FrancophonIA/ELRC3.0 huggingface dataset:
English: Although greater sensitivity to develop adverse reactions in some older patients and Asian patients cannot be ruled out, overall, no major differences were observed in the safety and effectiveness of axitinib between patients who were ≥ 65 years of age and non-elderly, and between
Slovenian: Čeprav večje občutljivosti za pojav neželenih učinkov pri nekaterih starejših bolnikih in bolnikih azijskega porekla ni mogoče izključiti, pa na splošno niso opažali nobenih večjih razlik glede varnosti in učinkovitosti aksitiniba med bolniki, starimi 65 let ali več, in mlajšimi bolniki ter med bolniki bele rase in bolniki drugih ras.
English: Paediatric population
Slovenian: Paediatrična populacija
English: The safety and efficacy of Inlyta in children and adolescents < 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Inlyta pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
English: d Fatal (Grade 5) cases were reported.
Slovenian: Poročali so o smrtnih primerih (5. stopnja).
English: • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.
Slovenian: • Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden vzamete to zdravilo.
English: Genotoxicity findings are not considered clinically relevant at exposure levels observed in humans.
Slovenian: Menijo, da ugotovitve glede genotoksičnosti niso klinično pomembne pri stopnjah izpostavljenosti, do katerih prihaja pri ljudeh.
English: If you have any questions about how this medicine works or why this medicine has been prescribed for you, ask your doctor.
Slovenian: Če imate kakršnakoli vprašanja o tem, kako to zdravilo deluje ali zakaj vam je bilo predpisano, se posvetujte z zdravnikom.
English: • Joint pain, pain in hands or feet
Slovenian: • bolečine v sklepih, bolečine v dlaneh ali stopalih
English: Your doctor may subsequently increase or decrease your dose depending on how you tolerate treatment with Inlyta.
Slovenian: Zdravnik vam lahko odmerek zdravila pozneje zveča ali zmanjša, odvisno od tega, kako prenašate zdravljenje z zdravilom Inlyta.
English: These receptors are implicated in pathologic angiogenesis, tumour growth, and metastatic progression of cancer.
Slovenian: Ti receptorji so vključeni v patološko angiogenezo, rast tumorjev in metastatsko razrast raka.
English: Please tell your doctor, pharmacist or nurse about all the medicines you have recently taken, are currently taking, or plan to take, including medicines obtained without a prescription, vitamins, and herbal medicines.
Slovenian: Obvestite zdravnika, farmacevta ali medicinsko sestro, če ste pred kratkim jemali, trenutno jemljete ali pa boste morda začeli jemati katerokoli drugo zdravilo, tudi če gre za zdravila brez recepta, vitamine in zdravila rastlinskega izvora.
English: Categories have been assigned based on absolute frequencies in the pooled clinical studies data.
Slovenian: Kategorije pogostnosti so določene na osnovi absolutnih pogostnosti pojavljanja iz združenih podatkov iz kliničnih preskušanj.
English: Treatment with Inlyta should be conducted by a physician experienced in the use of anticancer therapies.
Slovenian: Zdravljenje z zdravilom Inlyta mora izvajati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje rakavih bolezni.
English: There were no statistically significant differences between the arms in OS in the overall population or in the subgroups by prior therapy.
Slovenian: Kar se tiče OS, ni bilo nobenih statistično pomembnih razlik med skupinama, bodisi pri celokupni populaciji bodisi pri podskupinah po predhodnem zdravljenju.
English: Dose adjustment is not required on the basis of patient age, race, gender, or body weight.
Slovenian: Prilagajanje odmerka glede na bolnikovo starost, raso, spol ali telesno maso ni potrebno.
English: The following medicines may reduce the effectiveness of Inlyta:
Slovenian: Naslednja zdravila lahko zmanjšajo učinkovitost zdravila Inlyta:
English: • High blood pressure, or increases in blood pressure
Slovenian: • visok krvni tlak ali zvišanje krvnega tlaka
English: In case of severe or persistent arterial hypertension and symptoms suggestive of posterior reversible encephalopathy syndrome (PRES) (see below), a diagnostic brain magnetic resonance image (MRI) should be considered.
