FrancophonIA/ELRC3.0 huggingface dataset:
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.
Spanish: En el estudio HOT (Hypertension Optimal Treatment), se estudió el efecto sobre acontecimientos cardiovasculares graves (p. ej., infarto agudo de miocardio, ictus y muerte cardiovascular) en relación a los objetivos de presión diastólica < 90 mmHg, < 85 mmHg y < 80 mmHg y presión arterial conseguida, con felodipino como tratamiento inicial.
English: Plendil contains lactose and castor oil
Spanish: Plendil contiene lactosa y aceite de ricino
English: Cyclosporin: Felodipine does not affect plasma concentrations of cyclosporin.
Spanish: Ciclosporina: Felodipino no afecta a las concentraciones plasmáticas de ciclosporina.
English: Felodipine is administered as extended-release tablets, from which it is completely absorbed in the gastrointestinal tract.
Spanish: Felodipino se administra en forma de comprimidos de liberación prolongada, absorbiéndose completamente en el tracto gastrointestinal.
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).
Spanish: En un estudio aleatorizado, doble ciego, de 3 semanas de duración, controlado con un grupo paralelo, en niños de edades entre 6-16 años con hipertensión primaria, se compararon los efectos antihipertensivos de felodipino 2,5 mg (n=33), 5 mg (n=33) y 10 mg (n=31) una vez al día con placebo (n=35).
English: Felodipine Cmax and AUC increased 8-fold and 6-fold, respectively, when felodipine was coadministered with the strong CYP3A4 inhibitor itraconazole.
Spanish: La Cmax y el AUC de felodipino aumentaron 8 veces y 6 veces, respectivamente, cuando se coadministró felodipino con itraconazol, un potente inhibidor del CYP3A4.
English: Elderly population Initial treatment with lowest available dose should be considered.
Spanish: Pacientes de edad avanzada Se debe considerar iniciar el tratamiento con la menor dosis disponible.
English: Do not take Plendil if you are pregnant.
Spanish: No tome use Plendil - si está embarazada.
English: Plendil contains the active substance felodipine.
Spanish: Plendil contiene el principio activo felodipino.
English: Macrogol 6000
Spanish: Polietilenglicol 6000
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.
Spanish: De acuerdo con el estudio STOP-2 (Swedish Trial in Old Patients with Hypertension-2), llevado a cabo en 6.614 pacientes, de 70-84 años de edad, los antagonistas del calcio dihidropiridínicos (felodipino e isradipino) han mostrado el mismo efecto preventivo sobre la mortalidad y la morbilidad cardiovascular que otras clases de medicamentos antihipertensivos usados frecuentemente - inhibidores de la ECA, betabloqueantes y diuréticos.
English: The tablet must not be divided, crushed or chewed.
Spanish: El comprimido no se debe dividir, triturar ni masticar.
English: • Carbamazepine
Spanish: • Carbamazepina
English: The relevance of these findings for patients receiving felopidine is unknown.
Spanish: Se desconoce la relevancia de estos hallazgos en pacientes que toman felodipino.
English: The tablets can be administered without food or following a light meal not rich in fat or carbohydrate.
Spanish: Los comprimidos se pueden administrar en ayunas o tras una comida ligera que no sea rica en grasas o hidratos de carbono.
English: Because there is no effect on venous smooth muscle or adrenergic vasomotor control, felodipine is not associated with orthostatic hypotension.
Spanish: Debido a que carece de efectos sobre el músculo liso venoso o sobre el control vasomotor adrenérgico, felodipino no se asocia con hipotensión ortostática.
English: PHARMACEUTICAL FORM AND CONTENTS 2.5 mg tablet
Spanish: FORMA FARMACÉUTICA Y CONTENIDO DEL ENVASE comprimido de 2,5 mg
English: It can be used as monotherapy or in combination with other antihypertensive medicinal products, eg, ß-adrenoceptor blockers, diuretics or ACE-inhibitors, in order to achieve an increased antihypertensive effect.
