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CLEBORIL 500 micrograms tablets

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Prescription review online

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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 CLEBORIL 500 micrograms tablets

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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

Cleboril 500 microgramos comprimidos

cleboprida

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

1. Qué es Cleboril y para qué se utiliza

Cleboril contiene cleboprida y pertenece al grupo de medicamentos llamados propulsivos, que regulan la motilidad gastrointestinal.

Cleboril está indicado en el:

  • Tratamiento sintomático de los trastornos funcionales de la motilidad gastrointestinal en adultos y adolescentes.
  • Tratamiento sintomático de náuseas y vómitos postquirúrgicos o inducidos por quimioterapia antineoplásica en adultos y adolescentes.
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 Cleboril

No tome Cleboril:

  • Si es alérgico a cleboprida o a cualquiera de los demás componentes de este medicamento (incluidos en la sección 6).
  • Si tiene hemorragia, obstrucción o perforación gastrointestinal, ya que la estimulación de la motilidad gástrica pueda resultar perjudicial.
  • Si sufre movimientos anormales e involuntarios (discinesia tardía) que aparecen en personas en tratamiento con un tipo de medicamentos llamados neurolépticos.
  • Si sufre convulsiones (epilepsia).
  • Si sufre enfermedad de Parkinson u otros trastornos extrapiramidales (que provocan alteraciones del tono muscular, de la postura y la aparición de movimientos involuntarios).

Advertencias y precauciones

Consulte a su médico o farmacéutico antes de empezar a tomar Cleboril:

  • Si tiene una enfermedad grave del hígado o del riñón (insuficiencia hepática o renal severa), ya que puede aumentar el efecto de este medicamento.
  • Si padece algunos tumores, como tumores de la mama o adenocarcinoma hipofisiario secretor de prolactina, porque puede aumentar el nivel en la sangre de una hormona llamada prolactina.

Niños y adolescentes

En niños, adolescentes y personas de edad avanzada el uso de dosis superiores a las recomendadas puede aumentar la posibilidad de aparición de reacciones extrapiramidales (alteraciones del tono muscular, de la postura y aparición de movimientos involuntarios).

En recién nacidos se han descrito casos de metahemoglobinemia adquirida (trastorno de la sangre que afecta a su capacidad para transportar el oxígeno) debida a ortopramidas (grupo de medicamentos al que pertenece Cleboril).

Otros medicamentos y Cleboril

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

Es especialmente importante que informe a su médico si está tomando alguno de los siguientes medicamentos:

  • Fenotiazinas, butirofenonas y otros antidopaminérgicos (utilizados para tratar ciertas enfermedades mentales) ya que Cleboril puede aumentar el efecto de estos medicamentos sobre el sistema nervioso central.
  • Digoxina (utilizada para tratar enfermedades del corazón) y cimetidina (utilizada en situaciones en las que es necesario disminuir la producción de ácido por el estómago) ya que Cleboril disminuye sus efectos.
  • Hipnóticos (medicamentos que mejoran la conciliación del sueño y su duración), ansiolíticos (reducen la ansiedad) o narcóticos (utilizados para tratar el dolor moderado o grave) ya que Cleboril puede potenciar sus efectos sedantes.
  • Anticolinérgicos (como atropina, utilizados para aliviar los calambres o espasmos estomacales, para el tratamiento de la enfermedad de Parkinson o para prevenir los mareos de viaje) o analgésicos narcóticos (opiáceos) porque neutralizan la acción de Cleboril sobre la motilidad gastrointestinal.
  • IMAO (utilizados para tratar la depresión), ya que su uso junto con Cleboril puede aumentar el riesgo de sufrir efectos adversos.

Toma de Cleboril con alcohol

Evite tomar alcohol mientras esté en tratamiento con Cleboril, ya que puede potenciar sus efectos sedantes.

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.

No se dispone de información suficiente sobre el uso de este medicamento en mujeres embarazadas ni si se excreta en la leche materna. Por este motivo, como medida de precaución, es preferible evitar su uso durante el embarazo, especialmente en los 3 primeros meses del mismo, y durante la lactancia.

