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PALONOSETRON SALA 250 micrograms Injectable Solution

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About the medicine

How to use PALONOSETRON SALA 250 micrograms Injectable Solution

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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

Palonosetron Sala 250 microgramos solución inyectable EFG

Lea todo el prospecto detenidamente antes deque le administreneste 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, farmacéutico o enfermero.
  • 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, farmacéutico o enfermero, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.

Contenido del prospecto

  1. Qué es Palonosetron Sala y para qué se utiliza
  2. Qué necesita saber antes de que le administren Palonosetron Sala
  3. Cómo le administrarán Palonosetron Sala
  4. Posibles efectos adversos
  5. Conservación de Palonosetron Sala
  6. Contenido del envase e información adicional

1. Qué es Palonosetron Sala y para qué se utiliza

Palonosetron Sala contiene el principio activo palonosetrón, que pertenece a un grupo de medicamentos denominados «antagonistas de la serotonina (5HT3)».

Palonosetron Sala se utiliza en adultos, adolescentes y niños mayores de 1 mes de edad para frenar el malestar general (náuseas y vómitos) cuando reciben tratamientos para el cáncer conocidos como quimioterapia.

Este medicamento actúa bloqueando la acción de una sustancia química llamada serotonina, que puede producirle náuseas o vómitos.

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 que le administren Palonosetron Sala

No tome Palonosetron Sala:

  • si es alérgico a palonosetrón o a cualquiera de los demás componentes de este medicamento (incluidos en la sección 6).

No le administrarán Palonosetron Sala si lo anterior aplica en su caso. En caso de duda, consulte a su médico, farmacéutico o enfermero antes de que le administren este medicamento.

Advertencias y precauciones

Consulte a su médico, farmacéutico o enfermero antes de que le administren Palonosetron Sala si:

  • tiene un bloqueo en el intestino o ha tenido estreñimiento repetido en el pasado;
  • ha tenido problemas de corazón o tiene antecedentes familiares de problemas de corazón, tales como cambios en el latido cardíaco («prolongación del intervalo QT»);
  • tiene un desequilibrio de ciertos minerales en la sangre que no se ha tratado, tales como el potasio y el magnesio.

Si alguno de los puntos anteriores aplica en su caso (o si tiene dudas), consulte a su médico o enfermero antes de que le administren este medicamento.

Otros medicamentos y Palonosetron Sala

Informe a su médico, farmacéutico o enfermero si está tomando, ha tomado recientemente o pudiera tener que tomar cualquier otro medicamento. En concreto, infórmeles si está tomando los siguientes medicamentos:

Medicamentos para la depresión o la ansiedad

Informe a su médico o enfermero si está tomando algún medicamento para la depresión o la ansiedad, incluidos:

  • los medicamentos llamados SSRI («inhibidores selectivos de la recaptación de serotonina»), como fluoxetina, paroxetina, sertralina, fluvoxamina, citalopram y escitalopram;
  • los medicamentos llamados SNRI («inhibidores de la recaptación de serotonina y noradrenalina»), como venlafaxina y duloxetina (pueden dar lugar al desarrollo del síndrome serotoninérgico y se deben utilizar con precaución).

Medicamentos que pueden afectar a su latido cardíaco

Informe a su médico, farmacéutico o enfermero si está tomando algún medicamento que afecte a su latido cardíaco. Esto se debe a que estos medicamentos pueden causar problemas en el latido cardíaco cuando se toman con Palonosetron Sala. Estos medicamentos son:

  • los medicamentos para los problemas de corazón, como amiodarona, nicardipino y quinidina;
  • los medicamentos para las infecciones, como moxifloxacino y eritromicina;
  • los medicamentos para los problemas graves de salud mental, como haloperidol, clorpromazina, quetiapina y tioridazina;
  • un medicamento para tratar el malestar general (náuseas y vómitos) llamado domperidona.

