natgillin/translations-raw huggingface dataset:
Shellac glaze (20% esterified) Propylene glycol Titanium dioxide (E171)
Črnilo za tisk glazura šelaka (20-odstotno esterificirana) propilenglikol titanov dioksid (E171)
What NUEDEXTA is and what it is used for What you need to know before you take NUEDEXTA How to take NUEDEXTA
Kaj je zdravilo NUEDEXTA in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo NUEDEXTA Kako jemati zdravilo NUEDEXTA Možni neželeni učinki
• you have a condition called myasthenia gravis (an autoimmune neuromuscular disease that causes muscle weakness and fatigability).
• imate bolezen, imenovano miastenija gravis (avtoimunska živčno-mišična bolezen, ki povzroča šibkost mišic in mišično utrujenost);
• medicines used to prevent nausea and vomiting during chemotherapy and after surgery, such as aprepitant
• zdravila, ki jih uporabljamo za preprečevanje navzee in bruhanja med kemoterapijo in po operacijah, npr. aprepitant;
While therapeutic doses of quinidine for treatment of cardiac arrhythmia or malaria are generally ≥10fold higher than the dose of quinidine in this medicinal product, potentially fatal cardiac arrhythmia, including torsades de pointes, can occur at quinidine exposures that are possible from NUEDEXTA overdose.
Medtem ko so terapevtski odmerki kinidina za zdravljenje srčne aritmije ali malarije navadno ≥ 10krat večji kot odmerek kinidina v tem zdravilu, se lahko pri izpostavljenosti kinidinu, ki je mogoča pri prevelikem odmerjanju zdravila NUEDEXTA, pojavi morebitno smrtna srčna aritmija, vključno s tipom torsades de pointes.
Liver enzyme inducers
Induktorji jetrnih encimov
In such UM patients, dextromethorphan is rapidly metabolised, leading to lower, potentially subtherapeutic concentrations.
Pri takšnih bolnikih z izjemno hitro presnovo se dekstrometorfan hitro presnavlja, kar povzroča zmanjšane, morebitno nezadostne terapevtske koncentracije.
• gall stones, increased bilirubin levels in the blood, abnormal liver function test
• žolčni kamni, povečane ravni bilirubina v krvi, nenormalni rezultati jetrnega delovanja
The higher dose of quinidine used in these studies would have resulted in approximately a 1.6 fold greater exposure to of dextromethorphan than with NUEDEXTA 23 mg/ 9 mg.
Večji odmerek kinidina, uporabljen v teh študijah, naj bi povzročil približno 1,6-krat večjo izpostavljenost dekstrometorfanu kot odmerek zdravila NUEDEXTA 23 mg/9 mg.
Quinidine is excreted in human milk and it is unknown whether dextromethorphan is excreted in human milk.
Kinidin se izloča v materino mleko, ni pa znano, ali se dekstrometorfan prav tako izloča v materino mleko.
The pharmacokinetics of dextromethorphan/quinidine in paediatric patients has not been studied (see section 5.1).
Farmakokinetika dekstrometorfana/kinidina ni bila proučevana pri pediatričnih bolnikih (glejte poglavje 5.1).
NUEDEXTA must not be used with monoamine oxidase inhibitors (MAOIs), such as phenelzine and moklobemide, or in patients who have taken MAOIs within the preceding 14 days due to the risk of serotonin syndrome (see section 4.3).
Zdravilo NUEDEXTA se ne sme uporabljati v kombinaciji z zaviralci monoamin-oksidaze (MAOI), kot sta fenelzin in moklobemid, ali pri bolnikih, ki so v zadnjih 14 dneh jemali zaviralce MAO, saj obstaja tveganje za serotoninski sindrom (glejte poglavje 4.3).
Given the pharmacodynamic and pharmacokinetic interactions, concomitant use of NUEDEXTA and TCAs is not recommended due to the elevated risk of serotonin syndrome (see section 4.5).