Slovenian: V primeru hude ali trdovratne arterijske hipertenzije in simptomov, ki kažejo na prisotnost sindroma posteriorne reverzibilne encefalopatije (PRES - Posterior Reversible Encephalopathy Syndrome) (glejte spodaj), je treba razmisliti o diagnostičnem slikanju možganov z uporabo magnetne resonance (MRI).
English: Axitinib has minor influence on the ability to drive and use machines.
Slovenian: Aksitinib ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: The magnitude of median PFS effect was different in the subgroups by prior therapy.
Slovenian: Mediana vpliva na PFS se je med podskupinami razlikovala glede na predhodno zdravljenje.
English: PRES is a neurological disorder which can present with headache, seizure, lethargy, confusion, blindness and other visual and neurologic disturbances.
Slovenian: PRES je nevrološka motnja, ki se lahko kaže z glavobolom, epileptičnim napadom, letargijo, zmedenostjo, slepoto in drugimi z vidom povezanimi ter nevrološkimi motnjami.
English: Axitinib reduces the blood supply to the tumour and slows down the growth of cancer.
Slovenian: Aksitinib zmanjšuje oskrbo tumorja s krvjo in upočasnjuje razraščanje raka.
English: The plasma half life of axitinib ranges from 2.5 to 6.1 hours.
Slovenian: Plazemski razpolovni čas aksitiniba je v razponu od 2,5 do 6,1 ure.
English: If possible, show the doctor the pack, or this leaflet.
Slovenian: Če je mogoče, zdravniku pokažite škatlo zdravila ali to navodilo za uporabo.
English: The adverse reactions are listed by system organ class, frequency category and grade of severity.
Slovenian: Neželeni učinki so navedeni glede na organski sistem, kategorijo pogostnosti in stopnjo izraženosti.
English: On the basis of the scientific conclusions for axitinib the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing axitinib is unchanged subject to the proposed changes to the product information.
Slovenian: Na podlagi znanstvenih zaključkov za aksitinib odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) aksitinib nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: This medicine has not been studied in children and adolescents.
Slovenian: Pri otrocih in mladostnikih uporabe tega zdravila niso preučevali.
English: Tell your doctor if you have a very high blood pressure, severe headache, or severe chest pain.
Slovenian: Obvestite zdravnika, če imate zelo visok krvni tlak, hud glavobol ali hude bolečine v prsnem košu.
English: Inlyta can raise your blood pressure.
Slovenian: Zdravilo Inlyta lahko zviša vaš krvni tlak.
English: If the dose of axitinib is increased, the patient should be monitored carefully for toxicity.
Slovenian: Če se odmerek aksitiniba zveča, je treba bolnika skrbno nadzorovati glede pojava toksičnosti.
English: In vitro studies with P-glycoprotein
Slovenian: In vitro študije s P-glikoproteinom
English: The decision to resume axitinib therapy after surgery should be based on clinical judgment of adequate wound healing.
Slovenian: Odločitev glede ponovne uvedbe zdravljenja z aksitinibom po kirurškem posegu mora temeljiti na klinični presoji ustreznosti celjenja rane.
English: Perinatal and postnatal developmental toxicity studies have not been conducted.
Slovenian: Študije škodljivih vplivov na perinatalni in postnatalni razvoj niso bile opravljene.
English: The primary endpoint, progression-free survival (PFS), was assessed using a blinded independent central review.
Slovenian: Primarni opazovani dogodek, preživetje brez napredovanja bolezni (PFS - Progression-Free Survival), so ocenjevali s slepim, neodvisnim, centralnim ocenjevanjem.
English: Axitinib is for oral use.
Slovenian: Aksitinib je za peroralno uporabo.
English: The recommended dose is 5 mg twice a day.
Slovenian: Priporočeni odmerek je 5 mg dvakrat na dan.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA): http://www.ema.europa.eu/.
