VITAMIN C -

Información principal

  • Denominación comercial:
  • VITAMIN C - 500 mg
  • Dosis:
  • 500 mg
  • formulario farmacéutico:
  • Tableta masticable
  • 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:
  • VITAMIN C - 500 mg
    Cuba
  • Idioma:
  • español

Otros datos

Estado

  • Fuente:
  • CECMED - Autoridad Reguladora de Medicamentos, Equipos y Dispositivos Médicos - Cuba
  • Número de autorización:
  • 032-17d3
  • última actualización:
  • 10-05-2018

Ficha Técnica

RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO

Nombre del producto:

VITAMIN C - 500 mg

(Ácido ascórbico)

Forma farmacéutica:

Tableta masticable

Fortaleza:

500 mg

Presentación:

Frasco de PEAD con 100 tabletas masticables.

Titular del Registro Sanitario, país:

MEDICARIBE S.A., LA HABANA, CUBA.

Fabricante, país:

MAJOR PHARMACEUTICALS, LIVONIA,

ESTADOS UNIDOS DE AMÉRICA.

Número de Registro Sanitario:

032-17D3

Fecha de Inscripción:

15 de marzo de 2017

Composición:

Cada tableta masticable contiene:

Ácido ascórbico

500,0 mg

Plazo de validez:

48 meses

Condiciones de almacenamiento:

Almacenar por debajo de 30 ºC. Protéjase de la

humedad.

Indicaciones terapéuticas:

El ácido ascórbico se usa para prevenir y tratar el escorbuto, una enfermedad provocada por

lam carencia de vitamina C en el cuerpo. Mejora la visión y ejerce funciones preventivas

ante la aparición de cataratas y glaucomas. Dada su capacidad antioxidante hace que la

misma elimine sustancias toxicas del organismo como son los nitritos y nitratos presentes

en los productos cárnicos, preparados o embutidos. Los nitratos y nitritos aumentan la

probabilidad de desarrollar cáncer. Es antibacteriana por lo que disminuye el crecimiento de

ciertas bacterias dañinas para el organismo. Reduce las complicaciones derivadas de la

diabetes tipo II. Disminuye los niveles de tensión arterial y previene la aparición de

enfermedades vasculares. Tiene propiedades antihistamínicas, por lo que se utiliza en

tratamientos alérgicos contra el asma y la sinusitis. Ayuda a prevenir o mejorar afecciones

de la piel como eccemas o soriasis. Es cicatrizante de heridas y quemaduras ya que es

imprescindible en la formación de colágeno. Aumenta la producción de estrógenos durante

la menopausia por lo que es utilizada para reducir o aliviar los síntomas de sofocos y

demás.

Mejora

estreñimiento

propiedades

laxantes.

Repara

mantiene

cartílagos, huesos y dientes.

Contraindicaciones:

Hipersensibilidad al ácido ascórbico. Pacientes que tienen o tuvieron cálculos renales,

deben consultar con su médico. Las personas diabéticas si ingieren grandes cantidades de

ácido ascórbico deben consultar como examinar su orina. Contiene sucrosa, no administrar

en pacientes con intolerancia a la fructosa o síndrome de malabsorción a la glucosa o

galactosa o deficiencia de sacarasa isomaltasa.

Precauciones:

Evite tomar más de una multivitaminicas al mismo tiempo. Algunas formas de acido

ascórbico contienen sodio y deben evitarse si usted mantiene una régimen bajo de

contenido de sal y de sodio.

Advertencias especiales y precauciones de uso:

No use más ni menos de la dosis indicada, ni tampoco más seguido de lo prescrito.

Efectos indeseables:

Aunque los efectos indeseables no son comunes, pueden producir diarreas y malestar

estomacal.

Ocasionales: náusea, vómito, dolor abdominal, fatiga, enrojecimiento facial,

cefalea, insomnio, somnolencia, Raras: pacientes con deficiencia de glucosa 6 fosfato

deshidrogenasa, altas dosis de vitamina C pueden causar anemia hemolítica.

Posología y método de administración:

Adultos: Una tableta diaria, preferentemente con un alimento.

Interacción con otros productos medicinales y otras formas de interacción:

Desferoxamina: su uso conjunto puede incrementar la toxicidad hística de hierro (por

aumento de la absorción gastrointestinal). Anticoagulantes orales: dosis alrededor de 10

g/día de ácido ascórbico suele disminuir la absorción oral del anticoagulante. Disulfiram:

interfiere con la interacción disulfiram-alcohol. Flufenacina: el ácido ascórbico disminuye sus

concentraciones plasmáticas. La acidificación del pH urinario puede alterar la excreción de

otros medicamentos.

Uso en Embarazo y lactancia:

Ingiera las cantidades de ácido ascórbico indicadas por el médico si está embarazada o

lactando.

Efectos sobre la conducción de vehículos/maquinarias:

No procede

Sobredosis:

Es poco probable que exista una intoxicación por vitamina C, puesto que es una vitamina

hidrosoluble y los excesos son eliminados a través de la orina. Pero si la dosis diaria supera

los 2000mg/día pueden aparecer molestias gastrointestinales, diarreas, malestar en el

estómago, cálculos renales, insomnio y exceso de absorción de hierro. Entonces acuda a

su médico.

Propiedades farmacodinámicas:

El ácido ascórbico es un poderoso agente reductor que sirve para proteger el lecho de la

membrana capilar; la vitamina C es necesaria para la biosíntesis de hidroxiprolina, un

precursor de colágeno, osteoides y dentina; favorece la absorción de hierro no hemo desde

los alimentos reduciendo el hierro férrico en el estómago.

