FrancophonIA/ELRC3.0 huggingface dataset:
English: Add on therapy Onduarp is indicated in adults whose blood pressure is not adequately controlled on amlodipine.
Danish: Tillægsbehandling Onduarp er indiceret til voksne, hvis blodtryk ikke er tilstrækkeligt kontrolleret med amlodipin.
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.
Danish: Onduarp fås i en pakning med 28 tabletter i alu/alu-blisterkort og i en pakning, der indeholder 360 (4 x 90 x 1) tabletter i perforerede enkeltdosis-alu/alu-blisterkort.
English: This means that both of these active substances work together to help stop your blood vessels tightening.
Danish: Begge stoffer forhindrer således blodkarrene i at trække sig sammen.
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).
Danish: I et andet randomiseret, dobbeltblindet, aktiv-kontrolleret, parallelgruppe, multicenterstudie fik i alt 947 let til svært hypertensive patienter, som ikke var tilstrækkeligt kontrolleret med amlodipin 10 mg, Onduarp (40 mg/10 mg eller 80 mg/10 mg) eller amlodipin alene (10 mg).
English: Vascular disorders hypotension, orthostatic hypotension, flushing
Danish: Vaskulære sygdomme hypotension, ortostatisk hypotension, rødmen
English: Remove the tablets from the blister only directly prior to intake.
Danish: Tag tabletterne ud af blisteren kort før administration.
English: Aluminium/aluminium blisters (PA/Al/PVC/Al) in a carton containing 28 tablets.
Danish: 6.5 Emballagetype og pakningsstørrelser Aluminium/aluminium-blisterkort (PA/Al/PVC/Al) i æske indeholdende 28 tabletter.
English: Should exposure to angiotensin II receptor antagonists have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Danish: Hvis der er behandlet med angiotensin II-receptorantagonister fra graviditetens andet trimester, anbefales ultralydsundersøgelse af fostrets nyrefunktion og kranium.
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.
Danish: Hos hypertensive patienter reduceres blodtrykket klinisk signifikant i alle døgnets 24 timer både i liggende og stående stilling efter 1 daglig dosis.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Danish: Yderligere information om Onduarp findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Telmisartan and amlodipine are not dialysable.
Danish: Telmisartan og amlodipin kan ikke fjernes ved dialyse.
English: The most common adverse reactions were peripheral oedema and dizziness, see also section 4.8.
Danish: De mest almindelige bivirkninger var perifert ødem og svimmelhed, se også pkt.
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).
Danish: I et yderligere randomiseret, dobbeltblindet, aktiv-kontrolleret, parallelgruppe, multicenterstudie fik 1.097 let til svær hypertensive patienter, som ikke var tilstrækkeligt kontrolleret med amlodipin 5 mg, Onduarp (40 mg/5 mg eller 80 mg/5 mg) eller amlodipin alene (5 mg eller 10 mg).
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.
Danish: Dette er bekræftet i placebokontrollerede kliniske studier, der blev foretaget på tidspunktet for maksimal effekt og umiddelbart forud for den næste dosis, hvor trough/peak ratio var over 80 % efter doser på 40 og 80 mg telmisartan.
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).
Danish: Amlodipin blev, i et langtids, placebokontrolleret studie (PRAISE-2) med patienter med NYHA-klasse III- og IV-hjerteinsufficiens af non-iskæmisk ætiologi, associeret med øget rapportering af pulmonært ødem, uden der var signifikant forskel i forekomsten af forværret hjerteinsufficiens når sammenlignet med placebo (se pkt.
English: Patients with rare hereditary problems of fructose intolerance should not take Onduarp.
Danish: Onduarp bør ikke anvendes til patienter med arvelig fructoseintolerans.
English: What Onduarp contains - The active substances are telmisartan and amlodipine.
Danish: Onduarp indeholder: - Aktive stoffer: telmisartan og amlodipin.
English: Onduarp is available in a folding box containing 28 tablets in aluminium/aluminium blisters.
Danish: Onduarp fås i en pakning med 28 tabletter i alu/alu-blisterkort.
English: Rare side effects (may affect up to 1 in 1,000 people): Confusion.