English: Secondary endpoints included objective response rate (ORR) and overall survival (OS).
Slovenian: Med sekundarnimi opazovanimi dogodki so bili objektivni odziv na zdravljenje (ORR - Objective Response Rate) in celokupno preživetje (OSOverall Survival).
English: Axitinib may be administered with or without food (see section 4.2).
Slovenian: Aksitinib se lahko jemlje skupaj s hrano ali brez nje (glejte poglavje 4.2).
English: If the patient vomits or misses a dose, an additional dose should not be taken.
Slovenian: Če bolnik bruha ali izpusti odmerek, ne sme vzeti dodatnega odmerka.
English: Within each system organ class, adverse reactions with the same frequency are presented in order of decreasing seriousness.
Slovenian: V posameznem organskem sistemu so neželeni učinki, ki se pojavljajo z enako pogostnostjo, navedeni po padajoči resnosti.
English: Do not use this medicine after the expiry date which is stated on the carton and on the blister foil or bottle after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na pretisnem omotu oziroma plastenki poleg oznake “Uporabno do”.
English: • If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
Slovenian: • Če imate ali ste imeli anevrizmo (razširitev in oslabitev stene krvne žile) ali raztrganino v steni krvne žile.
English: Other medicines and Inlyta
Slovenian: Druga zdravila in zdravilo Inlyta
English: This could be a rare neurological side effect named posterior reversible encephalopathy syndrome.
Slovenian: V tem primeru lahko gre za redek nevrološki neželeni učinek, imenovan sindrom posteriorne reverzibilne encefalopatije.
English: If you think you may be allergic, ask your doctor for advice.
Slovenian: Če menite, da bi lahko bili alergični na to zdravilo, se posvetujte z zdravnikom.
English: Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: • If you are going to have an operation or if you have an unhealed wound.
Slovenian: • Če je pri vas načrtovan kirurški poseg ali če imate nezaceljeno rano.
English: • If you suffer from bleeding problems.
Slovenian: • Če imate težave s krvavitvami.
English: Major toxicity findings in mice and dogs following repeated dosing for up to 9 months were the gastrointestinal, haematopoietic, reproductive, skeletal and dental systems, with No Observed Adverse Effect Levels (NOAEL) approximately equivalent to or below expected human exposure at the recommended clinical starting dose (based on AUC levels).
Slovenian: Najpomembnejše ugotovitve glede toksičnosti pri miših in psih po ponavljajočem se dajanju v obdobju do 9 mesecev so se nanašale na prebavne, krvotvorne, reproduktivne, skeletne in dentalne sisteme, pri čemer je bila raven ”brez opaznega neželenega učinka” (NOAEL - No Observed Adverse Effect Levels) približno enaka ali nižja od pričakovane ravni izpostavljenosti pri ljudeh ob priporočenem kliničnem začetnem odmerku (glede na vrednosti AUC).
English: Axitinib is a potent and selective tyrosine kinase inhibitor of vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2 and VEGFR-3.
Slovenian: Aksitinib je močan in selektiven zaviralec tirozin kinaze pri receptorjih žilnih endotelijskih rastnih faktorjev VEGFR-1, VEGFR-2 in VEGFR-3 (VEGFR - Vascular Endothelial Growth Factor Receptor).
English: Toxicity findings in immature animals
Slovenian: Ugotovitve glede toksičnosti pri mladih živalih
English: Each pack contains 28 or 56 film-coated tablets.
Slovenian: Eno pakiranje vsebuje 28 ali 56 filmsko obloženih tablet.
English: No concurrent elevations of ALT (> 3 times the upper limit of normal [ULN]) and bilirubin (> 2 times the ULN) were observed.
Slovenian: Sočasno prisotnih zvišanj ravni ALT (> 3-kratnik zgornje meje normale [ZMN]) in bilirubina (> 2-kratnik ZMN) niso opažali.
English: Unchanged axitinib, accounting for 12% of the dose, was the major component identified in faeces.
