FrancophonIA/ELRC3.0 huggingface dataset:
English: Adverse reactions previously reported with one of the individual components (telmisartan or amlodipine) may be potential adverse reactions with Onduarp as well, even if not observed in clinical trials or during the post-marketing period.
Slovenian: Neželeni učinki, o katerih so poročali pri uporabi posamičnih učinkovin (telmisartana ali amlodipina) se lahko pojavijo tudi ob zdraviluOnduarp, čeprav jih v kliničnih preskušanjih ali v obdobju po začetku trženja zdravila niso zasledili.
English: When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed.
Slovenian: Pri hkratnem dajanju telmisartana in digoksina je prišlo do srednje velikega povečanja največje koncentracije digoksina v plazmi (49 %) in njegove najnižje koncentracije (20 %).
English: Other conditions with stimulation of the renin-angiotensin-aldosterone system In patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with medicinal products that affect this system has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see section 4.8).
Slovenian: Druga stanja, pri katerih prihaja do spodbujanja renin-angiotenzin-aldosteronskega sistema Pri bolnikih, pri katerih sta žilni tonus in ledvična funkcija pretežno odvisna od delovanja reninangiotenzin-aldosteronskega sistema (npr. pri bolnikih s hudim kongestivnim srčnim popuščanjem ali ledvično boleznijo, tudi zožitvijo ledvične arterije), povezujejo zdravljenje z drugimi zdravili, katera delujejo na ta sistem, z akutno hipotenzijo, s hiperazotemijo, oligurijo in, redko, z akutno ledvično okvaro (glejte poglavje 4.8).
English: Patients with hepatic insufficiency have decreased clearance of amlodipine with resulting increase of approximately 40-60 % in AUC.
Slovenian: Pri bolnikih z zmanjšanim jetrnim delovanjem je amlodipinov očistek manjši, zato je njegova AUC za približno 40 do 60 % večja.
English: Serum potassium should be monitored closely in these patients (see section 4.5).
Slovenian: Pri teh bolnikih je treba natančno spremljati raven kalija v serumu (glejte poglavje 4.5).
English: Onduarp combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: an angiotensin II receptor antagonist, telmisartan, and a dihydropyridinic calcium channel blocker, amlodipine.
Slovenian: Zdravilo Onduarp vsebuje kombinacijo dveh antihipertenzivnih spojin s komplementarnima mehanizmoma za uravnavo krvnega tlaka pri bolnikih z esencialno hipertenzijo: angatonista receptorjev za angiotenzin II telmisartan in dihidropiridinskega zaviralca kalcijevih kanalov amlodipina.
English: Psychiatric disorders depression, anxiety, insomnia
Slovenian: Psihiatrične motnje depresija, tesnoba, nespečnost
English: In hypertensive patients with normal renal function, therapeutic doses of amlodipine resulted in a decrease in renal vascular resistance and an increase in glomerular filtration rate and effective renal plasma flow, without change in filtration fraction or proteinuria.
Slovenian: Pri hipertenzivnih bolnikih z normalnim ledvičnim delovanjem se je po dajanju amlodipina v terapevtskih odmerkih zmanjšal žilni upor v ledvicah, povečala pa sta se hitrost glomerulne filtracije in efektivni pretok plazme skozi ledvice, ne da bi se spremenila filtracijska frakcija ali proteinurija.
English: The antihypertensive efficacy of telmisartan is comparable to that of substances representative of other classes of antihypertensive medicinal products (demonstrated in clinical trials comparing telmisartan to amlodipine, atenolol, enalapril, hydrochlorothiazide, and lisinopril).
Slovenian: Antihipertenzivna učinkovitost telmisartana je primerljiva z učinkovitostjo zdravil iz drugih skupin antihipertenzivnih zdravil (primerljivost dokazujejo klinična preskušanja, v katerih so telmisartan primerjali z amlodipinom, atenololom, enalaprilom, hidroklorotiazidom in lizinoprilom).
English: • ACE inhibitors, angiotensin II receptor antagonists, renin inhibitors.
Slovenian: • ACE inhibitorji, antagonisti receptorjev angiotenzina II, inhibitorji renina;
English: The maximum recommended dose is Onduarp 80 mg/10 mg, one tablet per day.
Slovenian: Največji priporočeni odmerek zdravila Onduarp je 80 mg/10 mg, to je ena tableta na dan.
English: Furthermore, orthostatic hypotension may be aggravated by alcohol.
Slovenian: Alkohol lahko poslabša ortostatsko hipotenzijo.
English: Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle.
