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OXIBUPROCAINE HYDROCHLORIDE AGEPHA 4 MG/ML EYE DROPS IN SOLUTION

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About the medicine

How to use OXIBUPROCAINE HYDROCHLORIDE AGEPHA 4 MG/ML EYE DROPS IN 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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Introduction

Package Leaflet: Information for the User

Oxibuprocaine Hydrochloride Agepha 4 mg/ml Eye Drops Solution

Read this entire leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

  1. What is Oxibuprocaine Hydrochloride Agepha and what is it used for
  2. What you need to know before you start using Oxibuprocaine Hydrochloride Agepha
  3. How to use Oxibuprocaine Hydrochloride Agepha
  4. Possible side effects
  5. Storage of Oxibuprocaine Hydrochloride Agepha
  6. Contents of the pack and further information

1. What is Oxibuprocaine Hydrochloride Agepha and what is it used for

This medicine is an external anaesthetic for use in adults.

It acts by locally anaesthetizing the surface of the eye for short ophthalmological procedures.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you start using Oxibuprocaine Hydrochloride Agepha

Do not use Oxibuprocaine Hydrochloride

  • if you are hypersensitive (allergic) to oxibuprocaine or any of the other ingredients of oxibuprocaine hydrochloride (listed in section 6);
  • if you are hypersensitive (allergic) to other local anaesthetics belonging to the same group of active substances (p-aminobenzoic acid).

Warnings and Precautions

Be especially careful with Oxibuprocaine Hydrochloride

If you wear contact lenses. Remove your contact lenses before instillation and wait until the anaesthetic effect has completely worn off before putting them back in your eye (see also 3. How to use Oxibuprocaine Hydrochloride).

In patients with a history of allergies, heart disease, asthma, hyperactive thyroid gland (hyperthyroidism), or liver disease, as well as in elderly patients.

If you have an inflamed eye, as red eyes greatly increase blood flow through the surface of the eyes.

Prolonged and repeated use

Oxibuprocaine Hydrochloride Agepha is intended for use by a doctor only and for a short period of time. Repeated and uncontrolled use can cause serious damage to the cornea of the eye. The same can be said of its long-term use.

Children and adolescents

The safety and efficacy of Oxibuprocaine Hydrochloride in children and adolescents have not been established.

Other medicines and Oxibuprocaine Hydrochloride

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Sulphonamides (present in certain antibiotics): The efficacy of these antibiotics may be reduced.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor. He will tell you whether you can be given Oxibuprocaine Hydrochloride or not.

Driving and using machines

This medicine may affect your ability to react, as well as your ability to drive. The use of Oxibuprocaine Hydrochloride may affect your vision and, therefore, also your ability to react when driving or using machines. Do not drive vehicles or use tools or machinery before this effect has worn off.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

3. How to use Oxibuprocaine Hydrochloride Agepha

The recommended dose is 1 drop for the eyes before the examination or procedure; this dose may be repeated if necessary.

Method of administration

For use in the eye. (To be instilled in the eye to be examined)

Your doctor or ophthalmologist will put the drops in your eye. You may be asked to press the inner corners of your eyelid for 1-2 minutes, which prevents the solution from passing into the nose and throat. This measure is especially advisable in elderly patients and at-risk populations.

Your eye will be numb for about an hour, depending on how many drops you have been given. Avoid touching your eye until the anaesthetic effect has worn off.

If you need to instil another eye drop, you should wait at least 15 minutes before administering it.

Although you may have received more oxibuprocaine hydrochloride than you should, it is very unlikely that you will suffer from the effects of an overdose.

If you suddenly feel unwell after the drops have been instilled, inform your doctor or ophthalmologist or contact the nearest emergency department immediately.

Warning for contact lens wearers

Remove your contact lenses before the eye drops are instilled and wait at least one hour after instillation, until the anaesthetic effect has completely worn off, before putting them back in. Failure to follow this recommendation may cause damage to the cornea.

If you use more Oxibuprocaine Hydrochloride than you should

Overdose: Poisoning with local/topical anaesthetics, especially when administered orally, can trigger the following symptoms: muscle spasms, convulsions, drop in blood pressure, fainting, arrhythmias, cardiac arrest caused by conduction problems, respiratory paralysis.

In such cases, consult a doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

Instructions for healthcare professionals

You will find information on overdose at the end of this leaflet.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should contact a doctor immediately if you experience any of the following symptoms of a severe allergic/anaphylactic reaction: swelling, skin rash, itching, urticaria, difficulty breathing, chills, flushing, headache, general malaise, nausea, restlessness, rapid heartbeat, or low blood pressure (which occurs in an unknown number of patients).

Other side effects that may occur:

Frequent (may affect up to 1 in 10 people):

The most common side effect is local irritation. Other common side effects are: temporary burning after instillation, corneal damage with repeated use.

