FrancophonIA/ELRC3.0 huggingface dataset:
English: The frequency of possible side effects listed below is defined as using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000)
Slovenian: Pogostnost spodaj navedenih neželenih učinkov je razvrščena na naslednji način: zelo pogosti (pojavijo se pri več kot 1 od 10 bolnikov), pogosti (pojavijo se pri 1 do 10 bolnikih od 100 bolnikov), občasni (pojavijo se pri 1 do 10 bolnikih od 1.000 bolnikov), redki (pojavijo se pri 1 do 10 bolnikih od 10.000 bolnikov), zelo redki (pojavijo se pri manj kot 1 bolniku od 10.000 bolnikov), neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
English: HOW TO TAKE EXALIEF
Slovenian: KAKO JEMATI ZDRAVILO EXALIEF
English: Menstruation irregular
Slovenian: • neredna menstruacija,
English: • Tell your doctor if you are taking carbamazepine (a medicine used to treat epilepsy) since your dose may have to be adjusted and the following side effects of Exalief may occur in higher frequency: seeing double, abnormal coordination and dizziness.
Slovenian: • Povejte zdravniku, če jemljete karbamazepin (zdravilo za zdravljenje epilepsije), kajti morda bo treba prilagoditi odmerek; med jemanjem zdravila Exalief se lahko poveča pogostnost naslednjih neželenih učinkov : dvojni vid, nenormalna koordinacija in omotica.
English: These seizures may or may not be followed by a seizure affecting all of the brain (secondary generalisation).
Slovenian: Tem epileptičnim napadom lahko sledijo epileptični napadi, ki prizadenejo celotne možgane (sekundarna generalizacija), vendar ni nujno.
English: If you stop taking Exalief
Slovenian: Če ste prenehali jemati zdravilo Exalief
English: Exalief 400 mg tablets are white, circular and biconvex.
Slovenian: Tablete Exalief 400 mg so bele, okrogle in bikonveksne.
English: The allele HLA-B*1502 is not associated to SJS in the Caucasian population.
Slovenian: Pri belcih alel HLA-B*1502 ni povezan s SJS.
English: • Blood in faeces
Slovenian: • kri v blatu,
English: Exalief has been associated with some central nervous system adverse reactions, such as dizziness and somnolence, which could increase the occurrence of accidental injury.
Slovenian: Uporaba zdravila Exalief je povezana z nekaterimi neželenimi učinki v osrednjem živčevju, kot sta omotica in somnolenca, ki lahko povečajo pogostnost nezgodnih poškodb.
English: As a precaution, vitamin K1 should be administered as a preventive measure in the last few weeks of pregnancy and to the newborn.
Slovenian: V zadnjih nekaj tednih nosečnosti in novorojencu je treba preventivno dajati vitamin K1.
English: 20 tablets 30 tablets 60 tablets 90 tablets
Slovenian: 20 tablet 30 tablet 60 tablet 90 tablet peroralna uporaba Pred uporabo preberite priloženo navodilo.
English: Co-administration of eslicarbazepine acetate 1,200 mg once daily with warfarin showed a small (23%) but statistically significant decrease in exposure to S-warfarin.
Slovenian: Pri sočasni uporabi 1.200 mg eslikarbazepinacetata enkrat na dan in varfarina so opazili majhno (23odstotno), vendar statistično pomembno zmanjšanje izpostavljenosti S-varfarinu.
English: Symptoms include chronic abdominal cramps and diarrhoea or constipation.
Slovenian: Simptomi vključujejo kronične trebušne krče in drisko ali zaprtje.
English: • you have liver problems.
Slovenian: • imate težave z jetri.
English: The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Slovenian: Razdelilna zareza je namenjena delitvi tablete za lažje požiranje in ne delitvi na enaka odmerka.
English: • you have rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
Slovenian: • imate izpuščaj, težave pri požiranju ali dihanju in otekanje ustnic, obraza, grla ali jezika.
English: À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Portugal tel: +351 22 986 61 00 fax: +351 22 986 61 99 e-mail: info@bial.com
Slovenian: À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Portugalska telefon: +351 22 986 61 00 telefaks: +351 22 986 61 99 e-pošta: info@bial.com
English: Peak plasma concentrations (Cmax) of eslicarbazepine are attained at 2-3 hours post-dose and steady state plasma concentrations are attained after 4 to 5 days of once daily dosing, consistent with an effective half-life in the order of 20-24 h. In studies in healthy subjects and epileptic adult patients, the apparent half-life of eslicarbazepine was 10-20 h and 13-20 h, respectively.
