FrancophonIA/ELRC3.0 huggingface dataset:
English: • Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the excipients listed in section 6.1
Danish: • Overfølsomhed over for de aktive stoffer, dihydropyridinderivater eller over for et eller flere af hjælpestofferne anført i pkt.
English: Investigations hepatic enzymes increased blood uric acid increased
Danish: Undersøgelser forhøjede leverenzymtal forhøjet urinsyreniveau i blodet
English: Other medicines and Onduarp
Danish: Brug af anden medicin sammen med Onduarp
English: Remove your Onduarp tablet from the blister only directly prior to intake.
Danish: Tryk først Onduarp tabletten ud af blisterkortet, umiddelbart før du skal tage den.
English: Slow heart beat, dizziness, reduced kidney function including kidney failure, marked and prolonged low blood pressure including shock and death have also been reported.
Danish: Desuden er der set tilfælde af langsom hjerterytme, svimmelhed, nedsat nyrefunktion, herunder nyresvigt, udtalt og langvarigt lavt blodtryk, herunder shock og død.
English: Telmisartan In patients taking telmisartan alone the following additional side effects have been reported:
Danish: Telmisartan Hos patienter, der tager telmisartan alene, er følgende yderligere bivirkninger set:
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.
Danish: Amlodipin har uden problemer været administreret sammen med digoxin, warfarin, atorvastatin, sildenafil, antacida (aluminiumhydroxid, magnesiumhydroxid, simeticon), cimetidin, ciclosporin, antibiotika og perorale hypoglykæmiske lægemidler.
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
Danish: Patienter, der får telmisartan og amlodipin fra separate tabletter, kan i stedet én gang dagligt få Onduarp tabletter, der indeholder de samme aktive stoffer i én tablet, med henblik på f.eks. større bekvemmelighed eller bedre komplians.
English: In dogs, renal tubular dilation and atrophy were observed.
Danish: Hos hunde sås tubulær dilatation og atrofi.
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).
Danish: Onduarp kan øge den blodtrykssænkende virkning af andre lægemidler, der bruges til behandling af højt blodtryk, eller af lægemidler, der potentielt kan sænke blodtrykket (f.eks. baklofen, amifostin, antipsykotika eller antidepressiva).
English: The adverse reactions reported were in agreement with those anticipated from the safety profiles of the components telmisartan and amlodipine.
Danish: De rapporterede bivirkninger var i overensstemmelse med de forventede bivirkninger fra sikkerhedsprofilen for stofferne telmisartan og amlodipin.
English: Administration of amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients resulting in increased blood pressure lowering effects (see section
Danish: Administration af amlodipin sammen med grapefrugt eller grapejuice anbefales ikke, da biotilgængeligheden kan øges hos nogle patienter, hvilket kan resultere i en kraftigere blodtryksreduktion (se pkt.
English: Patients should be advised that they may experience adverse reactions such as syncope, somnolence, dizziness, or vertigo during treatment (see section 4.8).
Danish: Patienterne skal dog oplyses om, at de kan opleve bivirkninger såsom synkope, døsighed, svimmelhed eller vertigo under behandlingen (se pkt.
English: Do not take Onduarp
Danish: Tag ikke Onduarp
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.
Danish: Som ved andre blodtrykssænkende lægemidler kan virkningen af Onduarp være nedsat, hvis du samtidig tager NSAID'er (nonsteroide antiinflammatoriske lægemidler, f.eks. acetylsalicylsyre eller ibuprofen) eller kortikosteroider.
English: Anaemia Thrombocytopenia, eosinophilia
Danish: Anæmi Trombocytopeni, eosinofili
English: Adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of Onduarp containing the same component doses.
Danish: Voksne patienter, der får telmisartan og amlodipin fra separate tabletter, kan i stedet få Onduarp tabletter, der indeholder de samme doser af de aktive stoffer.
English: • Narrowing of the blood vessels to one or both kidneys (renal artery stenosis).
Danish: • Har forsnævring af blodkar, der fører til den ene eller begge nyrer (nyrearteriestenose).
English: • Biliary obstructive disorders and severe hepatic impairment
Danish: • Biliære obstruktive lidelser og svært nedsat leverfunktion
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.
Danish: Yderlig blev vist, at hos nogle patienter, der ikke var tilstrækkeligt kontrolleret med Onduarp 40 mg/10 mg, blev blodtrykket yderligere reduceret ved optitrering til Onduarp 80 mg/10 mg.
English: • if you are taking Rasilez, a medicine used to treat high blood pressure.
Danish: • hvis du tager Rasilez - et lægemiddel, der bruges til behandling af forhøjet blodtryk.
