natgillin/translations-raw huggingface dataset:
Eye irritation, Eye pain or asthenopia, Eye swelling, Lacrimation increased, Photophobia, Vision blurred 
Očesne bolezni neznana draženje oči, bolečina v očeh ali astenopija, otekanje oči, povečano solzenje, fotofobija,
• Week 2: One tablet twice a day, one in the morning and one in the evening 
• 2. teden: ena tableta dvakrat dnevno, ena zjutraj in ena zvečer;
Cardiovascular disease 
Srčnožilna bolezen
Naltrexone / bupropion is contraindicated in patients currently dependent on chronic opioid or opiate agonist therapy (e.g., methadone), or patients in acute opiate withdrawal (see section 4.3). 
Kombinacija naltrekson/bupropion je kontraindicirana pri bolnikih, ki so trenutno odvisni od kroničnega zdravljenja z opioidi ali opiatnimi agonisti (npr. metadonom), ali bolnikih, ki prestajajo akutno odtegnitev opiatov (glejte poglavje 4.3).
There have also been cases of elevated liver enzymes from post-marketing reporting. 
Poročanje v obdobju trženja zdravila je pokazalo tudi primere povišanih vrednosti jetrnih encimov.
Although not metabolised by the CYP2D6 isoenzyme, bupropion and its main metabolite, hydroxybupropion, inhibit the CYP2D6 pathway and the potential exists to affect medicinal products metabolised by CYP2D6. 
hidroksibupropion, ne presnavljata z izoencimom CYP2D6, pa ovirata pot encimu CYP2D6, zato obstaja možnost vpliva na zdravila, ki jih presnavlja encim CYP2D6.
Adverse reactions reported in subjects who received Naltrexone/Bupropion as a fixed-dose combination 
Neželeni učinki, o katerih so poročali pri preiskovancih, ki so prejemali naltrekson/bupropion kot fiksnega kombinacija odmerka Organski sistem
Palpitations, Heart rate increased Uncommon Tachycardia 
Srčne bolezni pogosti palpitacije, hitrejše bitje srca občasni tahikardija
The clinical consequences of the inhibition of the metabolism of bupropion via CYP2B6 enzyme and the consequent changes in the bupropion-hydroxybupropion ratio are currently unknown, but could potentially lead to reduced efficacy of naltrexone / bupropion. 
Klinične posledice zaviranja presnove bupropiona prek encima CYP2B6 in posledične spremembe razmerja bupropion : hidroksibupropion še niso znane,
Effects on glycaemic control in obese subjects with type 2 diabetes After 56 weeks of treatment in subjects with type 2 diabetes (NB-304), naltrexone / bupropion exhibited improvements in glycaemic control parameters compared to placebo (Table 5). 
Po 56 tednih zdravljenja preiskovancev s sladkorno boleznijo tipa 2 (NB-304) so pri uporabi naltreksona/bupropiona ugotovili izboljšave pri parametrih glikemičnega nadzora v primerjavi z uporabo placeba (Preglednica 5).
Naltrexone / bupropion is contraindicated in patients with end-stage renal failure. 
Kombinacija naltrekson/bupropion je kontraindicirana pri bolnikih s končno odpovedjo ledvic.
Adverse reactions reported with the fixed dose combination 
Povzetek neželenih učinkov v preglednici Neželeni učinki, o katerih so poročali pri fiksni kombinaciji odmerkov
Uncommon Ataxia (B), Incoordination (B) 
Občasni ataksija (B), motnje koordinacije (B)
Change in Cardiovascular and Metabolic Parameters from Baseline to Week 56 in Phase 3 Studies NB-301, NB-302, and NB-304 and from Baseline to Week 28 in Phase 3 Study NB-303 
Spremembe kardiovaskularnih in presnovnih parametrov od izhodiščne vrednosti do 56. tedna v študijah 3. faze NB-301, NB-302 in NB-304 ter od izhodiščne vrednosti do 28. tedna v študiji 3. faze NB-303
• Week 1: One tablet in the morning 
• 1. teden: ena tableta zjutraj;
Common events leading to withdrawal among elderly were nausea, vomiting, dizziness, constipation. 
Pogosti dogodki, ki so pri starejših bolnikih povzročili ukinitev zdravljenja, so bili navzea, bruhanje, omotica in zaprtje.
In patients with moderate (Child-Pugh scores of 7-9 [Class B]) and severe (Child-Pugh scores of 10 or higher [Class C]) hepatic impairment, increases in the maximum concentration of naltrexone of ~6and ~30-fold were observed for the moderate and severe patients respectively, while increases in bupropion were ~2-fold for both groups. 
