natgillin/translations-raw huggingface dataset:
Moreover, switching from leflunomide to another DMARD without following the washout procedure (see section 4.4) may also increase the risk of serious adverse reactions even for a long time after the 
Osim toga, prijelaz s leflunomida na neki drugi DMARD, bez provedbe ispiranja ("washout" postupak) leflunomida (vidjeti dio 4.4.), također može povećati rizik od ozbiljnih nuspojava, čak i
- If you already have low red or white blood cells (anaemia or leucopenia), low blood platelets, which may increase your bleeding or bruising (thrombocytopenia), low bone marrow function or if you are at risk of your bone marrow not working properly your doctor may advise you to take certain medicines to speed up the removal of Leflunomide Teva from your body. 
Ako već imate niske razine crvenih ili bijelih krvnih stanica (anemiju ili leukopeniju), niske razine trombocita, što može povećati rizik od krvarenja ili pojave modrica (trombocitopenija), odnosno ako imate smanjenu funkciju koštane srži ili ako postoji rizik od oštećenja funkcije koštane srži, liječnik Vam može savjetovati uzimanje određenih lijekova koji će ubrzati uklanjanje Leflunomida Teva iz tijela.
Marketing Authorisation Holder: Teva Pharma B.V. 
NOSITELJ ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET Teva Pharma B.V.
Leflunomide is metabolised to one primary (A771726) and many minor metabolites including TFMA (4-trifluoromethylaniline). 
Leflunomid se metabolizira u jedan glavni (A771726) i više manjih metabolita, uključujući (4-trifluorometilanilin).
This is thought to be achieved by a gastrointestinal dialysis mechanism and/or by interrupting enterohepatic recycling. 
Smatra se da se taj učinak postiže gastrointestinalnom dijalizom i/ili prekidom
No clinical data are available on the efficacy and safety of vaccinations under leflunomide treatment. 
Ne postoje klinički podaci o djelotvornosti i sigurnosti cijepljenja u osoba koje se istodobno liječe leflunomidom.
• The identified risk of synergistic hepato- or haematotoxicity associated with combination therapy with another Disease-Modifying Antirheumatic Drug (e.g. methotrexate). 
• Prepoznat rizik od sinergije između hepatotoksičnosti ili hematotoksičnosti i kombinirane terapije s nekim drugim antireumatikom koji modificira tijek bolesti (primjerice
In a small (n=30) study with co-administration of leflunomide (10 to 20 mg per day) with methotrexate (10 to 25 mg per week) a 2- to 3-fold elevation in liver enzymes was seen on 5 of 30 patients. 
U manjem ispitivanju (n=30) istodobne primjene leflunomida (10 do 20 mg na dan) i metotreksata (10 do 25 mg na tjedan) opaženo je povišenje jetrenih enzima dva do tri puta u 5 od 30 bolesnika.
HDPE containers: Do not store above 30°C. 
HDPE spremnici: Ne čuvati na temperaturi iznad 30°C.
Do not use this medicine after the expiry date that is stated on the outer carton or foil after EXP. 
Ovaj lijek ne smije se upotrijebiti nakon isteka roka valjanosti navedenog na vanjskom pakovanju ili foliji iza oznake „Rok valjanosti ili kratice „EXP“.
- Severe sometimes life-threatening reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme). 
- teške reakcije koje ponekad mogu biti opasne po život (Stevens-Johnsonov sindrom, toksična epidermalna nekroliza, multiformni eritem);
• alternatively, 50 g of activated powdered charcoal is administered 4 times daily for a period 
• alternativno, 50 g aktivnog ugljena u prahu četiri puta na dan tijekom 11 dana.
Caution is advised when leflunomide is given together with drugs, other than NSAIDs, metabolised by CYP2C9 such as phenytoin, warfarin, phenprocoumon and tolbutamide. 
Oprez je potreban kad se leflunomid daje zajedno s ostalim lijekovima, osim nesteroidnih protuupalnih lijekova, koji se metaboliziraju pomoću CYP2C9, poput fenitoina, varfarina, fenprokumona i tolbutamida.
Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare 
Vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10), manje često (≥ 1/1000 do <1/100), rijetko (≥ 1/10000 do <1/1000), vrlo rijetko (<1/10000), nepoznato (nije moguće procijeniti iz dostupnih podataka).
Leflunomide is indicated for the treatment of adult patients with active rheumatoid arthritis as a "disease modifying antirheumatic drug" (DMARD). 
Leflunomid je indiciran u liječenju odraslih bolesnika s aktivnim reumatoidnim artritisom kao antireumatik koji modificira tijek bolesti (DMARD od engl. disease-modifying antirheumatic drug).
- If you suffer from moderate to severe kidney problems. 
Ako imate umjerene do teške probleme s bubrezima.
Thereafter, the A771726 plasma concentration must be determined again after an interval of at least 14 days. 
Nakon toga, koncentracija A771726 u plazmi mora se ponovo utvrditi nakon intervala od najmanje 14 dana.
- Colestyramine (used to lower cholesterol levels and treat itching associated with jaundice) or activated charcoal as these medicines can reduce the amount of LeflunomideTeva absorbed by your body. 
- Kolestiramin (primjenjuje se za snižavanje razine kolesterola i liječenje svrbeža povezanog sa žuticom) ili aktivni ugljen jer ti lijekovi mogu smanjiti količinu Leflunomida Teva koju
It has been shown in man that administration of an oral suspension of activated powdered charcoal or colestyramine leads to a rapid and significant increase in A771726 elimination rate and decline in plasma concentrations (see section 4.9). 
Zabilježeno je da peroralna primjena suspenzije aktivnog ugljika ili kolestiramina u ljudi ubrzava i značajno povećava stupanj eliminacije A771726 i smanjuje njegovu koncentraciju u plazmi (vidjeti dio 4.9.).
Interstitial lung disease has been reported during treatment with leflunomide (see section 4.8). 
Za vrijeme liječenja leflunomidom zabilježena je intersticijska plućna bolest (vidjeti dio 4.8).
If a patient taking Leflunomide Teva develops a peripheral neuropathy, consider discontinuing Leflunomide Teva therapy and performing the drug elimination 
Ako se u bolesnika koji uzima Leflunomid Teva pojavi periferna neuropatija, treba razmotriti prestanak terapije
- If you develop a skin rash or ulcers in your mouth, as these may indicate severe, sometimes life-threatening reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema 
- Ako dobijete kožni osip ili čireve u ustima jer to može upućivati na teške reakcije, ponekad opasne po život (npr. Stevens-Johnsonov sindrom, toksična epidermalna nekroliza, multiformni
The initial period was followed by an open label maintenance period of three months, during which both groups received leflunomide 20 mg daily. 
Nakon početnog razdoblja uslijedilo je otvoreno ispitivanje doze održavanja u trajanju od tri mjeseca, tijekom kojeg su obje skupine dobivale luflonomid u dozi od 20 mg na dan.
Leflunomide Teva stored in bottles are available in pack sizes of 30 and 100 film-coated tablets. 
Leflunomid Teva u bočicama je dostupan u veličinama pakovanja od 30 i 100 filmom obloženih
Due to the very long half-lifeof A771726 (approximately 2 weeks), a loading dose of 100 mg for 3 days was used in clinical studies to facilitate the rapid attainment of steady-state levels of A771726. 
Zbog veoma dugog poluvijeka A771726 (oko 2 tjedna), u kliničkim je ispitivanjima primjenjivana udarna doza od 100 mg tijekom 3 dana kako bi se ubrzalo postizanje stanja dinamičke ravnoteže A771726.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
OSTALI UVJETI I ZAHTJEVI ZA STAVLJANJE GOTOVOG
The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Leflunomide Teva are provided with a physician educational pack containing the 
Nositelj odobrenja za stavljanje gotovog lijeka u promet dužan je osigurati da svi liječnici koji bi mogli propisivati/upotrebljavati Leflunomid Teva dobiju edukacijski komplet za liječnike koji
The patient must be advised that if there is any delay in onset of menses or any other reason to suspect pregnancy, they must notify the physician immediately for pregnancy testing, and if positive, the physician and patient must discuss the risk to the pregnancy. 
