FrancophonIA/ELRC3.0 huggingface dataset:
English: Rasilamlo is used to treat high blood pressure in adult patients whose blood pressure is not sufficiently controlled with aliskiren or amlodipine alone.
Danish: Rasilamlo kan bruges til behandling af forhøjet blodtryk hos voksne patienter, som ikke kan få deres blodtryk passende kontrolleret med aliskiren eller amlodipin anvendt alene.
English: • Severe skin reactions (toxic epidermal necrolysis and/or oral mucosal reactions - red skin, blistering of the lips, eyes or mouth, skin peeling, fever) (uncommon: may affect up to 1 in
Danish: • Alvorlige hudreaktioner (toksisk epidermal nekrolyse og/eller bivirkninger fra slimhinden i munden - rød hud, blæredannelse omkring læber, øjne eller mund, hudafskalning, feber) (ikke almindelig: kan forekomme hos op til 1 ud af 100 patienter).
English: In a study in 820 randomised patients not adequately responsive to aliskiren 300 mg treatment, the combination of aliskiren/amlodipine 300 mg/10 mg produced systolic/diastolic mean blood pressure reductions of 18.0/13.1 mmHg, which were statistically significantly greater than aliskiren 300 mg monotherapy.
Danish: I et studie med 820 randomiserede patienter, der ikke responderede tilstrækkeligt på behandling med aliskiren 300 mg, viste kombinationen af aliskiren/amlodipin 300 mg/10 mg gennemsnitlige systoliske/diastoliske blodtryksreduktioner på 18,0/13,1 mmHg, hvilket var signifikant større end for aliskiren 300 mg monoterapi.
English: As a result no dose adjustment for aliskiren or these co-administered
Danish: Dosisjustering af aliskiren eller disse samtidigt administrerede lægemidler er derfor ikke nødvendig.
English: Hypersensitivity reactions including anaphylactic reactions have also been reported in post-marketing
Danish: Der er også blevet indberettet overfølsomhedsreaktioner inklusive anafylaktiske reaktioner efter markedsføring (se pkt.
English: The other ingredients are cellulose microcrystalline, crospovidone, povidone, magnesium stearate, silica colloidal anhydrous, hypromellose, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172) and red iron oxide (E172).
Danish: Øvrige indholdsstoffer: mikrokrystallinsk cellulose, crospovidon, povidon, magnesiumstearat, vandfri silica kolloid, hypromellose, titandioxid (E 171), macrogol, talcum, gul jernoxid (E 172) og rød jernoxid (E 172).
English: You may need to stop Rasilamlo.
Danish: Hvis du har glemt at tage Rasilamlo
English: Tabulated list of adverse reactions:
Danish: Tabel over bivirkninger:
English: The other ingredients are cellulose microcrystalline, crospovidone, povidone, magnesium stearate, silica colloidal anhydrous, hypromellose, titanium dioxide (E171), macrogol, talc and yellow iron oxide (E172).
Danish: Øvrige indholdsstoffer: mikrokrystallinsk cellulose, crospovidon, povidon, magnesiumstearat, vandfri silica kolloid, hypromellose, titandioxid (E 171), macrogol, talcum og gul jernoxid (E 172).
English: - if you are taking either of the following classes of medicines used to treat high blood pressure: an angiotensin converting enzyme inhibitor such as enalapril, lisinopril, ramipril an angiotensin II receptor blocker such as valsartan, telmisartan, irbesartan - if you have diabetes (high blood sugar)
Danish: Hvis det sker, skal du stoppe med at tage Rasilamlo og du skal kontakte din læge - hvis du tager nogen af følgende typer lægemidler, som bruges til at behandle for højt blodtryk: en angiotensin-konverteringsenzym (ACE)-hæmmer, som fx enalapril, lisinopril, ramipril en angiotensin-II receptorblokker, som fx valsartan, telmisartan, irbesartan - hvis du har sukkersyge (diabetes, højt blodsukker)
English: In a study in 847 randomised patients not adequately responsive to amlodipine 10 mg treatment, the combination of aliskiren/amlodipine 150 mg/10 mg and 300 mg/10 mg produced systolic/diastolic mean blood pressure reductions of 11.0/9.0 mmHg and 14.4/11.0 mmHg respectively, which were statistically greater than for amlodipine 10 mg monotherapy.