Slovenian: Amlodipin je zaviralec pritoka kalcijevih ionov iz skupine dihidropiridinov (počasi delujoč blokator kanalov ali antagonist pretoka kalcijevih ionov) in zavira pritok kalcijevih ionov skozi membrano v srčno in žilno gladko mišico.
English: In patients with mild to moderate and severe renal impairment, doubling of plasma concentrations of telmisartan was observed.
Slovenian: Pri bolnikih z blago do zmerno in hudo ledvično okvaro so opazili podvojitev plazemskih koncentracij.
English: The concomitant use of CYP3A4 inducers (i.e. rifampicin, Hypericum perforatum) may lead to a lower plasma concentration of amlodipine.
Slovenian: Sočasna uporaba induktorjev CYP3A4 (rifampicina, Hypericum perforatum) lahko zniža amlodipinovo koncentracijo.
English: When Onduarp is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Slovenian: Kadar zdravimo z zdravilom Onduarp bolnike z okvarjenim ledvičnim delovanjem, je priporočeno redno spremljanje ravni kalija in kreatinina v serumu.
English: In this same population amlodipine was associated with increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo.
Slovenian: Pri isti populaciji bolnikov so amlodipin povezovali s povečanim številom poročil o pljučnem edemu, vendar pojavnost poslabšanja srčnega popuščanja v primerjavi s placebom ni bila značilno večja.
English: Amlodipine stops calcium from moving into the blood vessel wall which stops the blood vessels from tightening.
Slovenian: Amlodipin preprečuje prehajanje kalcija v stene krvnih žil, kar zaustavi oženje krvnih žil.
English: Co-administration of multiple doses of amlodipine with simvastatin 80 mg resulted in an increase in exposure to simvastatin up to 77 % compared to simvastatin alone.
Slovenian: Pri sočasnem, večkratnem dajanju amlodipina in odmerkov simvastatina po 80 mg se je v primerjavi z dajanjem samega simvastatina do 77 % povečala izpostavljenost simvastatinu.
English: The most prominent manifestations of telmisartan overdose are expected to be hypotension and tachycardia; bradycardia, dizziness, increase in serum creatinine, and acute renal failure have also been reported.
Slovenian: Pričakovana prevladujoča znaka po zaužitju prevelikega odmerka telmisartana sta hipotenzija in tahikardija; poročali so še o bradikardiji, omotici, povečani ravni kreatinina v serumu in akutni ledvični odpovedi.
English: • if you are taking Rasilez, a medicine used to treat high blood pressure.
Slovenian: • če jemljete Rasilez, zdravilo za zdravljenje visokega krvnega tlaka;
English: This means that both of these active substances work together to help stop your blood vessels tightening.
Slovenian: To pomeni, da obe učinkovini preprečujeta oženje krvnih žil.
English: High blood pressure, if not treated, can damage blood vessels in several organs, which puts patients at risk of serious events such as heart attack, heart or kidney failure, stroke, or blindness.
Slovenian: Če visokega krvnega tlaka ne zdravimo, lahko poškoduje krvne žile v različnih organih, zaradi česar se poveča nevarnost resnih dogodkov, kot so srčni infarkt, srčno pouščanje ali ledvična odpoved, možganska kap ali slepota.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: Treatment can be continued once blood pressure has been stabilised.
Slovenian: Ko se krvni tlak stabilizira, lahko zdravljenje nadaljuje.
English: In preclinical studies, no effects of telmisartan on male and female fertility were observed.
Slovenian: Telmisartan v predkliničnih študijah ni vplival na plodnost pri moških in ženskah.
English: Reproductive system, and breast disorders erectile dysfunction
Slovenian: Motnje reprodukcije in dojk erektilna disfunkcija
English: • Rasilez, a medicine used to treat high blood pressure.
Slovenian: • Rasilez, zdravilo za zdravljenje visokega krvnega tlaka;
English: Infections and infestations cystitis
Slovenian: Infekcijske in parazitske bolezni cistitis
English: Onduarp may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine, neuroleptics or antidepressants).
Slovenian: Zdravilo Onduarp lahko poveča učinek drugih zdravil za zdravljenje visokega krvnega tlaka ali zdravil, ki lahko znižajo krvni tlak (npr. baklofen, amifostin, nevroleptiki ali antidepresivi).
English: Studies with telmisartan in animals have shown reproductive toxicity (see section 5.3).
Slovenian: Študije s telmisartanom na živalih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje
English: In reproductive toxicity studies in rats, delayed parturition, difficult labour and impaired fetal and pup survival were seen at high doses.
