FrancophonIA/ELRC3.0 huggingface dataset:
English: There was no significant difference in the primary endpoint between amlodipine-based therapy and chlorthalidone-based therapy: risk ratio (RR) 0.98 95 % CI (0.90-1.07) p=0.65.
Danish: Der var ingen signifikant forskel mellem amlodipin-baseret behandling og chlorthalidon-baseret behandling på det primære endepunkt: Risikoratio (RR) 0,98; 95% KI (0,90-1,07); p=0,65.
English: If you think you may be allergic, talk to your doctor before taking Amlodipine/Valsartan Mylan.
Danish: Hvis du tror, du er allergisk, skal du tale med din læge, inden du tager Amlodipine/Valsartan Mylan.
English: 14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 98 film-coated tablets 14x1 film-coated tablets (unit dose) 28x1 film-coated tablets (unit dose) 30x1 film-coated tablets (unit dose) 56x1 film-coated tablets (unit dose) 90x1 film-coated tablets (unit dose) 98x1 film-coated tablets (unit dose)
Danish: 14 filmovertrukne tabletter 28 filmovertrukne tabletter 56 filmovertrukne tabletter 98 filmovertrukne tabletter 14x1 filmovertrukne tabletter (enkeltdosis) 28x1 filmovertrukne tabletter (enkeltdosis) 30x1 filmovertrukne tabletter (enkeltdosis) 56x1 filmovertrukne tabletter (enhedsdosis) 90x1 filmovertrukne tabletter (enkeltdosis) 98x1 filmovertrukne tabletter (enhedsdosis)
English: Patients taking amlodipine/valsartan and driving vehicles or using machines should take into account that dizziness or weariness may occasionally occur.
Danish: Patienter, som fører motorkøretøj eller betjener maskiner under behandling med amlodipin/valsartan, skal være opmærksomme på, at der lejlighedsvis kan optræde svimmelhed eller træthed.
English: You can take Amlodipine/Valsartan Mylan with or without food.
Danish: - Du kan tage Amlodipine/Valsartan Mylan med eller uden mad.
English: Similar changes were also seen in the valsartan alone group (exposure 8.5-11.0 times the clinical dose of 160 mg valsartan).
Danish: De samme forandringer blev også set i gruppen, som fik valsartan alene (eksponering på 8,5-11,0 gange den kliniske dosis på 160 mg valsartan).
English: No dosage adjustment is required for patients with mild to moderate renal impairment.
Danish: Det er ikke nødvendigt at justere dosis hos patienter med let til moderat nedsat nyrefunktion.
English: Inflamed pancreas, which may cause severe abdominal and back pain accompanied with feeling of being very unwell.
Danish: - Betændelse i bugspytkirtlen, som kan give stærke smerter i maven og ryggen og få dig til at føle dig meget utilpas.
English: Particular caution should be exercised when administering amlodipine/valsartan to patients with mild to moderate hepatic impairment or biliary obstructive disorders.
Danish: Der bør udvises særlig forsigtighed, når amlodipin/valsartan gives til patienter med let til moderat nedsat leverfunktion eller biliære obstruktive lidelser.
English: • Concomitant use of Amlodipine/Valsartan Mylan with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see sections 4.5 and
Danish: • Samtidig brug af Amlodipine/Valsartan Mylan og lægemidler indeholdende aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min/1,73 m2) (se pkt.
English: Other medicines and Amlodipine/Valsartan Mylan Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Amlodipine/Valsartan Mylan Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: NDEA Limit in ppm in API
Danish: NDEA Grænsev ærdi i ppm i det aktive stof
English: For convenience, patients receiving valsartan and amlodipine from separate tablets/capsules may be switched to Amlodipine/Valsartan Mylan containing the same component doses.
Danish: Patienter, som får valsartan og amlodipin fra hver sin tablet/kapsel, kan for nemhedens skyld skifte til Amlodipine/Valsartan Mylan med den samme dosis af hver komponent.
English: Fertility There are no clinical studies on fertility with amlodipine/valsartan.