Pughovi lestvici 10 ali več [razred C]) okvaro jeter so opazili povečanja največje koncentracije naltreksona, ki so bile ~6-krat večje pri bolnikih z zmerno in ~30-krat večje pri bolnikih s hudo okvaro, medtem ko je bilo pri bupropionu ~2-kratno povečanje prisotno v obeh skupinah.
Uncommon Visual disturbance (B) 
Občasni motnje vida (B)
Arthralgia, myalgia and fever have also been reported in association with rash and other symptoms suggestive of delayed hypersensitivity. 
Poročali so tudi o artralgiji, mialgiji in zvišani telesni temperaturi v povezavi z izpuščajem in drugimi simptomi, ki kažejo na zapoznelo preobčutljivost.
Patients should be aware that they may be more sensitive to lower doses of opioids after naltrexone / bupropion treatment is discontinued. 
Bolniki se morajo zavedati, da lahko po prekinitvi zdravljenja z naltreksonom/bupropionom postanejo bolj občutljivi na manjše odmerke opioidov.
Triglycerides, % change HDL-C, mg/dL 
HDL-C, mg/dl
At one year, the average weight loss (using LOCF methodology) among these Week 16 Responders who received naltrexone / bupropion was 11.3%, with 55% losing ≥10% bodyweight. 
LOCF) pri teh odzivnih preiskovancih 16. tedna, ki so prejemali naltrekson/bupropion, znašalo 11,3 %, ob tem pa jih je 55 % zmanjšalo telesno maso za ≥10 %.
Naltrexone / bupropion has not been extensively evaluated in subjects with renal insufficiency. 
Kombinacije naltrekson/bupropion niso obsežno preizkušali pri preiskovancih z ledvično insuficienco.
No study has been performed comparing AUC or Cmax of naltrexone / bupropion prolonged-release tablets with bupropion PR or naltrexone IR administered as single agents in the multiple dose setting (i.e., under steady state conditions). 
AUC ali Cmax za tablete kombinacije naltrekson/bupropion s podaljšanim sproščanjem primerjali z uporabo tablet bupropiona s podaljšanim sproščanjem ali tablet naltreksona s takojšnjim sproščanjem kot samostojnih zdravil v shemi večkratnega odmerjanja (tj. v stanju dinamičnega ravnovesja).
Naltrexone / bupropion is not recommended in patients with moderate hepatic impairment (see sections 4.4 and 5.2). 
Kombinacija naltrekson/bupropion se ne priporoča pri bolnikih z zmerno jetrno okvaro (glejte poglavji 4.4 in 5.2).
Naltrexone / bupropion is contraindicated in patients with severe hepatic impairment (see section 4.3) and is not recommended in patients with moderate hepatic impairment (see section 4.4). 
Kombinacija naltrekson/bupropion je kontraindicirana pri bolnikih s hudo jetrno okvaro (glejte poglavje 4.3), pri bolnikih z zmerno jetrno okvaro pa se ne priporoča (glejte poglavje 4.4).
Blood pressure fluctuation 
- spremembe krvnega tlaka; - oteženo dihanje;
Dystonia, Memory impairment, Parkinsonism, Restlessness 
epileptični napadi**, sinkopa neznana distonija, motnje spomina, parkinsonizem, nemir
Effect on cardiovascular and metabolic parameters Improvements were observed for waist circumference (including subjects with type 2 diabetes), triglycerides, HDL-C and LDL-C/HDL-C ratio for subjects treated with naltrexone / bupropion vs. placebo in all Phase 3 studies (Table 5). 
Za obseg pasu (vključno s preiskovanci s sladkorno boleznijo tipa 2), trigliceride, HDL-C in razmerje LDL-C/HDL-C so opazili izboljšave pri preiskovancih, zdravljenih z naltreksonom/bupropionom, v primerjavi z uporabo placeba v vseh študijah 3. faze (Preglednica 5).
Uncommon Abnormal dreams, Agitation, Mood swings, Nervousness, Tension, Dissociation (feeling spacey) 
Psihiatrične motnje pogosti tesnoba, nespečnost občasni nenavadne sanje, agitacija, nihanje razpoloženja, živčnost, napetost, dicociacija (občutek odsotnosti)
• Week 2: One tablet in the morning and one tablet in the evening 
• 2. teden: ena tableta zjutraj in ena tableta zvečer;
Improvements were observed for fasting glucose, fasting insulin, HOMA-IR and percent of subjects requiring rescue diabetes medicinal products for subjects treated with naltrexone / bupropion vs. placebo. 
