natgillin/translations-raw huggingface dataset:
Naltrexone and bupropion are known to be substantially excreted by the kidney, and the risk of adverse reactions to naltrexone / bupropion may be greater in patients with impaired renal function, a condition that is more common in elderly individuals. 
Poznato je da se naltrekson i bupropion značajno izlučuju preko bubrega, pa rizik od nuspojava na naltrekson / bupropion može biti veći u bolesnika s oštećenom funkcijom bubrega,
Four multicentre, double-blind, placebo-controlled obesity Phase 3 studies (NB-301, NB-302, NB-303 and NB-304) were conducted to evaluate the effect of naltrexone / bupropion in conjunction with lifestyle modification in 4,536 subjects randomised to naltrexone/bupropion or placebo. 
NB-302, NB-303 i NB-304) su provedena kako bi se procijenio učinak naltrekson / bupropiona uz promjene stila života u 4536 ispitanika randomiziranih na naltrekson / bupropion ili placebo.
Renal impairment: A single-dosepharmacokinetic study has been conducted for naltrexone / bupropion in subjects with mild, moderate, and severe renal impairment, compared with subjects with normal renal function. 
Oštećenje bubrega: Farmakokinetičko ispitivanje jedne doze provedeno je za naltrekson / bupropion u ispitanika s blagim, umjerenim i teškim oštećenjem bubrega, u usporedbi s ispitanicima s normalnom funkcijom bubrega.
PharmaSwiss Hellas A.E. Τηλ: 008001 612 2030 465 
Τηλ: 008001 612 2030 465
In patients with moderate or severe renal impairment, the maximum recommended daily dose for naltrexone / bupropion is two tablets (one tablet in the morning and one tablet in the evening) (see sections 4.4, 4.8 and 5.2). 
U bolesnika s umjerenim ili teškim oštećenjem bubrega, maksimalna preporučena dnevna doza naltreksona / bupropiona iznosi dvije tablete (jedna tableta ujutro i jedna tableta uvečer) (vidjeti dijelove 4.4, 4.8 i 5.2).
≥10% Weight 
izgubilo ≥ 10 % tjelesne težine.
Rare side effects (may affect up to 1 in 1,000 people): - Low amount of certain white blood cells (Lymphocyte count decreased) - Decreased haematocrit (indicating loss of red blood cell volume) - Swelling of eyelids, face, lips, tongue or throat, which can cause great difficulty in breathing 
Rijetke nuspojave (mogu se pojaviti u do 1 na 1000 osoba): - niska količina određenih bijelih krvnih stanica (smanjeni broj limfocita) - niski hematokrit (ukazuje na smanjenje volumena crvenih krvnih stanica)
Eye irritation, Eye pain or asthenopia, Eye swelling, Lacrimation increased, Photophobia, Vision blurred 
Poremećaji oka nepoznato iritacija oka, bol u oku ili astenopija, oticanje oka, pojačano suzenje, fotofobija, zamagljen vid
Since monoamine oxidase A and B inhibitors also enhance the catecholaminergic pathways, by a different mechanism from bupropion, naltrexone / bupropion must not be used with MAOI (see section 4.3). 
A i B također olakšavaju katekolaminergične puteve mehanizmom koji je različit od bupropionovog, naltrekson / bupropion se ne smije uzimati s MAOI
Full analysis set+ 
Komplet analize namjere liječenja+
Naltrexone/bupropion is not recommended in patients over 75 years of age. 
Ne preporučuje se davati naltrekson/bupropion bolesnicima preko 75 godina starosti.
There is no clinical experience with overdose with combined use of bupropion and naltrexone. 
Nema kliničkih iskustava o predoziranju s kombiniranom uporabom bupropiona i naltreksona.
Naltrexone / bupropion should not be used during breast-feeding. 
Naltrekson / bupropion se ne smije koristiti tijekom dojenja.
HOMA-IR, % change + Based on LOCF with the last on-drug observation carried forward. 
Na temelju LOCF sa zadnjim zapažanjem na lijeku prenesenim dalje.
