natgillin/translations-raw huggingface dataset:
- fald i antallet af røde blodlegemer (anæmi) og fald i antallet af blodplader (trombocytopeni), - fald i blodets kaliumniveau, - angst, - smagsforstyrrelser, - urticaria (nældefeber), - seneruptur, - stigning i fedtniveauet i blodet (kolesterol og triglycerider), - fald i fosfatniveauet i blodet. 
- 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.
Leflunomid Zentiva-behandlingen påbegyndes sædvanligvis med 1 tablet på 100 mg daglig i de første 3 dage. 
The usual starting dose of Leflunomide Zentiva is one 100 mg tablet once daily for the first three days.
I forsøg MN302 blev 999 forsøgspersoner med aktiv reumatoid artrit randomiseret til leflunomid 20 mg daglig (n = 501) eller methotrexat 7,5 mg ugentlig stigende til 15 mg ugentlig (n = 498). 
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).
Der var en stigning i den gennemsnitlige repaglinid Cmax og AUC (henholdsvis 1,7 og 2,4 gange), efter gentagne doser af A771726, hvilket tyder på, at A771726 hæmmer CYP2C8 in vivo. 
There was an increase in mean repaglinide Cmax and AUC (1.7- and 2.4-fold, respectively), following repeated doses of A771726, suggesting that A771726 is an inhibitor of CYP2C8 in vivo.
Effekt på oral antikonception (0,03 mg ethinylestradiol og 0,15 mg levonorgestrel) Der var en stigning i den gennemsnitlige ethinylestradiol Cmax og AUC0-24 (henholdsvis 1,58 og 1,54 gange) og levonorgestrel Cmax og AUC0-24 (henholdsvis 1,33 og 1,41 gange) efter gentagne doser af A771726. 
There was an increase in mean ethinylestradiol Cmax and AUC0-24 (1.58- and 1.54-fold, respectively) and levonorgestrel Cmax and AUC0-24 (1.33- and 1.41-fold, respectively) following repeated doses of
Efter 12 måneder med aktiv behandling var ACR-responsraterne hos leflunomidpatienterne 52,3% (forsøg MN301/303), 50,5% (forsøg MN302) og 49,4% (forsøg US301) sammenlignet med 53,8% (forsøg MN301/303) hos sulfasalazin-patienterne, og henholdsvis 64,8% (forsøg MN302) og 43,9% (forsøg US301) hos methotrexat-patienterne. 
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.
I forsøg US301 blev 482 forsøgspersoner med aktiv reumatoid artrit randomiseret til leflunomid 20 mg daglig (n = 182), methotrexat 7,5 mg ugentlig stigende til 15 mg ugentlig (n = 182), eller placebo (n = 118). 
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).
Patienten skal informeres om, at lægen ved uregelmæssigheder i menstruationscyklus eller andre tegn på graviditet omgående skal kontaktes, så graviditetstest kan udføres. 
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.
30 filmovertrukne tabletter 50 filmovertrukne tabletter 100 filmovertrukne tabletter 
30 film-coated tablets 50 film-coated tablets 100 film-coated tablets
Et randomiseret dobbelt-blind, parallelgruppe non-inferior forsøg sammenlignede den relative effekt af to forskellige daglige vedligeholdelsesdoser på leflunomid, 10 mg og 20 mg. 
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.
I forsøg MN301 blev 358 forsøgspersoner med reumatoid artrit randomiseret til leflunomid 20 mg daglig (n = 133), sulfasalazin 2 g daglig (n = 133) eller placebo (n = 92). 
Study MN301 randomised 358 subjects with active rheumatoid arthritis to leflunomide 20 mg/day (n=133), sulphasalazine 2 g/day (n=133), or placebo (n=92).
Leflunomid Zentiva 10 mg 
Leflunomide Zentiva 10 mg
Leflunomid Zentiva 100 mg 
Leflunomide Zentiva 100 mg
Behandlingsvarighed var 6 måneder. 
Treatment duration was 6 months.
Tabletterne er pakket i blisterpakninger Pakket i pakninger med 3 tabletter. 
The tablets are packed in blisters.
• Reumatoid artrit: Leflunomidbehandling indledes sædvanligvis med en startdosis på 100 mg en gang daglig i 3 dage. 