Z vidika farmakodinamičnih in farmakokinetičnih interakcij sočasna uporaba zdravila NUEDEXTA in tricikličnih antidepresivov ni priporočljiva zaradi povečanega tveganja za serotoninski sindrom (glejte poglavje 4.5).
Concomitant administration of medicines that inhibit CYP3A4 can be expected to increase plasma levels of quinidine, which could increase risk relating to QTc prolongation.
Sočasna uporaba zdravil, ki zavirajo encim CYP3A4, lahko pričakovano poviša ravni kinidina v plazmi, kar lahko poveča tveganje, povezano s podaljšanjem intervala QTc.
• Drug-drug interactions including involvement of CYP2D6 substrates and inhibitors
• medsebojnim delovanjem zdravil, vključno z vključevanjem substratov in zaviralcev CYP2D6;
Treatment should be discontinued if these symptoms occur.
Če se pojavijo ti simptomi, je treba zdravljenje prekiniti.
There are no or limited amount of data from the use of NUEDEXTA in pregnant women.
Podatkov o uporabi zdravila NUEDEXTA pri nosečnicah ni ali pa so omejeni.
The mean plasma Cmax of quinidine following NUEDEXTA 15 mg / 9 mg twice daily in subjects with PBA was 1 to 3% of the therapeutic concentrations associated with antiarrhythmic efficacy (2 to 5 µg/mL).
kinidina v plazmi po jemanju zdravila NUEDEXTA 15 mg/9 mg dvakrat dnevno je bila pri preskušancih s PBP 1 do 3 % terapevtskih koncentracij, povezanih z antiaritmično učinkovitostjo (2 do 5 µg/ml).
A 12 month open-label safety study, also using the higher dose combination of dextromethorphan 23 mg /quinidine 26 mg, included 553 subjects with PBA associated with thirty-four different neurological conditions.
12-mesečna odprta študija varnosti, v kateri so prav tako uporabili večji odmerek kombinacije dekstrometorfana 23 mg/kinidina 26 mg, je vključevala 553 preskušancev s PBP, povezano s štiriintridesetimi različnimi nevrološkimi boleznimi.
Pack size: 60 capsules
Velikost pakiranja: 60 kapsul
If the clinical response with NUEDEXTA 15 mg/9 mg is adequate, the dose taken in weeks 2-4 should be continued.
Če je klinični odziv z zdravilom NUEDEXTA 15 mg/9 mg zadosten, je treba nadaljevati z odmerkom, ki ga je bolnik jemal med 2.-4. tednom.
Capsule content Croscarmellose sodium Cellulose, microcrystalline Silica, colloidal anhydrous Lactose monohydrate Magnesium stearate
Vsebina kapsule natrijev karmelozat mikrokristalna celuloza koloidni brezvodni silicijev dioksid laktoza monohidrat magnezijev stearat
Quinidine at higher doses than in NUEDEXTA can cause immune-mediated thrombocytopenia that can be severe or fatal.
Kinidin lahko v večjih odmerkih, kot jih vsebuje zdravilo NUEDEXTA, povzroči imunsko trombocitopenijo, ki je lahko huda ali smrtna.
NUEDEXTA is indicated for the symptomatic treatment of pseudobulbar affect (PBA) in adults (see section 4.4).
Zdravilo NUEDEXTA je indicirano za simptomatsko zdravljenje psevdobulbarne paralize (PBP) pri odraslih (glejte poglavje 4.4).
The effect of the combination on the patient's QTc interval should be evaluated with pre- and post-dose ECGs.
Učinek te kombinacije na bolnikov interval QTc je treba pred odmerjanjem in po njem oceniti z EKG.
A population pharmacokinetic analysis of 170 subjects (148 subjects <65 years old and 22 subjects ≥65 years old) administered dextromethorphan 23 mg / quinidine 26 mg revealed similar pharmacokinetics in subjects <65 years and those ≥65 years of age.