When driving vehicles or using machines, it should be taken into account that dizziness, somnolence, loss of consciousness and seizure may occur during treatment. 
Kad se upravlja vozilima ili se radi sa strojevima mora se uzeti u obzir da se tijekom liječenja može pojaviti omaglica,
Co-administration of medicinal products that may inhibit the metabolism of bupropion via CYP2B6 isoenzyme (e.g., CYP2B6 substrates: cyclophosphamide, ifosfamide, and CYP2B6 inhibitors: orphenadrine, ticlopidine, clopidogrel), may result in increased bupropion plasma levels and lower levels of active metabolite hydroxybupropion. 
Istodobna primjena lijekova koji mogu inhibirati metabolizam bupropiona putem CYP2B6 izoenzima (npr. CYP2B6 supstrati: ciklofosfamid, ifosfamid i CYP2B6 inhibitori: orfenadrin, tiklopidin,
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). 
Naltrekson / bupropion je kontraindiciran u bolesnika trenutno ovisnih o kroničnoj terapiji opioidima ili agonistima opijata (npr. metadon), ili u bolesnika u akutnom ustezanju od opijata (vidjeti dio 4.3).
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. 
Poboljšanja su opažena za glukozu natašte, inzulin natašte, HOMA-IR i postotak ispitanika kojima je trebalo hitno liječenje dijabetesa lijekovima a koji su liječeni naltrekson / bupropionom naspram placeba.
• if you have diabetes for which you use insulin or oral medicines that may cause low sugar levels in your blood (hypoglycaemia); or 
• ako imate dijabetes za koji koristite inzulin ili oralne lijekove koji mogu uzrokovati niske razine šećera u krvi (hipoglikemija); ili • ako uzimate lijekove koji mogu povećati rizik od napadaja (vidjeti „Drugi lijekovi i lijek
For patients with moderate or severe renal impairment, the maximum recommended daily dose for naltrexone / bupropion should be reduced (see section 4.2). 
Za bolesnike s umjerenim ili teškim oštećenjem bubrega, maksimalnu preporučenu dnevnu dozu naltreksona / bupropiona potrebno je smanjiti (vidjeti dio 4.2).
Decreased appetite (N) Uncommon Anorexia (B), Blood glucose disturbances (B) 
manje često anoreksija (B), poremećaji glukoze u krvi
Mysimba should not be used during pregnancy, or while breast-feeding. 
Trudnoća i dojenje Lijek Mysimba se ne smije koristiti tijekom trudnoće ili dojenja.
Naltrexone / bupropion should be used cautiously in patients with a history of mania. 
bupropion treba koristiti oprezno u bolesnika s manijom u anamnezi.
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. 
Kao što se očekivalo, ispitanici liječeni naltrekson / bupropionom su imali veću srednju vrijednost povećanja od početnih vrijednosti ukupne tjelesne bezmasne mase u usporedbi s ispitanicima koji su primali placebo.
Mean (95% CI) 
LS srednja vrijednost (95% CI) % promjene od početne
No specific antidotes for combined use of bupropion and naltrexone are known. 
Nisu poznati specifični antidoti kombinirane uporabe bupropiona i naltreksona.
Adverse reactions reported in subjects who received Naltrexone/Bupropion as a fixed-dose combination 
Nuspojave prijavljene u ispitanika koji su primali naltrekson/bupropion, kao fiksnu kombinaciju MedDRA - klasifikacije organskih sustava
In patients with moderate or severe renal 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 (see sections 4.2, 4.8, and 5.2). 
U bolesnika s umjerenim ili teškim oštećenjem bubrega, maksimalnu preporučenu dnevnu dozu naltreksona / bupropiona potrebno je smanjiti jer ti bolesnici mogu imati povećane koncentracije lijeka što može dovesti do porasta nuspojava (vidjeti dijelove 4.2, 4.8 i 5.2).
Diarrhoea, Flatulence, Haemorrhoids , Ulcer 
Učestalost Nuspojava (lijek*) nepoznato dijareja, flatulencija, hemoroidi, ulkus
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). 
