FrancophonIA/ELRC3.0 huggingface dataset:
English: The study failed to demonstrate the efficacy of felodipine in lowering blood pressure in children aged 6-16 years (see section 4.2)
Danish: Studiet formåede ikke at vise, at felodipin kunne sænke blodtrykket hos børn i alderen 6-16 år (se pkt.
English: The long-term efficacy of antihypertensive therapy as therapy in childhood to reduce cardiovascular morbidity and mortality in adulthood has also not been established.
Danish: Ligeledes er langtidseffekten af antihypertensionsbehandling i barndommen for at forebygge kardiovaskulær morbiditet og mortalitet som voksen ikke fastlagt.
English: Annex III Summary of product characteristics, labelling and package leaflet
Danish: BILAG III PRODUKTRESUME, ETIKETTERING OG INDLÆGSSEDDEL
English: No disturbances of fertility were observed when doses within the therapeutic range were given to rats.
Danish: Der blev ikke observeret nogen påvirkning af fertiliteten, når der blev givet doser inden for det terapeutiske interval til rotter.
English: Tacrolimus: Felodipine may increase the concentration of tacrolimus.
Danish: Tacrolimus: Felodipin kan øge koncentrationen af tacrolimus.
English: Practice good oral hygiene to help avoid your gums from swelling (see section 4).
Danish: Sørg for god mundhygiejne for at undgå, at dit tandkød hæver (se punkt 4).
English: Some medicines/herbal remedies can affect treatment with Plendil.
Danish: Nogle lægemidler/naturlægemidler kan påvirke behandlingen med Plendil, for eksempel:
English: Common ≥ 1/100 to < 1/10
Danish: Almindelig ≥ 1/100 til < 1/10
English: If you forget to take Plendil
Danish: Hvis du har glemt at tage Plendil
English: When felodipine was coadministered with carbamazepine, phenytoin or phenobarbital, the Cmax and AUC of felodipine were decreased by 82% and 96% respectively.
Danish: Når felodipin blev administreret sammen med carbamazepin, phenytoin eller phenobarbital blev felodipin-Cmax og -AUC reduceret med henholdsvis 82 % og 96 %.
English: In a study on fertility and general reproductive performance in rats treated with felodipine, a prolongation of parturition resulting in difficult labour/increased foetal deaths and early postnatal deaths was observed in the medium and high dose groups.
Danish: I et studie af fertilitet og generel reproduktionsevne hos rotter, som blev behandlet med felodipin, blev der observeret en forlængelse af fødslen, hvilket medførte svær fødsel/øget føtal død og tidlig postnatal død i mellem- og højdosisgrupperne.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION <Date of first authorisation: {DD month YYYY}> <Date of latest renewal: {DD month YYYY}>
Danish: <Dato for første markedsføringstilladelse: {DD måned ÅÅÅÅ}> <Dato for seneste fornyelse: {DD måned ÅÅÅÅ}>
English: If this is not sufficient, plasma volume should be increased by infusion of e.g., glucose, saline, or dextran.
Danish: Hvis dette ikke er tilstrækkeligt, øges plasmavolumen ved infusion af fx glucose, natriumchlorid eller dextran.
English: • barbiturates (medicine to treat anxiety, sleeping problems and epilepsy)
Danish: • barbitursyrederivater (medicin til behandling af angst, søvnproblemer og epilepsi)
English: Cimetidine increased the felodipine Cmax and AUC by approximately 55%.
Danish: Cimetidin øgede felodipin-Cmax og -AUC med ca. 55 %.
English: This may lead to myocardial ischaemia in susceptible patients.
Danish: Dette kan føre til myokardieiskæmi hos følsomme patienter.
English: Elderly population Initial treatment with lowest available dose should be considered.
Danish: Ældre Hos ældre bør det overvejes at indlede behandlingen med den lavest tilgængelige dosis.
English: Generally, a reduction in blood pressure is evident two hours after the first oral dose and lasts for at least 24 hours and the trough/peak ratio is usually well above 50%.
Danish: Generelt er en reduktion af blodtrykket tydelig inden for to timer efter den første orale dosis, og virkningen holder i mindst 24 timer.
