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FORTASEC PLUS 2 mg / 125 mg TABLETS

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This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use FORTASEC PLUS 2 mg / 125 mg TABLETS

Translated with AI

This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Contents of the leaflet

  1. Introducción
  2. Qué es Fortasec Plus y para qué se utiliza
  3. Qué necesita saber antes de empezar a tomar Fortasec Plus
  4. Cómo tomar Fortasec Plus
  5. Posibles efectos adversos
  6. Conservación de FORTASEC PLUS
  7. Contenido del envase e información adicional

Introducción

Fortasec Plus 2 mg/ 125 mg comprimidos

Loperamida hidrocloruro/ Simeticona

Lea todo el prospecto detenidamente antes de empezar a usar este medicamento porque contiene información importante para usted

Siga exactamente las instrucciones de administración del medicamento contenidas en este prospecto o las indicadas por su farmacéutico.

  • Conserve este prospecto, ya que puede tener que volver a leerlo.
  • Si necesita consejo o más información, consulte a su farmacéutico.
  • Si experimenta efectos adversos, consulte a su médico o farmacéutico, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.
  • Debe consultar a un médico si empeora o si no mejora después de 2 días.

Contenido del prospecto:

  1. Qué es Fortasec plus y para qué se utiliza
  2. Qué debe saber antes de tomar Fortasec plus
  3. Cómo tomar Fortasec plus
  4. Posibles efectos adversos
  5. Conservación de Fortasec plus

Contenido del envase e información adicional

1. Qué es Fortasec Plus y para qué se utiliza

Los comprimidos contienen dos principios activos:

  • Loperamida hidrocloruro, ayuda a reducir la diarrea disminuyendo la actividad del intestino. También ayuda a absorber más agua y sales del intestino.
  • Simeticona, rompe el aire atrapado en el intestino, que causa calambres e hinchazón.

Fortasec Plus se usa en adultos y adolescentes a partir de 12 años para el tratamiento de la diarrea cuando va asociada a calambres estomacales, hinchazón y gases.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. Qué necesita saber antes de empezar a tomar Fortasec Plus

No tome Fortasec plus:

  • En niños menores de 12 años
  • Si es alérgico a loperamida hidrocloruro, simeticona o a alguno de los demás componentes de este medicamento incluídos en la sección 6.
  • Si tiene fiebre alta (por encima de 38ºC) o sangre en heces.
  • Si sufre inflamación del intestino como colitis ulcerosa.
  • Si sufre diarrea grave después de haber tomado antibióticos.
  • Si está estreñido o si se le produce hinchazón de estómago.

Advertencias y precauciones:

Consulte con su médico o farmacéutico antes de empezar a tomar Fortasec plus

  • Fortasec plus solo trata los síntomas de la diarrea, En algunos casos, el causante de la diarrea puede requerir tratamiento, si los síntomas persisten o empeoran consulte con su médico. Si sufre diarrea grave su cuerpo pierde más líquidos, azúcares y sales, de lo normal necesitará reponer los líquidos bebiendo más de lo habitual. Pregunte a su farmacéutico sobre preparados para reponer los azúcares y las sales
  • Si padece SIDA y su estómago se hincha, suspenda la administración de los comprimidos inmediatamente y consulte a su médico
  • Si padece alguna enfermedad de hígado, consulte con su médico antes de tomar los comprimidos.

Algunas de las reacciones adversas pueden ser más molestas.

No tome este medicamento para un uso distinto del indicado (ver sección 1) y nunca tome más de la cantidad recomendada (ver sección 3). Se han notificado problemas de corazón graves (cuyos síntomas incluyen latidos cardiacos rápidos o irregulares) en pacientes que han tomado una cantidad excesiva de loperamida, uno de los principios activos de Fortasec plus.

En diarrea aguda, los síntomas normalmente desaparecen en dos días. Si los síntomas persisten después de este periodo, cese el tratamiento y consulte con su médico.

