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EMADINE 0.5 mg/ml EYE DROPS SOLUTION

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About the medicine

How to use EMADINE 0.5 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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Introduction

Package Leaflet: Information for the User

EMADINE 0.5mg/mleye drops solution.

emedastine

Read the entire package leaflet carefully before starting to use this medication, as it containsimportant information for you.

  • Keep this package leaflet, as you may need to read it again.
  • If you have any questions, consult your doctor or pharmacist.
  • This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

  1. What is EMADINE and what is it used for
  2. What you need to know before taking EMADINE
  3. How to use EMADINE
  4. Possible side effects
  5. Storage of EMADINE
  6. Package contents and additional information

1. What is EMADINE and what is it used for

EMADINE is a medicationfor the treatment of seasonal allergic conjunctivitis in the eyes (allergic eye conditions). It works by reducing the intensity of the allergic reaction.

Allergic conjunctivitis.Certain elements (allergens) such as pollen, house dust, or animal hair can cause allergic reactions that lead to itching and redness, as well as inflammation of the surface of your eyes.

You should consult a doctor if it worsens or does not improve.

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 taking EMADINE

Do not use EMADINE

  • If you are allergicto emedastine or any of the other components of this medication (listed in section 6).

Consult your doctor.

Warnings and precautions

  • Do not use EMADINE in children under 3years of age.
  • If you wear contact lenses, see section "EMADINE contains benzalkonium chloride".
  • It is not recommended to use EMADINEin patients over 65 years of age, as this age group has not been studied in clinical trials.
  • It is not recommended to use EMADINEin patients with liver or kidney problems.

Consult your doctor or pharmacist before starting to use EMADINE.

Other medications and EMADINE

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

If you use other eye drops at the same time as EMADINE, follow the recommendation at the end of section 3 "How to use EMADINE".

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

Immediately after applying EMADINE, you may notice that your vision becomes blurry. Do not drive or use machines until your vision is clear.

EMADINE contains benzalkonium chloride

This medication contains 0.5 mg of benzalkonium chloride in every 5 ml, equivalent to 0.1 mg/ml.

The preservative in EMADINE, benzalkonium chloride, can be absorbed by soft contact lenses and may alter their color. Remove your contact lenses before using this medication and wait 15 minutes before putting them back in. Benzalkonium chloride can cause eye irritation, especially if you have dry eyes or other corneal diseases (the transparent layer on the front of the eye). Consult your doctor if you feel any unusual sensation, itching, or pain in the eye after using this medication.

3. How to use EMADINE

Follow the instructions for administering EMADINE exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is for adults and children over 3 years of age: One drop in the eye, twice a day.

Follow the instructions for administering the medication contained in this package leaflet or as indicated by your doctor. If you are unsure, ask your doctor or pharmacist.

These drops should only be usedin the eyes.

Hand applying drops to the eye with a white dropper and lower eyelid slightly pulled downHand holding an auto-injector with the needle pointing downwards preparing for injection

1 2

  • Take the EMADINE bottle and stand in front of a mirror.
  • Wash your hands.
  • Take the bottle and unscrew the cap.
  • After opening the bottle for the first time, you must remove the security seal ring before using this medication.
  • Hold the bottle, upside down, between your thumb and index finger.
  • Tilt your head back. Gently separate the eyelid of the eye with a finger, until a pouch forms, where the drop should fall (Figure 1).
  • Bring the tip of the bottle close to the eye. You may find it helpful to use a mirror.
  • Do not touch the eye, eyelid, or surrounding areas with the dropper,as the drops remaining in the bottle may become infected.
  • Gently press the baseof the bottle to release one drop of EMADINE at a time.
  • Do not squeeze the bottle, as it is designed to release a drop with a gentle pressure on the base (Figure 2).
  • If you are applying drops to both eyes, repeat the previous steps for the other eye.
  • Screw the cap back on the bottle immediately after using the product.

If you accidentally swallow or inject EMADINE, contact your doctor immediately.It may affect your heart rate.

If a drop falls outside the eye,try again.

If you have applied too much,you can remove it by washing your eyes with sterile saline solution or, if not possible, with warm water. Do not apply more drops until it is time for your next dose.

If you forget to apply EMADINEwhen it is due, apply one drop as soon as you remember, and then continue with your usual treatment regimen. Do not apply adouble doseto make up for forgotten doses.

If you are using another eye drop, wait at least 10 minutes between applying EMADINE and the other drops. Ointments should be applied last.

If you have any further questions about using this medication, ask your doctor or pharmacist.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Unless the effects are severe, continue with the treatment as usual. If these effects concern you, consult your doctor or pharmacist.

Common side effects (may affect up to 1 in 10 people)

  • Eye effects: eye pain, itching of the eyes, redness of the eyes

Uncommon side effects (may affect up to 1 in 100 people)

  • Eye effects: corneal disorder, abnormal sensation in the eye, increased tear production, tired eyes, eye irritation, blurred vision, corneal spots, dry eye.
  • Other effects: headache, difficulty sleeping, headache (around the nasal sinuses), bad taste, rash

Frequency not known (cannot be estimated from available data)

  • Other effects: increased heart rate

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of EMADINE

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

Do not use EMADINE after the expiration date stated on the bottle and carton after "EXP". The expiration date is the last day of the month indicated.

