FrancophonIA/ELRC3.0 huggingface dataset:
English: Decreased appetite (N) Uncommon Anorexia (B), Blood glucose disturbances (B)
Danish: Anoreksi (B), blodglukoseforstyrrelser (B)
English: 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).
Danish: Naltrexon/bupropion er kontraindiceret til patienter, der samtidigt er afhængige af kronisk opioid- eller opiatagonist-terapi (fx. metadon) eller patienter i akut opiat-afvænning (se pkt 4.3).
English: - 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.
Danish: Mysimba; - hvis du har en bipolar lidelse (ekstreme humørsvingninger); - hvis du bruger anden medicin, som indeholder bupropion eller naltrexon; - hvis du har en spiseforstyrrelse eller havde en tidligere (fx. bulimi eller anoreksi); - hvis du i øjeblikket er afhængig af kroniske opiater eller opiatagonister (fx. metadon), eller du gennemgår en akut afvænning (kold tyrker); - hvis du tager medicin mod depression eller Parkinsons sygdom kaldet monoaminooxidasehæmmere (MAO-hæmmere) eller har taget dem i de sidste 14 dage; - hvis du har alvorlig leversygdom; - hvis du har nyresygdom i terminalfasen.
English: What you need to know before you take Mysimba
Danish: Det skal du vide, før du begynder at tage Mysimba
English: Blood and Lymphatic System Disorders Rare
Danish: Blod og lymfesystem
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.
Danish: Kontakt din læge med det samme, hvis du bemærker nogen af følgende alvorlige bivirkninger: - Selvmordstanker og følelse af at være deprimeret Hyppigheden af bivirkningerne selvmordsforsøg, selvmordsadfærd, selvmordstanker og følelse af at være deprimeret er ikke kendt og kan ikke estimeres ud fra de forhåndenværende data fra personer, der tager Mysimba.
English: Induction of emesis is not recommended.
Danish: Det anbefales ikke at fremkalde opkastning.
English: Close supervision of patients, particularly those at high risk, should accompany therapy with naltrexone / bupropion especially in early treatment and following dose changes.
Danish: Behandlingen med naltrexon/bupropion bør følges med tæt overvågning af patienterne, navnlig dem med høj risiko - især tidligt i behandlingen og efter dosisændringer.
English: The use of naltrexone/bupropion has been associated with somnolence and episodes of loss of consciousness, sometimes caused by seizure.
Danish: Virkning på evnen til at føre motorkøretøj og betjene maskiner Brugen af naltrexon/bupropion har været forbundet med døsighed og episoder med bevidsthedstab, sommetider forårsaget af krampeanfald.
English: This incidence of seizure, along with incidence of seizure in subjects who received naltrexone / bupropion in a large cardiovascular outcomes trial (CVOT), was no higher than the seizure rate with bupropion as a single agent at approved doses.
Danish: kardiovaskulære udfald (cardiovascular outcomes tria, CVOT), var ikke højere end antallet af krampeanfald med bupropion som enkeltstof i godkendte doser.
English: 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).
Danish: Hos patienter med let leverinsufficiens, er den maksimale anbefalede daglige dosis naltrexon/bupropion to tabletter (én tablet om morgenen og én tablet om aftenen) (se pkt.
English: Do not cut them, chew them or crush them.
Danish: De må ikke skæres, tygges eller knuses.
English: 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
Danish: Ændring i kardiovaskulære og metaboliske parametre fra baseline til uge 56 i fase 3 undersøgelser NB301, NB302 og NB304 og fra baseline til uge 28 i fase 3 undersøgelse NB303
English: Concentration disturbance (B)
Danish: Synsforstyrrelse (B)
English: Palpitations, Heart rate increased Uncommon Tachycardia
Danish: Almindelig Palpitationer, forhøjet puls Ikke almindelig
English: Fits (seizures)
Danish: Anfald (kramper)
English: Other frequent adverse reactions: The majority of subjects treated with naltrexone / bupropion who reported dizziness, headache, insomnia, or dry mouth, first reported these events during the dose escalation phase.
Danish: Andre hyppige bivirkninger: De fleste forsøgspersoner, der blev behandlet med naltrexonbupropion, rapporterede først om svimmelhed, hovedpine, søvnløshed eller mundtørhed i den dosiseskalerende fase.
