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.
Croatian: Prethodno prijavljene nuspojave uz jednu od pojedinih komponenti (telmisartan ili amlodipin) mogu biti potencijalne nuspojave i uz Onduarp, čak iako nisu primijećene u kliničkim ispitivanjima ili tijekom razdoblja nakon stavljanja lijeka u promet.
English: The following side effects have been observed with the components telmisartan or amlodipine and may occur also with Onduarp:
Croatian: Sljedeće nuspojave su primijećene uz komponente telmisartan ili amlodipin te se također mogu pojaviti uz Onduarp:
English: Onduarp is contraindicated in patients with severe hepatic impairment (see section 4.3).
Croatian: Onduarp je kontraindiciran kod bolesnika s teškim oštećenjem jetre (vidjeti dio 4.3).
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.
Croatian: Istodobna primjena višestrukih doza amlodipina i simvastatina 80 mg rezultirala je povećanjem izloženosti simvastatinu do 77 % u usporedbi s monoterapijom simvastatina.
English: The blood pressure lowering effect of Onduarp can be increased by concomitant use of other antihypertensive medicinal products.
Croatian: Učinak snižavanja krvnog tlaka Onduarpa se može povećati istovremenom primjenom drugih antihipertenzivnih lijekova.
English: What you need to know before you take Onduarp
Croatian: Što morate znati prije nego počnete uzimati Onduarp
English: In humans, an 80 mg dose of telmisartan almost completely inhibits the angiotensin II evoked blood pressure increase.
Croatian: Kod ljudi, doza od 80 mg telmisartana gotovo potpuno inhibira povišenje krvnog tlaka izazvano angiotenzinom II.
English: Onduarp is available in a folding box containing 28 tablets in aluminium/aluminium blisters.
Croatian: Onduarp je dostupan u kutiji koja sadrži 28 tableta u aluminij/aluminij blisterima.
English: After oral administration of therapeutic doses, amlodipine is well absorbed with peak blood levels between 6-12 hours post dose.
Croatian: Nakon peroralne primjene terapijskih doza, amlodipin se dobro apsorbira s maksimalnim vrijednostima u krvi između 6-12 sati nakon doziranja.
English: Read the package leaflet for further information.
Croatian: Pročitati Uputu o lijeku za dodatne informacije.
English: The adverse reactions reported were in agreement with those anticipated from the safety profiles of the components telmisartan and amlodipine.
Croatian: Prijavljene nuspojave odgovarale su onima koje su predviđene sigurnosnim profilima komponenata telmisartana i amlodipina.
English: Patients with hepatic insufficiency have decreased clearance of amlodipine with resulting increase of approximately 40-60 % in AUC.
Croatian: Bolesnici s insuficijencijom jetre imaju smanjen klirens amlodipina, s rezultirajućim porastom u AUC od oko 40-60%.
English: Reversible biochemical changes in the head of spermatozoa which can impair fecundation have been observed for calcium channel blockers in preclinical and in vitro studies.
Croatian: Reverzibilne biokemijske promjene glave spermija koje mogu poremetiti oplodnju su primijećene za blokatore kalcijevih kanala u pretkliničkim i in vitro studijama.
English: In patients with mild to moderate and severe renal impairment, doubling of plasma concentrations of telmisartan was observed.
Croatian: Kod bolesnika s blagim do umjerenim i teškim oštećenjem bubrega primijećeno je udvostručenje koncentracija telmisartana u plazmi.
English: • Narrowing of the aorta (aortic stenosis).
Croatian: • Suženje aorte (stenoza aorte).
English: If use of the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Croatian: Ako se primjena kombinacije dokaže potrebnom, preporučuje se pažljivo praćenje vrijednosti litija u serumu.
English: The incidence of dry cough was significantly lower in patients treated with telmisartan than in those given angiotensin converting enzyme inhibitors in clinical trials directly comparing the two antihypertensive treatments.
Croatian: Incidencija suhog kašlja bila je znatno niža kod bolesnika liječenih telmisartanom nego kod onih koji su liječeni inhibitorima enzima angiotenzin-konvertaze u kliničkim ispitivanjima u kojima se izravno uspoređuju dva antihipertenzivna liječenja.
English: Telmisartan In patients taking telmisartan alone the following additional side effects have been reported:
Croatian: Telmisartan Kod bolesnika koji uzimaju samo telmisartan prijavljene su sljedeće nuspojave:
English: Method of administration Onduarp can be taken with or without food.
