FrancophonIA/ELRC3.0 huggingface dataset:
English: There was a greater LS mean increase from Baseline in height after 104 weeks (at LT Visit 19 [Week 156], secondary hypertension patients) compared to the increase observed after 52 weeks (at LT Visit 18 [Week 104], primary hypertension patients), which is expected in these growing paediatric patients.
Slovenian: Za višino je bilo po 104 tednih večje povprečno povečanje najmanjših kvadratov od izhodišča (LT obisk 19 [teden 156], bolniki s sekundarno hipertenzijo) v primerjavi s povečanjem, ki so ga opazili po 52 tednih (LT obisk 18 [teden 104], bolniki s primarno hipertenzijo), kot je pričakovano pri rastočih pediatričnih bolnikih.
English: At the end of this extension study, changes in msSBP from baseline were similar with aliskiren compared to enalapril (-7.63 mmHg vs. -7.94 mmHg) in the full analysis set.
Slovenian: Na koncu te podaljšane študije so bile spremembe srednjih vrednosti sistoličnega krvnega tlaka v sedečem položaju od izhodišča približno enake pri uporabi aliskirena v primerjavi z uporabo enalaprila (-7,63 mmHg v primerjavi z -7,94 mmHg) v celotnem kompletu podatkov za analizo (angl. full analysis set).
English: At steady state meals with low fat content reduce Cmax by 76% and AUC0-tau by 67% in hypertensive patients.
Slovenian: Obroki z majhno vsebnostjo maščob pri hipertenzivnih bolnikih v stanju dinamičnega ravnovesja zmanjšajo Cmax za 76 % in AUC0-tau za 67 %.
English: Before you drive a vehicle, use machinery, or carry out other activities that require concentration, you should make sure you know how you react to the effects of this medicine.
Slovenian: Preden se namenite upravljati vozilo, uporabljati stroje ali opravljati druge dejavnosti, ki zahtevajo zbranost,
English: Rasilez 150 mg film-coated tablets EU/1/07/405/001-010
Slovenian: Rasilez 150 mg filmsko obložene tablete EU/1/07/405/001-010
English: Medicinal products affecting serum potassium levels
Slovenian: Zdravila, ki vplivajo na koncentracijo kalija v serumu
English: Hyponatraemia *Isolated cases of liver disorder with clinical symptoms and laboratory evidence of more marked hepatic dysfunction.
Slovenian: *posamezni primeri bolezni jeter s kliničnimi simptomi in laboratorijskimi znaki izrazitejše jetrne disfunkcije
English: There were no statistically significant differences in the mean changes in weight, height, or BMI between the treatment groups from Baseline to LT Visit 18 (Week 104) (primary analysis).
Slovenian: Pri povprečni spremembi višine, telesne mase ali ITM ni bilo statistično značilnih razlik med skupinama zdravljenja od izhodišča do LT pri obisku 18 (teden 104) (primarna analiza).
English: Aliskiren is an orally active, non-peptide, potent and selective direct inhibitor of human renin.
Slovenian: Aliskiren je peroralno delujoč nepeptiden, močan in selektiven neposreden zaviralec človeškega renina.
English: In clinical studies in hypertensive patients, Rasilez had no clinically important effects on total cholesterol, high density lipoprotein cholesterol (HDL-C), fasting triglycerides, fasting glucose or uric acid.
Slovenian: V kliničnih študijah s hipertenzivnimi bolniki zdravilo Rasilez ni klinično pomembno vplivalo na vrednosti celokupnega holesterola, holesterola lipoproteinov visoke gostote (HDL holesterola), trigliceridov na tešče,
English: Black iron oxide (E 172) Red iron oxide (E 172)
Slovenian: smukec, titanov dioksid (E 171), črni železov oksid (E 172), rdeči železov oksid (E 172).
English: If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom,
English: A single dose interaction study in healthy subjects has shown that ciclosporin (200 and 600 mg) increases Cmax of aliskiren 75 mg approximately 2.5-fold and AUC approximately 5-fold.