English: Other undesirable effects may occur.
Danish: Der kan forekomme andre bivirkninger.
English: Plendil extended release tablets should be taken in the morning and be swallowed with water.
Danish: Plendil depottabletter skal tages om morgenen og synkes med vand.
English: Cardiac effects
Danish: Kardielle virkninger
English: Plendil, like other blood-pressure lowering medicinal products, may in rare cases lead to pronounced low blood pressure which in some patients may result in an inadequate supply of blood to the heart.
Danish: I sjældne tilfælde kan Plendil, ligesom andre blodtrykssænkende lægemidler, medføre udtalt lavt blodtryk, som hos nogle patienter kan betyde, at der ikke føres tilstrækkeligt blod til hjertet.
English: • Acute myocardial infarction
Danish: • Akut myokardieinfarkt
English: Plendil contains the active substance felodipine.
Danish: Plendil indeholder det aktive stof felodipin.
English: Plendil is used in the treatment of high blood pressure (hypertension) and heart and chest pain brought on by for example exercise or stress (angina pectoris).
Danish: Plendil anvendes til behandling af forhøjet blodtryk (hypertension) og hjerte- og brystsmerter (angina pectoris), der for eksempel er udløst af motion eller stress.
English: • Impotence/sexual dysfunction
Danish: • Impotens/seksuelle forstyrrelser
English: In a randomised, double-blind, 3-week, parallel group study in children aged 6-16 years with primary hypertension, the antihypertensive effects of once daily felodipine 2.5 mg (n=33), 5 mg (n=33) and 10 mg (n=31) were compared with placebo (n=35).
Danish: I et randomiseret, dobbeltblindet, parallelgruppestudie af 3 ugers varighed med børn i alderen 6-16 år med primær hypertension blev den antihypertensive virkning af felodipin 2,5 mg (n=33), 5 mg (n=33) og 10 mg (n=31) én gang dagligt sammenlignet med placebo (n=35).
English: if you suffer from uncompensated heart failure.
Danish: - hvis du lider af ubehandlet hjertesvigt.
English: The tablets can be administered without food or following a light meal not rich in fat or carbohydrate.
Danish: Tabletterne kan administreres uden mad eller efter et let måltid, som ikke er rigt på fedt eller kulhydrater.
English: Felodipine may cause significant hypotension with subsequent tachycardia.
Danish: Felodipin kan medføre signifikant hypotension med efterfølgende takykardi.
English: Because there is no effect on venous smooth muscle or adrenergic vasomotor control, felodipine is not associated with orthostatic hypotension.
Danish: Da der ikke er nogen påvirkning af venernes glatte muskulatur eller den adrenerge vasomotoriske kontrol, er felodipin ikke forbundet med ortostatisk hypotension.
English: Photosensitivity reactions, leucocytoclastic vasculitis
Danish: Fotosensibilitetsreaktioner, leukocytoklastisk vaskulitis
English: Uncommon Tachycardia, palpitations
Danish: Ikke almindelig Takykardi, palpitationer
English: Felodipine was given as monotherapy or in combination with a betablocker, and/or an ACE-inhibitor and/or a diuretic.
Danish: Felodipin blev givet som monoterapi eller i kombination med en betablokker og/eller en ACE-hæmmer og/eller et diuretikum.
English: Felodipine Cmax and AUC increased 8-fold and 6-fold, respectively, when felodipine was coadministered with the strong CYP3A4 inhibitor itraconazole.
Danish: Felodipin-Cmax og -AUC blev øget henholdsvis 8 gange og 6 gange, når felodipin blev administreret samtidig med den potente CYP3A4-inhibitor itraconazol.
English: Cyclosporin: Felodipine does not affect plasma concentrations of cyclosporin.
Danish: Ciclosporin: Felodipin påvirker ikke plasmakoncentrationen af ciclosporin.
English: There were no other pre clinical findings considered to be of concern and the reproductive findings are considered to be related to the pharmacological action of felodipine, when given to normotensive animals.
