FUNGUSFIN

Información principal

  • Denominación comercial:
  • FUNGUSFIN
  • Dosis:
  • 1 g/100 mL
  • formulario farmacéutico:
  • Solución tópica
  • 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:
  • FUNGUSFIN
    Cuba
  • Idioma:
  • español

Otros datos

Estado

  • Fuente:
  • CECMED - Autoridad Reguladora de Medicamentos, Equipos y Dispositivos Médicos - Cuba
  • Número de autorización:
  • 095-17d3
  • última actualización:
  • 10-05-2018

Ficha Técnica: dosis, interacciones, efectos secundarios

RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO

Nombre del producto:

FUNGUSFIN®

(clorhidrato de terbinafina)

Forma farmacéutica:

Solución tópica

Fortaleza:

1 g/100 mL

Presentación:

Estuche por un frasco gotero de PEAD con 30 mL.

Titular del Registro Sanitario, país:

LABORATORIO SAN LUIS, S.A., SANTO DOMINGO

OESTE, REPÚBLICA DOMINICANA.

Fabricante, país:

LABORATORIO SAN LUIS, S.A., SANTO DOMINGO

OESTE, REPÚBLICA DOMINICANA.

Número de Registro Sanitario:

095-17D3

Fecha de Inscripción:

29 de diciembre de 2017

Composición:

Cada 100 mL contiene:

Clorhidrato de terbinafina

1,0 g

Propilenglicol

Etanol

25 g

Plazo de validez:

36 meses

Condiciones de almacenamiento:

Protéjase de la humedad.

Indicaciones terapéuticas:

Tratamiento de afecciones micóticas de piel, pelo y uñas causadas por Trichophyton

rubrum,

Microsporum

canis

Epidermophyton

floccosum.

También

para

tratar

onicomicosis causadas por dermatofitos y demás agentes micóticos sensibles a la

terbinafina.

Contraindicaciones:

Hipersensibilidad a los componentes de la fórmula. Uso durante el embarazo y la

lactancia: No se recomienda el uso de FUNGUSFIN® en ninguna de sus formas

farmacéuticas en estas etapas.

Uso tópico en niños: Debido a las escasas informaciones relativas al tema, no se

recomienda su aplicación tópica ni oral a menores de 5 años.

Advertencias especiales y precauciones de uso:

No aplique FUNGUSFIN® sobre los ojos, heridas abiertas, quemadas o laceradas.

Efectos indeseables:

Comezón, resecamiento, enrojecimiento, hinchazón u otra señal de irritación no

presente antes del uso de este Medicamento.

Otros efectos secundarios no listados arriba también pueden ocurrir en algunos

pacientes. Si nota cualquier otro efecto, consulte con su médico, enfermera o

farmacéutico

Posología y método de administración:

La duración y frecuencia del tratamiento varía según el tipo de infección y la

localización de la infección micótica. Salvo que su médico recomiende otro tipo de

aplicaciones,

evite

ocluir

zonas

tratadas

FUNGUSFIN®

Solución.

Tiña corporis: Aplique un poco de solución una vez al día durante una semana.

Tiña pedis (pie de atleta) y Tiña interdigital: Aplique una vez al día durante una

semana.

Pitiriasis

versicolor:

Aplique

veces

día

durante

semana.

Tratamiento de onicomicosis de manos y pies (hongos de las uñas).

Interacción con otros productos medicinales y otras formas de interacción:

De acuerdo a los resultados de los estudios llevados a cabo in Vitro y en voluntarios

sanos, la terbinafina muestra un potencial insignificante para inhibir o incrementar la

depuración

mayoría

medicamentos

metabolizados

vías

citocromo P450. Se requiere precaución con FUNGUSFIN® en mujeres que toman

anticonceptivos orales, ya que se han registrado algunos casos de trastornos

menstruales,

pacientes

usan

esta

combinación

medicamentos.

depuración plasmática de la terbinafina puede ser acelerada por medicamentos que

inhiben el citocromo P-450.

Uso en Embarazo y lactancia: contraindicado.

Efectos sobre la conducción de vehículos/maquinarias: No procede

Sobredosis:

riesgo

toxicidad

FUNGUSFIN

bastante

bajo.

caso

sobredosificación o ingesta accidental, consulte a su médico.

Propiedades farmacodinámicas: ATC:D01AE15

ç

FUNGUSFIN® es un antimicótico sintético, de espectro ampliado, perteneciente al

grupo de las alilaminas, con propiedades farmacológicas de tipo fungistáticos y

fungicidas.

Propiedades

farmacocinéticas

(Absorción,

distribución,

biotransformación,

eliminación):

Menos del 5% de la dosis se absorbe tras aplicación tópica en el

hombre; se estima que la exposición sistémica es muy baja, en muchos de los

pacientes,

concentraciones

plasmáticas

terbinafina

metabolito

son indetectables después de una administración tópica.

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

producto: No procede

Fecha de aprobación/ revisión del texto: 29 de diciembre 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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