natgillin/translations-raw huggingface dataset:
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).
What you need to know before you take Mysimba
Kaj je zdravilo Mysimba in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Mysimba Kako jemati zdravilo Mysimba
Naltrexone / bupropion is contraindicated in patients with severe hepatic impairment (see section 4.3).
Bolniki z jetrno okvaro Kombinacija naltrekson/bupropion je kontraindicirana pri bolnikih s hudo jetrno okvaro (glejte poglavje 4.3).
A patient should stop taking naltrexone / bupropion and consult a doctor if experiencing allergic or anaphylactoid/anaphylactic reactions (e.g., skin rash, pruritus, hives, chest pain, oedema, and shortness of breath) during treatment.
Če se med zdravljenjem pri bolniku pojavijo alergijske ali anafilaktoidne/anafilaktične reakcije (npr. kožni izpuščaji, pruritus, urtikarija, bolečine v prsnem košu, edem in kratka sapa), mora prenehati jemati naltrekson/bupropion in se posvetovati z zdravnikom.
A patient with suspected DILI should stop taking naltrexone / bupropion.
Bolnik, pri katerem sumimo na poškodbe jeter, povzročene z zdravili, mora prenehati jemati naltrekson/bupropion.
Ejaculation delayed (N)
Pogosti zmanjšan apetit (N)
Co-administration of bupropion with drugs that are metabolised by CYP2D6 isozyme including certain antidepressants (SSRIs and many tricyclic antidepressants, e.g. desipramine, imipramine, paroxetine), antipsychotics (e.g., haloperidol, risperidone and thioridazine), beta-blockers (e.g., metoprolol) and Type 1C antiarrhythmics (e.g., propafenone and flecainide), should be approached with caution and should be initiated at the lower end of the dose range of the concomitant medicinal product.
antipsihotiki (npr. haloperidol, risperidon in tioridazin), antagonisti adrenergičnih receptorjev beta (npr. metoprolol) in antiaritmiki skupine 1C (npr. propafenon in flekainid), mora potekati previdno,
Cough, Dysphonia, Dyspnoea, Nasal congestion, Nasal discomfort, Oropharyngeal pain, Rhinorrhea, Sinus disorder, Sneezing, Yawning
neprijeten občutek v nosu, bolečina v ustih/žrelu, rinoreja, težave s sinusi, kihanje, zehanje
Immune System Disorders
Bolezni imunskega sistema zelo redki
Frequency Adverse Reaction
Pogostnost Neželeni učinek
Blood and Lymphatic System Disorders Rare
Presnovne in prehranske motnje redki dehidracija
Phase 3 Studies NB-301, NB-302, and NB-304 and from Baseline to Week 28 in Phase 3 Study NB-303
tedensko (študije NB-301, NB-302 in NB-304) ali 28-tedensko (NB-303) zdravljenje.
The most frequent adverse reactions for naltrexone / bupropion are nausea, constipation, vomiting, dizziness, and dry mouth.
Najpogostejši neželeni učinki pri kombinaciji naltrekson/bupropion so navzea, zaprtje, bruhanje,
Fatigue, Feeling jittery, Irritability Uncommon Asthenia, Feeling abnormal, Feeling hot, Increased appetite, Thirst
Splošne težave in spremembe na mestu aplikacije pogosti utrujenost, občutek živčnosti, razdražljivost občasni astenija, neobičajno počutje, občutek vročine, povečan apetit, žeja redki bolečina v prsnem košu, hladne okončine,
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
- znižana raven nekaterih belih krvnih celic (zmanjšano število limfocitov); - zmanjšanje hematokrita (kaže na zmanjšanje volumna rdečih krvnih celic);
• Week 4 and onward: Two tablets twice a day, two in the morning and two in the evening
• 3. teden: tri tablete vsak dan, dve zjutraj in ena zvečer; • 4. teden in naprej: dve tableti dvakrat dnevno, dve zjutraj in dve zvečer.
• history of head trauma
• poškodba glave v anamnezi;
Arthralgia, myalgia, and fever with rash and other symptoms suggestive of delayed hypersensitivity have been reported in association with bupropion.
V povezavi z bupropionom so poročali o artralgiji, mialgiji in povišani telesni temperaturi z izpuščaji ter drugih simptomih, ki kažejo na zapoznelo preobčutljivost.