Danish: Fertilitet Der er ikke udført fertilitetsstudier med amlodipin/valsartan.
English: If you stop taking Amlodipine/Valsartan Mylan Stopping your treatment with Amlodipine/Valsartan Mylan may cause your disease to get worse.
Danish: Hvis du holder op med at tage Amlodipine/Valsartan Mylan Hvis du holder op med at tage Amlodipine/Valsartan Mylan, kan det resultere i, at din sygdom bliver værre.
English: The MAH must ensure that the manufacturing processes of the drug substances used for their drug products are reviewed for the potential risk of formation of N
Danish: Indehaverne af markedsføringstilladelse skal sikre, at fremstillingsprocesserne for de stoffer, der anvendes i deres lægemidler, gennemgås for den mulige risiko for dannelse af N-nitrosaminer og ændres i nødvendigt omfang for at minimere nitrosamin-forureningen mest muligt.
English: An increased incidence and severity of renal tubular basophilia/hyalinisation, dilation and casts, as well as interstitial lymphocyte inflammation and arteriolar medial hypertrophy were found at an exposure of 8-13 (valsartan) and 7-8 (amlodipine) times the clinical doses of 160 mg valsartan and 10 mg amlodipine.
Danish: En øget forekomst og sværhedsgrad af renal tubulær basofili/hyalinisering, dilation og cylindre i urinen, såvel som interstitiel lymfocytinflammation og arteriolær medial hypertrofi blev set ved en eksponering på 8-13 (valsartan) og 7-8 (amlodipin) gange den kliniske dosis på 160 mg valsartan og 10 mg amlodipin.
English: ACE inhibitors and angiotensin II receptor blockers (ARBs) should not be used concomitantly in patients with diabetic nephropathy.
Danish: ACE-hæmmere og angiotensin II-receptorhæmmere (ARBer) bør ikke anvendes samtidigt hos patienter med diabetisk nefropati.
English: Amlodipine/Valsartan Mylan tablets contain two active substances called amlodipine and valsartan.
Danish: Amlodipine/Valsartan Mylan tabletter indeholder to aktive stoffer, som kaldes amlodipin og valsartan.
English: ACE inhibitors or aliskiren (see also information under the headings “Do not take Amlodipine/Valsartan Mylan” and “Warnings and precautions”); diuretics (a type of medicine also called “water tablets” which increases the amount of urine you produce); lithium (a medicine used to treat some types of depression); potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels; certain types of painkillers called non-steroidal anti-inflammatory medicines (NSAIDs) or selective cyclooxygenase-2 inhibitors (COX-2 inhibitors).
Danish: Det gælder især for den medicin, som er beskrevet herunder: - hvis du samtidig tager en ACE-hæmmer eller aliskiren (se også information under overskrifterne ”Tag ikke Amlodipine/Valsartan Mylan” og ”Advarsler og forsigtighedsregler”); - diuretika (en type medicin, som også kaldes ”vanddrivende tabletter”, og som forhøjer den mængde urin, du producerer); - medicin til behandling af visse typer depression (lithium); - kaliumbesparende diuretika, kaliumtilskud, salterstatninger, som indeholder kalium eller andre stoffer, der kan øge indholdet af kalium i blodet; - en bestemt type smertestillende medicin, som kaldes non-steroide anti-inflammatoriske lægemidler (NSAID'er) eller selektive cyclooxygenase-2-hæmmere (COX-2-hæmmere).
English: Excessive hypotension was seen in 0.4 % of patients with uncomplicated hypertension treated with amlodipine/valsartan in placebo-controlled studies.
Danish: Under placebokontrollerede studier blev der set udtalt hypotension hos 0,4% af patienterne med ukompliceret hypertension, som blev behandlet med amlodipin/valsartan.
English: medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir); medicines used to treat fungal infections (e.g. ketoconazole, itraconazole); medicines used to treat bacterial infections (such as rifampicin, erythromycin, talithromycin); clarithromycin (for infections caused by bacteria); verapamil, diltiazem (heart medicines); simvastatin (a medicine used to control high cholesterol levels); tacrolimus (used to control your body's immune response, enabling your body to accept the transplanted organ); dantrolene (infusion for severe body temperature abnormalities); medicines used to protect against transplant rejection (ciclosporin).