Información importante sobre algunos ingredientes de Fortasec Plus:

Cada comprimido de Fortasec Plus contiene menos de 0,026 mg de alcohol bencílico. El alcohol bencílico puede causar reacciones alérgicas. Consulte a su médico o farmacéutico si tiene alguna enfermedad hepática o renal, o si está embarazada o en periodo de lactancia. Se pueden acumular grandes cantidades de alcohol bencílico en su cuerpo y causar efectos secundarios ( llamados “acidosis metabólica”).

Este medicamento contiene menos de 1 mmol de sodio (23 mg) por comprimido, es decir, esencialmente “exento de sodio”.

Este medicamento contiene menos de 0,00044 mg de alcohol (etanol) por comprimido. La pequeña cantidad de alcohol que contiene este medicamento no supondrá ningún efecto perceptible .

Este medicamento contiene maltodextrina que contiene glucosa. Si su médico le ha dicho que padece una intolerancia a ciertos azúcares, consulte con él antes de tomar este medicamento.

Niños

Los niños menores de 12 años no deben tomar Fortasec plus.

Uso de Fortasec plus con otros medicamentos

Informe a su médico o farmacéutico si está utilizando, ha utilizado recientemente o pudiera tener que utilizar cualquier otro medicamento, incluyendo:

  • Quinidina (usado para el tratamiento del ritmo cardíaco anómalo o la malaria)
  • Itraconazol o ketoconazol (antifúngicos)
  • Gemfibrozilo (usado para el tratamiento del colesterol alto)
  • Ritonavir (usado para el tratamiento de infección por VIH y SIDA)
  • Desmopresina (usado para el control de la sed y la producción de orina en pacientes con diabetes insípida)

Informe a su médico o farmacéutico si está utilizando o ha utilizado recientemente otros medicamentos, incluso los adquiridos sin receta porque Fortasec plus comprimidos puede interaccionar con ellos.

Embarazo y lactancia

Embarazo: Si está embarazada, piensa que pudiera estarlo o está planteando quedarse embarazada , consulte a su médico antes de tomar este medicamento.

Lactancia: Fortasec plus no está recomendado si está en período de lactancia. Pequeñas cantidades del medicamento podrían pasar a la lecha materna.

Conducción y uso de máquinas:

Este medicamento podría hacerle sentir cansancio, mareos o somnolencia. Si está afectado no conduzca ni use maquinaria.

3. Cómo tomar Fortasec Plus

Siga exactamente las instrucciones de administración del medicamento contenidas en este prospecto o las indicadas por su farmacéutico. En caso de duda, consulte a su farmacéutico.

  • Tragar el número correcto de comprimidos enteros con un vaso de agua
  • Usar sólo por vía oral
  • No tomar más de la dosis establecida

Uso en adultos por encima de 18 años

Iniciar el tratamiento tomando 2 comprimidos, seguido de 1 comprimido después de cada deposición diarreica (movimiento intestinal). No tomar más de 4 comprimidos al día. Si sus síntomas persisten después de 2 días, suspenda el tratamiento y consulte con su médico.

Uso en niños y adolescentes entre 12 y 18 años

Iniciar el tratamiento tomando 1 comprimido, seguido de 1 comprimido después de cada deposición diarreica (movimiento intestinal). No tomar más de 4 comprimidos al día. Si sus síntomas persisten después de 2 días, suspenda el tratamiento y consulte con su médico.

Uso en niños menores de 12 años

No administrar los comprimidos a niños menores de 12 años.

Si toma más Fortasec plus del que debe

Si ha tomado demasiado Fortasec plus, póngase en contacto cuanto antes con un médico u hospital para solicitar ayuda. Los síntomas pueden incluir: aumento de la frecuencia cardíaca, latidos cardiacos irregulares, alteraciones del latido cardiaco (estos síntomas pueden tener consecuencias potencialmente graves y peligrosas para la vida), rigidez muscular, movimientos descoordinados, somnolencia, dificultad para orinar o respiración débil.

