natgillin/translations-raw huggingface dataset:
The major circulating inactive metabolite is the glucuronide conjugate of O-demethylated apremilast (M12). 
Glavni cirkulirajući neaktivni metabolit je glukunoridni konjugat Odemetiliranog apremilasta (M12).
There was no clinically meaningful interaction between ketoconazole and apremilast. 
Nije bilo klinički značajne interakcije između ketokonazola i apremilasta.
If your doctor considers you to be underweight, and you observe an unintentional loss of body weight while being treated with Otezla, you should talk to your doctor. 
Ako liječnik smatra da ste pothranjeni, a Vi primijetite nenamjerni gubitak tjelesne težine za vrijeme terapije lijekom Otezla, morate se obratiti svom liječniku.
What Otezla is used for Otezla is used to treat adults with the following conditions: 
Otezla se koristi za liječenje odraslih sa sljedećim stanjima:
Oxidative metabolism of apremilast is primarily mediated by CYP3A4, with minor contributions from CYP1A2 and CYP2A6. 
Oksidacijski metabolizam apremilasta prvenstveno je posredovan CYP3A4, uz manje doprinose od strane CYP1A2 i CYP2A6.
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. 
Preosjetljivost na djelatnu(e) tvar(i) ili neku od pomoćnih tvari navedenih u dijelu 6.1.
Apremilast 30 mg twice daily 
Apremilast 30 mg dvaput na dan
Subjects with missing data were counted as nonresponders. 
Ispitanici za koje nije bilo podataka smatrali su se ispitanicima bez odgovora.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Wallet card containing 2-week treatment initiation pack 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kartonski ovitak sadrži pakiranje za početna 2 tjedna liječenja
Psoriasis is an inflammatory disease of the skin, which can cause red, scaly, thick, itchy, painful patches on your skin and can also affect your scalp and nails. 
Psorijaza je upalna bolest kože koja može uzrokovati crvene, ljuskaste, zadebljane, svrbljive, bolne dijelove na koži, a može također zahvatiti vlasište i nokte.
Apremilast was studied in healthy subjects at a maximum total daily dose of 100 mg (given as 50 mg twice daily) for 4.5 days without evidence of dose limiting toxicities. 
Apremilast je ispitan u zdravih ispitanika pri maksimalnoj ukupnoj dnevnoj dozi od 100 mg (davanoj kao 50 mg dvaput na dan) tijekom 4,5 dana bez znakova toksičnosti koja bi ograničila dozu.
A total of 18% of patients had a history of psoriatic arthritis. 
Ukupno 18% bolesnika imalo je psorijatični artritis u anamnezi.
Patients and caregivers should be instructed to notify the prescriber of any suicidal ideation (see section 4.4). 
Bolesnike i njegovatelje potrebno je uputiti da obavijeste liječnika koji propisuje lijek o svim suicidalnim idejama (vidjeti dio 4.4).
Patients in these studies had a diagnosis of PsA for at least 6 months. 
Bolesnici u ovim ispitivanjima imali su dijagnozu psorijatičnog artritisa najmanje 6 mjeseci.
Approximately 30% of all patients had received prior phototherapy and 54% had received prior conventional systemic and/or biologic therapy for the treatment of psoriasis (including treatment failures), with 37% receiving prior conventional systemic therapy and 30% receiving prior biologic therapy. 
Približno 30% svih bolesnika prethodno je primilo fototerapiju, a 54% bolesnika prethodno je primilo konvencionalnu sistemsku i/ili biološku terapiju za liječenje psorijaze (uključujući neuspjela liječenja), s tim da je 37% prethodno primalo konvencionalnu sistemsku terapiju, a 30% biološku terapiju.
• Once the recommended dose has been reached, you will only get the 30 mg tablet strength in your prescribed packs. 
• Kada dosegnete preporučenu dozu, dobit ćete u svom propisanom pakiranju samo tablete jačine 30 mg.
A risk to the breastfed infant cannot be excluded, therefore apremilast should not be used during breast-feeding. 
Ne može se isključiti rizik za dojenče, stoga se apremilast ne smije primjenjivati u razdoblju dojenja.
For initial dose titration in this group, it is recommended that apremilast be titrated using only the AM schedule listed in Table 1 and the PM doses be skipped (see section 5.2). 
