DIOSMINA Kern Pharma

Información principal

  • Denominación comercial:
  • DIOSMINA Kern Pharma 500 mg
  • formulario farmacéutico:
  • Comprimido recubierto
  • Usar para:
  • Humanos
  • Tipo de medicina:
  • medicamento alopático

Documentos

  • para el público en general:
  • El prospecto de información de este producto no está disponible actualmente, puede enviar una petición a nuestro servicio al cliente y le notificaremos tan pronto como nos sea posible para conseguirlo.


    Solicitar el prospecto de información al público.

Localización

  • Disponible en:
  • DIOSMINA Kern Pharma   500 mg
    Cuba
  • Idioma:
  • español

Otros datos

Estado

  • Fuente:
  • CECMED - Autoridad Reguladora de Medicamentos, Equipos y Dispositivos Médicos - Cuba
  • Número de autorización:
  • m15004c05
  • última actualización:
  • 10-05-2018

Ficha Técnica

RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO

Nombre del producto:

DIOSMINA Kern Pharma ® 500 mg

Forma farmacéutica:

Comprimido recubierto

Fortaleza:

Presentación:

Estuche por 3 ó 6 blísteres de PVC/AL

con 10 comprimidos recubiertos cada uno.

Titular del Registro Sanitario, país:

KERN PHARMA, S.L., BARCELONA, ESPAÑA.

Fabricante, país:

KERN PHARMA, S.L., BARCELONA, ESPAÑA.

Número de Registro Sanitario:

M-15-004-C05

Fecha de Inscripción:

9 de enero de 2015

Composición:

Cada comprimido recubierto contiene:

Fracción flavonoica micronizada

conteniendo:

Diosmina (90 %)

Flavonoides expresados en hesperidina

(10 %)

500 mg

450 mg

50 mg

Plazo de validez:

36 meses

Condiciones de almacenamiento:

No requiere condiciones especiales de almacenamiento.

Indicaciones terapéuticas:

Alivio a corto plazo del edema y síntomas relacionados con la insuficiencia venosa crónica

en adultos.

Contraindicaciones:

Hipersensibilidad conocida a diosmina, otros flavonoides, o a alguno de los excipientes.

Precauciones:

Embarazo:

No se tiene constancia de ningún efecto nocivo en la especie humana.

Los datos clínicos conocidos sobre un número limitado de embarazos tratados con diosmina

permitido

detectar

efectos

perjudiciales

para

embarazo,

desarrollo

fetal

postnatal. Hasta la fecha, no se dispone de otros datos epidemiológicos relevantes. Los

estudios que se han realizado en animales no mostraron efectos perjudiciales directos o

indirectos para el embarazo, desarrollo embrionario/fetal, parto y desarrollo postnatal (ver

sección 5.3.)

Lactancia:

No se tiene constancia de que el medicamento se excrete a la leche materna, por lo que, en

ausencia de datos, no se aconseja su uso durante la lactancia.

Fertilidad:

No se ha observado toxicidad para la fertilidad o función reproductora.

Advertencias especiales y precauciones de uso:

Contiene entre sus excipientes Glicerol que puede causar alteraciones digestivas, diarreas

y dolor de cabeza.

Efectos indeseables:

A continuación se describen las reacciones adversas en relación a su frecuencia de

aparición:

Muy frecuentes (

1/10)

Frecuentes (

1/100 a <1/10)

Poco frecuentes (

1/1.000 a <1/100)

Raras (

1/10.000 a <1/1.000)

Muy raras (<1/10.000)

Frecuencia no conocida (no puede estimarse a partir de los datos disponibles)

Trastornos gastrointestinales: Frecuentes: náuseas, vómitos, diarrea, dispepsia.

Trastornos generales y alteraciones en el lugar de administración. Raras: cefalea, malestar,

vértigo.

Trastornos de la piel y del tejido subcutáneo: Raras: erupción, prurito, urticaria.

Posología y método de administración:

Adultos:

La dosis terapéutica usual es de 2 comprimidos al día, repartidos en dos tomas, un

comprimido al medio día y otro por la noche, con las comidas. La duración máxima del

tratamiento es de 2 a 3 meses.

Población pediátrica:

No se ha establecido la seguridad y eficacia de diosmina en la población pediátrica.

Interacción con otros productos medicinales y otras formas de interacción:

No se han realizado estudios específicos sobre las posibles interacciones farmacocinéticas

y/o farmacodinámicas de diosmina con otros medicamentos o con alimentos. Sin embargo, y

aun considerando la extensa experiencia post-comercialización con el producto, no se ha

notificado ninguna interacción con otros fármacos hasta la fecha.

Uso en Embarazo y lactancia:

Embarazo:

No se tiene constancia de ningún efecto nocivo en la especie humana.