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 brugere): Forvirring.
English: Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Danish: Aorta-og mitralklapstenose, obstruktiv hypertrofisk kardiomyopati Patienter, der lider af aorta- eller mitralklapstenose eller obstruktiv hypertrofisk kardiomyopati behandles med særlig forsigtighed som ved behandling med andre vasodilatatorer.
English: Blood and lymphatic system disorders Very rare:
Danish: Blod og lymfesystem Sjælden:
English: Nervous system disorders Very rare:
Danish: Nervesystemet Meget sjælden:
English: Skin and subcutaneous tissue disorders pruritus eczema, erythema, rash
Danish: Hud og subkutane væv pruritus eksem, erytem, udslæt
English: The use of angiotensin II receptor antagonists is not recommended during the first trimester of pregnancy (see section 4.4).
Danish: Brug af angiotensin II-receptorantagonister frarådes i graviditetens første trimester (se pkt.
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.
Danish: Hypotension, synkope, hyperkaliæmi og ændringer i nyrefunktionen (herunder akut nyresvigt) er set hos følsomme patienter.
English: Haemodynamic studies and exercise based controlled clinical trials in NYHA Class II-IV heart failure patients have shown that amlodipine did not lead to clinical deterioration as measured by exercise tolerance, left ventricular ejection fraction and clinical symptomatology.
Danish: Hæmodynamiske undersøgelser og exercise-baserede kontrollerede kliniske studier med hjerteinsufficiente patienter i NYHA klasse II-IV har vist, at amlodipin ikke fremkalder klinisk forværring som målt ved arbejdstolerance, venstre ventrikels uddrivningsfraktion og klinisk symptomatologi.
English: Each tablet contains 168.64 mg sorbitol (E420).
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på: Hver tablet indeholder 168,64 mg sorbitol (E420).
English: Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute bioavailability of telmisartan up to nearly 100 %.
Danish: Den absolutte biotilgængelighed af telmisartan var hos patienter med nedsat leverfunktion øget med op til næsten 100%.
English: LIST OF EXCIPIENTS Contains sorbitol (E420).
Danish: LISTE OVER HJÆLPESTOFFER Indeholder sorbitol (E420).
English: After 8 weeks of treatment, each of the combinations was statistically significantly superior to both amlodipine monotherapy doses in reducing systolic and diastolic blood pressures (−13.6/−9.4 mmHg,
Danish: Efter 8 ugers behandling var hver af kombinationerne statistisk signifikant overlegen amlodipin som monoterapi, for så vidt angik reduktion af diastolisk og systolisk blodtryk (-11,1/-9,2 mmHg, -11,3/-9,3 mmHg med
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).
Danish: Frekvensen af forekomst af ødem var signifikant lavere med 40 mg/5 mg og 80 mg/5 mg end med amlodipin 10 mg (4,4% versus 24,9%).
English: Telmisartan works by blocking the effect of angiotensin II.
Danish: - Telmisartan er en angiotensin II-receptorantagonist, og virker ved at blokere virkningen af angiotensin II.
English: Telmisartan is mostly eliminated in the bile.
Danish: Telmisartan udskilles overvejende med galden.
English: Telmisartan and Amlodipine are not removed by haemodialysis.
Danish: Telmisartan og amlodipin fjernes ikke ved hæmodialyse.
English: Each tablet contains 337.28 mg sorbitol (E420).
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på: Hver tablet indeholder 337,28 mg sorbitol (E420).
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.
Danish: Onduarp 80 mg/10 mg tabletter kan ordineres til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med Onduarp 40 mg/10 mg eller med Onduarp 80 mg/5 mg.
English: Musculoskeletal and connective tissue disorders arthralgia, muscle spasms (cramps in legs), myalgia back pain, pain in extremity (leg pain)
Danish: Knogler, led, muskler og bindevæv artralgi, muskelspasmer (kramper i benene), myalgi rygsmerter, smerter i ekstremiteterne (smerter i benene)
English: Onduarp tablets contain two active substances called telmisartan and amlodipine.
Danish: Onduarp tabletter indeholder to aktive stoffer - telmisartan og amlodipin.
