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EBASTINE STADA 10 mg FILM-COATED 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 EBASTINE STADA 10 mg FILM-COATED 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

Ebastina STADA 10 mg comprimidos recubiertos con película EFG

Lea todo el prospecto detenidamente antes de empezar a tomar este 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 Ebastina Stada 10 mg comprimidos y para qué se utiliza
  1. Qué necesita saber antes de empezar a tomar Ebastina Stada 10 mg comprimidos
  2. Cómo tomar Ebastina Stada 10 mg comprimidos
  3. Posibles efectos adversos
  1. Conservación de Ebastina Stada 10 mg comprimidos
  2. Contenido del envase e información adicional

1. Qué es Ebastina Stada 10 mg comprimidos y para qué se utiliza

Ebastina, el componente activo de Ebastina Stada 10 mg, pertenece a un grupo de fármacos denominados antihistamínicos (antialérgicos).

Ebastina Stada 10 mg está indicado en el tratamiento de procesos alérgicos tales como rinitis alérgica estacional o perenne asociada o no a conjuntivitis alérgica (como goteo nasal, picor de nariz, picor de ojos, lagrimeo, ganas de estornudar), urticaria crónica y dermatitis alérgica.

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 Ebastina Stada 10 mg comprimidos

No tome Ebastina Stada 10 mg:

  • si es alérgico al principio activo o a alguno de los demás componentes de este medicamento (incluidos en la sección 6).

Advertencias y precauciones

Consulte a su médico o farmacéutico antes de empezar a tomar Ebastina Stada

Este medicamento debe usarse con precaución:

  • si los resultados de su electrocardiograma están alterados (prolongación del intervalo QT).
  • si tiene altos los niveles de potasio en sangre.
  • si sufre de enfermedad grave del hígado (ver apartado “Cómo tomar Ebastina Stada”).
  • si está en tratamiento con un tipo de medicamentos utilizados para tratar infecciones producidas por hongos llamados antifúngicos azólicos o con medicamentos utilizados para tratar ciertas infecciones llamados antibióticos macrólidos (ver apartado “Otros medicamentos y Ebastina Stada 10 mg”).
  • si está en tratamiento con rifampicina, un tipo de medicamento utilizado para tratar la tuberculosis.

No utilice este medicamento si presenta un cuadro alérgico agudo de urgencia, ya que ebastina (principio activo de este medicamento) tarda de 1 a 3 horas en hacer efecto.

Niños

Ebastina Stada no debe ser administrada a niños menores de 12 años.

Otros medicamentos y Ebastina Stada 10 mg

Comunique a su médico o farmacéutico que está tomando, ha tomado recientemente, o podría tener que tomar cualquier otro medicamento.

Los medicamentos que se mencionan a continuación pueden interferir con ebastina; en estos casos puede ser necesario cambiar la dosis o interrumpir el tratamiento con alguno de ellos:

  • Ebastina puede aumentar el efecto de otros medicamentos que se utilizan para tratar la alergia (antihistamínicos).
  • Ebastina se debe usar con precaución en pacientes en tratamiento con medicamentos llamados ketoconazol e itraconazol, utilizados para tratar infecciones producidas por hongos, o con un antibiótico utilizado para tratar ciertas infecciones llamado eritromicina (ya que pueden producir una alteración en su electrocardiograma).
  • El efecto antihistamínico de la ebastina puede verse disminuido en pacientes en tratamiento con un medicamento llamado rifampicina que se utiliza para tratar la tuberculosis.

No se han descrito interacciones entre ebastina y teofilina, warfarina, cimetidina, diazepam y alcohol.

Interferencias con pruebas de diagnóstico

Ebastina Stada puede interferir con los resultados de las pruebas de alergia sobre la piel, por lo que se aconseja no realizarlas hasta transcurridos 5-7 días desde la interrupción del tratamiento.

Toma de Ebastina Stada 10 mg con alimentos y bebidas

Los comprimidos pueden tomarse con o sin alimentos.