Za početnu titraciju doze u toj skupini, preporučuje se titracija apremilasta samo prema prijepodnevnom rasporedu navedenom u tablici 1, a poslijepodnevne doze treba preskočiti (vidjeti dio 5.2).
• Do not store above 30°C. 
• Ne čuvati na temperaturi iznad 30C.
In these patients, ACR 20/50/70 responses at week 52 were of 57%, 25%, and 11% respectively. 
U tih bolesnika, odgovori ACR 20/50/70 u 52. tjednu bili su 57%, 25% odnosno 11%.
It is not known whether apremilast, or its metabolites, are excreted in human milk. 
Nije poznato izlučuju li se apremilast ili njegovi metaboliti u majčino mlijeko u ljudi.
• Do not use this medicine after the expiry date which is stated on the blister or on the wallet or on the carton after EXP. 
• Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru, kartonskom ovitku ili kutiji iza oznake „EXP“.
Otezla contains lactose (a type of sugar). 
Otezla sadrži laktozu (vrsta šećera).
What you need to know before you take Otezla 
Što morate znati prije nego počnete uzimati lijek Otezla
If it is close to the time for your next dose, just skip the missed dose. 
Ako je uskoro vrijeme za sljedeću dozu, preskočite propuštenu dozu.
Elderly patients No dose adjustment is required for this patient population (see sections 4.8 and 5.2). 
U ovoj populaciji bolesnika nije potrebna prilagodba doze (vidjeti dijelove 4.8 i 5.2).
Detailed and updated information on this medicine is available by scanning the QR code on the outer packaging with a smartphone. 
Detaljne i ažurirane informacije o ovome lijeku možete saznati tako da pametnim telefonom očitate QR kôd na vanjskom pakiranju.
Effects of apremilast on pregnancy included embryofoetal loss in mice and monkeys, and reduced foetal weights and delayed ossification in mice at doses higher than the currently recommended highest human dose. 
Učinci apremilasta na trudnoću uključivali su embriofetalni gubitak u miševa i majmuna, smanjenje fetalne težine te odgođenu osifikaciju u miševa pri dozama višim od trenutačno preporučene najviše doze za ljude.
Apremilast administered at doses of up to 50 mg twice daily did not prolong the QT interval in healthy subjects. 
Apremilast primijenjen u dozama do 50 mg dvaput na dan nije produljio QT interval u zdravih ispitanika.
Otezla works by reducing the activity of an enzyme in the body called ‘phosphodiesterase 4', which is involved in the process of inflammation. 
Otezla djeluje tako da u tijelu smanjuje aktivnost enzima koji se naziva 'fosfodiesteraza 4' a uključen je u upalni proces.
Fertility and early embryonic development 
Plodnost i rani embrionalni razvoj
If you stop taking Otezla 
Ako prestanete uzimati lijek Otezla
In vitro, apremilast is not an inhibitor or inducer of cytochrome P450 enzymes. 
In vitro, apremilast nije inhibitor niti induktor enzima citokroma P450.
How Otezla works 
Kako Otezla djeluje
Patients with pre-existing enthesopathy (63%) or pre-existing dactylitis (42%) were enrolled. 
Uključeni su i bolesnici s postojećom entezopatijom (63%) ili postojećim daktilitisom (42%).
*p ≤ 0.01 for apremilast vs. placebo **p ≤ 0.001 for apremilast vs. placebo a N is the number of patients as randomised and treated 
*p ≤ 0,01 za apremilast naspram placeba **p ≤ 0,001 za apremilast naspram placeba a N je broj randomiziranih i liječenih bolesnika
Hypersensitivity reactions are uncommonly observed (see section 4.3). 
Reakcije preosjetljivosti opažene su manje često (vidjeti dio 4.3).
Apremilast can be co-administered with oral contraceptives. 
Apremilast se može primjenjivati istodobno s oralnim kontraceptivima.
After 40 weeks of treatment with apremilast, there was a decrease in plasma protein levels of IL-17 and IL-23, and an increase in IL-10. 
Nakon 40 tjedana liječenja apremilastom, došlo je do smanjenja razina plazmatskih proteina IL-17 i IL-23 te do porasta IL-10.