Danish: Der blev ikke gjort andre prækliniske fund, som ansås for at være relevante, og de reproduktive fund anses for værende forbundet med felodipins farmakologiske virkning, når det blev givet til normotensive dyr.
English: Elderly people Your doctor may initiate treatment with the lowest available dose.
Danish: Ældre Lægen kan indlede behandlingen med lavest mulige dosis.
English: 5.3 Preclinical safety data
Danish: 5.3 Prækliniske sikkerhedsdatastudier
English: In the HOT (Hypertension Optimal Treatment) study, the effect on major cardiovascular events (ie, acute myocardial infarction, stroke and cardiovascular death) was studied in relation to diastolic blood pressure targets < 90 mmHg, < 85 mmHg and < 80 mmHg and achieved blood pressure, with felodipine as baseline therapy.
Danish: HOT-studiet (Hypertension Optimal Treatment) undersøgte virkningen på større kardiovaskulære hændelser (dvs. akut myokardieinfarkt, apopleksi og kardiovaskulær død) i relation til målet for diastolisk blodtryk: < 90 mmHg, < 85 mmHg og < 80 mmHg og opnået blodtryk, med felodipin som baselinebehandling.
English: This results in even felodipine plasma concentrations within the therapeutic range for 24 hours.
Danish: Dette resulterer i en jævn felodipinplasmakoncentration inden for det terapeutiske interval over 24 timer.
English: • tacrolimus (medicine used in organ transplantations)
Danish: • tacrolimus (medicin, der anvendes ved organtransplantation)
English: According to the STOP-2 (Swedish Trial in Old Patients with Hypertension-2 study), performed in 6614 patients, aged 70-84 years, dihydropyridine calcium antagonists (felodipine and isradipine) have shown the same preventive effect on cardiovascular mortality and morbidity as other commonly used classes of antihypertensive medicinal products - ACE inhibitors, beta-blockers and diuretics.
Danish: Ifølge STOP (Swedish Trial in Old Patients with Hypertension)-2-studiet, der blev udført med 6.614 patienter i alderen 70-84 år, har dihydropyridin-calciumantagonister (felodipin og isradipin) udvist samme præventive virkning på kardiovaskulær mortalitet og morbiditet som andre almindeligt anvendte klasser af antihypertensiva - ACE-hæmmere, betablokkere og diuretika.
English: In order to keep the prolongedrelease properties, the tablets must not be divided, crushed or chewed.
Danish: For at bevare depotegenskaberne må tabletterne ikke deles, knuses eller tygges.
English: Due to the high degree of selectivity for smooth muscle in the arterioles, felodipine in therapeutic doses has no direct effect on cardiac contractility or conduction.
Danish: Som følge af den høje selektivitet for den glatte muskulatur i arteriolerne har felodipin i terapeutiske doser ingen direkte virkning på den kardielle kontraktilitet eller overledning.
English: What you need to know before you take Plendil
Danish: Det skal du vide, før du begynder at tage Plendil
English: Plasma concentrations are directly proportional to dose within the therapeutic dose range 2.5 - 10 mg.
Danish: Der er direkte proportionalitet mellem plasmakoncentration og dosis inden for det terapeutiske dosisinterval 2,5-10 mg.
English: This medicine can be taken without food or following a light meal not high in fat or carbohydrates.
Danish: Denne medicin kan tages uden mad eller efter et let måltid, som ikke har et højt indhold af fedt eller kulhydrater.
English: In elderly patients, a starting dose of 2.5 mg daily may be considered.
Danish: Hos ældre patienter kan det overvejes at starte med en dosis på 2,5 mg.
English: Should such reactions occur, they are usually brief and diminish in intensity with time.
Danish: Hvis sådanne bivirkninger opstår, er de sædvanligvis kortvarige og bliver mindre udtalte med tiden.
English: In a single dose (felodipine prolonged-release 5 mg) pharmacokinetic study with a limited number of children aged between 6 and 16 years (n=12) there was no apparent relationship between the age and AUC, Cmax or half-life of felodipine.
Danish: I et farmakokinetisk studie med enkeltdosis (felodipindepottablet 5 mg) med et begrænset antal børn mellem 6 og 16 år (n=12) var der ikke en tydelig sammenhæng mellem alder og felodipins AUC, Cmax eller halveringstid.
