natgillin/translations-raw huggingface dataset:
EU/1/12/768/001 - 56 film-coated tablets EU/1/12/768/002 - 28 film-coated tablets EU/1/12/768/003 - 98 film-coated tablets EU/1/12/768/004 - 112 film-coated tablets EU/1/12/768/005 - 168 film-coated tablets
EU/1/12/768/001- 56 filmsko obloženih tablet EU/1/12/768/002 - 28 filmsko obloženih tablet EU/1/12/768/003 - 98 filmsko obloženih tablet EU/1/12/768/004 - 112 filmsko obloženih tablet EU/1/12/768/052 - 168 filmsko obloženih tablet
There is no evidence that Riluzole Zentiva exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms.
Ni dokazov, da bi zdravilo Riluzol Zentiva terapevtsko učinkovalo na motorično funkcijo, pljučno funkcijo, fascikulacije, mišično moč ali motorične simptome.
Riluzole should be prescribed with care in patients with a history of abnormal liver function, or in patients with slightly elevated serum transaminases (ALT/SGPT; AST/SGOT up to 3 times the upper limit of the normal range (ULN)), bilirubin and/or gamma-glutamyl transferase (GGT) levels.
Previdnost je potrebna pri predpisovanju riluzola bolnikom z anamnezo motenega delovanja jeter ali bolnikom z nekoliko zvišano ravnjo serumskih transaminaz (ALT/SGPT, AST/SGOT do vrednosti, ki je enaka 3-kratni zgornji meji normalne vrednosti (ULN)), bilirubina in/ali gama-glutamiltransferaze
Riluzole Zentiva is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).
Zdravilo Riluzol Zentiva je indicirano za podaljšanje življenja ali časa do mehanične ventilacije pri bolnikih z amiotrofično lateralno sklerozo (ALS).
Hepatic disease or baseline transaminases greater than 3 times the upper limit of normal.
Bolezen jeter ali izhodiščna raven transaminaz, ki več kot 3-krat presega zgornjo normalno mejo.
The tablets are film-coated, capsule-shaped and white.
Tablete so filmsko obložene, imajo kapsulam podobno obliko in so bele barve.
Riluzole Zentiva is not recommended for use in patients with impaired renal function, as studies at repeated doses have not been conducted in this population (see section 4.4).
Zdravila Riluzol Zentiva ni priporočljivo uporabljati pri bolnikih z okvarjenim delovanjem ledvic, ker v tej populaciji ni bilo študij s ponavljajočimi odmerki (glejte poglavje 4.4).
In vitro studies using human liver microsomal preparations suggest that CYP 1A2 is the principal isozyme involved in the initial oxidative metabolism of riluzole.
Študije in vitro z uporabo mikrosomskih preparatov človeških jeter kažejo, da je CYP 1A2 glavni izoencim, ki sodeluje v uvodni oksidativni presnovi riluzola.
A clinical study conducted to evaluate the pharmacokinetics of riluzole and its metabolite N-hydroxyriluzole following repeated oral administration twice daily for 8 days in 16 healthy Japanese and 16 Caucasian adult males showed in the Japanese group a lower exposure of riluzole (Cmax 0.85 [90% CI 0.68-1.08] and AUC inf. 0.88 [90% CI 0.69-1.13]) and similar exposure to the metabolite.
Za oceno farmakokinetike riluzola in njegovega presnovka N-hidroksiriluzola po ponavljajočem peroralnem jemanju dvakrat na dan 8 dni, so pri 16 zdravih japonskih in 16 zdravih kavkaških odraslih moških izvedli klinično študijo, ki je pri japonskih moških pokazala nižjo izpostavljenost riluzolu (Cmax 0,85 [90 % IZ 0,68-1,08] in AUCinf.
Treatment with Riluzole Zentiva should only be initiated by specialist physicians with experience in the management of motor neurone diseases.
Zdravljenje z zdravilom Riluzol Zentiva sme uvesti samo zdravnik specialist z izkušnjami v zdravljenju bolezni motoričnega nevrona.
Film-coated tablet The tablets are capsule-shaped, white and engraved with “RPR 202” on one side.
filmsko obložena tableta Tablete imajo kapsulam podobno obliko, so bele barve in imajo na eni strani vrezan napis "RPR 202".