If you are 65 years of age or older, you might have a higher risk of complications of severe diarrhoea, nausea and vomiting. 
Ako ste u dobi od 65 godina i više, možda ste pod povećanim rizikom od komplikacija poput teškog proljeva, mučnine i povraćanja.
There is no evidence of immunotoxic, dermal irritation, or phototoxic potential. 
Nema dokaza za potencijalnu imunotoksičnost, dermalnu iritaciju ili fototoksičnost.
There is little information about the effects of Otezla in pregnancy. 
Malo je podataka o učincima lijeka Otezla u trudnoći.
By reducing the activity of this enzyme, Otezla can help to control the inflammation associated with psoriatic arthritis and psoriasis, and thereby reduce the signs and symptoms of these conditions. 
Smanjujući aktivnost tog enzima, Otezla može pomoći u kontroli upale povezane s psorijatičnim artritisom i psorijazom, a time i smanjiti znakove i simptome tih stanja.
If you have severe kidney problems then the recommended dose of Otezla is 30 mg once a day (morning dose). 
Ako imate teške tegobe s bubrezima, tada je preporučena doza lijeka Otezla 30 mg jedanput na dan (jutarnja doza).
The recommended dose of apremilast is 30 mg taken orally twice daily, approximately 12 hours apart (morning and evening), with no food restrictions. 
Preporučena doza apremilasta je 30 mg peroralno dvaput na dan, u razmaku od približno 12 sati (ujutro i navečer), bez ograničenja u odnosu na hranu.
Week 16 Week 32 Week 52 
16. tjedan 32. tjedan 52. tjedan
Hence, clinically relevant drug-drug interactions are unlikely when apremilast is co-administered with drugs that are substrates or inhibitors of these transporters. 
Dakle, nisu vjerojatne klinički važne interakcije lijekova kada se apremilast primjenjuje istodobno s lijekovima koji su supstrati ili inhibitori tih prijenosnika.
If it is close to the time for their next dose, the missed dose should not be taken and the next dose should be taken at the regular time. 
Ako je uskoro vrijeme za sljedeću dozu, ne smiju uzeti propuštenu dozu nego uzeti tu sljedeću dozu u uobičajeno vrijeme.
• The recommended dose of Otezla is 30 mg twice a day after the titration phase is complete - one 30 mg dose in the morning and one 30 mg dose in the evening, approximately 12 hours apart, with or without food. 
• Preporučena doza lijeka Otezla je 30 mg dvaput na dan nakon završene faze podešavanja doze (titracija) - jedna doza od 30 mg ujutro i jedna doza od 30 mg navečer, u razmaku od približno 12 sati, s hranom ili bez nje.
If you experience severe diarrhoea, nausea, or vomiting, you should talk to your doctor. 
Ako imate teški proljev, mučninu ili povraćanje, morate se obratiti svom liječniku.
• Moderate to severe chronic plaque psoriasis - if you cannot use one of the following treatments or when you have tried one of these treatments and it did not work: - phototherapy - a treatment where certain areas of skin are exposed to ultraviolet light - systemic therapy - a treatment that affects the entire body rather than just one local area, such as ‘ciclosporin', ‘methotrexate' or ‘psoralen '. 
• umjerena do teška kronična plak psorijaza - ako ne možete primjenjivati jednu od sljedećih terapija ili kada ste je probali nije djelovala: - fototerapija - liječenje pri kojem se određeni dijelovi kože izlažu ultraljubičastom svjetlu - sistemska terapija - terapija lijekom koji utječe na cijelo tijelo a ne samo na jedno određeno područje (lokalno), kao što su ciklosporin, metotreksat ili psoralen.
Apremilast has no or negligible influence on the ability to drive and use machines. 
Apremilast ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
A total of 0.1% of patients treated with apremilast discontinued due to adverse reaction of weight decreased. 
Ukupno je 0,1% bolesnika liječenih apremilastom prekinulo liječenje zbog nuspojave smanjenja tjelesne težine.
Name and address of the manufacturer responsible for batch release Celgene Distribution B.V. 
Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Celgene Distribution B.V.
Based on the study design, patients whose tender and swollen joint counts had not improved by at least 20% were considered non-responders at week 16. 