Danish: I et studie med 847 randomiserede patienter, der ikke responderede tilstrækkeligt på behandling med amlodipin 10 mg, viste kombinationen af aliskiren/amlodipin 150 mg/10 mg og 300 mg/10 mg gennemsnitlige systoliske/diastoliske blodtryksreduktioner på henholdsvis 11,0/9,0 mmHg og 14,4/11,0 mmHg, hvilket var statistisk større end for amlodipin 10 mg monoterapi.
English: Do not stop taking this medicine, even if you are feeling well unless your doctor tells you to do so. People who have high blood pressure often do not notice any signs of the problem.
Danish: Du må ikke stoppe med denne medicin, selvom du har det godt, medmindre du har aftalt det med din læge.
English: Multipack containing 280 (20 packs of 14) tablets.
Danish: Multipakninger indeholdende 280 tabletter (20 pakninger af 14).
English: In a subset of 1,069 patients, Rasilamlo produced mean blood pressure reductions (systolic/diastolic) ranging between 20.6/13.6 mmHg and 24.2/17.3 mmHg (the subset of patients without aberrant readings, defined as difference in SBP ≥10 mmHg at baseline or endpoint).
Danish: I en undergruppe med 1.069 patienter, gav Rasilamlo gennemsnitlige blodtryksreduktioner (systolisk/diastolisk) på mellem 20,6/13,6 mmHg og 24,2/17,3 mmHg (undergruppen udgøres af patienter uden afvigende målinger, defineret som forskel i systolisk blodtryk ≥ 10 mmHg ved behandlingsstart (baseline) eller
English: • skin reaction with skin reddening and peeling, blistering of lips, eyes or mouth
Danish: • hudreaktioner med rødme og afskalning, blister omkring læber, øjne eller mund
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs
English: Aliskiren should be used with caution in patients with heart failure treated with furosemide or
Danish: Der skal udvises forsigtighed, når aliskiren anvendes til patienter med hjertesvigt, der behandles med
English: Concomitant intake with fruit juice and/or drinks containing plant extracts (including herbal teas) should be avoided (see section 4.5).
Danish: Indtagelse af frugtjuice og/eller drikkevarer indeholdende planteekstrakter (inklusive urteteer) sammen med Rasilamlo bør undgås (se pkt.
English: - Digoxin and verapamil bioavailability may be slightly decreased by aliskiren.
Danish: Aliskiren kan nedsætte biotilgængeligheden af digoxin og verapamil i let grad.
English: Consistent with the monotherapy formulation, food had no effect on the pharmacokinetics of amlodipine in the
Danish: Tilsvarende, som ved monoterapi formuleringerne, havde føde ingen virkning på amlodipins farmakokinetik i den faste kombinationstablet.
English: These decreases in blood pressure are not accompanied by a significant change in heart rate or plasma catecholamine
Danish: Ved kronisk dosering ledsages det nedsatte blodtryk ikke af en signifikant påvirkning af pulsen eller af
English: In a subset of 584 patients, the combination of aliskiren/amlodipine produced additional systolic/diastolic mean blood pressure reductions of 7.9/4.8 mmHg and 11.7/7.7 mmHg for the 300/5 mg and 300/10 mg strengths respectively compared to aliskiren 300 mg (the subset constitutes patients without aberrant readings, defined as difference in systolic blood pressure (SBP) ≥10 mmHg at baseline or endpoint).