Za vrednosti glukoze na tešče, insulina na tešče, HOMA-IR in odstotek preiskovancev, ki potrebujejo urgentne antidiabetike, so opazili izboljšave pri preiskovancih, zdravljenih z naltreksonom/bupropionom, v primerjavi z uporabo placeba.
Bupropion is extensively metabolised with three active metabolites: hydroxybupropion, threohydrobupropion and erythrohydrobupropion. 
Bupropion Bupropion se obsežno presnavlja s tremi aktivnimi presnovki: hidroksibupropionom,
There is limited experience with overdose of naltrexone monotherapy in humans. 
Izkušenj s prevelikim odmerjanjem naltreksona pri samostojnem zdravljenju pri človeku je malo.
Do not cut them, chew them or crush them. 
Tablet ne smete prerezati, žvečiti ali zdrobiti.
What you need to know before you take Mysimba 3. 
Kaj morate vedeti, preden boste vzeli zdravilo Mysimba Ne jemljite zdravila Mysimba:
Naltrexone (100 mg/kg/day, approximately 30 times the dose of naltrexone in naltrexone/bupropion on a mg/m2 basis) caused a significant increase in pseudo-pregnancy in the rat. 
Vpliv na sposobnost razmnoževanja: Uporaba naltreksona (100 mg/kg/dan, približno 30-kratnik odmerka naltreksona v obliki kombinacije naltrekson/bupropion po merilu mg/m2) je povzročila znatno povečanje pogostnosti namišljene brejosti pri podganah.
In contrast, naltrexone tested positive in the following assays: Drosophila recessive lethal frequency assay, non-specific DNA damage in repair tests with E. coli and WI-38 cells, and urinalysis for methylated histidine residues. 
nespecifične poškodbe DNA pri testih popravljanja z E. coli in celicami WI-38 ter analiza urina za metilirane ostanke histidina.
The prescriber guide shall contain the following key elements: - a reminder of the indication and the need to discontinue treatment if there are concerns with the safety or tolerability of ongoing treatment, or if after 16 weeks patients have lost less than 5% of their initial body weight; 
- opomnik glede indikacije in potrebe po prekinitvi zdravljenja, če obstajajo zadržki glede varnosti ali prenašanja potekajočega zdravljenja ali če po 16 tednih bolniki izgubijo manj kot 5 % izhodiščne telesne mase; - opomnik glede kontraindikacij, opozoril in previdnostnih ukrepov ter značilnosti bolnikov, pri katerih obstaja večje tveganje za pojav neželenih učinkov pri uporabi zdravila Mysimba, da se zagotovi ustrezna izbira bolnikov.
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release MIAS Pharma Ltd 
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij
As expected, naltrexone / bupropion -treated subjects had a greater mean increase from baseline compared with placebo-treated subjects in percent of total body lean mass. 
Po pričakovanjih so pri preiskovancih, zdravljenih z naltreksonom/bupropionom, ugotovili večje povprečno povečanje odstotka skupne puste telesne mase glede na izhodiščno vrednost v primerjavi s preiskovanci, ki so prejemali placebo.
Administration of naltrexone / bupropion to patients receiving either levodopa or amantadine concurrently should be undertaken with caution. 
Kombinacijo naltrekson/bupropion je treba uporabljati previdno pri bolnikih, ki sočasno prejemajo bodisi levodopo bodisi amantadin.
• you have any kidney problems before you start Mysimba. 
• če imate težave z ledvicami, preden začnete jemati zdravilo Mysimba;
• Week 1: One tablet once a day in the morning 
• 1. teden: ena tableta enkrat dnevno, in sicer zjutraj;
Haematochezia, Hernia, Lip swelling, Lower abdominal pain, Dental caries***, Toothache*** 
bolečina v spodnjem delu trebuha, zobni karies***, zobobol***
OCT2 substrates 
OCT2 cimetidinu.
NB-303 NB PBO NB PBO NB PBO NB PBO Intent-to-Treat Analysis Set+ N Baseline (kg) LS Mean (95% CI) 
NB-303 NB PBO NB PBO NB PBO NB PBO Analiza za preiskovance, ki so jih nameravali zdraviti+ N
Ear discomfort, Ear pain 
- bolečine v ušesih, nelagodje v ušesih;
Naltrexone / bupropion is contraindicated in patients with severe hepatic impairment, and not recommended in patients with moderate hepatic impairment (see sections 4.2 4.3, and 5.2). 