Bolesnice treba savjetovati da u slučaju kašnjenja menstruacije ili sumnje na trudnoću odmah obavijeste liječnika zbog provođenja testa na trudnoću.
• Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being 
Farmakovigilancijski plan ili aktivnosti smanjenja rizika • U roku od 60 dana od novih važnih saznanja (farmakovigilancijskih ili u sklopu minimalizacije
Because you may get increased side effects, it is not recommended to take any of these medicines while you are taking Leflunomide Teva. 
Budući da se nuspojave mogu pogoršati, ne preporučuje se istodobna primjena tih lijekova i Leflunomida Teva.
A771726, the active metabolite of leflunomide, inhibits the human enzyme dihydroorotate dehydrogenase (DHODH) and exhibits antiproliferative activity. 
A771726, aktivni metabolit leflunomida, inhibira humani enzim dihidroorotat dehidrogenazu
If you are pregnant, your doctor will discuss with you the risks to the pregnancy. 
Ako je test pozitivan, liječnik mora razgovarati s bolesnicom o riziku za trudnoću.
As soon as skin and/or mucosal reactions are observed which raise the suspicion of such severe reactions, Leflunomide Teva and any other possibly associated treatment must be discontinued, and a leflunomide washout procedure initiated immediately. 
Čim se pojave reakcije na koži i/ili sluznici koje izazivaju sumnju na teške nuspojave, uzimanje Leflunomida Teva ili bilo kojeg dodatnog lijeka treba prekinuti i odmah započeti postupak eliminacije leflunomida.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON/BLISTER PACK 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU VANJSKA KARTONSKA KUTIJA/BLISTER
All leflunomide patients in the phase III trials used an initial dose of 100 mg for 3 days. 
Svi bolesnici koji su uzimali leflunomid u ispitivanjima faze III počeli su s dozom od 100 mg tijekom tri dana.
- Low blood levels of potassium which can cause muscle weakness, twitching or abnormal heart - An increase in the levels of fat in the blood (cholesterol and triglycerides). 
- smanjenje koncentracije kalija u krvi, što može uzrokovati mišićnu slabost, mišićne kontrakcije ili - povećanje razine masnoća u krvi (kolesterol i trigliceridi);
An in vivo interaction study with cimetidine (non-specific cytochrome P450 inhibitor) has demonstrated a lack of a significant interaction. 
U in vivo ispitivanjima interakcija s cimetidinom (nespecifičnim inhibitorom citokroma P450) nisu opažene značajne interakcije.
Consistent with extensive protein binding A771726 has a low apparent volume of distribution (approximately 11 litres). 
A771726 ima mali prividni volumen distribucije (oko 11 litara).
- If you develop swollen spongy gums, ulcers, and loose teeth (an infectious mouth disease known as ulcerative stomatitis) then you should contact your doctor who may advise you to stop 
- Ako Vam otiču desni, imate čireve u usnoj šupljini ili gubite zube (odnosno imate infekciju usne šupljine koja se zove ulcerozni stomatitis), morate se javiti svom liječniku koji će Vam možda savjetovati da prestanete uzimati Leflunomid Teva.
- Inflammation of the small vessels (vasculitis, including cutaneous necrotizing vasculitis). 
- upala malih krvnih žila (vaskulitis, uključujući kožni nekrotizirajući vaskulitis);
- Severe infections (including sepsis), which may be fatal. 
teške infekcije, uključujući sepsu koja može biti smrtonosna
Pulmonary symptoms, such as cough and dyspnoea, may be a reason for discontinuation of the therapy and for further investigation, as appropriate. 
Plućni simptomi, kao što su kašalj i dispneja, mogu biti razlogom za prekid liječenja i provođenje
Leflunomide Teva is used to treat adult patients with active rheumatoid arthritis. 
Leflunomid Teva primjenjuje se za liječenje odraslih bolesnika s aktivnim oblikom reumatoidnog
- Yellowing of the skin or whites of the eyes caused by liver or blood problems (jaundice). 
- žuta boja kože ili bjeloočnica, koja je posljedica poremećaja jetre ili krvi (žutica).
