je treba opozoriti, da morajo biti pozorni na kakršno koli klinično poslabšanje, pojav samomorilnega vedenja, misli na samomor in pojav neobičajnih vedenjskih sprememb ter da se morajo v primeru, da takšni simptomi ne minejo, nemudoma posvetovati z zdravnikom.
English: Studies with naltrexone in animals have shown reproductive toxicity (see section 5.3); animal studies with bupropion show no clear evidence of reproductive harm.
Slovenian: Študije na živalih z naltreksonom so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3); študije na živalih z bupropionom niso pokazale jasnih dokazov o škodljivem učinku na sposobnost razmnoževanja.
English: Based on these results, there are no dose adjustments recommended for patients with mild renal impairment.
Slovenian: Na podlagi teh rezultatov ni priporočil o prilagajanju odmerka za bolnike z blago okvaro ledvic.
English: Pharmacotherapeutic group: A08AA Centrally acting antiobesity products, ATC code: A08AA62 bupropion and naltrexone.
Slovenian: Farmakoterapevtska skupina: A08AA zaviralci apetita s centralnim delovanjem, oznaka ATC: A08AA62 bupropion in naltrekson.
English: Excipient with known effect: Each prolonged-release tablet contains 73.2 mg of lactose (see section 4.4).
Slovenian: Pomožne snovi z znanim učinkom: Ena tableta s podaljšanim sproščanjem vsebuje 73,2 mg laktoze (glejte poglavje 4.4).
English: Any effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Slovenian: Učinke so v predkliničnih študijah opazili samo pri izpostavljenosti, ki je močno presegala največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo.
English: Blocking this inhibitory feedback loop with naltrexone is proposed to facilitate a more potent and longer-lasting activation of POMC neurons, thereby amplifying the effects of bupropion on energy balance.
Slovenian: Z blokado te zaviralne povratne zanke z naltreksonom naj bi se sprožilo močnejše in daljše aktiviranje nevronov POMC, tako da se okrepijo učinki bupropiona na energijsko ravnotežje.
English: If you take too many tablets, you may be more likely to have a fit or other side effects similar to those described in section 4 below.
Slovenian: Če ste vzeli večji odmerek zdravila Mysimba, kot bi smeli Če ste vzeli preveč tablet, se bodo pri vas bolj verjetno pojavili krči ali drugi neželeni učinki, podobni tistim, ki so opisani spodaj v poglavju 4.
English: Attempt to overcome blockade: The attempt to overcome any naltrexone opioid blockade by administering large amounts of exogenous opioids is very dangerous and may lead to a fatal overdose or life endangering opioid intoxication (e.g., respiratory arrest, circulatory collapse).
Slovenian: Poskus premostitve blokade: Poskus premostitve kakršne koli opioidne blokade, ki jo povzroča naltrekson, z jemanjem velike količine eksogenih opioidov je zelo nevaren in lahko vodi do prevelikega odmerjanja s smrtnim izidom ali smrtno nevarne zastrupitve z opioidi (npr. respiratornega zastoja ali cirkulatornega kolapsa).
English: * Difference from placebo, p<0.001 ** Difference from placebo, p<0.01
Slovenian: * Razlika glede na placebo, p<0,001 ** Razlika glede na placebo, p<0,01
English: Stevens Johnson Syndrome is a rare skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals.
Slovenian: Stevens-Johnsonov sindrom je redka kožna bolezen s hudimi mehurji in krvavitvami na ustnicah, v očesih, ustih,
English: • Medicines that may, when used alone or in combination with naltrexone/bupropion, increase the risk of fits such as:
Slovenian: • zdravila, ki lahko pri samostojni uporabi ali v kombinaciji z naltreksonom/bupropionom povečajo tveganje za krče:
English: These components affect two principal areas of the brain, specifically the arcuate nucleus of the hypothalamus and the mesolimbic dopaminergic reward system.
Slovenian: Ti sestavini vplivata na dva glavna predela v možganih, in sicer na arkuatno jedro hipotalamusa in mezolimbični dopaminergični sistem za nagrajevanje.
