natgillin/translations-raw huggingface dataset:
Study US301 randomised 482 subjects with active rheumatoid arthritis to leflunomide 20 mg/day (n=182), methotrexate 7.5 mg/week increasing to 15 mg/week (n=182), or placebo (n=118). 
U ispitivanju US301 482 randomizirana bolesnika s aktivnim reumatoidnim artritisom primala su leflunomid 20 mg/dan (n=182), metotreksat 7,5 mg/tjedan, s povećanjem doze na 15 mg/tjedan (n=182), ili placebo (n=118).
The extensive protein binding of A771726 could lead to displacement of other highly-bound drugs. 
Ekstenzivnim vezanjem za proteine A771726 može istisnuti ostale lijekove koji se u velikoj mjeri vežu za proteine plazme.
After stopping treatment with leflunomide: 
Nakon prekida uzimanja leflunomida treba primijeniti:
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 
Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.
Other side effects such as kidney failure, a decrease in the levels of uric acid in your blood, pulmonary hypertension, male infertility (which is reversible once treatment with this medicine is stopped), cutaneous lupus (characterized by rash/erythema on skin areas that are exposed to light), psoriasis (new or worsening) and DRESS may also occur with an unknown frequency. 
Također se mogu javiti druge nuspojave, poput zatajenja bubrega, smanjene koncentracije mokraćne kiseline u krvi, plućne hipertenzije, muške neplodnosti (koja se povlači nakon prestanka primjene ovoga lijeka), kožnog lupusa (karakteriziran osipom/crvenilom na područjima kože izloženima svjetlu), psorijaze (novonastala psorijaza ili pogoršanje psorijaze) i reakcije na lijek s eozinofilijom i sistemskim simptomima (DRESS), ali je njihova učestalost nepoznata.
How to take Leflunomide Zentiva 
Kako uzimati lijek Leflunomide Zentiva
Uncommon: taste disturbances 
Manje često: ruptura tetive
pulmonary hypertension Gastrointestinal disorders Common: 
plućna hipertenzija Poremećaji probavnog sustava Često:
Neoplasms benign, malignant and unspecified (incl. 
Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe)
Uncommon: anaemia, mild thrombocytopenia (platelets <100 G/L) Rare: 
Manje često: anemija, blaga trombocitopenija (trombociti < 100 g/l).
Leflunomide Zentiva 100 mg film-coated tablets are white to almost white and round. 
Kako Leflunomide Zentiva izgleda i sadržaj pakiranja Leflunomide Zentiva 100 mg filmom obložene tablete su bijele do gotovo bijele i okrugle.
- a marked decrease of some white blood cells (agranulocytosis), - severe and potentially severe allergic reactions, - inflammation of the small vessels (vasculitis, including cutaneous necrotizing vasculitis), - inflammation of the pancreas (pancreatitis), - severe liver injury such as liver failure or necrosis which may be fatal, - severe sometimes life-threatening reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme). 
Vrlo rijetke nuspojave (mogu se javiti u manje od 1 na 10 000 osoba): - izrazito smanjenje broja određenih bijelih krvnih stanica (agranulocitoza), - teške i potencijalno teške alergijske reakcije, - upala malih krvnih žila (vaskulitis, uključujući kožni nekrotizirajući vaskulitis), - upala gušterače (pankreatitis), - teško oštećenje jetre, poput zatajenja jetre ili nekroze, koje može biti opasno po život, - teške reakcije koje ponekad mogu biti opasne po život (Stevens-Johnsonov sindrom, toksična epidermalna nekroliza, multiformni eritem).
Excipients with known effect Each tablet contains 78 mg of lactose monohydrate. 
Pomoćne tvari s poznatim učinkom Jedna tableta sadrži 78 mg laktoze hidrata.
Leflunomide Zentiva 10 mg film-coated tablets are white to almost white and round. 
Kako Leflunomide Zentiva izgleda i sadržaj pakiranja Leflunomide Zentiva 10 mg filmom obložene tablete su bijele do gotovo bijele i okrugle.
In the phase III trials, the ACR response rates for leflunomide 20 mg/day versus placebo were 54.6% versus 28.6% (study MN301), and 49.4% versus 26.3% (study US301).After 12 months with active treatment, the ACR response rates in leflunomide patients were 52.3% (studies MN301/303), 50.5% (study MN302) and 49.4% (study US301), compared to 53.8% (studies MN301/303) in sulphasalazine patients, 64.8% (study MN302), and 43.9% (study US301) in methotrexate patients. 
