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MIZOLEN 10 mg MODIFIED-RELEASE TABLETS

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Prescription review online

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Talk to a doctor about this medicine

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Discuss your symptoms and possible next steps in a quick online consultation.

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 MIZOLEN 10 mg MODIFIED-RELEASE 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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Introducción

Prospecto: información para el usuario

Mizolen 10 mg comprimidos de liberación modificada

Mizolastina

Lea todo el prospecto detenidamente antes de empezar a tomar el medicamento, porque contiene información importante para usted.

  • Conserve este prospecto ya que puede tener que volver a leerlo.
  • Si tiene alguna duda, consulte a su médico o farmacéutico.
  • Este medicamento se le ha recetado solamente a usted, y no debe dárselo a otras personas aunque tengan los mismos síntomas que usted, ya que puede perjudicarles.
  • 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

Contenido del prospecto

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

1. Qué es Mizolen y para qué se utiliza

El principio activo de Mizolen es mizolastina. Mizolen es un antihistamínico.

Mizolen se utiliza para reducir los síntomas de:

  • fiebre del heno (rinoconjuntivitis alérgica estacional)
  • otras reacciones alérgicas que producen irritación en los ojos y la nariz (rinoconjuntivitis alérgica crónica)
  • urticaria (picor en la piel, como erupción cutánea).
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 Mizolen

No tome Mizolen

  • si es alérgico a la mizolastina o a cualquiera de los demás componentes de este medicamento (incluidos en la sección 6)
  • si está tomando antibióticos macrólidos (como eritromicina, claritromicina, azitromicina)
  • si está tomando antifúngicos imidazólicos (como ketoconazol, fluconazol, itraconazol, utilizados para el tratamiento de infecciones de hongos)
  • si tiene problemas de hígado
  • si tiene problemas de corazón
  • si ha tenido alguna vez latidos irregulares o lentos
  • si su ECG (registro eléctrico de los latidos de su corazón) no es normal
  • si ya está tomando medicamentos para un ritmo irregular de corazón
  • si sus niveles de sales en sangre son anómalos, especialmente niveles bajos de potasio.

Si se encuentra en cualquiera de estos casos, o no está seguro de ello, consulte con su médico o farmacéutico antes de tomar este medicamento.

Advertencias y precauciones

En pacientes de edad avanzada –Mizolen puede hacer que las personas se sientan somnolientas y puede producir un latido de corazón más rápido o irregular – estos efectos son más probables en los pacientes de edad avanzada.

Análisis de sangre

Su médico puede solicitar que se realicen análisis de sangre regulares u otras pruebas para revisar cómo está actuando el medicamento en usted. Esto es más probable si:

  • usted tiene diabetes (su nivel de azúcar en sangre no está controlado)
  • los niveles de sales en sangre cambian algunas veces (desequilibrio electrolítico)
  • si tiene problemas con los latidos de su corazón (arritmias cardiacas)

Toma de Mizolen con otros medicamentos

Informe a su médico o farmacéutico si está utilizando, ha utilizado recientemente:

  • un antibiótico macrólido como eritromicina, claritromicina, azitromicina
  • un medicamento antifúngico imidazólico como ketoconazol, fluconazol, itraconazol.

Estos medicamentos no deben tomarse junto con Mizolen.

También debe informar a su médico o farmacéutico si está tomando:

  • cimetidina (utilizada para tratar úlceras de estómago)
  • ciclosporina (un inmunosupresor)
  • nifedipino (utilizado para tratar la presión sanguínea elevada o enfermedades del corazón) ya que estos medicamentos pueden alterar los niveles de Mizolen (mizolastina) en sangre.

Informe a su médico o farmacéutico si está utilizando, ha utilizado recientemente o podría tener que utilizar cualquier otro medicamento.

Toma de Mizolen con alimentos y bebidas

Mizolen puede tomarse con las comidas o entre ellas.

Mizolen no modifica los efectos producidos por el alcohol. No obstante, como con cualquier otro medicamento, no debe beber alcohol en cantidades excesivas, cuando esté tomando Mizolen.

Embarazo y lactancia

Consulte a su médico o farmacéutico antes de utilizar este medicamento.

No se ha establecido la seguridad de Mizolen en el embarazo. Como con todos los medicamentos, debería evitarse el empleo de mizolastina durante el embarazo, en especial durante los tres primeros meses.

Mizolastina se excreta en la leche materna, por lo que no se recomienda su uso durante la lactancia.