The overall urinary excretion accounts for about 90% of the dose.
V celoti se v urinu izloči približno 90 % odmerka.
About 90% of the dose is absorbed and the absolute bioavailability is 60 ± 18%.
Absorbira se okrog 90 % odmerka in absolutna biološka uporabnost je
Although the pathogenesis of ALS is not completely elucidated, it is suggested that glutamate (the primary excitatory neurotransmitter in the central nervous system) plays a role for cell death in the disease.
Patogeneza ALS sicer ni povsem pojasnjena, vendar domnevajo, da igra vlogo pri odmiranju celic pri tej bolezni glutamat (primarni ekscitatorni nevrotransmitor v osrednjem živčevju).
Clinical trials have demonstrated that Riluzole Zentiva extends survival for patients with ALS (see section 5.1).
Klinična preskušanja so pokazala, da zdravilo Riluzol Zentiva podaljša preživetje bolnikov z ALS (glejte poglavje 5.1).
The median survival time was 17.7 months versus 14.9 months for riluzole and placebo, respectively.
Mediano preživetje je bilo ob riluzolu 17,7 mesecev in ob placebu 14,9 mesecev.
The report of a febrile illness should prompt physicians to check white blood cell counts and to discontinue riluzole in case of neutropenia (see section 4.8).
Po obvestilu o febrilni bolezni mora zdravnik preveriti belo krvno sliko in v primeru nevtropenije uporabo riluzola prekiniti (glejte poglavje 4.8).
In patients treated with riluzole 100 mg/day, survival was significantly higher compared to patients who received placebo.
zdravljenih z riluzolom 100 mg/dan, je bilo preživetje značilno večje kot pri bolnikih, ki so dobivali placebo.
Each tablet contains 50 mg of riluzole and is engraved with “RPR 202” on one side.
50 mg riluzola in ima na eni strani vrezan napis "RPR 202".
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
Riluzole is proposed to act by inhibiting glutamate processes.
Riluzol naj bi deloval z zavrtjem dogajanj, povezanih z glutamatom.
If you forget to take Riluzole Zentiva
Če ste pozabili vzeti zdravilo Riluzol Zentiva
The pharmacokinetic parameters of riluzole after multiple dose administration (4.5 days of treatment at 50 mg riluzole bid) are not affected in the older people (>70 years).
Farmakokinetični parametri riluzola se po večkratnem odmerjanju (4,5 dni zdravljenja s 50 mg riluzola dvakrat na dan) pri starejših (> 70 let) ne spremenijo.
Each film-coated tablet contains 50 mg of riluzole.
Ena filmsko obložena tableta vsebuje 50 mg riluzola.
Other medicines and Riluzole Zentiva
Druga zdravila in zdravilo Riluzol Zentiva
Cases of interstitial lung disease have been reported in patients treated with riluzole, some of them were severe (see section 4.8).
Med zdravljenjem z riluzolom so bili opisani primeri intersticijske bolezni pljuč; nekateri od njih so bili hudi (glejte poglavje 4.8).
The metabolites identified in urine are three phenolic derivatives, one ureido-derivative and unchanged riluzole.
V urinu so določili tri fenolne presnovke, enega ureidnega in nespremenjeni riluzol.
Riluzole did not show any carcinogenicity potential in either rats or mice.
Riluzol pri podganah in miših ni pokazal karcinogenega potenciala.
If you take more Riluzole Zentiva than you should
Če ste vzeli večji odmerek zdravila Riluzol Zentiva, kot bi smeli
Riluzole Zentiva is used in patients with amyotrophic lateral sclerosis (ALS).
Zdravilo Riluzol Zentiva uporabljamo pri bolnikih z amiotrofično lateralno sklerozo (ALS).
In a dose-ranging trial, 959 patients with ALS were randomised to one of four treatment groups: riluzole 50, 100, 200 mg/day, or placebo and were followed-up for 18 months.
V preskušanju razpona odmerjanja so 959 bolnikov z ALS randomizirali v eno od štirih terapevtskih skupin - riluzol 50, 100, 200 mg/dan ali placebo - in jih spremljali 18 mesecev.
The AUC of riluzole after a single oral dose of 50 mg increases by about 1.7 fold in patients with mild chronic liver insufficiency and by about 3 fold in patients with moderate chronic liver insufficiency.