English: The MAH should conduct and submit results of a multicentre, randomised, doubleblind, placebo-controlled, phase 4 study to assess the effect of naltrexone extended release (ER) /bupropion ER on the occurrence of major adverse cardiovascular events (MACE) in overweight and obese subjects.
Danish: Indehaveren af markedsføringstilladelsen skal gennemføre og indsende resultaterne af et multicenter, randomiseret, dobbelt-blindt, placebo-kontrolleret, fase 4 undersøgelse, der vurderer effekten af naltrexon (depot) / bupropion (depot) vedr.
English: Mysimba 8 mg/90 mg prolonged-release tablets naltrexone hydrochloride / bupropion hydrochloride
Danish: Mysimba 8 mg/90 mg depottabletter naltrexon-hydrochlorid/bupropion-hydrochlorid
English: ++ 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.
Danish: ++ Forsøgspersoner, der har en baseline og en post-baseline kropsvægtmåling og har gennemført 56 uger (Undersøgelser NB-301, NB-302 og NB-304) eller 28 uger (NB-303) med behandling.
English: At recommended doses in humans, bupropion does not induce its own metabolism.
Danish: Bupropion inducerer ikke sin egen metabolisme ved anbefalede doser hos mennesker.
English: NAME OF THE MEDICINAL PRODUCT Mysimba 8 mg/90 mg prolonged-release tablets naltrexone hydrochloride / bupropion hydrochloride
Danish: LÆGEMIDLETS NAVN Mysimba 8 mg/90 mg depottabletter naltrexon-hydrochlorid/bupropion-hydrochlorid
English: In addition, in subjects who did not have type 2 diabetes, there were reductions in fasting insulin and HOMA-IR, a measure of insulin resistance, in naltrexone / bupropion-treated subjects.
Danish: Derudover var der reduktion i fastende insulin og HOMA-IR, et mål for insulinresistens, i naltrexon/bupropion-behandlede forsøgspersoner, der ikke har type 2-diabetes.
English: 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.
Danish: vægttab vægttab + Med ‘baseline observation carried forward' (BOCF) ++ Forsøgspersoner, der har en baseline og en post-baseline kropsvægtmåling og har gennemført 56 uger (Undersøgelser NB-301, NB-302 og NB-304) eller 28 uger (NB-303) med behandling.
English: 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.
Danish: Hver tablet indeholder 8 mg naltrexon-hydrochlorid, svarende til 7,2 mg naltrexon og 90 mg bupropion-hydrochlorid, hvilket svarer til 78 mg bupropion.
English: Elderly patients may be more sensitive to the central nervous system adverse reactions of naltrexone / bupropion.
Danish: Ældre patienter kan være mere følsomme over for bivirkninger af naltrexon/bupropion i centralnervesystemet.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release MIAS Pharma Ltd
Danish: Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse
English: In patients with mild hepatic impairment, the maximum recommended daily dose for naltrexone / bupropion should be reduced (see section 4.2).
Danish: Hos patienter med let nedsat leverfunktion skal den anbefalede maksimale daglige dosis naltrexon/bupropion reduceres (se pkt.
English: Naltrexone / bupropion is contraindicated in patients with end-stage renal failure.
Danish: Naltrexon/bupropion er kontraindiceret hos patienter med nyresvigt i terminalfasen.
English: Uncommon Abnormal dreams, Agitation, Mood swings, Nervousness, Tension, Dissociation (feeling spacey)
Danish: Unormale drømme, agitation, humørsvingninger, nervøsitet, anspændthed
English: • Patients with a current seizure disorder or a history of seizures (see section 4.4)
Danish: • Patienter med en aktuelle krampeanfald eller tidligere krampeanfald (se pkt.
English: 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
Danish: Gennemsnitligt vægttab (% ændring) fra baseline til uge 56 i naltrexon/bupropion (NB) fase 3 undersøgelser NB-301, NB-302 og NB-304 og fra baseline til uge 28 i fase 3 undersøgelse NB-303
English: 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.