Danish: primidon); - perikon; - glyceryltrinitrat (nitroglycerin) og andre nitrater eller andre stoffer, som kaldes ”vasodilatorer”; - medicin mod hiv/aids (f.eks. ritonavir, indinavir, nelfinavir); - medicin til behandling af svampeinfektioner (f.eks. ketoconazol, itraconazol); - medicin til behandling af bakterieinfektioner (f.eks. rifampicin, erythromycin, talithromycin); - clarithromycin (til infektioner forårsaget af bakterier); - verapamil, diltiazem (hjertemedicin); - simvastatin (medicin som bruges til at behandle højt kolesterol); - Tacrolimus (bruges til at styre din krops immunforsvar og giver din krop mulighed for at acceptere det transplanterede organ); - dantrolen (infusion ved alvorligt forhøjet kropstemperatur); - medicin som bruges til at beskytte mod organafstødning efter transplantation (ciclosporin).
English: Hepatic impairment Amlodipine/valsartan is contraindicated in patients with severe hepatic impairment (see section 4.3).
Danish: Nedsat leverfunktion Amlodipin/valsartan er kontraindiceret hos patienter med alvorligt nedsat leverfunktion (se pkt.
English: The use of Amlodipine/Valsartan Mylan in children and adolescents is not recommended (aged below 18 years old).
Danish: Børn og unge Brug af Amlodipine/Valsartan Mylan til børn og unge frarådes (under 18 år).
English: Posology The recommended dose of Amlodipine/Valsartan Mylan is one tablet per day.
Danish: Dosering Den anbefalede dosis af Amlodipine/Valsartan Mylan er én tablet dagligt.
English: Iron oxide yellow (E172) Iron oxide red (E172) Iron oxide black (E172)
Danish: Gul jernoxid (E172) Rød jernoxid (E172) Sort jernoxid (E172)
English: Amlodipine/Valsartan Mylan with food and drink Grapefruit and grapefruit juice should not be consumed by people who are taking Amlodipine/Valsartan Mylan.
Danish: Amlodipine/Valsartan Mylan sammen med mad og drikke Du må ikke indtage grapefrugt og grapefrugtjuice, mens du tager Amlodipine/Valsartan Mylan.
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE inhibitors, angiotensin II receptor blockers (ARBs) or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
Danish: Dobbelt hæmning af renin-angiotensin-aldosteronsystemet (RAAS) Der er tegn på, at samtidig brug af ACE-hæmmere, angiotensin II-receptorhæmmere (ARBer) eller aliskiren øger risikoen for hypotension, hyperkaliæmi og nedsat nyrefunktion (inklusive akut nyresvigt).
English: In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan.
Danish: Den maksimale anbefalede dosis til patienter med let til moderat nedsat leverfunktion uden kolestase er 80 mg valsartan.
English: Amlodipine/Valsartan Mylan is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Danish: Amlodipine/Valsartan Mylan er indiceret til voksne, hvis blodtryk ikke er tilstrækkeligt kontrolleret med amlodipin eller valsartan monoterapi.
English: If any of the above applies to you, do not take Amlodipine/Valsartan Mylan and talk to your doctor.
Danish: Hvis noget af ovenstående gælder for dig, må du ikke tage Amlodipine/Valsartan Mylan, men skal kontakte din læge.
English: The following adverse reactions were found to be the most frequently occurring or the most significant or severe: nasopharyngitis, influenza, hypersensitivity, headache, syncope, orthostatic hypotension, oedema, pitting oedema, facial oedema, oedema peripheral, fatigue, flushing, asthenia and hot flush.
Danish: Følgende bivirkninger viste sig at være de hyppigste eller de mest signifikante eller alvorlige: nasofaryngitis, influenza, overfølsomhed, hovedpine, synkope, ortostatisk hypotension, ødem, fingertryksødem, ansigtsødem, perifert ødem, træthed, rødmen, asteni og hedeture.