19.3% of placebo-treated subjects (Week 16 Responders).
(odzivni preiskovanci 16. tedna).
• you have high blood pressure before taking Mysimba, because it can become worse.
• če imate visok krvni tlak pred jemanjem zdravila Mysimba, kajti stanje se lahko poslabša; pred začetkom jemanja zdravila Mysimba in med jemanjem naj vam izmerijo krvni tlak in srčni utrip; če se vam krvni tlak ali srčni utrip izrazito poveča, boste morali prenehati jemati zdravilo
Uncommon Cholecystitis, ALT increased, AST increased, Hepatic enzyme increased
Bolezni jeter, žolčnika in žolčevodov občasni holecistitis, zvišane vrednosti ALT, zvišane vrednosti AST, povečanje vrednosti jetrnih encimov redki poškodbe jeter zaradi zdravila neznana hepatitis
There is no clinical experience with overdose with combined use of bupropion and naltrexone.
Pri kombinirani uporabi bupropiona in naltreksona ni kliničnih izkušenj s prevelikim odmerjanjem.
- Feeling shaky (tremor) - Difficulty in sleeping (make sure you do not take Mysimba near to bedtime) - Changes in the taste of food (dysgeusia), dry mouth - Difficulty concentrating - Feeling of tiredness (fatigue) and sleepiness, drowsiness or lack of energy (lethargy) - Ringing in the ears (tinnitus) - Fast or irregular heartbeat - Hot flush - Increased blood pressure (sometimes severe) - Pain in the upper part of the abdomen - Pain in the abdomen - Excessive sweating (hyperhidrosis) - Rash, itching (pruritus) - Hair loss (alopecia) - Irritability - Feeling jittery
- hiter ali nepravilen srčni utrip; - vročinski oblivi; - zvišan krvni tlak (včasih resno); - bolečina v zgornjem delu trebuha; - bolečina v trebuhu; - čezmerno potenje (hiperhidroza); - izpuščaji, srbenje (pruritus);
PHARMACEUTICAL PARTICULARS 6.1 List of excipients Tablet core:
6.1 Seznam pomožnih snovi
Dry mouth, Abdominal pain upper, Abdominal pain Uncommon Abdominal discomfort, Dyspepsia, Eructation, Rare
Bolezni dihal, prsnega koša in mediastinalnega prostora neznana kašelj, disfonija, dispneja, zamašen nos,
(photophobia) - Ear pain, ear discomfort - Fluctuating blood pressure - Difficulty in breathing - Nasal discomfort, congestion, runny nose, sneezing, sinus disorder - Sore throat, disorder of the voice, cough, yawning - Haemorrhoids, ulcer - Diarrhoea - Passing wind (flatulence) - Hepatitis - Acne - Groin pain - Muscle pain - Joint pain - Abnormally frequent urination, painful urination - Chills - Increased energy
- vneto žrelo, motnje glasu, kašelj, zehanje; - hemoroidi, razjeda; - driska; - vetrovi (flatulenca); - hepatitis; - akne;
Suicide and suicidal behaviour
(vključno s samomorilnimi mislimi).
Not known side effects (frequency cannot be estimated from the available data): - Swollen glands in the neck, armpit or groin (lymphadenopathy) - Mood disorders - Irrational ideas (delusions) - Psychosis - Loss of sexual desire - Feeling hostile - Severe suspiciousness (paranoia) - Aggression - Attention disturbance - Nightmares - Confusion, disorientation - Memory impairment - Restlessness - Muscle stiffness, uncontrolled movements, problems with walking or coordination - Blurred vision, eye pain, eye irritation, eye swelling, watery eyes, increased sensitivity to light
- otekle bezgavke na vratu, pod pazduho ali v dimljah (limfadenopatija); - motnje razpoloženja; - iracionalne ideje (blodnje); - psihoza; - izguba spolne sle; - občutek sovražnosti;
Close supervision of patients, particularly those at high risk, should accompany therapy with naltrexone / bupropion especially in early treatment and following dose changes.
Med zdravljenjem z naltreksonom/bupropionom, zlasti po uvedbi zdravljenja in pri vsaki spremembi odmerka, je treba bolnike skrbno nadzirati, še posebno bolnike z velikim tveganjem.