Slovenian: Najvišje koncentracije eslikarbazepina v plazmi (Cmax) so dosežene 2-3 ure po odmerku, koncentracije v stanju dinamičnega ravnovesja pa po 4 do 5 dneh odmerjanja enkrat na dan, kar je skladno z efektivnim razpolovnim časom 20-24 h. V študijah pri zdravih osebah je bil razpolovni čas eslikarbazepina 10-20 h, pri odraslih bolnikih z epilepsijo pa 13-20 h. Manj pomembni presnovki v plazmi so R-likarbazepin in okskarbazepin, za katera so ugotovili, da sta aktivna, ter konjugati glukuronske kisline z eslikarbazepinacetatom, eslikarbazepinom, R-likarbazepinom in okskarbazepinom.
English: Eslicarbazepine acetate metabolites are eliminated from the systemic circulation primarily by renal excretion, in the unchanged and glucuronide conjugate forms.
Slovenian: Presnovki eslikarbazepinacetata se izločajo iz sistemskega obtoka predvsem skozi ledvice, v nespremenjeni obliki in kot glukuronidni konjugat.
English: Insomnia, apathy, depression, nervousness, agitation, irritability, attention deficit/ hyperactivity disorder, confusional state, mood swings, crying, psychomotor retardation, stress, psychotic disorder
Slovenian: Psihiatrične motnje insomnija, apatija, depresija, živčnost, agitacija, razdražljivost, motnje pozornosti/hiperaktivnost, stanje zmedenosti, spremembe razpoloženja, jok, psihomotorična retardacija, stres, psihotične motnje
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 20, 30, 60 or 90 tablets
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla z 20, 30, 60 ali 90 tabletami
English: Caution should be exercised in patients with medical conditions (e.g. low levels of thyroxine, cardiac conduction abnormalities), or when taking concomitant medicinal products known to be associated with PR prolongation.
Slovenian: Pri bolnikih z boleznimi (npr. nizke ravni tiroksina, motnje srčne prevodnosti), povezanimi s podaljšanjem intervala PR, ali bolnikih, ki sočasno jemljejo zdravila, za katera je znano, da so povezana s podaljšanjem intervala PR, morate biti previdni.
English: • Irritable Bowel Syndrome (IBS).
Slovenian: • sindrom razdražljivega kolona (dela debelega črevesa).
English: A study in healthy subjects showed no effect of eslicarbazepine acetate 1,200 mg once daily on digoxin pharmacokinetics, suggesting that eslicarbazepine acetate has no effect on the transporter P-glycoprotein.
Slovenian: Študija pri zdravih osebah je pokazala, da uporaba 1.200 mg eslikarbazepinacetata enkrat na dan nima učinka na farmakokinetiko digoksina, kar kaže na to, da eslikarbazepinacetat nima učinka na transportni Pglikoprotein.
English: Adverse reactions associated with PR interval prolongation (e.g. AV block, syncope, bradycardia) may occur.
Slovenian: Uporaba eslikarbazepinacetata je povezana s podaljšanjem intervala PR. Lahko se pojavijo neželeni učinki, povezani s podaljšanjem intervala PR (npr. AV-blok, sinkopa in bradikardija).
English: Do not use Exalief after the expiry date, which is stated on the blister package and the carton after EXP.
Slovenian: Zdravila Exalief ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake »EXP«.
English: • Feeling unsteady or having a sensation of spinning or floating
Slovenian: • občutek nestabilnosti ali vrtenja ali lebdenja,
English: The need for antiepileptic therapy should be reviewed when a woman is planning to become pregnant.
Slovenian: Pri ženskah, ki načrtujejo nosečnost, je treba potrebo po zdravljenju epilepsije znova oceniti.
English: In vitro studies have shown that plasma protein binding was not relevantly affected by the presence of warfarin, diazepam, digoxin, phenytoin and tolbutamide.
Slovenian: Prisotnost eslikarbazepina ni bistveno vplivala na vezavo varfarina, diazepama, digoksina, fenitoina in tolbutamida.