English: Very rare side effects (may affect up to 1 in 10,000 people):
Danish: Meget sjældne bivirkninger (kan forekomme hos op til 1 ud af 10.000 brugere):
English: • Diabetes.
Danish: • Sukkersyge (diabetes).
English: Gastro-intestinal disorders abdominal pain, diarrhoea, nausea vomiting, gingival hypertrophy, dyspepsia, dry mouth
Danish: Mave-tarm-kanalen abdominale smerter, diarré, nausea opkastning, gingival hypertrofi, dyspepsi, mundtørhed
English: Blood and lymphatic system disorders Uncommon:
Danish: Blod og lymfesystem Ikke almindelig: Sjælden:
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,
Danish: - Øvrige indholdsstoffer: kolloid vandfri silica, brilliant blue FCF (E133), sort jernoxid (E172),
English: Mood changes, impaired vision, ringing in the ears, shortness of breath, sneezing/running nose, change of bowel habit, hair loss, unusual bruising and bleeding (red blood cell damage), skin discolouration, increased sweating, difficulty passing urine, increased need to pass urine especially at night, enlarging of male breasts, pain, weight increased, weight decreased.
Danish: Humørsvingninger, nedsat syn, ringen for ørerne, åndenød, nysen/løbende næse, ændring af afføringsvaner, hårtab, usædvanlige blå mærker og blødning (beskadigelse af røde blodlegemer), misfarvning af huden, øget svedtendens, vandladningsbesvær, øget vandladningsbehov især om natten, brystforstørrelse hos mænd, smerter, vægtøgning, vægttab.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere information om Onduarp findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
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.
Danish: Sepsis (ofte kaldet "blodforgiftning", en alvorlig infektion med betændelsesreaktion i hele kroppen) eller hurtig hævelse af hud og slimhinder (angioødem).
English: Onduarp 40 mg/5 mg tablets may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg alone.
Danish: Onduarp 40 mg/5 mg tabletter kan ordineres til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med 5 mg amlodipin alene.
English: Potassium sparing diuretics or potassium supplements Angiotensin II receptor antagonists such as telmisartan, attenuate diuretic induced potassium loss.
Danish: Angiotensin II-receptorantagonister såsom telmisartan svækker det diuretisk inducerede kaliumtab.
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.
Danish: Når patienter med bilateral nyrearteriestenose eller patienter med stenose af arterien til den eneste fungerende nyre, behandles med lægemidler, der påvirker renin-angiotensin-aldosteronsystemet, er der en øget risiko for svær hypotension og nyresvigt.
English: Read the package leaflet for further information.
Danish: Se flere oplysninger i indlægssedlen.
English: Ear and labyrinth disorders Uncommon:
Danish: Ikke almindelig: Øre og labyrint Ikke almindelig:
English: When Onduarp is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Danish: Periodisk monitorering af kalium- og kreatininniveauerne i serum anbefales, når Onduarp bruges til patienter med nedsat nyrefunktion.
English: However, lower plasma concentrations were observed in patients with renal insufficiency undergoing dialysis.
Danish: For patienter med nyreinsufficiens og som var i dialyse, blev der dog observeret lavere plasmakoncentrationer.
English: General disorders and administration site conditions peripheral oedema asthenia, chest pain, fatigue, oedema malaise
Danish: Almene symptomer og reaktioner på administrationsstedet perifert ødem asteni, smerter i brystet, træthed, ødemer utilpashed
English: Vascular disorders Very rare:
Danish: Vaskulære sygdomme Sjælden:
English: The main risk factors for hyperkalaemia to be considered are: - Diabetes mellitus, renal impairment, age (>70 years) - Combination with one or more other medicinal products that affect the renin-angiotensinaldosterone system and/or potassium supplements.
Danish: De vigtigste risikofaktorer for hyperkaliæmi, der skal overvejes, er: - Diabetes mellitus, nedsat nyrefunktion, alder (> 70 år).
English: heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.