Nakon 12 mjeseci aktivnog liječenja stopa odgovora prema ACRu u bolesnika koji su primali leflunomid bila je 52,3% (ispitivanja MN301/303), 50,5% (ispitivanje MN302) i 49,4% (ispitivanje US301) u usporedbi s 53,8% (ispitivanja MN301/303) u bolesnika koji su primali sulfasalazin te 64,8% (ispitivanje MN302) i 43,9% (ispitivanje US301) u bolesnika koji su primali metotreksat.
30 film-coated tablets 50 film-coated tablets 100 film-coated tablets 
OBLIK I SADRŽAJ 30 filmom obloženih tableta 50 filmom obloženih tableta 100 filmom obloženih tableta
Breast-feeding women must, therefore, not receive leflunomide. 
Dojilje, stoga, ne smiju uzimati leflunomid.
Excipients with known effect Each tablet contains 72 mg of lactose monohydrate. 
Pomoćne tvari s poznatim učinkom Jedna tableta sadrži 72 mg laktoze hidrata.
Pregnancy must be excluded before start of treatment with leflunomide. 
Prije liječenja leflunomidom mora se isključiti trudnoća.
This is especially important if you are taking: - other medicines for rheumatoid arthritis such as antimalarials (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive medicines (e.g. methotrexate) as these combinations are not advisable, - warfarin and other oral medicines used to thin the blood, as monitoring is necessary to reduce the risk of side effects of this medicine - teriflunomide for multiple sclerosis - repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes - daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer - duloxetine for depression, urinary incontinence or in kidney disease in diabetics - alosetron for the management of severe diarrhoea - theophylline for asthma - tizanidine, a muscle relaxant - oral contraceptives (containing ethinylestradiol and levonorgestrel) - cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections - indomethacin, ketoprofen for pain or inflammation - furosemide for heart disease (diuretic, water pill) 
azatioprina i drugih imunosupresivnih lijekova (npr. metotreksat), jer se ne preporučuje istodobna primjena tih lijekova, - varfarin i druge oralne lijekove koji se koriste za razrjeđivanje krvi, jer je potrebno praćenje kako bi se smanjio rizik od nuspojava tih lijekova - teriflunomid za liječenje multiple skleroze - repaglinid, pioglitazon, nateglinid ili roziglitazon za liječenje šećerne bolesti - daunorubicin, doksorubicin, paklitaksel ili topotekan za liječenje raka - duloksetin za liječenje depresije, nesposobnosti zadržavanja mokraće ili bolesti bubrega u oboljelih od šećerne bolesti - alosetron za liječenje teškog proljeva - teofilin za liječenje astme - tizanidin, lijek za opuštanje mišića - oralni lijekovi za sprječavanje trudnoće (koji sadrže etinilestradiol i levonorgestrel) - cefaklor, benzilpenicilin (penicilin G), ciprofloksacin, za liječenje infekcija
Musculoskeletal and connective tissue disorders Common: 
Poremećaji mišićno-koštanog sustava i vezivnog tkiva Često:
Methotrexate 
Cijepljenje
Yellowish to ochre and triangular film-coated tablet, imprinted with ZBO on one side. 
Žućkasta do oker filmom obložena tableta u obliku trokuta, s utisnutom oznakom ZBO na jednoj strani.
• In rheumatoid arthritis: leflunomide therapy is usually started with a loading dose of 100 mg once daily for 3 days. 
• U bolesnika s reumatoidnim artritisom: terapija leflunomidom započinje primjenom udarne doze od 100 mg jedanput na dan tijekom 3 dana.
- a decrease in the number of red blood cells (anaemia) and a decrease in the number of blood platelets (thrombocytopenia), - a decrease in the levels of potassium in the blood, - anxiety, - taste disturbances, - urticaria (nettle rash), - tendon rupture, - an increase in the levels of fat in the blood (cholesterol and triglycerides), - a decrease in the levels of phosphate in the blood. 
Manje česte nuspojave (mogu se javiti u manje od 1 na 100 osoba): - smanjen broj crvenih krvnih stanica (anemija) i smanjen broj krvnih pločica (trombocitopenija), - smanjenje koncentracije kalija u krvi, - tjeskoba, - poremećaji okusa, - urtikarija (koprivnjača), - puknuće tetive, - povećanje razine masnoća u krvi (kolesterol i trigliceridi), - smanjenje razine fosfata u krvi.