Tell your doctor immediately if you experience: - Pale skin, tiredness, or bruising, as these may indicate blood disorders caused by an imbalance in the different types of blood cells which make up blood. 
- Bljedoće kože, umora ili pojave modrica jer to može upućivati na krvne poremećaje uzrokovane poremećenom ravnotežom različitih vrsta krvnih stanica.
HDPE tablet container with polypropylene screw cap. 
HDPE spremnik za tablete s polipropilenskim čepom s navojem.
The use of leflunomide with antimalarials used in rheumatic diseases (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive agents including Tumour Necrosis Factor alpha-Inhibitors has not been adequately studied up to now in randomised trials (with the exception of methotrexate, see section 4.5). 
Do sada u randomiziranim ispitivanjima nije ispitivana primjena leflunomida s antimalaricima koji se koriste za reumatske bolesti (npr. klorokin i hidroksiklorokin), intramuskularno ili peroralno primijenjenim solima zlata, D-penicilaminom, azatioprinom te ostalim imunosupresivnim lijekovima uključujući inhibitore faktora nekroze tumora alfa (s izuzetkom metotreksata, vidjeti dio 4.5.).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON/BOTTLE PACK 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU VANJSKA KARTONSKA KUTIJA/BOČICA
In clinical trials no safety problems were observed when leflunomide and NSAIDs metabolised by CYP2C9 were co-administered. 
kliničkim ispitivanjima nisu zabilježeni problemi sa sigurnošću primjene kad se leflunomid davao istodobno s nesteroidnim protuupalnim lijekovima koji se metaboliziraju pomoću CYP2C9.
- Inflammation of the lung (interstitial lung disease), which may be fatal. 
intersticijska plućna bolest (uključujući intersticijski pneumonitis), koja može biti smrtonosna
White, round film-coated tablets, engraved with “10” on one side and “L” on the other. 
Bijele, okrugle, filmom obložene tablete, s oznakom „10“ utisnutom na jednoj strani i „L“ na drugoj.
A771726 plasma levels can be expected to be above 0.02 mg/l for a prolonged period. 
Očekuje se da će se koncentracija A771726 u plazmi, viša od 0,02 mg/l, zadržati duže vrijeme.
A more rapid elimination of A771726 was observed in haemodialysis subjects which was not due to extraction of drug in the dialysate. 
Znatno brža eliminacija A771726 zapažena je u hemodijaliziranih bolesnika, što nije bilo povezano s ekstrakcijom lijeka u
urticaria 
Cijepljenje
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET
The PSUR cycle of Leflunomide Teva will correspond to the one attributed to the reference medicinal product, Arava, until otherwise specified. 
Plan predavanja PSUR-a za Leflunomid Teva trebao bi pratiti raspored prijave PSUR-a referentnog lijeka Arava, osim ako nije određeno drukčije.
- A decrease in the levels of phosphate in the blood. 
poremećaj koncentracije mokraćne kiseline u krvi;
Rheumatoid arthritis is a crippling form of arthritis. 
Reumatoidni artritis je oblik artritisa koji dovodi do invaliditeta.
What Leflunomide Teva looks like and contents of the pack Leflunomide Teva 10 mg film-coated tablets are white, round film-coated tablets, engraved with “10” on one side and “L” on the other. 
Kako Leflunomid Teva izgleda i sadržaj pakovanja Leflunomid Teva 10 mg filmom obložene tablete su bijele, okrugle, filmom obložene tablete, s utisnutom oznakom „10“ na jednoj strani i „L“ na drugoj.
- A cough or breathing problems as these may indicate inflammation of the lung (interstitial lung disease). 
- Kašlja ili problema s disanjem jer to može upućivati na upalu pluća (intersticijska plućna bolest)
• Tablet core: lactose monohydrate, povidone, crospovidone type A, pregelatinized starch (maize), talc, anhydrous colloidal silica, lactose anhydrous and magnesium stearate. 
• Jezgra tablete: laktoza hidrat, povidon, krospovidon vrste A, prethodno geliran škrob (kukuruzni), talk, bezvodni koloidni silicijev dioksid, bezvodna laktoza i magnezijev stearat.