Danish: I en undergruppe på 584 patienter gav kombinationen af aliskiren og amlodipin en yderligere gennemsnitlig reduktion i systolisk/diastolisk blodtryk på henholdsvis 7,9/4,8 mmHg og 11,7/7,7 mmHg for styrkerne 300/5 mg og 300/10 mg sammenlignet med aliskiren 300 mg (undergruppen består af patienter uden afvigende målinger defineret som forskel i systolisk blodtryk ≥ 10 mmHg før behandlingsstart (baseline) eller ved
English: , hypoesthesia paraesthesia
Danish: , synkope hypæstesi
English: - clarithromycin, telithromycin, erythromycin which are antibiotics used to treat infections - amiodarone, a medicine used to treat abnormal heart rhythms - atorvastatin, a medicine used to treat high cholesterol - furosemide or torasemide, medicines belonging to the type known as diuretics, which are used to increase the amount of urine you produce and are also used to treat a certain kind of heart problem (heart failure) or oedema (swelling) - antiepileptics (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone) - rifampicin, a medicine used to prevent or treat infections - St. John's wort (hypericum perforatum), a herbal medicine used to elevate mood - certain types of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs) (used especially in patients over 65 years old) - diltiazem, a medicine used to treat heart problems - ritonavir, a medicine used to treat viral infection
Danish: Diuretika bruges også til behandling af visse hjerteproblemer (hjertesvigt) eller ophobning af væske (ødem) - antiepileptika (fx carbamazepin, phenobarbital, phenytoin, fosphenytoin, primidon) - rifampicin, medicin, der bruges til at forebygge eller behandle infektioner - prikbladet perikum (hypericum perforatum), naturmedicin, der bruges til at bringe humøret i
English: , palpitations a,am
Danish: , palpitationer a,am
English: In a subset of 549 patients, the combination of aliskiren/amlodipine produced additional systolic/diastolic mean blood pressure reductions of 4.0/2.2 mmHg and 7.6/4.7 mmHg for the 150/10 mg and 300/10 mg strengths respectively compared to amlodipine 10 mg (the subset constitutes patients without aberrant readings, defined as difference in SBP ≥10 mmHg at baseline or endpoint).
Danish: I en undergruppe på 549 patienter gav kombinationen af aliskiren/amlodipin yderligere reduktioner i systolisk/diastolisk blodtryk på i gennemsnit 4,0/2,2 mmHg og 7,6/4,7 mmHg for henholdsvis 150/10 mg og 300/10 mg styrkerne sammenlignet med amlodipin 10 mg (undergruppen udgøres af patienter uden afvigende målinger defineret som forskel i systolisk blodtryk ≥ 10 mg før behandlingsstart (baseline) eller ved
English: Unit dose pack (perforated unit dose blister) containing 56x1 tablet Multi-packs of unit dose (perforated unit dose blister) containing 98x1 tablet (2 packs of 49x1)
Danish: Enkeltdoserede multipakninger (perforeret enkeltdosisblister) indeholdende 98x1 tabletter (2 pakninger af 49x1).
English: 280 tablets (20x14, PA/Alu/PVC blisters)
Danish: 28 tabletter (PA/Alu/PVC blister)
English: Arthralgia a,am
Danish: Artralgi a,am
English: , Quincke oedema photosensitivity
Danish: , angioødem lysfølsomhed
English: Transporters
Danish: Fremstiller
English: Rasilamlo is contraindicated in children from birth to less than 2 years and should not be used in children aged 2 to less than 6 years because of safety concerns due to potential aliskiren overexposure (see sections 4.3, 4.4, 5.2, and 5.3).
Danish: Rasilamlo er kontraindiceret hos børn fra fødslen og op til 2 år og bør ikke anvendes til børn i alderen fra 2 år og op til 6 år på grund af sikkerhedsproblemer med hensyn til potentiel overeksponering for
English: The increased incidence of stroke was greater in patients with renal
Danish: Forekomsten af apopleksi var højere blandt patienter med nyreinsufficiens.
English: - furosemide or torasemide, medicines belonging to the type known as diuretics, which are used to increase the amount of urine you produce and are also used to treat a certain kind of heart problem (heart failure) or oedema (swelling) - some medicines used to treat infections, such as ketoconazole
Danish: Diuretika bruges også til behandling af visse hjerteproblemer (hjertesvigt) eller ophobning af væske (ødem) - visse lægemidler, som bruges til behandling af infektioner, som fx ketoconazol
English: A bioequivalence study under light meal conditions has not been conducted for Rasilamlo.
Danish: Et bioækvivalensstudie, der undersøger Rasilamlo efter indtagelse af lette måltider, er
English: The effects of Rasilamlo on all cause and cardiovascular mortality and on cardiovascular morbidity and target organ damage are currently unknown.