• In psoriatic arthritis: leflunomide therapy is started with a loading dose of 100 mg once daily for 3 days. 
• U bolesnika s psorijatičnim artritisom: liječenje leflunomidom započinje primjenom udarne doze od 100 mg jedanput na dan tijekom 3 dana.
The concentration may be expected to decrease below 0.02 mg/L about 2 years after stopping the treatment with leflunomide. 
Smanjenje koncentracije A771726 u plazmi na razinu nižu od 0,02 mg/l očekuje se približno 2 godine nakon prekida liječenja leflunomidom.
agranulocytosis 
hipouricemija
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
MN301/303) in sulphasalazine patients, 64.8% (study MN302), and 43.9% (study US301) in methotrexate patients. 
MN302) i 49,4% (ispitivanje US301) u usporedbi s 53,8% (ispitivanja MN301/303) u bolesnika koji su primali sulfasalazin te 64,8% (ispitivanje MN302) i 43,9% (ispitivanje US301) u bolesnika koji su primali metotreksat.
colitis including microscopic colitis such as lymphocytic colitis, collagenous colitis, diarrhoea, nausea, vomiting, oral mucosal disorders (e.g., aphthous stomatitis, mouth ulceration), abdominal pain 
kolitis, uključujući mikroskopski kolitis poput limfocitnog kolitisa, kolagenog kolitisa, proljev, mučnina, povraćanje, poremećaji sluznice usne šupljine (npr. aftozni stomatitis, ulceracije u ustima), bol u abdomenu Manje često: poremećaji okusa
Certain vaccinations should not be given while taking Leflunomide Zentiva, and for a certain amount of time after stopping treatment. 
Za vrijeme uzimanja lijeka Leflunomide Zentiva, kao i određeno vrijeme nakon prekida liječenja, ne smije se provoditi cijepljenje određenim cjepivima.
All elevations resolved 2 with continuation of both medicinal products and 3 after discontinuation of leflunomide. 
Sve su se povišene vrijednosti smanjile, u 2 bolesnika koji su nastavili istodobno uzimati oba lijeka i u 3 bolesnika koji su prekinuli uzimati leflunomid.
Pack size: 3 film-coated tablets. 
Veličina pakiranja: 3 filmom obložene tablete
How to store Leflunomide Zentiva 
Kako čuvati lijek Leflunomide Zentiva
In either case the A771726 plasma concentration is then measured for the first time. 
U oba se slučaja tek tada prvi put mjeri koncentracija A771726 u plazmi.
The active metabolite A771726 is extensively protein bound and cleared via hepatic metabolism and biliary secretion. 
Aktivni metabolit A771726 ekstenzivno se veže za proteine u plazmi, a uklanja se jetrenim metabolizmom te izlučuje putem žuči.
• Patients with significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia due to causes other than rheumatoid or psoriatic arthritis. 
• Bolesnici sa značajno oštećenom funkcijom koštane srži ili izraženom anemijom, leukopenijom,
- The other ingredients are: maize starch, povidone (E1201), crospovidone (E1202), silica colloidal anhydrous, magnesium stearate (E470b), and lactose monohydrate in the tablet core, as well as talc (E553b), hypromellose (E464), titanium dioxide (E171), and macrogol 8000 in the film-coating. 
- Drugi sastojci su: kukuruzni škrob, povidon (E1201), krospovidon (E1202), bezvodni koloidni silicijev dioksid, magnezijev stearat (E470b) i laktoza hidrat u jezgri tablete te talk (E553b), hipromeloza (E464), titanijev dioksid (E171), makrogol 8000 i žuti željezov oksid (E172) u film ovojnici.
The long half-life of leflunomide should be considered when contemplating administration of a live attenuated vaccine after stopping Leflunomide Zentiva. 
Kad se razmatra primjena živih atenuiranih cjepiva nakon prekida liječenja lijekom Leflunomide Zentiva, potrebno je uzeti u obzir dugi poluvijek leflunomida.
All of these also resolved, 2 with continuation of both medicinal products and 3 after discontinuation of leflunomide. 
Sve su se te vrijednosti smanjile, u 2 bolesnika koji su nastavili istodobno uzimati oba lijeka i u 3 bolesnika koji su prekinuli uzimati leflunomid.