Danish: Lægemidler, der metaboliseres af cytokrom P450- (CYP) enzymer Bupropion metaboliseres primært til dets aktive hovedmetabolit hydroxybupropion af cytochrom P450 CYP2B6.
English: Uncommon Cholecystitis, ALT increased, AST increased, Hepatic enzyme increased
Danish: Cholecystitis, forhøjet ALAT, forhøjet ASAT, forhøjede leverenzymer
English: NB-303 NB PBO NB PBO NB PBO NB PBO
Danish: NB PBO NB PBO NB PBO NB PBO Fuldt analysesæt +
English: Uncommon side effects (may affect up to 1 in 100 people): - Hives (uticaria) - Hypersensitivity - Abnormal dreams, - Feeling nervous, feeling spacey, tension, agitation, mood swings, Tremor of the head or a limb which increases when trying to perform a particular function (intention tremor) - Balance disorder - Loss of memory (amnesia), Tingling or numbness of the hands or feet - Motion sickness - Burping - Abdominal discomfort - Indigestion - Inflammation of the gallbladder (cholecystitis) - Increased creatinine levels in the blood (indicating loss of kidney function) - Increased liver enzymes and bilirubin levels, liver disorders - Difficulty in getting or keeping an erection - Feeling abnormal, weakness (asthenia) - Thirst, feeling hot - Chest pain - Increased appetite, weight gain
Danish: Ikke almindelige bivirkninger (kan påvirke op til 1 ud af 100 personer): - Nældefeber (uticaria) - Overfølsomhed - Unormale drømme - Følelse af nervøsitet, følelse af at være excentrisk, anspændthed, ophidselse, humørsvingninger, - Hovedrysten eller rystelser i arme eller ben, der øges, når man forsøger at udføre en bestemt funktion (intention tremor) - Balance-lidelse - Hukommelsestab (amnesi) - Prikken eller følelsesløshed i hænder eller fødder - Transportsyge - Bøvsen - Maveubehag - Fordøjelsesbesvær - Betændelse i galdeblæren (cholecystitis) - Øgede kreatininniveauer i blodet (hvilket indikerer tab af nyrefunktion) - Forhøjede leverenzymer og bilirubin-niveauer, leversygdomme - Vanskeligheder ved at få eller bevare en erektion - Følelse af at være unormal, svaghed (asteni) - Tørst, varmefølelse - Brystsmerter - Øget appetit, vægtøgning
English: Naltrexone / bupropion must not be administered to patients receiving chronic opiate therapy (see section 4.3).
Danish: Der må ikke gives naltrexon/bupropion til patienter, der får kronisk opiat-behandling (se pkt.
English: 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.
Danish: Hver tablet indeholder 8 mg naltrexon-hydrochlorid, svarende til 7,2 mg naltrexon og 90 mg bupropionhydrochlorid, hvilket svarer til 78 mg bupropion.
English: For patients with moderate or severe renal impairment, the maximum recommended daily dose for naltrexone / bupropion should be reduced (see section 4.2).
Danish: For patienter med moderat eller svær nyreinsufficiens, skal den maksimale anbefalede dosis for naltrexon/bupropion reduceres (se pkt.
English: Naltrexone / bupropion should not be used during breast-feeding.
Danish: Naltrexon/bupropion bør ikke anvendes under amning.
English: Blood and Lymphatic system disorders Uncommon Idiopathic thrombocytopenic purpura (N) Immune system disorders
Danish: Idiopatisk trombocytopenisk purpura (N)
English: Naltrexone / bupropion should be used with caution in patients over 65 years of age and is not recommended in patients over 75 years of age (see sections 4.4, 4.8 and 5.2).
Danish: Naltrexon/bupropion bør anvendes med forsigtighed hos patienter over 65 år og anbefales ikke til patienter over 75 år (se pkt.
English: The effects of naltrexone / bupropion on weight loss, weight maintenance, waist circumference, body composition, obesity-related markers for cardiovascular and metabolic parameters and patient reported assessments were examined in double-blind, placebo-controlled obesity Phase 2 and Phase 3 trials (BMI range 27-45 kg/m2) with study durations of 16 to 56 weeks randomised to naltrexone hydrochloride (16 to 50 mg/day) and/or bupropion hydrochloride (300 to 400 mg/day) or placebo.