Spanish: Se puede utilizar en monoterapia o en combinación con otros fármacos antihipertensivos, p.ej. bloqueantes de los adrenorreceptores-β, diuréticos o inhibidores de la ECA, para conseguir un mayor efecto antihipertensivo.
English: Common ≥ 1/100 to < 1/10
Spanish: Frecuente ≥1/100 a <1/10
English: Felodipine has anti-anginal and anti-ischaemic effects due to improved myocardial oxygen supply/demand balance.
Spanish: Felodipino posee efectos antianginosos y antiisquémicos ya que mejora el equilibrio miocárdico de suministro/demanda de oxígeno.
English: The pharmacokinetics of felodipine is not changed in patients with renal impairment, including those treated with haemodialysis.
Spanish: La farmacocinética de felodipino no varía en pacientes con insuficiencia renal, incluidos los tratados en hemodiálisis.
English: Renal impairment Dose adjustment is not needed in patients with impaired renal function.
Spanish: Insuficiencia renal No se necesita ajuste de dosis en pacientes con insuficiencia renal.
English: Cimetidine increased the felodipine Cmax and AUC by approximately 55%.
Spanish: Cimetidina aumentó la Cmax y el AUC de felodipino en aproximadamente un 55%.
English: • Anti HIV/protease inhibitors (e.g. ritonavir)
Spanish: • Anti VIH/inhibidores de la proteasa (p. ej., ritonavir)
English: • Gingivitis (swollen gums)
Spanish: • Gingivitis (encías inflamadas)
English: Felodipine can be used as monotherapy or in combination with ß-adrenoceptor blockers in patients with stable angina pectoris.
Spanish: Felodipino se puede usar en monoterapia o en combinación con bloqueantes de los adrenorreceptores-β en pacientes con angina de pecho estable.
English: It lowers blood pressure by dilating small blood vessels.
Spanish: Disminuye la presión arterial dilatando los capilares sanguíneos.
English: • Barbiturates
Spanish: • Barbitúricos
English: Felodipine was given as monotherapy or in combination with a betablocker, and/or an ACE-inhibitor and/or a diuretic.
Spanish: Se administró felodipino en monoterapia o en combinación con un betabloqueante y/o un inhibidor de la ECA y/o un diurético.
English: • Increased liver enzymes
Spanish: • Aumento de las enzimas hepáticas
English: Tell your doctor if you are breast-feeding or about to start breast-feeding.
Spanish: Informe a su médico si está dando el pecho o va a comenzar a darlo.
English: Photosensitivity reactions, leucocytoclastic vasculitis
Spanish: Reacciones de fotosensibilidad, vasculitis leucocitoclástica
English: • Pain in joints
Spanish: • Dolor en las articulaciones
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg felodipine.
Spanish: COMPOSICIÓN CUALITATIVA Y CUANTITATIVA Cada comprimido contiene 2,5 mg de felodipino.
English: Felodipine can cause flushing, headache, palpitations, dizziness and fatigue.
Spanish: Felodipino puede causar sofocos, cefaleas, palpitaciones, mareos y fatiga.
English: Felodipine may cause significant hypotension with subsequent tachycardia.
Spanish: Felodipino puede dar lugar a hipotensión significativa con taquicardia secundaria.
English: Iron oxide reddish-brown (E172) (Only used for Plendil 5 mg and 10 mg) Iron oxide yellow (E172)
Spanish: Óxido de hierro marrón-rojizo (E172) (Sólo utilizado para Plendil 5 mg y 10 mg) Óxido de hierro amarillo (E172)
English: The standard maintenance dose is 5 mg once daily.
Spanish: La dosis normal de mantenimiento es de 5 mg una vez al día.
English: If patients taking felodipine suffer from headache, nausea, dizziness or fatigue and ability to react may be impaired.
Spanish: Si los pacientes que tomen felodipino sufren de cefaleas, náuseas, mareos o fatiga, su capacidad de reacción puede estar afectada.
English: In cyclosporin-treated renal transplant recipients, felodipine reduces blood pressure and improves both the renal blood flow and the glomerular filtration rate.