English: INFORMATION IN BRAILLE mysimba
Slovenian: PODATKI V BRAILLOVI PISAVI mysimba
English: • Patients with uncontrolled hypertension (see section 4.4)
Slovenian: • Bolniki z nenadzorovano hipertenzijo (glejte poglavje 4.4)
English: Older People
Slovenian: Starejše osebe
English: Neuropsychiatric symptoms and activation of mania Activation of mania and hypomania have been reported in patients with mood disorders who were treated with other similar medicinal products for major depressive disorder.
Slovenian: Nevropsihiatrični simptomi in aktivacija manije O aktivaciji manije in hipomanije so poročali pri bolnikih z razpoloženjskimi motnjami, ki so bili zdravljeni s podobnimi zdravili za veliko depresivno motnjo.
English: Your doctor may suggest you do not drink alcohol while you are taking Mysimba, or try to drink as little as possible.
Slovenian: Zdravnik vam bo morda svetoval, da v obdobju jemanja zdravila Mysimba ne uživate alkohola oziroma da ga poskušate zaužiti čim manj.
English: * Difference from placebo, p<0.001.
Slovenian: * Razlika glede na placebo, p<0,001.
English: Other medicines and Mysimba
Slovenian: Druga zdravila in zdravilo Mysimba
English: The types of tolerability events were similar to the events observed in patients with normal renal function (see sections 4.2, 4.4, and 5.2).
Slovenian: Dogodki v zvezi s toleranco so bili glede na vrsto podobni tistim, ki so jih opazili pri bolnikih z normalno ledvično funkcijo (glejte poglavja 4.2, 4.4 in 5.2).
English: Mysimba with alcohol
Slovenian: Zdravilo Mysimba skupaj z alkoholom
English: Uncommon Delusions (B), Depersonalisation (B), Libido disorder (N), Paranoid ideation (B)
Slovenian: Občasni deluzije (B), depersonalizacija (B), motnje libida (N), paranoidne misli (B)
English: In vitro findings suggest that CYP2B6 is the principal isozyme involved in the formation of hydroxybupropion, while CYP1A2, 2A6, 2C9, 3A4 and 2E1 are less involved.
Slovenian: In vitro ugotovitve kažejo, da je CYP2B6 glavni izoencim, vpleten v tvorbo hidroksibupropiona, medtem ko so CYP1A2, 2A6, 2C9, 3A4 in 2E1 manj vpleteni.
English: Greater HbA1c improvement compared to placebo was observed at the first post-baseline measurement (Week 16, p<0.001).
Slovenian: Večje izboljšave za HbA1c v primerjavi z uporabo placeba so opazili pri prvem poizhodiščnem merjenju (16. teden, p<0,001).
English: If naltrexone / bupropion is added to the treatment regimen of a patient already receiving a drug metabolised by CYP2D6, the need to decrease the dose of the original medicinal product should be considered, particularly for those concomitant medicinal products with a narrow therapeutic index.
Slovenian: Če se kombinacija naltrekson/bupropion doda k shemi zdravljenja pri bolniku, ki že prejema zdravilo, ki ga presnavlja encim CYP2D6, je treba upoštevati potrebo po zmanjšanju odmerka prvotnega zdravila, še posebej pri sočasno uporabljenih zdravilih z ozkim terapevtskim indeksom.
English: Induction of emesis is not recommended.
Slovenian: Sproženje bruhanja ni priporočljivo.
English: Faecal excretion is a minor elimination pathway.
Slovenian: Izločanje z blatom je manj pomembna pot izločanja.
English: The tablets should preferably be taken with food.
Slovenian: Priporoča se, da tablete jemljete skupaj s hrano.
English: The major metabolite of naltrexone is 6-beta-naltrexol.
Slovenian: Glavni presnovek naltreksona je 6-beta-naltreksol.
English: Treatment adherence rates for the integrated Phase 3 studies were: 67% NB vs. 74% Placebo at 16 weeks, 63% NB vs. 65% Placebo at 26 Weeks, 55% NB vs. 55% Placebo at 52Weeks.