• In rheumatoid arthritis: leflunomide therapy is usually started with a loading dose of 100 mg once daily for 3 days.
Såfremt patienten i forvejen behandles med NSAID og/eller kortikosteroider, kan der fortsættes hermed efter påbegyndt behandling med leflunomid. 
If the patient is already receiving nonsteroidal anti-inflammatory drugs (NSAIDs) and/or corticosteroids, these may be continued after starting leflunomide.
6), eller hvis du er allergisk over for teriflunomid (til behandling af multipel sklerose), - hvis du har leverproblemer, - hvis du har har moderate til svære nyreproblemer, - hvis du har et alvorligt lavt antal proteiner i dit blod (hypoproteinæmi), - hvis du lider af en sygdom der påvirker dit immunforsvar (f.eks. aids) - hvis du har problemer med din knoglemarv, eller hvis du har et lavt antal røde eller hvide blodlegemer, eller et reduceret antal blodplader, - hvis du lider af en alvorlig infektion, - hvis du er gravid, tror du er gravid eller ammer. 
often accompanied by fever, joint pain, red skin stains, or blisters e.g. Stevens-Johnson syndrome) or to any of the other ingredients of this medicine (listed in section 6), or if you are allergic to teriflunomide (used to treat multiple sclerosis), - if you have any liver problems, - if you have moderate to severe kidney problems, - if you have severely low numbers of proteins in your blood (hypoproteinaemia), - if you suffer from any problem which affects your immune system (e.g. AIDS), - if you have any problem with your bone marrow, or if you have low numbers of red or white cells in your blood or a reduced number of blood platelets, - if you are suffering from a serious infection, - if you are pregnant, think you may be pregnant, or are breast-feeding.
Luftvejsreaktioner 
Respiratory reactions
30 filmovertrukne tabletter 100 filmovertrukne tabletter 
30 film-coated tablets 100 film-coated tablets
LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) 
PHARMACEUTICAL FORM AND CONTENTS
Behandlingsvarigheden var 6 måneder. 
The treatment duration was 6 months.
• Arthritis psoriatica: Leflunomidbehandling indledes med en startdosis på 100 mg en gang daglig i 3 dage. 
• In psoriatic arthritis: leflunomide therapy is started with a loading dose of 100 mg once daily for 3 days.
Risikoen for interstitiel lungesygdom og pulmonal hypertension kan være øget hos patienter med interstitiel lungesygdom i anamnesen. 
The risk of their occurrence can be increased in patients with a history of interstitial lung disease.
Gem indlægssedlen. 
- Keep this leaflet.
Gullig til okkerfarvet trekantet filmovertrukken tablet, præget med ZBO på den ene side. 
Yellowish to ochre and triangular film-coated tablet, imprinted with ZBO on one side.
pancytopeni skal Leflunomid Zentiva og anden samtidig behandling med myelosuppresive lægemidler seponeres og leflunomid udvaskningsproceduren påbegyndes. 
In case of severe haematological reactions, including pancytopenia, Leflunomide Zentiva and any concomitant myelosuppressive treatment must be discontinued and a leflunomide washout procedure initiated.
I forsøg med gentagen dosering til patienter med reumatoid artrit er de farmakokinetiske parametre for A771726 lineære i doseringsintervallet 5-25 mg. I disse forsøg hænger den kliniske effekt tæt sammen med plasmakoncentrationen af A771726 og den daglige dosis af leflunomid. 
In multiple dose studies in patients with rheumatoid arthritis, the pharmacokinetic parameters of A771726 were linear over the dose range of 5 to 25 mg.
Alle patienter fik folininsyre 1 mg 2 gange daglig. 
All patients received folate 1 mg bid.
De hyppigst rapporterede bivirkninger ved behandling med leflunomid er: let blodtryksstigning, leukopeni, paræstesi, hovedpine, svimmelhed, diarré, kvalme, opkastning, gener fra mundslimhinden, (f.eks. aftøs stomatitis, mundsår), abdominalsmerter, øget hårtab, eksem, udslæt (inklusive makulopapuløst udslæt), pruritus, tør hud, seneskedehindebetændelse, øget kreatinkinase, anoreksi, vægttab (sædvanligvis ubetydeligt), asteni, milde allergiske reaktioner og stigning i leverparametre (transaminaser særligt ALAT), mindre hyppigt gamma-GT, basisk fosfatase og bilirubin). 