Danish: • NSAID'er (nonsteroide antiinflammatoriske lægemidler, f.eks. acetylsalicylsyre eller ibuprofen), heparin, immunsupprimerende lægemidler (f.eks. ciclosporin eller tacrolimus) og det antibiotiske middel trimethoprim.
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.
Danish: Bradykardi, svimmelhed, stigning i serumkreatinin og akut nyresvigt er også blevet rapporteret.
English: The pharmacokinetics of amlodipine are not significantly influenced by renal impairment.
Danish: Nedsat nyrefunktion har ikke nogen signifikant indflydelse på amlodipins farmakokinetik.
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS) The combination of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) and is not recommended in other patients (see sections
Danish: Dobbelt hæmning af renin-angiotensin-aldosteronsystemet (RAAS) Kombination af telmisartan med aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min/1,73 m2) og anbefales ikke til andre patienter (se pkt.
English: Respiratory, thoracic and mediastinal disorders cough
Danish: Luftveje, thorax og mediastinum hoste
English: Increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty of breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), impaired vision, fast heart beat, upset stomach, abnormal liver function*, hives (urticaria), medicine rash, inflammation of the tendons, flu-like illness (for example muscle pain, feeling generally unwell), decreased haemoglobin (a blood protein), increased levels of creatinine phosphokinase in the blood.
Danish: Øget antal af visse hvide blodlegemer (eosinofili), lavt antal blodplader (trombocytopeni), overfølsomhedsreaktion (f.eks. udslæt, kløe, åndedrætsbesvær, hiven efter vejret, hævelse af ansigtet eller lavt blodtryk), lave blodsukkerniveauer (hos sukkersygepatienter), nedsat syn, hurtig hjerterytme, mavebesvær, unormal leverfunktion*, nældefeber (urticaria), lægemiddeludslæt, betændelse i sener, influenzalignende sygdom (f.eks. muskelsmerter, generel utilpashed), nedsatte niveauer af hæmoglobin (et blodprotein), forhøjet indhold i blodet af kreatininfosfokinase.
English: Urinary tract infections, upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels in the blood, shortness of breath, bloating, increased sweating, kidney damage including sudden inability of the kidneys to work, increased levels of creatinine.
Danish: Urinvejsinfektioner, infektioner i de øvre luftveje (f.eks. ondt i halsen, bihulebetændelse, forkølelse), mangel på røde blodlegemer (anæmi), forhøjede kaliumniveauer i blodet, kortåndethed, oppustethed, øget svedtendens, nyreskade herunder akut nyresvigt, forhøjede kreatininniveauer.
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.
Danish: I prækliniske studier og in vitro-studier med calciumantagonister er set reversible biokemiske forandringer i hovedet af spermatozoer, som kan nedsætte befrugtningsevnen.
English: microcrystalline cellulose, povidone K25, pregelatinized starch, sodium hydroxide, sorbitol
Danish: povidon K25, prægelatineret stivelse, natriumhydroxid, sorbitol (E420).
English: Reduced number of white blood cells (leucopenia), low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), excess sugar in blood , uncontrollable twitching or jerking movements, heart attack, irregular heart beat, inflammation of the blood vessels, inflamed pancreas, inflammation of the stomach lining (gastritis), inflammation of the liver, yellowing of the skin (jaundice), increased levels of hepatic enzymes with jaundice, rapid swelling of skin and mucosa (angioedema), severe skin reactions, hives (urticaria), severe allergic reactions with blistering eruptions of the skin and mucous membranes (exfoliative dermatitis, Stevens-Johnson-Syndrome), increased sensitivity of the skin to sun.
Danish: Færre hvide blodlegemer (leukopeni), lavt antal blodplader (trombocytopeni), overfølsomhedsreaktion (f.eks. udslæt, kløe, åndedrætsbesvær, hiven efter vejret, hævelse af ansigtet eller lavt blodtryk), for højt blodsukker, ukontrollerede spjættende eller rykkende bevægelser, hjerteanfald, uregelmæssig hjerterytme, betændelse i blodkarrene, betændelse i bugspytkirtel, betændelse i mavesækkens slimhinde (gastritis), leverbetændelse, gulfarvning af huden (gulsot), forhøjede leverenzymtal med gulsot, hurtig hævelse af hud og slimhinder (angioødem), alvorlige hudreaktioner, nældefeber (urticaria), alvorlige overfølsomhedsreaktioner med udvikling af blærer på hud og slimhinder (eksfoliativ dermatitis, Stevens-Johnsons syndrom), øget hudfølsomhed over for sol.