Prema planu ispitivanja, bolesnici u kojih nije nastupilo poboljšanje u broju bolnih i otečenih zglobova za najmanje 20%, smatrani su u 16. tjednu bolesnicima bez odgovora.
Apremilast can be co-administered with methotrexate. 
Apremilast se može primjenjivati istodobno s metotreksatom.
In clinical studies in patients with psoriatic arthritis, apremilast significantly modulated, but did not fully inhibit, plasma protein levels of IL-1α, IL-6, IL-8, MCP-1, MIP-1β, MMP-3, and TNF-α. 
U kliničkim ispitivanjima u bolesnika s psorijatičnim artritisom, apremilast je značajno modulirao ali nije potpuno inhibirao razine plazmatskih proteina IL-1α, IL-6, IL-8, MCP-1, MIP-1β, MMP-3 i TNF-α.
There were no apremilast-related effects on duration of pregnancy, number of pregnant mice at the end of the gestation period, number of mice that delivered a litter, or any developmental effects in the pups beyond postnatal day 7. 
Nije bilo učinaka povezanih s apremilastom na trajanje trudnoće, na broj skotnih ženki miševa na kraju gestacijskog razdoblja, na broj ženki miševa koje su okotile leglo ili na neke druge razvojne učinke u mladunčadi nakon 7. postnatalnog dana.
In vitro, apremilast is a substrate, and a weak inhibitor of P-glycoprotein (IC50>50µM), however clinically relevant drug interactions mediated via P-gp are not expected to occur. 
In vitro, apremilast je supstrat i slabi inhibitor P-glikoproteina (IC50 > 50 µM), međutim, ne očekuje se da će doći do klinički važnih interakcija lijekova posredovanih putem P-gp-a.
Further improvements in nail psoriasis were observed at week 32 in patients continuously treated with apremilast. 
Daljnja poboljšanja u psorijazi noktiju opažena su u 32. tjednu u bolesnika kontinuirano liječenih apremilastom.
4.5 Interaction with other medicinal products and other forms of interaction Co-administration of strong cytochrome P450 3A4 (CYP3A4) enzyme inducer, rifampicin, resulted in a reduction of systemic exposure of apremilast, which may result in a loss of efficacy of apremilast. 
4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Istodobna primjena s jakim induktorom enzima citokroma P450 3A4 (CYP3A4), rifampicinom, rezultirala je smanjenjem sistemske izloženosti apremilastu, što za posljedicu može imati gubitak djelotvornosti apremilasta.
The median time to loss of 50% of their week 32 PASI improvement was 12.4 weeks. 
Medijan vremena do gubitka poboljšanja u rezultatu PASI od 50% iz 32. tjedna iznosio je 12,4 tjedna.
Do not store above 30ºC. 
Ne čuvati na temperaturi iznad 30C.
The primary endpoint was the percentage of patients achieving American College of Rheumatology (ACR) 20 response at week 16. 
Primarni ishod bio je postotak bolesnika koji prema kriterijima Američkog reumatološkog društva (ACR) postigne odgovor 20 u 16. tjednu.
You or your caregiver should also immediately inform your doctor of any changes in behaviour or mood and of any suicidal thoughts you may have. 
Također je potrebno da Vi ili vaš njegovatelj odmah obavijestite vašeg liječnika o svim promjenama u ponašanju ili raspoloženju te o svim suicidalnim mislima koje imate.
Long-term experience in open-label extension studies with apremilast was generally comparable to the 52-week studies. 
Iskustvo s apremilastom u dugoročnim otvorenim nastavcima ispitivanja većinom je bilo slično onom u ispitivanjima od 52 tjedna.
In case of an overdose, it is recommended that the patient is monitored for any signs or symptoms of adverse effects and appropriate symptomatic treatment is instituted. 
U slučaju predoziranja preporučuje se praćenje bolesnika zbog pojave znakova ili simptoma nuspojava te uvođenje odgovarajućeg simptomatskog liječenja.
Therefore, the use of strong CYP3A4 enzyme inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin and St. John's Wort) with apremilast is not recommended. 
Stoga se ne preporučuje primjena jakih induktora enzima CYP3A4 (npr. rifampicin, fenobarbital, karbamazepin, fenitoin i gospina trava) s apremilastom.
