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ETALPHA 2 micrograms/ml ORAL DROPS IN SOLUTION

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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 ETALPHA 2 micrograms/ml ORAL DROPS IN SOLUTION

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

Etalpha2 microgramos/ml gotas orales en solución

alfacalcidol

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

1. Qué es Etalpha y para qué se utiliza

Etalpha pertenece a un grupo de medicamentos llamados análogos de la vitamina D que regulan los niveles de calcio y fósforo en su organismo.

El principio activo de Etalpha es alfacalcidol, una forma de la vitamina D.

Alfacalcidol ejerce su acción al ser transformado en calcitriol (forma activa de la vitamina D) en el hígado.

El medicamento está indicado en situaciones en las que existe una alteración del metabolismo del calcio y del fósforo debida a una producción reducida de 1,25-dihidroxivitamina D.

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 Etalpha

No tome Etalpha

  • si es alérgico al alfacalcidol o a alguno de los demás componentes de este medicamento (incluidos en la sección 6).
  • si tiene elevados los niveles de calcio en sangre (hipercalcemia).

Como durante el tratamiento con Etalpha pueden aparecer niveles elevados de calcio en sangre (hipercalcemia), debe conocer los siguientes signos y síntomas de la hipercalcemia:

  • falta de apetito (anorexia)
  • fatiga
  • náuseas
  • vómitos
  • estreñimiento o diarrea
  • incremento de la producción de orina
  • sudoración
  • dolor de cabeza
  • sed
  • tensión arterial elevada
  • somnolencia
  • vértigo

Advertencias y precauciones

Consulte a su médico o farmacéutico antes de empezar a tomar Etalpha.

Tenga especial cuidado con Etalpha si:

  • tiene arteriosclerosis, esclerosis de las válvulas cardíacas o piedras en el riñón (nefrolitiasis). Estas afecciones pueden agravarse si tiene niveles elevados de calcio en su sangre (hipercalcemia).
  • sufre calcificación del tejido pulmonar.
  • padece enfermedad ósea renal o alguna alteración en los riñones. Para mantener un nivel en suero aceptable de fósforo, pueden emplearse quelantes de fósforo.
  • padece enfermedades inflamatorias como sarcoidosis. Estas afecciones tienen un potencial de incrementar la sensibilidad a Etalpha.
  • está siendo tratado con medicamentos para su corazón (glucósidos cardiacos). Si el nivel de calcio en su sangre aumenta demasiado (hipercalcemia), el empleo de estos medicamentos puede causar alteraciones en su ritmo cardiaco.

Durante el tratamiento, su médico le realizará análisis de sangre a fin de controlar los niveles de calcio y fósforo.

Uso de Etalpha con otros medicamentos

Informe a su médico o farmacéutico si está utilizando, ha utilizado recientemente o pudiera tener que utilizar cualquier otro medicamento.

Es importante que informe a su médico si:

  • está siendo tratado con diuréticos, preparados que contienen calcio u otros preparados que contienen vitamina D, pues éstos pueden incrementar el riesgo de elevación de los niveles de calcio en su sangre (hipercalcemia).
  • está siendo tratado con medicamentos contra las crisis epilépticas (barbitúricos, fenitoína, carbamacepina o primidona). Puede precisar una dosis superior de Etalpha.
  • está tomando antiácidos que contienen magnesio, ya que pueden aumentar el riesgo de niveles elevados de magnesio en su sangre (hipermagnesemia).
  • está siendo tratado con preparados que contienen aluminio (como hidróxido de aluminio o sucralfato), ya que puede aumentar la absorción de aluminio.
  • está tomando quelantes de las sales biliares como colestiramina al mismo tiempo que Etalpha, puesto que puede alterar la absorción intestinal de Etalpha. Con el fin de disminuir la posibilidad de interferencia, alfacalcidol debe administrarse al menos 1 hora antes o 4-6 horas después de la ingesta de quelantes de las sales biliares.

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.

Etalpha podrá emplearse durante el embarazo y la lactancia sólo cuando su médico lo considere esencial.

Consulte a su médico o farmacéutico antes de utilizar cualquier medicamento.

Conducción y uso de máquinas

La influencia de Etalpha sobre la capacidad para conducir y utilizar máquinas es nula o insignificante.

Sin embargo, puede producirse mareo durante el tratamiento, lo que debe tener en cuenta si conduce o utiliza máquinas.

Etalpha contiene etanol, sorbitol, hidroxiestearato de macrogolglicerol y parahidroxibenzoato de metilo

Este medicamento contiene hasta 113 mg de alcohol (etanol) en cada dosis (correspondiente a 2

microgramos de alfacalcidol), que equivale a un 14 % de etanol (alcohol). La cantidad en cada dosis de este medicamento es equivalente a menosde 3 ml de cerveza o 1,5 ml de vino.

La pequeña cantidad de alcohol que contiene este medicamento no produce ningún efecto

perceptible .

Este medicamento contiene 452 mg de sorbitol en cada ml, equivalente a 6,5 mg sorbitol/kg/día para un adulto (70 kg). El sorbitol es una fuente de fructosa. Si su médico le ha indicado que usted (o su hijo) padecen una intolerancia a ciertos azúcares, o se les ha diagnosticado intolerancia hereditaria a la fructosa (IHF), una enfermedad genética rara, en la que el paciente no puede descomponer la fructosa, consulte usted (o su hijo) con su médico antes de tomar este medicamento.