Slovenian: Nespremenjeni aksitinib, ki je predstavljal 12 % odmerka, je bil prevladujoča sestavina, ki so jo ugotovili v blatu.
English: Your doctor should stop Inlyta at least 24 hours before your operation as it may affect wound healing.
Slovenian: Zdravnik mora zdravljenje z zdravilom Inlyta prekiniti vsaj 24 ur pred kirurškim posegom, ker lahko vpliva na celjenje rane.
English: e Cutoff date: 31 August 2010.
Slovenian: Presečni datum: 31. avgust 2010.
English: Dosing of axitinib at 5 mg twice daily resulted in less than two-fold accumulation compared to administration of a single dose.
Slovenian: Dajanje aksitiniba v odmerku 5 mg dvakrat na dan je povzročilo manj kot dvakratno kopičenje v primerjavi z dajanjem enkratnega odmerka.
English: Hypothyroidism or hyperthyroidism should be treated according to standard medical practice to maintain euthyroid state.
Slovenian: Hipotiroidizem oziroma hipertiroidizem je treba zdraviti v skladu z običajno medicinsko prakso za vzdrževanje evtirotičnega stanja.
English: Population pharmacokinetic analyses have shown that axitinib clearance was not altered in subjects with renal impairment and no dose adjustment of axitinib is required.
Slovenian: Analize populacijske farmakokinetike so pokazale, da se očistek aksitiniba pri bolnikih z okvaro ledvic ni spremenil ter da prilagajanje odmerka aksitiniba ni potrebno.
English: • Reversible swelling of the brain (posterior reversible encephalopathy syndrome).
Slovenian: • Otekanje možganov, ki lahko izzveni (sindrom posteriorne reverzibilne encefalopatije).
English: It is unknown whether axitinib is excreted in human milk.
Slovenian: Ni znano, ali se aksitinib izloča v materino mleko.
English: Population pharmacokinetic analyses in patients with advanced cancer (including advanced RCC) and healthy volunteers indicate that there are no clinically relevant effects of age, gender, body weight, race, renal function, UGT1A1 genotype, or CYP2C19 genotype.
Slovenian: Analize populacijske farmakokinetike pri bolnikih z napredovalim rakavim obolenjem (vključno z napredovalim RCC) in pri zdravih prostovoljcih kažejo, da ni nobenih klinično pomembnih vplivov starosti, spola, telesne mase, delovanja ledvic, genotipa UGT1A1 oziroma genotipa CYP2C19.
English: Grapefruit may also increase axitinib plasma concentrations.
Slovenian: Uživanje grenivk lahko prav tako zveča plazemske koncentracije aksitiniba.
English: • The active substance is axitinib.
Slovenian: • Učinkovina je aksitinib.
English: Patients who tolerate the axitinib starting dose of 5 mg twice daily with no adverse reactions > Grade 2 (i.e. without severe adverse reactions according to the Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) for two consecutive weeks may have their dose increased to 7 mg twice daily unless the patient's blood pressure is > 150/90 mmHg or the patient is receiving antihypertensive treatment.
Slovenian: Pri bolnikih, ki aksitinib v začetnem odmerku 5 mg dvakrat na dan prenašajo brez neželenih učinkov > 2. stopnje (tj. brez hudih neželenih učinkov po merilih za poenoteno terminologijo neželenih dogodkov (Common Terminology Criteria for Adverse Events [CTCAE] različica 3.0)) dva tedna zapored, je odmerek mogoče zvečati na 7 mg dvakrat na dan, razen če je krvni tlak pri bolniku višji od 150/90 mmHg ali če bolnik jemlje antihipertenzive.
English: A high fat, high-calorie meal resulted in 19% higher exposure compared to overnight fasting.
Slovenian: Obrok zelo mastne, visoko kalorične hrane je povzročil 19 % večjo izpostavljenost v primerjavi z jemanjem zdravila zjutraj, na tešče.
English: Aluminium/aluminium blister containing 14 film-coated tablets.
