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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 TIORFAN NIÑOS 30 mg ORAL SUSPENSION GRANULES

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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

Tiorfan Niños 30 mg granulado para suspensión oral

racecadotrilo

Lea todo el prospecto detenidamente antes de empezar a tomar el medicamento.

  • 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 a su hijo y no debe dárselo a otras personas aunque tengan los mismos síntomas que su hijo, ya que puede perjudicarles.
  • Si su hijo 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 Tiorfan y para qué se utiliza
  2. Qué necesita saber antes de empezar a tomar Tiorfan
  3. Cómo tomar Tiorfan
  4. Posibles efectos adversos
  5. Conservación de Tiorfan
  6. Contenido del envase e información adicional

1. Qué es Tiorfan y para qué se utiliza

Tiorfan es un medicamento para el tratamiento de la diarrea.

Tiorfan se usa en el tratamiento de los síntomas de la diarrea aguda en niños mayores de 3 meses. Debe usarse junto con una ingestión abundante de líquido y las medidas dietéticas habituales, cuando estas medidas por sí solas sean insuficientes para controlar la diarrea, y cuando las causas de la diarrea no puedan tratarse.

Si es posible el tratamiento causal, racecadotrilo puede administrarse como tratamiento complementario.

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 Tiorfan

No useTiorfan

  • Si su hijo es alérgicoa racecadotrilo o a alguno de los demás componentes de Tiorfan (incluidos en la sección 6).
  • Si su médico le ha dicho que su hijo tiene intolerancia a algunos azúcares, pregunte a su médico antes de dar Tiorfan a su hijo.
  • Si alguna vez ha desarrollado una erupción cutánea grave o descamación de la piel, ampollas y/o llagas en la boca después de tomar racecadotrilo.

Advertencias y precauciones

Consulte a su médico o farmacéutico antes de empezar a dar Tiorfan a su hijo si:

  • su hijo tiene menos de 3 meses,
  • hay sangre o pus en las deposiciones de su hijo y si tiene fiebre. La causa de su diarrea puede ser una infección bacteriana que debe ser tratada por su médico,
  • su hijo sufre de diarrea crónica o de diarrea causada por antibióticos,
  • su hijo sufre de vómitos prolongados o incontrolados,
  • su hijo tiene una enfermedad de riñón o la función del hígado insuficiente,
  • su hijo padece diabetes (ver “Información importante sobre algunos de los componentes de Tiorfan”).

El racecadotril, el principio activo de Tiorfan, puede provocar una reacción alérgica llamada angioedema, que puede causar hinchazón de la cara, los labios, la garganta o la lengua. Si su hijo experimenta estos efectos adversos, interrumpa el tratamiento inmediatamente y póngase en contacto con su médico. La hinchazón puede aparecer en cualquier momento durante el tratamiento con este producto.

El uso concomitante de este producto y algunos otros medicamentos puede aumentar el riesgo de angioedema (ver "Otros medicamentos y Tiorfan").

Se han notificado reacciones cutáneas con el uso de este producto. En la mayoría de los casos son leves y no requieren tratamiento. En algunos casos, pueden producirse reacciones cutáneas graves. En estos casos, el tratamiento debe interrumpirse inmediatamente y el niño no debe ser tratado con racecadotril de nuevo.

Se han notificado reacciones cutáneas graves, incluyendo reacción a fármaco con eosinofilia y síntomas sistémicos (DRESS), asociados con el tratamiento con racecadotrilo. Suspenda el uso de racecadotrilo y busque atención médica inmediatamente si nota alguno de los síntomas relacionados con estas reacciones cutáneas graves descritas en la sección 4.