Este medicamento puede producir molestias de estómago y diarrea porque contiene hidroxiestearato de macrogolglicerol.

Puede producir reacciones alérgicas (posiblemente retardadas) porque contiene parahidroxibenzoato de metilo.

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

3. Cómo tomar Etalpha

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.

1 ml o 20 gotas de Etalpha gotas orales en solución equivalen a 2 microgramos de alfacalcidol (1 gota equivale a 0,1 microgramo de alfacalcidol).

Adultos y niños de más de 20 kg de peso:

La dosis inicial es de 1 microgramo (0,5 ml) al día, es decir 10 gotas al día.

Niños de menos de 20 kg de peso:

La dosis inicial es de 0,05 microgramos por kg de peso al día.

La dosis de mantenimiento está generalmente comprendida entre 0,25 y 1 microgramo al día.

Su médico puede ajustar estas dosis de acuerdo a sus necesidades. Para ello su médico le realizará determinaciones en sangre o podrá solicitarle otras pruebas diagnósticas.

Si toma más Etalpha del que debe

Si ha tomado demasiado Etalpha, debe contactar con su médico o farmacéutico.

Una sobredosis puede dar lugar a una elevada cantidad de calcio en su sangre y orina. Por tanto, el médico puede necesitar realizarle los análisis oportunos.

En caso de sobredosis o ingestión accidental consulte al Servicio de Información Toxicológica, teléfono 91 562 04 20, indicando el medicamento y la cantidad utilizada.

Si olvidó tomar Etalpha

No tome una dosis doble para compensar las dosis olvidadas. Continúe según la posología prescrita.

Si interrumpe el tratamiento con Etalpha

Su médico le indicará la duración de su tratamiento con Etalpha. No suspenda el tratamiento antes, ya que puede ser perjudicial para su salud.

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.

Efectos adversos frecuentes (pueden afectar hasta 1 de cada 10 pacientes):

  • niveles elevados de calcio en sangre
  • cantidad excesiva de fósforo en sangre
  • dolor y malestar abdominal
  • erupción cutánea
  • picor
  • exceso de calcio en orina

Efectos adversos poco frecuentes (pueden afectar hasta 1 de cada 100 pacientes):

  • confusión
  • dolor de cabeza
  • diarrea
  • vómitos
  • estreñimiento
  • náuseas
  • dolor muscular
  • empeoramiento de la función renal (incluyendo insuficiencia renal aguda)
  • piedras en el riñón
  • depósitos de calcio en los riñones
  • fatiga
  • cansancio
  • malestar
  • depósitos de calcio en tejidos no óseos

Efectos adversos raros (pueden afectar hasta 1 de cada 1000 pacientes):

  • mareo

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 Etalpha

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

Conservar en nevera (entre 2ºC y 8ºC).

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 Etalpha

  • El principio activo es alfacalcidol.

Un ml de solución (20 gotas) contiene 2 microgramos de alfacalcidol.

  • Los demás componentes son sorbitol (E-420), etanol, hidroxiestearato de macrogolglicerol, citrato de sodio, parahidroxibenzoato de metilo (E-218), ácido cítrico monohidrato, todo-rac-α-tocoferol y agua purificada.

Aspecto del producto y contenido del envase

Solución incolora, transparente o ligeramente opalescente.

Etalpha gotas orales en solución se presenta en un frasco de vidrio ámbar de 10 ml con gotero dosificador.

Titular de la autorización de comercialización

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Alemania

Representante local

Laboratorios Rubió, S.A.

Industria, 29 – Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

España

Responsable de la fabricación

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Dinamarca

Fecha de la última revisión de este prospecto: Enero 2022

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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General medicine 21 years exp.

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Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

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Lina Travkina

Family medicine 13 years exp.

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Family medicine 13 years exp.

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Yevgen Yakovenko

General surgery 12 years exp.

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Frequently Asked Questions

Is a prescription required for ETALPHA 2 micrograms/ml ORAL DROPS IN SOLUTION?
ETALPHA 2 micrograms/ml ORAL DROPS IN 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 ETALPHA 2 micrograms/ml ORAL DROPS IN SOLUTION?
The active ingredient in ETALPHA 2 micrograms/ml ORAL DROPS IN SOLUTION is alfacalcidol. This information helps identify medicines with the same composition but different brand names.
Who manufactures ETALPHA 2 micrograms/ml ORAL DROPS IN SOLUTION?
ETALPHA 2 micrograms/ml ORAL DROPS IN SOLUTION is manufactured by Cheplapharm Arzneimittel Gmbh. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of ETALPHA 2 micrograms/ml ORAL DROPS IN 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 ETALPHA 2 micrograms/ml ORAL DROPS IN SOLUTION 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 ETALPHA 2 micrograms/ml ORAL DROPS IN SOLUTION?
Other medicines with the same active substance (alfacalcidol) include ETALPHA 1 microgram INJECTABLE SOLUTION, ETALPHA 2 micrograms INJECTABLE SOLUTION, ALDEXINA 25,000 IU 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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