English: Pregelatinised starch Sodium hydroxide Sorbitol (E420)
Danish: Prægelatineret stivelse Natriumhydroxid Sorbitol (E420)
English: Posology The recommended dose of Onduarp is one tablet per day.
Danish: Dosering Den anbefalede dosis af Onduarp er én tablet dagligt.
English: When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started.
Danish: Ved konstateret graviditet bør behandling med angiotensin II-receptorantagonister stoppes øjeblikkeligt, og om nødvendigt bør en alternativ behandling påbegyndes.
English: • Rasilez, a medicine used to treat high blood pressure.
Danish: • Rasilez - et lægemiddel, der bruges til behandling af højt blodtryk.
English: What you need to know before you take Onduarp
Danish: Det skal du vide, før du begynder at tage Onduarp
English: Tendon pain (tendinitis like symptoms)
Danish: Smerter i sener (tendinitis-lignende symptomer)
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.
Danish: Der er ingen data, som understøtter anvendelsen af Onduarp ved ustabil angina pectoris eller under og inden for en måned efter myokardieinfarkt.
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.
Danish: NSAID'er (dvs. acetylsalicylsyre ved antiinflammatoriske dosisregimener, COX-2-hæmmere og ikkeselektive NSAID'er) kan reducere den antihypertensive virkning af angiotensin IIreceptorantagonister.
English: • if you have severe liver problems or biliary obstruction (problems with drainage of the bile from the liver and gall bladder).
Danish: • hvis du har svære leverproblemer eller galdevejsobstruktion (problemer med afløb af galde fra leveren eller galdeblæren).
English: Renal impairment including acute renal failure General disorders and administration site conditions Rare:
Danish: Nedsat nyrefunktion, herunder akut nyresvigt Almene symptomer og reaktioner på administrationsstedet Sjælden:
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.
Danish: Hyperkaliæmi kan medføre døden hos ældre patienter, patienter med nyresvigt, diabetespatienter, patienter, der samtidig bliver behandlet med andre lægemidler, der kan øge kaliumniveauet og/eller patienter med interkurrente hændelser.
English: Telmisartan is highly bound to plasma protein in renal-insufficient subjects and cannot be removed by dialysis.
Danish: Hos patienter med nyreinsufficiens er telmisartan i høj grad bundet til plasmaprotein og det kan ikke fjernes ved dialyse.
English: The time to reach peak plasma concentrations of amlodipine is similar in elderly and younger subjects.
Danish: For amlodipin var tiden, der går før den maksimale plasmakoncentration er opnået, er ens hos ældre og yngre patienter.
English: After oral administration of therapeutic doses, amlodipine is well absorbed with peak blood levels between 6-12 hours post dose.
Danish: Amlodipin absorberes godt efter oral indgift af terapeutiske doser, og der opnås maksimale blodkoncentrationer 6-12 timer efter indgift.
English: Common side effects (may affect up to 1 in 10 people): Dizziness, ankle swelling (oedema).
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 brugere): Svimmelhed, hævede ankler (ødem).
English: • Second and third trimesters of pregnancy (see sections 4.4 and 4.6)
Danish: • Graviditet i andet og tredje trimester (se pkt.
English: • Heart trouble.
Danish: • Hjerteproblemer.
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.
Danish: Disse farmakologisk-medierede uønskede virkninger, som er kendt fra prækliniske studier med både ACEhæmmere og angiotensin II-receptorantagonister, blev forebygget ved peroralt saltvandstilskud.
English: • ACE inhibitors, angiotensin II receptor antagonists, renin inhibitors.
Danish: • ACE-hæmmere, angiotensin II-receptorantagonister, renin-hæmmere.
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.
Danish: I prækliniske sikkerhedsstudier medførte doser, hvor eksponeringen var sammenlignelig med den i det klinisk terapeutiske område, fandt man reduktion af røde blodcelleparametre (erytrocytter, hæmoglobin, hæmatokrit), ændringer i den renale hæmodynamik (forhøjet carbamid-niveau og kreatinin) såvel som forhøjet serumkalium hos normotensive dyr.
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.
Danish: Din læge kan vælge en anden behandling til dig, hvis du ønsker at amme - især hvis dit barn er nyfødt eller født for tidligt.
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.
Danish: Aluminium/aluminium-blisterkort (PA/Al/PVC/Al) i æske indeholdende 28 tabletter eller perforerede enkeltdosis-aluminium/aluminium-blisterkort (PA/Al/PVC/Al) i multipakninger indeholdende 360 (4 pakninger med 90 x 1) tabletter.
English: Onduarp is contraindicated in patients with severe hepatic impairment (see section 4.3).
Danish: Onduarp er kontraindiceret til patienter med svært nedsat leverfunktion (se pkt.