Po enkratnem peroralnem odmerku 50 mg se je AUC riluzola pri bolnikih z blago kronično insuficienco jeter zvečal za približno 1,7-krat in pri bolnikih z zmerno kronično insuficienco jeter za približno 3-krat.
Contents of the pack and other information What Riluzole Zentiva contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Riluzol Zentiva
What Riluzole Zentiva is and what it is used for What you need to know before you take Riluzole Zentiva How to take Riluzole Zentiva Possible side effects
Kaj je zdravilo Riluzol Zentiva in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Riluzol Zentiva Kako jemati zdravilo Riluzol Zentiva
The active substance in Riluzole Zentiva is riluzole which acts on the nervous system.
Zdravilna učinkovina v zdravilu Riluzol Zentiva je riluzol, ki deluje na živčevje.
Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
In a double-blind placebo-controlled trial designed to assess the efficacy and safety of riluzole in Japanese patients, 204 patients were randomised to riluzole 100 mg/day (50 mg twice daily) or placebo and were followed-up for 18 months.
V dvojno slepem, s placebom kontroliranem preskušanju za oceno učinkovitosti in varnosti riluzola pri japonskih bolnikih so 204 bolnike randomizirali na riluzol 100 mg/dan (50 mg dvakrat na dan) ali placebo in jih spremljali 18 mesecev.
In phase III clinical studies conducted in ALS patients treated with riluzole, the most commonly reported adverse reactions were asthenia, nausea and abnormal liver function tests.
V kliničnih študijah III faze opravljenih pri bolnikih z ALS, so bili najpogostejši z riluzolom povezani neželeni učinki astenija, navzeja in nenormalni testi jetrnih funkcij.
Tablets are packaged in opaque pvc/aluminium blister cards.
Tablete so pakirane v neprosojne pretisne omote iz PVC in aluminija.
Riluzole Zentiva is available in a pack of 28, 56, 98, 112 or 168 tablets to be taken orally.
Zdravilo Riluzol Zentiva je na voljo v pakiranjih s 28, 56, 98, 112 ali 168 tabletami in ga jemljemo z zaužitjem.
Riluzole Zentiva is contraindicated in pregnancy (see sections 4.3 and 5.3).
Zdravilo Riluzol Zentiva je kontraindicirano med nosečnostjo (glejte poglavji 4.3 in 5.3).
In a single toxicity study, the absence of corpora lutea was noted at a higher incidence in the ovary of treated compared to control female rats.
V eni sami študiji toksičnosti so pri podganjih samicah v skupini, ki je prejela zdravilo pogosteje ugotavljali odsotnost corpora lutea kot v primerjalni skupini.
Glucuronides accounted for more than 85% of the metabolites in the urine.
Več kot 85 % presnovkov v urinu je glukuronidov.
Common side effects (may affect up to 1 in 10 people) of Riluzole Zentiva are: dizziness numbness or tingling of the mouth vomiting sleepiness increase in heart beat diarrhoea headache abdominal pain pain
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) zdravila Riluzol Zentiva so: omotica odrevenelost ali mravljinčavost ust bruhanje zaspanost pospešen srčni utrip driska glavobol bolečine v trebuhu bolečine
Not known
Pogostost neznana
There is no significant difference in pharmacokinetic parameters between patients with moderate or severe chronic renal insufficiency (creatinine clearance between 10 and 50 ml.min-1) and healthy volunteers after a single oral dose of 50 mg riluzole.
Po enkratnem peroralnem odmerku 50 mg riluzola ni značilnih razlik v farmakokinetičnih parametrih med bolniki z zmerno ali hudo ledvično odpovedjo (očistek kreatinina med 10 in 50 ml.min-1) in zdravimi prostovoljci.
Neurological and psychiatric symptoms, acute toxic encephalopathy with stupor, coma, and methaemoglobinaemia have been observed in isolated cases.
V posameznih primerih so opazili nevrološke in psihiatrične simptome, akutno toksično encefalopatijo s stuporjem, komo in methemoglobinemijo.
Please consult your doctor for more information about ALS and the reason why this medicine has been prescribed for you.
O dodatnih informacijah o ALS in o razlogu, zakaj ste dobili to zdravilo, se prosimo posvetujte s svojim zdravnikom.