Slovenian: V študiji medsebojnega delovanja zdravil z enkratnim odmerjanjem pri zdravih osebah se je pokazalo, da ciklosporin (200 in 600 mg) zviša Cmax aliskirena (75 mg) približno 2,5-krat, AUC pa približno
English: In patients who did not adequately respond to 5 mg of the calcium channel blocker amlodipine, the addition of aliskiren 150 mg had a blood-pressure-lowering effect similar to that obtained by increasing amlodipine dose to 10 mg, but had a lower incidence of oedema (aliskiren 150 mg/amlodipine 5 mg 2.1% vs. amlodipine 10 mg 11.2%).
Slovenian: Pri bolnikih, ki se niso zadostno odzvali na zdravljenje z zaviralcem kalcijevih kanalčkov amlodipinom v odmerku 5 mg, je dodatek aliskirena v odmerku 150 mg povzročil učinek zniževanja krvnega tlaka, ki je bil podoben, kot če bi zvišali odmerek amlodipina na 10 mg, vendar je bila incidenca edemov pri tem nižja (aliskiren 150 mg/amlodipin 5 mg: 2,1 %; v primerjavi z amlodipinom 10 mg: 11,2 %).
English: - if you have serious congestive heart failure (a type of heart disease where the heart cannot pump enough blood around the body).
Slovenian: - če imate stenozo ledvične arterije (zoženje krvnih žil, ki dovajajo kri do ene ali obeh ledvic); - če imate hudo kongestivno popuščanje srca (oblika bolezni srca, pri kateri srce ne more načrpati dovolj krvi po telesu).
English: Symptomatic hypotension could occur after initiation of treatment with aliskiren in the following cases: - Patients with marked volume depletion or patients with salt depletion (e.g. those receiving high doses of diuretics) or - Combined use of aliskiren with other agents acting on the RAAS.
Slovenian: Po uvedbi zdravljenja z aliskirenom lahko pride do simptomatske hipotenzije v naslednjih primerih: - pri bolnikih z izrazito hipovolemijo ali pri bolnikih s primanjkljajem natrija (na primer pri tistih, ki prejemajo visoke odmerke diuretikov) ali - pri kombinirani uporabi aliskirena in drugih zdravil, ki delujejo na RAAS.
English: This study was extended with a 52-week double-blind, randomised study to evaluate the safety, tolerability and efficacy of aliskiren compared to enalapril in 208 paediatric hypertensive patients aged 6 to 17 years (at baseline in the previous study).
Slovenian: Navedeno študijo so podaljšali z nadaljevanjem v 52-tedenski dvojno slepi, randomizirani študiji za oceno varnosti, prenosljivosti in učinkovitosti aliskirena v primerjavi z enalaprilom pri 208 pediatričnih bolnikih, ki so imeli hipertenzijo in so bili stari od 6 do 17 let (ob izhodišču predhodne osnovne študije).
English: - verapamil, a medicine used to lower high blood pressure, to correct heart rhythm or to treat angina pectoris.
Slovenian: - verapamil, zdravilo za zniževanje visokega krvnega tlaka, uravnavanje srčnega ritma ali za zdravljenje angine pektoris;
English: If co-administration with an agent affecting the level of serum potassium is considered necessary, routine monitoring of potassium levels would be advisable.
Slovenian: Če je sočasna uporaba zdravila, ki vpliva na koncentracijo kalija v serumu, neizogibna, je priporočeno rutinsko spremljanje ravni kalija.
English: Warfarin The effects of aliskiren on warfarin pharmacokinetics have not been evaluated.
Slovenian: Učinkov aliskirena na farmakokinetične lastnosti varfarina niso ocenjevali.
English: In obese hypertensive patients who did not adequately respond to HCTZ 25 mg, add-on treatment with aliskiren 300 mg provided additional blood pressure reduction that was comparable to add-on treatment with irbesartan 300 mg or amlodipine 10 mg.
Slovenian: Pri debelih bolnikih s hipertenzijo, ki se niso zadostno odzvali na zdravljenje s hidroklorotiazidom25 mg, je dodatek aliskirena 300 mg povzročil dodatno znižanje krvnega tlaka, ki je bilo primerljivo z dodatkom irbesartana 300 mg ali amlodipina 10 mg.
English: In this study, aliskiren at a target dose of 300 mg was compared to enalapril at a target dose of 20 mg when added to standard of care which included a beta blocker (and a mineralocorticoid receptor antagonist in 37% of patients) and a diuretic as needed.