English: Adverse reactions observed in animal studies with possible clinical relevance were as follows: Histopathological signs of inflammation of the glandular stomach was seen in male rats at an exposure of about 1.9 (valsartan) and 2.6 (amlodipine) times the clinical doses of 160 mg valsartan and 10 mg amlodipine.
Danish: Følgende bivirkninger blev set i dyrestudier, og kan være klinisk relevante: Histopatologiske tegn på inflammation i maveslimhinden blev set hos hanrotter ved en eksponering ca. 1,9 (valsartan) og 2,6 (amlodipin) gange de kliniske doser på 160 mg valsartan og 10 mg amlodipin.
English: ACE inhibitors and angiotensin II receptor blockers (ARBs) should therefore not be used concomitantly in patients with diabetic nephropathy (see section 4.4).
Danish: ACE-hæmmere og angiotensin II-receptorhæmmer (ARBer) bør derfor ikke anvendes samtidigt hos patienter med diabetisk nefropati (se pkt.
English: Heart attack, abnormal heart beat.
Danish: - Hjertetilfælde, unormal hjerterytme (puls).
English: Other: dual blockade of the renin-angiotensin-aldosterone system (RAAS) Two large randomised, controlled trials (ONTARGET [ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial] and VA NEPHRON-D [The Veterans Affairs Nephropathy in Diabetes]) have examined the use of the combination of an ACE inhibitor with an angiotensin II receptor blocker (ARB).
Danish: Andet: dobbeltblokade af renin-anfiotensin-aldosteronsystemet (RAAS) Kombinationen af en ACE-hæmmer og en angiotensin II-receptorhæmmer (ARB) er undersøgt i to store randomiserede, kontrollerede studier (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) og VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)).
English: * Mostly consistent with cholestasis
Danish: *oftest som følge af kolestase.
English: Exposure to AIIRA therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).
Danish: Eksponering af AIIA-behandling under andet og tredje trimester af graviditeten er kendt for at medføre toksicitet på humane fostre (nedsat nyrefunktion, oligohydramnion, hæmning af kraniets knogledannelse) og hos nyfødte (nyresvigt, hypotension, hyperkaliæmi) (se pkt.
English: Your doctor will normally advise you to stop taking Amlodipine/Valsartan Mylan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Amlodipine/Valsartan Mylan.
Danish: Normalt vil din læge råde dig til at stoppe med at tage Amlodipine/Valsartan Mylan, inden du bliver gravid, eller så snart du har konstateret, at du er gravid.
English: NDMA Limit in ppm in API
Danish: NDMA Grænseværdi i ppm i det aktive stof
English: Talk to your doctor before taking Amlodipine/Valsartan Mylan: if you have been sick (vomiting or diarrhoea).
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du tager Amlodipine/Valsartan Mylan: - hvis du har været syg (opkastning eller diarré).
English: Amlodipine/Valsartan Mylan is used to treat high blood pressure in adults whose blood pressure is not controlled enough with either amlodipine or valsartan on its own.
Danish: Amlodipine/Valsartan Mylan bruges til at behandle forhøjet blodtryk hos voksne, som ikke kan få deres blodtryk passende kontrolleret med enten amlodipin eller valsartan alene.
English: Food decreases exposure (as measured by AUC) to valsartan by about 40 % and peak plasma concentration (Cmax) by about 50 %, although from about 8 h post dosing plasma valsartan concentrations are similar for the fed and fasted groups.
Danish: Føde nedsætter eksponering af valsartan (målt ved AUC) med ca. 40% og plasmakoncentrationen (Cmax) med ca. 50%.
English: For N-nitrosodimethylamine (NDMA) and N nitrosodiethylamine (NDEA) the MAH must introduce the following specifications for the drug substance:
Danish: For N-nitrosodimethylamin (NDMA) og N-nitrosodiethylamin (NDEA) skal indehaverne af markedsføringstilladelse indføre følgende specifikationer for stoffet: 1) De nedenfor angivne grænseværdier for NDMA og NDEA bør implementeres i løbet af en overgangsperiode på to år:
English: If any of these apply to you, tell your doctor before taking Amlodipine/Valsartan Mylan.