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)).
- et mindre fald i antallet af hvide blodlegemer (leukopeni), - lette allergiske reaktioner, - appetitløshed, vægttab (sædvanligvis ubetydeligt), - slaphed (asteni), - hovedpine, svimmelhed, - unormale hudfornemmelser såsom prikken (paræstesi), - let forhøjelse af blodtrykket, - colitis 
- a slight decrease in the number of white blood cells (leucopenia), - mild allergic reactions, - loss of appetite, weight loss (usually insignificant), - tiredness (asthenia), - headache, dizziness, - abnormal skin sensations like tingling (paraesthesia), - mild increase in blood pressure,
Efter 16 ugers behandling var forskellen i responsraterne statistisk signifikant til methotrexats fordel til børnegigt ”definition of improvement (DOI)” ≥30 % (p=0,02 %). 
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).
Er du i tvivl, så spørg lægen eller på apoteket. 
- If you have any further questions, ask your doctor, pharmacist or nurse.
Endvidere kan det at skifte fra leflunomid til et andet DMARD uden at følge udvaskningsproceduren (se pkt. 
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 switching.
Meget sjældne bivirkninger (kan påvirke op til 1 ud af 10.000 personer) 
Very rare side effects (may affect up to 1 in 10,000 people)
For at sikre, at fosteret ikke udsættes for toksiske koncentrationer af A771726 (fokuskoncentration under 0,02 mg/l) anbefales en af følgende procedurer til kvinder i leflunomidbehandling, som ønsker at blive gravide: 
For women receiving leflunomide treatment and who wish to become pregnant, one of the following procedures is recommended in order to ascertain that the foetus is not exposed to toxic concentrations of A771726 (target concentration below 0.02 mg/L):
Efter ophør med leflunomidbehandling administreres: 
After stopping treatment with leflunomide:
Leverreaktioner 
Liver reactions
Sådan skal du tage Leflunomid Zentiva 
How to take Leflunomide Zentiva
Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 78 mg lactosemonohydrat. 
Excipients with known effect Each tablet contains 78 mg of lactose monohydrate.
Leflunomid Zentiva 20 mg filmovertrukne tabletter er gullige til okkerfarvede og trekantede Præget med ZBO på den ene side. 
Leflunomide Zentiva 20 mg film-coated tablets are yellowish to ochre and triangular.
Præget med ZBP på den ene side. 
Imprint on one side: ZBP
MÆRKNING DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON, BLISTER PAKNING 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER PACKAGING/BLISTER PACK
Hjælpestof som behandleren skal være opmærksom på Hver tablet indeholder 72 mg lactosemonohydrat. 
Excipients with known effect Each tablet contains 72 mg of lactose monohydrate.
Det skal du vide, før du begynder at tage Leflunomid Zentiva Sådan skal du tage Leflunomid Zentiva Bivirkninger 
What Leflunomide Zentiva is and what it is used for What you need to know before you take Leflunomide Zentiva How to take Leflunomide Zentiva Possible side effects
I fase III forsøgene var ACR-responsraterne for leflunomid 20 mg daglig versus placebo 54,6% versus 28,6% (forsøg MN301) og 49,4% versus 26,3% (forsøg US301). 
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
Leflunomid kan tages i forbindelse med et måltid, idet absorptionen er uændret, hvad enten patienten er fastende eller ej. På grund af den lange halveringstid af A771726 (ca. 2 uger), blev der i kliniske forsøg givet en initialdosis på 100 mg i 3 dage for at opnå hurtig steady-state koncentrationer af A771726. 
Due to the very long half-life of 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.
Sjældne bivirkninger (kan påvirke op til 1 ud af 1.000 personer) 
Rare side effects (may affect up to 1 in 1,000 people)
Ved behandling med leflunomid er beskrevet colitis, herunder mikroskopisk colitis. 
Colitis, including microscopic colitis has been reported in patients treated with leflunomide.
- Aktivt stof: Leflunomid. 
- The active substance is leflunomide.
