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KETOBRILL 0.25 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS

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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 KETOBRILL 0.25 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS

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

Ketobrill 0,25 mg/ml colirio en solución en envase unidosis

Ketotifeno

Lea todo el prospecto detenidamente antes de empezar a usar el 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 presenten 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 Ketobrill y para qué se utiliza
  2. Qué necesita saber antes de empezar a usar Ketobrill
  3. Cómo usar Ketobrill
  4. Posibles efectos adversos
  5. Conservación de Ketobrill
  6. Contenido del envase e información adicional

1. Qué es Ketobrill y para qué se utiliza

Ketobrill contiene el principio activo hidrógeno fumarato de ketotifeno, que es una sustancia antialérgica. Ketobrill se usa para tratar los síntomas oculares de la conjuntivitis alérgica estacional (fiebre del heno).

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 usar Ketobrill

No use Ketobrill

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

Advertencias y precauciones

Consulte a su médico o farmacéutico antes de empezar a usar Ketobrill.

Niños

No se ha establecido la seguridad y la eficacia en niños menores de 3 años.

Otros medicamentos y Ketobrill.

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

Informe 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 Ketobrill con alcohol

Ketobrill puede aumentar los efectos del alcohol.

Embarazo y lactancia

Si está embarazada, cree que podría estar embarazada o tiene intención de quedarse embarazada, consulte a su médico o farmacéutico antes de utilizar este medicamento.

Ketobrill se puede usar durante la lactancia.

Conducción y uso de máquinas

Ketobrill puede causar visión borrosa o somnolencia. Si esto sucede, espere hasta que estos efectos hayan desaparecido antes de conducir o usar máquinas.

3. Cómo usar Ketobrill

Siga exactamente las instrucciones de administración de este medicamento indicadas por su médico. Consulte a su médico o farmacéutico si tiene dudas.

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

Uso en niños menores de 3 años

No se ha establecido la eficacia y seguridad en niños menores de 3 años.

Un envase unidosis contiene una cantidad de solución suficiente para tratar ambos ojos en una aplicación.

Instrucciones de uso

  1. Lávese las manos.
  2. Abra la bolsa de aluminio y saque una tira de envases unidosis.
  3. Separe un envase unidosis de la tira (Fig. 1).
  4. Guarde los envases unidosis restantes de nuevo en la bolsa de aluminio y cierre doblando el borde de la misma. Guarde la bolsa en la caja.
  5. Abra el envase unidosis mediante torsión de su extremo superior. Tras abrir el envase no toque la punta del cuentagotas (Fig. 2).
  6. Incline la cabeza hacia atrás (Fig. 3).
  7. Tire del párpado inferior hacia abajo con el dedo y sujete el envase con la otra mano. Apriete el envase de forma que caiga una gota en el ojo (Fig. 4).
  8. Cierre los ojos y presione con la punta de un dedo el ángulo interior del ojo durante 1-2 minutos aproximadamente. Esto evita que la gota baje por el conducto lagrimal hasta la garganta y la mayor parte de la gota permanezca en el ojo (Fig. 5). Si es necesario, repita los pasos 6 al 8 en el otro ojo.
  9. Deseche el envase unidosis después de su uso.

Serie de ilustraciones esquemáticas mostrando la aplicación de gotas en el ojo desde diferentes ángulos

Fig. 1 Fig. 2 Fig. 3 Fig. 4 Fig. 5

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

Si usa más Ketobrill del que debe

Si accidentalmente toma Ketobrill por vía oral no supone ningún peligro, ni tampoco si accidentalmente cae más de una gota en su ojo. En caso de duda, consulte a su médico. Asimismo, en caso de sobredosis o ingestión accidental, puede usted consultar al Servicio de Información Toxicológica Tel.: 91 596 04 20.

Si olvidó usar Ketobrill

Si olvidó usar Ketobrill debe aplicarse el tratamiento tan pronto como se acuerde. Después vuelva a su régimen habitual de tratamiento. No use 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 comunicado los siguientes efectos adversos.