Embarazo y lactancia

Si está embarazada o en periodo de lactancia, cree que podría estar embarazada o tiene intención de quedarse embarazada, consulte a su médico o farmacéutico antes de utilizar este medicamento.

Embarazo

No existe experiencia en mujeres embarazadas por lo que se recomienda consultar con un médico antes de tomar Ebastina Stada. Este decidirá la conveniencia o no de iniciar el tratamiento.

Lactancia

Se desconoce si el medicamento pasa a leche materna, por lo que no debe utilizarse durante la lactancia.

Conducción y uso de máquinas

En el hombre no se han observado efectos sobre la función psicomotora, ni sobre la capacidad para conducir o utilizar maquinaria, a las dosis terapéuticas recomendadas. No obstante, dado que entre los efectos adversos figura la somnolencia y el mareo, observe su respuesta a la medicación antes de conducir o utilizar maquinaria.

Información importante sobre alguno de los componentes de Ebastina Stada

Este medicamento no contiene gluten.

Ebastina Stada contiene sodio

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

3. Cómo tomar Ebastina Stada 10 mg comprimidos

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.

Su médico le indicará la duración de su tratamiento con Ebastina Stada 10 mg. No suspenda el tratamiento antes, ya que puede que empeoren sus síntomas.

Recuerde tomar su medicamento.

Posología

Uso en adultos y niños mayores de 12 años:La dosis recomendada es de 1 comprimido (10 mg de ebastina) una vez al día.

Uso en niños de entre 6 y 11 años:la dosis recomendada es de medio comprimido (5 mg) una vez al día.

Uso en pacientes con enfermedad grave del hígado:No se debe superar la dosis de 10 mg de ebastina al día (1 comprimido).

Forma de administración

Este medicamento es para administración por vía oral.

Los comprimidos deben tragarse enteros, sin masticarlos, con ayuda de un vaso de líquido, preferiblemente agua.

Si estima que la acción de Ebastina Stada 10 mg es demasiado fuerte o débil, comuníqueselo a su médico o farmacéutico.

Si toma más Ebastina Stada 10 mg del que debe

En caso de sobredosis o ingestión accidental, consulte inmediatamente a su médico o farmacéutico o llame al Servicio de Información Toxicológica, teléfono: 91 562 04 20 indicando el medicamento y la cantidad tomada.

El tratamiento de la intoxicación de este medicamento consiste en un lavado gástrico y la administración de la medicación adecuada. Lleve este prospecto con usted.

Si olvidó tomar Ebastina Stada 10 mg

No tome una dosis doble para compensar las dosis olvidadas. Tome la dosis olvidada cuando se acuerde y luego siga con el horario habitual. Sin embargo, si faltan pocas horas para la siguiente dosis, no tome la dosis olvidada y espere a tomar la siguiente dosis a la hora que le corresponda.

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.

En los ensayos clínicos y el la experiencia postcomercialización se han observado los siguientes efectos adversos:

Muy frecuentes (pueden afectar a más de 1 de cada 10 personas):

  • dolor de cabeza

Frecuentes (pueden afectar hasta 1 de cada 10 personas):

  • somnolencia
  • sequedad de boca

Raros (pueden afectar hasta 1 de cada 1.000 personas):

  • reacciones de hipersensibilidad: reacciones alérgicas (como anafilaxis y angioedema)
  • nerviosismo, insomnio
  • mareo, disminución de la sensación del tacto o la sensibilidad, disminución o alteración del gusto
  • palpitaciones, taquicardia
  • dolor abdominal, vómitos, náuseas, problemas digestivos
  • inflamación del hígado (hepatitis), colestasis, pruebas analíticas de función hepática anómalas (aumento de transaminasas, gamma-GT, fosfatasa alcalina y bilirrubina)
  • urticaria, erupción cutánea, dermatitis
  • trastornos menstruales
  • edema (hinchazón por acumulación de líquido), fatiga

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

  • aumento de peso
  • aumento del apetito

Comunicación de efectos adversos

Si experimenta cualquier tipo de efecto adverso, consulte a su médico o farmacéutico, 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 Ebastina Stada 10 mg comprimidos

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

Este medicamento no requiere condiciones especiales de conservación.