Both colestyramine and activated powdered charcoal may influence the absorption of oestrogens and progestogens such that reliable contraception with oral contraceptives may not be guaranteed during the washout procedure with colestyramine or activated powdered charcoal. 
Stoga se kontracepcija oralnim kontraceptivima ne može smatrati pouzdanom tijekom postupka ispiranja u kojem se primjenjuje kolestiramin ili aktivni ugljen u prahu.
A randomised study assessed the clinical efficacy response rate in DMARD-naïve patients (n=121) with early RA, who received either 20 mg or 100 mg of leflunomide in two parallel groups during the initial three day double blind period. 
Bolesnici su podijeljeni u dvije paralelne skupine i dobivali su ili 20 mg ili 100 mg leflunomida tijekom prva tri dana dvostruko slijepog ispitivanja.
Talc (E553b) Hypromellose (E464) Titanium dioxide (E171) Macrogol 8000 
Ovojnica tablete: talk (E553b) hipromeloza (E464) titanijev dioksid (E171) makrogol 8000
Human pharmacology 
Farmakologija u ljudi
Hepatic impairment 
zatajenje bubrega
Vaccination with live attenuated vaccines is, however, not recommended. 
Ne preporučuje se, međutim, cijepljenje živim atenuiranim cjepivima.
NAME OF THE MARKETING AUTHORISATION HOLDER 
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit/risk aspects. 
Nedavno ili istodobno liječenje hepatotoksičnim ili hematotoksičnim DMARD-ima (npr. metotreksatom) može povećati rizik od ozbiljnih nuspojava.
(pancytopenia), - severe increase in blood pressure, - inflammation of the lung (interstitial lung disease), - an increase in some liver results which may develop into serious conditions such as hepatitis and jaundice, - severe infections called sepsis which may be fatal, - an increase of certain enzymes in the blood (lactate dehydrogenase). 
Rijetke nuspojave (mogu se javiti u manje od 1 na 1000 osoba): - porast broja krvnih stanica zvanih eozinofili (eozinofilija), blago smanjenje broja bijelih krvnih stanica (leukopenija), smanjenje broja svih krvnih stanica (pancitopenija), - značajan porast krvnog tlaka, - upala pluća (intersticijska plućna bolest), - porast vrijednosti određenih jetrenih enzima koji može dovesti do ozbiljnih stanja poput hepatitisa i žutice, - teške infekcije koje se nazivaju sepsa, a mogu dovesti do smrtnog ishoda, - porast vrijednosti određenih enzima u krvi (laktat dehidrogenaze).
Povidone (E1201) Crospovidone (E1202) Silica colloidal anhydrous Magnesium stearate (E470b) Lactose monohydrate 
kukuruzni škrob povidon (E1201) krospovidon (E1202) silicijev dioksid, koloidni, bezvodni magnezijev stearat (E470b) laktoza hidrat
Hypromellose (E464) Titanium dioxide (E171) Macrogol 8000 
hipromeloza (E464), titanijev dioksid (E171) i makrogol 8000 u film ovojnici.
3 film-coated tablets 
50 filmom obloženih tableta
Silica colloidal anhydrous Magnesium stearate (E470b) Lactose monohydrate 
bezvodni koloidni silicijev dioksid, magnezijev stearat (E470b) i laktoza hidrat u jezgri tablete,
In the phase III trials, the ACR response rates for leflunomide 20 mg/day versus placebo were 54.6% versus 28.6% (study MN301), and 49.4% versus 26.3% (study US301).After 12 months with active treatment, the ACR response rates in leflunomide patients were 52.3% (studies MN301/303), 50.5% (study MN302) and 49.4% (study US301), compared to 53.8% (studies 
U ispitivanjima faze III terapijske stope prema ACR-u bile su 54,6% za leflunomid 20 mg/dan naspram 28,6% za placebo (ispitivanje MN301), odnosno 49,4% naspram 26,3% (ispitivanje US301).
- colitis, - diarrhoea, - nausea, vomiting, - inflammation of the mouth or mouth ulcers, - abdominal pain, - an increase in some liver test results, - increased hair loss, - eczema, dry skin, rash, itching, - tendonitis (pain caused by inflammation in the membrane surrounding the tendons usually in the feet or hands), - an increase of certain enzymes in the blood (creatine phosphokinase), - problems in the nerves of the arms or legs (peripheral neuropathy). 
