natgillin/translations-raw huggingface dataset:
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).
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.
Istodobnoj primjeni bupropiona s lijekovima koji se metaboliziraju putem CYP2D6 izoenzima uključujući određene antidepresive (selektivne inhibitore ponovne pohrane serotonina i mnoge tricikličke antidepresive, npr. dezipramin, imipramin, paroksetin), antipsihotike (npr. haloperidol,
Naltrexone / bupropion is contraindicated in patients with end-stage renal failure (see section 4.3).
Naltrekson / bupropion je kontraindiciran u bolesnika sa završnim stadijem zatajenja bubrega (vidjeti dio 4.3).
Anaphylactoid/anaphylactic reactions characterized by symptoms such as pruritus, urticaria, angioedema, and dyspnoea requiring medical treatment have been reported in clinical trials with bupropion.
U kliničkim ispitivanjima s bupropionom su prijavljene anafilaktoidne / anafilaktičke reakcije okarakterizirane simptomima kao što su pruritus, urtikarija, angioedem, i dispneja koji su zahtijevali liječenje.
The effects of cigarette smoking on the pharmacokinetics of bupropion were studied in 34 healthy male and female volunteers; 17 were chronic cigarette smokers and 17 were nonsmokers.
Učinci pušenja cigareta na farmakokinetiku bupropiona su ispitivani u 34 zdravih ženskih i muških dobrovoljaca; 17 su bili kronični pušači cigareta a nepušača je bilo 17. Nakon peroralne primjene jedne doze od 150 mg bupropionklorida, nije bilo statistički značajne razlike u Cmax, poluvijeku, Tmax, AUC ili klirensu bupropiona ili njegovih aktivnih metabolitima između pušača i nepušača.
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.
Budući da se bupropion opsežno metabolizira, potreban je oprez kada se naltrekson / bupropion primjenjuju istodobno s lijekovima za koje se zna da induciraju CYP2B6 (npr. karbamazepin, fenitoin,
Uncommon Postural hypotension (B), Vasodilatation (B)
Krvožilni poremećaji manje često posturalna hipotenzija (B), vazodilatacija (B)
Naltrexone / bupropion has not been extensively evaluated in subjects with renal insufficiency.
Naltrekson / bupropion nije opsežno ocijenjen u ispitanika s insuficijencijom bubrega.
Fits (seizures)
- koprivnjača (urtikarija)
Taste disorders (B)
Klasifikacija organskih sustava Učestalost Nuspojava (B)
Drug induced liver injury
Bolesnici s oštećenjem jetre
Metabolism and Nutrition Disorders
Poremećaji metabolizma i prehrane rijetko dehidracija
• Patients currently dependent on chronic opioids (see sections 4.4 and 4.5) or opiate agonists
• Bolesnici trenutno ovisni o kroničnoj primjeni opioida (vidjeti dijelove 4.4 i 4.5) ili agonistima opijata (npr. metadon) ili bolesnici u akutnom ustezanju od opijata • Bolesnici koji primaju istodobno inhibitore monoaminooksidaze (MAOI).
- 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.
ili prolazite kroz akutno ustezanje; - ako uzimate lijekove za depresiju ili Parkinsonovu bolest pod nazivom inhibitori monoaminooksidaze (MAOI), ili ste ih uzeli u posljednjih 14 dana; - ako imate tešku bolest jetre; - ako imate završni stadij bolesti bubrega.
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.
U kliničkim ispitivanjima faze 3 s naltrekson /bupropionom opaženo je rano, prolazno povišenje srednje vrijednosti sistoličkog i dijastoličkog krvnog tlaka u odnosu na početne vrijednosti do 1 mmHg.
Blood and Lymphatic System Disorders Rare
Poremećaji krvi i limfnog sustava rijetko smanjen hematokrit, smanjen broj limfocita nepoznato limfadenopatija
Submission of final study report by 31
Dostaviti konačno izvješće ispitivanja do 31. ožujka 2022.
There is no experience with the use of forced diuresis, dialysis, hemoperfusion, or exchange transfusion in the management of combined use of bupropion and naltrexone overdoses.
hemoperfuzije ili zamjenske transfuzije u liječenju predoziranja kombinirane uporabe bupropiona i naltreksona.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients Tablet core:
PRILOG I. SAŽETAK OPISA SVOJSTAVA LIJEKA
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.
