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ALERLISIN 10 mg/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 ALERLISIN 10 mg/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

Alerlisin 10mg/ml gotas orales en solución

cetirizina dihidrocloruro

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

1. Qué es Alerlisin y para qué se utiliza

El principio activo de Alerlisin es la cetirizina dihidrocloruro.

Alerlisin es un medicamento antialérgico.

Alerlisin 10 mg/ml gotas orales en solución está indicado en adultos y pacientes pediátricos a partir de 2 años, para:

  • el alivio de los síntomas nasales y oculares de la rinitis alérgica estacional y perenne.
  • el alivio de la urticaria crónica (urticaria crónica idiopática).
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 Alerlisin

No tome Alerlisin

  • si tiene una enfermedad renal grave (insuficiencia renal grave con aclaramiento de creatinina por debajo de 10 ml/min);
    • si es alérgico al principio activo, a alguno de los demás componentes de este medicamento (incluidos en la sección 6), a hidroxizina o a derivados de piperazina (principios activos estrechamente relacionados con otros fármacos).

Advertencias y precauciones

Consulte a su médico o farmacéutico antes de empezar a tomar Alerlisin

  • si es un paciente con insuficiencia renal, consulte a su médico; si es necesario, tomará una dosis más baja. Su médico determinará la nueva dosis.
  • si es un paciente epiléptico o un paciente con riesgo de convulsiones, consulte a su médico.

No se han observado interacciones susceptibles de tener un impacto notable entre el alcohol (con un nivel en sangre de 0,5 por mil, correspondiente a un vaso de vino) y el uso de cetirizina a dosis normales. Sin embargo, como en el caso de todos los antihistamínicos, se recomienda evitar el consumo conjunto de alcohol durante el tratamiento.

Niños

No se recomienda el uso del medicamento en niños menores de 2 años.

Toma de Alerlisin con otros medicamentos

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

Debido al perfil de la cetirizina, no se esperan interacciones con otros fármacos.

Toma de Alerlisin con los alimentos y bebidas

La comida no afecta notablemente a la absorción de la cetirizina.

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.

Se debe evitar el uso en mujeres embarazadas de Alerlisin. El uso accidental del medicamento en mujeres embarazadas no debe producir ningún efecto dañino sobre el feto. Sin embargo, debe interrumpirse la administración del medicamento.

No debe tomar Alerlisin durante la lactancia, ya que la cetirizina se excreta por la leche materna.

Conducción y uso de máquinas

Los estudios clínicos no han mostrado evidencia de que Alerlisin produzca alteraciones de la atención, disminución de la capacidad de reacción y la habilidad para conducir a la dosis recomendada.

Si tiene intención de conducir, realizar actividades potencialmente peligrosas o utilizar maquinaria, no debe exceder de la dosis recomendada. Debe observar su respuesta al medicamento estrechamente.

Si es un paciente sensible, puede encontrar que el uso simultáneo de alcohol u otros agentes depresores del sistema nervioso puede afectar además a su atención y su capacidad para reaccionar.

Alerlisin contieneparahidroxibenzoato de metilo (E-218) y parahidroxibenzoato de propilo (E-216), propilenglicol (E-1520) y sodio

Puede producir reacciones alérgicas (posiblemente retardadas) porque contiene parahidroxibenzoato de metilo (E-218) y parahidroxibenzoato de propilo (E-216).

Este medicamento contiene 350 mg de propilenglicol en cada ml (equivalente a 20 gotas).

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

3. Cómo tomar alerlisin

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

Adultos y adolescentes a partir de 12 años

10 mg una vez al día como 20 gotas.

Uso en niños entre 6 y 12 años

5 mg dos veces al día, como 10 gotas dos veces al día.

Uso en niños entre 2 y 6 años

2,5 mg dos veces al día administrado como 5 gotas dos veces al día.

Pacientes con insuficiencia renal de moderada a grave

Se recomienda a los pacientes con insuficiencia renal moderada tomar 5 mg como 10 gotas una vez al día.

Si nota que el efecto de Alerlisin es demasiado débil o fuerte, consulte a su médico.

Duración del tratamiento

La duración del tratamiento depende del tipo, duración y curso de sus molestias y se determinará por su médico.

Si toma más Alerlisin del que debe

Después de una sobredosis, los efectos adversos descritos a continuacón pueden ocurrir con una mayor intensidad. Se han comunicado efectos adversos como confusión, diarrea, mareo, fatiga, debilidad, dolor de cabeza, dilatación de la pupila, hormigueo, irritación, sedación, somnolencia, estupor, taquicardia anormal, temblor y retención urinaria.

Informe a su médico si piensa que ha tomado una sobredosis de Alerlisin.

Su médico decidirá entonces que medidas deben tomarse.

En caso de sobredosis o ingestión accidental, acudir inmediatamente a un centro médico o llamar al Servicio de Información Toxicológica, teléfono 91 562 04 20, indicando el medicamento y la cantidad ingerida.

Si olvidó tomar Alerlisin

No tome una dosis doble para compensar las dosis olvidadas.

Si interrumpe el tratamiento con Alerlisin

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.

