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COLECALCIFEROL ROVI 30,000 IU FILM-COATED TABLETS

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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 COLECALCIFEROL ROVI 30,000 IU 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 usuario

Colecalciferol Rovi 30000 UI comprimidos recubiertos con película

colecalciferol (vitamina D3)

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

1. Qué es Colecalciferol Rovi y para qué se utiliza

El principio activo de Colecalciferol Rovi comprimidos recubiertos con película es la vitamina D3.

La vitamina D se puede encontrar en algunos alimentos y es producida por el organismo cuando la piel se expone a la luz solar. Su médico puede recetarle Colecalciferol Rovi para tratar la deficiencia grave de vitamina D. La deficiencia de vitamina D puede ocurrir cuando su alimentación o estilo de vida no le proporcionan suficiente vitamina D o cuando su organismo requiere más vitamina D. Colecalciferol Rovi está indicado en adultos.

Colecalciferol Rovi está indicado en adultos y personas de edad avanzada.

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 Colecalciferol Rovi

No tome Colecalciferol Rovi:

  • si es alérgico a la vitamina D o a alguno de los demás componentes de este medicamento (incluidos en la sección 6),
  • si presenta altos niveles de calcio en sangre u orina,
  • si tiene cálculos renales (piedras) o depósitos de calcio en los riñones,
  • si tiene insuficiencia renal severa,
  • si ya está tomando dosis adicionales de vitamina D (por ejemplo, multivitaminas o complementos alimenticios que contengan vitamina D).
  • si es menor de 18 años.

Advertencias y precauciones

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

  • si tiene tendencia a la formación de cálculos (piedras) en el riñón
  • si tiene cáncer o cualquier otra alteración que pueda afectar a sus huesos
  • si tiene un desequilibrio de la hormona paratiroidea (pseudohipoparatiroidismo)

Si alguna de las siguientes situaciones le afecta, su médico controlará los niveles de calcio o fosfato en sangre, o el nivel de calcio en orina:

  • Si está en tratamiento prolongado con este medicamento,
  • Si tiene problemas de riñón,
  • Si sufre “sarcoidosis”, una enfermedad del sistema inmunitario que puede afectar al hígado, pulmones, piel o ganglios linfáticos.

Uso de colecalciferol con otros medicamentos

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

En particular, informe a su médico si está tomando alguno de los siguientes medicamentos:

  • diuréticos (comprimidos para la eliminación de agua) – se controlarán regularmente sus niveles de calcio en sangre;
  • corticoesteroides (‘esteroides’ por ejemplo: prednisolona, dexametasona) – puede ser necesario aumentar su dosis de vitamina D;
  • colestiramina (medicamento para reducir el colesterol) o laxantes (por ejemplo, aceite de parafina) - reducen la absorción de vitamina D;
  • medicamentos para el corazón (glucósidos cardiacos) – debe ser monitorizado por un médico y posiblemente su ECG y los niveles de calcio en sangre, deban ser controlados;
  • anticonvulsionantes (para el tratamiento de la epilepsia), medicamentos para dormir (por ejemplo, hidantoína, barbitúricos) o primidona – éstos reducen los efectos de la vitamina D;
  • medicamentos que contienen altas dosis de calcio: pueden aumentar el riesgo de niveles altos de calcio en sangre;
  • medicamentos que contienen altas dosis de fósforo – pueden aumentar el riesgo de niveles altos de fosfato en sangre;
  • orlistat (medicamento que ayuda a perder peso) – reduce la absorción de vitamina D.

Embarazo, lactancia y fertilidad

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.

Si está en periodo de lactancia, su médico controlará los niveles de calcio y fosfato en su sangre, o los niveles de calcio en su orina.

Conducción y uso de máquinas

No hay efectos conocidos sobre la capacidad para conducir o usar máquinas.

Colecalciferol Rovi contiene lactosa y sacarosa

Si su médico le ha indicado que padece una intolerancia a ciertos azúcares, consulte con él antes de tomar este medicamento.

3. Cómo tomar Colecalciferol Rovi

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.

Los comprimidos pueden tomarse con o sin alimentos.

Dosis

La cantidad de colecalciferol dependerá de sus niveles de vitamina D, de la gravedad de la enfermedad y de la respuesta al tratamiento.

Dosis recomendada:

1 comprimido de Colecalciferol Rovi 30000 UI a la semana. Después del primer mes, se pueden considerar dosis más bajas.

Después de este tratamiento inicial, podría ser necesario un tratamiento de mantenimiento con una dosis determinada por su médico. Además, se pueden seguir recomendaciones nacionales para el tratamiento con vitamina D.

Pacientes con problemas de riñón

Es posible que su médico establezca análisis rutinarios de sangre y/o orina.

Uso en niños

Colecalciferol Rovi no está recomendado en niños menores de 18 años.