Do not store above 25°C.

To avoid infections, you must discard the bottle fourweeks after opening it for the first time.Note the opening date on the space provided on the carton.

Opening date:

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of EMADINE

  • The active ingredient is emedastine 0.5 mg/ml as difumarate.
  • The other ingredients are benzalkonium chloride, trometamol, sodium chloride, hypromellose, and purified water. Small amounts of hydrochloric acid and/or sodium hydroxide are added to maintain normal acidity levels (pH levels).

Appearance of the product and package contents

EMADINE is a liquid (a solution) that comes in a carton containing a 5 ml plastic bottle with a screw cap. Only certain pack sizes may be marketed.

Marketing authorization holder

Immedica Pharma AB

SE-113 63 Stockholm

Sweden

Manufacturer

S.A. Alcon-Couvreur N.V.

Rijksweg 14

B-2870 Puurs

Belgium

Manufacturer

Siegfried El Masnou, S.A.

Camil Fabra 58,

08320 El Masnou

Barcelona

Spain

Manufacturer

Immedica Pharma AB

SE-113 63 Stockholm

Sweden

Date of the last revision of this package leaflet:

Other sources of information

Detailed information on this medication is available on the European Medicines Agency website: http://www.ema.europa.eu

Online doctors for EMADINE 0.5 mg/ml EYE DROPS SOLUTION

Discuss questions about EMADINE 0.5 mg/ml EYE DROPS SOLUTION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

5.0 (3)
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. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

  • seasonal and perennial allergies
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  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns

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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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:

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  • 12+ years of clinical experience in university hospitals in Germany and Spain.
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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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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.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
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  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
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.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
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  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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€58
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Doctor

Svetlana Kolomeeva

Cardiology 18 years exp.

Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

Patients commonly seek her help for:

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Dr Kolomeeva combines clinical expertise with personalised care. She clearly explains diagnoses, guides patients through symptoms and treatment options, and provides actionable plans. Her consultations are designed not only to address current complaints but also to stabilise chronic conditions and prevent future complications. She supports patients through every stage of care – from first symptoms to ongoing health management.

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€55
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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.

Cardiology – Diagnosis and treatment of:

  • High blood pressure, blood pressure fluctuations, and cardiovascular risk prevention.
  • Chest pain, shortness of breath, arrhythmias (tachycardia, bradycardia, palpitations).
  • Leg swelling, chronic fatigue, reduced exercise tolerance.
  • EKG interpretation, lipid profile evaluation, cardiovascular risk assessment (heart attack, stroke).
  • Post-COVID-19 cardiac monitoring and care.
Endocrinology – Diabetes, thyroid, metabolism:
  • Diagnosis and management of type 1 and type 2 diabetes, and prediabetes.
  • Individual treatment plans including oral medications and insulin therapy.
  • GLP-1 therapy– modern pharmacological treatment for weight management and diabetes control, including drug selection, monitoring, and safety follow-up.
  • Thyroid disorders – hypothyroidism, hyperthyroidism, autoimmune thyroid diseases (Hashimoto’s, Graves’ disease).
  • Metabolic syndrome – obesity, lipid disorders, insulin resistance.
Gastroenterology – Digestive health:
  • Abdominal pain, nausea, heartburn, gastroesophageal reflux (GERD).
  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
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  • Lab test analysis, therapy adjustments, medication management.
  • Adult vaccinations – planning, contraindications assessment.
  • Cancer prevention – screening strategies and risk assessment.
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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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€60

Frequently Asked Questions

Is a prescription required for EMADINE 0.5 mg/ml EYE DROPS SOLUTION?
EMADINE 0.5 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 EMADINE 0.5 mg/ml EYE DROPS SOLUTION?
The active ingredient in EMADINE 0.5 mg/ml EYE DROPS SOLUTION is emedastine. This information helps identify medicines with the same composition but different brand names.
How much does EMADINE 0.5 mg/ml EYE DROPS SOLUTION cost in pharmacies?
The average pharmacy price for EMADINE 0.5 mg/ml EYE DROPS SOLUTION is around 12.72 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures EMADINE 0.5 mg/ml EYE DROPS SOLUTION?
EMADINE 0.5 mg/ml EYE DROPS SOLUTION is manufactured by Immedica Pharma Ab. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of EMADINE 0.5 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 EMADINE 0.5 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.
What are the alternatives to EMADINE 0.5 mg/ml EYE DROPS SOLUTION?
Other medicines with the same active substance (emedastine) include AFLUON 0.5 mg/ml EYE DROPS SOLUTION, APADIN 1 mg/ml EYE DROPS SOLUTION, AZELASTINE ABAMED 0.5 mg/ml EYE DROPS SOLUTION. 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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