Slovenian: Pretisni omot aluminij/aluminij, ki vsebuje 14 filmsko obloženih tablet.
English: Following oral administration of a 5 mg radioactive dose of axitinib, 30-60% of the radioactivity was recovered in faeces and 23% of the radioactivity was recovered in urine.
Slovenian: Po peroralnem jemanju 5 mg radioaktivnega odmerka aksitiniba so 30 do 60 % radioaktivnosti ugotovili v blatu, 23 % radioaktivnosti pa v urinu.
English: Tablet film-coating Hypromellose 2910 (15 mPa·s) Titanium dioxide (E171) Lactose monohydrate Triacetin (E1518) Iron oxide red (E172)
Slovenian: Filmska obloga tablete hipromeloza 2910 (15 mPa·s) titanov dioksid (E171) laktoza monohidrat triacetin (E1518) rdeči železov oksid (E172)
English: Carcinogenicity Carcinogenicity studies have not been performed with axitinib.
Slovenian: Kancerogenost Študije kancerogenosti z aksitinibom niso bile opravljene.
English: Take your next dose at your regular time.
Slovenian: Naslednji predpisani odmerek vzemite ob običajnem času.
English: Unchanged axitinib was not detected in urine; the carboxylic acid and sulfoxide metabolites accounted for the majority of radioactivity in urine.
Slovenian: Nespremenjenega aksitiniba v urinu niso zaznali; presnovki v obliki karboksilne kisline in sulfoksida so predstavljali največji del radioaktivnosti v urinu.
English: Therefore, the product information should be updated to include cholecystitis as an ADR in section 4.8 of the SmPC and section 4 of the PL, with frequency ‘common'.
Slovenian: Zato je treba posodobiti informacije o zdravilu z dodatkom holecistitisa med neželene učinke v poglavje 4.8 SmPC-ja in poglavje 4 navodila za uporabo s pogostnostjo 'pogosti'.
English: If haemoglobin or haematocrit becomes elevated above the normal level, patients should be treated according to standard medical practice to decrease haemoglobin or haematocrit to an acceptable level.
Slovenian: V primeru zvišanja ravni hemoglobina ali hematokrita nad normalno vrednost je treba bolnike zdraviti v skladu z običajno medicinsko prakso za znižanje ravni hemoglobina ali hematokrita na sprejemljivo raven.
English: If your thyroid gland is not producing enough thyroid hormone before, or while on treatment with this medicine, you should be treated with thyroid hormone replacement.
Slovenian: Če vaša žleza ščitnica pred začetkom zdravljenja ali med zdravljenjem ne tvori dovolj ščitničnega hormona, morate jemati zdravila za nadomeščanje ščitničnega hormona.
English: No dosage adjustment is required on the basis of patient age or race (see sections 4.2 and 5.2).
Slovenian: Prilagajanje odmerka glede na bolnikovo starost ali raso ni potrebno (glejte poglavji 4.2 in 5.2).
English: There is no specific treatment for axitinib overdose.
Slovenian: Specifičnega zdravljenja pri prevelikem odmerjanju aksitiniba ni.
English: Axitinib has not been studied in patients who have evidence of untreated brain metastasis or recent active gastrointestinal bleeding, and should not be used in those patients.
Slovenian: Aksitiniba niso preučevali pri bolnikih, pri katerih obstajajo znaki nezdravljenih možganskih metastaz ali nedavne aktivne krvavitve v prebavilih, zato se ga pri teh bolnikih ne sme uporabljati.
English: • If you have liver problems.
Slovenian: • Če imate težave z jetri.
English: Hypersensitivity to axitinib or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na aksitinib ali katerokoli pomožno snov, navedeno v poglavju 6.1.
English: The baseline demographic and disease characteristics were similar between the axitinib and sorafenib groups with regard to age, gender, race, Eastern Cooperative Oncology Group (ECOG) performance status, geographic region, and prior treatment.