English: Onduarp 80 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled with Onduarp 40 mg/5 mg.
Danish: Onduarp 80 mg/5 mg tabletter kan ordineres til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med Onduarp 40 mg/5 mg.
English: Sleepiness, migraine, headache, tingling or numbness of the hands or feet, feeling of spinning (vertigo), slow heart rate, palpitations (awareness of your heart beat), low blood pressure (hypotension), dizziness on standing up (orthostatic hypotension), flushing, cough, stomach ache (abdominal pain), diarrhoea, feeling sick (nausea), itching, joint pain, muscle cramps, muscle pain, inability to obtain an erection, weakness, chest pain, tiredness, swelling (oedema), increased levels of hepatic enzymes.
Danish: Søvnighed, migræne, hovedpine, snurren eller følelsesløshed i hænder eller fødder, følelse af at dreje rundt (vertigo), langsom puls, hjertebanken (bevidsthed om din hjerterytme), lavt blodtryk (hypotension), svimmelhed, når du rejser dig op (ortostatisk hypotension), rødmen, hoste, mavekneb (mavesmerter), diarré, kvalme, kløe, ledsmerter, muskelkramper, muskelsmerter, manglende evne til at få erektion, svaghed, brystsmerter, træthed, hævelser (ødemer), forhøjede leverenzymtal.
English: Onduarp 40 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg.
Danish: Onduarp 40 mg/10 mg tabletter kan ordineres til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med 10 mg amlodipin.
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.
Danish: Baseret på de farmakologiske egenskaber kan f.eks. lægemidlerne baclofen, amifostin, antipsykotika eller antidepressiva forventes at forstærke de hypotensive virkninger af alle antihypertensiva, herunder Onduarp.
English: Urinary bladder infection, feeling sad (depression), feeling anxious, sleeplessness, fainting, nerve damage in the hands or feet, reduced sense of touch, taste abnormalities, trembling, vomiting, enlarged gums, discomfort in the abdomen, dry mouth, eczema (a skin disorder), redness of skin, rash, back pain, leg pain, urge to urinate during the night, feeling unwell (malaise), increased levels of uric acid in the blood.
Danish: Infektion i urinblæren, tristhed (depression), angst, søvnløshed, besvimelse, nerveskader i hænder eller fødder, reduceret følsomhed, smagsforstyrrelser, rysten, opkastning, overvækst af tandkød, ubehag i maven, mundtørhed, eksem (hudsygdom), hudrødme, udslæt, rygsmerter, smerter i benene, natlig trang til at lade vandet, utilpashed, forhøjede urinsyreniveauer i blodet.
English: If you take more Onduarp than you should
Danish: Hvis du har taget for mange Onduarp
English: The observed mean changes in systolic/diastolic blood pressure with a combination therapy containing amlodipine 5 mg (−22.2/−17.2 mmHg with 40 mg/5 mg; −22.5/−19.1 mmHg with 80 mg/5 mg) were comparable to or greater than those seen with amlodipine 10 mg (−21.0/−17.6 mmHg) and associated with significant lower oedema rates (1.4 % with 40 mg/5 mg; 0.5 % with 80 mg/5 mg; 17.6 % with amlodipine 10 mg).
Danish: De observerede gennemsnitlige ændringer i systolisk/diastolisk blodtryk set ved kombinationsbehandling indeholdende amlodipin 5 mg (-22,2/-17,2 mmHg med 40 mg/5 mg; -22,5/-19,1 mmHg med 80 mg/5 mg) var lig med eller større end de reduktioner set med amlodipin 10 mg (-21,0/-17,6 mmHg), og var forbundet med signifikant lavere frekvens af ødem (1,4% med 40 mg/5 mg; 0,5% med 80 mg/5 mg; 17,6% med amlodipin 10 mg).