Uso de Tiorfan con otros medicamentos

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

Especialmente informe su médico si su hijo utiliza alguno de los siguientes medicamentos ya que pueden incrementar el riesgo de efectos secundarios (véase “Advertencias y precauciones”):

  • inhibidor de la ECA (por ejemplo, perindopril o ramipril) utilizado para disminuir la presión arterial o para tratar la insuficiencia cardiaca.
  • Los antagonistas de la angiotensina II (por ejemplo, candesartán o irbesartán) utilizados para tratar la hipertensión arterial y la insuficiencia cardíaca.
  • Sacubitril, utiliado para tratar la insuficiencia cardíaca.
  • Algunos inmunosupresores (por ejemplo, sirolimus o everolimus).
  • Algunos antidiabéticos ( por ejemplo, sitagliptina o vildagliptina).
  • Estramustina, utilizada para el tratamiento del cáncer.
  • Altepasa, utilizada para el tratamiento de los coágulos de sangre.

Embarazo y lactancia

No se recomienda el uso de Tiorfan durante el embarazo y la lactancia.

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

Conducción y uso de máquinas

Tiorfan tiene poco efecto, o no tiene, en la capacidad de conducir o manejar maquinaria.

Tiorfan contiene sacarosa

Tiorfan contiene aproximadamente 3 g de sacarosa por sobre.

Si su medico le ha dicho que su hijo tiene intolerancia a algunos azúcares, pregunte a su médico antes de dar Tiorfan a su hijo.

En niños con diabetes, la cantidad de sacarosa ingerida con Tiorfan debe tenerse en cuenta en la ingesta diaria total de azúcar del niño.

3. Cómo tomar Tiorfan

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

Tiorfan se presenta en forma de granulado.

El granulado puede añadirse a los alimentos o mezclarse en un vaso de agua o en el biberón. Mézclelo bien y déselo inmediatamente a su hijo.

La dosis diaria recomendada depende del peso de su hijo: 1,5 mg/kg por toma (correspondientes a 1-2 sobres), tres veces al día a intervalos regulares.

En niños de 13 a 27 Kg de peso: un sobre por toma.

En niños de más de 27 kg de peso, aproximadamente: dos sobres por toma.

Su médico le indicará la duración del tratamiento con Tiorfan. El tratamiento debe mantenerse hasta que se produzcan 2 deposiciones normales, sin exceder los 7 días.

Para compensar la pérdida de líquido debido a la diarrea de su hijo, este medicamento debe usarse junto con una restitución adecuada de fluidos y sales (electrolitos). La mejor restitución de los fluidos y las sales se consigue con una solución llamada de rehidratación oral (por favor, pregunte a su médico o farmacéutico si no está seguro).

Si da más Tiorfan del que debiera

Si su hijo ha tomado más Tiorfan del que debiera, contacte inmediatamente con su médico o farmacéutico.

Si olvidó dar Tiorfan

No le de una dosis doble a su hijo para compensar una dosis olvidada. Simplemente continúe con el tratamiento.

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.

Deje de administrar Tiorfan a su hijo y contacte inmediatamente con un médico si su hijo experimenta síntomas de angioedema, como:

  • hinchazón de la cara, lengua o faringe
  • dificultad para tragar
  • ronchas y dificultad para respirar

Suspenda el uso de racecadotrilo y busque atención médica inmediatamente si nota alguno de los siguientes síntomas:

  • Erupción cutánea generalizada, temperatura corporal elevada y aumento de los ganglios linfáticos (síndrome DRESS)
  • Dificultad respiratoria, hinchazón, aturdimiento, taquicardia, sudoración y sensación de pérdida de conocimiento, síntomas de una reacción alérgica grave y repentina.

Se han descrito los siguientes efectos adversos:

Poco frecuentes (pueden afectar a hasta 1 de cada 100 personas): tonsilitis (inflamación de las amígdalas), erupción y eritema (enrojecimiento de la piel).

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

eritema multiforme (lesiones rojizas en las extremidades e interior de la boca), hinchazón de lengua, hinchazón de cara, hinchazón de los labios, hinchazón de los párpados, urticaria, eritema nodoso (inflamación en forma de bultos bajo la piel), erupción papular (erupción en la piel con lesiones pequeñas, duras y abultadas), prurigo (lesiones en la piel con picor) y prurito (picor generalizado).