Farmakokinetična analiza populacije pri 170 bolnikih (148 bolnikov < 65 let in 22 bolnikov ≥ 65 let), ki so prejemali dekstrometorfan 23 mg/kinidin 26 mg, je pokazala podobno farmakokinetiko pri bolnikih, starih < 65 let, in bolnikih, starih ≥ 65 let.
Jenson Pharmaceutical Services Limited
Imetnik dovoljenja za promet z zdravilom in izdelovalec Jenson Pharmaceutical Services Limited
Quinidine is a potent inhibitor of CYP2D6.
Kinidin je močan zaviralec encima CYP2D6.
Because of this effect on CYP2D6, accumulation of parent drug substances and/or failure of active metabolite formation may affect the safety and/or the efficacy of medicinal products used concomitantly with NUEDEXTA that are metabolised by CYP2D6 (see section 4.5).
Zaradi tega učinka na encim CYP2D6 lahko kopičenje primarnih snovi v zdravilu in/ali odsotnost tvorbe aktivnih presnovkov vpliva na varnost in/ali učinkovitost zdravil, ki se uporabljajo sočasno z zdravilom NUEDEXTA in jih presnavlja encim CYP2D6 (glejte poglavje 4.5).
CYP2D6 substrates include certain beta-blockers such as metoprolol, antipsychotics such as haloperidol, perphenazine and aripiprazole, antidepressants such as nortriptyline, imipramine, amitriptyline and desipramine, the chemotherapeutic tamoxifen, and the noradrenaline transporter inhibitor atomoxetine.
Substrati encima CYP2D6 vključujejo nekatere beta-adrenergične antagoniste, kot je metoprolol, antipsihotike, kot so haloperidol, perfenazin in aripiprazol, antidepresive, kot so nortriptilin, imipramin, amitriptilin ter dezipramin, kemoterapevtik tamoksifen in zaviralec prenašalca noradrenalina, atomoksetin.
There is no relevant use of NUEDEXTA in the paediatric population for the symptomatic treatment of pseudobulbar affect.
Zdravilo NUEDEXTA ni primerno za uporabo pri pediatrični populaciji za simptomatsko zdravljenje psevdobulbarne paralize.
• Studies with Higher Dose Combinations of dextromethorphan / quinidine
• Študije z večjim odmerkom kombinacije dekstrometorfana/kinidina
Quinidine-associated thrombocytopenia usually, but not always, resolves within a few days of discontinuation of the sensitising medicinal product.
Trombocitopenija, povezana s kinidinom, navadno (vendar ne vedno) izzveni v nekaj dneh po prekinitvi jemanja zdravila, ki povzroča preobčutljivost.
In the case of pro-drugs whose actions are mediated by the CYP2D6-produced metabolites (for example, codeine and hydrocodone, whose analgesic and antitussive effects appear to be mediated by morphine and hydromorphone, respectively), efficacy may be substantially reduced by NUEDEXTA due to inhibition of CYP2D6 and hence impaired formation of the active metabolite.
Pri predzdravilih, katerih delovanje je odvisno od presnovkov, ki jih tvori encim CYP2D6 (na primer kodeina in hidrokodona, pri katerih se zdi, da sta analgetični in antitusični učinek odvisna od morfina oziroma hidromorfona), lahko zdravilo NUEDEXTA zmanjša učinek zaradi zaviranja encima CYP2D6 in posledično poslabšane tvorbe aktivnega presnovka.
Most cases remit when quinidine is withdrawn.
Pri večini primerov po prekinitvi kinidina pride do izboljšanja.
Patients receiving concomitant treatment with quinidine, quinine, or mefloquine (see section 4.5).
Bolniki, ki se sočasno zdravijo s kinidinom, kininom ali meflokinom (glejte poglavje 4.5).