Los niños reaccionan de una manera más severa a cantidades elevadas de Fortasec plus que los adultos. Si un niño toma una cantidad excesiva o presenta alguno de los síntomas anteriores, llame a un médico de inmediato.

Si usted ha tomado demasiados comprimidos, consulte con su médico o acuda inmediatamente a un centro médico o llamar al Servicio de Información Toxicológica, Teléfono 91 562 04 20, indicando el medicamento y la cantidad ingerida.

Si olvidó tomar Fortasec plus

Tome un comprimido después de la siguiente deposición diarreica (movimiento intestinal). No tome una dosis doble para compensar las dosis olvidadas.

Si tiene cualquier otra duda sobre el uso de este producto, pregunte a su médico o farmacéutico.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Posibles efectos adversos

Al igual que todos los medicamentos, este medicamento puede tener efectos adversos, aunque no todas las personas los sufran.

Si experimenta algunos de los efectos, deje de tomar el medicamento y consulte inmediatamente a su médico.

Reacciones alérgicas incluyen hinchazón de la cara, lengua y garganta, dificultad en la deglución, inexplicable jadeo, falta de respiración que suele ir acompañada de erupción en la piel o urticaria.

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

Dolor abdominal superior, dolor abdominal que se irradia hacia la espalda, sensibilidad al tocar el abdomen, fiebre, pulso rápido, náuseas, vómitos, que pueden ser síntomas de inflamación del páncreas (pancreatitis aguda).Si experimenta algunos de los efectos, deje de tomar el medicamento y hable con su medico

  • Dificultad para tragar agua
  • Dolor abdominal severo, protuberancia o hinchazón abdominal o fiebre que puede deberse a bloqueo o distensión del intestino
  • Estreñimiento severo

Otros efectos que pueden ocurrir incluyen:

Efectos adversos frecuentes (menos de 1 de cada 10 pero más de 1 de cada 100 personas los sufren)

  • Dolor de cabeza
  • Sentirse enfermo
  • Cambio en el sabor de algunas cosas.

Efectos adversos poco frecuentes (menos de 1 de cada 100 pero más de 1 de cada 1000 personas los sufren):

  • Somnolencia
  • Mareos
  • Debilidad
  • Estreñimiento
  • Vómitos
  • Indigestión
  • Flatulencia
  • Boca seca
  • Erupción

Efectos adversos raros (menos de 1 de cada 1000 pero más de 1 de cada 10000 personas los sufren):

  • Pérdida o disminución de consciencia
  • Contracción excesiva de la pupila del ojo
  • Erupción en la piel, que puede conducir a la aparición de ampollas graves o peladura
  • Urticaria
  • Picor
  • Cansancio
  • Tensión muscular
  • Movimientos descoordinados

Comunicación de efectos adversos

Si experimenta cualquier tipo de efectos adversos, consulte a su médico o farmacéutico, incluso si se trata

de efectos adversos que no aparecen en este prospecto. También puede comunicarlos directamente a

través del Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano:

www.notificaRAM.es. Mediante la comunicación de efectos adversos usted puede contribuir a

proporcionar más información sobre la seguridad de este medicamento.

5. Conservación de FORTASEC PLUS

Mantener este medicamento fuera de la vista y del alcance de los niños.

No utilizar este medicamento después de la fecha de caducidad que aparece en el blister y en la caja después de CAD. La fecha de caducidad es el último día del mes que se indica.

Este medicamento no requiere condiciones especiales de conservación.

Los medicamentos no se deben tirar por los desagües ni a la basura. Deposite los envases y los medicamentos que no necesita en el Punto Sigre de la farmacia. En caso de duda pregunte a su farmacéutico cómo deshacerse de los envases y de los medicamentos que no necesita. De esta forma ayudará a proteger el medio ambiente.