Kombinacija naltrekson/bupropion je kontraindicirana pri bolnikih s hudo jetrno okvaro, pri bolnikih z zmerno jetrno okvaro pa se ne priporoča (glejte poglavja 4.2, 4.3 in 5.2).
There is an increased incidence of gastrointestinal disorders with higher age categories. 
Pri skupinah starejših bolnikov se pojavnost bolezni prebavil poveča.
• concomitant administration of medicinal products that may lower the seizure threshold, including antipsychotics, antidepressants, antimalarials, tramadol, theophylline, systemic steroids, quinolones and sedating antihistamines 
antidepresivi, antimalariki, tramadolom, teofilinom, sistemskimi steroidi, kinoloni in sedativnimi antihistaminiki.
Early, transient mean increases from baseline in systolic and diastolic blood pressure of up to 1 mmHg were observed in naltrexone / bupropion Phase 3 clinical trials. 
Dvig krvnega tlaka V kliničnih preskušanjih 3. faze z naltreksonom/bupropionom so opazili zgodnje in prehodno povprečno povečanje sistoličnega in diastoličnega krvnega tlaka do 1 mmHg glede na začetno vrednost.
Mean Weight Loss (% Change) from Baseline to Week 56 in Naltrexone / Bupropion (NB) Phase 3 Studies NB-301, NB-302, and NB-304 and from Baseline to Week 28 in Phase 3 Study NB-303 
Povprečno zmanjšanje telesne mase (sprememba v %) od izhodiščne vrednosti do 56. tedna v študijah 3. faze s kombinacijo naltrekson/bupropion NB-301, NB-302 in NB-304 ter od izhodiščne vrednosti do 28. tedna v študiji 3. faze NB-303
Naltrexone / bupropion contains bupropion. 
Samomor in samomorilno vedenje Kombinacija naltrekson/bupropion vsebuje bupropion.
Following single oral administration of naltrexone / bupropion tablets to healthy subjects, peak concentrations of naltrexone and bupropion occurred approximately 2 and 3 hours post administration of naltrexone / bupropion, respectively. 
Po enkratni peroralni aplikaciji tablet kombinacije naltrekson/bupropion pri zdravih preiskovancih so bile najvišje koncentracije naltreksona dosežene približno 2 uri po aplikaciji kombinacije naltrekson/bupropion, najvišje koncentracije bupropiona pa približno 3 ure po aplikaciji kombinacije naltrekson/bupropion.
Mysimba 8 mg/90 mg prolonged-release tablets naltrexone hydrochloride / bupropion hydrochloride 
Mysimba 8 mg/90 mg tablete s podaljšanim sproščanjem naltreksonijev klorid/bupropionijev klorid
Dizziness, Tremor, Dysgeusia, Lethargy, Somnolence Uncommon Intention tremor, Balance disorder, Amnesia, Rare 
Bolezni živčevja zelo pogosti glavobol pogosti omotica, tremor, disgevzija, letargija, somnolenca občasni intencijski tremor, motnje ravnotežja, amnezija redki izguba zavesti, parestezija, presinkopa,
Increases of ~2- and ~4-fold for the area under the curve for bupropion were observed for patients with moderate and severe impairment respectively. 
Pri površini pod krivuljo za bupropion so opazili ~2-kratno povečanje pri bolnikih z zmerno in ~4-kratno povečanje pri bolnikih s hudo okvaro.
Use caution when taking Mysimba, if you are 65 years or older. 
Če ste stari 65 let ali več, bodite previdni pri jemanju zdravila Mysimba.
Naltrexone / bupropion must not be administered to patients receiving chronic opiate therapy (see section 4.3). 
Bolniki, ki prejemajo opioidne analgetike Kombinacija naltrekson/bupropion se ne sme uporabljati pri bolnikih, ki so vključeni v kronično zdravljenje z opiati (glejte poglavje 4.3).
Adverse reactions of the individual components Naltrexone and Bupropion identified in the respective approved SmPCs. 
Neželeni učinki za posamično učinkovino naltrekson ali bupropion, opredeljeni v zadevnem odobrenem povzetku glavnih značilnosti zdravila.