Slovenian: V študiji o reproduktivni toksičnosti pri podganah so po dajanju velikih odmerkov opazili zapoznel porod, težaven porod in manjše preživetje plodov in zaroda.
English: Amlodipine should be used with caution together with CYP3A4 inhibitors.
Slovenian: Pri hkratni uporabi amlodipina z zaviralci CYP3A4 je potrebna previdnost.
English: If you forget to take Onduarp
Slovenian: Če ste pozabili vzeti zdravilo Onduarp
English: Amlodipine has been safely administered with digoxin, warfarin, atorvastatin, sildenafil, anti-acid medicinal products (aluminium hydroxide, magnesium hydroxide, simeticone), cimetidine, ciclosporin, antibiotics and oral hypoglycaemic medicinal products.
Slovenian: Uporaba amlodipina je bila varna v kombinaciji z digoksinom, varfarinom, atorvastatinom, s sildenafilom, z antacidi (aluminijevim hidroksidom, magnezijevem hidroksidom, simetikonom), s cimetidinom, ciklosporinom, z antibiotiki in peroralnimi hipoglikemiki.
English: Telmisartan is highly bound to plasma protein in renal-insufficient subjects and cannot be removed by dialysis.
Slovenian: Telmisartan se pri bolnikih z ledvično okvaro obsežno veže na plazemske beljakovine in ga z dializo ne moremo odstraniti.
English: In preclinical safety studies, doses producing exposure comparable to that in the clinical therapeutic range caused reduced red cell parameters (erythrocytes, haemoglobin, haematocrit), changes in renal haemodynamics (increased blood urea nitrogen and creatinine), as well as increased serum potassium in normotensive animals.
Slovenian: V predkliničnih študijah o varnosti so se po vnosu odmerkov, po katerih je bila izpostavljenost zdravilu primerljiva s tisto pri kliničnem terapevtskem razponu odmerjanja, zmanjšali parametri rdečih krvničk (eritrociti, hemoglobin, hematokrit), spremenila se je ledvična hemodinamika (povečala se je vsebnost dušika sečnine v krvi in kreatinina) in povečala količina kalija v serumu normotenzivnih živali.
English: This is confirmed by trough to peak ratios consistently above 80 % seen after doses of 40 and 80 mg of telmisartan in placebo controlled clinical studies.
Slovenian: Enakomerno trajanje učinka potrjujejo razmerja med najmanjšimi in največjimi vrednostmi, ki so bila v s placebom nadzorovanih kliničnih preskušanjih po vnosu odmerkov po 40 in 80 mg telmisartana dosledno večja od 80 %.
English: Onduarp once daily produces effective and consistent reductions in blood pressure across the 24-hour therapeutic dose range.
Slovenian: En odmerek zdravila Onduarp na dan učinkovito in enakomerno znižuje krvni tlak vseh 24 ur znotraj terapevtskega razpona odmerkov.
English: No dose adjustment is necessary for elderly patients.
Slovenian: Starejši bolniki Starejšim bolnikom odmerka ni treba prilagajati.
English: The concomitant use of amlodipine and grapefruit or grapefruit juice is still not recommended in patients as the bioavailability of amlodipine may increase in some and may result in increased hypotensive effects.
Slovenian: Hkratnega uživanja grenivke ali pitja grenivkinega soka z amlodipinom bolnikom še vedno ne priporočajo, ker se pri nekaterih lahko poveča amlodipinova biološka uporabnost, kar poveča njegove hipotenzivne učinke.
English: • Elevated potassium levels in your blood.
Slovenian: • zvišano raven kalija v krvi,
English: When amlodipine and sildenafil were used in combination, each agent independently exerted its own blood pressure lowering effect.
Slovenian: Pri kombinirani uporabi amlodipina in sildenafila sta delovali obe zdravili in neodvisno zniževali krvni tlak.
English: In a subset of 1050 patients with moderate to severe hypertension (DBP ≥100 mmHg) 32.7 - 51.8 % responded sufficiently to monotherapy of either telmisartan or amlodipine.
Slovenian: V podskupini 1050 bolnikov z zmerno do hudo hipertenzijo (DKT ≥ 100 mm Hg) je pri 32,7 do 51,8 % bolnikov krvni tlak dovolj znižala monoterapija s telmisartanom ali amlodipinom.
English: heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.
Slovenian: imunosupresivi (na primer ciklosporin ali takrolimus) in antibiotik trimetoprim;
English: As with other blood pressure lowering medicines, the effect of Onduarp may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. acetylsalicylic acid or ibuprofen) or corticosteroids.