Povidon (E 1201) Crospovidon, (E 1202) Kolloid vandfri silica Magnesiumstearat (E 470b) Lactosemonohydrat 
Povidone (E1201) Crospovidone (E1202) Silica colloidal anhydrous Magnesium stearate (E470b) Lactose monohydrate
Dog har doseringen til lette individer resulteret i en relativ lav eksponering over for leflunomid (se pkt. 
The pattern of adverse events of leflunomide and methotrexate seems to be similar, but the dose used in lighter subjects resulted in a relatively low exposure (see section 5.2).
Kontakt din læge for yderligere information om blodprøverne. 
For further information on the laboratory testing please contact your doctor.
Indlægsseddel: Information til brugeren Leflunomid Zentiva 100 mg filmovertrukne tabletter leflunomid 
Package leaflet: Information for the user Leflunomide Zentiva 100 mg film-coated tablets leflunomide
Indlægsseddel: Information til brugeren Leflunomid Zentiva 20 mg filmovertrukne tabletter leflunomid 
Package leaflet: Information for the user Leflunomide Zentiva 20 mg film-coated tablets leflunomide
Hjerte Almindelig: 
Common:
Indlægsseddel: Information til brugeren Leflunomid Zentiva 10 mg filmovertrukne tabletter leflunomid 
Package leaflet: Information for the user Leflunomide Zentiva 10 mg film-coated tablets leflunomide
Da det ikke kan udelukkes, at Leflunomid Zentiva findes i sæden, skal der bruges pålidelige prævention under behandlingen med Leflunomid Zentiva. 
- 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.
Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter. 
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Øvrige indholdsstoffer: Majsstivelse, povidon (E1201), crospovidon (E1202), kolloid vandfri silica, magnesiumstearat (E470b) og lactosemonohydrat i tabletkernen, såvel som talcum (E553b), hypromellose (E464), titaniumoxid (E171) og macrogol 8000 i filmovertrækningen. 
- 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.
Almindelige bivirkninger (kan påvirke op til 1 ud af 10 personer) 
Common side effects (may affect up to 1 in 10 people)
Øvrige indholdsstoffer: Majsstivelse, povidon (E1201), crospovidon (E1202), talkum, kolloid vandfri silica, magnesiumstearat (E470b) og lactosemonohydrat i tabletkernen, såvel som talcum (E553b), hypromellose (E464), titaniumoxid (E171) og macrogol 8000 i filmovertrækningen. 
- The other ingredients are: maize starch, povidone (E1201), crospovidone (E1202), talc (E553b), 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.
Ikke almindelige bivirkninger (kan påvirke op til 1 ud af 100 personer) 
Uncommon side effects (may affect up to 1 in 100 people)
EU/1/09/604/005 30 tabletter EU/1/09/604/006 50 tabletter EU/1/09/604/007 100 tabletter 
EU/1/09/604/005 30 tablets EU/1/09/604/006 50 tablets EU/1/09/604/007 100 tablets
Der findes pakninger med 30, 50 og 100 tabletter Ikke alle pakningsstørrelser er nødvendigvis markedsført. 
Packs of 30, 50 and 100 tablets are available.
Hver tablet indeholder 20 mg leflunomid. 
Each tablet contains 20 mg leflunomide.
- hvis du nogensinde har haft en allergisk reaktion over for leflonumid (specielt en alvorlig hudreaktion, ofte ledsaget af feber, ledsmerter, røde pletter på huden eller blærer, f.eks. Stevens 
- if you have ever had an allergic reaction to leflunomide (especially a serious skin reaction,
Hver filmovertrukket tablet indeholder 20 mg leflunomid. 
Each film-coated tablet contains 20 mg leflunomide.
Hvis du har taget for meget Leflunomid Zentiva 
If you take more Leflunomide Zentiva than you should
Hver tablet indeholder 10 mg leflunomid. 
Each tablet contains 10 mg leflunomide.
Hver tablet indeholder 100 mg af leflunomid. 
Each tablet contains 100 mg of leflunomide.
Leflunomid Zentiva 100 mg filmovertrukne tabletter leflunomid 
Leflunomide Zentiva 100 mg film-coated tablets leflunomide
Leflunomid Zentiva 20 mg filmovertrukne tabletter leflunomid 
Leflunomide Zentiva 20 mg film-coated tablets leflunomide
Hver filmovertrukket tablet indeholder 100 mg leflunomid. 
Each film-coated tablet contains 100 mg leflunomide.