Tracheostomy-free survival in patients treated with riluzole did not differ significantly from placebo.
Preživetje brez traheostomije se pri bolnikih, zdravljenih z riluzolom, ni značilno razlikovalo od tistega pri bolnikih, ki so dobivali placebo.
How to store Riluzole Zentiva Contents of the pack and other information
Shranjevanje zdravila Riluzol Zentiva Vsebina pakiranja in dodatne informacije
IMPORTANT Tell your doctor immediately if you experience any fever (increase in temperature) because Riluzole Zentiva may cause a decrease in the number of white blood cells.
- če imate vročino (zvišanje telesne temperature), saj zdravilo Riluzol Zentiva lahko povzroči znižanje števila belih krvnih celic.
ALS is a form of motor neurone disease where attacks of the nerve cells responsible for sending instructions to the muscles lead to weakness, muscle waste and paralysis.
ALS je ena od bolezni motoričnega nevrona, kjer pride do propada živčnih celic, ki so odgovorne za pošiljanje navodil mišicam.
In patients (n=20) from clinical studies with increases in ALT to more than 5 times the ULN, treatment was discontinued and the levels returned to less than 2 times the ULN within 2 to 4 months in most cases (see section
sodelujočih v kliničnih študijah, z zvišano ALT več kot 5 kratno ULN je bilo zdravljenje prekinjeno in v večini primerov so se koncentracije znižale na manj kot 2 kratno ULN v 2 do 4 mesecih (glejte poglavje 4.4).
What Riluzole Zentiva looks like and content of the pack
Izgled zdravila Riluzol Zentiva in vsebina pakiranja
Riluzole Zentiva is not recommended for use paediatric population, due to a lack of data on the safety and efficacy of riluzole in any neurodegenerative diseases occurring in children or adolescents.
Pediatrična populacija Zaradi pomanjkanja podatkov o varnosti in učinkovitosti riluzola, pri katerikoli nevrodegenerativni bolezni otrok in mladostnikov, uporaba zdravila Riluzol Zentiva pri pediatrični populaciji ni priporočljiva.
Uncommon side effects (may affect up to 1 in 100 people) of Riluzole Zentiva are: anaemia allergic reactions inflammation of the pancreas (pancreatitis).
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) zdravila Riluzol Zentiva so: - slabokrvnost - alergijske reakcije - vnetje trebušne slinavke (pankreatitis).
Anaphylactoid reaction, angioedema
Bolezni imunskega sistema anafilaktoidna reakcija, angioedem
Česká republika
Češka republika
Riluzole Zentiva is contraindicated in breast-feeding women (see sections 4.3 and 5.3).
Dojenje Zdravilo Riluzol Zentiva je kontraindicirano pri ženskah, ki dojijo (glejte poglavji 4.3 in 5.3).
Riluzole should be discontinued if the ALT levels increase to 5 times the ULN.
Če se raven ALT zviša na 5-kratno vrednost ULN, je treba uporabo riluzola prekiniti.
ALT should be measured every month during the first 3 months of treatment, every 3 months during the remainder of the first year, and periodically thereafter.
Zaradi tveganja za hepatitis je treba pred začetkom zdravljenja z riluzolom in med zdravljenjem z njim določati serumske transaminaze, vključno z ALT. ALT je treba prve 3 mesece zdravljenja določiti vsak mesec, preostanek prvega leta na 3 mesece, pozneje pa v rednih presledkih.
LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS
FARMACEVTSKA OBLIKA IN VSEBINA
Each package contains 28, 56, 98, 112 or 168 tablets.
Eno pakiranje vsebuje 28, 56, 98, 112 ali 168 tablet Na trgu morda ni vseh navedenih pakiranj.
In the pregnant rat, the transfer of 14C-riluzole across the placenta to the foetus has been detected.
Pri brejih podganah je ugotovljeno prehajanje 14C-riluzola prek placente v plod.
The other ingredients are:
- Pomožne snovi v tabletah so:
The pharmacokinetics of riluzole have been evaluated in healthy male volunteers after single oral administration of 25 to 300 mg and after multiple-dose oral administration of 25 to 100 mg bid.
