FrancophonIA/ELRC3.0 huggingface dataset:
English: In an 8-week multicenter, randomised, double-blind, placebo-controlled, parallel group factorial study in 1461 patients with mild to severe hypertension (mean seated diastolic blood pressure ≥95 and ≤119 mmHg), treatment with each combination dose of Onduarp resulted in significantly greater diastolic and systolic blood pressure reductions and higher control rates compared to the respective monotherapy components.
Slovenian: V 8-tedenski, multicentrični, dvojno slepi, s placebom nadzorovani faktorski študiji pri paralelnih skupinah naključno izbranih bolnikov, ki je zajela 1461 bolnikov z blago do hudo hipertenzijo (srednji diastolični krvni tlak v sedečem položaju so imeli ≥ 95 in < 119 mm Hg), sta bila znižanje diastoličnega in sistoličnega krvnega tlaka ter odstotek uravnanega krvnega tlaka med zdravljenjem s kombiniranimi odmerki zdravila Onduarp značilno večja kot med zdravljenjem s posamičnima učinkovinama.
English: As a consequence of inhibiting the renin-angiotensin-aldosterone system, hypotension, syncope, hyperkalaemia and changes in renal function (including acute renal failure) have been reported in susceptible individuals, especially if combining medicinal products that affect this system.
Slovenian: Pri občutljivih posameznikih so poročali o hipotenziji, sinkopi, hiperkaliemiji in spremembah ledvičnega delovanja (tudi akutni ledvični odpovedi) kot posledicah zaviranja renin-angiotenzinaldosteronskega sistema, zlasti pri uporabi kombinacije zdravil, ki delujejo na ta sistem.
English: Adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of Onduarp containing the same component doses.
Slovenian: Bolniki, ki jemljejo telmisartan in amlodipin v dveh ločenih tabletah, lahko začnejo jemati tablete zdravilaOnduarp, ki vsebujejo enaka odmerka obeh učinkovin.
English: How to take Onduarp
Slovenian: Kako jemati zdravilo Onduarp
English: If any of the above applies to you, tell your doctor or pharmacist before taking Onduarp.
Slovenian: Če imate katero od naštetih stanj, o tem obvestite zdravnika ali farmacevta, preden boste vzeli zdraviloOnduarp.
English: Furthermore it was shown that some patients not adequately controlled with Onduarp 40 mg/10 mg had additional blood pressure reduction by uptitration to Onduarp 80 mg/10 mg.
Slovenian: Poleg tega se je pri nekaterih bolnikih, pri katerih zdravilo Onduarp v odmerkih po 40 mg/10 mg ni ustrezno uravnalo krvnega tlaka, izkazalo, da se je le ta dodatno znižal, ko so odmerek zdravila Onduarp povečali na 80 mg/10 mg.
English: Method of administration Onduarp can be taken with or without food.
Slovenian: Zdravilo Onduarp lahko bolniki jemljejo s hrano ali brez nje.
English: Musculoskeletal and connective tissue disorders Rare:
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Redki:
English: Hyperkalaemia may be fatal in the elderly, in patients with renal insufficiency, in diabetic patients, in patients concomitantly treated with other medicinal products that may increase potassium levels, and/or in patients with intercurrent events.
Slovenian: Hiperkaliemija je lahko usodna za starejše bolnike in tiste z ledvičnim popuščanjem ali s sladkorno boleznijo ter vse, ki se sočasno zdravijo z drugimi zdravili, katera lahko povečajo raven kalija, ali bolnike s sočasnimi dogodki.
English: In a follow-up, long term, placebo controlled study (PRAISE-2) of amlodipine in patients with NYHA III and IV heart failure without clinical symptoms or objective findings suggestive of underlying ischaemic disease, on stable doses of ACE inhibitors, digitalis, and diuretics, amlodipine had no effect on total cardiovascular mortality.
