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METOXALENE G.L. PHARMA 20 micrograms/ml SOLUTION FOR MODIFICATION OF BLOOD FRACTIONS

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About the medicine

How to use METOXALENE G.L. PHARMA 20 micrograms/ml SOLUTION FOR MODIFICATION OF BLOOD FRACTIONS

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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 paciente

Metoxaleno G. L. Pharma 20 microgramos/ml solución para modificación de las fracciones sanguíneas

Lea todo el prospecto detenidamente antes de empezar a usar 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.
  • 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 Metoxaleno G. L. Pharma y para qué se utiliza
  2. Qué necesita saber antes de empezar a usar Metoxaleno G. L. Pharma
  3. Cómo usar Metoxaleno G. L. Pharma
  4. Posibles efectos adversos
  5. Conservación de Metoxaleno G. L. Pharma
  6. Contenido del envase e información adicional

1. Qué es Metoxaleno G. L. Pharma y para qué se utiliza

El principio activo de Metoxaleno G. L. Pharma es metoxaleno, un medicamento que se activa por la radiación UV.

El metoxaleno se adhiere a sus leucocitos fuera del cuerpo y se activa por luz ultravioleta (luz UV de onda larga). Los leucocitos luego se devuelven a su cuerpo. Este proceso se llama fotoféresis. Como resultado de este proceso, los leucocitos enfermos pueden ser destruidos.

Metoxaleno G. L. Pharma se utiliza para aliviar los síntomas cutáneos del linfoma cutáneo de células T en estadío avanzado (un tumor que ocurre en la piel y que es causado por leucocitos específicos, conocidos como linfocitos T) cuando otros tratamientos no han sido eficaces.

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2. Qué necesita saber antes de empezar a usar Metoxaleno G. L. Pharma

No use Metoxaleno G. L. Pharma:

  • si es alérgico a metoxaleno, sustancias relacionadas (psoralenos) o a alguno de los demás componentes de este medicamento (incluidos en la sección 6)
  • si tiene cáncer de piel (por ejemplo melanoma o basalioma)
  • si tiene una enfermedad asociada con una mayor sensibilidad a la luz, como porfiria, lupus eritematoso sistémico o albinismo
  • si es sexualmente activo y está en edad de procrear y aún no ha tomado ninguna medida anticonceptiva
  • si le han extraido el cristalino
  • si está embarazada o en periodo de lactancia

No debe utilizarse el procedimiento de fotoféresis:

  • si su cuerpo no puede tolerar la pérdida temporal de sangre causada por el tratamiento, por ejemplo, debido a enfermedades del corazón o a anemia severa.
  • i le han extraído el bazo.
  • si tiene un trastorno de coagulación sanguínea.
  • si tiene un número elevado de leucocitos (más de 25.000 por mm3).

Advertencias y precauciones

Consulte a su médico antes de empezar a usar Metoxaleno G. L. Pharma.

  • Si normalmente toma medicamentos que disminuyen la presión arterial alta, debe esperar hasta el final del tratamiento con fotoféresis antes de volver a tomarlos.
  • Para asegurarse de que el procedimiento de fotoféresis se puede llevar a cabo de manera eficaz, el nivel de triglicéridos (un determinado componente de la grasa) en la sangre debe ser lo más bajo posible. Por lo tanto, su médico le indicará que ayune antes de cada tratamiento.
  • Durante el tratamiento con Metoxaleno G. L. Pharma, los hombres y mujeres sexualmente activos y en edad fértil deben utilizar un método anticonceptivo adecuado.
  • Si tiene problemas de hígado, su médico puede tomar medidas para controlar los valores de su hígado.

Notas importantes para prevenir daños en la piel y en los ojos

Metoxaleno G. L. Pharma hará que su piel sea más sensible a la luz solar y a la luz artificial parecida al sol. Como la cantidad de medicamento utilizado en el tratamiento con fotoféresis es muy baja, es poco probable que ocurra este efecto adverso. Sin embargo, para minimizar el riesgo de efectos adversos, especialmente en los ojos y la piel, no debe exponerse a la luz solar durante las primeras 24 horas después del tratamiento con fotoféresis.

Durante el tratamiento con Metoxaleno G. L. Pharma y las 24 horas posteriores debe usar gafas de sol especiales (que impidan el paso de los rayos UVA ) para evitar que la luz dañe sus ojos.

Informe a su médico si tiene problemas con su función hepática, ya que puede que tenga que continuar con estas precauciones contra la exposición solar durante un período más largo.