Nakon 56 tjedana liječenja u bolesnika s dijabetesom tipa 2 (NB-304), naltrekson / bupropion je pokazao poboljšanja parametara glikemijske kontrole u usporedbi s placebom (Tablica 5).
Mechanism of action and pharmacodynamic effects The exact neurochemical appetite suppressant effects of naltrexone / bupropion are not fully understood. 
Točni neurokemijski učinci naltrekson / bupropiona na suzbijanje apetita nisu u potpunosti razjašnjeni.
Naltrexone and bupropion are well absorbed from the gastrointestinal tract (>90% absorbed), however, naltrexone has a significant first pass effect thereby limiting systemic bioavailablity, with only 5-6% reaching the systemic circulation intact. 
međutim, naltrekson ima značajan učinak prvog prolaska čime se ograničava sistemska bioraspoloživost, sa samo 5-6 % u sistemskoj cirkulaciji u nepromijenjenom obliku.
For individuals who are at elevated risk for renal impairment, in particular patients with diabetes or elderly individuals, estimated glomerular filtration rate (eGFR) should be assessed prior to initiating therapy with naltrexone / bupropion. 
Za osobe u kojih je rizik od oštećenja bubrega povećan, naročito u bolesnika s dijabetesom ili starijih osoba, procijenjena brzina glomerularne filtracije se mora utvrditi prije početka liječenja s naltrekson / bupropionom.
Do not cut, chew or crush. 
Ne smijete rezati, žvakati, ili drobiti.
There have also been cases of elevated liver enzymes from post-marketing reporting. 
Nakon stavljanja lijeka u promet, također su prijavljeni slučajevi povećanja razine jetrenih enzima.
How to take Mysimba 
Kako uzimati lijek Mysimba
Hepatic impairment: A single-dose pharmacokinetic study has been conducted with naltrexone / bupropion in patients with hepatic impairment. 
Oštećenje jetre: Provedena su farmakokinetička ispitivanja jedne doze naltreksona / bupropiona u bolesnika s oštećenjem jetre.
Cysteine Hydrochloride Microcrystalline Cellulose Hydroxypropyl Cellulose Magnesium Stearate 
Jezgra tablete: cisteinklorid celuloza, mikrokristalična hidroksipropilceluloza magnezijev stearat laktoza, bezvodna laktoza hidrat krosprovidon vrste
Of the subjects with observed data at Week 16 in the four Phase 3 clinical trials, 50.8% of those randomized to receive naltrexone / bupropion had lost ≥5% of their baseline body weight, compared to 
Od ispitanika s opaženim podacima 16. tjedna u četiri klinička ispitivanja faze 3, 50,8 % randomiziranih za primanje naltrekson / bupropiona izgubilo je ≥ 5 % svoje početne tjelesne težine, u usporedbi s 19,3 % u ispitanika koji su primali placebo (koji su odgovorili na liječenje u 16. tjednu).
Data summaries for mean change in body weight reflect the Intent-to-Treat (ITT) population, defined as subjects who were randomized, had a baseline body weight measurement, and had at least one post-baseline body weight measurement during the defined treatment phase, using a last observation carried forward (LOCF) 
Intent-to-Treat, ITT), definiranu kao ispitanici koji su bili randomizirani i imali su mjerenje tjelesne težine na početku te barem jedno mjerenje tjelesne težine nakon početnog tijekom definirane faze liječenja, pomoću analize zadnjeg zapažanja prenesenog dalje
Adverse reactions of the individual components Naltrexone and Bupropion identified in the respective approved SmPCs. 
Nuspojave prijavljene za pojedinačne komponente naltrekson i bupropion navedene u njihovim odobrenim sažecima opisa svojstava lijeka.
There are no data on fertility from the combined use of naltrexone and bupropion. 
Nema podataka o plodnosti s kombiniranom primjenom naltreksona i bupropiona.