Danish: svær overvægt fase 2 og fase 3 (BMI-område 27-45 kg/m2) med undersøgelser, der varede mellem 16 og 56 uger randomiseret til naltrexonhydrochlorid (16 til 50 mg/dag) og/eller bupropionhydrochlorid (300 til 400 mg/dag) eller placebo.
English: Uncommon Delusions (B), Depersonalisation (B), Libido disorder (N), Paranoid ideation (B)
Danish: (B), libidoforstyrrelse (N), paranoia (B)
English: Lactose Anhydrous
Danish: Laktosemonohydrat
English: • Week 1: One tablet in the morning
Danish: • Uge 1: Én tablet om morgenen
English: Decreased haematocrit, Lymphocyte count decreased
Danish: Nedsat hæmatokrit, Nedsat lymfocyttal
English: Haematochezia, Hernia, Lip swelling, Lower abdominal pain, Dental caries***, Toothache***
Danish: Hæmatokesi, brok, læbehævelse, smerter i den nedre del af maven, caries***, tandpine
English: Cysteine Hydrochloride Microcrystalline Cellulose Hydroxypropyl Cellulose Magnesium Stearate
Danish: Hydroxypropylcellulose
English: Dry mouth may be associated with toothache and dental caries; in the subset of patients with dry mouth, a higher incidence of toothache and dental caries were observed in subjects treated with naltrexone / bupropion compared to subjects treated with placebo.
Danish: I undergruppen af forsøgspersoner med mundtørhed blev der observeret en højere forekomst af tandpine og caries hos forsøgspersoner, der behandlet med naltrexonbupropion sammenlignet med forsøgspersoner, der blev behandlet med placebo.
English: 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).
Danish: Hos patienter med moderat eller svær nyreinsufficiens er den maksimale anbefalede daglige dosis for naltrexon/bupropion to tabletter (én tablet om morgenen og én tablet om aftenen (se pkt.
English: How to take Mysimba
Danish: Sådan skal du tage Mysimba
English: Monoamine oxidase inhibitors (MAOI)
Danish: Monoaminooxidasehæmmere (MAO-hæmmere)
English: • Week 4 and onward: Two tablets twice a day, two in the morning and two in the evening
Danish: • Uge 4 og fremefter: To tabletter to gange dagligt, dvs. to tabletter om morgenen og to tabletter om aftenen
English: - 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
Danish: - Angst - Svimmelhed, følelse af svimmelhed eller “snurren rundt” (vertigo) - Følelse af rystelser (tremor) - Søvnbesvær (tag ikke Mysimba lige inden sengetid) - Ændringer i smagen af mad (smagsforstyrrelser), mundtørhed - Koncentrationsbesvær - Følelse af træthed (energiløshed) og søvnighed, sløvhed eller mangel på energi (letargi) - Ringen for ørerne (tinnitus) - Hurtig eller uregelmæssig hjerterytme - Hedeture - Forhøjet blodtryk (nogle gange alvorligt) - Smerter i den øvre del af maven - Mavesmerter - Øget svedproduktion (hyperhidrosis) - Udslæt, kløe (pruritus) - Hårtab (alopeci) - Irritabilitet - Nervøsitet
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.
Danish: Undersøgelser med naltrexon i dyr har vist reproduktiv toksicitet (se pkt.