Danish: Hvis dette gælder for dig, så tal med din læge inden du tager Amlodipine/Valsartan Mylan.
English: No drug-drug interaction studies have been performed with amlodipine/valsartan and other medicinal products.
Danish: Almindelige interaktioner med kombinationen Der er ikke udført lægemiddelinteraktionsstudier med amlodipin/valsartan og andre lægemidler.
English: What you need to know before you take Amlodipine/Valsartan Mylan
Danish: Det skal du vide, før du begynder at tage Amlodipine/Valsartan Mylan
English: If you forget to take Amlodipine/Valsartan Mylan If you forget to take this medicine, take it as soon as you remember.
Danish: Hvis du har glemt at tage Amlodipine/Valsartan Mylan Hvis du glemmer at tage din medicin, skal du tage den så snart du kommer i tanke om det. Du skal tage din næste dosis på dit sædvanlige tidspunkt.
English: Dual blockade of the RAAS with ARBs, ACE inhibitors or aliskiren Clinical trial data have shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE inhibitors, angiotensin II receptor blockers (ARBs) or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Danish: Dobbelt hæmning af RAAS med ARBer, ACE-hæmmere eller aliskiren Data fra kliniske studier har vist, at dobbelthæmning af renin-angiotensin-aldosteronsystemet (RAAS) ved kombinationsbehandling med ACE-hæmmere, angiotensin II-receptorhæmmere (ARBer) eller aliskiren er forbundet med en højere hyppighed af bivirkninger som hypertension, hyperkaliæmi og nedsat nyrefunktion (inklusive akut nyresvigt) sammenlignet med brug af et enkelt RAAS-virkende lægemiddel (se pkt.
English: In an embryo-foetal development study in the rat, increased incidences of dilated ureters, malformed sternebrae, and unossified forepaw phalanges were noticed at exposures of about 12 (valsartan) and 10 (amlodipine) times the clinical doses of 160 mg valsartan and 10 mg amlodipine.
Danish: I et embryo-føtal udviklingsstudie med rotter blev der bemærket en øget forekomst af udvidede urinledere, misdannede brystben og ikke-ossificerede forpoteknogler ved en eksponering ca. 12 (valsartan) og 10 (amlodipin) gange de kliniske doser på 160 mg valsartan og 10 mg amlodipin.
English: In a clinical trial of patients with a history of dry cough during ACE inhibitor therapy, 19.5 % of trial subjects receiving valsartan and 19.0 % of those receiving a thiazide diuretic experienced coughing, compared to 68.5 % of those treated with an ACE inhibitor (p <0.05).
Danish: I et klinisk studie med patienter, som tidligere havde haft tør hoste under behandling med en ACE-hæmmer, oplevede 19,5% af patienterne, som fik valsartan, og 19,0% af dem, som fik thiazid-diuretika, hoste.
English: Not known (frequency cannot be estimated from the available data): Decrease in red blood cells, fever, sore throat or mouth sores due to infections; spontaneous bleeding or bruising; high level of potassium in the blood; abnormal liver test results; decreased renal functions and severely decreased renal functions; swelling mainly of the face and the throat; muscle pain; rash, purplish-red spots; fever; itching; allergic reaction; blistering skin (sign of a condition called dermatitis bullous).
Danish: Ikke kendt (hyppigheden kan ikke klarlægges ud fra de tilgængelige data): Nedsat antal røde blodlegemer i blodet, feber, ondt i halsen eller sår i munden pga. infektioner; pludselige blødninger eller blå mærker; forhøjet kaliumniveau i blodet; unormale testresultater for leveren; nedsat nyrefunktion og alvorlig nedsat nyrefunktion; hævelse hovedsageligt i ansigt og hals; muskelsmerter; udslæt, lilla-farvede mærker; feber; kløe; overfølsomhedsreaktioner; blærer på huden (tegn på en lidelse kaldet bulløs dermatit).