CYP2B6 inducers, inhibitors and substrates 
Induktorji, zaviralci in substrati encima CYP2B6
NAME OF THE MEDICINAL PRODUCT Mysimba 8 mg/90 mg prolonged-release tablets naltrexone hydrochloride / bupropion hydrochloride 
Navodilo za uporabo Mysimba 8 mg/90 mg tablete s podaljšanim sproščanjem naltreksonijev klorid/bupropionijev klorid
Naltrexone / bupropion has not been extensively evaluated in subjects with hepatic impairment. 
Kombinacije naltrekson/bupropion niso obširno preizkušali pri preiskovancih z jetrno okvaro.
Drugs metabolised by cytochrome P450 (CYP) enzymes Bupropion is metabolised to its major active metabolite hydroxybupropion primarily by the cytochrome P450 CYP2B6; thus, the potential exists for interaction when administered with medicinal products that induce or inhibit CYP2B6. 
P450 CYP2B6; zato obstaja možnost za medsebojno delovanje, če se uporabi skupaj z zdravili, ki inducirajo ali zavirajo encim CYP2B6.
Naltrexone / bupropion was evaluated for safety in five double-blind placebo-controlled studies in 4,754 overweight or obese subjects (3,239 subjects treated with naltrexone / bupropion and 1,515 subjects treated with placebo) for a treatment period up to 56 weeks. 
(3.239 preiskovancev je prejemalo naltrekson/bupropion, 1.515 preiskovancev pa je prejemalo placebo) v obdobju zdravljenja do 56 tednov.
Therefore, naltrexone / bupropion should not be used in children and adolescents below 18. 
Zato uporaba naltreksona/bupropiona pri otrocih in mladostnikih, mlajših od 18 let, ni dovoljena.
Naltrexone / bupropion is contraindicated in patients with end-stage renal failure (see section 4.3). 
Kombinacija naltrekson/bupropion je kontraindicirana pri bolnikih s končno odpovedjo ledvic (glejte poglavje 4.3).
Fits (seizures) 
- koprivnica (utikarija);
Naltrexone / bupropion should be given with caution to those patients with controlled hypertension and must not be given to patients with uncontrolled hypertension (see section 4.3). 
Pri dajanju naltreksona/bupropiona bolnikom z nadzorovano hipertenzijo velja posebna previdnost, pri bolnikih z nenadzorovano hipertenzijo pa uporaba ni dovoljena (glejte poglavje 4.3).
• ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of one or more weight-related co-morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension) Treatment with Mysimba should be discontinued after 16 weeks if patients have not lost at least 5% of their initial body weight (see Section 5.1). 
• ≥27 kg/m2 do <30 kg/m2 (bolniki s čezmerno telesno maso) z enim ali več spremljajočimi dejavniki tveganja (npr. sladkorna bolezen tipa 2, dislipidemija ali nadzorovana hipertenzija).
Lactose Monohydrate Crospovidone type A Indigo Carmine Aluminium Lake (E132) Hypromellose 
Jedro tablete: cisteinijev klorid mikrokristalna celuloza hidroksipropilceluloza magnezijev stearat brezvodna laktoza laktoza monohidrat krospovidon vrste A indigotin (E132) hipromeloza dinatrijev edetat koloidni silicijev dioksid
- if you have a condition that causes fits (seizures) or if you have a history of fits; - if you have a brain tumour; - if you are usually a heavy drinker and you have just stopped drinking alcohol, or are going to stop while you are taking Mysimba; - if you have recently stopped taking sedatives or medicines to treat anxiety (especially benzodiazepines), or if you are going to stop them while you are taking Mysimba; - if you have a bipolar disorder (extreme mood swings); - if you are using any other medicines which contain bupropion or naltrexone; - if you have an eating disorder or had one in the past (for example, bulimia or anorexia nervosa); - if you are currently dependent on chronic opiates or opiate agonists (for example methadone), or you are going through acute withdrawal (cold turkey); - if you are taking medicines for depression or Parkinson's disease called monoamine oxidase inhibitors (MAOIs) or have taken them in the last 14 days; - if you have severe liver disease; - if you have endstage kidney disease. 
- če ste trenutno odvisni od kroničnega zdravljenja z opiati ali opiatnimi agonisti (na primer metadonom) ali če prestajate akutno odtegnitev (hitra ukinitev); - če jemljete zdravila za zdravljenje depresije ali Parkinsonove bolezni, imenovana zaviralci monoaminooksidaze (MAO), ali ste jih jemali v zadnjih 14 dneh;
Anaphylactoid/anaphylactic reactions characterized by symptoms such as pruritus, urticaria, angioedema, and dyspnoea requiring medical treatment have been reported in clinical trials with bupropion. 