English: The pharmacokinetics of eslicarbazepine is linear and dose-proportional in the range 400-1200 mg both in healthy subjects and patients.
Slovenian: V razponu od 400 do 1.200 mg je farmakokinetika eslikarbazepina linearna in odvisna od odmerka pri zdravih osebah in pri bolnikih.
English: Alopecia, dry skin, hyperhidrosis, erythema, nail disorder, skin disorder
Slovenian: Bolezni kože in podkožja alopecija, suha koža, hiperhidroza, eritem, bolezni nohtov, bolezni kože
English: Memory impairment, balance disorder, amnesia, hypersomnia, sedation, aphasia, dysaesthesia, dystonia, lethargy, parosmia, autonomic nervous system imbalance, cerebellar ataxia, cerebellar syndrome, grand mal convulsion, neuropathy peripheral, sleep phase rhythm disturbance, nystagmus, speech disorder, dysarthria, hypoaesthesia, ageusia, burning sensation
Slovenian: motnje spomina, motnje ravnotežja, amnezija, hipersomnija, sedacija, afazija, disestezija, distonija, letargija, parozmija, neravnovesje avtonomnega živčevja, cerebralna ataksija, cerebralni sindrom, napadi grand mal, periferna nevropatija, motnje ritma faz spanja, nistagmus, motnje govora, disartrija, hipoestezija, agevzija, pekoč občutek
English: If you accidently take more Exalief than you should, tell a doctor or go to a hospital accident and emergency department immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Exalief, kot bi smeli Če ponesreči vzamete več zdravila Exalief, kot bi smeli, takoj povejte zdravniku ali pojdite na oddelek za nujno zdravstveno pomoč.
English: Studies in healthy subjects and patients showed that pharmacokinetics of eslicarbazepine acetate were not affected by gender.
Slovenian: Študije pri zdravih osebah in bolnikih so pokazale, da spol ne vpliva na farmakokinetiko eslikarbazepinacetata.
English: A study in healthy subjects with eslicarbazepine acetate 1,200 mg once daily showed a minor average pharmacokinetic interaction (exposure of lamotrigine decreased 15%) between eslicarbazepine acetate and lamotrigine and consequently no dose adjustments are required.
Slovenian: V študiji pri zdravih osebah, ki so prejemale 1.200 mg eslikarbazepinacetata enkrat na dan, so opazili majhno povprečno farmakokinetično interakcijo (izpostavljenost lamotriginu se je povečala za 15 %) med eslikarbazepinacetatom in lamotriginom, zato prilagajanje odmerka ni potrebno.
English: Rare side effects are:
Slovenian: Redki neželeni učinki so:
English: The tablets have ‘ESL 800'engraved on one side and are scored on the other side, enabling the tablets to be divided into equal halves.
Slovenian: Tablete imajo vtisnjen napis ‘ESL 800' na eni strani in zarezo na drugi, ki omogoča delitev tablete na enaki polovici.
English: The scoreline is only to facilitate breaking the tablet into two for ease of swallowing, and it does not divide the tablet into two equal doses.
Slovenian: Zareza zgolj pomaga pri lomljenju tablete, da jo lažje pogoltnete, in ni namenjena deljenju tablete na enaka odmerka.
English: Eslicarbazepine acetate is extensively converted to eslicarbazepine, which is mainly eliminated by glucuronidation.
Slovenian: Eslikarbazepinacetat se v veliki meri spremeni v eslikarbazepin, ki se večinoma izloča z glukuronidacijo.
English: Eslicarbazepine acetate is rapidly and extensively biotransformed to its major active metabolite eslicarbazepine by hydrolytic first-pass metabolism.
Slovenian: Eslikarbazepinacetat se s hidrolitično presnovo prvega prehoda skozi jetra hitro in v veliki meri biološko transformira v glavni aktivni presnovek, eslikarbazepin.
English: The tablets have ‘ESL 600'engraved on one side and are scored on the other side, enabling the tablets to be divided into equal halves.
Slovenian: Tablete imajo vtisnjen napis ‘ESL 600' na eni strani in zarezo na drugi, ki omogoča delitev tablete na enaki polovici.
English: Interactions with other antiepileptic medicinal products Carbamazepine
Slovenian: Interakcije z drugimi antiepileptiki
English: Exalief may make you feel dizzy, drowsy and affect your vision, particularly at the beginning of treatment.