Croatian: Onduarp se može uzimati sa ili bez hrane.
English: The mean absolute bioavailability for telmisartan is about 50 %.
Croatian: Prosječna apsolutna bioraspoloživost telmisartana je oko 50%.
English: Amlodipine has been studied in patients with chronic stable angina, vasospastic angina and angiographically documented coronary artery disease.
Croatian: Amlodipin je ispitivan na bolesnicima s kroničnom stabilnom anginom, vazospastičnom anginom i angiografski potvrđenom koronarnom bolešću.
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system, angiotensin II antagonists and calcium channel blockers; ATC Code: C09DB04.
Croatian: Farmakoterapijska skupina: lijekovi koji djeluju na sustav renin-angiotenzin, antagonisti angiotenzina II i blokatori kalcijevih kanala; ATK oznaka: C09DB04.
English: It cannot be ruled out that strong inhibitors of CYP3A4 (i.e. ketoconazole, itraconazole, ritonavir) may increase the plasma concentrations of amlodipine to a greater extent than diltiazem.
Croatian: Ne može se isključiti da snažni inhibitori CYP3A4 (tj. ketokonazol, itrakonazol, ritonavir) mogu povećati koncentracije amlodipina u plazmi u većoj mjeri nego diltiazem.
English: • ACE inhibitors, angiotensin II receptor antagonists, renin inhibitors.
Croatian: • ACE inhibitori, anatgonisti receptora angiotenzina II, inhibitori renina.
English: Hepatitis, jaundice, hepatic enzyme elevations (mostly consistent with cholestasis
Croatian: Hepatitis, žutica, povišene vrijednosti jetrenih enzima (uglavnom uvijek uz kolestazu)
English: • Narrowing of the blood vessels to one or both kidneys (renal artery stenosis).
Croatian: • Suženje krvnih žila jednog ili oba bubrega (stenoza bubrežne arterije).
English: Hypersensitivity, anaphylactic reaction
Croatian: Preosjetljivost, anafilaktička reakcija
English: Separate reproductive toxicity studies with the combination of telmisartan and amlodipine have not been conducted.
Croatian: Zasebne studije o reproduktivnoj toksičnosti u kombinaciji telmisartana i amlodipina nisu provođene.
English: Both of these substances help to control your high blood pressure: - Telmisartan belongs to a group of substances called “angiotensin-II receptor antagonists”.
Croatian: Obje ove tvari pomažu u kontroli visokog krvnog tlaka: - Telmisartan pripada skupini lijekova koji se nazivaju „antagonisti receptora angiotenzina II“.
English: • if you have diabetes mellitus or impaired kidney function and you are treated with Rasilez.
Croatian: • ako imate dijabetes mellitus ili oštećenu bubrežnu funkciju i liječite se Rasilezom.
English: The reduction in diastolic blood pressure <90 mmHg was achieved in 71.6 %, 74.8 %, 82.1 %, 85.3% of patients respectively.
Croatian: Sniženje dijastoličkog krvnog tlaka <90 mmHg bilo je postignuto kod 71,6%, 74,8%, 82,1%, 85,3% bolesnika, po istom redoslijedu.
English: If your liver is not working properly, the usual dose should not exceed one 40 mg/5 mg tablet or one 40 mg/10 mg tablet per day.
Croatian: Ako imate poremećenu funkciju jetre, uobičajena doza ne smije prelaziti jednu tabletu od 40 mg/5 mg ili jednu tabletu od 40 mg/10 mg dnevno.
English: Because no information is available regarding the use of telmisartan and/or amlodipine during breastfeeding, Onduarp is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while breast-feeding a newborn or preterm infant.
Croatian: Zbog nedostupnih informacija o primjeni telmisartana i/ili amlodipina tijekom dojenja, Onduarp se ne preporučuje, već se preporučuje alternativno liječenje sa sigurnim profilom primjene tijekom dojenja, osobito u dojenju novorođenčadi ili prijevremeno rođene djece.
English: Patients treated with 10 mg amlodipine who experience any dose limiting adverse reactions such as oedema, may be switched to Onduarp 40 mg/5 mg once daily, reducing the dose of amlodipine without reducing the overall expected antihypertensive response.
Croatian: Bolesnici liječeni s 10 mg amlodipina, koji imaju ograničeno doziranje zbog nuspojava, kao što je edem, mogu se prebaciti na Onduarp 40 mg/5 mg tablete jedanput dnevno, snižavajući dozu amlodipina bez smanjenja ukupnog očekivanog antihipertenzivnog učinka.