Niños y adolescentes (menores de 18 años)

Metoxaleno G. L. Pharma no se debe usar en niños y adolescentes ya que no hay suficiente experiencia disponible para este grupo de edad.

Uso de Metoxaleno G. L. Pharma con otros medicamentos

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

Fenitoína (un medicamento utilizado para tratar las convulsiones) puede conducir a una eliminación más rápida de Metoxaleno G. L. Pharma del cuerpo y por lo tanto a reducir la eficacia del tratamiento con fotoféresis.

El efecto de Metoxaleno G. L. Pharma está influenciado por sustancias que también pueden destruir células o aumentar la sensibilidad a la luz. Éstas incluyen:

  • otros medicamentos utilizados para tratar enfermedades de la piel (por ejemplo, antralina, alquitrán de hulla, griseofulvina, retinoides).
  • diversos antibióticos (por ejemplo tetraciclinas, fluoroquinolonas) y agentes quimioterapéuticos (por ejemplo ácido nalidíxico, sulfonamidas).
  • medicamentos utilizados para tratar la diabetes (sulfonilureas, en particular tolbutamida)
  • diuréticos («comprimidos de agua», por ejemplo tiazidas, furosemida).
  • medicamentos con efecto calmante y/o sedante (fenotiazinas).
  • ciertos medicamentos que afectan la coagulación de la sangre (anticoagulantes orales derivados de cumarina, derivados de salicilanilida halogenados).
  • colorantes (por ejemplo, azul de metileno/toluidina, rosa de bengala, naranja de metilo)
  • medicamentos que contengan cafeína.

Uso de Metoxaleno G. L. Pharma con bebidas y alcohol

Debe evitar tomar café o té durante el tratamiento con Metoxaleno G. L. Pharma. Las sustancias presentes en estos alimentos (cafeína, teofilina) pueden prolongar la duración de la sensibilidad a la luz.

Debe evitar el alcohol durante el tratamiento con Metoxaleno G. L. Pharma porque los efectos del etanol (alcohol) contenido en Metoxaleno G. L. Pharma pueden aumentar con otros medicamentos tomados al mismo tiempo.

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.

Metoxaleno G. L. Pharma no debe usarse durante el embarazo y la lactancia.

Si usted es sexualmente activo y está en edad de procrear, debe usar métodos anticonceptivos apropiados durante el tratamiento con Metoxaleno G. L. Pharma, porque el principio activo metoxaleno puede provocar lesiones en los niños concebidos durante el tratamiento con Metoxaleno G. L. Pharma.

Conducción y uso de máquinas

Advertencia: este medicamento puede afectar la reactividad y la capacidad de conducir.

No debe conducir ni utilizar máquinas inmediatamente después del tratamiento.

Metoxaleno G. L. Pharma contiene etanol 96% (alcohol)

Este medicamento contiene 10,4% de etanol (alcohol), esta pequeña cantidad se corresponde con 10,4 mg/ampolla.

Metoxaleno G. L. Pharma contiene pequeñas cantidades de etanol (alcohol), menos de 100 mg por mililitro. En la terapia extracorpórea se puede esperar que los efectos generales sobre su cuerpo sean limitados. Sin embargo, el médico que le prescribe le vigilará para detectar posibles interacciones con otros medicamentos. Se requiere precaución especial en pacientes con trastornos hepáticos, alcoholismo, epilepsia, lesión cerebral o enfermedad cerebral.

Metoxaleno G. L. Pharma contiene sodio

Este medicamento contiene menos de 23 mg (1 mmol) de sodio por mililitro, por lο que se considera esencialmente "exento de sodio".

3. Cómo usar Metoxaleno G. L. Pharma

Este medicamento siempre lo administra un medico especialista que está completamente familiarizado con el manejo de Metoxaleno G. L. Pharma. Su médico decidirá cuántas sesiones de tratamiento necesita usted.

Método de administración

Uso extracorporal (es decir, fuera del cuerpo del paciente).

El contenido de la ampolla nunca se inyecta directamente en el paciente.

Un profesional especialmente entrenado en la administración de fotoféresis usará una aguja para extraer una pequeña cantidad de sangre de una de sus venas. Esta sangre se separa en hematíes, leucocitos y plasma. Los hematíes y la mayor parte del plasma se devuelven a la circulación sanguínea durante el procedimiento. Los leucocitos y el resto del plasma se mezclarán con una dosis de Metoxaleno G. L. Pharma calculada individualmente para usted, se expondrá a la radiación de luz UV y luego se devolverá de nuevo a su cuerpo.