Slovenian: V dolgotrajni, nadaljevalni, s placebom nadzorovani študiji (PRAISE-2) o spremljanju zdravljenja z amlodipinom pri bolnikih s srčnim popuščanjem stopenj III. in IV. po NYHA, ki niso imeli kliničnih simptomov ali objektivnih izvidov, kateri bi kazali na ishemično bolezen, in so se zdravili s stabilnimi odmerki zaviralcev ACE, digitalisa in diuretikov, amlodipin ni vplival na skupno srčno-žilno umrljivost.
English: In patients with mild to moderate hepatic impairment Onduarp should be administered with caution.
Slovenian: Bolnikom z blago do zmerno jetrno okvaro je treba zdravilo Onduarp dajati previdno.
English: • NSAIDs (non steroidal anti-inflammatory medicines, e.g. acetylsalicylic acid or ibuprofen),
Slovenian: • nesteroidna protivnetna zdravila (na primer acetilsalicilna kislina ali ibuprofen), heparin,
English: Vascular disorders hypotension, orthostatic hypotension, flushing
Slovenian: Žilne bolezni hipotenzija, ortostatska hipotenzija, rdečica
English: These pharmacologicallymediated undesirable effects, known from preclinical studies with both angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists, were prevented by oral saline supplementation.
Slovenian: Te farmakološke neželene učinke, ki so jih odkrile predklinične študije tako pri zaviralcih angiotenzinske konvertaze kot antagonistih receptorjev angiotenzina II, so preprečili s peroralnim dajanjem fiziološke raztopine.
English: Telmisartan and Amlodipine are not removed by haemodialysis.
Slovenian: Telmisartan in amlodipin se med hemodializo ne odstranita.
English: Preclinical data available for the components of this fixed dose combination are reported below.
Slovenian: Predklinični podatki o učinkovinah fiksne kombinacije so navedeni v nadaljevanju.
English: However, the clinical relevance of this finding is uncertain.
Slovenian: Klinični pomen tega izsledka ni povsem pojasnjen.
English: The adverse reactions reported were in agreement with those anticipated from the safety profiles of the components telmisartan and amlodipine.
Slovenian: Neželeni učinki, o katerih so poročali, so se ujemali z učinki, ki veljajo za pričakovane na podlagi varnostnih profilov učinkovin zdravila, telmisartana in amlodipina.
English: Remove the tablets from the blister only directly prior to intake.
Slovenian: Tablete je treba vzeti iz pretisnega omota tik pred jemanjem.
English: Each tablet contains 168.64 mg sorbitol (E420).
Slovenian: Pomožne snovi z znanim učinkom: Ena tableta vsebuje 168,64 mg sorbitola (E420).
English: Pharmacokinetic of the fixed dose combination (FDC) The rate and extent of absorption of Onduarp are equivalent to the bioavailability of telmisartan and amlodipine when administered as individual tablets.
Slovenian: Hitrost in obseg absorpcije zdravila Onduarp sta enakovredna biološki uporabnosti telmisartana in amlodipina, kadar jih bolniki jemljejo kot posamični zdravili.
English: Blood and lymphatic system disorders Very rare:
Slovenian: Bolezni krvi in limfatičnega sistema Zelo redki:
English: Alopecia, purpura, skin discolouration, hyperhidrosis Angioedema, erythema multiforme, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome, photosensitivity
Slovenian: angioedem, multiformni eritem, urtikarija, eksfoliativni dermatitis, Stevens-Johnsonov sindrom, fotosenzitivnost
English: Contents of the pack and other information What Onduarp contains - The active substances are telmisartan and amlodipine.
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Onduarp - Zdravilni učinkovini sta telmisartan in amlodipin.
English: No data from controlled clinical studies with the Fixed Dose Combination or with the individual components are available.
Slovenian: O uporabi fiksne kombinacije ali posameznih sestavin ni na voljo podatkov iz nadzorovanih kliničnih študij.
English: Remove your Onduarp tablet from the blister only directly prior to intake.
Slovenian: Tableto zdravila Onduarp vzemite iz pretisnega omota tik, preden jo boste zaužili.