NUEDEXTA should be discontinued if hepatitis occurs unless it is clearly not treatment related.
Če se pojavi hepatitis, je treba jemanje zdravila NUEDEXTA prekiniti, razen če je jasno, da hepatitis ni povezan z zdravljenjem.
• weakness (asthenia), irritability
• šibkost (astenija), razdražljivost
• certain medicines for depression, called monoamine oxidase inhibitors (MAOIs- for example phenelzine and moklobemide).
• določena zdravila za depresijo, imenovana zaviralci monoamin-oksidaze (MAOI, npr. fenelzin in moklobemid).
Concomitant use of flecainide, chlorpromazine or haloperidol, CYP2D6 substrates that also prolong QT interval, requires caution (see section 4.4).
Pri sočasni uporabi flekainida, klorpromazina ali haloperidola, substratov encima CYP2D6, ki prav tako podaljšajo interval QT, je potrebna previdnost (glejte poglavje 4.4).
The quinidine in NUEDEXTA inhibits CYP2D6 in patients in whom CYP2D6 is not otherwise genetically absent or of low activity (“CYP2D6 Poor Metabolisers” see “Pharmacogenomics” in section 5.2).
Kinidin v zdravilu NUEDEXTA zavira encim CYP2D6 pri bolnikih, pri katerih encim CYP2D6 ni genetsko odsoten ali nima počasne dejavnosti („Počasni metabolizatorji encima CYP2D6“, glejte „Farmakogenomika“ v poglavju 5.2).
The no effect dose in rabbits is 2 and 60 times higher than the RHD.
Odmerek brez učinka pri kuncih je približno 2-krat in 60
Plasma concentrations of dextromethorphan and dextrorphan are proportional to dextromethorphan dose in the presence of a fixed dose of quinidine such as that contained in NUEDEXTA.
Plazemske koncentracije dekstrometorfana in dekstrorfana so sorazmerne z odmerkom dekstrometorfana v prisotnosti fiksnega odmerka kinidina, kot ga vsebuje zdravilo NUEDEXTA.
Caution should be used when this medicinal product is taken in combination with alcohol or other centrally acting medicinal products that might increase the risk of adverse reactions such as somnolence and dizziness.
Pri uporabi tega zdravila v kombinaciji z alkoholom ali drugimi zdravili z delovanjem na osrednje živčevje, ki lahko povečajo tveganje za neželene učinke, kot sta somnolenca in omotica, je treba biti previden.
If you have taken more capsules than you should, speak to your doctor immediately.
Če ste vzeli večji odmerek zdravila NUEDEXTA, kot bi smeli Če ste vzeli več kapsul, kot bi smeli, se nemudoma obrnite na svojega zdravnika.
During development of this medicinal product, dose combinations of dextromethorphan/quinidine containing up to 6-times higher dextromethorphan dose and 12-times higher quinidine dose were studied.
Med razvojem tega zdravila so proučili kombinacije odmerkov dekstrometorfana/kinidina, ki so vsebovale do 6-krat večji odmerek dekstrometorfana in 12-krat večji odmerek kinidina.
Approximately 7-8% of individuals of Caucasian descent, 3-6% of Black African descent, 2-3% of Arab descent and 1-2% of Asian descent generally lack the capacity to metabolize CYP2D6 substrates and are classified as Poor
Približno 7-8 % posameznikov kavkazijskega porekla, 3-6 % posameznikov afriškega črnega porekla, 2-3 % posameznikov arabskega porekla in 1-2 % posameznikov azijskega porekla v splošnem primanjkuje sposobnosti za presnavljanje substratov CYP2D6 in so označeni kot osebe s slabo presnovo.
Quinidine plasma concentrations are proportional to quinidine dose.
Plazemske koncentracije kinidina so sorazmerne z odmerkom kinidina.
Potent CYP3A4 inducers (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, St John's wort/Hypericum perforatum) may accelerate the metabolism of quinidine, resulting in lower plasma concentrations and hence decreased inhibition of CYP2D6.
