Patient leaflet - Lumobry 0.25 mg/ml, eye drops, solution
1. What Lumobry is and what it is used for
Lumobry eye drops is a drug topically applied on the eye(s). The product contains brimonidine tartrate as an active substance. Brimonidine tartrate is an α2-adrenoceptors agonist (sympathomimetic) displaying potent blood-vessels constricting properties thus provides the eye blanching activity.
Therapeutic indications
Lumobry eye drops is indicated in topical, short-term treatment of isolated conjunctival hyperaemia due to minor eye irritation in adults.
2. What you need to know before you use Lumobry eye drops
Do not use Lumobry eye drops:
if you are allergic to brimonidine or any
of the other ingredients of this medicine (listed in section 6).
in prolonged ocular hyperaemia
(ocular redness)
- in prolonged eye irritation
in bacterial, viral and fungal ocular
infections (manifesting e.g. with the eye mucous or purulent discharge)
- in eye(s) pain
- in cases of vision changes or disturbances.
Do not use this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using Lumobry eye drops.
Warnings and precautions
Talk to your doctor, pharmacist before using Lumobry eye drops.
For external use only.
Lumobry is designed only for short-term use.
If your doctor will be able to define the cause of your eye redness (e.g. allergic reaction, dry eye disease), appropriate measures will be introduced.
A reduction in ocular redness should occur within 5-15 minutes, however, if after the use of Lumobry eye drops the condition worsens or persists for more than 3 days (72 hours), stop using this product and refer to ophthalmologist immediately.
If after the use of Lumobry eye drops you experience eye pain, changes in vision, skin or eye allergy, continued redness or irritation of the eye, stop using the product and refer to ophthalmologist immediately.
Eye irritation or redness caused by a serious ocular condition, such as infection, foreign body or damage to the cornea, acute glaucoma or iritis (inflammation of the iris) requires immediate medical attention.
In the case of infection at the site of application of the medicinal product, you should refer to ophthalmologist who will decide about appropriate antibacterial and/or antifungal treatment introduction. Any spread of infection requires referring to ophthalmologist who will decide about Lumobry eye drops withdrawal till the time of infection cure.
If you suffer from cardiovascular diseases such as: severe or unstable and uncontrolled cardiovascular disease, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension or thromboangiitis obliterans (inflammation and clotting of arteries and veins of hands and feet), you should take special care when using this product since brimonidine if absorbed (when used incorrectly or for prolonged time) may affect circulatory functions and worsen disease symptoms.
If you suffer from depression, you should special attention when using this product since brimonidine, if absorbed (when used incorrectly or for prolonged time), easily passes the blood-brain barrier and attenuates the central nervous system functions. Dizziness, somnolence, sedation and other similar symptoms may occur. If you notice worsening of disease symptoms, you should refer to a doctor.
If you use contact lenses you should avoid contact them with the drug solution as it may cause lenses discolouration. After ocular installation of Lumobry eye drops you should maintain at least 15-minute interval before lenses reinsertion.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine.
Children and adolescents
The Lumobry eye drops should not be used in children and adolescents.
Other medicines and Lumobry eye drops
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
No interactions are known for ocular use of brimonidine tartrate in combination with other drugs used onto the eye. However, if brimonidine is absorbed to the blood circulation after application onto the eye, it may interfere with activity of several groups of medicines administered orally or parenterally.
These groups include antidepressant medicines (attenuated activity), CNS depressants (enhanced activity), hypotensive and other cardiovascular-active drugs (decreased or enhanced activity).
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, do not use this medicine or ask your doctor or pharmacist for advice before using it.
Driving and using machines
Lumobry 0.25 mg/ml, eye drops, medicinal product has minor influence on the ability to drive and use machines. As all products administered to eye, it may cause transient blurred vision, which may impair the ability to drive or to use machinery, especially at night or in reduced lighting. If you experience such disturbances you should wait until these symptoms have cleared before driving or using machinery.
Lumobry eye drops contains benzalkonium chloride
This medicine contains 0.0034 mg
benzalkonium chloride in each drop, which is equivalent to 0.10 mg/ml. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.
