FrancophonIA/ELRC3.0 huggingface dataset:
English: Edarbi may be less effective in lowering the blood pressure in black patients.
Slovenian: Zdravilo Edarbi je lahko manj učinkovito pri nižanju krvnega tlaka pri temnopoltih bolnikih.
English: Edarbi is unlikely to have an effect on driving or using machines.
Slovenian: Zdravilo Edarbi verjetno ne bo imelo vpliva na vožnjo ali upravljanje strojev.
English: What you need to know before you take Edarbi
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Edarbi
English: Near-maximal antihypertensive effect is evident at 2 weeks, with maximal effects attained by 4 weeks.
Slovenian: Skoraj najvišji antihipertenzivni učinek se pokaže v 2 tednih, največji učinki pa so doseženi po 4 tednih.
English: Protein binding is constant at azilsartan plasma concentrations well above the range achieved with recommended doses.
Slovenian: Vezava na beljakovine je konstantna tudi pri koncentracijah azilsartana v plazmi, ki so daleč nad območjem, doseženim s priporočenimi odmerki.
English: Angiotensin II is a substance which occurs naturally in the body and which causes the blood vessels to tighten, therefore increasing your blood pressure.
Slovenian: Angiotenzin II je snov, ki se naravno pojavlja v telesu in povzroča oženje krvnih žil in s tem povečanje krvnega tlaka.
English: Stop taking Edarbi and seek medical help immediately if you have any of the following allergic reactions, which occur rarely (may affect up to 1 in 1,000 people): - Difficulties in breathing, or swallowing, or swelling of the face, lips, tongue and/or throat
Slovenian: Prenehajte z jemanjem zdravila Edarbi in takoj poiščite zdravniško pomoč, če opazite katero od naslednjih alergičnih reakcij, ki se pojavijo redko (pojavi se lahko pri največ 1 od 1.000 bolnikov): - težave pri dihanju ali požiranju, zatekanje obraza, ustnic, jezika in/ali žrela (angioedem).
English: These effects, which were prevented by oral saline supplementation, do not have clinical significance in treatment of hypertension.
Slovenian: Ti učinki, ki so bili preprečeni s peroralnim dajanjem raztopine NaCl, nimajo kliničnega pomena pri zdravljenju hipertenzije.
English: 14, 28, 30, 56, 90 or 98 tablets.
Slovenian: 14, 28, 30, 56, 90 ali 98 tablet.
English: In seven double blind controlled studies, a total of 5,941 patients (3,672 given Edarbi, 801 given placebo, and 1,468 given active comparator) were evaluated.
Slovenian: V sedmih dvojno slepih kontroliranih študijah je bilo skupaj vključenih 5.941 bolnikov (3.672 jih je prejemalo zdravilo Edarbi, 801 jih je prejemalo placebo, 1.468 pa jih je prejemalo primerjalno učinkovino).
English: In these two studies, clinically important and most common adverse events included dizziness, headache and dyslipidemia.
Slovenian: V teh dveh študijah so klinično pomembni in najpogostejši neželeni učinki vključevali omotico, glavobol in dislipidemijo.
English: Edarbi at doses of 20, 40 or 80 mg has been evaluated for safety in clinical studies in patients treated for up to 56 weeks.
Slovenian: Varnost zdravila Edarbi v odmerkih po 20, 40 ali 80 mg je bilo opredeljena s kliničnimi študijami pri bolnikih v trajanju do 56 tednov.
English: Older people
Slovenian: Starejši
English: Steady-state levels of azilsartan are achieved within 5 days and no accumulation in plasma occurs with repeated once-daily dosing.
Slovenian: Dinamično ravnovesje koncentracij azilsartana je doseženo v 5-ih dneh, pri ponavljajočih se dnevnih odmerkih v plazmi pa ne prihaja do akumulacije.
English: In the reproduction toxicity studies, there were no effects on male or female fertility.
Slovenian: V študijah vplivov na sposobnost razmnoževanja niso bili ugotovljeni vplivi na moško ali žensko plodnost.