English: In this study (baseline blood pressure 171/113 mmHg), an amlodipine/valsartan regimen of 5 mg/160 mg titrated to 10 mg/160 mg reduced sitting blood pressure by 36/29 mmHg as compared to 32/28 mmHg with a regimen of lisinopril/hydrochlorothiazide 10 mg/12.5 mg titrated to 20 mg/12.5 mg.
Danish: I dette studie (baseline blodtryk 171/113 mmHg) nedsatte amlodipin/valsartan 5 mg/160 mg titreret op til 10 mg/160 mg blodtrykket i siddende stilling med 36/29 mmHg.
English: Leukocytopenia, thrombocytopenia, allergic reactions, hyperglycaemia, hypertonia, peripheral neuropathy, myocardial infarction, arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation), vasculitis, pancreatitis, gastritis, gingival hyperplasia, hepatitis, jaundice, hepatic enzymes increased*, angioedema, erythema multiforme, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome, Quincke oedema, photosensitivity.
Danish: Meget sjælden Leukopeni, trombocytopeni, allergiske reaktioner, hyperglykæmi, hypertoni, perifer neuropati, myokardieinfarkt, arytmi (herunder bradykardi, ventrikulær takykardi og atrieflimren), vaskulitis, pankreatitis, gastritis, gingival hyperplasi, hepatitis, gulsot, forhøjede leverenzymer*, angioødem, erythema multiforme, urticaria, eksfoliativ dermatitis, Stevens-Johnsons syndrom, quinckes ødem, lysfølsomhed.
English: The active substances of Amlodipine/Valsartan Mylan are amlodipine (as amlodipine besilate) and valsartan.
Danish: Amlodipine/Valsartan Mylan indeholder: Aktive stoffer: amlodipin (som amlodipinbesilat) og valsartan.
English: Paediatric population (age below 18 years) No pharmacokinetic data are available in the paediatric population.
Danish: Der er ingen farmakokinetiske data tilgængelige for den pædiatriske population.
English: Severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson Syndrome, toxic epidermal necrolysis) or other allergic reactions.
Danish: intens kløe, blæredannelse, afskalning eller hævelse i huden, betændelseslignende tilstand i slimhinderne (Stevens-Johnsons syndrom, toksisk epidermal nekrolyse) eller andre allergiske reaktioner.
English: Somnolence, dizziness, palpitations, abdominal pain, nausea, ankle swelling.
Danish: Amlodipin Almindelig Døsighed, svimmelhed, palpitationer, abdominalsmerter, kvalme, hævede ankler.
English: The other ingredients are cellulose microcrystalline; crospovidone; magnesium stearate; silica colloidal anhydrous; hypromellose; macrogol 8000; talc; titanium dioxide (E171); iron oxide yellow (E172); iron oxide red (E172); iron oxide black (E172).
Danish: Øvrige indholdsstoffer: mikrokrystallinsk cellulose, crospovidon, magnesiumstearat, kolloid vandfri silica, hypromellose, macrogol 8000, talcum, titandioxid (E171), gul jernoxid (E172), rød jernoxid (E172), sort jernoxid (E172).
English: The effect of amlodipine/valsartan on infants is unknown.
Danish: Amlodipins virkning på spædbørn er ikke kendt.
English: All packs are available in perforated unit dose blisters; the 14, 28, 56 and 98 tablet packs are also available in standard blisters.
Danish: Tabletpakningerne med 14, 28, 56 og 98 tabletter findes også som standard blisterpakninger.
English: The other ingredients are cellulose microcrystalline; crospovidone; magnesium stearate; silica colloidal anhydrous; hypromellose; macrogol 8000; talc, titanium dioxide (E171); iron oxide yellow (E172).
Danish: Øvrige indholdsstoffer: mikrokrystallinsk cellulose, crospovidon, magnesiumstearat, kolloid vandfri silica, hypromellose, macrogol 8000, talcum, titandioxid (E171), gul jernoxid (E172).