English: No clear evidence of a teratogenic effect was observed, however at toxic dose levels of telmisartan an effect on the postnatal development of the offspring such as lower body weight and delayed eye opening was observed.
Danish: Ved toksiske doser af telmisartan blev der imidlertid observeret en virkning på den postnatale udvikling af afkommet, såsom lavere legemsvægt og forsinket åbning af øjnene.
English: • Kidney disease or kidney transplant.
Danish: • Nyresygdom eller har fået en nyretransplantation.
English: PHARMACEUTICAL FORM AND CONTENTS Component of a multipack comprising 4 packs, each containing 90 x 1 tablets
Danish: LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) Del af en multipakning med 4 pakninger, hver med 90 x 1 tabletter
English: There is no experience regarding the administration of Onduarp in patients with a recent kidney transplant.
Danish: Der er ingen data for anvendelse af Onduarp hos patienter, som kort tid forinden har fået foretaget en nyretransplantation.
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.
Danish: 32,7 - 51,8% patienter i en delgruppe med 1.050 moderat til svært hypertensive patienter (DBP ≥100 mmHg), responderede i tilstrækkelig grad på monoterapi med enten telmisartan eller amlodipin.
English: Furthermore low blood pressure may be aggravated by alcohol.
Danish: Derudover kan indtagelse af alkohol sænke blodtrykket.
English: Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).
Danish: Behandling med angiotensin II-receptorantagonist i andet og tredje trimester er kendt for at inducere føtotoksicitet hos mennesker (nedsat nyrefunktion, oligohydramnios, forsinket ossifikation af kraniet) og neonatal toksicitet (nyresvigt, hypotension, hyperkaliæmi) (se pkt.
English: Additional information on individual components
Danish: Yderligere oplysninger for de aktive stoffer
English: Colloidal anhydrous silica Brilliant blue FCF (E 133) Ferric oxide black (E172) Ferric oxide yellow (E172) Magnesium stearate Maize starch
Danish: Kolloid vandfri silica Brilliant blue FCF (E133) Sort jernoxid (E172) Gul jernoxid (E172) Magnesiumstearat Majsstivelse
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.
Danish: I et 8-ugers randomiseret, dobbeltblindet, placebokontrolleret, faktuelt, parallelgruppe-, multicenterstudie med 1.461 patienter med let til svær hypertension (gennemsnitligt DBP siddende ≥95 og ≤119 mmHg) resulterede behandling med enhver Onduarp kombination i signifikant større reduktion af diastolisk og systolisk blodtryk og bedre blodtrykskontrol sammenlignet med monoterapi med de to aktive stoffer.
English: Pregelatinised starch
Danish: Prægelatineret stivelse
English: Cardiac disorders bradycardia, palpitations
Danish: Hjerte bradykardi, palpitationer
English: The elimination half-life is not changed in patients with renal impairment.
Danish: Eliminationshalveringstiden ændres ikke hos patienter med nedsat nyrefunktion.
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.
Danish: Overdreven nedsættelse af blodtryk hos patienter med iskæmisk kardiomyopati eller iskæmisk hjertekarsygdom kan, som ved andre antihypertensiva, medføre myokardieinfarkt eller slagtilfælde.
English: • Narrowing of the aorta (aortic stenosis).
Danish: • Forsnævring af hjertets legemspulsåre, aorta (aortastenose).
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.
Danish: Lægemidler, der kan fremprovokere hyperkaliæmi, er kaliumholdige salterstatninger, kaliumbesparende diuretika, ACE-hæmmere, angiotensin II-receptorantagonister, nonsteroide antiinflammatoriske lægemidler (NSAID'er, herunder selektive COX-2-hæmmere), heparin, immunosuppressiva (ciclosporin eller tacrolimus) og trimethoprim.
English: Serum potassium should be monitored closely in these patients (see section 4.5).
Danish: Hos disse patienter bør kaliumniveauet i serum monitoreres tæt (se pkt.
English: Micturition disorder, pollakiuria Reproductive system and breast disorders Uncommon:
Danish: Vandladningsforstyrrelser, pollakisuri Det reproduktive system og mammae Ikke almindelig:
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.
Danish: Amlodipin er en calciuminflukshæmmer (langsom kanalblokker eller calciumionantagonist), der hæmmer den transmembranale calciuminfluks i hjerte og glat muskulatur.
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
Danish: Ved konstateret graviditet bør behandling med angiotensin II-receptorantagonister stoppes øjeblikkeligt, og hvis det er nødvendigt, bør alternativ behandling påbegyndes (se pkt.
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.
Danish: Især efter den første dosis kan symptomatisk hypotension forekomme hos patienter med væskeog/eller natriummangel som følge af behandling med højdosis-diuretika, saltfattig kost, diarré eller opkastning.