Farmakokinetiko riluzola so ovrednotili pri zdravih moških prostovoljcih po enkratni peroralni uporabi odmerkov od 25 do 300 mg in po večkratni peroralni uporabi odmerkov od 25 do 100 mg dvakrat na dan. Koncentracija v plazmi narašča linearno z odmerkom in farmakokinetični profil je neodvisen od odmerka.
Reductions in red blood cell parameters and/or alterations in liver parameters were noted inconsistently in subacute and chronic toxicity studies in rats and monkeys.
Občasno so v subakutnih in kroničnih študijah toksičnosti pri podganah in opicah opažali zmanjšanje parametrov eritrocitov in/ali spremembe jetrnih parametrov.
What Riluzole Zentiva is and what it is used for What Riluzole Zentiva is
Kaj je zdravilo Riluzol Zentiva in za kaj ga uporabljamo Kaj je zdravilo Riluzol Zentiva
Riluzole Zentiva 50 mg film-coated tablets
Riluzol Zentiva 50 mg filmsko obložene tablete
With multiple dose administration (10 day-treatment at 50 mg riluzole bid), unchanged riluzole accumulates in plasma by about 2 fold and steady-state is reached in less than 5 days.
Ob uporabi z večkratnim odmerjanjem (10-dnevno zdravljenje s 50 mg riluzola dvakrat na dan) se nespremenjeni riluzol kopiči v plazmi do približno 2-krat višjih koncentracij od tistih pri posamičnem odmerjanju.
How to take Riluzole Zentiva
Kako jemati zdravilo Riluzol Zentiva
Core: anhydrous dibasic calcium phosphate, micro crystalline cellulose, anhydrous colloidal silica, magnesium stearate, croscarmellose sodium;
Jedro: brezvodni kalcijev hidrogenfosfat, mikrokristalna celuloza, brezvodni koloidni silicijev dioksid, magnezijev stearat, premreženi natrijev karmelozat;
In a trial, 155 patients were randomised to riluzole 100 mg/day (50 mg twice daily) or placebo and were followed-up for 12 to 21 months.
V preskušanju so od 12 do 21 mesecev spremljali 155 bolnikov, randomiziranih na 100 mg riluzola/dan (50 mg dvakrat na dan) ali na placebo.
What you need to know before you take Riluzole Zentiva Do not take Riluzole Zentiva if you are allergic to riluzole or any of the other ingredients of this medicine (listed in section if you have any liver disease or increased blood levels of some enzymes of the liver (transaminases),
- če ste alergični na riluzol ali katero koli sestavino tega zdravila (navedeno v poglavju 6), - če imate katero od bolezni jeter ali zvišanje krvnih koncentracij določenih jetrnih encimov
Dibasic calcium phosphate, anhydrous Micro crystalline cellulose Colloidal silica, anhydrous Magnesium stearate Croscarmellose sodium
Jedro brezvodni kalcijev hidrogenfosfat mikrokristalna celuloza brezvodni koloidni silicijev dioksid magnezijev stearat premreženi natrijev karmelozat
This leaflet was last approved in {MM/YYYY}.
Navodilo je bilo nazadnje revidirano dne
Inhibitors of CYP 1A2 (e.g. caffeine, diclofenac, diazepam, nicergoline, clomipramine, imipramine, fluvoxamine, phenacetin, theophylline, amitriptyline and quinolones) could potentially decrease the rate of riluzole elimination, while inducers of CYP 1A2 (e.g. cigarette smoke, charcoal-broiled food, rifampicin and omeprazole) could increase the rate of riluzole elimination.
amitriptilin in kinoloni) bi potencialno lahko upočasnili eliminacijo riluzola, induktorji CYP 1A2 (npr. cigaretni dim, nad ogljem pečena hrana, rifampicin in omeprazol) pa bi jo lahko pospešili.
Abnormal liver function tests
žolčnika in žolčevodov nenormalni testi jetrnih funkcij hepatitis
If respiratory symptoms develop such as dry cough and/or dyspnoea, chest radiography should be performed, and in case of findings suggestive of interstitial lung disease (e.g. bilateral diffuse lung opacities), riluzole should be discontinued immediately.
Če se pojavijo simptomi na dihalih, npr. suh kašelj in/ali dispneja, je treba narediti rentgenogram prsnih organov.
The primary metabolic pathway for riluzole is initial oxidation by cytochrome P450 1A2 producing N-hydroxy-riluzole (RPR112512), the major active metabolite of riluzole.