Rare (may affect up to 1 in 1,000 people):

Tremors, blurred vision, slow heartbeat, low blood pressure, dizziness.

Frequency not known (frequency cannot be estimated from the available data):

Ocular allergy, allergic blepharitis (inflammation of the eyelids). The symptoms of ocular allergy and allergic blepharitis may be: itching, red and swollen eyelids, red eyes, irritated and watery eyes, burning or stinging eyes, scales and crusts on the edge of the eyelashes, similar to dandruff, sensitivity to light.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.

You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Oxibuprocaine Hydrochloride Agepha

This medicine does not require any special storage conditions.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month indicated.

To be used within 4 weeks after first opening.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Oxibuprocaine Hydrochloride Agepha

  • The active substance is oxibuprocaine hydrochloride

Each ml contains 4 mg of oxibuprocaine hydrochloride

  • The other ingredients are: boric acid, chlorhexidine diacetate, hydrochloric acid (for pH adjustment), water for injection.

Appearance and pack contents

Oxibuprocaine Hydrochloride Agepha 4 mg/ml eye drops solution is a clear and colourless solution, presented in a plastic bottle. Each pack contains a 10 ml bottle.

Marketing authorisation holder and manufacturer

AGEPHA Pharma s.r.o.,

Dialnicná cesta 5,

Senec 903 01,

Slovakia

This medicine is authorised in the Member States of the European Economic Area under the following names:

Member State

Medicine name

Austria

Novain 4 mg/ml Augentropfen, Lösung

Denmark

Obupro 4 mg/ml øjendråber, opløsning

Estonia

Novain 4 mg/ml silmatilgad, lahus

Finland

Obupro 4 mg/ml silmätipat, liuos

Ireland

Oxybuprocaine Agepha 4 mg/ml eye drops, solution

Latvia

Obupro 4 mg/ml acu pilieni, šķīdums

Iceland

Obupro 4 mg/ml augndropar, lausn

Croatia

Ophtesia 4 mg/ml kapi za oko, otopina

Lithuania

Novain 4 mg/ml akiu lašai (tirpalas)

Netherlands

Obupro 4 mg/ml oogdruppels, oplossing

Norway

Novain 4 mg/ml øyedråper, løsning

Poland

Obupro 4 mg/ml, krople do oczu, roztwór

Portugal

Novain 4 mg/ml colírio, solução

Sweden

Obupro 4 mg/ml ögondroppar, lösning

Spain

Oxibuprocaine Hydrochloride Agepha 4 mg/ml eye drops solution

Hungary

Obupro 4 mg/ml oldatos szemcsepp

Date of last revision of this leaflet: March 2024

This information is intended only for healthcare professionals:

Treatment in case of poisoning

Immediate management of respiratory and circulatory function (intubation and artificial ventilation), cardiovascular stimulation, perfusions (without adrenaline!). In case of cardiac arrest, external cardiac massage and electrostimulation should be performed. In case of convulsions, ultra-short-acting barbiturates or diazepam should be administered (long-acting barbiturates should not be administered due to the risk of respiratory depression)

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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Doctor

Daniel Cichi

Family medicine 24 years exp.

Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance. His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation. Patients commonly consult Dr Daniel Cichi for: 

  • acute symptoms: fever, infections, flu-like illness, cough, sore throat, shortness of breath;
  • chest discomfort, palpitations, dizziness, fatigue, and blood pressure concerns;
  • digestive problems: abdominal pain, nausea, diarrhoea, constipation, reflux;
  • sexually transmitted infections, erectile dysfunction;
  • muscle, joint, and back pain, minor injuries, post-traumatic symptoms;
  • chronic conditions: hypertension, diabetes, high cholesterol, thyroid disorders, weight loss, hair loss;
  • review and interpretation of lab tests, imaging reports, and medical documents;
  • medication review and treatment adjustment;
  • medical advice while travelling or living abroad;
  • second opinions and guidance on whether in-person care is needed.

Dr Cichi’s consultations are structured and practical. He focuses on clear explanations, risk assessment, and actionable recommendations, helping patients understand their symptoms and make informed decisions about their health.

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€55
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Doctor

Chikeluo Okeke

General medicine 4 years exp.

Dr Chikeluo Okeke is an internal medicine doctor with extensive international clinical experience. Originally from Nigeria, he has worked across multiple European healthcare systems and currently practises in Sweden. This professional path has given him a strong understanding of different medical approaches and the ability to work effectively with patients from diverse cultural and linguistic backgrounds.

Dr Okeke focuses on general internal medicine and adult primary care, combining clinical accuracy with careful attention to lifestyle, personal context, and everyday health concerns. His consultations are particularly well suited for people who seek medical advice online, live abroad, or need clear guidance without unnecessary complexity.

He provides online consultations covering symptom assessment, prevention, and long-term management of chronic conditions, helping patients understand what is happening and decide on appropriate next steps.

