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ZADITEN 0.25 mg/ml EYE DROPS SOLUTION

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 ZADITEN 0.25 mg/ml EYE DROPS SOLUTION

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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

Zaditen 0,25mg/ml colirio en solución

Ketotifeno

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, farmacéutico o enfermero.
  • 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, farmacéutico o enfermero, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.

Contenido del prospecto:

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

1. Qué es Zaditen y para qué se utiliza

Zaditen contiene el principio activo ketotifeno, que es una sustancia antialérgica. Zaditen se usa para tratar los síntomas oculares de la conjuntivitis alérgica estacional.

Debe consultar a un médico si empeora o si no mejora.

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 usar Zaditen

No use Zaditen

Si es alérgico (hipersensible) al ketotifeno o a cualquiera de los demás componentes de este medicamento (incluidos en la sección 6).

Advertencias y precauciones

Consulte a su médico, farmacéutico o enfermero antes de empezar a usar Zaditen.

Uso de Zaditen con otros medicamentos

Si necesita aplicarse en los ojos cualquier otro medicamento además de Zaditen, espere como mínimo 5 minutos entre la aplicación de cada producto.

Comunique a su médico o farmacéutico si está utilizando, ha utilizado recientemente o podría tener que utilizar cualquier otro medicamento. Esto es especialmente importante en el caso de medicamentos que se usan para tratar:

  • depresión, ansiedad y trastornos del sueño
  • alergia (por ejemplo antihistamínicos)

Uso de Zaditen con alimentos, bebidas y alcohol

Zaditen puede aumentar los efectos del alcohol.

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.

Zaditen se puede usar durante la lactancia.

Conducción y uso de máquinas

Zaditen puede causar visión borrosa o somnolencia. No conduzca ni utilice máquinas hasta que hayan desaparecido estos efectos.

Zaditen contiene cloruro de benzalconio.

Este medicamento contiene 2,6 microgramos de cloruro de benzalconio en cada gota.

El cloruro de benzalconio se puede absorber por las lentes de contacto blandas y puede alterar el color de las lentes de contacto. Retirar las lentes de contacto antes de usar este medicamento y esperar 15 minutos antes de volver a colocarlas.

El cloruro de benzalconio puede causar irritación ocular, especialmente si padece de ojo seco u otras enfermedades de la córnea (capa transparente de la zona frontal del ojo). Consulte a su médico si siente una sensación extraña, escozor o dolor en el ojo después de usar este medicamento.

3. Cómo usar Zaditen

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 si tiene dudas.

La dosis recomendada en adultos, ancianos y niños (de 3 años o más), es de una gota en el ojo (u ojos) afectado(s) dos veces al día (por la mañana y por la noche).

Instrucciones de uso

  1. Lávese las manos.
  2. Abra el frasco. No toque la punta del cuentagotas tras la apertura del frasco.
  3. Incline la cabeza hacia atrás (Fig. 1).
  4. Tire del párpado inferior hacia abajo con el dedo y sujete el frasco con la otra mano. Apriete el frasco de forma que caiga una gota en el ojo (Fig. 2).
  5. Cierre los ojos y presione con la punta de un dedo el ángulo interior del ojo durante 1-2 minutos aproximadamente. Esto previene que la gota baje por el conducto lagrimal hasta la garganta y la mayor parte de la gota permanecerá en el ojo (Fig. 3). Si es necesario, repita los pasos 3 al 5 con el otro ojo.
  6. Cierre el frasco después de su uso.

Perfil de cabeza mostrando punto de inyección, mano sosteniendo dispositivo aplicador y rostro con ojos cerrados durante aplicación

Fig. 1 Fig. 2 Fig. 3

Si tiene cualquier otra duda sobre el uso de este producto, pregunte a su médico, farmacéutico o enfermero.

Si usa más Zaditen del que debe

No hay peligro alguno si toma Zaditen por vía oral accidentalmente, ni tampoco si más de una gota cae accidentalmente en su ojo. En caso de duda, consulte con su médico. Asimismo, en caso de sobredosis o ingestión accidental, puede usted consultar al Servicio de Información Toxicológica Tel.: 91 562 04 20.

Si olvidó usar Zaditen

Si olvidó usar Zaditen debe aplicarse el tratamiento tan pronto se acuerde. Después vuelva a su régimen habitual de tratamiento.

No tome una dosis doble para compensar las dosis olvidadas.

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.

