Prospect: Patient Information

Lumobry 0.25 mg/ml Eye Drops in Solution

brimonidine, tartrate

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.

-This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor, pharmacist, or nurse,even if they are not listed in this prospect. See section4.

1.What is Lumobry Eye Drops and for what it is used

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

3.How to use Lumobry Eye Drops

4.Possible adverse effects

5.Storage of Lumobry Eye Drops

6.Contents of the package and additional information

Lumobry eye drops is a medication that is applied topically to the eyes. This product contains the active ingredient brimonidine tartrate. Brimonidine tartrate is an α2-adrenergic receptor agonist (sympathomimetic) with potent vasoconstrictive properties responsible for the bleaching action of the eye.

Therapeutic indications

Lumobry eye drops is indicated for the topical and short-term treatment of isolated conjunctival hyperemia due to mild ocular irritation in adults.

Do not use Lumobry eye drops:

• If you are allergic to brimonidine or any of the other components of this medication (listed in section6)
• In case of prolonged ocular hyperemia (eye redness)
• In case of prolonged ocular irritation
• In case of bacterial, viral, or fungal ocular infection (manifested, for example, with mucous or purulent ocular discharge)
• In case of eye pain
• In cases of changes or alterations in vision

Do not use this medication if any of the above conditions apply to you. If you are unsure, consult your doctor or pharmacist before using Lumobry eye drops.

Warnings and precautions

Consult your doctor or pharmacist before using Lumobry eye drops.

For external use only.

Lumobry is designed for short-term use only.

If your doctor can determine the cause of your eye redness (e.g., allergic reaction, dry eye syndrome), they may add 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), discontinue use of this medication and seek immediate attention from an ophthalmologist.

If, after using Lumobry eye drops, you experience eye pain, changes in vision, skin or eye allergy, continued eye irritation or redness, discontinue use of the product and seek immediate attention from an ophthalmologist.

Eye redness or irritation due to a serious ocular condition (such as infection, foreign body, or corneal damage, acute glaucoma, or iritis [inflammation of the iris]) requires immediate medical attention.

In case of infection at the site of application of the medication, you should seek the opinion of an ophthalmologist to decide on the introduction of an appropriate antibacterial and/or antifungal treatment. The spread of the infection requires referral to an ophthalmologist, who will decide on the removal of Lumobry eye drops until the infection has been cured.

If you have cardiovascular diseases such as severe or uncontrolled cardiovascular disease, coronary or cerebral insufficiency, Raynaud's phenomenon, orthostatic hypotension, or thromboangiitis obliterans (inflammation and obstruction of the arteries and veins of the hands and feet), you should exercise special caution when using this medication, as brimonidine absorption (due to incorrect use or prolonged use) may affect circulation and worsen symptoms of the disease.

If you have depression, you should exercise special attention when using this medication, as brimonidine absorption (due to incorrect use or prolonged use) may easily cross the blood-brain barrier and attenuate the functions of the central nervous system. Dizziness, somnolence, sedation, and other similar symptoms may appear. If you observe worsening of the disease symptoms, you should contact a doctor.

If you wear contact lenses, you should avoid them coming into contact with the medication, as it may cause discoloration of the lenses. After ocular instillation of Lumobry eye drops, you should wait at least 15 minutes before reinserting the lenses.

If you are unsure whether any of these aspects apply to you, consult your doctor or pharmacist before using this medication.

Children and adolescents

Lumobry eye drops should not be used in children and adolescents.

Other medications and Lumobry eye drops

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

No interactions have been reported between topical brimonidine and other eye medications. However, if brimonidine is absorbed into the bloodstream after its application in the eye, it may interfere with the activity of different groups of medications administered orally or parenterally. These groups include antidepressants (attenuated activity), central nervous system depressants (increased activity), hypotensives, and other cardiovascular medications (decreased or increased activity).

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

Lumobry 0.25 mg/mL eye drops have a small effect on the ability to drive and operate machinery. Like all eye medications, it may cause temporary blurred vision, which may affect the 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 these symptoms have disappeared.