- gubitak teka, gubitak težine (obično beznačajan), - umor (astenija), - glavobolja, omaglica, - neuobičajeni osjeti na koži, poput trnaca (parestezije), - blaži porast krvnog tlaka, - kolitis, - proljev, - mučnina, povraćanje, - upala ili čirevi u ustima, - bol u trbuhu, - porast vrijednosti određenih jetrenih enzima, - pojačan gubitak kose, - ekcem, suha koža, osip, svrbež, - tendinitis (bol izazvana upalom membrane koja okružuje tetive, obično na stopalima ili šakama), - porast koncentracije određenih enzima u krvi (kreatin fosfokinaze), - problemi sa živcima u rukama ili nogama (periferna neuropatija).
Leflunomide Zentiva 20 mg film-coated tablets are yellowish to ochre and triangular. 
Kako Leflunomide Zentiva izgleda i sadržaj pakiranja Leflunomide Zentiva 20 mg filmom obložene tablete su žućkaste do oker boje i trokutastog oblika.
Leflunomide Zentiva 20 mg 
16. PODACI NA BRAILLEOVOM PISMU Leflunomide Zentiva 20 mg
30 film-coated tablets 100 film-coated tablets 
OBLIK I SADRŽAJ 30 filmom obloženih tableta 100 filmom obloženih tableta
In this trial, the loading dose and maintenance dose of leflunomide was based on three weight categories: <20 kg, 20-40 kg, and >40 kg. After 16 weeks treatment, the difference in response rates was statistically significant in favour of methotrexate for the JRA Definition of Improvement (DOI) ≥30% (p=0.02). 
U ovom su se ispitivanju udarna doza i doza održavanja leflunomida zasnivale na 3 kategorije tjelesne težine: < 20 kg, 20-40 kg i > 40 kg.
Liver reactions 
Jetrene reakcije
Leflunomide Zentiva 20 mg film-coated tablets leflunomide 
Leflunomide Zentiva 20 mg filmom obložene tablete leflunomid
Each film-coated tablet contains 20 mg leflunomide. 
Jedna filmom obložena tableta sadrži 20 mg leflunomida.
Leflunomide Zentiva 100 mg film-coated tablets leflunomide 
Leflunomide Zentiva 100 mg filmom obložene tablete leflunomid
- if you have ever had an allergic reaction to leflunomide (especially a serious skin reaction, 
Nemojte uzimati lijek Leflunomide Zentiva - ako ste ikada imali alergijsku reakciju na leflunomid (pogotovo tešku kožnu reakciju, često udruženu s vrućicom, bolovima u zglobovima, crvenim kožnim mrljama ili mjehurićima, npr.
Leflunomide Zentiva 10 mg 
16. PODACI NA BRAILLEOVOM PISMU Leflunomide Zentiva 10 mg
Also contains lactose. 
POPIS POMOĆNIH TVARI Također sadrži laktozu.
General disorders and administration site conditions Common: 
Opći poremećaji i reakcije na mjestu primjene Često:
cysts and polyps) The risk of malignancy, particularly lymphoproliferative disorders, is increased with use of some immunosuppressive agents. 
Neki od imunosupresivnih lijekova mogu povećati rizik od pojave tumora, osobito limfoproliferativnih poremećaja.
INSTRUCTIONS ON USE 16. 
15. UPUTE ZA UPORABU
One film-coated tablet contains 100 mg of leflunomide. 
Jedna filmom obložena tableta sadrži 100 mg leflunomida.
Leflunomide Zentiva 100 mg 
16. PODACI NA BRAILLEOVOM PISMU Leflunomide Zentiva 100 mg
Each tablet contains 20 mg leflunomide. 
TVARI Jedna tableta sadrži 20 mg leflunomida
• The Summary of Product Characteristics 
• Sažetak opisa svojstava lijeka
Leflunomide Zentiva 10 mg film-coated tablets leflunomide 
Leflunomide Zentiva 10 mg filmom obložene tablete leflunomid
- if you are male and wish to father a child. As it can not be excluded that Leflunomide Zentiva passes into semen, reliable contraception should be used during treatment with Leflunomide Zentiva. 
Budući da se ne može isključiti izlučivanje lijeka Leflunomide Zentiva u spermu, tijekom terapije lijekom Leflunomide Zentiva treba primjenjivati učinkovitu kontracepciju.