Durante la administración del tratamiento y las 24 horas posteriores debe llevar puestas todo el tiempo unas gafas de sol (que impiden el paso de los rayos UVA), para evitar que la luz dañe sus ojos provocando la formación de cataratas.

Duración del tratamiento

Durante los primeros 3 meses se recomienda tratar a los pacientes 2 días seguidos cada 2 a 4 semanas. Posteriormente, los ciclos de tratamiento de 2 días suelen tener lugar una vez cada 3 a 4 semanas. En el momento de la mejor respuesta al tratamiento, los intervalos se irán ampliando lentamente a 4 a 8 semanas y el tratamiento se continuará después cada 8 semanas.

La fotoféresis debe realizarse durante al menos 6 meses.

Si responde bien al tratamiento o si su enfermedad no empeora, la fotoféresis se debe continuar durante 2 años o más.

Si usted no responde al tratamiento solo de fotoféresis, su médico puede recomendarle otro medicamento adiccional (por ejemplo, interferón y/o bexaroteno).

Esto es una guía general. Su médico puede adaptar el ciclo de tratamiento de acuerdo a los síntomas individuales y a la respuesta.

El procedimiento dura de tres a cuatro horas en total, desde el momento en que su médico coloca la aguja hasta el momento en que todos los componentes de su sangre le han sido devueltos.

Pacientes con insuficiencia hepática o renal

Si tiene problemas de hígado o riñón, su médico probablemente revisará su recuento de células sanguíneas regularmente; Metoxaleno G. L. Pharma no ha sido probado clínicamente en pacientes con insuficiencia renal o hepática.

Después del tratamiento

Después de recibir el tratamiento debe evitar la luz del sol directa durante al menos 24 horas porque podría dañarle la piel al provocar quemaduras solares o envejecimiento prematuro de la piel a largo plazo. Si tiene que salir al exterior, debe cubrirse la piel, usar un producto con filtro de protección solar alto y ponerse gafas de sol especiales (consulte más arriba).

Si usa más Metoxaleno G. L. Pharma del que debe

Es improbable una sobredosis. Sin embargo, si le administran una sobredosis, tendrá que permanecer en una sala oscura durante 24 horas o más como parte de su tratamiento.

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

Medicine questions

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4. Posibles efectos adversos

Al igual que todos los medicamentos, este medicamento puede producir efectos adversos, aunque no todas las personas los sufran.

Se ha informado de los siguientes efectos adversos:

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

  • infecciones.
  • presión arterial baja, mareos.
  • náuseas vómitos.
  • complicaciones en el acceso a la vena después del acceso repetido a las venas (venopunción).

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

  • cambios en el ojo como resultado de la exposición a la luz (reacciones fototóxicas), tales como opacificación del cristalino (formación de cataratas) e inflamación de la capa media del ojo (coroides) con posterior inflamación de la retina (coriorretinitis).
  • cambios en la piel debido a la exposición a la luz (reacciones fototóxicas) como picazón o enrojecimiento.
  • fiebre (puede aparecer fiebre leve entre las 2 y 12 horas después del tratamiento).

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 Metoxaleno G. L. Pharma

Conservar en el embalaje original para protegerlo de la luz.

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

6. Contenido del envase e información adicional

Composición de Metoxaleno G. L. Pharma

  • El principio activo es metoxaleno. Una ampolla de 5 ml contiene 100 microgramos (μg) de metoxaleno. Un ml de solución contiene 20 microgramos de metoxaleno.
  • Los demás componentes son: cloruro de sodio, etanol al 96%, agua para preparaciones inyectables.

Aspecto del producto y contenido del envase

Solución transparente e incolora.

La solución tiene un valor de pH de 5,0 a 7,0.

Ampollas de vidrio ámbar de 5 ml.

Tamaño de los envases: envases de 5, 25, 50 ampollas y envase múltiple de 5 cajas con 25 ampollas cada una.

Es posible que no se comercialicen todos los tamaños de envase.

Titular de la autorización de comercialización y responsable de la fabricación

G.L. Pharma GmbH,

Schlossplatz 1, 8502

Lannach, Austria

Representante Local

Waas-Anita, S.A.

C/ General Prim, 13

28035 Madrid

España

Este medicamento está autorizado en los Estados miembros del EEA con los siguientes nombres:

Austria: Oxsoralen 20 µg/ml-Lösung zur Modifikation einer Blutfraktion

Alemania: Methoxsalen G.L. Pharma 20 µg/ml Lösung zur Modifikation einer Blutfraktion

Italia: Metoxsalene G.L. Pharma 20 µg/ml soluzione per la modifica di frazione ematica

Reino Unido: Methoxsalen G.L. Pharma 20 µg/ml solution for blood fraction modification

Fecha de la última revisión de este prospecto: Julio 2017

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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Dermatology 21 years exp.

