Luxfen

PATIENT INFORMATION LEAFLET: USER INFORMATION

Luxfen, 2 mg/ml, eye drops, solution
brimonidine tartrate

Read the leaflet carefully before using the medicine, as it contains important information for the patient

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Luxfen and what is it used for

Luxfen is used to lower the pressure inside the eye. Luxfen may be used as
a single medication in patients for whom beta-blocker eye drops are contraindicated or as an adjunctive therapy with other eye drops when intraocular pressure is not sufficiently lowered with single-agent therapy for open-angle glaucoma or ocular hypertension. The active substance of Luxfen is brimonidine tartrate, which reduces the pressure inside the eye.

2. Important information before using Luxfen

When not to use Luxfen:

• If the patient has been diagnosed with hypersensitivity to brimonidine tartrate or any of the other ingredients of this medicine (listed in section 6).
• If the patient is taking monoamine oxidase inhibitors (MAOIs) and certain antidepressants. The doctor should be informed if any antidepressants are being taken.
• In newborns, infants, and children under 2 years of age.
• In breastfeeding women, the use of the medicine is not recommended.

Warnings and precautions

Before starting treatment with Luxfen, discuss it with your doctor or
pharmacist:

• If the patient has or has had depression, impaired mental function, cerebral circulatory disorders, heart problems, limb circulatory disorders, or blood pressure disorders.
• If the patient has or has had kidney or liver function disorders.
• If the medicine is used in children between 2 and 12 years of age, as Luxfen is not recommended in this age group.

Consult a doctor if any of the above situations apply to the patient!

Children and adolescents

Brimonidine is not recommended for use in children (between 2 and 12 years of age).
The medicine is contraindicated in newborns, infants (and children under 2 years of age).

Luxfen and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.
Inform your doctor if the patient is taking:

• analgesics, sedatives, opioid analgesics, barbiturates, and in case of regular alcohol consumption;
• anesthetics;
• cardiac or antihypertensive medications;
• chlorpromazine, methylphenidate, reserpine;
• medicines acting on the same receptor as Luxfen, e.g., isoprenaline and prazosin;
• monoamine oxidase inhibitors (MAOIs) and other antidepressants;
• other medicines, even if their use is not related to eye disease;
• or if the doses of currently used medicines have changed. They may affect treatment with Luxfen.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
Do not breastfeed while using Luxfen.

Driving and operating machinery

• Luxfen may cause blurred and/or disturbed vision. These symptoms may worsen at night or in low light.
• In some patients, Luxfen may cause drowsiness or a feeling of fatigue.
• Do not drive or operate machinery until the above symptoms have resolved.

Luxfen contains benzalkonium chloride.

The medicine contains 0.05 mg of benzalkonium chloride per ml, which corresponds to 0.025 mg/5 ml.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Remove contact lenses before instillation and wait at least 15 minutes before reinserting.
Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations in the eye, stinging, or eye pain occur after using the medicine, consult a doctor.

3. How to use Luxfen

This medicine should always be used exactly as advised by your doctor or pharmacist. In
case of doubt, consult your doctor or pharmacist.

Use in adults

The usual dose is one drop into each affected eye, administered twice daily, approximately 12 hours apart.

Use in children under 12 years of age

Do not use Luxfen in newborns, infants, and children under 2 years of age.
Do not recommend the use of Luxfen in children (2-12 years of age)

Method of administration

Brimonidine is intended for ophthalmic use only. Do not take the medicine orally.
Before instillation, always wash your hands. Information on the number of drops to be administered in each dose can be found on the prescription. When using Luxfen with other eye drops, wait at least 5-15 minutes between instillation of Luxfen and administration of other drops.
Administer the medicine as follows:

• 1. Tilt your head back and look up at the ceiling.
• 2. Gently pull the lower eyelid down to create a small pocket.
• 3. Hold the bottle upside down and press to release one drop into the eye.
• 4. Immediately after administering each drop, close your eye and press the inner corner of your eye (near your nose) with your finger for 1 minute. This helps to reduce the absorption of brimonidine into the body.