Los datos clínicos conocidos sobre un número limitado de embarazos tratados con diosmina

permitido

detectar

efectos

perjudiciales

para

embarazo,

desarrollo

fetal

postnatal. Hasta la fecha, no se dispone de otros datos epidemiológicos relevantes. Los

estudios que se han realizado en animales no mostraron efectos perjudiciales directos o

indirectos para el embarazo, desarrollo embrionario/fetal, parto y desarrollo postnatal.

Lactancia:

No se tiene constancia de que el medicamento se excrete a la leche materna, por lo que, en

ausencia de datos, no se aconseja su uso durante la lactancia.

Efectos sobre la conducción de vehículos/maquinarias:

La influencia de diosmina sobre la capacidad para conducir y utilizar máquinas es nula o

insignificante.

Sobredosis:

No se han descrito casos de sobredosis.

Propiedades farmacodinámicas:

Grupo farmacoterapéutico: Protectores capilares: Bioflavonoides, código ATC: C05CA53

Diosmina es un agente venotónico y vasoprotector (produciendo una venoconstricción,

aumento de la resistencia de los vasos y disminución de su permeabilidad).

En modelos experimentales, diosmina ejerce una doble acción sobre el sistema venoso de

retorno:

a nivel de las venas y vénulas: aumenta la tonicidad parietal y ejerce una acción

antiestásica;

a nivel de la microcirculación: normaliza la permeabilidad capilar y refuerza la resistencia

capilar.

En humanos, la existencia de relaciones dosis/efecto, estadísticamente significativas, ha

sido

establecida

sobre

parámetros

pletismográficos

venosos:

capacitancia,

distensibilidad y tiempo de vaciado. La mejor relación dosis/efecto ha sido obtenida con 2

comprimidos.

Actividad venotónica: diosmina aumenta el tono venoso. La pletismografía de oclusión

venosa con anillo de mercurio ha puesto de manifiesto una disminución de los tiempos de

vaciado venoso.

Actividad microcirculatoria: En los enfermos que presentan signos de fragilidad capilar,

aumenta la resistencia capilar medida por angioesterometría.

Propiedades

farmacocinéticas

(Absorción,

distribución,

biotransformación,

eliminación):

Absorción:

Tras la administración oral, la diosmina es transformada en el intestino rápidamente por la

flora intestinal y se absorbe en su forma aglicona, diosmetina. La biodisponibilidad oral es de

aproximadamente el 57,9%.

Distribución:

La diosmetina se distribuye extensamente en los tejidos, siendo el volumen de distribución

de 62,1 l.

Biotransformación:

La diosmetina se degrada rápidamente y ampliamente a ácidos flebotónicos o a sus

derivados conjugados con glicina, que se eliminan en la orina. El metabolito predominante

en el hombre es el ácido hidroxifenilpropiónico que se elimina mayoritariamente en su forma

conjugada. Los metabolitos encontrados en menores cantidades incluyen otros ácidos

fenólicos

correspondientes

ácido

1-hidroxi-4-metoxibenzoico,

ácido

3-metoxi-4-

hidroxifenilacético y ácido 3,4-dihidroxibenzoico.

Eliminación:

La eliminación es relativamente rápida en los humanos. En estudios con diosmina marcada

radioactivamente, el 34% de la dosis se recuperó en orina y heces tras las primeras 24 h, y

aproximadamente el 86% se recuperó en orina y heces tras las primeras 48 h.

Linealidad/No linealidad

La farmacocinética de diosmina es lineal.

Instrucciones de uso, manipulación y destrucción del remanente no utilizable del

producto:

Ninguna especial.

Fecha de aprobación/ revisión del texto: 31 de octubre de 2015.

  • El prospecto de información de este producto no está disponible actualmente, puede enviar una petición a nuestro servicio al cliente y le notificaremos tan pronto como nos sea posible para conseguirlo.

    Solicitar el prospecto de información al público.



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19-9-2018

 12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

This forum brings together regulators with patients, healthcare professionals and industry, to take stock of what we have achieved and what needs to be the focus over the coming years.

Europe - EMA - European Medicines Agency

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

This joint Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) meeting will include results of the 2017 EMA perception survey. EMA regulatory science to 2025 will be discussed together with updates on Good Pharmacovigilance Practices (GVP). The Topic Group on Digital media and health will feedback to the working parties’ members. Participants will also receive an update on ongoing work on electronic product information and on availability of authorised med...

Europe - EMA - European Medicines Agency

12-9-2018

 Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

This information day will update participants on the Agency’s medicine risk management activities and provide advice to marketing authorisation holders and applicants on drafting a risk management plan (RMP) in view of the full implementation of the second revision of the RMP template after the transitional period has elapsed. It will also provide an opportunity for an exchange of experiences with this template between regulators and industry. A dedicated session will discuss the streamlining of safety s...