Slovenian: Enako kot pri drugih zdravilih za znižanje krvnega tlaka se lahko učinek zdravila Onduarp zmanjša, če jemljete nesteroidna protivnetna zdravila (na primer acetilsalicilno kislino ali ibuprofen) ali kortikosteroide.
English: Suggested measures include induction of emesis and / or gastric lavage.
Slovenian: Predlagani ukrepi so sprožitev bruhanja in/ali izpiranje želodca.
English: Nervous system disorders somnolence, migraine, headache, paraesthesia syncope, peripheral neuropathy, hypoaesthesia, dysgeusia, tremor
Slovenian: Bolezni živčevja omotica zaspanost, migrena, glavobol, parestezija sinkopa, periferna nevropatija, hipestezija, disgevzija, tremor
English: Do not take Onduarp
Slovenian: Ne jemljite zdravila Onduarp
English: The elimination half-life is not changed in patients with renal impairment.
Slovenian: Razpolovna doba izločanja se pri bolnikih z jetrno okvaro ne spremeni.
English: In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function), the co-administration of angiotensin II receptor antagonists and medicinal products that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Slovenian: Pri nekaterih bolnikih z zmanjšanim ledvičnim delovanjem (na primer pri dehidriranih ali starejših z zmanjšanim ledvičnim delovanjem) lahko sočasno dajanje antagonistov receptorjev angiotenzina II in zdravil, ki zavirajo ciklooksigenazo, povzroči nadaljnje poslabšanje ledvičnega delovanja, tudi akutno ledvično odpoved, ki je običajno reverzibilna.
English: PHARMACEUTICAL FORM AND CONTENTS Multipack comprising 4 packs, each containing 90 x 1 tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Skupinsko pakiranje vsebuje 4 enote po 90 x 1 tableto.
English: Automated ambulatory blood pressure monitoring (ABPM) performed in a subset of 562 patients confirmed the results seen with in-clinic systolic and diastolic blood pressure reductions consistently over the entire 24-hours dosing period.
Slovenian: Spremljanje krvnega tlaka z ambulantnim prenosnim merilnikom pri podskupini 562 bolnikov je potrdilo izsledke o enakomernem znižanju sistoličnega in diastoličnega krvnega tlaka v 24-urnem razmiku med dvema odmerkoma.
English: Non-steroidal anti-inflammatory medicinal products NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and nonselective NSAIDs) may reduce the antihypertensive effect of angiotensin II receptor antagonists.
Slovenian: Nesteroidna protivnetna zdravila (acetilsalicilna kislina v odmerkih, ki učinkujejo protivnetno; zaviralci ciklooksigenaze 2; in neselektivna nesteroidna protivnetna zdravila) lahko zmanjšajo antihipertenzivni učinek antagonistov receptorjev angiotenzina II.
English: • Rifampicin, St. John's wort.
Slovenian: • rifampicin, šentjanževka,
English: Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter.
Slovenian: Bolniki morajo biti ustrezno hidrirani, na začetku sočasnega zdravljenja in v rednih razmikih med njim pa je treba presoditi tudi o spremljanju ledvičnega delovanja.
English: Posology The recommended dose of Onduarp is one tablet per day.
Slovenian: Odmerjanje Priporočeni odmerek zdravila Onduarp je ena tableta na dan.
English: Onduarp is available in a folding box containing 28 tablets in aluminium/aluminium blisters.
Slovenian: Zdravilo Onduarp je na voljo v škatlah po 28tablet v pretisnih omotih iz aluminija.
English: Micturition disorder, pollakiuria
Slovenian: motnje mokrenja, polakiurija
English: This is because grapefruit and grapefruit juice may lead to increased blood levels of the active ingredient amlodipine in some patients and may increase the blood pressure lowering effect of Onduarp.
Slovenian: Grenivka in grenivkin sok lahko pri nekaterih bolnikih povečata količino zdravilne učinkovine amlodipina v krvi in okrepita učinek zdravila Onduarp na znižanje krvnega tlaka.
English: Onduarp is available in a folding box containing 28 tablets in aluminium/aluminium blisters and in a folding box containing 360 (4 x 90 x 1) tablets in aluminium/aluminium perforated unit dose blisters.
Slovenian: Zdravilo Onduarp je na voljo v škatlah po 28tablet v pretisnih omotih iz aluminija in v škatlah po 360 (4 x 90 x 1) tablet v perforiranih pretisnih omotih za enkratni odmerek iz aluminija.
English: In a long-term, placebo controlled study (PRAISE-2) of amlodipine in patients with NYHA III and IV heart failure of non-ischaemic aetiology, amlodipine was associated with increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo (see section 5.1).