English: • Elevated potassium levels in your blood.
Croatian: • Povišene vrijednosti kalija u krvi.
English: • if you are taking Rasilez, a medicine used to treat high blood pressure.
Croatian: • ako uzimate Rasilez, lijek koji se primjenjuje u liječenju visokog krvnog tlaka,
English: However, lower plasma concentrations were observed in patients with renal insufficiency undergoing dialysis.
Croatian: Međutim, niže koncentracije u plazmi primijećene su kod bolesnika s insuficijencijom bubrega podvrgnutih dijalizi.
English: In both species, increased plasma renin activity and hypertrophy/hyperplasia of the renal juxtaglomerular cells were observed.
Croatian: Kod obje vrste zabilježene su povišena aktivnost renina u plazmi i hipertrofija/hiperplazija renalnih jukstaglomerularnih stanica.
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.
Croatian: Onduarp kombinira dvije antihipertenzivne tvari s komplementarnim mehanizmima za kontrolu krvnog tlaka kod bolesnika s esencijalnom hipertenzijom: antagonist receptora angiotenzina II, telmisartan i dihidropiridinski blokator kalcijevih kanala, amlodipin.
English: Dual blockade of the renin-angiotensin-aldosterone system (e.g. by administering telmisartan with other blockers of the renin-angiotensin-aldosterone system) is therefore not recommended.
Croatian: Dvostruka blokada sustava renin-angiotenzin-aldosteron (npr. dodavanjem telmisartana drugim blokatorima sustava renin-angiotenzin-aldosteron) se stoga ne preporučuje.
English: Cardiac disorders bradycardia, palpitations
Croatian: Poremećaji srca bradikardija, palpitacije
English: There is an apparent trend to a dose relationship to a time to recovery of baseline systolic blood pressure (SBP).
Croatian: Postoji očigledan trend odnosa doze s vremenom potrebnim za oporavak početne vrijednosti sistoličkog krvnog tlaka (SKT).
English: In preclinical studies, no effects of telmisartan on male and female fertility were observed.
Croatian: U pretkliničkim studijama, nije uočen učinak telmisartana na mušku i ženku plodnost.
English: Amlodipine has not been associated with any adverse metabolic effects or changes in plasma lipids and is suitable for use in patients with asthma, diabetes, and gout.
Croatian: Amlodipin nije povezan s nepoželjnim metaboličkim učincima ili promjenama lipida plazme pa je prikladan za primjenu u bolesnika s astmom, dijabetesom i gihtom.
English: In reproductive toxicity studies in rats, delayed parturition, difficult labour and impaired fetal and pup survival were seen at high doses.
Croatian: U studijama reproduktivne toksičnosti na štakorima, primijećen je odgođen porođaj, otežani trudovi i narušeno fetalno preživljenje, kao i preživljenje štenaca pri visokim dozama.
English: Amlodipine should be used with caution together with CYP3A4 inhibitors.
Croatian: Potreban je oprez u primjeni amlodipina istovremeno s CYP3A4 inhibitorima.
English: The concomitant use of CYP3A4 inducers (i.e. rifampicin, Hypericum perforatum) may lead to a lower plasma concentration of amlodipine.
Croatian: Istovremena primjena CYP3A4 induktora (tj. rifampicin, Hypericum perforatum) može dovesti do nižih koncentracija amlodipina u plazmi.
English: Do not take Onduarp
Croatian: Ne uzimajte Onduarp
English: Amlodipine In patients taking amlodipine alone the following additional side effects have been reported:
Croatian: Amlodipin Kod bolesnika koji su uzimali samo amlodipin prijavljene su sljedeće nuspojave:
English: There is no experience regarding the administration of Onduarp in patients with a recent kidney transplant.
Croatian: Ne postoji iskustvo u pogledu primjene Onduarpa kod bolesnika s nedavno presađenim bubregom.
English: Some people may experience side effects such as fainting, sleepiness, dizziness or a feeling of spinning (vertigo) when they are treated for high blood pressure.
Croatian: Neke osobe mogu imati nuspojave kao što su nesvjestica, pospanost, omaglica, ili osjećaj vrtnje (vrtoglavica) tijekom liječenja visokog krvnog tlaka.
English: Patients should be advised that they may experience adverse reactions such as syncope, somnolence, dizziness, or vertigo during treatment (see section 4.8).