Conducción y uso de máquinas

Durante el tratamiento con Cleboril debe evitar situaciones que requieran un estado especial de alerta, como la conducción de vehículos o el manejo de maquinaria peligrosa.

Cleboril 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 Cleboril

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

La dosis recomendada en adultos es de 1 comprimido (500 microgramos de cleboprida) 3 veces al día, antes de cada comida.

La dosis recomendada en adolescentes (de 12 años a menos de 18 años) es de medio comprimido (250 microgramos de cleboprida) 3 veces al día, antes de cada comida.

Este medicamento es para administración por vía oral.

El comprimido se puede partir en dosis iguales.

Tome su dosis con ayuda de algo de líquido, preferiblemente agua.

Si toma más Cleboril 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 5620420, indicando el medicamento y la cantidad tomada.

En caso de sobredosis pueden aparecer somnolencia, desorientación y reacciones extrapiramidales (alteraciones del tono muscular, de la postura y aparición de movimientos involuntarios) que normalmente desaparecen al suspender el tratamiento.

De persistir los síntomas se practicará lavado de estómago y medicación sintomática. Las reacciones extrapiramidales se controlan con la administración de medicamentos adecuados.

Si olvidó tomar Cleboril

No tome una dosis doble para compensar las dosis olvidadas.

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.

Los siguientes efectos adversos han sido notificados en ensayos clínicos y durante la experiencia poscomercialización:

Efectos adversos raros (pueden afectar hasta 1 de cada 1.000 pacientes)

  • Alteraciones del tono muscular, de la postura y aparición de movimientos involuntarios (trastornos extrapiramidales)
  • Parkinsonismo
  • Movimientos involuntarios anormales (distonías, notificadas con más frecuencia en cuello, lengua o cara; discinesia; discinesia tardía, en pacientes de edad avanzada tras tratamientos prolongados).
  • Sedación
  • Temblor
  • Somnolencia

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

  • Aumento de los niveles de prolactina en sangre (hiperprolactinemia)
  • Secreción de leche fuera del periodo de lactancia (galactorrea)
  • Aumento del tamaño de las mamas en el varón (ginecomastia)
  • Dificultad para lograr o mantener una erección (disfunción eréctil)
  • Ausencia de menstruación (amenorrea)

Estos efectos adversos han sido notificados tras tratamientos prolongados

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 Cleboril

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

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. 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 Cleboril

  • El principio activo es cleboprida. Cada comprimido contiene 500 microgramos de cleboprida (como cleboprida malato).
  • Los demás componentes (excipientes) son lactosa anhidra, povidona, celulosa microcristalina, carboximetilalmidón sódico (procedente de patata), sílice coloidal y estearato de magnesio.

Aspecto del producto y contenido del envase

Cleboril se presenta en forma de comprimidos de color blanco, planos, circulares y ranurados, en envases blíster de PVC/Aluminio, que contienen 30 o 60 comprimidos.

Titular de la autorización de comercialización y responsable de la fabricación

Titular de la autorización de comercialización

Almirall, S.A.

General Mitre, 151

08022 – Barcelona

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:noviembre 2023

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 CLEBORIL 500 micrograms tablets, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

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Family medicine 13 years exp.

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Family medicine 13 years exp.

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General medicine 6 years exp.

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Frequently Asked Questions

Is a prescription required for CLEBORIL 500 micrograms tablets?
CLEBORIL 500 micrograms 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 CLEBORIL 500 micrograms tablets?
The active ingredient in CLEBORIL 500 micrograms tablets is clebopride. This information helps identify medicines with the same composition but different brand names.
How much does CLEBORIL 500 micrograms tablets cost in pharmacies?
The average pharmacy price for CLEBORIL 500 micrograms tablets is around 3.33 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures CLEBORIL 500 micrograms tablets?
CLEBORIL 500 micrograms tablets is manufactured by Almirall S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of CLEBORIL 500 micrograms 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 CLEBORIL 500 micrograms 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 CLEBORIL 500 micrograms tablets?
Other medicines with the same active substance (clebopride) include CLEBORIL 100 micrograms/ml ORAL SOLUTION, CLEBORIL PEDIATRIC 62.5 micrograms oral drops in solution, FLATORIL 500 micrograms/200 mg HARD CAPSULES. 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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