English: If you experience any of the following symptoms and they persist, please tell your doctor.
Danish: Hvis du oplever nogen af følgende symptomer, og de varer ved, skal du fortælle det til lægen.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications Hypertension
Danish: 4.1 Terapeutiske indikationer
English: Nausea, abdominal pain Vomiting
Danish: Kvalme, abdominalsmerter Opkastning
English: • Inflammation of small blood vessels of the skin
Danish: • Betændelseslignende reaktion (inflammation) i små blodkar i huden
English: • Decompensated heart failure
Danish: • Ukompenseret hjerteinsufficiens
English: Consequently higher therapeutic concentrations and response can be expected in patients with clearly reduced liver function (see section 4.2).
Danish: Der kan derfor forventes højere plasmakoncentrationer og øget respons hos patienter med klart nedsat leverfunktion (se pkt.
English: It is bound pre-dominantly to the albumin fraction.
Danish: Det er hovedsageligt bundet til albuminfraktionen.
English: Patients with impaired hepatic function may have elevated plasma concentrations of felodipine and may respond to lower doses (see section 4.4).
Danish: Patienter med nedsat leverfunktion kan have forhøjet felodipinplasmakoncentration og respondere på lavere doser (se pkt.
English: INFORMATION IN BRAILLE <Justification for not including Braille accepted> [To be completed nationally]
Danish: INFORMATION I BRAILLE-SKRIFT <Fritaget fra krav om brailleskrift>
English: If patients taking felodipine suffer from headache, nausea, dizziness or fatigue and ability to react may be impaired.
Danish: Hvis patienter, der tager felodipin, oplever hovedpine, kvalme, svimmelhed eller træthed, kan reaktionsevnen blive nedsat.
English: The tablet must not be divided, crushed or chewed.
Danish: Tabletten må ikke deles, knuses eller tygges.
English: The pharmacokinetics of felodipine is not changed in patients with renal impairment, including those treated with haemodialysis.
Danish: Felodipins farmakokinetik er uændret hos patienter med nedsat nyrefunktion, herunder patienter i hæmodialyse.
English: The extended-release tablets produce a prolonged absorption phase of felodipine.
Danish: Depottabletterne har en forlænget absorptionsfase for felodipin.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg felodipine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 2,5 mg felodipin.
English: Felodipine can be used as monotherapy or in combination with ß-adrenoceptor blockers in patients with stable angina pectoris.
Danish: Felodipin kan anvendes som monoterapi eller i kombination med betablokkere til patienter med stabil angina pectoris.
English: Felodipine can cause flushing, headache, palpitations, dizziness and fatigue.
Danish: Felodipin kan forårsage ansigtsrødme, hovedpine, palpitationer, svimmelhed og træthed.
English: Most of these adverse reactions are dose-dependent and appear at the start of treatment or after a dose increase.
Danish: De fleste af disse bivirkninger er dosisafhængige og optræder i starten af behandlingen og ved dosisøgning.
English: Depending on the patient's response, the dosage can, where applicable, be decreased to 2.5 mg or increased to 10 mg daily.
Danish: Afhængigt af patientens respons kan dosis nedsættes til 2,5 mg eller øges til 10 mg dagligt efter behov.
English: Felodipine reduces both systolic and diastolic blood pressure and can be used in isolated systolic hypertension.
Danish: Felodipin reducerer både systolisk (SBP) og diastolisk (DBP) blodtryk og kan anvendes ved isoleret systolisk hypertension.
English: These effects were attributed to the inhibitory effect of felodipine in high doses on uterine contractility.
Danish: Disse påvirkninger blev tillagt felodipins hæmmende virkning på uteruskontraktioner ved høje doser.
English: The enlargement can be avoided or reversed by careful oral hygiene.
Danish: Fortykkelsen kan undgås eller fjernes igen ved omhyggelig mundhygiejne.
English: Felodipine is administered as extended-release tablets, from which it is completely absorbed in the gastrointestinal tract.
Danish: Felodipin administreres som depottabletter, hvorfra det absorberes fuldstændigt i mave-tarmkanalen.