3. How to use Lumobry eye drops
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The drug should not be used longer than it was recommended by a doctor.
You should use the medicine locally onto the eye(s).
Do not apply Lumobry eye drops
simultaneously with other ophthalmic medicinal products used topically. If you use other topical ophthalmic medicinal products, you should keep the 15-minute interval between application of your medicines.
Wash your hands and remove your contact lenses before application of the product.
The cap of the bottle should be pushed down while turning then taken off.
The patient’s head must be tilted back and the lower eyelid must be pulled gently down to form a small pocket between the eyelid and the eye.
The bottle should be inverted and squeezed until a single drop is dispensed into the eye.
Apply one drop in the affected eye(s) every 6 – 8 hours, no more than four times daily. The tip of the dispensing container should not contact with the eye or surrounding structures in order to prevent contamination.
Lumobry should not be used longer than 3 days (72 hours). A reduction in ocular redness should normally occur within 5-15 minutes, however. if the condition worsens or persists for more than 72 hours, you should stop using the product and your eyes should be re-evaluated by an ophthalmologist.
After application of the Lumobry eye drops in the affected eye(s), you should press the corner(s) of the eye near the nose and close the eyelids for 2 minutes.
The cap must be put back on and the bottle must be closed tightly straight after it has been used.
Wash your hands thoroughly after using the product.
Renal/hepatic impairment
Brimonidine has not been studied in patients with hepatic or renal impairment.
Use in children and adolescents
The Lumobry should not be used in children and adolescents.
If you use more Lumobry eye drops than it is recommended
After long-term use of Lumobry eye drops overdose or after accidental oral ingestion, the following symptoms may occur: decreased blood pressure, weakness, vomiting, lethargy, sedation, slow or irregular heart rhythm, excessive constriction of the pupil, difficulty breathing or no breath, decreased muscle tone, decreased body temperature or seizures.
If overdose symptoms occur, talk to your doctor or go to hospital as soon as possible.
If you forget to use Lumobry eye drops
Do not take a double dose to make up for a forgotten dose.
If you stop using Lumobry eye drops
If you have any further questions on 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.
In clinical studies, Lumobry medicinal product has been shown to possess similar safety profile as the product without active substance (Placebo).
Common local adverse reactions (may occur in 1 to 10 patients per 100 treated patients): - Ocular hyperaemia (also known as ocular
redness - small dilated blood vessels) - Installation site pain.
Uncommon local adverse reactions
(may occur in 1 to 10 patients per 1 000 treated patients):
- Dry eye
- Photophobia
- Eye discharge
- Eye irritation
- Eye pain
- Foreign body sensation in eyes
- Installation site irritation, burning or itching.
Uncommon systemic adverse reactions
(may occur in 1 to 10 patients per 1 000 treated patients):
- Headache
- Palpitations
- Muscle twitching
Lymphocytosis, monocytosis (high count of
lymphocytes or monocytes in blood) - Nasal discomfort
- Hypotension (decreased blood pressure).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Lumobry
2 years (unopened)
Do not store above 25°C.
Discard 121 days after the first opening.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle after EXP The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will 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: Glycerin (Glycerol) E422, Sodium Borate Decahydrate (Borax) E285, Boric Acid E284, Potassium Chloride E508, Calcium Chloride Dihydrate, Sodium Chloride. Benzalkonium Chloride 0.01% is added as a preservative. Sodium Hydroxide E524 and Hydrochloric Acid E507 are added to adjust pH, water for injection.
What Lumobry looks like and contents of the pack
The Brimonidine Tartrate Ophthalmic Solution, 0.25 mg/ml drug product is a clear, colorless to slightly yellow, sterile, preserved ophthalmic solution formulated for topical delivery to the eye.
Marketing Authorisation Holder
Bausch + Lomb UK Ltd.
106 London Road
Kingston-upon-Thames
Surrey
KT2 6TN
UK
Manufacturer
Bausch + Lomb Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
This leaflet was last revised in May 2024.
9804900 (Folded) 9805000 (Flat)