Slovenian: V tej študiji so aliskiren s ciljnim odmerkom 300 mg primerjali z enalaprilom s ciljnim odmerkom20 mg, pri čemer so enega ali drugega dodajali standardnemu zdravljenju, ki je vključevalo zaviralec adrenergičnih receptorjev beta (in antagonist mineralokortikoida pri 37 % bolnikov) ter diuretik po potrebi.
English: The most common adverse reaction is diarrhoea.
Slovenian: Najpogostejši neželeni učinek je driska.
English: Optional titration of the respective study drug doses to the next highest weight-based dose level was available by doubling the dose with each of the two allowed dose titrations, up to 600 mg (highest studied dose in adults) for aliskiren and 40 mg for enalapril in the ≥80 to ≤150 kg weight group, if medically necessary to control the mean sitting systolic blood pressure (i.e. msSBP should be less than the 90th percentile for age, gender and height).
Slovenian: 10 mg. Vsako od obeh študijskih zdravil je bilo mogoče titrirati na naslednjo odmerno stopnjo do najvišje za posamezno kategorijo telesne mase in sicer s podvojitvijo odmerka ob vsaki od dveh dovoljenih titracij do največ 600 mg za aliskiren (najvišji preučevani odmerek pri odraslih) in do 40 mg za enalapril v skupini s telesno maso ≥80 do ≤150 kg, če je bilo to potrebno iz zdravstvenih razlogov za uravnavanje srednje vrednosti sistoličnega krvnega tlaka v sedečem položaju (kar pomeni za doseganje vrednosti sistoličnega krvnega tlaka v sedečem položaju, ki je manjša od 90. percentila za starost, spol in telesno višino).
English: The usual recommended starting dose of aliskiren in elderly patients aged 65 years or older is 150 mg.
Slovenian: Običajni priporočeni začetni odmerek aliskirena pri odraslih bolnikih, starih 65 let ali več, je 150 mg.
English: Rasilez should be taken once a day, always with or always without food, preferably at the same time each day.
Slovenian: Zdravilo Rasilez je treba jemati enkrat na dan, vedno s hrano ali vedno brez nje, najbolje vsak dan ob istem času.
English: As for other medicinal products acting on the renin-angiotensin system, caution should be exercised when aliskiren is given in the presence of conditions pre-disposing to kidney dysfunction such as hypovolaemia (e.g. due to blood loss, severe prolonged diarrhoea, prolonged vomiting, etc.), heart disease, liver disease, diabetes mellitus or kidney disease.
Slovenian: Kot pri uporabi drugih zdravil, ki delujejo na sistem renin-angiotenzin, je potreba previdnost pri uporabi aliskirena pri bolnikih z drugimi boleznimi, zaradi katerih so bolj nagnjeni k slabšemu delovanju ledvic, kot so hipovolemija (na primer zaradi izgube krvi, hude ali dolgotrajne diareje, dolgotrajnega bruhanja in podobno), bolezni srca, jeter, sladkorna bolezen ali bolezen ledvic.
English: After single dose administration in the dose range of 75 to 600 mg, a 2-fold increase in dose results in a ~2.3 and 2.6-fold increase in AUC and Cmax, respectively.
Slovenian: Pri aplikaciji enkratnih odmerkov v obsegu od 75 do 600 mg dvakratno zvišanje odmerka povzroči 2,3-kratno povečanje AUC in 2,6-kratno zvišanje Cmax.
English: Administration of fruit juice with aliskiren resulted in a decrease in AUC and Cmax of aliskiren.
Slovenian: Uživanje sadnega soka z aliskirenom je zmanjšalo AUC in znižalo Cmax aliskirena.
English: You should take this medicine either with a light meal or without a meal once a day, preferably at the same time each day.
Slovenian: To zdravilo je treba jemati ali z lahkim obrokom ali brez hrane enkrat na dan, najbolje vsak dan ob istem času.
English: - if you have diabetes or impaired kidney function and you are treated with either of the following classes of medicines used to treat high blood pressure: an angiotensin converting enzyme inhibitor such as enalapril, lisinopril, ramipril or an angiotensin II receptor blocker such as valsartan, telmisartan, irbesartan.