Propiedades

farmacocinéticas

(Absorción,

distribución,

biotransformación,

eliminación):

El ácido ascórbico es absorbido en el cuerpo por transporte activo y difusión simple.

Dependiente

activo

transporte

sodio-ascorbato

socioCo-Transporters

(SVCTs)

transportadores de hexosa (superabundancia) son los dos transportadores necesarios para

la absorción. SVCT1 y SCVT2 importan la forma reducida de ascorbato a través de la

membrana plasmática. GLUY1 y GLUT3 son los dos transportadores de glucosa y transferir

solo forma ácido dehidroascórbico de vitamina C Aunque el ácido dehidroascórbico es

absorbido en la tasa más alta que el ascorbato, la cantidad de ácido dehidroascórbico que

se encuentra en el plasma y tejidos en condiciones normales es baja, como las células

rápidamente reducen ácido dehidroascórbico ascorbato. Así SVCTs parecen ser el sistema

predominante para el transporte de la vitamina C en el cuerpo. SVCT2 participa en el

transporte de la vitamina C en casi todos los tejidos, animales Knockout para SVCT2

mueren poco después del nacimiento, sugiriendo que el transporte medido por SVCT2

vitamina C es necesaria para la vida.

Con la ingesta regular la tasa de absorción varía entre 70 y 95%. Sin embargo, el grado de

absorción disminuye a medida que aumenta el consumo. El alto consumo (12 g), absorción

humana fraccional dl ácido ascórbico puede ser tan bajo como el 16% en baja ingesta (˂ 20

mg) la tasa de absorción puede alcanzar hasta el 98%. Las concentraciones de ascorbato

en el umbral de reabsorción renal pasan libremente en la orina y son excretadas. Las altas

dosis dietéticas (correspondientes a varios cientos de mg/día en los seres humanos)

ascorbato se acumula en el cuerpo los niveles de plasma hasta el umbral de reabsorción

renal,

aproximadamente

1,5mg/dL

hombres

mg/dL

mujeres.

Concentraciones en el plasma superior a este valor (pensado para representar la saturación

del cuerpo) son rápidamente excretadas en la orina con una vida media de 30 minutos;

Concentraciones inferiores a esta cantidad umbral activamente son retenido por los riñones,

Half-Life

para

resto

tienda

vitamina

cuerpo

aumentan

considerablemente,

prolongación

Half-Life

como

cuerpo

almacena

están

agotadas.

Aunque la tienda máxima de vitamina C en el cuerpo es determinado principalmente por el

umbral renal en la sangre, hay muchos tejidos que mantienen concentraciones de vitamina

C mucho mayores que en sangre. Tejidos biológicos que acumulan más de 100 veces el

nivel en el plasma sanguíneo de vitamina C son las glándulas suprarrenales, pituitaria, timo,

cuerpo lúteo y retina. Aquellas con 10 a 50 veces la concentración presente en el plasma

sanguíneo incluyen el cerebro, bazo, pulmón, testículos, ganglios linfáticos, hígado, tiroides,

pequeña mucosa intestinal, leucocitos, páncreas, riñón y glándulas salivales.

El ácido ascórbico puede ser oxidado (desglosado) en el cuerpo humano por la enzima L-

ascorbato oxidasa que directamente no es excretado en la orina como consecuencia de la

saturación del cuerpo o destruido en el metabolismo de otro cuerpo y es oxidado por esta

enzima y eliminado.

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

producto:

No procede.

Fecha de aprobación/ revisión del texto: 15 de Marzo de 2017.

  • 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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EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)6427 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/183/16/T/02

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6486 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6466 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

24-9-2018

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Active substance: zoledronic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6243 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2365/T/33

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

15-8-2018

Watched Vitamania? Here’s how the TGA regulates vitamins in Australia

Watched Vitamania? Here’s how the TGA regulates vitamins in Australia

Find out how the TGA regulates vitamins in Australia

Therapeutic Goods Administration - Australia

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)5386 of Mon, 06 Aug 2018

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

27-7-2018

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Active substance: Synthetic cyclic 8 amino acid analogue of human unacylated ghrelin) - Transfer of orphan designation - Commission Decision (2018)5049 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/066/17/T/01

Europe -DG Health and Food Safety

11-7-2018

Vantavo (Merck Sharp and Dohme B.V.)

Vantavo (Merck Sharp and Dohme B.V.)

Vantavo (Active substance: alendronic acid / colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4511 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1180/T/30

Europe -DG Health and Food Safety

3-7-2018

Granupas (Eurocept International B.V.)

Granupas (Eurocept International B.V.)

Granupas (Active substance: Para-aminosalicylic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4256 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2709/T/25

Europe -DG Health and Food Safety

27-6-2018

EU/3/11/849 (Merck Sharp and Dohme B.V.)

EU/3/11/849 (Merck Sharp and Dohme B.V.)

EU/3/11/849 (Active substance: (S)-{8-fluoro-2-2[4-(3-methoxyphenyl)-1-piperazinyl]-3-[2-methoxy-5-(trifluoromethyl)-phenyl]-3,4-dihydro-4-quinazolinyl} acetic acid) - Transfer of orphan designation - Commission Decision (2018)4102 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/090/10/T/02

Europe -DG Health and Food Safety

19-6-2018

Dany's BienenWohl (Dany Bienenwohl GmbH)

Dany's BienenWohl (Dany Bienenwohl GmbH)

Dany's BienenWohl (Active substance: oxalic acid dihydrate) - Centralised - Authorisation - Commission Decision (2018)3892 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4667

Europe -DG Health and Food Safety