Conducción y uso de máquinas

Podría sentir somnolencia después de tomar este medicamento. Si esto ocurre, no conduzca o utilice herramientas o maquinaria.

Mizolen contiene lactosa y aceite de ricino hidrogenado

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

Este medicamento puede producir molestias de estómago y diarrea porque contiene aceite de ricino hidrogenado.

3. Cómo tomar Mizolen

Siga exactamente las instrucciones de administración de este medicamento indicadas por su médico. En caso de duda, consulte de nuevo a su médico o farmacéutico.

Para adultos, incluyendo pacientes de edad avanzada y niños a partir de 12 años.

La dosis habitual es un comprimido (10 mg) al día.

Los comprimidos deben tomarse con agua abundante.

Si toma más Mizolen del que debiera

En caso de sobredosis o ingestión accidental de Mizolen, consulte inmediatamente a su médico, farmacéutico o llame al Servicio de Información Toxicológica, teléfono: 915 620 420, indicando el medicamento y la cantidad tomada. Podría ser necesario acudir a un Hospital. Se recomienda llevar el envase y el prospecto del medicamento al profesional sanitario.

Si olvidó tomar Mizolen

Si se olvida de tomar algún comprimido de Mizolen, tome el siguiente a su hora habitual.

No tome una dosis doble para compensar las dosis olvidadas.

Si interrumpe el tratamiento con Mizolen

Consulte a su médico si desea interrumpir su tratamiento antes de su finalización.

Si tiene cualquier otra duda sobre el uso de este medicamento, 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 producir efectos adversos, aunque no todas las personas los sufran.

Informe a su médico inmediatamente y deje de tomar Mizolen si experimenta mareos, hinchazón de la cara, labios, lengua o garganta y dificultad para respirar, dado que pueden ser signos de una reacción alérgica grave.

Efectos adversos frecuentes(pueden afectar hasta 1 de cada 10 pacientes):

  • sequedad de boca, dolor de cabeza, vértigos, somnolencia, falta de energía
  • diarrea, náuseas
  • dolor de estómago, indigestión
  • aumento del apetito asociado a incremento de peso.

Efectos adversos poco frecuentes(pueden afectar hasta 1 de cada 100 pacientes):

  • ansiedad y depresión
  • alteración de los análisis de sangre que muestran el funcionamiento del hígado
  • presión sanguínea disminuida
  • dolor en músculos y articulaciones.

Efectos adversos muy raros(pueden afectar hasta 1 de cada 10.000 pacientes):

  • disminución de glóbulos blancos sanguíneos que facilita la aparición de infecciones
  • reacciones alérgicas graves que pueden causar mareos, hinchazón de la cara, labios, lengua o garganta y dificultad para respirar
  • erupción cutánea generalizada (urticaria), picor
  • desmayos.

Otros efectos adversos frecuencia no conocida(no puede estimarse a partir de los datos disponibles):

  • vómitos.

También algunas personas que toman Mizolen han sufrido: dificultad o pitidos al respirar, empeoramiento de su asma o cambios leves en los niveles de azúcar o sales en sangre. Su médico puede planificar análisis de sangre para controlar su evolución.

Algunos antihistamínicos (medicamentos antialérgicos) se han relacionado con anomalías en el registro eléctrico del latido cardiaco, lo que aumenta el riesgo de latidos irregulares.

Comunicación de efectos adversos:

Si experimenta cualquier tipo de efecto adverso, consulte a su médico, farmacéutico o enfermero, incluso si se trata de posibles efectos adversos que no aparecen en este prospecto. También puede comunicarlos directamente a través del Sistema Español de Farmacovigilancia de medicamentos de Uso Humano: https://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 Mizolen

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

No utilice este medicamento después de la fecha de caducidad que aparece en el envase después de CAD.

La fecha de caducidad es el último día del mes que se indica.

Conservar en el embalaje original para protegerlo de la humedad.

Si Mizolen se encuentra en blisters de aluminio/PVC o en frascos de polipropileno con tapón de polietileno, no conservar a temperatura superior a 25ºC.

Si Mizolen se encuentra en blisters de oPA/aluminio/PVC, no requiere condiciones especiales de conservación.

Tenga en cuenta las condiciones de conservación descritas en la caja.

No tome Mizolen si observa que los comprimidos han cambiado de color.