English: PC: {number} SN: {number} NN: {number}
Slovenian: PC: {številka} [koda zdravila]
English: Primary end point:
Slovenian: Primarni opazovani dogodek:
English: A thorough QT/QTc study was conducted to assess the potential of azilsartan medoxomil to prolong the QT/QTc interval in healthy subjects.
Slovenian: Izvedena je bila temeljita QT/QTc študija, katere cilj je bila ocena zmožnosti medoksomilazilsartanata, da pri zdravih osebah podaljša QT/QTc interval.
English: Mannitol (E 421) Fumaric acid (E 297) Sodium hydroxide Hydroxypropylcellulose (E 463) Croscarmellose sodium Microcrystalline cellulose (E 460) Magnesium stearate (E 572)
Slovenian: 6.1 Seznam pomožnih snovi manitol (E 421) fumarna kislina (E 297) natrijev hidroksid hidroksipropilceluloza (E 463) premreženi natrijev karmelozat mikrokristalna celuloza (E 460) magnezijev stearat (E 572)
English: o an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
Slovenian: o zaviralec ACE (na primer enalapril, lizinopril ali ramipril), zlasti če imate kakšne težave z ledvicami, ki so povezane s sladkorno boleznijo,
English: Excessive blood pressure decreases in patients with ischaemic cardiomyopathy or ischaemic cerebrovascular disease could result in a myocardial infarction or stroke.
Slovenian: Velik padec krvnega tlaka pri bolnikih z ishemično kardiomiopatijo ali ishemično cerebrovaskularno boleznijo lahko povzroči infarkt miokarda ali možgansko kap.
English: No dose adjustment is required in the black population, although smaller reductions in blood pressure are observed compared with a non-black population (see section 5.1).
Slovenian: Prilagajanje odmerka pri temnopolti populaciji ni potrebna, opaženo pa je bilo, da je zmanjšanje krvnega tlaka v primerjavi z ne-temnopolto populacijo manjše (glejte poglavje 5.1).
English: The dose may be increased to a maximum of 80 mg once daily for patients whose blood pressure is not adequately controlled at the lower dose.
Slovenian: Priporočeni začetni odmerek je 40 mg enkrat na dan. Odmerek se lahko poveča do največ 80 mg enkrat na dan za bolnike, pri katerih krvni tlak ni ustrezno urejen z nižjimi odmerki.
English: If you take too many tablets, or if someone else takes your medicine, contact your doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Edarbi, kot bi smeli Če ste vzeli preveč tablet ali če je kdo drug vzel vaše zdravilo, takoj pokličite svojega zdravnika.
English: Blood pressure reductions compared with placebo based on 24 hour mean blood pressure by ambulatory blood pressure monitoring (ABPM) and clinic blood pressure measurements at trough are shown in the table below for both studies.
Slovenian: Znižanja krvnega tlaka v primerjavi s placebom, ki temeljijo na 24 urnem srednjem krvnem tlaku, pri ambulantnem spremljanju krvnega tlaka in kliničnem merjenju krvnega tlaka, so prikazana v spodnji tabeli za obe študije.
English: 14, 28, 56 or 98 tablets; or
Slovenian: 14, 28, 56 ali 98 tablet; ali
English: Based on pharmacological considerations, the main manifestation of an overdose is likely to be symptomatic hypotension and dizziness.
Slovenian: Ob upoštevanju farmakoloških lastnosti sta glavna znaka prevelikega odmerjanja simptomatična hipotenzija in omotica.
English: C-labelled azilsartan medoxomil, approximately 55% of radioactivity was recovered in faeces and approximately 42% in urine, with 15% of the dose excreted in urine as azilsartan.
Slovenian: C-označenega medoksomilazilsartanata je bilo 55 % radioaktivnosti ugotovljene v blatu in približno 42 % v urinu.
English: In rats and dogs, increased plasma renin activity and hypertrophy/hyperplasia of the renal juxtaglomerular cells were observed.
Slovenian: Pri podganah in psih je bila opažena povečana aktivnost renina v plazmi in hipertrofija/hiperplazija jukstaglomerulnih celic.
English: - have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Slovenian: - imate sladkorno bolezen ali okvarjeno delovanje ledvic in se zdravite z zdravilom za znižanje krvnega tlaka, ki vsebuje aliskiren.