English: • Week 2: One tablet in the morning and one tablet in the evening
Danish: • Uge 2: Én tablet om morgenen og én tablet om aftenen
English: 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
Danish: Ikke kendte bivirkninger (hyppighed kan ikke estimeres ud fra forhåndenværende data): - Hævede kirtler i hals, armhuler eller lyske (lymfadenopati) - Humørsygdomme - Irrationelle tanker (vrangforestillinger) - Psykose - Tab af seksuel lyst - Følelse af fjendtlighed - Overdreven mistanke (paranoia) - Aggression - Opmærksomhedsforstyrrelse - Mareridt - Forvirring, desorientering - Hukommelsesbesvær - Rastløshed - Muskelstivhed, ukontrollerede bevægelser, problemer med gang eller koordination - Sløret syn, øjensmerter, øjenirritation, hævelse af øjne, vandige øjne, øget følsomhed over for lys (fotofobi) - Øresmerter, ubehag i øret - Svingende blodtryk - Vejrtrækningsbesvær - Ubehag i næsen, tilstoppet næse, løbenæse, nysen, bihuleforstyrrelser - Ondt i halsen, stemmeforstyrrelse, hosten, gaben - Hæmorroider, mavesår - Diarré - Luftafgang fra tarmen (flatulens) - Leverbetændelse - Acne - Lyskesmerter - Muskelsmerter - Ledsmerter - Unormalt hyppig vandladning, smertefuld vandladning - Kuldegysninger - Øget energi
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Mysimba Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: • Week 3: Two tablets in the morning and one tablet in the evening
Danish: • Uge 3: To tabletter om morgenen og én tablet om aftenen
English: Tabulated summary of adverse reactions
Danish: Tabuleret oversigt over bivirkninger
English: Taste disorders (B)
Danish: Almindelig Smagsforstyrrelser (B)
English: Respiratory, thoracic and mediastinal disorders
Danish: Hyppighed Bivirkning Luftveje, thorax og mediastinum Ikke kendt
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Tablet core:
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer
English: 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).
Danish: Hos patienter med moderat eller svær nyreinsufficiens skal den maksimale anbefalede daglige dosis for naltrexon/bupropion nedsættes, idet disse patienter kan have højere lægemiddelkoncentrationer, som kan føre til en stigning i bivirkninger (se pkt.
English: Naltrexone / bupropion has not been extensively evaluated in subjects with hepatic impairment.
Danish: Naltrexon/bupropion er ikke blevet grundigt evalueret hos patienter med nedsat leverfunktion.
English: (listed in section 6); - if you have an abnormally high blood pressure (hypertension) that is not controlled using a medicinal product;
Danish: - hvis du har et unormalt højt blodtryk (hypertension), der ikke kan kontrolleres med et lægemiddel; - hvis du har en tilstand, der forårsager anfald (krampeanfald), eller hvis du har en sygehistorik med krampeanfald;
English: • Week 3: Three tablets every day, two in the morning and one in the evening
Danish: • Uge 3: Tre tabletter hver dag, dvs. to tabletter om morgenen og én tablet om aftenen
English: Naltrexone / bupropion is contraindicated in end-stage renal failure (see section 4.3).
Danish: Naltrexon/bupropion er kontraindiceret ved nyresvigt i terminalfasen (se pkt.
English: • Week 1: One tablet once a day in the morning
Danish: • Uge 1: Én tablet dagligt om morgenen
English: Do not cut, chew or crush.
Danish: Må ikke skæres, tygges eller knuses.
English: Dysuria, Pollakiuria, Urinary frequency and/or retention Reproductive System and Breast Disorders Uncommon Erectile dysfunction Rare
Danish: Dysuri, pollakisuri, vandladningshyppighed og/eller retention
English: NB-303 NB PBO NB PBO NB PBO NB PBO Intent-to-Treat Analysis Set+ N Baseline (kg) LS Mean (95% CI)
Danish: NB PBO NB PBO NB PBO NB PBO Intent-to-Treat analysesæt+
English: ≥10% Weight
Danish: Nedsat leverfunktion
English: 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;
Danish: Den ordinerende lægevejledning skal indeholde følgende hovedelementer: - En påmindelse om indikation og behovet for at afbryde behandlingen, hvis der er bekymringer vedr.
English: 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).
Danish: Naltrexon/bupropion er kontraindiceret hos patienter med svært nedsat leverfunktion og anbefales ikke til patienter med moderat nedsat leverfunktion (se pkt.
English: What you need to know before you take Mysimba 3.
Danish: Det skal du vide, før du begynder at tage Mysimba Sådan skal du tage Mysimba Bivirkninger
English: Seizures
Danish: Nyreinsufficiens
English: Very common Headache Common
Danish: Meget almindelig
English: During naltrexone / bupropion clinical studies, the use of concomitant opioid or opioid-like medicinal products, including analgesics or antitussives were excluded.
Danish: Samtidig brug af opioid eller opioid-lignende lægemidler, herunder analgetika eller hostestillende, blev udelukket under kliniske undersøgelser med naltrexon/bupropion.