Lumobry

Package leaflet: Information for the patient

Lumobry, 0.25 mg/mL, eye drops, solution
Brimonidini tartras
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Lumobry is and what it is used for
2. Important information before using Lumobry
3. How to use Lumobry
4. Possible side effects
5. How to store Lumobry
6. Contents of the pack and other information

1. What Lumobry is and what it is used for

Lumobry is an ophthalmic (eye) medicine. The active substance in Lumobry is brimonidine tartrate, which reduces eye redness by constricting small blood vessels in the conjunctiva (the white part of the eye).
Indications
Lumobry is used for the temporary, symptomatic relief of isolated eye redness resulting from minor, non-infectious eye irritation in adults.

2. Important information before using Lumobry

When not to use Lumobry:

• if the patient is allergic to brimonidine or 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 situations listed above apply to the patient. If in doubt, consult a doctor or pharmacist before using Lumobry.

Warnings and precautions

If the doctor is able to identify the cause of eye redness (e.g. allergic reaction, dry eye syndrome), appropriate measures will be taken.

Reduction of eye redness should occur within 5–15 minutes. However, if after using Lumobry the redness worsens or persists for longer than 3 days (72 hours), discontinue use and contact an ophthalmologist immediately.

Discontinue use and contact an ophthalmologist immediately if eye irritation, eye infection, eye pain, changes in vision, persistent redness, eye injury, or light sensitivity occur.

There is a risk of brimonidine being absorbed into the bloodstream if Lumobry is used for longer than prescribed by a doctor or if the inner corners of the eyes near the nose are not pressed after instillation. This may cause dizziness and drowsiness, as well as cardiovascular problems, especially if the patient has untreated heart disease, cerebral or cardiovascular vessel narrowing, Raynaud's syndrome, low blood pressure upon standing, or Buerger's disease.

Children and adolescents

Lumobry should not be used in children and adolescents.

Lumobry with other medicines

Inform the doctor about all medicines currently used or recently used, as well as any medicines planned for future use.

If Lumobry is used for longer than prescribed by a doctor or if the inner corners of the eyes near the nose are not pressed after instillation, brimonidine may enter the bloodstream. This may affect the action of other medicines the patient is taking. Inform the doctor if the patient is using:

• medicines used to treat elevated intraocular pressure. Lumobry may reduce intraocular pressure and may enhance the effect of these medicines,
• antidepressants (monoamine oxidase inhibitors (MAO inhibitors) or tricyclic antidepressants),
• blood pressure-lowering medicines,
• alcohol, barbiturates, opioid painkillers, sedatives, or anesthetics.

Eye drops containing brimonidine may also reduce intraocular pressure. Inform the doctor or pharmacist if the patient is using medicines for ocular hypertension (elevated intraocular pressure), as Lumobry may enhance the effect of these medicines.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery

Lumobry may affect the ability to drive and operate machinery. Like all medicines administered into the eye, it may cause transient blurred vision, which may impair the ability to drive or operate machinery, especially at night or under low lighting conditions. If such symptoms occur, wait until they resolve before driving or operating machinery.

Lumobry contains benzalkonium chloride

The 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 and may change their color. Remove contact lenses before using the medicine and reinsert them 15 minutes after application.

Benzalkonium chloride may cause eye irritation, especially if the patient has dry eyes or corneal disorders (the transparent layer at the front of the eye). If after using this medicine the patient experiences unusual sensations inside the eye, stinging, or eye pain, contact a doctor.

3. How to use Lumobry

This medicine should always be used exactly as directed by the doctor. In case of doubt, consult
the doctor or pharmacist. Do not use this medicine for longer than prescribed by the doctor.
This medicine is for ophthalmic use (in the eye[s]).
Do not use Lumobry simultaneously with other ophthalmic medicines. If the patient is using other
eye medications, a 15-minute interval should be maintained between the administration of these
medicines.
Wash hands thoroughly.
Remove contact lenses before using the medicine (see section 2, Lumobry contains benzalkonium chloride).
Press the bottle cap while unscrewing it, then remove the cap.
Tilt the head backward and gently pull down the lower eyelid to create a small pocket between
the eyelid and the eye.
Invert the bottle and squeeze it until one drop is instilled into the eye.
Instill one drop into the affected eye(s) every 6–8 hours, no more than four times daily. The tip of
the dosing container must not touch the eye or surrounding structures to avoid contamination.
After instillation of Lumobry into the affected eye(s), press the inner corner (corners) of the eye(s)
near the nose and keep the eyelids closed for 2 minutes.
Replace the cap and close the bottle tightly immediately after use.
Wash hands thoroughly after using the medicine.
Redness of the eyes should improve within 5–15 minutes. If the condition worsens or persists for
longer than 72 hours, discontinue use and consult a doctor or pharmacist.
Using more Lumobry eye drops than recommended
If the patient has used an excessive dose of Lumobry eye drops or accidentally ingested the
medicine orally, the following symptoms may occur: low blood pressure, weakness, vomiting,
lethargy, sedation, slow or irregular heartbeat, excessive pupil constriction, breathing difficulties
or respiratory arrest, reduced muscle tone, lowered body temperature, or seizures.
In case of overdose symptoms, seek immediate medical attention from a doctor or go to the
hospital.
Missing a dose of Lumobry
Do not use a double dose to make up for a missed dose.
For any further questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.

Common adverse reactions (may occur in up to 1 in 10 patients):

• Redness of the eye
• Pain at the site of administration

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• Dry eye
• Light sensitivity
• Eye discharge
• Eye irritation
• Eye pain
• Foreign body sensation in the eyes
• Irritation, burning, or itching at the site of administration
• Headache
• Palpitations
• Muscle tremor
• Lymphocytosis, monocytosis (high number of lymphocytes or monocytes in the blood)
• Nasal discomfort
• Hypotension (low blood pressure)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921301
Fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Lumobry

Do not store above 25°C.
Discard 4 months after first opening the bottle.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, label, or bottle after "EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Lumobry contains

• The active substance 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 injections.

What Lumobry looks like and contents of the pack
Lumobry is a clear, colourless to slightly yellow, sterile eye drop solution, intended for topical ocular use.
Lumobry is available in a 10 mL LDPE bottle filled with 7.5 mL of solution, packed in a cardboard box. The bottle is equipped with a dropper made of LLDPE and a two-part cap made of PP/HDPE, which is child-resistant.
Marketing Authorisation Holder
Bausch + Lomb Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24 PPT3
Ireland
email: [email protected]
Importer:
Bausch + Lomb Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24 PPT3
Ireland