English: The possibility of similar effects cannot be excluded with Edarbi.
Slovenian: Tudi pri zdravilu Edarbi podobnih učinkov ni mogoče izključiti.
English: In active-comparator studies with either valsartan or ramipril, the blood-pressure-lowering effect with Edarbi was sustained during long-term treatment.
Slovenian: V primerjalnih študijah z valsartanom ali ramiprilom, se je učinek znižanja krvnega tlaka z zdravilom Edarbi ohranjal pri dolgotrajnem zdravljenju.
English: Essential hypertension
Slovenian: Esencialna hipertenzija
English: Edarbi is not recommended in early pregnancy, and must NOT be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Slovenian: Zdravilo Edarbi v zgodnji nosečnosti ne priporočajo; NE smete pa ga jemati, ko boste noseči dlje kot 3 mesece, ker lahko po tretjem mesecu nosečnosti resno škoduje vašemu otroku.
English: Epidemiological evidence regarding the risk of teratogenicity following exposure to angiotensin converting enzyme inhibitors during the first trimester of pregnancy has not been conclusive; however, a small increase in risk cannot be excluded.
Slovenian: Epidemiološki podatki niso pokazali teratogenega učinka pri nosečnicah, ki so bile v prvem trimesečju izpostavljene zaviralcem angiotenzinske konvertaze, vendar pa majhnega povečanega tveganja ni možno izključiti.
English: 14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets
Slovenian: 14 tablet 28 tablet 30 tablet 56 tablet 90 tablet 98 tablet
English: Systemic exposures to the major and minor metabolites in humans were approximately 50% and less than 1% that of azilsartan, respectively.
Slovenian: Sistemska izpostavljenost glavnemu in stranskemu presnovku v primerjavi z azilsartanom je bila pri človeku 50 % oz. manj kot 1 %.
English: Edarbi blocks this effect so that the blood vessels relax, which helps lower your blood pressure.
Slovenian: Zdravilo Edarbi preprečuje ta vpliv, krvne žile se sprostijo in to prispeva k znižanju krvnega tlaka.
English: Takeda Pharma A/S, Dybendal Alle 10, 2630 Taastrup, Denmark
Slovenian: Takeda Pharma A/S, Dybendal Alle 10, 2630 Taastrup, Danska
English: Edarbi is for oral use and may be taken with or without food (see section 5.2).
Slovenian: Zdravilo Edarbi se jemlje peroralno, s hrano ali brez nje (glejte poglavje 5.2).
English: If you stop taking Edarbi
Slovenian: Če ste prenehali jemati zdravilo Edarbi
English: Black population
Slovenian: Temnopolta populacija
English: There is limited data on the use of Edarbi in children or adolescents under 18 years of age.
Slovenian: Podatki o uporabi zdravila Edarbi pri otrocih in mladostnikih, mlajših od 18 let, so omejeni.
English: - The other ingredients are mannitol, fumaric acid, sodium hydroxide, hydroxypropylcellulose, croscarmellose sodium, microcrystalline cellulose, and magnesium stearate.
Slovenian: - Pomožne snovi so manitol, fumarna kislina, natrijev hidroksid, hidroksipropilceluloza, premreženi natrijev karmelozat, mikrokristalna celuloza in magnezijev stearat.
English: Azilsartan is metabolised to two primary metabolites.
Slovenian: Azilsartan se presnovi v dva primarna presnovka.
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system, angiotensin II antagonists, plain, ATC Code: C09CA09
Slovenian: Farmakoterapevtska skupina: Zdravila z delovanjem na renin-angiotenzinski sistem, antagonisti angiotenzina II, enokomponentna zdravila, oznaka ATC: C09CA09
English: Edarbi is not recommended in early pregnancy, and must NOT be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see section "Pregnancy section and breast-feeding").
Slovenian: Uporaba zdravila Edarbi ni priporočljiva v zgodnjem obdobju nosečnosti in ga NE smete jemati, če ste noseči dlje kot 3 mesece, ker lahko v tem obdobju resno škoduje vašemu otroku (glejte poglavje “Nosečnost in dojenje”).