Slovenian: Izhodiščne demografske in na bolezen nanašajoče se značilnosti obeh skupin (z aksitinibom in sorafenibom) so bile podobne kar se tiče starosti, spola, rase, stanja zmogljivosti, ocenjenega po Eastern Cooperative Oncology Group (ECOG), zemljepisnega področja in predhodnega zdravljenja.
English: Subsequently, using the same criteria, patients who tolerate an axitinib dose of 7 mg twice daily may have their dose increased to a maximum of 10 mg twice daily.
Slovenian: Kasneje je z uporabo enakih meril pri bolnikih, ki prenašajo aksitinib v odmerku 7 mg dvakrat na dan, odmerek mogoče zvečati na največ 10 mg dvakrat na dan.
English: • Headache, taste disturbance or loss of taste
Slovenian: • glavobol, motnje v zaznavanju okusa ali nezmožnost zaznavanja okusa
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE17
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, zaviralci proteinskih kinaz; oznaka ATC: L01XE17
English: When dose reduction is necessary, the axitinib dose may be reduced to 3 mg twice daily and further to 2 mg twice daily.
Slovenian: Kadar je potrebno zmanjšanje odmerka, se lahko odmerek aksitiniba zmanjša na 3 mg dvakrat na dan in nato na 2 mg dvakrat na dan.
English: In a controlled clinical study, the median onset time for hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg) was within the first month of the start of axitinib treatment and blood pressure increases have been observed as early as 4 days after starting axitinib.
Slovenian: V nadzorovanem kliničnem preskušanju se je mediani čas do pojava hipertenzije (sistolični krvni tlak > 150 mmHg ali diastolični krvni tlak > 100 mmHg), nahajal znotraj prvega meseca po začetku zdravljenja z aksitinibom, zvišanja krvnega tlaka pa so opažali že samo 4 dni po začetku zdravljenja z aksitinibom.
English: Inlyta may increase side effects associated with theophylline, used to treat asthma or other lung diseases.
Slovenian: Zdravilo Inlyta lahko okrepi neželene učinke, povezane s teofilinom, ki se uporablja za zdravljenje astme ali drugih pljučnih bolezni.
English: Adverse reactions reported in RCC studies in patients who received axitinib (N = 672)
Slovenian: Neželeni učinki, o katerih so poročali v študijah RCC pri bolnikih, ki so prejemali aksitinib (n = 672)
English: For patients who develop severe hypertension, temporarily interrupt axitinib and restart at a lower dose once the patient is normotensive.
Slovenian: Pri bolnikih, pri katerih pride do hude hipertenzije, je treba zdravljenje z aksitinibom začasno prekiniti in ga ponovno uvesti z manjšim odmerkom potem, ko se krvni tlak pri bolniku normalizira.
English: The effect of strong inhibitors of these isozymes on axitinib pharmacokinetics has not been studied.
Slovenian: Vpliva močnih zaviralcev teh izoencimov na farmakokinetiko aksitiniba niso preučevali.
English: Uncommon: may affect up to 1 in 100 people • Reduction in the number of white blood cells (may show in your blood tests)
Slovenian: Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov • zmanjšanje števila belih krvnih celic (to se lahko pokaže pri preiskavah krvi)
English: After oral administration of axitinib tablets, the mean absolute bioavailability is 58% compared to intravenous administration.
Slovenian: Po peroralnem zaužitju tablet aksitiniba je povprečna absolutna biološka uporabnost v primerjavi z intravenskim dajanjem 58 %.
English: Microcrystalline cellulose Lactose monohydrate Croscarmellose sodium Magnesium stearate
Slovenian: Jedro tablete mikrokristalna celuloza laktoza monohidrat premreženi natrijev karmelozat magnezijev stearat
English: • If during treatment with this medicine you get severe stomach (abdominal) pain or stomach pain that does not go away.
Slovenian: • Če se vam med zdravljenjem s tem zdravilom pojavijo hude bolečine v želodcu (trebuhu) ali bolečine v želodcu, ki ne minejo.