Si toma más Colecalciferol Rovi del que debe

Puede desarrollar los siguientes síntomas: pérdida de apetito, sed, náuseas, vómitos, estreñimiento, dolor abdominal, debilidad muscular, cansancio, confusión, orinar con mayor frecuencia que la habitual, dolor en los huesos, problemas de riñón y, en casos graves, latidos cardíacos irregulares, coma o incluso la muerte.

En caso de sobredosis o ingestión accidental, consulte inmediatamente a su médico o farmacéutico o llame al Servicio de Información Toxicológica, teléfono: 91 562 04 20, indicando el medicamento y la cantidad ingerida.

Si olvidó tomar Colecalciferol Rovi

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.

Debe interrumpir la toma de colecalciferol y consultar inmediatamente con su médico si experimenta síntomas de reacciones alérgicas graves, tales como:

  • Hinchazón de la cara, labios, lengua o garganta.
  • Dificultad para tragar.
  • Urticaria y dificultad para respirar.

Poco frecuentes(afectan a 1 de cada 100 personas):

  • Exceso de calcio en sangre (hipercalcemia) – los síntomas incluyen náuseas, vómitos, pérdida de apetito, estreñimiento, dolor de estómago, dolor en los huesos, sed extrema, necesidad de beber agua con mayor frecuencia, debilidad muscular, somnolencia y confusión.
  • Exceso de calcio en orina (hipercalciuria).

Raros(afectan a 1 de cada 1.000 personas):

  • Prurito, erupción y urticaria.

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 Colecalciferol Rovi

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

Conservar por debajo de 25°C.

Conservar en su envase original, para protegerlo de la luz.

No utilice este medicamento después de la fecha de caducidad que aparece en la caja 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 deColecalciferol Rovi

El principio activo es colecalciferol (vitamina D3).

Cada comprimido recubierto con película contiene 300 mg de colecalciferol concentrado (en forma de polvo) (equivalente a 750 µg de colecalciferol = 30.000 UI de vitamina D3).

Los demás componentes son:

  • Núcleo del comprimido: cellactose 80 (lactosa monohidrato y celulosa en polvo (E-460 (ii)) almidón modificado, almidón de maíz, croscarmelosa sódica (E-468), sacarosa, sílice coloidal anhidra (E-551), sílice coloidal hidratada (E-551), estearato de magnesio (E-572), ascorbato de sodio (E-301), triglicéridos de cadena media, DL-alfa-tocoferol (E-307).
  • Recubrimiento del comprimido: Opadry II amarillo 85F 32659, formado por: alcohol polivinílico (E-1203), dióxido de titanio (E-171), macrogol, talco (E-553b), amarillo de quinoleína (E-104), óxido de hierro amarillo (E-172).

Aspecto del producto y contenido del envase

Comprimido recubierto con película, amarillo, redondo, de 13,2 mm de diámetro con una superficie convexa lisa en ambos lados.

Envase: 1, 2 o 4 comprimidos recubiertos con película en blíster opaco de PVC/PVdC- aluminio, acondicionado en caja.

Puede que no se comercialicen todos los tamaños de envase.

Titular de la autorización de comercialización y responsable de fabricación

Titular de la autorización de comercialización

Laboratorios Farmacéuticos Rovi, S.A.

Julián Camarillo, 35

28037 Madrid

España

Responsable de la fabricación

Pharma Patent Ltd.

Váci út 36-38. 4. em

1132 Budapest

Hungría

Este medicamento está autorizado en los Estados Miembros del Espacio Económico Europeo con los siguientes nombres:

Nombre del estado miembro

Nombre del medicamento

España

Colecalciferol Rovi 30000 UI comprimidos recubiertos con película

Fecha de la última revisión de este prospecto:Marzo 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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Frequently Asked Questions

Is a prescription required for COLECALCIFEROL ROVI 30,000 IU FILM-COATED TABLETS?
COLECALCIFEROL ROVI 30,000 IU FILM-COATED 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 COLECALCIFEROL ROVI 30,000 IU FILM-COATED TABLETS?
The active ingredient in COLECALCIFEROL ROVI 30,000 IU FILM-COATED TABLETS is colecalciferol. This information helps identify medicines with the same composition but different brand names.
How much does COLECALCIFEROL ROVI 30,000 IU FILM-COATED TABLETS cost in pharmacies?
The average pharmacy price for COLECALCIFEROL ROVI 30,000 IU FILM-COATED TABLETS is around 2.81 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures COLECALCIFEROL ROVI 30,000 IU FILM-COATED TABLETS?
COLECALCIFEROL ROVI 30,000 IU FILM-COATED TABLETS is manufactured by Laboratorios Farmaceuticos Rovi S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of COLECALCIFEROL ROVI 30,000 IU 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 COLECALCIFEROL ROVI 30,000 IU 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 COLECALCIFEROL ROVI 30,000 IU FILM-COATED TABLETS?
Other medicines with the same active substance (colecalciferol) include ALDEXINA 25,000 IU HARD CAPSULES, ALDEXINA 50,000 IU HARD CAPSULES, BENFEROL CHOQUE 50,000 IU SOFT GEL 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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