Slovenian: Zaradi zdravila Exalief ste lahko omotični ali dremavi in utegnete imeti motnje vida, zlasti na začetku zdravljenja.
English: Exalief is not recommended in patients with severe renal disease.
Slovenian: Zdravilo Exalief ni priporočeno pri bolnikih s hudo ledvično boleznijo.
English: A study in healthy subjects showed an average decrease of 50% in systemic exposure to simvastatin when co-administered with eslicarbazepine acetate 800 mg once daily, most likely caused by an induction of CYP3A4.
Slovenian: Študija pri zdravih preskušancih je pokazala povprečno 50-odstotno zmanjšanje sistemske izpostavljenosti simvastatinu pri sočasnem dajanju eslikarbazepinacetata v odmerku 800 mg enkrat dnevno, kar je najverjetneje posledica indukcije CYP3A4.
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema anemija trombocitopenija, levkopenija
English: EU/1/09/520/012 20 tablets - ALU/ALU blister EU/1/09/520/013 30 tablets - ALU/ALU blister EU/1/09/520/014 60 tablets - ALU/ALU blister EU/1/09/520/015 90 tablets - ALU/ALU blister EU/1/09/520/016 20 tablets - PVC/ALU blister EU/1/09/520/017 30 tablets - PVC/ALU blister EU/1/09/520/018 60 tablets - PVC/ALU blister EU/1/09/520/019 90 tablets - PVC/ALU blister
Slovenian: EU/1/09/520/012 20 tablet - Pretisni omot iz ALU/ALU EU/1/09/520/013 30 tablet - Pretisni omot iz ALU/ALU EU/1/09/520/014 60 tablet - Pretisni omot iz ALU/ALU EU/1/09/520/015 90 tablet - Pretisni omot iz ALU/ALU EU/1/09/520/016 20 tablet - Pretisni omot iz PVC/ALU EU/1/09/520/017 30 tablet - Pretisni omot iz PVC/ALU EU/1/09/520/018 60 tablet - Pretisni omot iz PVC/ALU EU/1/09/520/019 90 tablet - Pretisni omot iz PVC/ALU
English: Therefore it is recommended that you use other forms of safe and effective contraception, when taking Exalief up to the end of the current menstrual cycle after stopping treatment.
Slovenian: Zato je med jemanjem zdravila Exalief in do konca trenutnega menstrualnega cikla po končanem zdravljenju priporočeno uporabljati drugo obliko varne in učinkovite kontracepcije.
English: Therefore, an alternative, effective and safe method of contraception should be used during treatment and up to the end of the current menstrual cycle after treatment has been stopped.
Slovenian: Med zdravljenjem in do konca trenutnega menstrualnega cikla po koncu zdravljenja je zato treba uporabljati drugo, učinkovito in varno kontracepcijsko metodo.
English: Marketing Authorisation Holder and Manufacturer BIAL - Portela & Cª , S.A., À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal tel: +351 22 986 61 00 fax: +351 22 986 61 99 e-mail: info@bial.com
Slovenian: BIAL - Portela & Cª , S.A., À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugalska telefon: +351 22 986 61 00 faks: +351 22 986 61 99 e-pošta: info@bial.com
English: In the mouse, the overall incidence of major abnormalities and the incidence for major skeletal abnormalities were increased.
Slovenian: Pri miših se je zvečala skupna pogostnost pomembnih patoloških sprememb ter pogostnost pomembnih patoloških sprememb na okostju.
English: Plasma levels of eslicarbazepine acetate usually remain below the limit of quantification, following oral administration.
Slovenian: Po peroralni uporabi ostajajo ravni eslikarbazepinacetata v plazmi ponavadi pod mejo določljivosti.
English: • Tell your doctor if you are taking phenytoin (a medicine used to treat epilepsy) since your dose may need to be adjusted.
Slovenian: • Povejte zdravniku, če jemljete fenitoin (zdravilo za zdravljenje epilepsije), ker bo morda moral prilagoditi odmerek.
English: Increased appetite, decreased appetite, hyponatraemia, electrolyte imbalance, cachexia, dehydration, obesity
Slovenian: Presnovne in prehranske motnje zvečan apetit, zmanjšan apetit, hiponatriemija, neravnovesje elektrolitov, kaheksija, dehidracija, debelost
English: Rash developed as an adverse reaction in 1.1% of total population treated with Exalief in placebo-controlled add-on studies in epileptic patients.