Comunicación de efectos adversos

Si experimenta cualquier tipo de efecto adverso, consulte a su médico, farmacéutico o enfermero, 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 (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 Tiorfan

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 sobre y en la caja después de CAD. La fecha de caducidad es el último día del mes que se indica.

No requiere condiciones especiales de conservación.

Los medicamentos no se deben tirar por los desagües ni a la basura. 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 Tiorfan

La sustancia activa es racecadotrilo. Cada sobre contiene 30 mg de racecadotrilo.

Los demás componentes son:

sacarosa,

sílice coloidal anhidra,

dispersión de poliacrilato al 30 por ciento,

aroma de albaricoque.

Aspecto de Tiorfan y contenido del envase

Tiorfan se presenta en forma granulado para suspensión oral en sobres.

Cada envase contiene 10, 16, 20, 30, 50 o 100 sobres (100 sobres sólo como envase clínico).

Puede que solamente estén comercializados algunos tamaños de envases.

Titular de la autorización de comercialización y responsable de la fabricación

Titular de la autorización de comercialización

BIOPROJET-FERRER, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (España)

Responsable de la fabricación

FERRER INTERNACIONAL, S.A.

Joan Buscallà 1-9

08173 Sant Cugat del Vallès, Barcelona (España)

o

SOPHARTEX,

21 rue de Pressoir,

28500 Vernouillet (Francia)

Este medicamento está autorizado en los estados miembros del Espacio Económico Europeo con los siguientes nombres:

ALEMANIA: Tiorfan

PORTUGAL: Tiorfan

GRECIA: Hidrasec

ITALIA: Tiorfix

AUSTRIA: Hidrasec

BELGICA:Tiorfast

REPÚBLICA CHECA: Hidrasec

DINAMARCA: Hidrasec

ESTONIA: Hidrasec

FINLANDIA: Hidrasec

HUNGRIA: Hidrasec

IRLANDA: Hidrasec

LETONIA: Hidrasec

LITUANIA: Hidrasec

LUXEMBURGO: Tiorfast

PAÍSES BAJOS: Tiorfan

POLONIA: Hidrasec

REPUBLICA ESLOVACA: Hidrasec

ESLOVENIA: Hidrasec

SUECIA: Hidrasec

REINO UNIDO: Hidrasec

Fecha de la última revisión de este prospecto 24-11-2024

La información detallada y actualizada de este medicamento está disponible en la página Web de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) www.aemps.gob.es.

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Frequently Asked Questions

Is a prescription required for TIORFAN NIÑOS 30 mg ORAL SUSPENSION GRANULES?

TIORFAN NIÑOS 30 mg ORAL SUSPENSION GRANULES 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 TIORFAN NIÑOS 30 mg ORAL SUSPENSION GRANULES?

The active ingredient in TIORFAN NIÑOS 30 mg ORAL SUSPENSION GRANULES is racecadotril. This information helps identify medicines with the same composition but different brand names.

Who manufactures TIORFAN NIÑOS 30 mg ORAL SUSPENSION GRANULES?

TIORFAN NIÑOS 30 mg ORAL SUSPENSION GRANULES is manufactured by Bioprojet Ferrer. Pharmacy brands and packaging may differ depending on the distributor.

Which doctors can assess the use of TIORFAN NIÑOS 30 mg ORAL SUSPENSION GRANULES 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 TIORFAN NIÑOS 30 mg ORAL SUSPENSION GRANULES 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 TIORFAN NIÑOS 30 mg ORAL SUSPENSION GRANULES 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 TIORFAN NIÑOS 30 mg ORAL SUSPENSION GRANULES 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 TIORFAN NIÑOS 30 mg ORAL SUSPENSION GRANULES?

Other medicines with the same active substance (racecadotril) include HIDRASEC 100 mg HARD CAPSULES, TIORFAN 100 mg HARD CAPSULES, TIORFAN INFANTIL 4 mg/mL ORAL SUSPENSION. 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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