Slovenian: - če imate sladkorno bolezen ali okvarjeno delovanje ledvic in jemljete zdravilo iz katere od naslednjih skupin zdravil za zdravljenje visokega krvnega tlaka: zaviralci encima angiotenzinske konvertaze, na primer enalapril, lizinopril ali ramipril,
English: Rasilez should not be used in children aged 2 to less than 6 years because of safety concerns due to potential aliskiren overexposure (see sections 4.3, 4.4, 5.2, and 5.3).
Slovenian: Zdravila Rasilez se ne sme uporabljati pri otrocih, starih od 2 let do dopolnjenega 6. leta starosti zaradi pomislekov glede varnosti v povezavi z možnostjo prevelike izpostavljenosti aliskirenu (glejte poglavja 4.3, 4.4,
English: INFORMATION IN BRAILLE Rasilez 150 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Rasilez 150 mg
English: Co-administration of ketoconazole (200 mg) or verapamil (240 mg) with aliskiren (300 mg) resulted in a 76% or 97% increase in aliskiren AUC, respectively.
Slovenian: Zmerni zaviralci P-gp Sočasna uporaba ketokonazola (200 mg) ali verapamila (240 mg) z aliskirenom (300 mg) je povzročila povečanje AUC aliskirena za 76 % oziroma 97 %.
English: In an 8-week randomised, double-blind study with aliskiren monotherapy in 267 paediatric hypertensive patients aged 6 to 17 years, mostly overweight/obese, fasting trough aliskiren concentrations at day 28 were comparable to those observed in other studies in both adults and children using similar aliskiren doses (see section 5.1).
Slovenian: V 8-tedenski randomizirani, dvojno slepi študiji z aliskirenom v monoterapiji pri 267 pediatričnih bolnikih, ki so imeli hipertenzijo in so bili stari od 6 do 17 let ter so bili večinoma debeli oziroma prekomerno prehranjeni, so bile 28. dan zdravljenja najnižje koncentracije aliskirena na tešče podobne kot v drugih študijah, v katerih so tako pri odraslih kot pri otrocih uporabljali podobne odmerke aliskirena (glejte poglavje 5.1).
English: The average differences between aliskiren and placebo for the low and mid dose groups were <0.2 mmHg.
Slovenian: Povprečne razlike v krvnem tlaku med bolniki, ki so jemali aliskiren, in tistimi, ki so jemali placebo, v odmernih skupinah z nizkimi ali srednje visokimi odmerki, so bile <0,2 mmHg.
English: Common (may affect up to 1 in 10 people): Diarrhoea, joint pain (arthralgia), high level of potassium in the blood, dizziness.
Slovenian: Pogosti (lahko se pojavijo pri največ 1 od 10 ljudi): driska, bolečine v sklepih (artralgija), zvišana raven kalija v krvi, omotičnost.
English: Co-administration of Rasilez had no significant impact on atorvastatin, metformin or amlodipine pharmacokinetics.
Slovenian: Sočasna uporaba zdravila Rasilez ni pomembno vplivala na farmakokinetične lastnosti atorvastatina, metformina in amlodipina.
English: In another juvenile toxicity study in 14-day-old rats, aliskiren administration at 300 mg/kg/day (8.5-fold the maximum recommended human dose) was associated with delayed mortality.
Slovenian: V drugi toksikološki študiji, pri 14 dni starih podganjih mladičih, je aliskiren v odmerkih 300 mg/kg/dan (8,5-kratnik najvišjega priporočenega odmerka pri ljudeh) povzročil zapoznelo smrtnost.
English: If this happens, stop taking this medicine and contact your doctor.
Slovenian: V tem primeru prenehajte jemati to zdravilo in obvestite zdravnika;
English: Rasilez may be used alone or in combination with other antihypertensive agents with the exception of use in combination with angiotensin converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB) in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) < 60 ml/min/1.73 m2) (see sections 4.3, 4.4 and 5.1).
Slovenian: Zdravilo Rasilez se lahko jemlje samostojno ali v kombinaciji z drugimi učinkovinami za zniževanje krvnega tlaka, razen v kombinaciji z zaviralci encima angiotenzinske konvertaze (zaviralci ACE) ali antagonisti angiotenzinskih receptorjev II pri bolnikih s sladkorno boleznijo ali okvaro ledvic (s hitrostjo glomerulne filtracije (GFR) < 60 ml/min/1,73 m2) (glejte poglavja 4.3, 4.4 in 5.1).
