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OXIBUPROCAINE HYDROCHLORIDE AGEPHA 4 MG/ML EYE DROPS IN SOLUTION

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Talk to a doctor about this medicine

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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 OXIBUPROCAINE HYDROCHLORIDE AGEPHA 4 MG/ML EYE 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

Oxibuprocaína hidrocloruro Agepha 4 mg/ml colirio en solución

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 o farmacéutico.
  • 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 Oxibuprocaína hidrocloruro Agepha y para qué se utiliza
  2. Qué necesita saber antes de empezar a usar Oxibuprocaína hidrocloruro Agepha
  3. Cómo usar Oxibuprocaína hidrocloruro Agepha
  4. Posibles efectos adversos
  5. Conservación de Oxibuprocaína hidrocloruro Agepha
  6. Contenido del envase e información adicional

1. Qué es Oxibuprocaína hidrocloruro Agepha y para qué se utiliza

Este medicamento es un anestésico para uso externo en adultos.

Actúa anestesiando localmente la superficie del ojo para procedimientos oftalmológicos cortos.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. Qué necesita saber de empezar a usar Oxibuprocaína hidrocloruro Agepha

No use Oxibuprocaína hidrocloruro

  • si es hipersensible (alérgico) a la oxibuprocaína o a cualquiera de los componentes de oxibuprocaína hidrocloruro (incluidos en la sección 6);
  • si es hipersensible (alérgico) a otros anestésicos locales que pertenecen al mismo grupo de principios activos (ácido p-aminobenzoico).

Advertencias y precauciones

Tenga especial cuidado con Oxibuprocaína hidrocloruro

Si utiliza lentes de contacto. Quítese las lentes de contacto antes de la instilación y espere hasta que el efecto anestésico haya disminuido por completo antes de volver a ponérselas en el ojo (ver también 3.Cómo usar Oxibuprocaína hidrocloruro).

En pacientes con antecedentes de alergias, enfermedades cardíacas, asma, glándula tiroides hiperactiva (hipertiroidismo) o enfermedades hepáticas, así como en pacientes de edad avanzada.

Si tiene un ojo inflamado, ya que los ojos rojos aumentan en gran medida el paso al torrente sanguíneo a través de la superficie de los ojos.

Uso prolongado y repetido

Oxibuprocaína hidrocloruro Agepha está pensado para que lo utilice solo un médico y por un espacio de tiempo breve. El uso repetido e incontrolado puede provocar daños graves en la córnea del ojo. Lo mismo puede decirse de su uso a largo plazo.

Niños y adolescentes

No se ha determinado la seguridad y eficacia de Oxibuprocaína hidrocloruro en niños y adolescentes.

Otros medicamentos y Oxibuprocaína hidrocloruro

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

Sulfonamidas (presentes en ciertos antibióticos): La eficacia de estos antibióticos puede verse reducida.

Embarazo y lactancia

Si está embarazada o en periodo de lactancia, cree que puede estar embarazada o tiene intención de quedarse embarazada, consulte a su médico. Él le dirá si se le puede administrar Oxibuprocaína hidrocloruro o no.

Conducción y uso de máquinas

Este medicamento puede afectar a su capacidad de reacción, así como su a capacidad para conducir. El uso de Oxibuprocaína hidrocloruro puede afectar a su visión y, por lo tanto, también a su capacidad de reacción al conducir o al utilizar máquinas. No conduzca vehículos ni use herramientas o maquinaria antes de que este efecto haya disminuido.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

3. Cómo usar Oxibuprocaína hidrocloruro Agepha

La dosis recomendada es de 1 gota para los ojos antes del examen o procedimiento; esta dosis se puede repetir si es necesario.

Forma de administración

Para uso en el ojo. (Para instilar en el ojo que se va a examinar)

El médico o el oftalmólogo le pondrá las gotas en el ojo. Es posible que le pidan que ejerza presión las comisuras internas de su párpado durante 1-2 minutos, lo que evita que la solución pase a la nariz y a la garganta. Esta medida es especialmente aconsejable en personas mayores y población de riesgo.