English: Coadministration of Edarbi 40 and 80 mg with a calcium channel blocker (amlodipine) or a thiazidetype diuretic (chlortalidone) resulted in additional blood pressure reductions compared with the other antihypertensive alone.
Slovenian: Sočasna uporaba 40 in 80 mg zdravila Edarbi z zaviralci kalcijevih kanalčkov (amlodipin) ali z diuretiki tiazidnega tipa (klortalidon) je v primerjavi z zdravljenjem z drugim antihipertenzivom samim pokazala dodatna znižanja krvnega tlaka.
English: As with other angiotensin II receptor antagonists and angiotensin converting enzyme inhibitors the antihypertensive effect was lower in black patients (usually a low-renin population).
Slovenian: Kot pri drugih antagonistih angiotenzina II in zaviralcih angiotenzinske konvertaze je antihipertenzivni učinek nižji pri temnopoltih bolnikih (običajno je to populacija z nizkim reninom).
English: What Edarbi is and what it is used for What you need to know before you take Edarbi How to take Edarbi
Slovenian: Kaj je zdravilo Edarbi in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Edarbi Kako jemati zdravilo Edarbi Možni neželeni učinki
English: Caution required with concomitant use
Slovenian: Pri sočasni uporabi je potrebna previdnost
English: This generally has been true for other angiotensin II receptor (AT1) antagonists and angiotensin-converting enzyme inhibitors.
Slovenian: To na splošno velja tudi za druge antagoniste angiotenzina II (AT1) in zaviralce angiotenzinske konvertaze.
English: Blockade of the AT1 receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increases in plasma renin activity and angiotensin II circulating levels do not overcome the antihypertensive effect of azilsartan.
Slovenian: Blokada AT1 receptorjev zavira negativni regulacijski povratni vpliv angiotenzina II na izločanje renina, vendar posledično povečanje aktivnosti renina v plazmi in koncentracije angiotenzina II v obtoku ne presegajo antihipertenzivnega učinka azilsartana.
English: - The concomitant use of Edarbi with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73m2) (see sections 4.5 and 5.1).
Slovenian: - Sočasna uporaba zdravila Edarbi in zdravil, ki vsebujejo aliskiren, je kontraindicirana pri bolnikih s sladkorno boleznijo ali okvaro ledvic (hitrost glomerularne filtracije < 60 ml/min/1,73 m2) (glejte poglavji 4.5 in 5.1).
English: M-I and M-II do not contribute to the pharmacologic activity of azilsartan medoxomil.
Slovenian: Presnovka M-I in M-II ne prispevata k farmakološki aktivnosti medoksomilazilsartanata.
English: Edarbi is for oral use.
Slovenian: Zdravilo Edarbi je za peroralno uporabo.
English: No dose adjustment is necessary based on gender.
Slovenian: Na osnovi spola prilagoditev odmerka ni potrebna.
English: A similar effect may occur with angiotensin II receptor antagonists.
Slovenian: Do podobnega pojava lahko pride tudi pri antagonistih angiotenzina II.
English: Edarbi has not been studied in patients with severe hepatic impairment.
Slovenian: Zdravilo Edarbi ni bilo raziskano pri bolnikih s hudo jetrno okvaro.
English: In the elderly, in patients with renal insufficiency, in diabetic patients and/or in patients with other co-morbidities, the risk of hyperkalaemia, which may be fatal, is increased.
Slovenian: Pri starejših bolnikih, bolnikih z ledvično odpovedjo, s sladkorno boleznijo in/ali bolnikih z drugimi sočasnimi boleznimi se tveganje za hiperkaliemijo, ki je lahko smrtna, poveča.
English: No clinically significant interactions have been reported in studies of azilsartan medoxomil or azilsartan given with amlodipine, antacids, chlortalidone, digoxin, fluconazole, glyburide, ketoconazole, metformin, and warfarin.
Slovenian: Študije zdravljenja z medoksomilazilsartanatom ali azilsartanom niso odkrile klinično pomembnih interakcij ob sočasnem dajanju z naslednjimi učinkovinami: amlodipin, antacidi, klortalidon, digoksin, flukonazol, gliburid, ketokonazol, metformin in varfarin.