Croatian: Potrebno je upozoriti bolesnike na mogućnost nuspojava, kao što su sinkopa, somnolencija, omaglica, ili vrtoglavica tijekom liječenja (vidjeti dio 4.8).
English: Angiotensin II is a substance produced in the body which causes blood vessels to narrow, thus increasing blood pressure.
Croatian: Angiotenzin II je tvar koja se stvara u tijelu i uzrokuje sužavanje krvnih žila, što dovodi do povišenja krvnog tlaka.
English: Gastric mucosal injury (erosion, ulcers or inflammation) also was noted in rats and dogs.
Croatian: Također su primijećene ozljede želučane sluznice (erozija, ulkusi, ili upala) kod štakora i pasa.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Croatian: Ako imate dodatna pitanja o primjeni ovog lijeka, upitajte liječnika ili ljekarnika.
English: The maximum plasma concentration (Cmax) and, to a smaller extent, the area under the plasma concentration-time curve (AUC), increase disproportionately with dose.
Croatian: Maksimalne koncentracije u plazmi (Cmax), i u manjoj mjeri površina ispod krivulje-vrijeme (AUC) povećavaju se disproporcionalno s dozom.
English: • Rifampicin, St. John's wort.
Croatian: • Rifampicin, Gospina trava.
English: There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
Croatian: Postoji povećan rizik od teške hipotenzije i insuficijencije bubrega kada se bolesnici s bilateralnom stenozom bubrežne arterije ili stenozom arterije jedinog funkcionalnog bubrega liječe lijekovima koji utječu na sustav renin-angiotenzin-aldosteron.
English: In dogs, renal tubular dilation and atrophy were observed.
Croatian: Kod pasa su primijećene renalna tubularna dilatacija i atrofija.
English: The mechanism of the antihypertensive action of amlodipine is due to a direct relaxant effect on vascular smooth muscle, leading to reductions in peripheral vascular resistance and in blood pressure.
Croatian: Mehanizam antihipertenzivnog djelovanja amlodipina temelji se na izravnom relaksirajućem učinku na glatke mišiće krvih žila, čime se smanjuje periferni otpor u krvnim žilama i krvni tlak.
English: Unstable angina pectoris, acute myocardial infarction There are no data to support the use of Onduarp in unstable angina pectoris and during or within one month of a myocardial infarction.
Croatian: Nestabilna angina pektoris, akutni infarkt miokarda Ne postoje podaci koji idu u prilog primjeni Onduarpa u nestabilnoj angini pektoris te tijekom ili u roku 1 mjeseca nakon infarkta miokarda.
English: Telmisartan is mostly eliminated in the bile.
Croatian: Telmisartan se uglavnom eliminira putem žuči.
English: When Onduarp is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Croatian: Kada se Onduarp primjenjuje kod bolesnika s oštećenom funkcijom bubrega, preporučuje se povremeno praćenje serumskih vrijednosti kalija i kreatinina.
English: If hypotension occurs, the patient should be placed in a supine position with elevation of extremities, with salt and volume replacement given quickly.
Croatian: Ako dođe do pojave hipotenzije, bolesnika treba staviti u ležeći položaj s podignutim donjim ekstremitetima, uz brzu nadoknadu volumena i soli.
English: Telmisartan displaces angiotensin II with very high affinity from its binding site at the AT1 receptor subtype, which is responsible for the known actions of angiotensin II.
Croatian: Telmisartan istiskuje angiotenzin II s vrlo visokim afinitetom s njegova mjesta vezivanja na AT1 receptorskom podtipu, zbog čega dolazi do poznatog djelovanja angiotenzina II.
English: Before considering the concomitant use of medicinal products that affect the renin-angiotensinaldosterone system, the benefit risk ratio should be evaluated.
Croatian: Prije razmatranja istovremene primjene lijekova koji utječu na sustav renin-angiotenzinaldosteron potrebno je ocijeniti omjer koristi i rizika.
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.
Croatian: Ako dođe do pojave hipotenzije uz Onduarp, bolesnika staviti u ležeći/supinacijski položaj i, prema potrebi, dati intravensku infuziju obične fiziološke otopine.
English: Therefore, the dose of simvastatin in patients on amlodipine should be limited to 20 mg daily.
Croatian: Stoga, doza simvastatina mora biti ograničena na 20 mg dnevno za bolesnike na amlodipinu.
English: Onduarp has not been studied in any patient population other than hypertension.