Močni induktorji CYP3A4 (npr. rifampicin, fenitoin, fenobarbital, karbamazepin, šentjanževka/Hypericum perforatum) lahko pospešijo presnovo kinidina, kar povzroči manjše koncentracije v plazmi in posledično zmanjšano zaviranje encima CYP2D6.
• to continue the treatment with NUEDEXTA 15 mg/9 mg capsules, or
• za nadaljevanje zdravljenja z zdravilom NUEDEXTA 15 mg/9 mg kapsule ali
A population pharmacokinetic analysis based on data from 109 subjects (75 male; 34 female) showed no apparent gender differences in the pharmacokinetics of dextromethorphan/quinidine.
Farmakokinetična analiza populacije na podlagi podatkov 109 bolnikov (75 moških; 34 žensk) ni pokazala očitnih razlik med spoloma pri farmakokinetiki dekstrometorfana/kinidina.
Treatment with NUEDEXTA may therefore result in elevated plasma levels and accumulation of co-administered medicinal products that undergo extensive CYP2D6 metabolism.
Zdravljenje z zdravilom NUEDEXTA lahko zato povzroči povišane ravni v plazmi in kopičenje sočasnih zdravil, ki se obsežno presnavljajo z encimom CYP2D6.
The efficacy of dextromethorphan/quinidine for the treatment of PBA was demonstrated in three randomised, controlled, double-blind, multicentre clinical trials in PBA subjects with underlying amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS).
Učinkovitost dekstrometorfana/kinidina za zdravljenje PBP so proučevali v treh randomiziranih, nadzorovanih, dvojno slepih, multicentričnih kliničnih preskušanjih pri preskušancih s PBP in osnovno boleznijo, amiotrofično lateralno sklerozo (ALS) ali multiplo sklerozo (MS).
Tricyclic antidepressants (TCAs e.g. desipramine, nortriptyline, imipramine, amitriptyline) are metabolised by CYP2D6 and therefore are also subject to pharmacokinetic interaction with quinidine.
Triciklični antidepresivi (npr. dezipramin, nortriptilin, imipramin, amitriptilin) se presnavljajo z encimom CYP2D6, zato so prav tako izpostavljeni farmakokinetični interakciji s kinidinom.
Driving and using machines NUEDEXTA may cause dizziness.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo NUEDEXTA lahko povzroči omotico.
Dextromethorphan has been shown to be a mild/moderate inhibitor of the OCT1 transporter in vitro.
Pokazalo se je, da je dekstrometorfan blag/zmeren zaviralec prenašalca OCT1 in vitro.
• you experience symptoms such as bruising, bleeding under the skin, nosebleeds and/or bleeding gums, as this may be a sign of low levels of blood cells called platelets (thrombocytopenia).
• opazite simptome, kot so modrice, podkožne krvavitve, krvavitev iz nosu in/ali krvaveče dlesni, saj je to lahko znak nizkih ravni krvnih celic, imenovanih krvne ploščice ali trombociti (trombocitopenija);
This test dose is adequate to represent the steady state exposure in patients with CYP2D6 extensive metabolizer phenotype.
Ta testni odmerek zadovoljivo predstavlja izpostavljenost dinamičnemu ravnovesju pri bolnikih s fenotipom izčrpne presnove CYP2D6.
Patients receiving concomitant treatment with thioridazine, a medicinal product that both significantly prolongs QT interval and is primarily metabolized by CYP2D6.
Bolniki, ki se sočasno zdravijo s tioridazinom, zdravilom, ki pomembno podaljša interval QT in se primarno presnavlja z encimom CYP2D6.
ritonavir, saquinavir, amprenavir, fosamprenavir
indinavir, nelfinavir, ritonavir, sakvinavir, amprenavir, fosamprenavir;
The maximum daily dose from week 4 onwards is NUEDEXTA 23 mg/9 mg, twice daily.