Spanish: En receptores de trasplante de riñón tratados con ciclosporina, felodipino disminuye la presión arterial y mejora tanto el flujo sanguíneo renal como la tasa de filtración glomerular.
English: Felodipine reduces both systolic and diastolic blood pressure and can be used in isolated systolic hypertension.
Spanish: Felodipino reduce tanto la presión arterial sistólica como diastólica y se puede utilizar en la hipertensión sistólica aislada.
English: Skin and subcutaneous tissue disorders
Spanish: Trastornos de la piel y tejido subcutáneo
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.
Spanish: Se debe iniciar el tratamiento con 5 mg una vez al día y si fuese necesario, su médico podrá aumentar la dosis a 10 mg una vez al día.
English: Felodipine improves exercise tolerance and reduces anginal attacks in patients with stable effort-induced angina pectoris.
Spanish: Felodipino mejora la tolerancia al ejercicio y reduce las crisis de angina en pacientes con angina de pecho estable inducida por esfuerzo.
English: Felodipine does not influence urinary albumin excretion.
Spanish: Felodipino no influye sobre la excreción urinaria de albúmina.
English: Felodipine in therapeutic doses has no effect on cardiac contractility or atrioventricular conduction or refractoriness.
Spanish: A dosis terapéuticas, felodipino no tiene efecto sobre la contractilidad cardiaca, la conducción cardiaca o la refractariedad.
English: Felodipine is cleared by the liver.
Spanish: Felodipino se elimina por el hígado.
English: The primary haemodynamic effect of felodipine is a reduction of total peripheral vascular resistance, which leads to a decrease in blood pressure.
Spanish: El efecto hemodinámico primario de felodipino es la reducción de la resistencia vascular periférica total, lo cual conduce a un descenso de la presión sanguínea.
English: - The active substance felodipine.
Spanish: - El principio activo es felodipino.
English: Mild enlargement of the gums has been reported in patients with an inflammation in the mouth (gingivitis/periodontitis).
Spanish: Se ha notificado una ligera hinchazón de las encías en pacientes con inflamación en la boca (gingivitis/periodontitis).
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.
Spanish: Debido a su elevado grado de selectividad sobre la musculatura lisa arteriolar, felodipino, a dosis terapéuticas, no tiene efectos directos sobre la contractilidad o la conducción cardíacas.
English: • Decompensated heart failure
Spanish: • Insuficiencia cardíaca no compensada
English: • Acute myocardial infarction
Spanish: • Infarto agudo de miocardio
English: Felodipine is a vascular selective calcium antagonist, which lowers arterial blood pressure by decreasing systemic vascular resistance.
Spanish: Felodipino es un antagonista selectivo del calcio vascular, que disminuye la presión arterial mediante reducción de la resistencia vascular sistémica.
English: When felodipine and erythromycin were coadministered, the Cmax and AUC of felodipine were increased by about 2.5-fold.
Spanish: Cuando se coadministraron felodipino y eritromicina, la Cmax y el AUC de felodipino aumentaron aproximadamente 2,5 veces.
English: This medicine can be taken without food or following a light meal not high in fat or carbohydrates.
Spanish: Este medicamento se puede tomar en ayunas o junto con una comida ligera baja en grasas o carbohidratos.
English: This may lead to myocardial ischaemia in susceptible patients.
Spanish: Esto podría precipitar una isquemia miocárdica en individuos susceptibles.
English: Sodium aluminium silicate Sodium stearyl fumarate
Spanish: Silicato de aluminio sódico Estearil fumarato sódico
English: The reduction in systemic blood pressure caused by felodipine leads to decreased left ventricular afterload and myocardial oxygen demand.
Spanish: La reducción de la presión sanguínea sistémica causada por felodipino conduce al descenso de la poscarga ventricular izquierda y de la demanda miocárdica de oxígeno.
English: Felodipine is extensively metabolised in the liver by cytochrome P450 3A4 (CYP3A4) and all identified metabolites are inactive.