English: A placebo controlled study (PRAISE) designed to evaluate patients in NYHA Class III-IV heart failure receiving digoxin, diuretics and ACE inhibitors has shown that amlodipine did not lead to an increase in risk of mortality or combined mortality and morbidity with heart failure.
Slovenian: S placebom nadzorovana študija (PRAISE), v kateri so bolniki s srčnim popuščanjem III. do IV. stopnje po NYHA jemali digoksin, diuretike in zaviralce ACE, je pokazala, da amlodipin pri srčnem popuščanju ne poveča tveganja smrti niti umrljivosti in zbolevnosti.
English: Patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of Onduarp containing the same component doses in one tablet once daily, e.g. to enhance convenience or compliance
Slovenian: Bolniki, ki jemljejo telmisartan in amlodipin v dveh ločenih tabletah, lahko začnejo enkrat na dan jemati tablete zdravilaOnduarp, ki vsebujejo enaka odmerka obeh učinkovin, kar lahko poenostavi jemanje in izboljša bolnikovo sodelovanje v zdravljenju.
English: Each tablet contains 337.28 mg sorbitol (E420).
Slovenian: Pomožne snovi z znanim učinkom: Ena tableta vsebuje 337,28 mg sorbitola (E420).
English: Myocardial infarction, arrhythmia, ventricular tachycardia, atrial fibrillation
Slovenian: miokardni infarkt, aritmija, prekatna tahikardija, fibrilacija preddvorov
English: Concomitant use to be taken into account
Slovenian: Sočasno zdravljenje, ki ga je treba upoštevati
English: Add on therapy Onduarp is indicated in adults whose blood pressure is not adequately controlled on amlodipine.
Slovenian: Zdravilo Onduarp je indicirano pri odraslih bolnikih, pri katerih krvnega tlaka ne moremo ustrezno uravnati z amlodipinom.
English: Patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance.
Slovenian: Pri bolnikih z boleznimi z zaporo žolča ali zmanjšanim jetrnim delovanjem je njegov očistek predvidoma manjši.
English: Medicinal products with blood pressure lowering potential Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the hypotensive effects of all antihypertensives including Onduarp, e.g. baclofen, amifostine, neuroleptics or antidepressants.
Slovenian: Zdravila, ki zaradi svojih farmakoloških lastnosti lahko povečajo hipotenzivne učinke vseh antihipertenzivov, tudi zdravilaOnduarp, so na primer baklofen, amifostin, nevroleptiki ali antidepresivi.
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Slovenian: Predklinični podatki, pridobljeni v običajnih farmakoloških študijah o varnosti, toksičnosti po večkratnih odmerkih, genotoksičnosti in kancerogenem delovanju ne kažejo na posebno tveganje za ljudi.
English: Common side effects (may affect up to 1 in 10 people): Dizziness, ankle swelling (oedema).
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov): omotica, otekanje gležnjev (edem).
English: Onduarp tablets contain two active substances called telmisartan and amlodipine.
Slovenian: Zdravilo Onduarp vsebujejo dve zdravilni učinkovini, telmisartan in amlodipin.
English: • Biliary obstructive disorders and severe hepatic impairment
Slovenian: • bolezni z zaporo žolča in huda jetrna okvara,
English: • Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the excipients listed in section 6.1
Slovenian: • preobčutljivost za zdravilni učinkovini, derivate dihidropiridina ali katerokoli pomožno snov,
English: Increased incidence of sepsis has been observed with telmisartan only, however can not be ruled out for Onduarp.
Slovenian: Povečano pojavnost sepse so opazili samo pri telmisartanu, vendar je pri zdravilu Twynsta ne moremo izključiti.
English: • Diabetes.
Slovenian: • sladkorno bolezen,
English: The following side effects have been observed with the components telmisartan or amlodipine and may occur also with Onduarp:
Slovenian: Neželeni učinki, ki so jih opazili pri učinkovinah zdravila telmisartanu ali amlodipinu in se lahko pojavijo tudi pri zdraviluOnduarp:
English: Due to the slow onset of action, acute hypotension is not a feature of amlodipine administration.