Si alguno de los puntos anteriores aplica en su caso (o si tiene dudas), consulte a su médico o enfermero antes de que le administren Palonosetron Sala. Esto se debe a que estos medicamentos pueden causar problemas en el latido cardiaco cuando se toman con Palonosetron Sala.

Embarazo

Si está embarazada o cree que podría estar embarazada, el médico no le administrará Palonosetron Sala a menos que sea claramente necesario. Esto se debe a que no sabemos si Palonosetron Sala es perjudicial para el niño.

Consulte a su médico, farmacéutico o enfermero antes de que le administren este medicamento si está embarazada o cree que podría estar embarazada.

Lactancia

Se desconoce si Palonosetron Sala se encuentra en la leche materna.

Consulte a su médico, farmacéutico o enfermero antes de que le administren este medicamento si está en período de lactancia.

Conducción y uso de máquinas

Puede sentir mareos o cansancio después de que le administren este medicamento. Si le ocurre esto, no conduzca ni utilice herramientas o máquinas.

Palonosetron Sala contiene sodio

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

3. Cómo le administrarán Palonosetron Sala

Un médico o un enfermero le administrarán normalmente Palonosetron Sala.

  • Le administrarán el medicamento unos 30 minutos antes del inicio de la quimioterapia.

Adultos

  • La dosis recomendada de Palonosetron Sala es de 250 microgramos.
  • Se administra en forma de una inyección en una vena.

Niños y adolescentes (desde 1 mes hasta 17 años de edad)

  • El médico calculará la dosis en función del peso corporal.
  • La dosis máxima es de 1500 microgramos.
  • Palonosetron Sala se administrará en forma de goteo (una perfusión lenta en una vena).

No se recomienda que le administren Palonosetron Sala en los días siguientes a la quimioterapia a menos que vaya a recibir otro ciclo de quimioterapia.

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

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.

Pueden producirse los siguientes efectos adversos con este medicamento:

Efectos adversos graves

Informe a su médico de inmediato si observa alguno de los siguientes efectos adversos graves:

  • reacción alérgica: los signos pueden incluir hinchazón de labios, cara, lengua o garganta, dificultad respiratoria o desmayo, erupción cutánea con picor y ronchas (urticaria). Esta reacción es muy rara: puede afectar hasta 1 de cada 10.000 personas.

Informe a su médico de inmediato si observa alguno de los efectos adversos graves mencionados anteriormente.

Otros efectos adversos

Informe a su médico si observa alguno de los siguientes efectos adversos:

Adultos

Frecuentes:pueden afectar hasta 1 de cada 10 personas

  • dolor de cabeza, mareos;
  • estreñimiento, diarrea.

Poco frecuentes:pueden afectar hasta 1 de cada 100 personas

  • cambio en el color de la vena y venas que se agrandan;
  • estar más feliz de lo normal o sensación de ansiedad;
  • somnolencia o problemas para dormir;
  • disminución o pérdida de apetito;
  • debilidad, cansancio, fiebre o síntomas seudogripales;
  • entumecimiento, quemazón, picor o sensación de hormigueo en la piel;
  • erupción cutánea con picor;
  • alteración de la vista o irritación ocular;
  • enfermedad del movimiento;
  • zumbido en los oídos;
  • hipo, gases (flatulencia), sequedad de boca o dispepsia;
  • dolor abdominal (del estómago);
  • dificultad para orinar;
  • dolor articular.

Informe a su médico si observa alguno de los efectos adversos mencionados anteriormente.

Efectos adversos poco frecuentes observados en las pruebas:pueden afectar hasta 1 de cada 100 personas

  • tensión arterial alta o baja;
  • latido cardiaco anormal o falta de flujo sanguíneo al corazón;
  • niveles anormalmente altos o bajos de potasio en sangre;
  • niveles altos de azúcar en sangre o azúcar en orina;
  • niveles bajos de calcio en sangre;
  • niveles altos de bilirrubina en sangre;
  • niveles altos de ciertas enzimas hepáticas;
  • anomalías en el electrocardiograma («prolongación del intervalo QT»).