English: Treatment should be started with 5 mg once a day and if needed, your doctor may increase the dose to 10 mg once a day.
Danish: Behandlingen skal indledes med 5 mg én gang dagligt, og om nødvendigt kan din læge øge dosis til 10 mg én gang dagligt.
English: Tell your doctor if you are breast-feeding or about to start breast-feeding.
Danish: Fortæl det til din læge, hvis du ammer eller skal begynde med at amme.
English: PHARMACEUTICAL FORM AND CONTENTS 2.5 mg tablet
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 2,5 mg tablet
English: if you are allergic to felodipine or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for felodipin eller et af de øvrige indholdsstoffer i dette lægemiddel
English: Felodipine has anti-anginal and anti-ischaemic effects due to improved myocardial oxygen supply/demand balance.
Danish: Felodipin har antianginøs og antiiskæmisk virkning som følge af en forbedret balance mellem myokardiets iltforsyning og iltbehov.
English: In non-clinical reproductive toxicity studies there were foetal developmental effects, which are considered to be due to the pharmacological action of felodipine.
Danish: I prækliniske reproduktionstoksicitetsstudier sås påvirkninger af den føtale udvikling, som anses at skyldes felodipins farmakologiske virkning.
English: If you have any bothersome or unusual reaction while taking Plendil, check with your doctor right away.
Danish: Hvis du får nogen generende eller usædvanlige bivirkninger, mens du tager Plendil, skal du straks tale med lægen.
English: Very common Uncommon Very rare
Danish: Meget almindelig Ikke almindelig Meget sjælden
English: If you experience headache, nausea, dizziness or fatigue your ability to react may be impaired.
Danish: Hvis du får hovedpine eller kvalme eller bliver svimmel eller træt, kan din reaktionsevne blive nedsat.
English: Felodipine has a natriuretic and diuretic effect due to reduced tubular reabsorption of filtered sodium.
Danish: Felodipin har en natriuretisk og diuretisk virkning på grund af reduceret tubulær reabsorption af natrium.
English: Plendil contains lactose and castor oil
Danish: Plendil indeholder lactose og ricinusolie
English: The combination with strong CYP3A4 inducers should be avoided.
Danish: Kombination med potente CYP3A4-induktorer bør undgås.
English: • medicines to treat HIV infection (such as efavirenz, nevirapine)
Danish: • medicin til behandling af hiv-infektion (såsom efavirenz, nevirapin og proteasehæmmere f.eks.
English: Plasma concentrations of felodipine are positively correlated to the decrease in total peripheral resistance and blood pressure.
Danish: Plasmakoncentrationen af felodipin er positivt korreleret til faldet i samlet perifer modstand og blodtryk.
English: Other medicines and Plendil
Danish: Brug af anden medicin sammen med Plendil
English: The usual dose when treating this disease for a long time is 5-10 mg once a day.
Danish: Den sædvanlige dosis ved langvarig behandling af hypertension er 5-10 mg én gang dagligt.
English: In cyclosporin-treated renal transplant recipients, felodipine reduces blood pressure and improves both the renal blood flow and the glomerular filtration rate.
Danish: Hos ciclosporinbehandlede, nyretransplanterede patienter reducerer felodipin blodtrykket og forbedrer blodgennemstrømningen i nyrerne og den glomerulære filtrationshastighed.
English: Felodipine is a vascular selective calcium antagonist, which lowers arterial blood pressure by decreasing systemic vascular resistance.
Danish: Felodipin er en selektiv calciumantagonist med vaskulær effekt, der nedsætter det arterielle blodtryk ved at mindske den systemiske vaskulære modstand.
English: Felodipine does not influence urinary albumin excretion.
Danish: Felodipin påvirker ikke udskillelse af albumin i urinen.
English: The standard maintenance dose is 5 mg once daily.
Danish: Den sædvanlige vedligeholdelsesdosis er 5 mg én gang dagligt.
English: Stable angina pectoris
Danish: Stabil angina pectoris
English: If you experience these symptoms, seek emergency care immediately.
Danish: Hvis du har disse symptomer, skal du straks søge læge eller skadestue.