Spanish: Felodipino se metaboliza ampliamente en el hígado por el citocoromo P450 3A4 (CYP3A4) y todos los metabolitos identificados son inactivos.
English: How to store Plendil Contents of the pack and other information
Spanish: 5 Conservación de Plendil Contenido del envase e información adicional
English: 1 blister of 28 tablets 2 blisters of 14 tablets 4 blisters of 7 tablets
Spanish: 1 blíster de 28 comprimidos 2 blísters de 14 comprimidos 4 blísters de 7 comprimidos
English: Treatment should be initiated with 5 mg once daily and, if needed, increased to 10 mg once daily.
Spanish: El tratamiento se debe iniciar con 5 mg una vez al día y, si fuese necesario, aumentarse a 10 mg una vez al día.
English: In case of lack of efficacy due to decreased felodipine exposure when combined with potent inducers of CYP3A4, adjustment of felodipine dose and/or discontinuation of the CYP3A4 inducer should be considered.
Spanish: En caso de falta de eficacia debido a una exposición disminuida a felodipino cuando se combina con inductores potentes del CYP3A4, se debe considerar un ajuste de la dosis de felodipino y/o interrumpir el inductor del CYP3A4.
English: • Ketoconazole
Spanish: • Ketoconazol
English: • Burning/prickling/numbness
Spanish: • Quemazón/pinchazos/hormigueo
English: Headache Dizziness, paraesthesia
Spanish: Cefaleas Poco frecuente Mareo, parestesia
English: Plendil and associated names (see Annex I) 2.5 mg [5 mg or, 10 mg] prolonged-release tablets [See Annex I - To be completed nationally] felodipine
Spanish: Plendil y denominaciones asociadas (Ver Anexo I) 2,5 mg [5 mg o 10 mg] comprimidos de liberación prolongada [Ver Anexo I - Para completar a nivel nacional] felodipino
English: The combination with strong CYP3A4 inhibitors should be avoided.
Spanish: Se debe evitar la combinación con inhibidores potentes del CYP3A4.
English: Felodipine is metabolised in the liver by cytochrome P450 3A4 (CYP3A4).
Spanish: Felodipino se metaboliza en el hígado por el citocromo P450 3A4 (CYP3A4).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2.5 mg (or 5 mg, or 10 mg) felodipine
Spanish: PRINCIPIO(S) ACTIVO(S) Cada comprimido contiene 2,5 mg (ó 5 mg, ó 10 mg) de felodipino
English: Carnauba wax Iron oxide yellow (E172) Hypromellose 6 mPa·s Macrogol 6000
Spanish: Cera de carnauba Óxido de hierro amarillo (E172) Hipromelosa 6 mPa·s Polietilenglicol 6000
English: If you experience headache, nausea, dizziness or fatigue your ability to react may be impaired.
Spanish: Si experimenta dolor de cabeza, náuseas, mareos o fatiga, su capacidad de reacción puede estar alterada.
English: Treatment can be started with 5 mg once daily.
Spanish: El tratamiento se puede iniciar con 5 mg una vez al día.
English: • Itraconazole
Spanish: • Itraconazol
English: The combination with strong CYP3A4 inducers should be avoided.
Spanish: Se debe evitar la combinación con inductores potentes del CYP3A4.
English: Felodipine possesses a mild natriuretic/diuretic effect and fluid retention does not occur.
Spanish: Felodipino posee un moderado efecto diurético/natriurético y no causa retención de líquidos.
English: In case of clinically significant adverse events due to elevated felodipine exposure when combined with strong CYP3A4 inhibitors, adjustment of felodipine dose and/or discontinuation of the CYP3A4 inhibitor should be considered.
Spanish: En caso de reacciones adversas clínicamente significativas debido a una alta exposición a felodipino cuando se combina con inhibidores potentes del CYP3A4, se debe considerar un ajuste de la dosis de felodipino y/o la interrupción del inhibidor del CYP3A4.
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.
Spanish: Felodipino disminuye la resistencia vascular coronaria, aumenta el flujo sanguíneo coronario y el suministro miocárdico de oxígeno debido a la dilatación de las arterias y arteriolas epicárdicas.