Danish: Gavnlige virkninger af Rasilamlo på samlet og kardiovaskulær mortalitet, kardiovaskulær morbiditet
English: Description of selected adverse reactions: Hypersensitivity reactions including anaphylactic reactions and angioedema have occurred during
Danish: Overfølsomhedsreaktioner inklusive anafylaktiske reaktioner og angioødem er forekommet under behandling med aliskiren.
English: Effects of amlodipine on other medicinal products - The blood pressure lowering effects of amlodipine adds to the blood pressure-lowering effects of other antihypertensive medicinal products.
Danish: Amlodipins blodtrykssænkende virkning øger den blodtrykssænkende virkning af andre
English: • disturbed sense of taste
Danish: , smagsforstyrrelser
English: Do not take Rasilamlo - if you are allergic to aliskiren or amlodipine, to any of the other ingredients of this medicine (listed in section 6) or to other dihydropyridine-derived medicines (known as calcium channel blockers) - if you have experienced the following forms of angioedema (difficulties in breathing or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue): angioedema when taking aliskiren
Danish: Brug ikke Rasilamlo - hvis du er allergisk over for aliskiren eller amlodipin, et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6) eller andre dihydropyridin-afledte lægemidler (kendt som calcium-antagonister).
English: SCIENTIFIC CONCLUSIONS AND GROUNDS RECOMMENDING THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION
Danish: VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF
English: Yellow, convex, ovaloid tablet with a bevelled edge, with “T7” debossed on one side and “NVR” on
Danish: Gul, udadbuet, oval tablet med facetslebne kanter præget med ”T7” på den ene side og ”NVR” på den
English: Smaller changes in furosemide pharmacokinetics and efficacy were
Danish: Der blev observeret mindre ændringer i furosemids farmakokinetik og effekt ved aliskiren 150 mg/dag.
English: 56x1 tablet (PVC/PCTFE single-unit-dose blisters)
Danish: 56 tabletter (PVC/PCTFE blister)
English: 98 tablets (2x49x1, PVC/PCTFE single-unit-dose blisters) 280 tablets (20x14, PVC/PCTFE blisters)
Danish: 56x1 tabletter (PVC/PCTFE enkeltdosisblister) 90 tabletter (PVC/PCTFE blister)
English: Respiratory, thoracic and mediastinal disorders
Danish: Aorta- og mitralklapstenose, obstruktiv hypertrofisk kardiomyopati
English: - if you are between three and nine months pregnant - if you are taking any of the following medicines ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g. rheumatoid arthritis or atopic dermatitis) itraconazole (a medicine used to treat fungal infections) quinidine (a medicine used to correct heart rhythm) - if you have diabetes or impaired kidney function and you are treated with either of the following classes of medicines used to treat high blood pressure: an angiotensin converting enzyme inhibitor such as enalapril, lisinopril, ramipril an angiotensin II receptor blocker such as valsartan, telmisartan, irbesartan - if the patient is less than 2 years of age - if you have very low blood pressure - if you are suffering from shock, including cardiogenic shock - if you have a narrowing of the aortic heart valve (aortic stenosis) - if you have heart failure after an acute heart attack If any of the above applies to you, do not take Rasilamlo and talk to your doctor.
Danish: Bruges også til andre tilstande, fx gigt eller hudeksem) itraconazol (medicin, der bruges til behandling af svampeinfektioner) quinidin (medicin, som bruges til at korrigere hjerterytmen) - hvis du har sukkersyge eller nedsat nyrefunktion, og du bliver behandlet med nogen af følgende typer lægemidler, som bruges til at behandle for højt blodtryk: en angiotensin-konverteringsenzym (ACE)-hæmmer, som fx enalapril, lisinopril, ramipril en angiotensin II-receptorblokker, som fx valsartan, telmisartan, irbesartan
English: Single pack containing 14, 28, 56 tablets Multi-packs containing 98 tablets (2 packs of 49) and 280 tablets (20 packs of 14)
Danish: Multipakninger indeholdende 98 tabletter (2 pakninger af 49) og 280 tabletter (20 pakninger af 14).