English: Carnauba wax Iron oxide yellow (E172) Hypromellose 6 mPa·s Macrogol 6000
Danish: Carnaubavoks Jernoxid, gul (E172) Hypromellose 6 mPa·s Macrogol 6000
English: Felodipine in therapeutic doses has no effect on cardiac contractility or atrioventricular conduction or refractoriness.
Danish: Felodipin har i terapeutiske doser ingen virkning på hjertets kontraktilitet, atrioventrikulære overledning eller refraktærperioden.
English: Iron oxide reddish-brown (E172) (Only used for Plendil 5 mg and 10 mg) Iron oxide yellow (E172)
Danish: Jernoxid, rødbrun (E172) (Bruges kun til Plendil 5 mg og 10 mg) Jernoxid, gul (E172)
English: Plendil contains castor oil, which may cause stomach upset and diarrhoea.
Danish: Plendil indeholder ricinusolie, der kan give mavebesvær og diarré.
English: When felodipine and erythromycin were coadministered, the Cmax and AUC of felodipine were increased by about 2.5-fold.
Danish: Når felodipin og erythromycin blev administreret samtidig, blev felodipin-Cmax og -AUC øget ca. 2,5 gange.
English: - The active substance felodipine.
Danish: - Aktivt stof: felodipin.
English: If you experience symptoms such as feeling faint, light-headedness or dizziness, contact your doctor immediately.
Danish: Hvis du oplever symptomer, såsom at du bliver svimmel eller føler, at du skal besvime, skal du straks kontakte lægen.
English: Felodipine possesses a mild natriuretic/diuretic effect and fluid retention does not occur.
Danish: Felodipin har en let natriuretisk/diuretisk virkning, og væskeretention forekommer ikke.
English: The combination with strong CYP3A4 inhibitors should be avoided.
Danish: Kombination med potente CYP3A4-inhibitorer bør undgås.
English: 1 blister of 28 tablets 2 blisters of 14 tablets 4 blisters of 7 tablets
Danish: 1 blister a 28 tabletter 2 blistere a 14 tabletter 4 blistere a 7 tabletter
English: Renal impairment Dose adjustment is not needed in patients with impaired renal function.
Danish: Nedsat nyrefunktion Det er ikke nødvendigt at justere dosis hos patienter med nedsat nyrefunktion.
English: In a nonclinical reproductive study in the rat (see section 5.3), there were effects on fetal development but no effect on fertility at doses approximating to therapeutic.
Danish: 5.3) sås påvirkninger af den føtale udvikling, men ingen indvirkning på fertiliteten i doser, der nærmer sig de terapeutiske.
English: Felodipine improves exercise tolerance and reduces anginal attacks in patients with stable effort-induced angina pectoris.
Danish: Felodipin forbedrer den fysiske udholdenhed og nedsætter anfaldsfrekvensen af angina pectoris hos patienter med stabil anstrengelsesudløst angina pectoris.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2.5 mg (or 5 mg, or 10 mg) felodipine
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 2,5 mg (eller 5 mg eller 10 mg) felodipin
English: Coronary vascular resistance is decreased and coronary blood flow and myocardial oxygen supply are increased by felodipine due to dilatation of both epicardial arteries and arterioles.
Danish: Felodipin nedsætter modstanden i koronarkar og øger blodgennemstrømningen og den myokardielle iltforsyning som følge af dilatationen af både epikardielle arterier og arterioler.
English: The primary haemodynamic effect of felodipine is a reduction of total peripheral vascular resistance, which leads to a decrease in blood pressure.
Danish: Felodipins primære hæmodynamiske virkning er en reduktion af den totale perifere vaskulære modstand, hvilket fører til en nedsættelse af blodtrykket.
English: Hypersensitivity reactions, e.g. angio-oedema, fever
Danish: Overfølsomhedsreaktioner, fx angioødem, feber
English: Treatment should be initiated with 5 mg once daily and, if needed, increased to 10 mg once daily.
Danish: Behandlingen skal indledes med 5 mg én gang dagligt og om nødvendigt øges til 10 mg én gang dagligt.