Slovenian: Zaradi počasnega začetka delovanja pri zdravljenju z amlodipinom ne prihaja do pojava akutne hipotenzije.
English: Gastro-intestinal disorders abdominal pain, diarrhoea, nausea vomiting, gingival hypertrophy, dyspepsia, dry mouth
Slovenian: Bolezni prebavil trebušna bolečina, driska, navzea bruhanje, hipertrofija dlesni, dispepsija, suha usta
English: There was no effect on the fertility of rats treated orally with amlodipine maleate (males for 64 days and females for 14 days prior to mating) at doses of up to 10 mg amlodipine/kg/day (about 10 times the Maximum Recommended Human Dose of 10 mg/day on an mg/m2 basis).
Slovenian: Peroralni odmerki amlodipinijevega maleata do 10 mg amlodipina na kilogram na dan (odmerek, ki je približno 10-krat večji od največjega priporočenega odmerka za ljudi 10 mg na dan na osnovi mg/m2) niso vplivali na plodnost podgan (samci 64 dni in samice 14 dni pred parjenjem).
English: Angioedema (with fatal outcome), drug eruption, toxic skin eruption, urticaria
Slovenian: angioedem (lahko povzroči tudi smrt), medikamentni izpuščaj, toksični kožni izpuščaj, urtikarija
English: Weight increased, weight decreased
Slovenian: povečana telesna masa, zmanjšana telesna masa
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.
Slovenian: Pri nekaterih ljudeh se lahko med zdravljenjem visokega krvnega tlaka pojavijo neželeni učinki, kot so omedlevica, zaspanost, omotica ali občutek vrtenja (vrtoglavica).
English: Amlodipine bioavailability is not affected by food ingestion.
Slovenian: Hrana ne vpliva na amlodipinovo biološko uporabnost.
English: Grapefruit juice and grapefruit should not be consumed when you take Onduarp.
Slovenian: Ko jemljete zdraviloOnduarp, ne smete piti grenivkinega soka ali jesti grenivke.
English: What Onduarp contains - The active substances are telmisartan and amlodipine.
Slovenian: Kaj vsebuje zdravilo Onduarp - Zdravilni učinkovini sta telmisartan in amlodipin.
English: Onduarp 80 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled on Onduarp 40 mg/10 mg or Onduarp 80 mg/5 mg.
Slovenian: Tablete Onduarp po 80 mg/10 mg lahko prejemajo bolniki, pri katerih krvnega tlaka ni mogoče ustrezno uravnati z zdravilom Onduarp po 40 mg/10 mg ali zdravilom Onduarp po 80mg/5 mg.
English: Individual dose titration with the components (i.e. amlodipine and telmisartan) is recommended before changing to the fixed dose combination.
Slovenian: Pred prehodom na fiksno kombinacijo priporočajo individualno prilagoditev odmerkov posameznih učinkovin (tj. amlodipina in telmisartana).
English: Cumulative urinary excretion is <1 % of dose.
Slovenian: S sečem se kumulativno izloči manj kot 1 % odmerka.
English: Investigations Uncommon: Rare:
Slovenian: zelo redki: neznana pogostnost:
English: In another multicentre, randomised, double-blind, active-controlled, parallel group study, a total of 947 patients with mild to severe hypertension who were not adequately controlled on amlodipine 10 mg received Onduarp (40 mg/10 mg or 80 mg/10 mg) or amlodipine alone (10 mg).
Slovenian: V drugi multicentrični, dvojno slepi raziskavi z aktivnim primerjalnim zdravilom in paralelnimi skupinami je 947 naključnih bolnikov z neustrezno uravnano blago do hudo hipertenzijo med zdravljenjem z 10-mg odmerkom amlodipina jemalo zdravilo Onduarp (40 mg/10 mg ali 80 mg/10 mg) ali amlodipin kot samostojno zdravilo (10 mg).
English: The overall incidence of adverse reactions with Onduarp in the clinical trial programme was low with only 12.7 % of patients on treatment experiencing adverse reactions.
Slovenian: Neželene učinke je imelo samo 12,7 % bolnikov.