Največji odmerek zdravila NUEDEXTA od 4. tedna naprej je 23 mg/9 mg dvakrat na dan.
• you experience symptoms, such as yellowing of the skin or eyes, dark urine, nausea or vomiting, loss of appetite, abdominal pain, and fever, as this may be a sign of drug-induced hepatitis (liver inflammation).
• opazite simptome, kot so porumenelost kože ali oči, temen urin, navzea ali bruhanje, izguba apetita, bolečine v trebuhu in vročina, saj je to lahko znak z zdravili povzročenega hepatitisa (vnetja jeter);
When initiating treatment with NUEDEXTA in patients at risk of QT prolongation, electrocardiographic (ECG) evaluation of the QT interval should be conducted at baseline and at 2 hours after the first dose administered in the fasted state (approximates to quinidine Tmax).
Če se zdravljenje z zdravilom NUEDEXTA uvaja pri bolnikih s tveganjem podaljšanja intervala QT, je treba ob izhodišču in 2 uri po prvem odmerku na tešče (kar je blizu Tmax kinidina) opraviti elektrokardiografsko (EKG) oceno intervala QT.
The tricyclic antidepressant desipramine is metabolized primarily by CYP2D6.
Triciklični antidepresiv dezipramin se primarno presnavlja z encimom CYP2D6.
Patients with renal and hepatic impairment
Bolniki z ledvično in jetrno okvaro
Concomitant administration of quinidine with digoxin, a P-glycoprotein substrate, results in serum digoxin levels that may be as much as doubled.
Sočasna uporaba kinidina in digoksina, substrata P-glikoproteina, povzroči tudi do dvakrat višje ravni digoksina v serumu.
• medicines to treat epilepsy or fits, such as phenytoin, carbamazepine and phenobarbital
• zdravila za zdravljenje epilepsije in napadov, npr. fenitoin, karbamazepin in fenobarbital.
The quinidine component is intended to inhibit CYP2D6 so that higher exposure to dextromethorphan can be achieved compared to when dextromethorphan is given alone.
Kinidinska komponenta je namenjena zaviranju CYP2D6, da je mogoče doseči višjo izpostavljenost dekstrometorfanu v primerjavi z dajanjem dekstrometorfana samostojno.
Neither dextromethorphan nor quinidine induced CYP1A2, CYP2B6 or CYP3A4 in human hepatocytes at concentrations up to 4.8 µM.
Dekstrometorfan in kinidin nista inducirala CYP1A2, CYP2B6 ali CYP3A4 v človeških hepatocitih pri koncentracijah do 4,8 µM.
No more than 2 capsules should be taken in any 24-hour period, with 12 hours between each dose.
Bolnik v 24-urnem obdobju ne sme vzeti več kot 2 kapsuli, pri čemer mora biti presledek med vsakim odmerkom 12 ur.
The risk of thrombocytopenia in association with the lower dose of quinidine in NUEDEXTA is unknown.
Tveganje za trombocitopenijo, povezano z manjšim odmerkom kinidina v zdravilu NUEDEXTA, ni znano.
Thioridazine, a CYP2D6 substrates that also prolong the QT interval is contraindicated (see section 4.3).
Tioridazin, substrat encima CYP2D6, ki prav tako podaljša interval QT, je kontraindiciran (glejte poglavje 4.3).
If you forget to take NUEDEXTA
Če ste pozabili vzeti zdravilo NUEDEXTA
• dizziness, headache, drowsiness
• omotica, glavobol, dremavost
• heart attack (myocardial infarction), heart palpitations
• srčna kap (miokardni infarkt), palpitacije srca
Drug interactions with desipramine and paroxetine have been studied in controlled clinical trials with a higher dose combination of dextromethorphan/quinidine (dextromethorphan 23 mg/ quinidine 26 mg) than in this medicinal product; study results are described below.