Avoid touching the eye or objects with the dropper tip.

Using more than the recommended dose of Luxfen

Adults

In adults who have been administered more drops than recommended, reported adverse reactions were those currently known to occur with Luxfen.
In adults who have accidentally ingested Luxfen, a decrease in blood pressure has been reported, followed by an increase in blood pressure in some patients.

Children

Severe adverse reactions have been reported in children who have accidentally ingested Luxfen. The following symptoms have been observed: drowsiness, decreased muscle tone, decreased body temperature, pallor, and breathing difficulties. If any of these symptoms occur, consult a doctor immediately.

Adults and children

In case of ingestion or administration of a higher dose of Luxfen than recommended, consult a doctor immediately.

Missing a dose of Luxfen

If a dose is missed, it should be administered as soon as possible.
However, if it is almost time for the next dose, skip the missed dose and continue with the previously established schedule.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Luxfen

To be effective, Luxfen should be used every day. Do not stop using Luxfen without consulting your doctor.
If you have any further questions about using the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Luxfen can cause side effects, although not everybody gets them. The likelihood of a side effect occurring is described below:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Rare: may affect up to 1 in 1,000 people

Very rare: may affect up to 1 in 10,000 people

Not known: frequency cannot be estimated from the available data

The following side effects may be observed during treatment with Luxfen

Eyelid and eye disorders:

Very common:

• Ocular discomfort (eye redness, burning, stinging, feeling of a foreign body in the eye, itching, lumps or white spots on the transparent layer covering the eye surface)
• Blurred vision
• Ocular allergic reactions (allergic blepharitis and conjunctivitis, allergic conjunctivitis)
• Lid allergic reactions (allergic blepharitis).

Common:

• Local irritation (inflammation, redness, and swelling of the eyelids, swelling of the conjunctiva, presence of discharge in the conjunctival sac, eye pain, and tearing),
• Increased sensitivity to light
• Corneal erosions and spots on the eye surface
• Dry eye
• Pale conjunctiva
• Visual disturbances
• Conjunctivitis

Very rare:

• Uveitis
• Miosis

Not known:

• Lid itching
• Uveitis and uveitic glaucoma

General disorders:

Very common:

• Headache
• Dry mouth
• Fatigue/drowsiness

Common:

• Dizziness
• Flu-like symptoms
• Gastrointestinal symptoms
• Taste disturbances
• General weakness

Uncommon:

• Depression
• Palpitations or irregular heartbeat
• Nasal dryness
• Generalized allergic reactions

Rare:

• Dyspnea

Very rare:

• Insomnia
• Fainting
• Hypertension
• Hypotension

Not known:

• Skin reactions including redness, facial swelling, itching, rash, and vasodilation.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Luxfen

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the month.
After first opening, Luxfen can be stored for a maximum of 28 days.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Luxfen contains:

• The active substance is brimonidine tartrate. 1 ml of solution contains 2 mg of brimonidine tartrate, equivalent to 1.3 mg of brimonidine
• Other ingredients are: benzalkonium chloride, polyvinyl alcohol, sodium chloride, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide, and hydrochloric acid (for pH adjustment).

What Luxfen looks like and contents of the pack

Luxfen is a clear, slightly yellowish-green solution. The eye drops are available in 5 ml and 10 ml bottles with a dropper in packs of 1, 3, or 6 bottles.
Not all pack sizes may be marketed.

Marketing authorization holder:

BAUSCH + LOMB IRELAND LIMITED
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3, Ireland

Manufacturer:

Pharma Stulln GmbH
Werksstraße 3
92551 Stulln
Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

European Economic Area:

Bulgaria:
Луксфен 2 mg/ml капки за очи, разтвор
Czech Republic:
Luxfen
Latvia:
Luxfen, 2 mg/ml Acu pilieni, šķīdums
Lithuania:
Luxfen 2 mg/ml akių lašai, tirpalas
Poland:
Luxfen
Slovakia:
Luxfen 2 mg/ml

Date of last revision of the leaflet: December 2023