Lumobry 0.25 mg/ml eye drops solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the patient
Lumobry 0.25 mg/ml, eye drops solution
brimonidine tartrate
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for use of this medicine provided 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 kind of adverse reaction, consult your doctor or pharmacist, even if it is an adverse reaction not listed in this leaflet. See section 4.
- If there is no improvement or if your condition worsens after 3 days of treatment, consult a doctor.
Leaflet contents
- What Lumobry is and what it is used for
- What you need to know before using Lumobry
- How to use Lumobry
- Possible adverse effects
- How to store Lumobry
- Contents of the pack and other information
1. What Lumobry is and what it is used for
Lumobry is a medication applied to the eyes. This product contains brimonidine tartrate as the active substance, which reduces eye redness by constricting the small blood vessels in the conjunctiva (the white part of the eye).
Therapeutic indications
Lumobry is used for the temporary symptomatic relief of isolated ocular redness due to mild non-infectious eye irritation in adults.
2. What you need to know before using Lumobry
Do not use Lumobry:
- If you are allergic to brimonidine or to any of the other ingredients of this medicine (listed in section 6)
- In children under 2 years of age.
Do not use this medicine if any of the above apply to you. If you are unsure, 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 recommend additional appropriate measures.
Reduction of eye redness should occur within 5–15 minutes. If your condition worsens or persists for more than 3 days (72 hours) after using Lumobry eye drops, stop using this product and seek immediate medical attention.
Stop using Lumobry and contact a doctor immediately if you experience eye irritation, eye infection, eye pain, changes in vision, persistent eye 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 directed by your doctor or if you do not press on the tear duct area of the eye near the nose after administration. If this occurs, you may experience dizziness and drowsiness. It may also cause cardiovascular problems, especially if you have untreated cardiovascular diseases, blood vessel blockages supplying the brain or heart, Raynaud's phenomenon, low blood pressure upon standing, or Buerger's disease.
Children and adolescents
Lumobry must not be used in children and adolescents.
Other medicines and Lumobry
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
When Lumobry is used for longer than directed by your doctor or if the tear duct area near the nose is not pressed after administration, brimonidine may be absorbed into the bloodstream. This could affect other medicines you are taking. Inform your doctor if you are taking:
- Medicines to treat intraocular pressure. Lumobry may reduce intraocular pressure and increase the effect of these medicines.
- Antidepressants (monoamine oxidase inhibitors [MAO inhibitors] or tricyclic antidepressants)
- Medicines to lower 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 enhance their effect.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, do not use this medicine or consult your doctor or pharmacist before using it.
Driving and use of machines
Lumobry may affect your ability to drive and use machinery. Like all eye products, it may cause temporary blurred vision, which could impair your ability to drive or operate machinery, especially at night or in low-light conditions. If you experience these symptoms, you should wait and avoid driving or operating machinery until the symptoms have resolved.
Lumobry contains benzalkonium chloride
This medicine contains 0.0034 mg of benzalkonium chloride per drop, equivalent to 0.1 mg/ml. Benzalkonium chloride may be absorbed by soft contact lenses, causing discoloration. You should remove your contact lenses before using this medicine and may reinsert them 15 minutes after administration.
Benzalkonium chloride may also cause eye irritation, particularly in cases of dry eye or corneal disorders (the transparent layer at the front of the eye). If you experience any unusual sensation, itching, or pain in your eyes after using this medicine, contact your doctor.
3. How to use Lumobry
Follow exactly the administration instructions for this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for ophthalmic use.
Do not use Lumobry simultaneously with other eye medications. If you are using other eye medications, you must wait 15 minutes between applications.
Wash your hands.
Remove contact lenses before using the product (see section 2: Lumobry contains benzalkonium chloride).
Press the cap while turning it, then remove it.
Tilt your head backward and gently pull down the lower eyelid to form a small pouch between the eyelid and the eye.
Hold the container upside down and squeeze it until one drop is dispensed into the eye.
Apply one drop into the affected eye every 6–8 hours, no more than four times a day. The tip of the container must not touch the eye or surrounding structures to avoid contamination.
After applying Lumobry to the affected eye(s), press gently on the tear duct area 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.
Reduction of ocular redness is usually achieved within 5–15 minutes. However, if the condition worsens or persists for more than 72 hours, discontinue use 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 accidentally ingest it, you may experience the following symptoms: decreased blood pressure, weakness, vomiting, lethargy, sedation, slow or irregular heartbeat, excessive pupil constriction, difficulty breathing or respiratory arrest, reduced muscle tone, decreased body temperature, or seizures.
In case of overdose symptoms, contact your doctor or go to the hospital as soon as possible.
In the event of overdose or accidental ingestion, seek immediate medical advice from your doctor or pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount ingested.
If you forget to use Lumobry
Do not apply a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
Common adverse effects (may affect up to 1 in 10 people):
- Eye redness
- Pain at the application site
Uncommon adverse effects (may affect up to 1 in 100 people):
- Dry eye
- Light sensitivity
- Eye discharge
- Eye irritation
- Eye pain
- Foreign body sensation in the eyes
- Irritation, burning, or itching at the instillation site
- Headache
- Palpitations
- Muscle fasciculations
- Lymphocytosis, monocytosis (elevated count of lymphocytes or monocytes in the blood)
- Nasal discomfort
- Hypotension (reduction in blood pressure)
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect 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 adverse 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 refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Take any unused medicines and empty containers to your pharmacy’s SIGRE disposal point. Ask your pharmacist how to dispose of medicines you no longer need. This helps protect the environment.
6. Contents of the pack and other information
Composition of Lumobry
The active substance is brimonidine tartrate.
The other components 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 injections.
Appearance of Lumobry and contents of the pack
Lumobry is a sterile, transparent eye drop solution, ranging from colourless to slightly yellowish, formulated for topical administration to the eyes.
Lumobry is available in 10 ml LDPE bottles with LLDPE dropper applicators (tips) and child-resistant two-part screw caps made of PP/HDPE. Each bottle has a fill volume of 7.5 ml.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 reviewed 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/).