English: In a further multicentre, randomised, double-blind, active-controlled, parallel group study, a total of 1097 patients with mild to severe hypertension who were not adequately controlled on amlodipine 5 mg received Onduarp (40 mg/5 mg or 80 mg/5 mg) or amlodipine alone (5 mg or 10 mg).
Slovenian: V multicentrični, dvojno slepi študiji z aktivnim primerjalnim zdravilom in paralelnimi skupinami je 1097 naključno izbranih bolnikov z blago do hudo neustrezno uravnano hipertenzijo med zdravljenjem s 5 mg amlodipina jemalo zdravilo Onduarp (40 mg/5 mg ali 80 mg/5 mg) ali amlodipin kot samostojno zdravilo (5 mg ali 10 mg).
English: Other antihypertensive medicinal products
Slovenian: Nesteroidna protivnetna zdravila
English: Skin and subcutaneous tissue disorders pruritus eczema, erythema, rash
Slovenian: Bolezni kože in podkožja pruritus ekcem, eritem, izpuščaj
English: * Most cases of abnormal liver function and liver disorder from post-marketing experience with telmisartan occurred in Japanese patients.
Slovenian: *O večini primerov nenormalnega jetrnega delovanja ali jetrne bolezni so v obdobju po začetku trženja telmisartana poročali pri japonskih bolnikih, pri katerih tudi sicer obstaja večja verjetnost teh neželenih učinkov.
English: Metabolism and nutrition disorders Very rare:
Slovenian: Presnovne in prehranske motnje Zelo redki:
English: Close monitoring of renal function is advisable if co-administration is considered necessary.
Slovenian: Če je hkratno dajanje potrebno, je treba natančno spremljati ledvično funkcijo.
English: LIST OF EXCIPIENTS Contains sorbitol (E420).
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje sorbitol (E 420).
English: In patients not controlled on amlodipine 5 mg the oedema rates were 4.4 % for 40 mg/5 mg and 80 mg/5 mg and 24.9 % for amlodipine 10 mg.
Slovenian: Pri bolnikih z neuravnanim krvnim tlakom med zdravljenjem z amlodipinom v odmerkih po 5 mg, je bila pogostost edemov med jemanjem kombinacije v odmerkih po 40 mg/5 mg in 80 mg/5 mg 4,4 % in med jemanjem amlodipina v odmerkih po 10 mg 24,9 %.
English: Oedema rates were significantly lower with 40 mg/5 mg and 80 mg/5 mg compared to amlodipine 10 mg (4.4 % versus 24.9 %, respectively).
Slovenian: Odstotek edemov je bil pri zdravljenju s kombinacijama po 40 mg/5 mg in 80 mg/5 mg značilno manjši kot pri zdravljenju z amlodipinom po 10 mg (4,4 % v primerjavi s 24,9 %).
English: In the factorial design trial the oedema rates were 1.3% with Onduarp 40 mg/5 mg and 80 mg/5 mg, 8.8 % with Onduarp 40 mg/10 mg and 80 mg/10 mg and 18.4 % with Amlodipine 10 mg.
Slovenian: V preskušanju z več dejavniki je bila pogostnost edemov pri zdravilu Onduarp po 40 mg/5 mg in 80 mg/5 mg 1,3 %, pri zdravilu Onduarp po 40 mg/10 mg in 80 mg/10 mg 8,8 % in pri amlodipinu po 10 mg 18,4 %.
English: The pharmacokinetics of amlodipine are not significantly influenced by renal impairment.
Slovenian: Ledvična okvara ne vpliva pomembneje na farmakokinetiko amlodipina.
English: No interactions between the two components of this fixed dose combinations have been observed in clinical studies.
Slovenian: V kliničnih študijah niso zasledili interakcij med učinkovinama te fiksne kombinacije.
English: Medicinal products or therapeutic classes of medicinal products that may provoke hyperkalaemia are salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal anti-inflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim.