6. Contenido del envase e información adicional

Composición de Fortasec plus:

  • Los principios activos son: loperamida hidrocloruro (2 mg por comprimido) y simeticona (medido como 125 mg de dimeticona por comprimido).
  • Los demás componentes son: fosfato cálcico hidrogenado, celulosa microcristalina, acesulfame potásico, aroma artificial de vainilla (incluye propilenglicol, maltodextrina, etanol y alcohol bencílico), carboximetilalmidón sódico (tipo A) y ácido esteárico.

Aspecto del productoy contenido del envase:

Los comprimidos son blancos con forma de cápsula, grabados con “IMO” en una de sus caras, la otra cara está grabada con una línea entre “2” y “125”.

Cada envase contiene 6, 8, 10, 12, 15, 16, 18 o 20 comprimidos en tiras en blister.

Puede que solo estén comercializados algunos tamaños de envases.

Titular de la autorización de comercialización:

JNTL Consumer Health (Spain), S.L.

C/ Vía de los Poblados 1, Edificio E, planta 3

28033-MADRID

Responsable de la fabricación:

JNTL Consumer Health (France) SAS Domaine de Maigremont

27100 Val de Reuil France

ó

Janssen-Cilag S.P.A, Via C. Janssen. Borgo San Michele, Latina. 04100 ITALIA

óJohnson & Johnson Consumer, Michel De Braeystraat 52,Antwerpen, 2000, Belgica.óJohnson & Johnson GmbH, Johnson & Johnson Platz 2, 41470 Neuss, Alemania

Este medicamento está autorizado en los siguientes países de la UE bajo las siguientes denominaciones:

Bélgica:Imodium Duo 2mg/125mg Tabletten

Bulgaria: Imodium Plus 2 mg/125 mg Caplets

Chipre: Imodium Plus

República Checa: Imodium Plus

Dinamarca:Imodium Plus

Finlandia:Imodium Plus Tabletit

Francia:Imodiumduo comprimé

Alemania:Imodium Akut Duo

Grecia:Imodium Plus

Hungría:Imodium Plus 2 mg/125 mg tabletta

Irlanda:Imodium Plus 2 mg/125 mg tablet

Luxemburgo:Imodium Duo 2 mg/125 mg Comprimés

Holanda:Imodium Duo 2 mg/125, tabletten

Noruega:Imodium Comp

Portugal:Imodium Plus 2 mg/125 mg Comprimidos

Rumania: Imodium Plus 2 mg/125 mg comprimate

Eslovaquia: Imodium Plus

España:Fortasec plus 2 mg/125 mg Comprimidos

Suecia:Imodium Plus 2 mg/125 mg tablett

Reino Unido (Irlanda del Norte) :Imodium Dual Action Relief Tablets

Este prospecto ha sido revisado en Abril 2023

La información detallada y actualizada de este medicamento está disponible en la página web de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) http://www.aemps.gob.es

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Frequently Asked Questions

Is a prescription required for FORTASEC PLUS 2 mg / 125 mg TABLETS?
FORTASEC PLUS 2 mg / 125 mg TABLETS does not require a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in FORTASEC PLUS 2 mg / 125 mg TABLETS?
The active ingredient in FORTASEC PLUS 2 mg / 125 mg TABLETS is loperamide, combinations. This information helps identify medicines with the same composition but different brand names.
Who manufactures FORTASEC PLUS 2 mg / 125 mg TABLETS?
FORTASEC PLUS 2 mg / 125 mg TABLETS is manufactured by Jntl Consumer Health (Spain) S.L.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of FORTASEC PLUS 2 mg / 125 mg TABLETS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether FORTASEC PLUS 2 mg / 125 mg TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to FORTASEC PLUS 2 mg / 125 mg TABLETS?
Other medicines with the same active substance (loperamide, combinations) include ABECLIN 2 mg TABLETS, DIARFIN 2 mg HARD CAPSULES, DIARFIN FLAS 2 mg ORAL LYOPHILIZED. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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