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.

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. Pregunte a su farmacéutico cómo deshacerse de los envases y de los medicamentos que ya no necesita. De esta forma ayudará a proteger el medio ambiente.

6. Contenido del envase e información adicional

Composición de Ebastina Stada 10 mg

  • El principio activo es ebastina. Cada comprimido contiene 10 mg de ebastina.
  • Los demás componentes son celulosa microcristalina, estearoil macrogolgliceridos, almidón glicolato sódico (almidón de patata) sin gluten, estearato de magnesio, agua purificada, opadry blanco.

Aspecto del producto y contenido del envase

Los comprimidos de Ebastina Stada 10 mg son oblongos, biconvexos, de color blanco y con una ranura. El comprimido se puede dividir en mitades iguales.

Los envases contienen 20 comprimidos.

Titular de la autorización de comercialización y responsable de la fabricación

Titular de la autorización de comercialización

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) España

[email protected]

Responsable de la fabricación:

Generis Farmacêutica S.A.

Rua João de Deus nº 19, Venda Nova

2700-487 Amadora

Portugal

Fecha de la última revisión de este prospecto:Mayo 2019

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

Online doctors for EBASTINE STADA 10 mg FILM-COATED TABLETS

Discuss questions about EBASTINE STADA 10 mg FILM-COATED TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

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Experience and qualifications:

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If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

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Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

Areas of expertise:

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Svetlana Kolomeeva

Cardiology 18 years exp.

Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

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Alexander Nazarchuk

Allergology 7 years exp.

Dr. Alexander Nazarchuk is a physician specialising in allergology and internal medicine. He provides online consultations for adults, following the principles of evidence-based medicine — no outdated treatments or unnecessary tests, with clear explanations and a personalised approach. He helps patients with a wide range of allergic and therapeutic conditions, from common day-to-day complaints to complex cases involving allergies, gastrointestinal issues, cardiovascular concerns, respiratory symptoms, and more.

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Marta Reguero Capilla

Allergology 8 years exp.

Dr Marta Reguero Capilla is an allergist and immunologist who works with both adults and children. She specialises in the diagnosis, treatment, and ongoing management of allergic and immune-related conditions through online consultations.

In her practice, Dr Reguero Capilla helps patients understand the causes of their symptoms, review test results, and choose appropriate treatment or monitoring strategies. Her consultations are suitable both for first-time assessments and for follow-up care over time.

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Dr Reguero Capilla works in a structured and attentive manner, explaining medical decisions clearly and helping patients make informed choices about their own health or their child’s care.

When clinically appropriate, she may provide recommendations for further tests or referrals that patients can use within Spanish medical networks, including Sanitas and DKV, in accordance with the terms and conditions of those services.

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Frequently Asked Questions

Is a prescription required for EBASTINE STADA 10 mg FILM-COATED TABLETS?
EBASTINE STADA 10 mg FILM-COATED 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 EBASTINE STADA 10 mg FILM-COATED TABLETS?
The active ingredient in EBASTINE STADA 10 mg FILM-COATED TABLETS is ebastine. This information helps identify medicines with the same composition but different brand names.
How much does EBASTINE STADA 10 mg FILM-COATED TABLETS cost in pharmacies?
The average pharmacy price for EBASTINE STADA 10 mg FILM-COATED TABLETS is around 4.4 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures EBASTINE STADA 10 mg FILM-COATED TABLETS?
EBASTINE STADA 10 mg FILM-COATED TABLETS is manufactured by Laboratorio Stada S.L.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of EBASTINE STADA 10 mg FILM-COATED 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 EBASTINE STADA 10 mg FILM-COATED 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 EBASTINE STADA 10 mg FILM-COATED TABLETS?
Other medicines with the same active substance (ebastine) include BACTIL 10 mg FILM-COATED TABLETS, BACTIL FLAS 10 mg ORAL LYOPHILIZED, BACTIL FORTE 20 mg FILM-COATED TABLETS. 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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