Se han notificado los siguientes efectos adversos en la experiencia post-comercialización:

Frecuentes: pueden afectar hasta 1 de cada 10 personas

  • Fatiga
  • Diarrea, sequedad de boca, náusea
  • Mareo, dolor de cabeza
  • Somnolencia
  • Faringitis, rinitis

Poco frecuentes: pueden afectar hasta 1 de cada 100 personas

  • Dolor abdominal
  • Astenia (fatiga extrema), malestar
  • Parestesia (sensación anormal de la piel)
  • Agitación
  • Prurito, sarpullido

Raros:puede afectar hasta 1 de cada 1.000 personas

  • Taquicardia (el corazón late demasiado rápido)
  • Edema (hinchazón)
  • Reacciones alérgicas, algunas graves (muy raro)
  • Función hepática anormal
  • Aumento de peso
  • Convulsiones, trastornos del movimiento
  • Agresividad, confusión, depresión, alucinación, insomnio
  • Urticaria

Muy raros:puede afectar hasta 1 de cada 10.000 personas

  • Trombocitopenia (niveles bajos de plaquetas en sangre)
  • Trastornos de la acomodación, visión borrosa, giro ocular (los ojos tiene un movimiento circular incontrolado)
  • Síncope, temblor, disgeusia (trastorno del gusto)
  • Tic
  • Eliminación anormal de la orina
  • Edema, erupción debida al fármaco

A los primeros síntomas de hipersensibilidad, deje de tomar Alerlisin.

Su médico evaluará la gravedad y decidirá las medidas que es necesario tomar.

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: 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 Alerlisin

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

Este medicamento no requiere condiciones especiales de conservación.

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 Alerlisin

  • El principio activo es cetirizina dihidrocloruro. Un ml (equivale a 20 gotas) contiene 10 mg de cetirizina dihidrocloruro. Una gota contiene 0,5 mg de cetirizina dihidrocloruro.
    • Los demás componentes son glicerol (E-422), propilenglicol (E-1520), sacarina sódica, parahidroxibenzoato de metilo (E-218), parahidroxibenzoato de propilo (E-216), acetato de sodio, ácido acético, agua purificada.

Aspecto del producto y contenido del envase

Alerlisin se suministra como un líquido transparente e incoloro.

Envase original con un frasco de 10, 15, 20 ó 30 ml de solución.

Puede que no se comercialicen todos los tamaños de envase.

Titular de la autorización de comercialización

RETRAIN, S.A.U.

Alfons XII, 587– 08918 Badalona (Barcelona) – España

Responsable de la fabricación

LABORATORIOS MENARINI, S.A.

Alfons XII, 587 – 08918 Badalona (Barcelona) – España

Pueden solicitar más información respecto a este medicamento dirigiéndose al representante local del titular de la autorización de comercialización:

LABORATORIOS MENARINI, S.A.

Alfons XII, 587 – 08918 Badalona (Barcelona) – España

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

Austria: Zyrtec 10 mg/ml – Tropfen

Bélgica: Ceterizine-UCB, Zyrtec, Virlix

Bulgaria: Zyrtec

República Checa: Zyrtec

Dinamarca: Zyrtec

Estonia: Zyrtec

Finlandia: Zyrtec

Francia: Virlix, Zyrtec

Alemania: Zyrtec P tropfen, Zyrtec tropfen

Grecia: Ziptek

Hungría: Zyrtec cseppek

Italia: Formistin, Zirtec 10 mg/ml gocce orali soluzione

Letonia: Zyrtec

Lituania: Zyrtec

Luxemburgo: Virlix, Zyrtec, Cetirizina-UCB

Noruega: Zyrtec

Polonia: Zyrtec

Portugal: Zyrtec

Rumanía: Zyrtec

Eslovaquia: Zyrtec gtt por 10 mg/ml

Eslovenia: Zyrtec 10 mg/ml peroralne kapljice, raztopina

España: Alerlisin, Virdos, Zyrtec gotas orales en solución

Suecia: Zyrlex

Fecha de la última revisión de este prospecto: Enero 2020

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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Frequently Asked Questions

Is a prescription required for ALERLISIN 10 mg/ml ORAL DROPS IN SOLUTION?
ALERLISIN 10 mg/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 ALERLISIN 10 mg/ml ORAL DROPS IN SOLUTION?
The active ingredient in ALERLISIN 10 mg/ml ORAL DROPS IN SOLUTION is cetirizine. This information helps identify medicines with the same composition but different brand names.
How much does ALERLISIN 10 mg/ml ORAL DROPS IN SOLUTION cost in pharmacies?
The average pharmacy price for ALERLISIN 10 mg/ml ORAL DROPS IN SOLUTION is around 3.12 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures ALERLISIN 10 mg/ml ORAL DROPS IN SOLUTION?
ALERLISIN 10 mg/ml ORAL DROPS IN SOLUTION is manufactured by Retrain, S.A.U.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of ALERLISIN 10 mg/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 ALERLISIN 10 mg/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 ALERLISIN 10 mg/ml ORAL DROPS IN SOLUTION?
Other medicines with the same active substance (cetirizine) include ALERCINA 10 mg TABLETS, ALERLISIN 1 mg/ml ORAL SOLUTION, ALERLISIN 10 mg FILM-COATED TABLETS. 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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