In case of severe haematological reactions, including pancytopenia, Leflunomide Teva and any concomitant myelosuppressive treatment must be discontinued and a leflunomide washout procedure initiated. 
U slučaju teških hematoloških reakcija, uključujući pancitopeniju, treba prekinuti liječenje Leflunomidom Teva i bilo kojim istodobno primijenjenim mijelosupresivnim lijekom te početi
What Leflunomide Teva looks like and contents of the pack Leflunomide Teva 20 mg film-coated tablets are dark beige, triangle shaped, film-coated tablets, engraved with ”20” on one side and “L” on the other. 
Kako Leflunomid Teva izgleda i sadržaj pakovanja Leflunomid Teva 20 mg filmom obložene tablete su tamno bež, filmom obložene tablete, trokutastog oblika, s utisnutom oznakom „20“ na jednoj strani i „L“ na drugoj.
- If you are allergic to leflunomide (especially a serious skin reaction, often with fever, joint pain, red skin stains, or blisters e.g. Stevens-Johnson syndrome) or any of the other ingredients of this 
Ako ste alergični na leflunomid (pogotovo ako imate teške kožne reakcije, često udružene s vrućicom, bolovima u zglobovima, crvenim kožnim mrljama ili mjehurićima, npr. Steven
severe infections, including sepsis which may be fatal Like other agents with immunosuppressive potential, leflunomide may increase susceptibility to infections, including opportunistic infections (see also section 4.4). 
Kao i druge tvari s imunosupresivnim potencijalom, leflunomid može povećati osjetljivost na infekcije, uključujući i oportunističke infekcije (vidjeti dio 4.4).
• Hypersensitivity to the active substance (especially previous Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) or to any of the excipients listed in section 6.1. 
• Preosjetljivost na djelatnu tvar (osobito u slučaju ranijeg Stevens-Johnsonovog sindroma, toksične epidermalne nekrolize, multiformnog eritema) ili neku od pomoćnih tvari navedenih u
Immune system disorders Common: 
Poremećaji probavnog sustava Često:
Teva Sweden AB Tel: +(46) 42 12 11 00 
Teva Sweden AB Tel: +(46) 42 12 11 00 United Kingdom Teva UK Limited
- Tiredness, abdominal pain, or jaundice (yellow discolouration of the eyes or skin), as these may indicate serious conditions such as liver failure, which may be fatal. 
- Umora, boli u trbuhu ili žutice (žuta boja bjeloočnica ili kože) jer to može upućivati na teška stanja kao što je zatajenje jetre, koje može dovesti do smrtnog ishoda.
Since the active metabolite of leflunomide, A771726, is highly protein bound and cleared via hepatic metabolism and biliary secretion, plasma levels of A771726 are expected to be increased in patients with hypoproteinaemia. 
Kako se aktivni metabolit leflunomida, A771726, snažno veže za proteine plazme i uklanja metaboliziranjem u jetri i sekrecijom putem žuči, u bolesnika s hipoproteinemijom očekuje se povećanje koncentracije A771726 u plazmi.
Before and during treatment with Leflunomide Teva, your doctor will carry out blood tests at regular times. 
Prije i za vrijeme liječenja Leflunomidom Teva liječnik će Vas u redovitim razmacima slati na krvne pretrage zbog kontrole Vaših krvnih stanica i jetre.
The most frequently reported adverse effects with leflunomide are: mild increase in blood pressure, leucopenia, paraesthesia, headache, dizziness, diarrhoea, nausea, vomiting, oral mucosal disorders (e.g. aphthous stomatitis, mouth ulceration), abdominal pain, increased hair loss, eczema, rash (including maculo-papular rash), pruritus, dry skin, tenosynovitis, CPK increased, anorexia, weight loss (usually insignificant), asthenia, mild allergic reactions and elevation of liver parameters (transaminases (especially ALT), less often gamma-GT, alkaline phosphatise, bilirubin)) 
Najčešće zabilježene nuspojave tijekom primjene leflunomida su: blagi porast krvnog tlaka, leukopenija, parestezija, glavobolja, omaglica, proljev, mučnina, povraćanje, poremećaji sluznice usne šupljine (npr. aftozni stomatitis, ulceracije u ustima), bol u trbuhu, pojačani gubitak kose, ekcem, osip (uključujući makulopapulozni osip), svrbež, suha koža, tenosinovitis, povećanje CPK, anoreksija,
For tablets stored in blisters: Do not store above 25°C. 