• Week 1: One tablet in the morning 
• 1. tjedan: jedna tableta ujutro
Each tablet contains 8 milligrams of naltrexone hydrochloride, equivalent to 7.2 milligrams of naltrexone, and 90 milligrams of bupropion hydrochloride, equivalent to 78 milligrams of bupropion. 
Jedna tableta sadrži 8 miligrama naltreksonklorida, što odgovara 7,2 miligrama naltreksona i 90 miligrama bupropionklorida, što odgovara 78 miligrama bupropiona.
• Week 4 and onward: Two tablets twice a day, two in the morning and two in the evening 
• 4. tjedan i nadalje: dvije tablete dva puta na dan, dvije ujutro i dvije navečer
If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine. 
Lijek Mysimba sadrži laktozu (vrsta šećera) Ako Vam je rečeno da ne podnosite neke šećere, obratite se svom liječniku prije uzimanja ovog lijeka.
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 
Promjene kardiovaskularnih i metaboličkih parametara od početka do 56. tjedna u ispitivanjima faze 3 NB-301, NB-302, i NB-304, i od početka do 28. tjedna u ispitivanju faze 3 NB-303.
4.5 Interaction with other medicinal products and other forms of interaction 
4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Inhibitori monoaminooksidaze (MAOI)
In patients with mild hepatic impairment, the maximum recommended daily dose for naltrexone / bupropion is two tablets (one tablet in the morning and one tablet in the evening) (see sections 4.4 and 5.2). 
U bolesnika s blagim oštećenjem jetre, najviša preporučena dnevna doza naltreksona / bupropiona je dvije tablete (jedna ujutro i jedna uvečer) (vidjeti dijelove 4.4 i 5.2).
There are no or limited amounts of data from the use of naltrexone / bupropion in pregnant women. 
Nema podataka ili su podaci o primjeni naltrekson / bupropiona u trudnica ograničeni.
Loss + With baseline observation carried forward (BOCF) ++ Subjects who have a baseline and a post-baseline body weight measurement and completed 56 weeks (Studies NB-301, NB-302, and NB-304) or 28 weeks (NB-303) of treatment. 
S početnim zapažanjem prenesenim dalje (BOCF) ++ Ispitanici kojima je mjerena početna i tjelesna težina nakon početne i završili su liječenje od 56 tjedana (ispitivanja NB-301, NB-302, i NB-304) ili 28 tjedana (NB-303).
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release MIAS Pharma Ltd 
Naziv(i) i adresa(e) proizvođača odgovornog(odgovornih) za puštanje serije lijeka u promet
• quinolones (antibiotics such as ciprofloxacine to treat infections); 
• lijekovi koji se koriste za sprječavanje malarije; • kinoloni (antibiotici poput ciprofloksacina za liječenje infekcija);
Naltrexone / bupropion is contraindicated in patients with end-stage renal failure. 
Naltrekson / bupropion je kontraindiciran u bolesnika sa završnim stadijem zatajenja bubrega.
Each tablet contains 8 mg naltrexone hydrochloride, equivalent to 7.2 mg of naltrexone, and 90 mg bupropion hydrochloride, equivalent to 78 mg of bupropion. 
Jedna tableta sadrži 8 mg naltreksonklorida, što odgovara 7,2 mg naltreksona i 90 mg bupropionklorida, što odgovara 78 mg bupropiona.
• Week 1: One tablet once a day in the morning 
• 1. tjedan: jedna tableta jedanput na dan ujutro
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 
Srednja vrijednost gubitka težine (% promjene) od početka do 56. tjedna u ispitivanjima faze 3 s naltrekson / bupropionom (NB) NB-301, NB-302, i NB-304 i od početka do 28. tjedna u ispitivanju faze 3 NB-303
Naltrexone / bupropion is not recommended in patients with moderate hepatic impairment (see sections 4.4 and 5.2). 
Naltrekson / bupropion se ne preporučuje bolesnicima s umjerenim oštećenjem jetre (vidjeti dijelove 4.4. i 5.2).
