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BACTIL 10 mg FILM-COATED TABLETS

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About the medicine

How to use BACTIL 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 paciente

Bactil 10 mg Comprimidos recubiertos con película

Ebastina

Lea todo el prospecto detenidamente antes de empezar a tomar 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 médico o 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 7 días de tratamiento.

Contenido del prospecto:

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

1. Qué es Bactil y para qué se utiliza

Bactil pertenece a un grupo de medicamentos denominados antihistamínicos (antialérgicos).

Bactil está indicado en el alivio de la rinoconjuntivitis alérgica (estornudos, picor nasal, secreción nasal, congestión nasal y ojos rojos y llorosos) y urticaria (habones) que cursen con síntomas leves, en adultos y adolescentes a partir de 12 años.

Debe consultar a un médico si empeora o si no mejora después de 7 días.

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 Bactil

No tome Bactil

  • si es alérgico a la ebastina o a cualquiera 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 Bactil:

  • si los resultados de su electrocardiograma están alterados.
  • si tiene altos los niveles de potasio en sangre.
  • si sufre de enfermedad grave del hígado (ver apartado “Cómo tomar Bactil”).
  • 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 “Toma de Bactil con otros medicamentos”).
  • 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.

En caso de que usted experimente síntomas como opresión de la garganta, dificultad para respirar, ronquera o dificultades para hablar, sibilancias (“pitos” al respirar), presión arterial baja, vómitos repetidos y/o pérdida del conocimiento, debe solicitar asistencia sanitaria urgente por riesgo de anafilaxia.

Niños

Bactil no debe ser administrado a niños menores de 12 años.

Toma de Bactil con otros medicamentos

Informe a su médico o farmacéutico si está tomando, ha tomado recientemente, o pudiera tener que tomar cualquier otro medicamento.

Especialmente si está en tratamiento con alguno de los medicamentos que se mencionan a continuación, porque puede ser necesario cambiar la dosis o interrumpir el tratamiento con alguno de ellos:

  • medicamentos que se utilizan para tratar la alergia (antihistamínicos) porque Bactil puede aumentar su efecto.
  • ketoconazol e itraconazol, utilizados para tratar infecciones producidas por hongos, o con eritromicina antibiótico utilizado para tratar ciertas infecciones ya que pueden producir una alteración en su electrocardiograma.
  • rifampicina que se utiliza para tratar la tuberculosis ya que puede disminuir el efecto antihistamínico de Bactil.

Interferencias con pruebas de diagnóstico

Bactil 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 Bactil con alimentos y bebidas

La toma del medicamento con alimentos o bebidas no afecta a la eficacia del mismo.

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

Se dispone de datos limitados relativos al uso del medicamento en mujeres embarazadas. Como medida de precaución, es preferible evitar el uso de Bactil durante el embarazo.

Lactancia

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

Conducción y uso de máquinas

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.

Bactil contiene lactosa y sodio

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

3. Cómo tomar Bactil

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

Posología

Uso en adultos y adolescentes mayores de 12 años

1 comprimido (10 mg de ebastina) 1 vez al día.

No obstante, en ocasiones puede ser necesario una dosis de 20 mg de ebastina 1 vez al día para controlar los síntomas. En estos casos, se recomienda 2 comprimidos de Bactil (10 mg de ebastina) 1 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 se toma por vía oral.

Los comprimidos se pueden tomar con o sin alimentos, con ayuda de un vaso de agua.

Debe consultar a un médico si empeora o si no mejora después de 7 días.

Si toma más Bactil del que debe

En caso de sobredosis o ingestión accidental, consulte a su médico o farmacéutico, o llame al Servicio de Información Toxicológica, teléfono 915 620 420 indicando el medicamento y la cantidad ingerida.

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 en 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
  • Boca seca

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, 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 Bactil

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

No conservar a temperatura superior a 30ºC.

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. 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 Bactil

  • El principio activo es ebastina. Cada comprimido contiene 10 mg de ebastina.
  • Los demás componentes (excipientes) son: Núcleo del comprimido:celulosa microcristalina (E-460i), almidón de maíz pregelatinizado, lactosa monohidrato, croscarmelosa sódica (E-468) y estearato de magnesio (E-572). Recubrimiento: hipromelosa (E-464), macrogol 6.000 y dióxido de titanio (E-171).

Aspecto del producto y contenido del envase

Bactil se presenta en forma de comprimidos recubiertos con película para administración oral acondicionados en blísters de PVC/Aluminio. Los comprimidos son circulares, de color blanco y con una cara marcada con E10.

Cada envase contiene 10 ó 20 comprimidos recubiertos con película.

Titular de la autorización de comercialización y responsable de la fabricación

Titularde la autorización de comercialización

Laboratorios Almirall, S.L.

Ronda General Mitre, 151

08022 – Barcelona (España)

Responsable de la fabricación

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca - Barcelona (España)

Fecha de la última revisión de este prospecto:Septiembre 2022

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

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Yevgen Yakovenko

General surgery 12 years exp.

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Family medicine 13 years exp.

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Frequently Asked Questions

Is a prescription required for BACTIL 10 mg FILM-COATED TABLETS?
BACTIL 10 mg FILM-COATED 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 BACTIL 10 mg FILM-COATED TABLETS?
The active ingredient in BACTIL 10 mg FILM-COATED TABLETS is ebastine. This information helps identify medicines with the same composition but different brand names.
Who manufactures BACTIL 10 mg FILM-COATED TABLETS?
BACTIL 10 mg FILM-COATED TABLETS is manufactured by Laboratorios Almirall S.L.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of BACTIL 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 BACTIL 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 BACTIL 10 mg FILM-COATED TABLETS?
Other medicines with the same active substance (ebastine) include BACTIL FLAS 10 mg ORAL LYOPHILIZED, BACTIL FORTE 20 mg FILM-COATED TABLETS, BACTIL FORTE 20 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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