Tablete u blisterima: Ne čuvati na temperaturi iznad 25°C.
In the phase III trials, the ACR response rates for leflunomide 20 mg/day vs. placebo were 54.6 % vs. 28.6 % (study MN301), and 49.4 % vs. 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 ACR-u u bolesnika koji su primali leflunomid bila je 52,3% (studije MN301/303), 50,5% (studija MN302) i 49,4% (studija US301) u usporedbi sa 53,8% (studije MN301/303) u bolesnika koji su primali sulfasalazin te 64,8% (studija MN302) i 43,9% (studija
Due to a potential for additive hepatotoxic effects, it is recommended that alcohol consumption be avoided during treatment with leflunomide. 
Zbog mogućnosti dodatnog hepatotoksičnog učinka tijekom liječenja leflunomidom preporučuje se
6.6 Special precautions for disposal No special requirements for disposal. 
6.6 Posebne mjere za zbrinjavanje
If after stopping treatment with Leflunomide Teva you plan to become pregnant, you need to ensure that Leflunomide Teva has left your body before trying to become pregnant. 
Obavijestite svog liječnika ako planirate zatrudnjeti nakon prekida terapije Leflunomidom Teva jer je potrebno osigurati da se svi tragovi Leflunomida Teva uklone iz organizma prije nego što pokušate zatrudnjeti.
A randomised, double-blind, parallel-group non-inferiority study compared the relative efficacy of two different daily maintenance doses of leflunomide, 10 mg and 20 mg. From the results it can be concluded that efficacy results of the 20 mg maintenance dose were more favourable, on the other hand, the safety results favoured the 10 mg daily maintenance dose. 
Randomiziranom, dvostruko slijepom, neinferiornom studijom paralelnih grupa uspoređivala se relativna učinkovitost dviju različitih dnevnih doza održavanja leflunomida, odnosno 10 i 20 mg.
Leflunomide Teva stored in blisters are available in pack sizes of 28, 30 and 100 film-coated tablets. 
Leflunomid Teva u bočicama je dostupan u veličinama pakovanja od 28, 30 i 100 filmom obloženih
If the patient is already receiving nonsteroidal anti-inflammatory drugs (NSAIDs) and/or corticosteroids, these may be continued after starting leflunomide. 
Bolesnici koji već uzimaju nesteroidne protuupalne lijekove (NSAIL-e) i/ili kortikosteroide mogu ih nastaviti uzimati nakon uvođenja leflunomida u liječenje.
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 snažno vežu za proteine plazme.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU NALJEPNICA NA BOČICI
Blisters: Do not store above 25°C. 
Blisteri: Ne čuvati na temperaturi iznad 25°C.
Study MN302 randomised 999 subjects with active rheumatoid arthritis to leflunomide 20 mg/day (n=501) or methotrexate at 7.5 mg/week increasing to 15 mg/week (n=498). 
U studiji MN302 bilo je 999 randomiziranih bolesnika s aktivnim reumatoidnim artritisom koji su primali leflunomid 20 mg/dan (n=501) ili metotreksat 7,5 mg/tjedan, s povećanjem doze na 15 mg/tjedan (n=498).
Adverse events consistent with the safety profile for leflunomide were: abdominal pain, nausea, diarrhoea, elevated liver enzymes, anaemia, leucopenia, pruritus and rash. 
Nuspojave u skladu sa sigurnosnim profilom leflunomida bile su: bol u trbuhu, mučnina, proljev, povišene vrijednosti jetrenih enzima,
• Tablet coating: titanium dioxide, polydextrose, hypromellose, triethyl citrate and macrogol 
• Ovojnica tablete: titanijev dioksid, polidekstroza, hipromeloza, trietilcitrat i makrogol 8000.