Europe - EMA - European Medicines Agency

12-9-2018

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Active substance: Brentuximab vedotin) - Centralised - Annual renewal - Commission Decision (2018)5973 of Wed, 12 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2455/R/58

Europe -DG Health and Food Safety

29-8-2018

Cometriq (Ipsen Pharma)

Cometriq (Ipsen Pharma)

Cometriq (Active substance: cabozantinib) - PSUSA - Modification - Commission Decision (2018)5761 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10180/201711

Europe -DG Health and Food Safety

29-8-2018

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Active substance: aliskiren hemifumarate / hydrochlorothiazide) - Centralised - Renewal - Commission Decision (2018)5769 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/964/R/87

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Active substance: (S)-(-)-3-(4-aminophenyl)-2-methoxypropanoic acid) - Orphan designation - Commission Decision (2018)5728 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/075/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Active substance: Autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor) - Orphan designation - Commission Decision (2018)5739 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/049/18

Europe -DG Health and Food Safety

27-8-2018

Yescarta (Kite Pharma EU B.V.)

Yescarta (Kite Pharma EU B.V.)

Yescarta (Active substance: axicabtagene ciloleucel) - Centralised - Authorisation - Commission Decision (2018)5718 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4480

Europe -DG Health and Food Safety

27-8-2018

Entyvio (Takeda Pharma A/S)

Entyvio (Takeda Pharma A/S)

Entyvio (Active substance: vedolizumab) - PSUSA - Modification - Commission Decision (2018)5712 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10186/201711

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

17-8-2018

EU/3/17/1870 (Pharma Gateway AB)

EU/3/17/1870 (Pharma Gateway AB)

EU/3/17/1870 (Active substance: Thymidine and deoxycytidine) - Transfer of orphan designation - Commission Decision (2018)5403 of Fri, 17 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/317/16/T/01

Europe -DG Health and Food Safety

7-8-2018

EU/3/18/2049 (Inozyme Pharma Ireland Ltd)

EU/3/18/2049 (Inozyme Pharma Ireland Ltd)

EU/3/18/2049 (Active substance: Recombinant human ectonucleotide pyrophosphatase/phosphodiesterase 1 fused to the Fc fragment of IgG1) - Orphan designation - Commission Decision (2018)5281 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/053/18

Europe -DG Health and Food Safety

6-8-2018

Kyntheum (Leo Pharma A/S)

Kyntheum (Leo Pharma A/S)

Kyntheum (Active substance: brodalumab) - Centralised - Yearly update - Commission Decision (2018)5383 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Active substance: N-acetylgalactosamine-conjugated synthetic double-stranded oligomer specific to serpin family A member 1 gene) - Orphan designation - Commission Decision (2018)5280 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/061/18

Europe -DG Health and Food Safety

1-8-2018

Ucedane (Lucane Pharma)

Ucedane (Lucane Pharma)

Ucedane (Active substance: carglumic acid) - Centralised - Yearly update - Commission Decision (2018)5230 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

1-8-2018

Opdivo (Bristol-Myers Squibb Pharma EEIG)

Opdivo (Bristol-Myers Squibb Pharma EEIG)

Opdivo (Active substance: nivolumab) - Centralised - 2-Monthly update - Commission Decision (2018)5204 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3985/II/41

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

23-7-2018

Dificlir (Astellas Pharma Europe B.V.)

Dificlir (Astellas Pharma Europe B.V.)

Dificlir (Active substance: fidaxomicin) - Centralised - Yearly update - Commission Decision (2018)4889 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

23-7-2018

Qarziba (EUSA Pharma (UK) Limited)

Qarziba (EUSA Pharma (UK) Limited)

Qarziba (Active substance: dinutuximab beta) - Centralised - Yearly update - Commission Decision (2018)4886 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

19-7-2018

Aplidin (Pharma Mar S.A.)

Aplidin (Pharma Mar S.A.)

Aplidin (Active substance: plitidepsin) - Refusal of authorisation - Commission Decision (2018)4831 of Thu, 19 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4354

Europe -DG Health and Food Safety

13-7-2018

Briviact (UCB Pharma S.A.)

Briviact (UCB Pharma S.A.)

Briviact (Active substance: brivaracetam) - Centralised - 2-Monthly update - Commission Decision (2018)4715 of Fri, 13 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3898/II/10/G

Europe -DG Health and Food Safety

10-7-2018

Ninlaro (Takeda Pharma A/S)

Ninlaro (Takeda Pharma A/S)

Ninlaro (Active substance: ixazomib) - Centralised - Yearly update - Commission Decision (2018)4463 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

4-7-2018

Prialt (RIEMSER Pharma GmbH)

Prialt (RIEMSER Pharma GmbH)

Prialt (Active substance: ziconotide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4334 of Wed, 04 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/551/T/56

Europe -DG Health and Food Safety