Common reasons for consultation:

  • General internal medicine concerns and initial health assessment.
  • Acute symptoms such as fever, cough, infections, pain, or weakness.
  • Chronic conditions and treatment adjustment.
  • Blood pressure issues, fatigue, metabolic concerns.
  • Preventive consultations and routine check-ups.
  • Interpretation of laboratory results and medical reports.
  • Medical advice for patients receiving care online.

Dr Okeke is known for his clear communication, calm approach, and cultural awareness. He listens carefully, explains medical decisions in a structured way, and supports patients in making informed choices about their health.

Online consultations with Dr Chikeluo Okeke offer reliable internal medicine care without geographic limitations, focused on medical relevance, clarity, and patient comfort.

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€60
5.0 (1061)
Doctor

Andrei Popov

General medicine 7 years exp.

Dr. Andrei Popov is a family physician with specialized training in the management of chronic pain. He provides video consultations for adults in Spain and across Europe: whether you have been living with pain for months that no one has been able to properly explain, or you need to resolve a health issue without waiting weeks for an appointment.

His approach is clear: to listen, organize your case, and provide you with a practical roadmap based on evidence-based medicine and adapted to your medical history and personal needs.

Pain: how he can help

  • Chronic pain (more than 3 months
  • Migraine and recurrent or high-intensity headaches
  •  Neck, lower back, back and joint pain
  •  Post-traumatic pain after injuries or surgeries
  •  Pain of neurological origin: neuralgia, neuropathic pain, fibromyalgia

General medicine

  • Frequent respiratory infections (cold, flu, persistent cough)
  • Hypertension, diabetes and metabolic disorders
  • Review of laboratory tests and MRI/CT reports (explained in clear language)
  • Preventive medicine and health monitoring
  • Second opinions and treatment adjustments (when clinically appropriate)

What the consultation is like
 Each session lasts up to 30 minutes. We review symptoms, medical history, medications and any tests you provide, and you finish the consultation with a clear treatment plan, defined next steps, and criteria to understand when follow-up may be needed. If warning signs are detected, he will clearly advise whether you need in-person care or urgent medical attention.

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€80
5.0 (184)
Doctor

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.

Areas of medical expertise:

  • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
  • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
  • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
  • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
  • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
  • Certified in radiological diagnostics and robotic surgery.
  • Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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€50
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Doctor

Joao Silva

General medicine 6 years exp.

Dr. João Silva is a physician with training and experience in the field of General and Family Medicine, dedicated to providing healthcare focused on the well-being and quality of life of his patients. Throughout his professional career, he has developed broad clinical competencies, striving to maintain a medical practice based on scientific evidence and continuous knowledge updates.

Between 2013 and 2019, he completed the Integrated Master's Degree in Medicine at the Abel Salazar Institute of Biomedical Sciences in Porto, where he acquired a solid academic and clinical education.

Subsequently, between January 2021 and December 2021, he completed the General Internship at the Entre Douro e Vouga Hospital Center in Santa Maria da Feira, where he had the opportunity to work in different hospital settings and deepen his competencies in several areas of medicine.

From January 2022 until March 2026, he works as a Resident Physician in General and Family Medicine at USF Salvador Machado in Oliveira de Azeméis, developing clinical activities in primary healthcare, follow-up of chronic patients, and health promotion in the community.

Complementing his medical training, Dr. João Silva also completed a Postgraduate Degree in Continuing and Palliative Care at CESPU, strengthening his preparation in the comprehensive approach to patient care, especially in situations requiring prolonged care and multidisciplinary support.

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€55
0.0 (0)
Doctor

Bulat Garipov

General medicine 15 years exp.

Dr. Bulat Garipov is a radiologist with more than 15 years of experience, specializing in magnetic resonance imaging (MRI). Throughout his professional career, he has worked in leading diagnostic imaging centers, both in on-site practice and teleradiology, which has allowed him to develop a broad and versatile approach to radiology.

Over the years, he has gained solid experience in interpreting MRI studies in various areas, including:

  •  Neuroimaging
  •  Musculoskeletal system (MSK)
  •  Angiography
  •  Abdomen and pelvis
  •  Soft tissues

Additionally, Dr. Garipov is open to new collaboration opportunities in radiology and teleradiology projects. He offers his expertise in MRI, providing both first and second readings of studies, as well as advanced image interpretation, ensuring accurate and high-quality diagnostics.

You could consult Dr. Bulat Garipov in cases where accurate interpretation of MRI studies or a second expert opinion is required. His expertise is especially valuable in cases of suspected neurological conditions, back and joint pain, vascular disorders, as well as in the diagnosis of abdominal and pelvic diseases. The doctor also provides support in complex or unclear clinical situations, including the review of previously performed studies, which helps improve diagnostic accuracy and determine the optimal treatment strategy. A teleradiology format is available, allowing you to receive a professional opinion remotely.

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€60

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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