English: Posology in patients not adequately controlled with aliskiren or amlodipine monotherapy Rasilamlo 300 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 300 mg or amlodipine 10 mg alone or Rasilamlo 150 mg/10 mg or
Danish: Rasilamlo 300 mg/10 mg kan gives til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med aliskiren 300 mg eller amlodipin 10 mg alene eller med Rasilamlo 150 mg/10 mg eller med Rasilamlo
English: Possible side effects
Danish: Beskrivelse af udvalgte bivirkninger:
English: Rasilamlo 150 mg/10 mg film-coated tablets are yellow, convex, oval film-coated tablets, with “T7” debossed on one side and “NVR” on the other.
Danish: Rasilamlo 150 mg/10 mg filmovertrukne tabletter er gule, udadbuede, ovale filmovertrukne tabletter præget med ”T7” på den ene side og ”NVR” på den anden side.
English: Aliskiren/amlodipine
Danish: Amlodipin
English: No data are
Danish: Der foreligger ingen data.
English: , malaise
Danish: , smerte
English: Posology in patients not adequately controlled with aliskiren or amlodipine monotherapy Rasilamlo 300 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 300 mg alone or with Rasilamlo 150 mg/5 mg.
Danish: Rasilamlo 300 mg/5 mg kan gives til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med aliskiren 300 mg alene eller med Rasilamlo 150 mg/5 mg.
English: Posology in patients not adequately controlled with aliskiren or amlodipine monotherapy Rasilamlo 150 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg alone or with Rasilamlo 150 mg/5 mg.
Danish: Rasilamlo 150 mg/10 mg kan gives til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med amlodipin 10 mg alene eller med Rasilamlo 150 mg/5 mg.
English: Haemoglobin decreased a, haematocrit decreased a,
Danish: Fald i hæmoglobin a, fald i hæmatokrit a, forhøjet blodkreatinin a
English: • depression
Danish: • træthed
English: Dizziness a,am
Danish: udslæt a,am
English: Rasilamlo 300 mg/10 mg film-coated tablets are brown-yellow, convex, oval film-coated tablets, with “T12” debossed on one side and “NVR” on the other.
Danish: Rasilamlo 300 mg/10 mg filmovertrukne tabletter er brungule, udadbuede, ovale filmovertrukne tabletter præget med ”T12” på den ene side og ”NVR” på den anden side.
English: Rasilamlo 300 mg/5 mg film-coated tablets are dark yellow, convex, oval film-coated tablets, with “T11” debossed on one side and “NVR” on the other.
Danish: Rasilamlo 300 mg/5 mg filmovertrukne tabletter er mørkegule, udadbuede, ovale filmovertrukne tabletter præget med ”T11” på den ene side og ”NVR” på den anden side.
English: Dyspnoea a, am
Danish: Dyspnø a, am
English: Rasilamlo 300 mg/10 mg film-coated tablets
Danish: Rasilamlo 300 mg/10 mg filmovertrukne tabletter
English: - Each Rasilamlo 300 mg/10 mg film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 10 mg amlodipine (as besylate).
Danish: - Hver Rasilamlo 300 mg/10 mg overtrukken tablet indeholder 300 mg aliskiren (som hemifumarat) og 10 mg amlodipin (som besylat).
English: Rasilamlo 150 mg/10 mg film-coated tablets
Danish: Rasilamlo 150 mg/10 mg filmovertrukne tabletter
English: Rasilamlo 150 mg/5 mg film-coated tablets
Danish: Rasilamlo 150 mg/5 mg filmovertrukne tabletter
English: - Each Rasilamlo 150 mg/10 mg film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 10 mg amlodipine (as besylate).
Danish: - Hver Rasilamlo 150 mg/10 mg overtrukken tablet indeholder 150 mg aliskiren (som hemifumarat) og 10 mg amlodipin (som besylat).
English: Rasilamlo 300 mg/5 mg film-coated tablets
Danish: Rasilamlo 300 mg/5 mg filmovertrukne tabletter
English: - Each Rasilamlo 300 mg/5 mg film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 5 mg amlodipine (as besylate).
Danish: - Hver Rasilamlo 300 mg/5 mg overtrukken tablet indeholder 300 mg aliskiren (som hemifumarat) og 5 mg amlodipin (som besylat).