English: Plendil and associated names (see Annex I) 2.5 mg prolonged-release tablets Plendil and associated names (see Annex I) 5 mg prolonged-release tablets Plendil and associated names (see Annex I) 10 mg prolonged-release tablets
Spanish: Plendil y denominaciones asociadas (Ver Anexo I) 2,5 mg comprimidos de liberación prolongada Plendil y denominaciones asociadas (Ver Anexo I) 5 mg comprimidos de liberación prolongada Plendil y denominaciones asociadas (Ver Anexo I) 10 mg comprimidos de liberación prolongada [Ver Anexo I - Para completar a nivel nacional]
English: Increased liver enzymes
Spanish: Aumento de enzimas hepáticas
English: Concomitant administration of substances which interfere with CYP3A4 enzyme system may affect plasma concentrations of felodipine.
Spanish: La administración concomitante de sustancias que interfieran con el sistema enzimático del CYP3A4 puede afectar a las concentraciones plasmáticas de felodipino.
English: Each tablet contains 2.5 mg 5 mg or 10 mg of felodipine.
Spanish: Cada comprimido contiene 2,5 mg, 5 mg o 10 mg de felodipino.
English: • Erythromycin
Spanish: • Eritromicina
English: Sympathomimetic medicinal products with predominant effect on the α1-adrenoceptor may be given if the above-mentioned measures are insufficient.
Spanish: Si estas medidas son insuficientes, se pueden administrar fármacos simpaticomiméticos con efecto predominante sobre los adrenorreceptores-α1.
English: The adverse reactions listed below have been identified from clinical trials and from post marketing surveillance.
Spanish: Durante los ensayos clínicos realizados y el seguimiento post-comercialización se han registrado las siguientes reacciones adversas.
English: • Rifampicin
Spanish: • Rifampicina
English: [See Annex I - to be completed nationally]
Spanish: [Ver Anexo I - Para completar a nivel nacional]
English: Nausea, abdominal pain Vomiting
Spanish: Poco frecuente Náuseas, dolor abdominal Rara
English: High-density polyethylene bottle with a cap of polypropylene PVC/PVDC blister and Aluminum blister
Spanish: 6.5 Naturaleza y contenido del envase Frasco de polietileno de alta densidad con una tapa de polipropileno Blíster de PVC/PVDC y blíster de aluminio Tamaño de envase
English: Prolonged-release tablet
Spanish: Comprimido de liberación prolongada.
English: • Nevirapine
Spanish: • Nevirapino
English: (see section 4.5).
Spanish: Por lo tanto, se deben evitar tales combinaciones (ver sección 4.5).
English: Treatment should be started with 5 mg once a day.
Spanish: Se debe iniciar el tratamiento con 5 mg una vez al día.
English: • Cimetidine
Spanish: • Cimetidina
English: Concomitant administration of drugs that strongly induce or inhibit CYP3 A4 enzymes result in extensively decreased or increased plasma levels of felodipine, respectively.
Spanish: La administración concomitante de fármacos fuertemente inductores o inhibidores de las enzimas CYP3A4 deriva en unas concentraciones plasmáticas de felodipino altamente disminuidas o aumentadas, respectivamente.
English: Each tablet contains 10 mg felodipine.
Spanish: Cada comprimido contiene 10 mg de felodipino.
English: Mild gingival enlargement has been reported in patients with pronounced gingivitis/periodontitis.
Spanish: Se ha notificado un aumento gingival leve en pacientes con gingivitis/periodontitis pronunciada.
English: • Haemodynamically significant cardiac valvular obstruction
Spanish: • Obstrucción de las válvulas cardíacas hemodinámicamente significativa
English: 3 blisters of 30 tablets
Spanish: 3 blísters de 30 comprimidos
English: 3 blisters of 10 tablets 1 bottle of 30 tablets
Spanish: 3 blísters de 10 comprimidos 1 frasco de 30 comprimidos
English: Interactions leading to decreased plasma concentration of felodipine Enzyme inducers of the cytochrome P450 3A4 system have been shown to cause a decrease in plasma concentrations of felodipine.