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 Mizolen

  • El principio activo es mizolastina.
  • Cada comprimido contiene 10 mg de mizolastina.
  • Los demás componentes son:
    • Núcleo: aceite de ricino hidrogenado, lactosa monohidrato, celulosa microcristalina, ácido tartárico, povidona, sílice coloidal anhidra, estearato de magnesio.
    • Recubrimiento: hipromelosa, dióxido de titanio (E171), propilenglicol.

Aspecto del producto y contenido del envase

Los comprimidos son oblongos, blancos, con una cara ranurada y las letras “MZI 10” grabadas en la cara opuesta.

Se presenta en envases con 4, 7, 10, 15, 20, 30, 50 ó 100 comprimidos en blisters de aluminio/ (oPA/aluminio/PVC), en blisters de aluminio/PVC ó en frascos de polipropileno con tapón de polietileno.

Puede que solamente estén comercializados algunos tamaños de envase.

Titular de la autorización de comercialización y responsable de la fabricación

Titular

Opella Healthcare Spain, S.L.

C/Roselló i Porcel, 21

08016 Barcelona

Grupo Sanofi

Responsable de la fabricación

SANOFI WINTHROP INDUSTRIE

Avenue Gustave Eiffel, 30-36

F-37100 Tours, Francia

ó

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst - Brüningstraße 50

65926 Frankfurt am Main

Alemania

Este medicamento está autorizado en los estados miembros del Espacio Económico

Europeo con los siguientes nombres:

Bélgica: Mizollen 10 mg comprimés à libération modifiée / Mizollen 10 mg Tabletten met gereguleerde afgifte / Mizollen 10 mg Tabletten mit veränderter Wirkstofffreisetzung.

Francia: MIZOLLEN 10 mg comprimés à libération modifiée.

Alemania: Mizollen 10 mg Tabletten mit veränderter Wirkstofffreisetzung.

Grecia: MIZOLLEN, δισκ?α ελεγχ?μενης αποδ?σμευσης 10 mg/TAB

Italia: Mizollen 10 mg compresse a rilascio modificato.

Luxemburgo: MIZOLLEN 10 mg comprimés à libération modifiée.

Portugal: Mizollen 10 mg comprimidos de libertação modificada.

España: Mizolen 10 mg comprimidos de liberación modificada.

Países Bajos: Mizollen® 10 mg, tablet met gereguleerde afgifte.

Reino Unido: Mizollen 10mg Modified-release tablets.

Fecha de la última revisión de este prospecto: Enero 2019

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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Dr. Anastasiia Shalko is a general practitioner with a background in both paediatrics and general medicine. She graduated from Bogomolets National Medical University in Kyiv and completed her paediatric internship at the P.L. Shupyk National Medical Academy of Postgraduate Education. After working as a paediatrician in Kyiv, she relocated to Spain, where she has been practising general medicine since 2015, providing care for both adults and children.Her work focuses on urgent, short-term medical concerns – situations where patients need quick guidance, symptom assessment and clear next steps. She helps people understand whether their symptoms require in-person evaluation, home management or a change in treatment. Common reasons for booking an online consultation include:

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Family medicine 24 years exp.

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Frequently Asked Questions

Is a prescription required for MIZOLEN 10 mg MODIFIED-RELEASE TABLETS?
MIZOLEN 10 mg MODIFIED-RELEASE TABLETS requires 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 MIZOLEN 10 mg MODIFIED-RELEASE TABLETS?
The active ingredient in MIZOLEN 10 mg MODIFIED-RELEASE TABLETS is mizolastine. This information helps identify medicines with the same composition but different brand names.
How much does MIZOLEN 10 mg MODIFIED-RELEASE TABLETS cost in pharmacies?
The average pharmacy price for MIZOLEN 10 mg MODIFIED-RELEASE TABLETS is around 9.74 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures MIZOLEN 10 mg MODIFIED-RELEASE TABLETS?
MIZOLEN 10 mg MODIFIED-RELEASE TABLETS is manufactured by Opella Healthcare Spain S.L.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of MIZOLEN 10 mg MODIFIED-RELEASE 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 MIZOLEN 10 mg MODIFIED-RELEASE 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 MIZOLEN 10 mg MODIFIED-RELEASE TABLETS?
Other medicines with the same active substance (mizolastine) include ABISAX 20 mg TABLETS, ABRILIA 20 mg TABLETS, AERIUS 0.5 mg/ml ORAL SOLUTION. 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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