U bolesnika s blagim oštećenjem jetre, najviša preporučena dnevna doza za naltrekson / bupropion mora se smanjiti jer ti bolesnici mogu imati više koncentracije lijeka što bi moglo rezultirati povećanjem učestalosti nuspojava (vidjeti dijelove 4.2 i 5.2).
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.
Naltrekson (100 mg / kg / dan, otprilike 30 puta veća doza od doze naltreksona u naltrekson /
Post Authorisation Safety Study :
Ispitivanje sigurnosti primjene lijeka nakon dobivanja odobrenja za stavljanje lijeka u promet:
System Organ Class
MedDRA - klasifikacije organskih sustava
What Mysimba looks like and contents of the pack Mysimba prolonged-release tablets are blue, biconvex, round tablets debossed with “NB-890” on one side.
Lijek Mysimba tablete s produljenim oslobađanjem su plave, bikonveksne, okrugle tablete s utisnutim
Naltrexone
Naltrekson
Uncommon Hypersensitivity, Urticaria Rare
Poremećaji imunološkog sustava manje često reakcije preosjetljivosti, urtikarija rijetko angiodem
Anxiety, Insomnia
- smetenost, dezorijentiranost
A patient with suspected DILI should stop taking naltrexone / bupropion.
Bolesnik kod kojeg se sumnja na oštećenje jetre uzrokovano lijekovima mora prekinuti uzimati naltrekson / bupropion.
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
- upala žučnog mjehura (kolecistitis) - povećana razina kreatinina u krvi (što znači gubitak funkcije bubrega) - povećane razine jetrenih enzima i bilirubina, poremećaji jetre - poteškoće postizanja ili održavanja erekcije - osjećaj abnormalnosti, slabost (astenija) - žeđ, osjećaj vrućine
Limited clinical data suggest a higher incidence of adverse reactions (e.g., nausea, vomiting, and neuropsychiatric adverse reactions - see section 4.8) in patients receiving bupropion concurrently with either levodopa or amantadine.
povraćanje, i neuropsihijatrijske nuspojave - vidjeti dio 4.8) u bolesnika koji primaju bupropion istodobno s bilo levodopom ili amantadinom.
CYP2B6 inducers, inhibitors and substrates
CYP2B6 induktori, inhibitori i supstrati Bupropion se metabolizira u svoj glavni aktivni metabolit hidroksibupropion prvenstveno preko
Respiratory, Thoracic and Mediastinal Disorders
Učinak na kardiovaskularne i metaboličke parametre
Fatigue, Feeling jittery, Irritability Uncommon Asthenia, Feeling abnormal, Feeling hot, Increased appetite, Thirst
Opći poremećaji i reakcije na mjestu primjene često umor, osjećaj nervoze, razdražljivost manje često astenija, abnormalni osjećaj, osjećaj vrućine, povećan apetit, žeđ rijetko bol u prsištu, periferna hladnoća, pireksija nepoznato zimica, povećana energija
Prolonged-release tablet.
Tableta s produljenim oslobađanjem
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
Poremećaji živčanog sustava vrlo često glavobolja često omaglica, tremor, disgeuzija, letargija, somnolencija manje često intencijski tremor, poremećaj ravnoteže, amnezija rijetko gubitak svijesti, parestezija, presinkopa, napadaj**, sinkopa nepoznato distonija, gubitak pamćenja, parkinsonizam, nemir
Uncommon Cholecystitis, ALT increased, AST increased, Hepatic enzyme increased
Poremećaji jetre i žuči manje često kolecistitis, povišen ALT, povišen AST, povišeni jetreni enzimi rijetko oštećenje jetre uzrokovano lijekovima nepoznato hepatitis
Micturition urgency
Prijavljivanje nuspojava
Uncommon Blood bilirubin increased (N), Jaundice (B)
Poremećaji jetre i žuči manje često povišen bilirubin u krvi (N) žutica (B)
Hepatic impairment
- osjećaj nervoze
Titanium dioxide (E171) Macrogol 3350
Filmska ovojnica: poli(vinilni alkohol) titanijev dioksid (E171) makrogol 3350 talk indigo carmine aluminium lake (E132)
PharmaSwiss EOOD Teл.
Valeant Pharma Magyarország Kft.
Valeant Pharma Magyarország Kft. Tel: 06 8 010 9471
PharmaSwiss d.o.o. Tel: 0800 81 944