Spanish: Interacciones que conducen a una disminución de los niveles plasmáticos de felodipino Los inductores enzimáticos del sistema del citocromo P450 3A4 han mostrado producir una disminución de las concentraciones plasmáticas de felodipino.
English: • Abnormally rapid heart rate
Spanish: • Ritmo cardíaco anormalmente acelerado
English: There is limited clinical trial experience of the use of felodipine in hypertensive paediatric patients.
Spanish: La experiencia sobre el uso del felodipino en pacientes pediátricos hipertensos en ensayos clínicos es limitada.
English: Stable angina pectoris
Spanish: Angina de pecho estable
English: Each tablet contains 5 mg felodipine.
Spanish: Cada comprimido contiene 5 mg de felodipino.
English: Plasma concentrations of felodipine are positively correlated to the decrease in total peripheral resistance and blood pressure.
Spanish: Existe una correlación positiva entre la concentración plasmática de felodipino y el descenso de la resistencia vascular periférica total y de la presión arterial.
English: • Fatigue
Spanish: • Fatiga
English: • Dynamic cardiac outflow obstruction
Spanish: • Obstrucción del flujo cardiaco dinámico
English: The renal vascular resistance is decreased by felodipine.
Spanish: Felodipino disminuye la resistencia vascular renal.
English: Interactions leading to increased plasma concentration of felodipine CYP3A4 enzyme inhibitors have been shown to cause an increase in felodipine plasma concentrations.
Spanish: Interacciones que conducen a un aumento de los niveles plasmáticos de felodipino Los inhibidores enzimáticos del CYP3A4 han mostrado producir un aumento de las concentraciones plasmáticas de felodipino.
English: 1 blister of 14 tablets
Spanish: 1 blíster de 14 comprimidos
English: 1 bottle of 100 tablets 10 blisters of 10 tablets
Spanish: 1 frasco de 100 comprimidos 10 blísters de 10 comprimidos
English: 2 blisters of 10 tablets
Spanish: 2 blísters de 10 comprimidos
English: 1 bottle of 30 tablets 3 blisters of 10 tablets
Spanish: 1 frasco de 30 comprimidos 3 blísters de 10 comprimidos
English: Felodipine has minor or moderate influence on the ability to drive and use machines.
Spanish: 4.7 Efectos sobre la capacidad para conducir y utilizar máquinas La influencia de felodipino sobre la capacidad para conducir y utilizar máquinas es pequeña o moderada.
English: Other medicines and Plendil
Spanish: Toma de Plendil con otros medicamentos
English: Pack sizes of 14, 20, 28, 30, 90, 98 and 100 tablets
Spanish: Tamaños de envase de 14, 20, 28, 30, 90, 98 y 100 comprimidos
English: Very rare: may affect up to 1 in 10,000 people
Spanish: Muy raros: puede afectar hasta 1 de cada 10.000 personas
English: Very common Uncommon Very rare
Spanish: Muy frecuente Edema periférico Poco frecuente Fatiga Muy rara
English: How to store Plendil [To be completed nationally]
Spanish: Conservación de Plendil [Para completar a nivel nacional]
English: If you stop taking Plendil
Spanish: Si interrumpe el tratamiento con Plendil
English: Rare: may affect up to 1 in 1,000 people
Spanish: Raros: puede afectar hasta 1 de cada 1.000 personas
English: 4 blisters of 7 tablets
Spanish: 4 blísters de 7 comprimidos
English: Germany: Modip Italy: Feloday, Prevex Portugal: Preslow Sweden: Felodipin AstraZeneca
Spanish: Suecia: Felodipin AstraZeneca
English: The tablet is yellow, circular, biconvex, engraved A/FL on one side and 2.5 on the other side, with a diameter of 8.5 mm.
Spanish: El comprimido es amarillo, redondo, biconvexo, grabado con A/FL por una cara y 2.5 por la otra, con un diámetro de 8,5 mm.