Croatian: Onduarp nije ispitivan niti na jednoj drugoj skupini bolesnika osim bolesnika sa hipertenzijom.
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.
Croatian: U istoj skupini amlodipin je bio povezan s povećanim brojem slučajeva plućnog edema unatoč činjenici da nije opažena značajna razlika u incidenciji zatajenja srca u usporedbi s placebom.
English: Reproductive system, and breast disorders erectile dysfunction
Croatian: Poremećaji reproduktivnog sustava i dojki erektilna disfunkcija
English: Sepsis (often called "blood poisoning", is a severe infection with whole-body inflammatory response), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medicine and see their doctor immediately.
Croatian: Sepsa* (često se naziva “trovanje krvi”, teška je infekcija s upalnom reakcijom cijelog tijela), vrlo brzo naticanje kože i sluznice (angioedem); ove nuspojave su rijetke (mogu pogoditi do 1 na 1000 osoba), ali izuzetno teške, te bolesnici moraju prekinuti s primjenom lijeka i trenutno se javiti liječniku.
English: Preclinical data available for the components of this fixed dose combination are reported below.
Croatian: Pretklinički podaci dostupni za komponente ove fiksne kombinacije su prijavljeni u nastavku.
English: In patients with hypertension telmisartan reduces both systolic and diastolic blood pressure without affecting pulse rate.
Croatian: Kod bolesnika s hipertenzijom, telmisartan snižava i sistolički i dijastolički krvni tlak, bez utjecaja na puls.
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.
Croatian: Kao i kod lijekova za snižavanje krvnog tlaka, učinak Onduarpa se može smanjiti kada uzimate NSAIL-e (nesteroidni protuupalni lijekovi, npr. acetilsalicilna kiselina ili ibuprofen) ili kortikosteroide.
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.
Croatian: Kao najizraženije manifestacije predoziranja telmisartanom očekuju se hipotenzija i tahikardija; također su prijavljeni bradikardija, omaglica, povišeni kreatinin u serumu i akutno zatajenje bubrega.
English: As with any antihypertensive medicinal product, excessive reduction of blood pressure in patients with ischaemic cardiomyopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
Croatian: Kao i uz druge antihipertenzivne lijekove, prekomjerno sniženje krvnog tlaka kod bolesnika s ishemičnom kardiopatijom ili ishemičnom kardiovaskularnom bolešću može rezultirati infarktom miokarda ili moždanim udarom.
English: Remove your Onduarp tablet from the blister only directly prior to intake.
Croatian: Izvadite Vašu Onduarp tabletu iz blistera tek neposredno prije primjene.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave su prikazane u padajućem nizu prema težini.
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).
Croatian: Onduarp može povećati učinak snižavanja krvnog tlaka drugih lijekova koji se primjenjuju u liječenju visokog krvnog tlaka ili lijekova s potencijalom za snižavanje krvnog tlaka (npr. baklofen, amifostin, neuroleptici, ili antidepresivi).
English: Telmisartan does not exhibit any partial agonist activity at the AT1 receptor.
Croatian: Telmisartan ne pokazuje parcijalno agonističko djelovanje na AT1 receptoru.
English: Angiotensin II receptor antagonists should not be initiated during pregnancy.
Croatian: Liječenje antagonistima receptora angiotenzina II se ne smije započinjati tijekom trudnoće.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove (EMA): http://www.ema.europa.eu/.
English: Remove the tablets from the blister only directly prior to intake.
Croatian: Izvaditi tablete iz blistera tek neposredno prije primjene.
English: Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by e.g. vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Croatian: Simptomatska hipotenzija, osobito nakon prve doze, može se pojaviti kod bolesnika s deplecijom volumena i/ili natrija, zbog npr. snažne diuretske terapije, restrikcije soli u prehrani, proljeva, ili povraćanja.
English: Amlodipine is relatively vessel-selective, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells.
Croatian: Amlodipin je relativno selektivan za krvne žile, s većim učinkom na glatke mišićne stanice krvnih žila nego na stanice srčanog mišića.
English: If any of the above applies to you, tell your doctor or pharmacist before taking Onduarp.
Croatian: Ako se nešto od navedenog odnosi na Vas, obavijestite liječnika ili ljekarnika prije početka primjene Onduarpa.
English: Increased incidence of sepsis has been observed with telmisartan only, however can not be ruled out for Onduarp.
Croatian: Povećana učestalost sepse je primijećena samo uz telmisartan, ali ne može se isključiti za Onduarp.