A total of 76.4% of patients were previously treated with only small-molecule DMARDs and 22.4% of patients were previously treated with biologic DMARDs, which includes 7.8% who had a therapeutic failure with a prior biologic DMARD. 
Ukupno 76,4% bolesnika bilo je prethodno liječeno samo malomolekulskim DMARD lijekovima, a 22,4% bolesnika bilo je prethodno liječeno biološkim DMARD lijekovima, uključujući 7,8% onih kojima je prethodna terapija biološkom DMARD terapijom bila neuspješna.
The long-term safety of apremilast 30 mg twice daily in patients with psoriatic arthritis and psoriasis was assessed for a total duration of treatment up to 5 years. 
Dugoročna sigurnost primjene apremilasta od 30 mg dvaput na dan u bolesnika s psorijatičnim artritisom i psorijazom procjenjivana je tijekom ukupnog trajanja liječenja od 5 godina.
Also some other medicines can affect the way Otezla works. 
Osim toga, neki drugi lijekovi mogu utjecati na to kako Otezla djeluje.
In addition, apremilast demonstrated a treatment benefit across multiple manifestations of psoriasis including pruritus, nail disease, scalp involvement and quality of life measures. 
Osim toga, apremilast je pokazao dobrobit liječenja u mnogim manifestacijama psorijaze uključujući pruritus, bolest noktiju, zahvaćenost vlasišta i mjere kvalitete života.
How and when to take Otezla 
Kako i kada uzimati lijek Otezla
Pre- and post-natal development 
Prenatalni i postnatalni razvoj
The most common adverse reactions leading to discontinuation during the first 16 weeks of treatment are diarrhoea (1.7%), and nausea (1.5%) (frequencies are based on Phase III clinical studies). 
Najčešće nuspojave koje dovode do prekida terapije u prvih 16 tjedana liječenja jesu proljev (1,7%) i mučnina (1,5%) (učestalosti se temelje na kliničkim ispitivanjima faze III).
In both studies, the primary endpoint was the proportion of patients who achieved PASI-75 at week 16. 
U oba ispitivanja primarni ishod bio je udio bolesnika koji su postigli PASI-75 u 16. tjednu.
Apremilast was not clastogenic in an in vivo mouse micronucleus assay at doses up to 2,000 mg/kg/day. 
Apremilast nije bio klastogen u in vivo testu mišjih mikronukleusa pri dozama do 2000 mg/kg na dan.
In clinical studies and post-marketing experience, uncommon cases of suicidal ideation and behaviour, were reported, while completed suicide was reported post-marketing. 
U kliničkim ispitivanjima te nakon stavljanja lijeka u promet, zabilježeni su manje česti slučajevi suicidalnih ideja i ponašanja, dok je izvršeno samoubojstvo zabilježeno nakon stavljanja lijeka u promet.
The same information is also available on the following URL: www.otezla-eu-pil.com. 
Iste informacije dostupne su i na sljedećoj internetskoj adresi: www.otezla-eupil.com.
There was no pharmacokinetic interaction between apremilast and oral contraceptives containing ethinyl estradiol and norgestimate. 
Nije bilo farmakokinetičke interakcije između apremilasta i oralnih kontraceptiva koji sadrže etinilestradiol i norgestimat.
In psoriatic arthritis, treatment with Otezla results in an improvement in swollen and painful joints, and can improve your general physical function. 
U psorijatičnom artritisu, liječenje lijekom Otezla rezultira poboljšanjem otečenih i bolnih zglobova i može poboljšati opću tjelesnu funkciju.
Frequent bowel movements Upper abdominal pain* Gastroesophageal reflux disease 
Često povraćanje* dispepsija česta pražnjenja crijeva bol u gornjem dijelu abdomena* gastroezofagealna refluksna bolest
• bleeding in the bowel or in the stomach 
• krvarenje u crijevima ili želucu
Apremilast dose should be reduced to 30 mg once daily in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2 or CLcr < 30 mL/min). 
Dozu apremilasta treba smanjiti na 30 mg jedanput na dan u bolesnika s teškim oštećenjem funkcije bubrega (eGFR manji od 30 ml/min/1,73 m2 ili CLcr < 30 ml/min).