Medsebojno delovanje z dezipraminom in paroksetinom so proučevali v nadzorovanih kliničnih preskušanjih z večjim odmerkom kombinacije dekstrometorfana/kinidina (23 mg dekstrometorfana/26 mg kinidina) kot v tem zdravilu; rezultati študij so opisani spodaj.
However, as there was a trend toward increased incidence of adverse reactions in patients with moderate hepatic impairment, additional monitoring of adverse reactions is advised in these patients.
Če pa se pri bolnikih z zmerno jetrno okvaro pojavi povečana pojavnost neželenih učinkov, se pri teh bolnikih priporoča dodatno spremljanje neželenih učinkov.
In all studies, the efficacy endpoints were “Count of episodes of laughing and crying” (PBA episodes) and subject scores on the Center for Neurologic Studies - Lability Scale (CNS-LS), a validated 7-item, self-administered questionnaire that provides a quantitative measure of the frequency and severity of PBA. CNS-LS scores range from a minimum of 7 (no symptoms) to a maximum of 35.
V vseh študijah je bil opazovani dogodek učinkovitosti „število epizod smeha in joka“ (epizod PBP) in rezultat preskušanca na lestvici labilnosti Centra za nevrološke študije - Lability Scale (CNS-LS), validiranem 7-stopenjskem vprašalniku za samostojno reševanje, ki omogoča kvantitativno meritev pogostnosti in resnosti PBP.
Patients with a prolonged QT interval, congenital long QT syndrome or a history suggestive of torsades de pointes ventricular tachycardia (see section 4.4).
Bolniki s podaljšanim intervalom QT, kongenitalnim sindromom dolgega intervala QT ali anamnezo, ki kaže na ventrikularno tahikardijo tipa torsades de pointes (glejte poglavje 4.4).
Rare (may affect up to 1 in 1,000 people)
Redki (pojavijo se lahko prinajveč 1 od 1.000 bolnikov)
Only for NUEDEXTA 15 mg/9 mg: Blister packs consist of a PVC based clear film with aluminium foil seal and contains 13 hard capsules.
Le za zdravilo NUEDEXTA 15 mg/9 mg: Pretisni omot je izdelan iz z prozorne folije na osnovi PVCja in iz aluminijaste folije ter vsebuje 13 trdih kapsul.
Uncommon side effects (may affect up to 1 in 100 people)
Občasni neželeni učinki (pojavijo se lahko prinajveč 1 od 100 bolnikov)
Blister of a PVC based clear film with aluminium foil seal.
Pretisni omot iz prozorne folije na osnovi PVC-ja in z aluminijasto folijo.
flecainide and beta-blockers (such as metoprolol)
digoksin, flekainid in beta-adrenergične antagoniste (npr. metoprolol);
There was no significant difference in the plasma concentrations of dextromethorphan and dextrorphan before and after the administration of memantine, and there was no effect on the plasma concentrations of memantine before and after the administration of dextromethorphan/quinidine.
Razlika v koncentracijah dekstrometorfana ter dekstrorfana v plazmi pred uporabo memantina in po njej ni bila statistično pomembna, učinkov na koncentracije memantina v plazmi pred uporabo kombinacije dekstrometorfana/kinidina in po njej pa ni bilo.
• redness of the skin (erythema), excessive sweating (hyperhidrosis), loss of sensation or numbness of the face, night sweats
• pordelost kože (eritem), prekomerno znojenje (hiperhidroza), izguba občutka ali odrevenelost obraza, nočno potenje
• if you are already taking medicines containing quinidine, quinine, or mefloquine.
• če že jemljete zdravila, ki vsebujejo kinidin, kinin ali meflokin.
If you forget to take 1 or more capsules, you must not take a double dose to make up for the missed doses.
Ne vzemite dvojnega odmerka, če ste pozabili vzeti 1 ali več kapsul.