Su ojo quedará adormecido durante aproximadamente una hora, dependiendo de cuántas gotas le hayan instilado. Evite tocarse el ojo hasta mientras el efecto de la anestesia no haya desaparecido.

Si tiene que instilarse otro colirio, debe esperar al menos 15 minutos antes de administrárselo.

Aunque haya recibido más oxibuprocaína hidrocloruro del que debiera, es muy poco probable que sufra los efectos de una sobredosis.

Si se siente repentinamente mal después de que le hayan instilado las gotas, informe a su médico u oftalmólogo o comuníquese de inmediato con el departamento de emergencias más cercano.

Advertencia para personas que usan lentes de contacto

Quítese las lentes de contacto antes de que le instilen el colirio y espere al menos una hora tras la instilación, hasta que el efecto anestésico haya disminuido por completo, para volver a ponérselas. El incumplimiento de esta recomendación puede provocar daños en la córnea.

Si usa más Oxibuprocaína hidrocloruro del que debe

Sobredosis: La intoxicación con anestésicos locales/tópicos, especialmente cuando se administra por vía oral, puede desencadenar los siguientes síntomas: espasmos musculares, convulsiones, descenso de la presión arterial, desmayos, arritmias cardíacas, paro cardíaco causado por problemas de conducción cardíaca, parálisis respiratoria.

En tales casos, consulte a un médico inmediatamente.

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.

Instrucciones para profesionales sanitarios

Encontrará información relativa a sobredosis al final de este prospecto.

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

4. Posibles efectos adversos

Al igual que todos los medicamentos, este medicamento puede producir efectos adversos, aunque no todas las personas los sufran.

Debe contactar inmediatamente con un médico si experimenta alguno de los siguientes síntomas de reacción alérgica/anafiláctica grave: hinchazón, erupción cutánea, picazón, urticaria, dificultad para respirar, escalofríos, sofocos, dolor de cabeza, malestar general, náuseas, inquietud, frecuencia cardíaca rápida o presión arterial baja (lo que ocurre con un número desconocido de pacientes).

Otros efectos adversos que pueden darse:

Frecuentes (pueden afectar hasta 1 de cada 10 personas):

El efecto secundario más común es la irritación local. Otros efectos adversos comunes son: ardor temporal después de la instilación, daño de la córnea con el uso repetido.

Raros (pueden afectar hasta 1 de cada 1.000 personas):

Temblores, visión borrosa, ritmo cardíaco lento, presión arterial baja, mareos.

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

Alergia ocular, blefaritis alérgica (inflamación de los párpados). Los síntomas de alergia ocular y blefaritis alérgica pueden ser: picazón, párpados rojos e hinchados, ojos rojos, ojos irritados y llorosos, ojos ardientes o punzantes, escamas y costras en el borde de las pestañas, similares a la caspa, sensibilidad a la luz.

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 Oxibuprocaína hidrocloruro Agepha

Este medicamento no requiere condiciones especiales de almacenamiento.

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 la caja después de EXP. La fecha de caducidad es el último día del mes indica.

Para utilizarse dentro de las 4 semanas posteriores a la primera apertura.

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 ya no necesita. De esta forma, ayudará a proteger el medio ambiente.

6. Contenido del envase e información adicional

Composición de Oxibuprocaína hidrocloruro Agepha

  • El principio activo es oxibuprocaína hidrocloruro

Cada ml contiene 4 mg de oxibuprocaína hidrocloruro

  • Los demás componentes son: ácido bórico, diacetato de clorhexidina, ácido clorhídrico (para ajustar el pH), agua para preparación inyectable.

Aspecto del producto y contenidodel envase

Oxibuprocaína hidrocloruro Agepha 4 mg/ml colirio en solución es una solución transparente e incolora, presentada en un frasco de plástico. Cada envase contiene un frasco de 10 ml.