Day 6 & thereafter AM AM PM AM PM AM PM AM PM AM PM 10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 30 mg 30 mg 30 mg 
6. dan i nadalje prije podne prije podne poslije podne prije podne poslije podne prije podne poslije podne prije podne poslije podne prije podne poslije podne 10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 30 mg 30 mg 30 mg
Co-administration of apremilast with multiple doses of rifampicin resulted in a decrease in apremilast area-under-the-concentration time curve (AUC) and maximum serum concentration (Cmax) by approximately 72% and 43%, respectively. 
Istodobna primjena apremilasta s više doza rifampicina rezultirala je smanjenjem površine ispod krivulje koncentracija/vrijeme (AUC) apremilasta za približno 72% i maksimalne koncentracije u serumu (Cmax) za približno 43%.
Film-coated tablet Treatment initiation pack 
Filmom obložena tableta Pakiranje za započinjanje liječenja
The major secondary endpoint was the proportion of patients who achieved a sPGA score of clear (0) or almost clear (1) at week 16. 
Glavni sekundarni ishod bio je udio bolesnika kojima je rezultat sPGA bio 'bez znakova psorijaze' (0) ili gotovo bez znakova (1) u 16. tjednu.
Accumulation is minimal when apremilast is administered once daily and approximately 53% in healthy subjects and 68% in patients with psoriasis when administered twice daily. 
Akumulacija je minimalna kada se apremilast primjenjuje jedanput na dan, a kada se primjenjivao dvaput na dan, iznosila je približno 53% u zdravih ispitanika i 68% u bolesnika s psorijazom.
Each pack of 27 film-coated tablets for a 2 week treatment schedule contains: 4 film-coated tablets of 10 mg 
Jedno pakiranje od 27 filmom obloženih tableta za početna 2 tjedna liječenja sadrži: 4 filmom obložene tablete od 10 mg
Patients received apremilast in combination with one or more of the following: methotrexate (MTX, ≤ 25 mg/week, 54.5%), sulfasalazine (SSZ, ≤ 2 g/day, 9.0%), and leflunomide (LEF; ≤ 20 mg/day, 7.4%). 
Bolesnici su primali apremilast u kombinaciji s jednim ili više od sljedećeg: metotreksat (MTX, ≤ 25 mg tjedno, 54,5%), sulfasalazin (SSZ, ≤ 2 g na dan, 9,0%) i leflunomid (LEF, ≤ 20 mg na dan, 7,4%).
All developmental effects were observed during the first week of the postnatal period; no apremilast-related effects were seen during the remaining pre- and post-weaning periods, including sexual maturation, behavioural, mating, fertility and uterine parameters. 
Svi razvojni učinci bili su opaženi u prvim tjednima postnatalnog razdoblja; tijekom preostalih razdoblja prije i poslije odvajanja od majke, uključujući spolno sazrijevanje, parametre ponašanja, parenja, plodnosti i maternice, nisu uočeni učinci povezani s apremilastom.
10 mg (pink) 
10 mg (ružičasta)
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister (Particulars printed directly onto the wallet card with the blank blister sealed inside) 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blister (Podaci otisnuti izravno na kartonski ovitak, s blisterom bez ikakvih podataka zalijepljenim unutar ovitka.)
Treatment with Otezla should be initiated by specialists experienced in the diagnosis and treatment of psoriasis or psoriatic arthritis. 
Liječenje lijekom Otezla trebaju započeti specijalisti s iskustvom u dijagnosticiranju i liječenju psorijaze ili psorijatičnog artritisa.
These GI adverse reactions are mostly mild to moderate in severity, with 0.3% of diarrhoea and 0.3% of nausea reported as severe. 
Nuspojave probavnog sustava većinom su blage do umjerene težine, s tim da je 0,3% proljeva i 0,3% mučnina prijavljeno kao teška nuspojava.
Very common side effects (may affect more than 1 in 10 people) 
Vrlo česte nuspojave (mogu se pojaviti u više od 1 na 10 osoba)
• The film-coating contains poly(vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc, iron oxide red (E172). 
• Film-ovojnica sadrži poli(vinilni alkohol), titanijev dioksid (E171), makrogol (3350), talk, željezov oksid, crveni (E172).