Muy raros: pueden afectar hasta 1 de cada 10.000 personas

  • quemazón, dolor o enrojecimiento en la zona de inyección.

Niños y jóvenes

Frecuentes:pueden afectar hasta 1 de cada 10 personas

  • dolor de cabeza

Poco frecuentes:pueden afectar hasta 1 de cada 100 personas

  • mareos;
  • movimientos espasmódicos;
  • latido cardíaco anormal;
  • tos o falta de aliento;
  • sangrado nasal;
  • erupción cutánea con picor o urticaria;
  • fiebre;
  • dolor en el lugar de administración de la perfusión.

Informe a su médico si observa alguno de los efectos adversos mencionados anteriormente.

Comunicación de efectos adversos

Si experimenta cualquier tipo de efecto adverso, consulte a su médico, 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.

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5. Conservación de Palonosetron Sala

  • Mantener este medicamento fuera de la vista y del alcance de los niños.
  • No utilice este medicamento después de la fecha de caducidad que aparece en el vial y la caja después de CAD. La fecha de caducidad es el último día del mes que se indica.
  • No requiere condiciones especiales de conservación.
  • Para un solo uso, deberá eliminarse cualquier resto de la solución sin utilizar.

6. Contenido del envase e información adicional / Información adicional

Composición de Palonosetron Sala

  • El principio activo es palonosetrón (como clorhidrato). Cada ml de solución contiene 50 microgramos de palonosetrón. Cada vial de 5 ml de solución contiene 250 microgramos de palonosetrón.
  • Los demás componentes son manitol, edetato de disodio (dihidrato), citrato de sodio (dihidrato), ácido cítrico monohidrato y agua para inyectables.

Aspecto del producto y contenido del envase

Palonosetron Sala solución inyectable es una solución transparente e incolora y se presenta en un envase de un vial de cristal de tipo I con tapón de caucho de clorobutilo siliconizado y cápsula de aluminio, que contiene 5 ml de la solución. Cada vial contiene una dosis.

Se presenta en envases de 1 vial que contiene 5 ml de solución.

Titular de la autorización de comercialización yResponsable de la fabricación:

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

España

Fecha de la última revisión de este prospecto: Febrero 2022

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

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General medicine 2 years exp.

Dr. Rita Isabel Calero Garcia is a physician with extensive experience in emergency medical care, general medicine, and healthcare assistance in various clinical and out-of-hospital settings.

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Alina Tsurkan

Family medicine 13 years exp.

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Frequently Asked Questions

Is a prescription required for PALONOSETRON SALA 250 micrograms Injectable Solution?

PALONOSETRON SALA 250 micrograms Injectable Solution 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 PALONOSETRON SALA 250 micrograms Injectable Solution?

The active ingredient in PALONOSETRON SALA 250 micrograms Injectable Solution is palonosetron. This information helps identify medicines with the same composition but different brand names.

Who manufactures PALONOSETRON SALA 250 micrograms Injectable Solution?

PALONOSETRON SALA 250 micrograms Injectable Solution is manufactured by Laboratorio Reig Jofre, S.A.. Pharmacy brands and packaging may differ depending on the distributor.

Which doctors can assess the use of PALONOSETRON SALA 250 micrograms Injectable Solution 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 PALONOSETRON SALA 250 micrograms Injectable Solution is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.

How to buy PALONOSETRON SALA 250 micrograms Injectable Solution in Spain?

Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.

You can buy PALONOSETRON SALA 250 micrograms Injectable Solution in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.

To obtain a prescription, you can use Oladoctor:

What are the alternatives to PALONOSETRON SALA 250 micrograms Injectable Solution?

Other medicines with the same active substance (palonosetron) include ALOXI 250 micrograms INJECTABLE SOLUTION, FERANT 250 micrograms injectable solution, PALONOSETRON ACCORD 250 micrograms Injectable 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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