Slovenian: Pri 1,1 % celotne populacije bolnikov z epilepsijo, ki so zdravilo Exalief prejemali v študijah dodatnega zdravljenja, nadzorovanih s placebom, se je pojavil izpuščaj.
English: • Rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
Slovenian: • izpuščaj, težave pri požiranju ali dihanju in otekanje ustnic, obraza, grla ali jezika.
English: The tablets are packaged in blisters in cardboard boxes containing 20, 30, 60 or 90 tablets, and in HDPE bottles with child resistant closure in cardboard boxes containing 90 tablets.
Slovenian: Tablete so pakirane v pretisne omote v kartonskih škatlah, ki vsebujejo 20, 30, 60 ali 90 tablet, in v steklenice iz HDPE z za otroke varno zaporko v kartonskih škatlah, ki vsebujejo 90 tablet.
English: Eslicarbazepine in vivo may have an inducing effect on the metabolism of medicinal products that are mainly eliminated by conjugation through the UDP-glucuronyl transferases.
Slovenian: Eslikarbazepin ima morda in vivo spodbujevalni učinek na presnovo zdravil, ki se izločajo predvsem s konjugacijo z UDP-glukuroniltransferazami.
English: EU/1/09/520/007 30 tablets - ALU/ALU blister EU/1/09/520/008 60 tablets - ALU/ALU blister EU/1/09/520/009 30 tablets - PVC/ALU blister EU/1/09/520/010 60 tablets - PVC/ALU blister
Slovenian: EU/1/09/520/007 30 tablet - Pretisni omot iz ALU/ALU EU/1/09/520/008 60 tablet - Pretisni omot iz ALU/ALU EU/1/09/520/009 30 tablet - Pretisni omot iz PVC/ALU EU/1/09/520/010 60 tablet - Pretisni omot iz PVC/ALU
English: In a study in healthy subjects, concomitant administration of eslicarbazepine acetate 1,200 mg once daily and topiramate showed no significant change in exposure to eslicarbazepine but an 18% decrease in exposure to topiramate, most likely caused by a reduced bioavailability of topiramate.
Slovenian: V študiji pri zdravih osebah sočasne uporabe 1.200 mg eslikarbazepinacetata enkrat na dan in topiramata ni povzročila pomembne spremembe v izpostavljenosti eslikarbazepinu, vendar so ugotovili 18-odstotno zmanjšanje izpostavljenosti topiramatu, ki je najverjetneje bilo rezultat zmanjšane biološke uporabnosti topiramata.
English: • Disturbances in the sense of smell and/or tasting
Slovenian: • motnje voha in/ali okušanja,
English: • you have kidney problems.
Slovenian: • imate težave z ledvicami.
English: No dose adjustment is recommended in patients with mild to moderate liver impairment (see section 4.2).
Slovenian: Pri bolnikih z blago do zmerno jetrno okvaro prilagajanje odmerka ni potrebno (glejte poglavje 4.2).
English: Exalief may make you feel dizzy and/or drowsy, particularly at the beginning of treatment.
Slovenian: Zaradi zdravila Exalief ste lahko omotični ali dremavi ali oboje, zlasti na začetku zdravljenja.
English: Exalief 800 mg tablets are packed in ALU/ALU or ALU/PVC blisters placed into cardboard boxes containing 20, 30, 60 or 90 tablets.
Slovenian: Tablete Exalief 800 mg so pakirane v pretisne omote iz ALU/ALU ali ALU/PVC, vložene v kartonske škatle, ki vsebujejo 20, 30, 60 ali 90 tablet.
English: • Tell your doctor if you are taking simvastatin (a medicine used to lower cholesterol levels) since your dose may have to be adjusted.
Slovenian: • Povejte zdravniku, če jemljete simvastatin (zdravilo za zniževanje koncentracije holesterola v krvi), kajti morda bo treba prilagoditi odmerek.