V kliničnih študijah z bupropionom so poročali o anafilaktoidnih/anafilaktičnih reakcijah, za katere so značilni simptomi, kot so pruritus, urtikarija, angioedem, in dispneji, ki so zahtevale zdravljenje.
Taste disorders (B) 
zlatenica (B)
If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine. 
Zdravilo Mysimba vsebuje laktozo (vrsto sladkorja) Če so vam povedali, da ne prenašate nekaterih sladkorjev, se pred jemanjem tega zdravila posvetujte s svojim zdravnikom.
Diarrhoea, Flatulence, Haemorrhoids , Ulcer 
neznana driska, napenjanje, hemoroidi, razjeda
• Week 4 and onwards: Two tablets in the morning and two tablets in the evening The maximum recommended daily dose of Mysimba is two tablets taken twice daily for a total dose of 32 mg naltrexone hydrochloride and 360 mg bupropion hydrochloride. 
Največji priporočeni dnevni odmerek zdravila Mysimba je dve tableti dvakrat dnevno v skupnem odmerku 32 mg naltreksonijevega klorida in 360 mg bupropionijevega klorida.
Irregular menstruation, Vaginal haemorrhage, Vulvovaginal dryness 
Motnje reprodukcije in dojk občasni erektilna disfunkcija redki neredna menstruacija, vaginalna krvavitev, suhost vulve/nožnice
LS 
O
How to store Mysimba 
Shranjevanje zdravila Mysimba
CI, Confidence Interval; LS, Least Squares. 
IZ, interval zaupanja.
Musculoskeletal and Connective Tissue Disorders 
Bolezni mišično-skeletnega sistema in vezivnega tkiva občasni trzanje (B)
In patients with mild hepatic impairment, the maximum recommended daily dose for naltrexone / bupropion should be reduced, as these patients may have higher drug concentrations which could result in an increase in adverse drug reactions. 
Pri bolnikih z blago jetrno okvaro je treba največji priporočeni dnevni odmerek kombinacije naltrekson/bupropion zmanjšati, saj imajo lahko ti bolniki večje koncentracije zdravila, kar lahko povzroči povečanje neželenih učinkov zdravila (glejte poglavji 4.2 in 5.2).
Talk to your doctor or pharmacist before taking Mysimba. 
Pred začetkom jemanja zdravila Mysimba se posvetujte z zdravnikom ali farmacevtom.
(angioedema) - Excessive loss of body water (dehydration) - Hallucinations - Fainting, almost fainting (presyncope), loss of consciousness - Fits - Passage of fresh blood through the anus usually in or with stool (haematochezia) - Projection of an organ or the tissue encompassing an organ through the wall of the cavity that normally contains it (hernia) - Toothache - Dental caries, cavities - Pain in the lower part of the abdomen - Injury to the liver due to drug toxicity - Jaw pain - A disorder characterised by a sudden compelling urge to urinate (micturition urgency) - Irregular menstrual cycle, vaginal bleeding, dryness of the female vulva and vagina 
- epileptični napadi; - izločanje sveže krvi skozi zadnjik, običajno v blatu ali z njim (hematohezija); - izboklina organa ali tkiva, ki obkroža organ, skozi steno votline, kjer se običajno nahaja
Hallucination 
redki halucinacije
Since bupropion is extensively metabolised, caution is advised when naltrexone / bupropion is co-administered with medicinal products known to induce CYP2B6 (e.g., carbamazepine, phenytoin, ritonavir, efavirenz) as these may affect the clinical efficacy of naltrexone / bupropion. 
Bupropion se obsežno presnavlja, zato se priporoča previdnost pri sočasni uporabi kombinacije naltrekson/bupropion in zdravil, za katere je znano, da inducirajo encim CYP2B6 (npr. karbamazepin,
The two co-primary endpoints were percent change from baseline body weight and the proportion of subjects achieving ≥5% total decreased body weight. 
Izhodiščna povprečna vrednost ITM je bila 36 kg/m2, povprečni obseg pasu pa je bil 110 cm. Sočasna primarna cilja sta bila odstotna sprememba glede na izhodiščno telesno maso in delež preiskovancev, ki so skupno zmanjšali telesno maso za ≥5 %.
HOMA-IR, % change + Based on LOCF with the last on-drug observation carried forward. 
+ Po metodi prenosa zadnjega opazovanja v zvezi z zdravilom naprej (LOCF).