English: Use in patients with heart failure
Danish: Patienter med hjerteinsufficiens
English: Amlodipine bioavailability is not affected by food ingestion.
Danish: Absorption af amlodipin er upåvirket af fødeindtagelse.
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.
Danish: Hos patienter, der fik amlodipin 5 mg, og som ikke var kontrollerede, var ødemfrekvensen 4,4% for 40 mg/5 mg og 80 mg/5 mg og 24,9% for amlodipin 10 mg.
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.
Danish: Et placebokontrolleret studie (PRAISE) designet til at evaluere patienter i NYHA-klasse III-IV hjerteinsufficiens, som fik digoxin, diuretika og ACE-hæmmere, har vist, at amlodipin ikke medførte en forøget risiko for mortalitet eller kombineret mortalitet og morbiditet hos patienter med hjerteinsufficiens.
English: No interactions between the two components of this fixed dose combinations have been observed in clinical studies.
Danish: Der er ikke i de kliniske studier observeret nogen interaktioner mellem de to aktive stoffer i denne fastdosiskombination.
English: If you experience these side effects, do not drive or use machines.
Danish: Kør ikke bil eller motorcykel, og lad være med at cykle eller bruge maskiner, hvis du oplever disse bivirkninger.
English: Angioedema (with fatal outcome), drug eruption, toxic skin eruption, urticaria
Danish: Angioødem (med dødelig udgang), lægemiddelrelateret udslæt, toksisk hududslæt, urticaria
English: Alopecia, purpura, skin discolouration, hyperhidrosis Angioedema, erythema multiforme, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome, photosensitivity
Danish: Angioødem, erythema multiforme, urticaria, dermatitis exfoliativa, Stevens-Johnsons syndrom, fotosensitivitet
English: - Intercurrent events, in particular dehydration, acute cardiac decompensation, metabolic acidosis, worsening of renal function, sudden worsening of the renal condition (e.g. infectious diseases), cellular lysis (e.g. acute limb ischemia, rhabdomyolysis, extensive trauma).
Danish: - Interkurrente hændelser, særligt dehydrering, akut hjertedekompensation, metabolisk acidose, forværret nyrefunktion, pludselig forværring af nyretilstanden (f.eks. infektionssygdomme), cellenedbrydning (f.eks. akut iskæmi i ekstremiteter, rabdomyolyse, længerevarende trauma).
English: Onduarp should therefore be used with caution in these patients.
Danish: Der skal udvises forsigtighed ved administration af Onduarp til disse patienter.
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).
Danish: Andre tilstande med stimulering af renin-angiotensin-aldosteronsystemet Hos patienter, hvis vaskulære tonus og nyrefunktion overvejende styres via aktiviteten i renin-angiotensin-aldosteronsystemet (f.eks. patienter med svær kongestiv hjerteinsufficiens eller underliggende nyresygdom, herunder nyrearteriestenose), er set akut hypotension, hyperazotæmi, oliguri eller sjældent akut nyresvigt (se pkt.
English: No posology adjustment is required for patients with mild to moderate renal impairment.
Danish: Ingen dosisjustering hos patienter med let til moderat nedsat nyrefunktion.
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret Onduarp til dig personligt.
English: Metabolism and nutrition disorders Very rare:
Danish: Metabolisme og ernæring Meget sjælden:
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.
Danish: I et langtids, follow-up, placebokontrolleret studie (PRAISE-2) med amlodipin hos hjerteinsufficiente patienter i NYHA-klasse III og IV uden kliniske symptomer eller objektive fund, der tydede på underliggende iskæmisk sygdom, som fik stabile doser af ACE-hæmmere, digitalis og diuretika, havde amlodipin ingen virkning på den totale kardiovaskulære mortalitet.
English: The use of angiotensin II receptor antagonists is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4).
Danish: Brug af angiotensin II-receptorantagonister er kontraindiceret i graviditetens andet og tredje trimester (se pkt.
English: Limited experience is available in patients with severe renal impairment or haemodialysis.
Danish: Der er begrænsede data for patienter med svært nedsat nyrefunktion eller som er i hæmodialyse.
English: Myocardial infarction, arrhythmia, ventricular tachycardia, atrial
Danish: Myokardieinfarkt, arytmi, ventrikulær takykardi, atrieflimren
English: Nervous system disorders somnolence, migraine, headache, paraesthesia syncope, peripheral neuropathy, hypoaesthesia, dysgeusia, tremor
Danish: Nervesystemet døsighed, migræne, hovedpine, paræstesi synkope, perifer neuropati, hypæstesi, dysgeusi, tremor
English: Patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance.
Danish: Nedsat clearance kan forventes hos patienter med biliære obstruktive forstyrrelser eller nedsat leverfunktion.