Primarna presnovna pot riluzola je uvodna oksidacija s citokromom P450 1A2, s čimer nastane N
Unchanged riluzole is the main component in plasma and is extensively metabolised by cytochrome P450 and subsequent glucuronidation.
V velikem obsegu se presnavlja s citokromom P450 in poznejšo glukuronidacijo.
Diarrhoea, abdominal pain, vomiting
Bolezni prebavil navzea diareja, bolečine v trebuhu, bruhanje pankreatitis
There is no experience with dose reduction or rechallenge in patients who have developed an increase of ALT to 5 times ULN.
Pri bolnikih, ki so doživeli porast ALT na 5-kratno vrednost ULN, ni izkušenj z zmanjšanjem odmerka ali ponovnim poskusom zdravljenja.
You can drive or use any tools or machines, unless you feel dizzy or light headed after taking this medicine.
Če po jemanju zdravila Riluzol Zentiva niste omotični ali vrtoglavi, lahko vozite ali upravljate s kakršnimikoli orodji ali stroji.
Titanium dioxide (E171)
Obloga hipromeloza makrogol 6000 titanov dioksid (E 171)
The active substance is riluzole.
- Zdravilna učinkovina je riluzol.
Riluzole Zentiva 50 mg film-coated tablets riluzole
Riluzol Zentiva 50 mg filmsko obložene tablete riluzol
Oral use
NAVODILA ZA UPORABO
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora intersticijska bolezen pljuč
Studies at repeated doses have not been conducted in patients with impaired renal function (see section
Pri bolnikih z okvarjenim delovanjem ledvic študije s ponavljajočimi odmerki niso bile izvedene (glejte poglavje 4.2).
if you are pregnant or breast-feeding.
- če ste noseči ali dojite.
Package leaflet: Information for the user Riluzole Zentiva 50 mg film-coated tablets riluzole
Navodilo za uporabo Riluzol Zentiva 50 mg filmsko obložene tablete riluzol
What Riluzole Zentiva is used for
Za kaj uporabljamo zdravilo Riluzol Zentiva
Headache, dizziness, oral paraesthesia, somnolence
Bolezni živčevja glavobol, omotica, peroralna parestezija in somnolenca
How to store Riluzole Zentiva
Shranjevanje zdravila Riluzol Zentiva
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PVC/ALUMINIUM BLISTER
PVC/ALUMINIJASTI PRETISNI OMOT
The median survival time approached 16.5 months versus 13.5 months for riluzole 100 mg/day and placebo, respectively.
Mediana časa preživetja bolnikov, ki so dobivali 100 mg riluzola/dan, je bil 16,5 meseca, in tistih, ki so dobivali placebo, 13,5 meseca.
Other side effects
DRUGI PODATKI
In vitro studies using human liver preparations demonstrated that cytochrome P450 1A2 is the principal isoenzyme involved in the metabolism of riluzole.
da je P450 1A2 glavni izoencim, ki sodeluje v presnovi riluzola.
if you experience any of the following symptoms: yellowing of your skin or the white of your eyes (jaundice), itching all over, feeling sick, being sick, as this may be signs of liver disease (hepatitis).Your doctor may do regular blood tests while you are taking Riluzole Zentiva to make sure that this does not occur.
Da se bo vaš zdravnik prepričal, da ni prišlo do pojava teh simptomov, vam bo morda med zdravljenjem z zdravilom Riluzol Zentiva opravljal redne preiskave krvi.
Nervous system disorders
Okvarjeno delovanje jeter
Very common side effects (may affect more than 1 in 10 people) of Riluzole Zentiva are: tiredness feeling sick increased blood levels of some enzymes of the liver (transaminases).
Drugi neželeni učinki Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) zdravila Riluzol
Talk to your doctor before taking Riluzole Zentiva: if you have any liver problems: yellowing of your skin or the white of your eyes (jaundice), itching all over, feeling sick, being sick if your kidneys are not working very well if you have any fever: it may be due to a low number of white blood cells which can cause an increased risk of infection
- če imate vročino: pojavi se lahko zaradi znižanega števila belih krvnih celic, kar lahko poveča tveganje za okužbo
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema anemija huda nevtropenija (glejte poglavje
Coating
Odmerjanje