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Daniel Cichi

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Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance. His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation. Patients commonly consult Dr Daniel Cichi for: 

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Andreea Mateescu

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Chikeluo Okeke

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Dr Chikeluo Okeke is an internal medicine doctor with extensive international clinical experience. Originally from Nigeria, he has worked across multiple European healthcare systems and currently practises in Sweden. This professional path has given him a strong understanding of different medical approaches and the ability to work effectively with patients from diverse cultural and linguistic backgrounds.

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Yevgen Yakovenko

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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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  • 12+ years of clinical experience in university hospitals in Germany and Spain.
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Joao Silva

General medicine 6 years exp.

Dr. João Silva is a physician with training and experience in the field of General and Family Medicine, dedicated to providing healthcare focused on the well-being and quality of life of his patients. Throughout his professional career, he has developed broad clinical competencies, striving to maintain a medical practice based on scientific evidence and continuous knowledge updates.

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Lisa Drigo

Paediatrics 34 years exp.

Dr Lisa Drigo is an experienced paediatrician based in Italy with over 30 years of clinical practice. She graduated from Università Cattolica del Sacro Cuore in Rome and has spent decades working within the Italian healthcare system, supporting children and families with both acute care and long-term prevention.

She is well familiar with Italian paediatric standards, including local vaccination schedules, preventive check-ups, growth monitoring, and everyday medical issues faced by families living in Italy. This makes her consultations especially valuable for parents who want guidance that aligns with local medical practice.

Her primary focus is paediatrics, with additional support in family medicine when a child’s health needs to be assessed in a broader family or preventive context.

Patients most often consult her for:

  • Acute infections in children (fever, cough, sore throat, runny nose).
  • Viral and bacterial illnesses, frequent colds.
  • Digestive symptoms such as abdominal pain, nausea, diarrhoea or constipation.
  • Monitoring of growth, weight, and developmental milestones.
  • Vaccination advice according to Italian schedules.
  • Allergic reactions, skin rashes, food sensitivities.
  • General health concerns and everyday questions from parents.
  • Preventive care, nutrition advice, and healthy lifestyle guidance.

Dr Drigo communicates in a clear, calm, and reassuring way, helping parents understand what is happening and what steps to take next. Online consultations allow families to receive reliable paediatric guidance aligned with Italian medical practice, without unnecessary stress or waiting.

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€180
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Get METOXALENE G.L. PHARMA 20 micrograms/ml SOLUTION FOR MODIFICATION OF BLOOD FRACTIONS Prescription Online

1

Fill in a 2-min form

Tell us your symptoms, history, and what medicine you're requesting.

2

Pick a doctor or let us assign

Choose a specialist or we'll match you with the next available doctor.

3

Doctor reviews your case

Usually within 30 minutes. They may ask follow-up questions via chat.

4

Collect from any pharmacy

Electronic prescription sent to your email — valid across Spain.

Frequently Asked Questions

Is a prescription required for METOXALENE G.L. PHARMA 20 micrograms/ml SOLUTION FOR MODIFICATION OF BLOOD FRACTIONS?
METOXALENE G.L. PHARMA 20 micrograms/ml SOLUTION FOR MODIFICATION OF BLOOD FRACTIONS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
Who manufactures METOXALENE G.L. PHARMA 20 micrograms/ml SOLUTION FOR MODIFICATION OF BLOOD FRACTIONS?
METOXALENE G.L. PHARMA 20 micrograms/ml SOLUTION FOR MODIFICATION OF BLOOD FRACTIONS is manufactured by G.L. Pharma Gmbh. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of METOXALENE G.L. PHARMA 20 micrograms/ml SOLUTION FOR MODIFICATION OF BLOOD FRACTIONS 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 METOXALENE G.L. PHARMA 20 micrograms/ml SOLUTION FOR MODIFICATION OF BLOOD FRACTIONS 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 METOXALENE G.L. PHARMA 20 micrograms/ml SOLUTION FOR MODIFICATION OF BLOOD FRACTIONS?
Other medicines with the same active substance () include BEROMUN 1 mg POWDER FOR SOLUTION FOR INFUSION, CEPLENE 0.5 mg/0.5 ml INJECTABLE SOLUTION, COPAXONE 20 mg/ml INJECTABLE SOLUTION IN PRE-FILLED SYRINGE. 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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