English: If you have accidentally taken too many tablets of this medicine, consult a doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Rasilez, kot bi smeli Če ste pomotoma vzeli več tablet tega zdravila, kot bi smeli, se takoj posvetujte z zdravnikom.
English: Aliskiren 150 mg or 300 mg per day or ramipril 5 mg or 10 mg per day were administered for 36 weeks with optional add-on therapy of hydrochlorothiazide (12.5 mg or 25 mg) at week 12, and amlodipine (5 mg or 10 mg) at week 22.
Slovenian: Bolnikom so 36 tednov dajali aliskiren v odmerku 150 mg ali 300 mg na dan oziroma ramipril v odmerku 5 mg ali 10 mg na dan z možnostjo dodajanja hidroklorotiazida (v odmerku 12,5 mg ali 25 mg) od 12.
English: This medicine may make you feel dizzy and this can affect your ability to concentrate.
Slovenian: Zaradi tega zdravila boste morda nekoliko omotični in se zato ne boste mogli zbrati.
English: Aliskiren monotherapy studies have shown blood pressure lowering effects comparable to other classes of antihypertensive agents including ACEI and ARB.
Slovenian: Rezultati študij aliskirena v monoterapiji so pokazali učinke zniževanja krvnega tlaka, ki so primerljivi z učinki drugih skupin antihipertenzivnih zdravil, vključno z zaviralci ACE in antagonisti angiotenzina II.
English: What you need to know before you take Rasilez
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Rasilez Ne jemljite zdravila Rasilez
English: Whereas other agents that inhibit the RAAS (ACEI and angiotensin II receptor blockers (ARB)) cause a compensatory rise in plasma renin activity (PRA), treatment with aliskiren decreases PRA in hypertensive patients by approximately 50 to 80%.
Slovenian: (zaviralci ACE in antagonisti angiotenzina II) in povzročajo kompenzacijsko zvišanje delovanja renina v plazmi, pa zdravljenje z aliskirenom zniža delovanje renina v plazmi pri hipertenzivnih bolnikih za približno 50 do 80 %.
English: 49 x 1 film-coated tablets.
Slovenian: 49 x 1 filmsko obložena tableta.
English: 98 film-coated tablets (2x49x1)
Slovenian: 98 filmsko obloženih tablet (2x49x1)
English: The primary endpoint was cardiovascular death or heart failure rehospitalisation within 6 months; secondary endpoints were assessed within 12 months.
Slovenian: Primarni cilj opazovanja je bila kardiovaskularna smrt ali ponovna hospitalizacija zaradi srčnega popuščanja v roku 6 mesecev;
English: There was no significant benefit of adding aliskiren to enalapril (primary endpoint: hazard ratio of 0.93 with 95% Confidence Interval: 0.85-1.03; p=0.1724, combination versus enalapril).
Slovenian: Od dodajanja aliskirena enalaprilu ni bilo bistvene koristi (primarni cilj opazovanja: razmerje ogroženosti 0,93 s 95-odstotnim intervalom zaupanja: 0,85-1,03; p=0,1724 za primerjavo med kombinacijo in enalaprilom).
English: Meals with a high fat content reduce Cmax by 85% and AUC by 70%.
Slovenian: Cmax za 85 % in AUC za 70 %.
English: In patients after 104 weeks (at LT Visit 19 [Week 156]), there were LS mean decreases from Baseline in weight and BMI in both treatment groups, with a slightly larger decrease in the aliskiren compared to the enalapril treatment group.
Slovenian: Po 104 tednih (LT obisk 19 [teden 156]) so pri bolnikih opazili povprečno zmanjšanje od izhodiščne telesne mase in ITM v obeh skupinah zdravljenja (izračunano z metodo povprečja najmanjših kvadratov), pri čemer je bilo zmanjšanje v skupini z aliskirenom nekoliko manjše v primerjavi s skupino z enalaprilom.
English: Inducers of P-gp (St. John's wort, rifampicin) might therefore decrease the bioavailability of Rasilez.
Slovenian: Zato lahko induktorji P-gp (šentjanževka, rifampicin) zmanjšajo biološko uporabnost zdravila Rasilez.
English: Unit packs containing 56x1 tablets in perforated unit dose blisters.