• Week 3: Three tablets every day, two in the morning and one in the evening 
• 3. tjedan: tri tablete svaki dan, dvije ujutro i jedna navečer
Baseline (kg) 
Početna vrijednost (kg)
Cough, Dysphonia, Dyspnoea, Nasal congestion, Nasal discomfort, Oropharyngeal pain, Rhinorrhea, Sinus disorder, Sneezing, Yawning 
prsišta i sredoprsja nepoznato kašalj, disfonija, dispneja, nazalna kongestija, nazalna nelagoda, orofaringealna bol, rinoreja, poremećaj sinusa, kihanje, zijevanje
Affective disorders, Aggression, Confusional state, Delusions, Depression, Disorientation, Disturbance in attention, Hostility, Loss of libido, Nightmares, Paranoia, Psychotic disorder, Suicidal ideation*, Suicide attempt, Suicidal behaviour 
rijetko halucinacije nepoznato afektivni poremećaji, agresija, konfuzno stanje, deluzije, depresija, dezorijentiranost, poremećaj pažnje, neprijateljstvo, gubitak libida, noćne more,
Naltrexone / bupropion has not been extensively evaluated in subjects with hepatic impairment. 
Naltrekson / bupropion nije opsežno ispitan u ispitanika s oštećenjem jetre.
Uncommon Abnormal dreams, Agitation, Mood swings, Nervousness, Tension, Dissociation (feeling spacey) 
nervoza, napetost, disocijacija (osjećaj odvojenosti)
• you have any kidney problems before you start Mysimba. 
• imate bilo kakvih problema s bubrezima prije nego što počnete uzimati lijek Mysimba.
Completers Analysis Set++ N 
Ispitanici koji završili ispitivanje++
• Week 2: One tablet twice a day, one in the morning and one in the evening 
• 2. tjedan: jedna tableta dva puta na dan, jedna ujutro i jedna navečer
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). 
Naltrekson / bupropion je kontraindiciran u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.3) i ne preporučuje se u bolesnika s umjerenim oštećenjem jetre (vidjeti dio 4.4).
Concentration disturbance (B) 
Psihijatrijski poremećaji često poremećaj koncentracije (B)
NB-303 NB PBO NB PBO NB PBO NB PBO Randomized Population+ N ≥5% Weight Loss 
NB PBO NB PBO NB PBO NB PBO Randomizirana populacija+
NAME OF THE MEDICINAL PRODUCT Mysimba 8 mg/90 mg prolonged-release tablets naltrexone hydrochloride / bupropion hydrochloride 
Mysimba 8 mg / 90 mg tablete s produljenim oslobađanjem naltreksonklorid / bupropionklorid
++ Subjects who have a baseline and a post-baseline body weight measurement and completed 56 weeks (Studies NB-301, NB-302, and NB-304) or 28 weeks (NB-303) of treatment. 
Ispitanici kojima je mjerena početna i tjelesna težina nakon početne i koji su završili liječenje od 56 tjedana (ispitivanja NB-301, NB-302, i NB-304) ili 28 tjedana (NB-303).
• ≥ 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 (prekomjerna tjelesna težina) u prisustvu jedne ili više bolesti povezane s težinom (npr. dijabetes tipa 2, dislipidemija, ili kontrolirana hipertenzija)
• Week 2: One tablet in the morning and one tablet in the evening 
• 2. tjedan: jedna tableta ujutro i jedna tableta navečer
How to store Mysimba 
Kako čuvati lijek Mysimba
• Patients with severe hepatic impairment (see sections 4.2 and 5.2) • Patients with end-stage renal failure (see sections 4.2 and 5.2) 
• Bolesnici sa završnim stadijem zatajenja bubrega (vidjeti dijelove 4.2 i 5.2).
The effects of combined bupropion and naltrexone use have not been studied in animals. 
5.3 Neklinički podaci o sigurnosti primjene Učinci kombinirane uporabe bupropiona i naltreksona nisu ispitivane u životinja.
• Week 3: Two tablets in the morning and one tablet in the evening 
• 3. tjedan: dvije tablete ujutro i jedna tableta navečer
The incidence of seizure in subjects receiving naltrexone / bupropion in clinical trials was approximately 0.06% (2/3239 subjects) vs. 0.0% (0/1515 subjects) on placebo. 