Slovenian: Zdravila ali terapevtske skupine zdravil, ki lahko povzročijo hiperkaliemijo so nadomestki soli s kalijem, diuretiki, ki zadržujejo kalij, zaviralci ACE, antagonisti receptorjev angiotenzina II, nesteroidna protivnetna zdravila (tudi selektivni zaviralci ciklooksigenaze 2); heparin, imunosupresivi (ciklosporin ali takrolimus) in trimetoprim; - sočasni dogodki, zlasti dehidracija, akutna srčna dekompenzacija, presnovna acidoza, poslabšanje ledvičnega delovanja, nenadno poslabšanje ledvične bolezni (na primer infekcijske bolezni), celična liza (na primer akutna ishemija uda, rabdomioliza, obsežna poškodba).
English: General disorders and administration site conditions peripheral oedema asthenia, chest pain, fatigue, oedema malaise
Slovenian: Splošne težave in spremembe na mestu aplikacije bolečina v prsih, utrujenost, edem slabo počutje
English: Upper respiratory tract infection including pharyngitis and sinusitis, urinary tract infection including cystitis Sepsis including fatal outcome1
Slovenian: okužbe zgornjih dihalnih poti, tudi faringitis in sinuzitis; okužbe sečil, tudi cistitis
English: Onduarp 40 mg/5 mg tablets may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg alone.
Slovenian: Tablete Onduarp po 40 mg/5 mg lahko prejemajo bolniki, pri katerih krvnega tlaka ni mogoče ustrezno uravnati s samim amlodipinom po 5 mg.
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.
Slovenian: Ker o uporabi telmisartana in/ali amlodipina med dojenjem ni podatkov, uporabe zdravila Onduarp ne priporočajo.
English: The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.2, 4.4, 4.5).
Slovenian: Sočasna uporaba telmisartana in aliskirena je kontraindicirana pri bolnikih s sladkorno boleznijo ali ledvično okvaro (GFR < 60 ml/min/1,73 m2) (glejte poglavja 4.2, 4.4 in 4.5).
English: There is no experience regarding the administration of Onduarp in patients with a recent kidney transplant.
Slovenian: Pri bolnikih z nedavno presajeno ledvico ni izkušenj z uporabo zdravilaOnduarp.
English: Concomitant use of telmisartan with aliskiren is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3).
Slovenian: Sočasna uporaba telmisartana in aliskirena je kontraindicirana pri bolnikih z ledvično okvaro (GFR < 60 ml/min/1,73 m2) (glejte poglavje 4.3).
English: The blood pressure lowering effect of Onduarp can be increased by concomitant use of other antihypertensive medicinal products.
Slovenian: Druga antihipertenzivna zdravila Sočasno jemanje drugih antihipertenzivov lahko poveča antihipertenzivni učinek zdravilaOnduarp.
English: Common
Slovenian: Pogostni
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.
Slovenian: V predkliničnih in in vitro študijah so za zaviralce kalcijevih kanalov poročali o reverzibilnih biokemičnih spremembah na glavah semenčic, ki bi lahko oslabila sposobnost oploditve.
English: Change of bowel habit Pancreatitis, gastritis
Slovenian: pankreatitis, gastritis
English: Meglumine
Slovenian: napenjanje
English: Therefore, in these patients an appropriate blood glucose monitoring should be considered; a dose adjustment of insulin or antidiabetics may be required when indicated.
Slovenian: Če za to obstaja indikacija, je včasih treba prilagoditi odmerek insulina ali peroralnega antidiabetika.
English: Onduarp 80 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled with Onduarp 40 mg/5 mg.
Slovenian: Tablete Onduarp po 80 mg/5 mg lahko prejemajo bolniki, pri katerih krvnega tlaka ni mogoče ustrezno uravnati z zdravilom Onduarp po 40 mg/5 mg.
English: - If you get any of the side effects, talk to your doctor or pharmacist.
Slovenian: - Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom ali farmacevtom.
English: Onduarp 40 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg.
Slovenian: Tablete Onduarp po 40 mg/10 mg lahko prejemajo bolniki, pri katerih krvnega tlaka ni mogoče ustrezno uravnati z amlodipinom po 10 mg.