English: Rasilamlo 300 mg/10 mg tablets
Danish: Rasilamlo 300 mg/10 mg
English: , gynaecomastia
Danish: , muskelkramper
English: , nausea a,am
Danish: , kvalme a,am
English: • tingling or numbness
Danish: • hudrødme (erytem)
English: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 10 mg amlodipine (as besylate).
Danish: Hver filmovertrukket tablet indeholder 300 mg aliskiren (som hemifumarat) og 10 mg amlodipin (som besylat).
English: Each tablet contains 300 mg aliskiren (as aliskiren hemifumarate) and 10 mg amlodipine (as
Danish: Hver tablet indeholder 300 mg aliskiren (som aliskiren hemifumarat) og 10 mg amlodipin (som
English: , exanthema
Danish: , eksantem
English: Therefore caution should be exercised in patients with hepatic impairment.
Danish: Der skal derfor udvises forsigtighed over for patienter med
English: Each tablet contains 150 mg aliskiren (as aliskiren hemifumarate) and 5 mg amlodipine (as
Danish: Hver tablet indeholder 150 mg aliskiren (som aliskiren hemifumarat) og 5 mg amlodipin (som
English: Brown-yellow, convex, ovaloid tablet with a bevelled edge, with “T12” debossed on one side and
Danish: Brungul, udadbuet, oval tablet med facetslebne kanter præget med ”T12” på den ene side og ”NVR”
English: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 5 mg amlodipine (as besylate).
Danish: Hver filmovertrukket tablet indeholder 300 mg aliskiren (som hemifumarat) og 5 mg amlodipin (som besylat).
English: Each film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 5 mg amlodipine (as besylate).
Danish: Hver filmovertrukket tablet indeholder 150 mg aliskiren (som hemifumarat) og 5 mg amlodipin (som besylat).
English: , jaundice a,am
Danish: , urticaria a,am
English: Each tablet contains 150 mg aliskiren (as aliskiren hemifumarate) and 10 mg amlodipine (as
Danish: Hver tablet indeholder 150 mg aliskiren (som aliskiren hemifumarat) og 10 mg amlodipin (som
English: Eesti
Danish: Ísland
English: Each tablet contains 300 mg aliskiren (as aliskiren hemifumarate) and 5 mg amlodipine (as
Danish: Hver tablet indeholder 300 mg aliskiren (som aliskiren hemifumarat) og 5 mg amlodipin (som
English: Talk to your doctor before taking Rasilamlo: - if you are suffering from vomiting or diarrhoea or if you are taking a diuretic (a medicine to increase the amount of urine you produce) - if you have already experienced angioedema (difficulties in breathing or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue).
Danish: - hvis du tidligere har haft angioødem (svært ved at trække vejret eller at synke eller har hævet ansigt, hænder og fødder, øjenomgivelser, læber og/eller tunge).
English: , pain
Danish: , asteni
English: - Each Rasilamlo 150 mg/5 mg film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 5 mg amlodipine (as besylate).
Danish: Rasilamlo indeholder: - Hver Rasilamlo 150 mg/5 mg overtrukken tablet indeholder 150 mg aliskiren (som hemifumarat) og 5 mg amlodipin (som besylat).
English: Each film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 10 mg amlodipine (as besylate).
Danish: Hver filmovertrukket tablet indeholder 150 mg aliskiren (som hemifumarat) og 10 mg amlodipin (som besylat).
English: Chest pain
Danish: CHMP er
English: Dark yellow, convex, ovaloid tablet with a bevelled edge, with “T11” debossed on one side and
Danish: Mørkegul, udadbuet, oval tablet med facetslebne kanter præget med ”T11” på den ene side og ”NVR”
English: , asthenia
Danish: • kvalme
English: Light yellow, convex, ovaloid tablet with a bevelled edge, with “T2” debossed on one side and
Danish: Lysegul, udadbuet, oval tablet med facetslebne kanter præget med ”T2” på den ene side og ”NVR” på
English: • Severe allergic reaction with symptoms such as rash, itching, swelling of face or lips or tongue,
Danish: • Alvorlige allergiske reaktioner med symptomer som fx udslæt, kløe, hævet ansigt, læber eller tunge, besvær med at trække vejret, svimmelhed (sjælden: kan forekomme hos op til 1 ud af
English: , cough a,am
Danish: , gulsot a,am