LUMOBRY 0.25 mg/ml EYE DROPS SOLUTION

Introduction

Leaflet: Information for the patient

Lumobry 0.25 mg/ml, eye drops solution

brimonidine tartrate

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

Follow exactly the instructions for use of this medicine contained in this leaflet or indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that is not listed in this leaflet. See section 4.
• If after 3 days of treatment you do not improve or worsen, consult a doctor.

Contents of the leaflet

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

1. What is Lumobry and what is it used for

Lumobry is a medicine that is applied to the eyes. This product contains brimonidine tartrate as the active ingredient, which reduces eye redness by constricting the small blood vessels of the conjunctiva (the white part of the eye).

Therapeutic indications

Lumobry is used for the symptomatic temporary relief of isolated eye redness due to mild non-infectious eye irritation in adults.

2. What you need to know before starting to use Lumobry

Do not use Lumobry:

• If you are allergic to brimonidine or any of the other components of this medicine (listed in section 6)
• In children under 2 years of age.

Do not use this medicine if any of the above assumptions apply to your case. If you have doubts, consult your doctor or pharmacist before using Lumobry.

Warnings and precautions

If your doctor can determine the cause of your eye redness (e.g., allergic reaction, dry eye syndrome), they may add the appropriate measures.

The reduction of eye redness should occur within 5-15 minutes. If after using Lumobry eye drops the situation worsens or persists for more than 3 days (72 hours), stop using this product and seek medical attention immediately.

Stop using Lumobry and contact a doctor immediately if you experience eye irritation, eye infection, eye pain, changes in vision, continuous redness, eye injury, or sensitivity to light.

There is a risk that brimonidine may be absorbed into the bloodstream if you use Lumobry for longer than indicated by your doctor or if you do not press the lacrimal area of the eye, near the nose, after use. If this happens, you may experience dizziness and drowsiness. It can also cause cardiovascular problems, especially if you have untreated cardiovascular diseases, obstruction of blood vessels that reach the brain or heart, Raynaud's phenomenon, low blood pressure when standing, or Buerger's disease.

Children and adolescents

Lumobry should not be used in children and adolescents.

Other medicines and Lumobry

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

When Lumobry is used for longer than indicated by your doctor or if the lacrimal area of the eye is not pressed after use, brimonidine may be absorbed into the bloodstream. This may affect other medicines you are taking. Inform your doctor if you are receiving:

• Medicines to treat intraocular pressure. Lumobry may reduce intraocular pressure and increase the effect of these medicines.
• Antidepressants (monoamine oxidase inhibitors [MAO] or tricyclic antidepressants)
• Medicines to reduce blood pressure
• Alcohol, barbiturates, opioids, sedatives, or anesthetics

Eye drops containing brimonidine may also reduce intraocular pressure. Inform your doctor or pharmacist if you are using medicines to treat ocular hypertension (increased pressure inside the eye), as Lumobry may increase their effect.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, do not use this medicine or consult your doctor or pharmacist before using it.

Driving and using machines

Lumobry may affect your ability to drive and use machines. Like all products administered to the eye, it may cause temporary blurred vision, which can alter your ability to drive or operate machinery, especially at night or in low light conditions. If you experience these changes, you should wait and not drive or operate machinery until the symptoms have disappeared.

Lumobry contains benzalkonium chloride

This medicine contains 0.0034 mg of benzalkonium chloride per drop, which is equivalent to 0.1 mg/ml. Benzalkonium chloride may be absorbed by soft contact lenses, causing changes in their color. You should remove your contact lenses before using this medicine and can put them back 15 minutes later.

Benzalkonium chloride can also cause eye irritation, especially in cases of dry eye or corneal disorders (the transparent layer of the front of the eye). If you notice any unusual sensation, itching, or pain in your eyes after using this medicine, contact your doctor.

3. How to use Lumobry

Follow exactly the instructions for administration of this medicine contained in this leaflet or indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

This medicine should be used in the eyes.

Do not apply Lumobry simultaneously with other eye medicines. If you use other eye medicines, you should wait 15 minutes between applications.

Wash your hands.

Remove your contact lenses before using the product (see section 2 Lumobry contains benzalkonium chloride).

Press the cap of the container while turning it and then remove it.

Tilt your head back and gently pull down the lower eyelid to form a small pocket between the eyelid and the eye.

Place the container upside down and squeeze until a drop is dispensed into the eye.

Apply one drop to the affected eye every 6-8 hours, no more than four times a day. The tip of the container should not come into contact with the eye or surrounding structures to avoid contamination.

After applying Lumobry to the affected eyes, press the lacrimal area of the eye near the nose and keep the eyelid closed for 2 minutes.

After application, replace the cap and close the container tightly.

Wash your hands after using the product.

The reduction of eye redness is usually achieved within 5-15 minutes, but if the situation worsens or persists for more than 72 hours, stop using the product and consult your doctor or pharmacist for an eye examination.

If you use more Lumobry than you should

If you use too much Lumobry or ingest it accidentally, you may experience the following symptoms: decreased blood pressure, weakness, vomiting, lethargy, sedation, slow or irregular heartbeat, excessive pupillary constriction, breathing difficulties or respiratory arrest, decreased muscle tone, reduced body temperature, or convulsions.

In case of overdose symptoms, contact your doctor or go to the hospital as soon as possible.

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.

If you forget to use Lumobry

You should not apply a double dose to make up for the forgotten dose.

If you have any other doubts about 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.

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

• Eye redness
• Pain at the application site.

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

• Dry eye
• Sensitivity to light
• Eye discharge
• Eye irritation
• Eye pain
• Foreign body sensation in the eyes
• Irritation, itching, or stinging at the application site.
• Headache
• Palpitations
• Muscle fasciculations
• Lymphocytosis, monocytosis (elevated lymphocyte or monocyte count in the blood)
• Nasal discomfort
• Hypotension (reduced blood pressure)

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance 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 Lumobry

Do not store above 25°C.

Discard 4 months after opening the container.

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

Do not use this medicine after the expiry date stated on the carton, label, or container after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines you no longer need at the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Lumobry

The active ingredient is brimonidine tartrate.

The other ingredients are: glycerol (E422), borax (E285), boric acid (E284), potassium chloride (E508), calcium chloride dihydrate, sodium chloride, benzalkonium chloride, sodium hydroxide (E524), hydrochloric acid (E507), water for injectable preparations.

Appearance of Lumobry and package contents

Lumobry is a sterile, transparent, colorless to slightly yellowish eye drop solution, formulated for topical administration in the eyes.

Lumobry is available in 10 ml LDPE bottles with LLDPE dropper tips and PP/HDPE two-piece child-resistant caps. Each bottle has a fill volume of 7.5 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Bausch + Lomb Ireland Limited

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24 PPT3

Ireland

Local representative in Spain

Bausch & Lomb S.A.

Avda. Valdelaparra, nº 4

28108 Alcobendas

Madrid, Spain.

Tel: 91 – 657 63 00

Manufacturer:

Bausch + Lomb Ireland Limited

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

This leaflet was last revised in June 2025.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).