English: Azilsartan medoxomil has no or negligible influence on the ability to drive and use machines.
Slovenian: Medoksomilazilsartanat nima vpliva ali pa ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: What Edarbi looks like and contents of the pack
Slovenian: Izgled zdravila Edarbi in vsebina pakiranja
English: These changes, also a class effect of angiotensin converting enzyme inhibitors and other angiotensin II receptor antagonists, do not appear to have clinical significance.
Slovenian: Videti je, da te spremembe, ki so značilni učinki zaviralcev angiotenzinske konvertaze in drugih antagonistov angiotenzina II, nimajo kliničnega pomena.
English: Azilsartan medoxomil is an orally active prodrug that is rapidly converted to the active moiety, azilsartan, which selectively antagonises the effects of angiotensin II by blocking its binding to the AT1 receptor in multiple tissues (see section 5.2).
Slovenian: Medoksomilazilsartanat je peroralno aktivno predzdravilo, ki se hitro spremeni v aktivni delazilsartan, ki selektivno nasprotuje učinkom angiotenzina II tako, da preprečuje, da bi se le-ta vezal na AT1 receptorje v več tkivih (glejte poglavje 5.2).
English: Adverse reactions based on pooled data (40 and 80 mg doses) are listed below according to system organ class and preferred terms.
Slovenian: Glede na zbrane podatke (v odmerkih 40 in 80 mg) so neželeni učinki prikazani spodaj, glede na organski sistem in preferenčni izraz.
English: The blood pressure lowering effect of azilsartan medoxomil was also maintained throughout the 24 hour dosing interval.
Slovenian: Učinek znižanja krvnega tlaka medoksomilazilsartanata se je ohranjal v vsem 24-urnem intervalu jemanja odmerka.
English: The elevations in serum creatinine during coadminstiration of Edarbi with diuretics were associated with larger blood pressure reductions compared with a single medicinal product.
Slovenian: Dvigi koncentracij serumskega kreatinina pri sočasnem jemanju zdravila Edarbi z diuretiki so bili povezani z večjimi znižanji krvnega tlaka, v primerjavi z jemanjem enega samega zdravila.
English: No dose adjustment is necessary based on race.
Slovenian: Na osnovi rase prilagoditev odmerka ni potrebna.
English: Tell your doctor if you are breast-feeding.
Slovenian: Povejte zdravniku, če dojite.
English: Swelling of the hands, ankles or feet is more common (in less than 1 in 10 users) when Edarbi is taken with amlodipine (a calcium channel blocker for treating hypertension) than when Edarbi is taken alone (less than 1 in 100 users).
Slovenian: Zatekanje rok, gležnjev ali nog je bilo pogostejše (pri manj kot 1 od 10 bolnikov), če so zdravilo Edarbi jemali sočasno z amlodipinom (zaviralec kalcijevih kanalčkov za zdravljenje hipertenzije), kot pa, če so jemali samo zdravilo Edarbi (manj kot 1 od 100 bolnikov).
English: Dose proportionality in exposure was established for azilsartan in the azilsartan medoxomil dose range of 20 mg to 320 mg after single or multiple dosing.
Slovenian: Sorazmernost odmerka in izpostavljenosti je bila dokazana za azilsartan in medoksomilazilsartanat za območje odmerkov od 20 do 320 mg po enkratnem ali večkratnem dajanju.
English: Administration of Edarbi for up to 5 days in subjects with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment resulted in slight increase in azilsartan exposure (AUC increased by 1.3 to 1.6 fold, see section 4.2).
Slovenian: Dajanje zdravila Edarbi bolnikom z blago (Child-Pugh A) ali zmerno (Child-Pugh B) jetrno okvaro v trajanju 5 dni, je pokazalo majhno povečanje izpostavljenosti azilsartanu (AUC se je povečala za 1,3 do 1,6-krat; glejte poglavje 4.2).
English: During controlled clinical studies in healthy subjects, once daily doses up to 320 mg of azilsartan medoxomil were administered for 7 days and were well tolerated.
Slovenian: V kontroliranih kliničnih študijah so udeleženci 7 dni prejemali enkratni dnevni odmerek 320 mg medoksomilazilsartanata, ki so ga dobro prenašali.