Da eventuelle leverskader forvoldt af alkohol kan forværres af behandling med Leflunomid Zentiva, anbefales det ikke at drikke alkohol under behandling med Leflunomid Zentiva. 
It is not recommended to drink alcohol during treatment with Leflunomide Zentiva.
- diarré, - kvalme, opkastning, - inflammation i munden eller mundsår - mavesmerter, - blodprøver, som viser en stigning i nogle resultater for leverfunktion, - øget hårtab, - eksem, tør hud, udslæt, kløe, - seneskedebetændelse (smerte forårsaget af en inflammation i den hinde der omgiver senerne, 
- 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).
Hver filmovertrukket tablet indeholder 10 mg leflunomid. 
Each film-coated tablet contains 10 mg leflunomide.
Leflunomid Zentiva 10 mg filmovertrukne tabletter leflunomid 
Leflunomide Zentiva 10 mg film-coated tablets leflunomide
Nedsat nyrefunktion 
renal failure
Leflunomid Zentiva 20 mg filmovertrukket tablet 
Leflunomide Zentiva 20 mg film-coated tablets
EU/1/09/604/008 30 tabletter EU/1/09/604/009 100 tabletter 
EU/1/09/604/008 30 tablets EU/1/09/604/009 100 tablets
En filmovertrukken tablet indeholder 100 mg leflunomid. 
One film-coated tablet contains 100 mg of leflunomide.
- Øvrige indholdsstoffer: Majsstivelse, povidon (E1201), crospovidon (E1202), kolloid vandfri silica, magnesiumstearat (E470b) og lactosemonohydrat i tabletkernen, såvel som talcum (E553b), hypromellose (E464), titaniumoxid (E171), macrogol 8000 og gul jernoxid (E172) i filmovertrækningen. 
One film-coated tablet contains 20 mg of leflunomide - 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), macrogol 8000 and yellow ferric oxide (E172) in the film-coating.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON, TABLETGLAS 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER PACKAGING/BOTTLE PACK
EU/1/09/604/001 30 tabletter EU/1/09/604/002 100 tabletter 
EU/1/09/604/001 30 tablets EU/1/09/604/002 100 tablets
En filmovertrukken tablet indeholder 10 mg leflunomid. 
One film-coated tablet contains 10 mg of leflunomide.
• Informationsfolder til læger 
• Periodic Safety Update Reports
Maksimale plasmakoncentrationer kan indtræde mellem 1-24 timer efter indgift af enkeltdosis. 
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.
EU/1/09/604/003 30 tabletter EU/1/09/604/004 100 tabletter 
EU/1/09/604/003 30 tablets EU/1/09/604/004 100 tablets
Leflunomid Zentiva 100 mg filmovertrukket tablet 
Leflunomide Zentiva 100 mg film-coated tablets
Bivirkninger 
Possible side effects
Leflunomid Zentiva 10 mg filmovertrukket tablet 
Leflunomide Zentiva 10 mg film-coated tablets
- hoste eller åndedrætsproblemer, da disse kan være tegn på lungeproblemer (interstitiel lungesygdom eller pulmonal hypertension) - usædvanlig prikken, svaghed eller smerte i dine hænder eller fødder, da dette kan være tegn på problemer med dine nerver (perifer neuropati). 
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, - 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, - any symptoms of an infection such as fever, sore throat or cough, as this medicine may increase the chance of a severe infection which may be life-threatening, - cough or breathing problems as these may indicate problems of the lung (interstitial lung disease or pulmonary hypertension), - unusual tingling, weakness or pain in your hands or feet as these may indicate problems with your nerves (peripheral neuropathy).
Knogler, led, muskler og bindevæv Almindelig: 
Musculoskeletal and connective tissue disorders Common:
MÆRKNING DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE ETIKET, TABLETGLAS 
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
A771726 var den eneste radioaktivt mærkede metabolit, som blev genfundet i plasma. 
The only plasma-radiolabelled metabolite detected was A771726.
- træthed, mavesmerter, eller gulsot (gul misfarvning af øjne og hud), da disse kan være tegn på alvorlige problemer, såsom leversvigt, der kan være dødeligt. 
severe liver injury such as hepatic failure and acute hepatic necrosis that may be fatal Skin and subcutaneous tissue disorders