Slovenian: Stopnje adherence pri zdravljenju za združene podatke študij 3. faze so: 67 % za NB v primerjavi s 74 % za placebo pri 16 tednih, 63 % za NB v primerjavi s 65 % za placebo pri 26 tednih, 55 % za NB v primerjavi s 55 % za placebo pri 52 tednih.
English: ≥5% Weight
Slovenian: Zmanjšanje telesne mase za ≥5 %
English: Naltrexone / bupropion was also evaluated in combination with intensive behavioural modification counseling in the NB-302 study.
Slovenian: Kombinacijo naltrekson/bupropion so ovrednotili tudi v kombinaciji z intenzivnim svetovalnim programom za spremembo vedenja v študiji NB-302.
English: Not known - frequency cannot be estimated from the available data in people taking Mysimba.
Slovenian: neznana - pogostnosti ni mogoče oceniti iz razpoložljivih podatkov za bolnike, ki jemljejo zdravilo Mysimba.
English: • if you have diabetes for which you use insulin or oral medicines that may cause low sugar levels in your blood (hypoglycaemia); or
Slovenian: • če imate sladkorno bolezen, pri kateri uporabljate insulin ali peroralna zdravila, ki lahko povzročijo nizke ravni sladkorja v krvi (hipoglikemija), ali
English: • you have uncontrolled coronary artery disease (a heart disease caused by poor blood flow in the blood vessels of the heart) with symptoms such as angina (characterised by chest pain) or a recent heart attack.
Slovenian: • če imate nenadzorovano koronarno bolezen (bolezen srca, ki jo povzroči slab pretok krvi skozi srčne žile) s simptomi, kot je angina pektoris (zanjo je značilna bolečina v prsnem košu) ali nedavni srčni infarkt;
English: LDL-C/HDL-C ratio
Slovenian: Razmerje LDL-C/HDLC
English: You should talk to your doctor, especially if:
Slovenian: Posvetujte se z zdravnikom še zlasti v naslednjih primerih:
English: If you have a fit (seizure), you should stop taking Mysimba and consult your doctor immediately.
Slovenian: Če imate krče (epileptične napade), morate prenehati jemati zdravilo Mysimba in se nemudoma posvetovati s svojim zdravnikom.
English: This medicine is for oral use.
Slovenian: Zdravilo je namenjeno za peroralno uporabo.
English: Naltrexone / bupropion (-3.7%) was significantly (p<0.001) more efficacious than placebo (-1.7%) treatment in this population.
Slovenian: Uporaba naltreksona/bupropiona (-3,7 %) je bila značilno (p<0,001) učinkovitejša kot uporaba placeba (-1,7 %) pri tej populaciji.
English: Plasma protein binding of hydroxybupropion is similar to that of bupropion (84%) whereas the other two metabolites have approximately half the binding.
Slovenian: Vezava hidroksibupropiona na proteine v plazmi je podobna vezavi bupropiona (84 %), druga dva presnovka pa beležita približno polovično vezavo.
English: The ≥5% weight loss threshold at Week 16 had 86.4% positive predictive value and 84.8% negative predictive value for determining whether a subject treated with naltrexone / bupropion would achieve at least 5% weight loss at Week 56.
Slovenian: Prag zmanjšanja telesne mase ≥5 % v 16. tednu je imel pozitivno napovedno vrednost 86,4 %, negativno napovedno vrednost pa 84,8 %, za oceno, ali bo preiskovanec, zdravljen z naltreksonom/bupropionom, dosegel zmanjšanje telesne mase za najmanj 5 % v 56. tednu.
English: The risk of seizures is also related to patient factors, clinical situations, and concomitant medicinal products, which must be considered in the selection of patients treated with naltrexone / bupropion.
Slovenian: Tveganje epileptičnih napadov je povezano tudi z bolnikovimi dejavniki, kliničnimi okoliščinami in sočasno uporabljenimi zdravili, kar je treba upoštevati pri izbiri bolnikov za zdravljenje z naltreksonom/bupropionom.