(2/3239 ispitanika) naspram 0,0 % (0/1515 ispitanika) na placebu.
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). 
Naltrekson / bupropion je kontraindiciran u bolesnika s teškim oštećenjem jetre, i ne preporučuje se u bolesnika s umjerenim oštećenjem jetre (vidjeti dijelove 4.2, 4.3, i 5.2).
Naltrexone is primarily metabolized to 6-beta-naltrexol by the dihydrodiol dehydrogenases (DD1, DD2 and DD4). 
Naltrekson se prvenstveno metabolizira u 6-beta-naltreksol pomoću dihidrodiol dehidrogenaza
In patients requiring intermittent opiate treatment, naltrexone / bupropion therapy should be temporarily discontinued and opiate dose should not be increased above the standard dose. 
bupropionom treba privremeno prekinuti, a dozu opijata se ne smije povisiti iznad standardne doze.
LDL-C/HDL-C ratio 
LDL-K/HDLK omjer
Uncommon Delusions (B), Depersonalisation (B), Libido disorder (N), Paranoid ideation (B) 
poremećaj libida (N), paranoja (B)
Do not take Mysimba: - if you are allergic to naltrexone, to bupropion or to any of the other ingredients of this medicine 
- ako ste alergični na naltrekson, na bupropion ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.);
Elderly patients may be more sensitive to the central nervous system adverse reactions of naltrexone / bupropion. 
Stariji bolesnici mogu biti osjetljiviji na nuspojave na naltrekson / bupropion u središnjem živčanom sustavu.
In patients with mild hepatic impairment, the maximum recommended daily dose for naltrexone / bupropion should be reduced (see section 4.2). 
U bolesnika s blagim oštećenjem jetre preporučena najviša dnevna doza naltreksona / bupropiona mora se smanjiti (vidjeti dio 4.2).
Lactose Monohydrate Crospovidone type A Indigo Carmine Aluminium Lake (E132) Hypromellose 
A indigo carmine aluminium lake (E132) hipromeloza dinatrijev edetat silicijev dioksid, koloidni
Naltrexone / bupropion must not be administered to patients receiving chronic opiate therapy (see section 4.3). 
Bolesnici koji primaju opioidne analgetike Naltrekson / bupropion se ne smije davati bolesnicima koji primaju kroničnu terapiju opijatima (vidjeti dio 4.3).
The incidence of severe nausea, severe constipation, and severe vomiting was low, but was higher in subjects treated with naltrexone / bupropion compared to subjects treated with placebo (severe nausea: naltrexone / bupropion 1.9%, placebo <0.1%; severe constipation: naltrexone / bupropion 0.6%, placebo 0.1%; severe vomiting: naltrexone / bupropion 0.7%, placebo 0.3%). 
(teška mučnina: naltrekson / bupropion 1,9 %, placebo < 0,1 %; težak zatvor: naltrekson / bupropion 0,6 %, placebo 0,1 %, teško povraćanje: naltrekson / bupropion 0,7 %, placebo 0,3 %).
PharmaSwiss d.o.o. 
PharmaSwiss Hellas A.E.
Uncommon Ataxia (B), Incoordination (B) 
Poremećaji živčanog sustava manje često ataksija (B), nekoordiniranost (B)
Uncommon Visual disturbance (B) 
Poremećaji oka manje često poremećaj vida (B)
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 Komplet potpune analize+
Palpitations, Heart rate increased Uncommon Tachycardia 
Srčani poremećaji često palpitacije, ubrzan rad srca manje često tahikardija
You will have your blood pressure and heart rate measured before you start taking Mysimba and while you are taking it. 
Prije nego što počnete uzimati lijek Mysimba i dok ga uzimate mjerit će Vam se krvni tlak i puls.
Naltrexone / bupropion is contraindicated in patients with severe hepatic impairment (see section 4.3). 
Naltrekson / bupropion je kontraindiciran u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.3).