Slovenian: V dolgotrajni, s placebom nadzorovani študiji (PRAISE-2) o amlodipinu pri bolnikih s srčnim popuščanjem neishemičnega izvora III. in IV. stopnje po NYHA so amlodipin v primerjavi s placebom povezovali s pogostejšimi poročili o pljučnem edemu, čeprav ni bilo značilnih razlik v pojavnosti poslabšanja srčnega popuščanja (glejte poglavje 5.1).
English: If hypotension occurs with Onduarp, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.
Slovenian: Bolnika, pri katerem se med zdravljenjem z zdravilom Onduarp pojavi hipotenzija, je treba namestiti v ležeč položaj in mu, če je potrebno, dati intravensko infuzijo fiziološke raztopine.
English: Hyperhidrosis
Slovenian: hiperhidroza
English: Blood creatinine increased
Slovenian: zvišana raven kreatinina v krvi
English: Interactions common to the combination No drug interaction studies have been performed.
Slovenian: Pogoste interakcije kombinacije Študij medsebojnih interakcij z drugimi zdravili niso izvedli.
English: If you stop taking Onduarp
Slovenian: Če ste prenehali jemati zdravilo Onduarp
English: Leukocytopenia, thrombocytopenia
Slovenian: levkocitopenija, trombocitopenija
English: Rare side effects (may affect up to 1 in 1,000 people): Confusion.
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1000 bolnikov): zmedenost.
English: Telmisartan is mostly eliminated in the bile.
Slovenian: Telmisartan se pretežno izloča z žolčem.
English: In patients with hypertension, once daily dosing provides clinically significant reductions of blood pressure in both the supine and standing positions throughout the 24 hour interval.
Slovenian: Pri bolnikih s hipertenzijo en odmerek na dan vseh 24 ur klinično pomembno znižuje krvni tlak v ležečem in stoječem položaju.
English: Diabetic patients treated with insulin or antidiabetics In these patients hypoglycaemia may occur under telmisartan treatment.
Slovenian: Bolniki s sladkorno boleznijo, ki se zdravijo z insulinom ali antidiabetiki Pri bolniki s sladkorno boleznijo, ki se zdravijo z insulinom ali peroralnimi antidiabetiki in telmisartanom, se lahko pojavi hipoglikemija.
English: Aluminium/aluminium blisters (PA/Al/PVC/Al) in a carton containing 28 tablets or aluminium/aluminium perforated unit dose blisters (PA/Al/PVC/Al) in multipacks containing 360 (4 packs of 90 x 1) tablets.
Slovenian: Pretisni omoti iz aluminija (PA/Al/PVC/Al) v kartonski škatli po 28tablet ali perforirani pretisni omoti za enkratni odmerek iz aluminija (PA/A1/PVC/Al) v skupinskem pakiranju po 360 (4 pakiranja po 90 x 1) tablet.
English: - The other ingredients are colloidal anhydrous silica, brilliant blue FCF (E 133), ferric oxide black (E172), ferric oxide yellow (E172), magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone K25, pregelatinized starch, sodium hydroxide, sorbitol (E420).
Slovenian: - Druge sestavine zdravila so koloidni brezvodni silicijev dioksid, briljantno modro FCF (E 133), črni železov oksid (E 172), rumeni železov oksid (E 172), magnezijev stearat, koruzni škrob, meglumin, mikrokristalna celuloza, povidon K25, predgelirani škrob, natrijev hidroksid, sorbitol (E 420).
English: • Severe hypotension
Slovenian: • huda hipotenzija,
English: Musculoskeletal and connective tissue disorders arthralgia, muscle spasms (cramps in legs), myalgia back pain, pain in extremity (leg pain)
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva artralgija, mišični krči (krči v nogah), mialgija bolečina v hrbtu, bolečina v okončini (bolečina v nogi)
English: microcrystalline cellulose, povidone K25, pregelatinized starch, sodium hydroxide, sorbitol
Slovenian: meglumin, mikrokristalna celuloza, povidon K25, predgelirani škrob, natrijev hidroksid,
English: Onduarp is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Slovenian: Če boste želeli dojiti, bo zdravnik za vas izbral drugo zdravilo, še zlasti, če je vaš otrok novorojenček ali se je prezgodaj rodil.
English: When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started (see section 4.3 and
Slovenian: Ob potrjeni nosečnosti je treba zdravljenje z antagonisti II takoj prekiniti in, če je primerno, začeti alternativno zdravljenje (glejte poglavji 4.3 in 4.6).