Frecuentes (pueden afectar hasta 1 de cada 10 pacientes)

  • irritación ocular o dolor en el ojo
  • inflamación en el ojo
  • lesión del epitelio corneal

Poco frecuentes (pueden afectar hasta 1 de cada 100 pacientes)

  • visión borrosa cuando se aplican las gotas en el ojo
  • sequedad en el ojo
  • alteración en el párpado
  • conjuntivitis
  • aumento de la sensibilidad 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 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 Ketobrill

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

No utilice este medicamento después de la fecha de caducidad que aparece en la caja y la bolsa después de CAD y en el envase unidosis después de CAD. La fecha de caducidad es el último día del mes que se indica.

No conservar a temperatura superior a 25°C. No refrigerar ni congelar.

Mantener el envase unidosis en la bolsa de aluminio.

Ketobrill no contiene conservantes. Una vez abierto, el contenido del envase unidosis se debe usar inmediatamente y no debe conservarse. Desechar la solución restante en el envase unidosis tras la aplicación.

Desechar Ketobrill a las 4 semanas tras la apertura de la bolsa de aluminio.

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 Ketobrill

-El principio activo es ketotifeno (como hidrógeno fumarato). Cada ml contiene 0,25 mg de ketotifeno, correspondiente a 0,345 mg de ketotifeno hidrógeno fumarato.

-Los demás componentes (excipientes) son glicerol (E422), hidróxido de sodio (E524) (para ajustar el pH) y agua para preparaciones inyectables.

Aspecto del producto y contenido del envase

Ketobrill es una solución transparente e incolora. Un envase unidosis contiene 0,4 ml.

Ketobrill se presenta en envases que contienen 5, 10, 20, 30, 50 y 60 envases unidosis.

Puede que solamente estén comercializados algunos tamaños de envase.

Titular de la autorización de comercialización y responsable de la fabricación

Pharma Stulln GmbH

Werksstrasse 3

92551 Stulln

(Alemania)

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

BRILL PHARMA, S.L.

C/ Munner, 8

08022 Barcelona

(España)

Este medicamento está autorizado en los estados miembros del Espacio Económico Europeo y en el Reino Unido (Irlanda del Norte) con los siguientes nombres:

Alemania Allergo-Vision sine 0,25 mg/ml Augentropfen, Lösung im Einzeldosisbehältnis

Austria Ketotifen Stulln 250 Mikrogramm/ml Augentropfen im Einzeldosisbehältnis

España Ketobrill 0,25 mg/ml colirio en solución en envase unidosis

Irlanda Ketofall 0.25 mg/ml eye drops, solution in single-dose container

Paises Bajos Ketotifen Stulln Unit Dose 0,25 mg/ml oogdruppels, oplossing in verpakking voor éénmalig gebruik

Reino Unido Ketofall 0.25 mg/ml eye drops, solution in single-dose container

(Irlanda del Norte)

Fecha de la última revisión de este prospecto: Julio 2022.

La información detallada y actualizada de este medicamento está disponible en la página web de la Agencia Española del Medicamento y Productos Sanitarios (AEMPS) http://www.aemps.gob.es/

Online doctors for KETOBRILL 0.25 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS

Discuss questions about KETOBRILL 0.25 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

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Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

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Doctor

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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Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.
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Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

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Doctor

Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

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Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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Frequently Asked Questions

Is a prescription required for KETOBRILL 0.25 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS?
KETOBRILL 0.25 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS 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 KETOBRILL 0.25 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS?
The active ingredient in KETOBRILL 0.25 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS is ketotifen. This information helps identify medicines with the same composition but different brand names.
How much does KETOBRILL 0.25 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS cost in pharmacies?
The average pharmacy price for KETOBRILL 0.25 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS is around 5.06 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures KETOBRILL 0.25 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS?
KETOBRILL 0.25 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS is manufactured by Pharma Stulln Gmbh. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of KETOBRILL 0.25 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS 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 KETOBRILL 0.25 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS 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 KETOBRILL 0.25 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS?
Other medicines with the same active substance (ketotifen) include BENTIFEN 0.25mg/ml EYE DROPS SOLUTION, KETISAL 0.25 mg/ml EYE DROPS SOLUTION, KETOTIFEN CODRAMOL 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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