One film-coated tablet contains 10 mg of leflunomide. 
Jedna filmom obložena tableta sadrži 10 mg leflunomida.
Postmarketing studies 
Ispitivanja nakon stavljanja lijeka u promet
Read the package leaflet before use. 
NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
Talc (E553b) Hypromellose (E464) Titanium dioxide (E171) Macrogol 8000. 
te talk (E553b), hipromeloza (E464), titanijev dioksid (E171) i makrogol 8000 u film ovojnici.
The time to peak plasma concentrations of A771726 is very variable; peak plasma levels can occur between 1 hour and 24 hours after single administration. 
Vrijeme do postizanja vršne koncentracije A771726 u plazmi jako varira.
Each tablet contains 10 mg leflunomide. 
TVARI Jedna tableta sadrži 10 mg leflunomida
Leflunomide Zentiva 20 mg film-coated tablets 
NAZIV LIJEKA Leflunomide Zentiva 20 mg filmom obložene tablete
In either case it should be confirmed by a blood test that Leflunomide Zentiva has been sufficiently removed from your body and you should then wait for at least another month before you become pregnant. 
U oba slučaja krvnim pretragama treba potvrditi da je Leflunomide Zentiva u dovoljnoj mjeri uklonjen iz Vašega organizma.
METHOD AND ROUTE(S) OF ADMINISTRATION 
Ispiranje („washout“ postupak)
Crospovidone (E1202) Talc (E553b) 
- Drugi sastojci su: kukuruzni škrob, povidon (E1201), krospovidon (E1202), talk (E553b),
EU/1/09/604/010 3 tablets 
EU/1/09/604/002 100 tableta
Leflunomide Zentiva 100 mg film-coated tablets 
NAZIV LIJEKA Leflunomide Zentiva 100 mg filmom obložene tablete
Very rare: 
Vrlo rijetko: pankreatitis
EU/1/09/604/008 30 tablets EU/1/09/604/009 100 tablets 
EU/1/09/604/009 100 tableta
The extent of leflunomide absorption is not affected if it is taken with food. 
Istodobno uzimanje s hranom ne ometa apsorpciju leflunomida.
Reliable contraception during treatment with leflunomide should also be guaranteed. 
Tijekom liječenja leflunomidom potrebno je koristiti učinkovitu kontracepciju.
- an increase in the numbers of blood cells called eosinophiles (eosinophilia); mild decrease in the number of white blood cells (leucopenia); decrease in the number of all blood cells 
Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba): - blago smanjen broj bijelih krvnih stanica (leukopenija), - blage alergijske reakcije,
Leflunomide Zentiva 10 mg film-coated tablets 
NAZIV LIJEKA Leflunomide Zentiva 10 mg filmom obložene tablete
Similarly, recent treatment with hepatotoxic or haematotoxic medicinal products (e.g. methotrexate) may result in increased side effects; therefore, the initiation of leflunomide treatment has to carefully be considered regarding these benefit/risk aspects and closer monitoring is recommended in the initial phase after switching. 
Isto tako, nedavno provedeno liječenje hepatotoksičnim ili hematotoksičnim lijekovima (npr. metotreksatom) može dovesti do pojave većeg broja nuspojava.
EU/1/09/604/003 30 tablets EU/1/09/604/004 100 tablets 
EU/1/09/604/004 100 tableta
Oral use. 
Primjena kroz usta.
Elderly patients (≥ 65 years) 
Stariji bolesnici (≥ 65 godina)
This leaflet was last revised in 
Ova uputa je zadnji puta revidirana u
3 years 
3 godine.
- The other ingredients are: 
- Drugi sastojci su:
OTHER Do not open before use. 
Ne otvarati prije uporabe.
Date of latest renewal: 23 September 2019 
Datum posljednje obnove odobrenja: 23. rujna 2019
Similar results were observed in analyses using a conservative threshold of 10%. 
Slični rezultati opaženi su u analizama u kojima je primijenjen konzervativni prag od 10%.
The treatment effect was consistent in both trials. 
Učinak liječenja bio je konzistentan u oba ispitivanja.
It is recommended that you take the capsules with food, i.e. during or immediately before or after a meal. 
Preporučeno je kapsule uzeti s hranom, tj. tijekom ili neposredno prije ili nakon obroka.