English: What Exalief is and what it is used for Before you take Exalief How to take Exalief Possible side effects How to store Exalief Further information
Slovenian: Kaj je zdravilo Exalief in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Exalief
English: EU/1/09/520/001 7 tablets - ALU/ALU blister EU/1/09/520/002 14 tablets - ALU/ALU blister EU/1/09/520/003 28 tablets - ALU/ALU blister EU/1/09/520/004 7 tablets - PVC/ALU blister EU/1/09/520/005 14 tablets - PVC/ALU blister EU/1/09/520/006 28 tablets - PVC/ALU blister
Slovenian: EU/1/09/520/001 7 tablet - Pretisni omot iz ALU/ALU EU/1/09/520/002 14 tablet - Pretisni omot iz ALU/ALU EU/1/09/520/003 28 tablet - Pretisni omot iz ALU/ALU EU/1/09/520/004 7 tablet - Pretisni omot iz PVC/ALU EU/1/09/520/005 14 tablet - Pretisni omot iz PVC/ALU EU/1/09/520/006 28 tablet - Pretisni omot iz PVC/ALU
English: Uncommon side effects are:
Slovenian: Občasni neželeni učinki so:
English: • Burning sensation
Slovenian: • pekoč občutek,
English: • Tell your doctor if you are taking the blood thinner - warfarin.
Slovenian: • Povejte zdravniku, če jemljete zdravilo za redčenje krvi varfarin.
English: In a study in healthy subjects, concomitant administration of eslicarbazepine acetate 800 mg once daily and carbamazepine 400 mg twice daily resulted in an average decrease of 32% in exposure to the active metabolite eslicarbazepine, most likely caused by an induction of glucuronidation.
Slovenian: V študiji pri zdravih preskušancih je sočasna uporaba eslikarbazepinacetata v odmerku 800 mg enkrat dnevno ter karbamazepina v odmerku 400 mg dvakrat dnevno povzročila povprečno 32-odstotno zmanjšanje izpostavljenosti aktivnemu presnovku eslikarbazepinu, kar je najverjetneje posledica indukcije glukuronidacije.
English: During treatment with Exalief dose adjustment is recommended in patients with creatinine clearance <60 ml/min (see section 4.2).
Slovenian: Pri bolnikih s kreatininskim očistkom < 60 ml/min, je med zdravljenjem z zdravilom Exalief priporočeno prilagoditi odmerek (glejte poglavje 4.2).
English: In a fertility study in male and female rats, impairment of female fertility by eslicarbazepine acetate was shown.
Slovenian: Študija plodnosti pri samcih in samicah podganah je pokazala, da eslikarbazepin acetat oslabi plodnost samic.
English: In a study in healthy subjects, concomitant administration of eslicarbazepine acetate 1,200 mg once daily and phenytoin resulted in an average decrease of 31-33% in exposure to the active metabolite, eslicarbazepine, most likely caused by an induction of glucuronidation, and an average increase of 31-35% in exposure to phenytoin, most likely caused by an inhibition of CYP2C19.
Slovenian: V študiji pri zdravih osebah je sočasna uporaba 1.200 mg eslikarbazepinacetata enkrat na dan in fenitoina povzročila povprečno 31- do 33-odstotno zmanjšanje izpostavljenosti aktivnemu presnovku eslikarbazepinu, ki je najverjetneje bilo posledica indukcije glukuronidacije, in povprečno 31- do 35-odstotno povečanje izpostavljenosti fenitoinu, ki je najverjetneje bilo posledica zaviranja CYP2C19.
English: • Heart burn, stomach upset, abdominal pain, abdominal bloating and discomfort or dry mouth
Slovenian: • zgaga, prebavne težave, bolečine v trebuhu, napihnjenost ali neprijeten občutek v trebuhu ali suha usta,
English: Eslicarbazepine acetate is extensively converted to eslicarbazepine.
Slovenian: Eslikarbazepinacetat se v veliki meri spremeni v eslikarbazepin.
English: However, Exalief is not recommended if you have severe liver problems.
Slovenian: Vendar uporaba zdravila Exalief ni priporočeno, če imate hude težave z jetri.
English: Eslicarbazepine acetate metabolites are eliminated from the systemic circulation primarily by renal excretion.
Slovenian: Presnovki eslikarbazepinacetata se izločajo iz sistemskega obtoka predvsem skozi ledvice.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 7, 14 or 28 tablets
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla s 7, 14 ali 28 tabletami
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 30 or 60 tablets
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla s 30 ali 60 tabletami
English: Patients with liver problems
Slovenian: Bolniki, ki imajo težave z jetri
English: INFORMATION IN BRAILLE Exalief 400 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Exalief 400 mg