Titular de la autorización de comercialización y responsable de la fabricación

AGEPHA Pharma s.r.o.,

Dialnicná cesta 5,

Senec 903 01,

Eslovaquia

Este medicamento está autorizado en los Estados miembros del Espacio Económico Europeo con las siguientes denominaciones:

Nombre del país miembro

Nombre del medicamento

Austria

Novain 4 mg/ml Augentropfen, Lösung

Dinamarca

Obupro 4 mg/ml øjendråber, opløsning

Estonia

Novain 4 mg/ml silmatilgad, lahus

Finlandia

Obupro 4 mg/ml silmätipat, liuos

Irlanda

Oxybuprocaine Agepha 4 mg/ml eye drops, solution

Letonia

Obupro 4 mg/ml acu pilieni, škidums

Islandia

Obupro 4 mg/ml augndropar, lausn

Croacia

Ophtesia 4 mg/ml kapi za oko, otopina

Lituania

Novain 4 mg/ml akiu lašai (tirpalas)

Países Bajos

Obupro 4 mg/ml oogdruppels, oplossing

Noruega

Novain 4 mg/ml øyedråper, løsning

Polonia

Obupro 4 mg/ml, krople do oczu, roztwór

Portugal

Novain 4 mg/ml colírio, solução

Suecia

Obupro 4 mg/ml ögondroppar, lösning

España

Oxibuprocaína hidrocloruro Agepha 4 mg/ml colirio en solución

Hungría

Obupro 4 mg/ml oldatos szemcsepp

Fecha de la última revisión de este prospecto: marzo 2024

Esta información está destinada únicamente a profesionales sanitarios:

Tratamiento en caso de intoxicación

Manejo inmediato de la circulación respiratoria y sanguínea (intubación y ventilación artificial), estimulación cardiovascular, perfusiones (¡sin adrenalina!). En caso de paro cardíaco, se realizará un masaje cardíaco externo y electroestimulación. En caso de convulsiones, se deben administrar barbitúricos de acción ultracorta o diazepam (no se deben administrar barbitúricos de acción prolongada debido al riesgo de depresión respiratoria)

Online doctors for OXIBUPROCAINE HYDROCHLORIDE AGEPHA 4 MG/ML EYE DROPS IN SOLUTION

Discuss questions about OXIBUPROCAINE HYDROCHLORIDE AGEPHA 4 MG/ML EYE DROPS IN SOLUTION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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General medicine 7 years exp.

Dr. Jorge Correa Bellido is a Spanish physician who offers online consultations in Spanish and English. He graduated from the University of La Laguna and has a solid background in clinical practice and international research.

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Frequently Asked Questions

Is a prescription required for OXIBUPROCAINE HYDROCHLORIDE AGEPHA 4 MG/ML EYE DROPS IN SOLUTION?
OXIBUPROCAINE HYDROCHLORIDE AGEPHA 4 MG/ML EYE 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 OXIBUPROCAINE HYDROCHLORIDE AGEPHA 4 MG/ML EYE DROPS IN SOLUTION?
The active ingredient in OXIBUPROCAINE HYDROCHLORIDE AGEPHA 4 MG/ML EYE DROPS IN SOLUTION is oxybuprocaine. This information helps identify medicines with the same composition but different brand names.
Who manufactures OXIBUPROCAINE HYDROCHLORIDE AGEPHA 4 MG/ML EYE DROPS IN SOLUTION?
OXIBUPROCAINE HYDROCHLORIDE AGEPHA 4 MG/ML EYE DROPS IN SOLUTION is manufactured by Agepha Pharma S.R.O.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of OXIBUPROCAINE HYDROCHLORIDE AGEPHA 4 MG/ML EYE 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 OXIBUPROCAINE HYDROCHLORIDE AGEPHA 4 MG/ML EYE 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 OXIBUPROCAINE HYDROCHLORIDE AGEPHA 4 MG/ML EYE DROPS IN SOLUTION?
Other medicines with the same active substance (oxybuprocaine) include COLIROFTA ANESTHETIC 5 mg/ml + 0.5 mg/ml EYE DROPS SOLUTION, COLIROFTA ANESTHETIC DOUBLE 1 mg/ml + 4 mg/ml EYE DROPS SOLUTION, OPHTESIC 20 mg/g OPHTHALMIC GEL SINGLE-DOSE CONTAINER. 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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