Frecuentes(afectan a menos de 1 de cada 10pacientes)

  • irritación en el ojo o dolor en el ojo
  • inflamación en el ojo

Poco frecuentes(afectan a menos de1 de cada 100 pacientes)

  • visión borrosa cuando se aplican las gotas en el ojo
  • sequedad en el ojo
  • alteración en el párpado
  • conjuntivitis
  • sensibilidad aumentada de los ojos a la luz
  • hemorragia visible en la zona blanca del ojo
  • dolor de cabeza
  • somnolencia
  • erupción (que puede también producir picor)
  • eczema (picor, enrojecimiento, erupción con escozor)
  • sequedad de boca
  • reacción alérgica (incluyendo hinchazón de la cara y los párpados) e incremento de la severidad de una condición alérgica ya existente como asma y eczema

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 Zaditen

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

No conservar a temperatura superior a 25°C.

El frasco en sí, no es estéril, pero su contenido es estéril hasta que se abre el frasco.

Tras la primera apertura del frasco, el colirio sólo se puede conservar durante 4 semanas.

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 Zaditen

El principio activo es ketotifeno (en forma de fumarato). Cada ml contiene 0,345 mg de ketotifeno fumarato, que corresponde a 0,25 mg de ketotifeno.

Los demás componentes son glicerol (E422), hidróxido de sodio (E524), agua para inyectables y cloruro de benzalconio.

Aspecto del producto y contenido del envase

Zaditen es una solución transparente, de incolora a amarillo pálido. La solución se presenta en un envase que contiene un frasco de 5 ml.

Titular de la autorización de comercialización

Laboratoires THEA – 12, rue Louis Blériot – 63017 Clermont-Ferrand Cedex 2 – Francia

Responsable de la fabricación

EXCELVISION – 27 rue de la Lombardière – 07100 Annonay - Francia.

Representante local

Laboratorios THEA S.A. – Pg. Sant Joan 91, 08009 Barcelona

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

Austria Zaditen 0,025% - Augentropfen

Dinamarca Zaditen

Finlandia Zaditen 0,25 mg/ml silmätipat, liuos

Francia Zalergonium, 0,25 mg/ml, collyre en solution

Alemania Zaditen ophtha 0,25 mg/ml Augentropfen

Grecia Zaditor οfθaλµικ?ς staγ?νeς

Islandia Zaditen

Irlanda Zaditen 0.25mg/ml, eye drops, solution

Luxemburgo Zaditen 0,25 mg/ml, collyre en solution

Noruega Zaditen

Portugal Zaditen 0,25 mg/ml colírio, solução

España Zaditen 0,25 mg/ml colirio en solución

Suecia Zaditen 0,25 mg/ml, ögondroppar, lösning

Holanda Zaditen 0,25 mg/ml, oogdruppels, oplossing

Reino Unido Zaditen 0.25 mg/ml, eye drops, solution

Fecha de la última revisión de este prospecto:10/2020

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.es/

Online doctors for ZADITEN 0.25 mg/ml EYE DROPS SOLUTION

Discuss questions about ZADITEN 0.25 mg/ml EYE DROPS SOLUTION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Dr. Rita Isabel Calero Garcia is a physician with extensive experience in emergency medical care, general medicine, and healthcare assistance in various clinical and out-of-hospital settings.

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Frequently Asked Questions

Is a prescription required for ZADITEN 0.25 mg/ml EYE DROPS SOLUTION?

ZADITEN 0.25 mg/ml EYE DROPS 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 ZADITEN 0.25 mg/ml EYE DROPS SOLUTION?

The active ingredient in ZADITEN 0.25 mg/ml EYE DROPS SOLUTION is ketotifen. This information helps identify medicines with the same composition but different brand names.

Who manufactures ZADITEN 0.25 mg/ml EYE DROPS SOLUTION?

ZADITEN 0.25 mg/ml EYE DROPS SOLUTION is manufactured by Laboratoires Thea. Pharmacy brands and packaging may differ depending on the distributor.

Which doctors can assess the use of ZADITEN 0.25 mg/ml EYE DROPS 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 ZADITEN 0.25 mg/ml EYE DROPS SOLUTION 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 ZADITEN 0.25 mg/ml EYE DROPS SOLUTION 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 ZADITEN 0.25 mg/ml EYE DROPS SOLUTION 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 ZADITEN 0.25 mg/ml EYE DROPS SOLUTION?

Other medicines with the same active substance (ketotifen) include BENTIFEN 0.25mg/ml EYE DROPS SOLUTION, KETISAL 0.25 mg/ml EYE DROPS SOLUTION, KETOBRILL 0.25 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS. 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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