Lumobry eye drops contain benzalkonium chloride

Benzalkonium chloride can be absorbed by soft contact lenses and may alter the color of the lenses. Remove contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases. Consult your doctor if you feel a strange sensation, burning, or pain in the eye after using this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. This medication should not be used for a longer period than recommended by your doctor.

This medication should be used locally in the eyes.

Do not apply Lumobry eye drops at the same time as other topical eye medications. If you use other topical eye medications, you should maintain a 15-minute interval between the application of the medications.

Wash your hands and remove your contact lenses before applying the product.

Pull the cap of the bottle down while turning it and then remove it.

The patient's head should be tilted back and the lower eyelid should be gently pulled down until a small space forms between the eyelid and the eye.

Place the bottle upside down and press until a drop is dispensed into the eye.

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

Lumobry should not be used for more than 3 days (72 hours). Reducing eye redness usually occurs in 5-15 minutes, but if the situation worsens or persists for more than 72 hours, discontinue use of the product and an ophthalmologist should re-evaluate your eyes.

After applying Lumobry eye drops in the affected eye, press the corner of the eye near the nose and keep the eyelid closed for 2 minutes.

Immediately after application, replace the cap and close the bottle tightly.

Wash your hands thoroughly after using the product.

Renal/hepatic insufficiency

Brimonidine has not been studied in patients with renal or hepatic impairment.

Use in children and adolescents

Lumobry should not be used in children and adolescents.

Using more Lumobry eye drops than you should

After long-term use of Lumobry eye drops, in case of overdose or accidental ingestion, the following symptoms may appear: decreased blood pressure, weakness, vomiting, drowsiness, sedation, slow or irregular heart rate, excessive pupil constriction, difficulty breathing or respiratory arrest, muscle tone reduction, reduced body temperature, or seizures.

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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Lumobry

Do not apply a double dose to compensate for the missed dose.

If you interrupt treatment with Lumobry eye drops

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

In clinical studies, Lumobry has shown a safety profile similar to that of the product without the active ingredient (placebo).

Frequent Local Adverse Reactions(may affect between 1 and 10 patients per 100 treated patients):

• Conjunctival hyperemia(also known as mild conjunctival redness or slight dilation of blood vessels)
• Pain at the site of instillation.

Possible Local Adverse Reactions(may affect between 1 and 10 patients per 1,000 treated patients):

• Dry eye
• Photophobia
• Ocular secretion
• Ocular irritation
• Ocular pain
• Sensation of a foreign body in the eyes
• Irritation, itching, or pruritus at the site of instillation.

Possible Systemic Adverse Reactions(may affect between 1 and 10 patients per 1,000 treated patients):

• Headache
• Palpitations
• Muscular fasciculations
• Lymphocytosis, monocytosis (elevated count of lymphocytes or monocytes in the blood)
• Nasal discomfort
• Hypotension (reduction in blood pressure)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse,even if it is a possible adverse effect that does not appear in this prospectus.You can also report adverse effects directly through the Spanish System for Human Pharmacovigilance:https://www.notificaram.es. Reporting adverse effects will contribute to the provision of more information on the safety of this medication.

2 years (without opening)

Do not conserve at a temperature above 25°C.

Discard 121 days after the opening of the packaging.

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

Do not use this medication after the expiration date that appears on the label or packaging.

The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash. Deposit the containers and medications that you no longer need at the SIGRE collection pointof the pharmacy. In case of doubt, ask your pharmacist how to dispose of the medications that you no longer need. By doing so, you will help protect the environment.

Composition of Lumobry

The active ingredient isbrimonidine tartrate.

The other components are: glycerol E422, Borax E285, boric acid E284, potassium chloride E508, dihydrate calcium chloride, sodium chloride, benzalkonium chloride at 0.01% added as a preservative, and sodium hydroxide E524 and hydrochloric acid E507 added to adjust the pH.

Appearance of Lumobry and contents of the packaging

Brimonidine tartrate 0.25 mg/ml eye drops is a clear, colorless to slightly yellow, sterile, and preservative-containing eye drop solution, formulated for topical ocular administration.

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 Responsible 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

Responsible Manufacturer:

Bausch + Lomb Ireland Limited

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

This leaflet was last reviewed in September 2024.

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).