Slovenian: Posamična pakiranja vsebujejo 56x1 tableto v perforiranih pretisnih omotih za enkratni odmerek.
English: In the majority of patients aged 65 years or older, the 300 mg dose of Rasilez shows no additional benefit in reducing blood pressure compared to the 150 mg dose.
Slovenian: Pri večini bolnikov, starih 65 let ali več, 300 mg odmerek zdravila Rasilez ni pokazal nobenih dodatnih koristi v zniževanju krvnega tlaka v primerjavi s 150 mg odmerkom.
English: 280 film-coated tablets (20x14)
Slovenian: 280 filmsko obloženih tablet (20x14)
English: Rasilez 150 mg film-coated tablets PA/Alu/PVC - Alu blisters:
Slovenian: Rasilez 300 mg filmsko obložene tablete PA/Alu/PVC - Alu pretisni omoti:
English: 90 film-coated tablets (3x30)
Slovenian: 90 filmsko obloženih tablet (3x30)
English: Aliskiren is minimally excreted via the renal route, and only 0.6% of the aliskiren dose is recovered in urine following oral administration (see section 5.2).
Slovenian: Aliskiren se le v majhni meri izloča skozi ledvice in po peroralnem odmerjanju je mogoče v urinu prestreči samo 0,6 % odmerka aliskirena
English: In a pooled analysis of efficacy and safety data from clinical studies up to 12 months duration, there was no statistically significant difference in blood pressure reduction between aliskiren 300 mg and aliskiren 150 mg in elderly patients (≥ 65 years).
Slovenian: Pri analizi združenih podatkov za oceno učinkovitosti in varnosti aliskirena v kliničnih študijah s trajanjem do 12 mesecev pri starejših bolnikih (≥ 65 let) niso opažali statistično značilne razlike v zniževanju krvnega tlaka pri odmerjanju aliskirena 300 mg v primerjavi z odmerjanjem aliskirena 150 mg.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Rasilez Vsebina pakiranja in dodatne informacije
English: 3 years
Slovenian: 6.3 Rok uporabnosti 3 leti
English: The starting doses for aliskiren were 37.5/75/150 mg in the low, mid and high weight groups, respectively.
Slovenian: Začetni odmerki aliskirena so bili v skupinah z nizko, srednjo in visoko telesno maso 37,5 mg, 75 mg oziroma 150 mg.
English: In general, dual blockade of the RAAS by combining aliskiren with an ACEI or an ARB is not recommended (see section “Dual blockade of the renin-angiotensin-aldosterone system (RAAS)” above and also sections 4.5 and 4.8).
Slovenian: Načeloma dvojno zaviranje sistema renin-angiotenzin-aldosteron s kombinacijo aliskirena in zaviralcev ACE ali antagonistov receptorjev angiotenzina II ni priporočljivo (glejte poglavje »Dvojno zaviranje sistema renin-angiotenzin-aldosteron (RAAS-renin-angiotensin-aldosterone system)« zgoraj in poglavji 4.5 ter 4.8).
English: Rifampicin, which is an inducer of P-gp, reduced aliskiren bioavailability by approximately 50% in a clinical study.
Slovenian: klinični študiji je rifampicin, ki je induktor P-gp, zmanjšal biološko uporabnost aliskirena za približno
English: Co-administration of grapefruit juice with aliskiren 150 mg resulted in a 61% decrease in aliskiren AUC and co-administration with aliskiren 300 mg resulted in a 38% decrease in aliskiren AUC.
Slovenian: Sočasna uporaba grenivkinega soka z aliskirenom v odmerku 150 mg je zmanjšala AUC aliskirena za 61 %, sočasna uporaba z aliskirenom v odmerku 300 mg pa je zmanjšala AUC aliskirena za 38 %.
English: The other ingredients are crospovidone type A, hypromellose substitution type 2910 (3 mPa s), magnesium stearate, macrogol 4000, microcrystalline cellulose, povidone K-30, colloidal anhydrous silica, talc, titanium dioxide (E 171), black iron oxide (E 172), red iron oxide (E 172).
Slovenian: Druge sestavine zdravila so: krospovidon tipa A, hipromeloza substitucijski tip 2910 (3 mPa s), magnezijev stearat, makrogol 4000, mikrokristalna celuloza, povidon K-30, brezvodni koloidni silicijev dioksid,