English: Rare side effects (may affect up to 1 in 1,000 people): - Changes in blood test results including decreased levels of a protein in the red blood cells
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): - spremembe vrednosti krvnih preiskav, vključno z znižanjem vrednosti beljakovine v rdečih krvničkah (hemoglobin).
English: Placebo at 0.05 level within the framework of the step-wise analysis † Significant difference vs. Comparator(s) at 0.05 level within the framework of the step-wise analysis # Maximum dose achieved in study 2.
Slovenian: OLM-M = medoksomilolmesartanat, NK = najmanjši kvadrati, ZOPN = zadnje opazovanje preneseno naprej * Pomembna razlika v primerjavi s placebom na nivoju 0,05 v okviru postopne analize † Pomembna razlika v primerjavi s primerjalno učinkovino(nami) na nivoju 0,05 v okviru postopne analize # Največji odmerek, dosežen v študiji 2.
English: Uric acid
Slovenian: Sečna kislina
English: Furthermore, concomitant use of angiotensin II receptor antagonists and NSAIDs may lead to an increased risk of worsening of renal function and an increase in serum potassium.
Slovenian: Poleg tega lahko sočasna uporaba antagonistov angiotenzina II in nesteroidnih protivnethih zdravil poveča tveganje za poslabšanje delovanja ledvic ter povečanje kalija v serumu.
English: Doses were force-titrated at Week 2 from 20 to 40 mg and 40 to 80 mg for Edarbi, and 20 to 40 mg and 160 to 320 mg, respectively, for olmesartan medoxomil and valsartan
Slovenian: Odmerki so se v 2. tednu povečali z 20 na 40 mg in s 40 na 80 mg zdravila Edarbi, ter z 20 na 40 mg medoksomilolmesartanata oz. s 160 na 320 mg valsartana.
English: Infants whose mothers have taken Angiotensin II receptor antagonists should be closely observed for hypotension (see sections 4.3 and 4.4).
Slovenian: Otroke, katerih matere so prejemale antagoniste angiotenzina II, je treba pozorno spremljati zaradi možnosti hipotenzije (glejte poglavji 4.3 in 4.4).
English: Angiotensin II is the principal pressor agent of the RAAS, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium.
Slovenian: Angiotenzin II je glavni agens zvišanja tlaka v RAAS in povzroča vazokonstrikcijo, stimulacijo tvorbe in sproščanja aldosterona, kardialno stimulacijo in ponovno absorpcijo natrija v ledvicah.
English: Store Edarbi in the original package in order to protect it from light and moisture.
Slovenian: Zdravilo Edarbi shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo in vlago.
English: ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) was a study designed to test the benefit of adding aliskiren to a standard therapy of an ACE inhibitor or an angiotensin II receptor blocker in patients with type 2 diabetes mellitus and chronic kidney disease, cardiovascular disease, or both.
Slovenian: Študija ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) je preučevala koristi dodatka aliskirena standardnemu zdravljenju z zaviralcem ACE ali blokatorjem receptorjev angiotenzina II pri bolnikih s sladkorno boleznijo tipa 2 in kronično boleznijo ledvic, kardiovaskularno boleznijo ali obojim.
English: Additionally, Edarbi 80 mg resulted in significantly greater reductions in SBP than the highest approved doses of olmesartan medoxomil and valsartan.
Slovenian: Poleg tega je zdravilo Edarbi 80 mg pokazalo pomembno večje znižanje sistoličnega krvnega tlaka (SKT) kot največji dovoljeni odmerki medoksomilolmesartanata in valsartana.
English: Other medicines and Edarbi Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: When Edarbi was coadministered with amlodipine, the frequency of peripheral oedema was increased from uncommon to common, but was lower than amlodipine alone.
Slovenian: Pri sočasni uporabi zdravila Edarbi in amlodipina se je pogostnost perifernega edema z občasne povečala na pogosto, vendar pa je bila nižja kot pri uporabi amlodipina samega.
English: No dose adjustment is required in patients with mild or moderate renal impairment.
Slovenian: Pri bolnikih z blago ali zmerno ledvično okvaro prilagoditev odmerka ni potrebna.