Brimogen

Package Leaflet: Information for the User

Brimogen, 2 mg/ml, Eye Drops, Solution

Brimonidine Tartrate

Read the package 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 for you only. Do not pass it on to others. It 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 inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Brimogen and what is it used for

Brimogen is used to lower the pressure inside the eye.
Brimogen can be used alone or in combination with other eye drops to lower the pressure in the eye in patients with open-angle glaucoma or ocular hypertension.
The active substance in Brimogen is brimonidine tartrate, which reduces the pressure inside the eye.

2. Important information before using Brimogen

When not to use Brimogen

• if you are allergic (hypersensitive) to brimonidine tartrate or any of the other ingredients of this medicine (listed in section 6; see also the end of section 2),
• if you are taking monoamine oxidase inhibitors (MAOIs) and certain antidepressants, such as tricyclic antidepressants or mianserin. If you are taking antidepressants, inform your doctor, who will decide whether you can use Brimogen,
• in newborns and infants (from birth to 2 years).

Warnings and precautions

Before starting to use Brimogen, discuss with your doctor if:

• you have or have had depression, your mental ability is impaired, you have had disturbances in blood circulation in the brain, heart problems, circulation problems in your limbs, or low blood pressure;
• you have or have had kidney or liver problems.

Children

Brimogen is not recommended for use in children under 12 years of age. If Brimogen has been prescribed for a child under 12 years of age, consult a doctor before use.

Brimogen and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
Inform your doctor if you are taking any of the following medicines, as they may affect your treatment with Brimogen:

• analgesics, sedatives, opioid analgesics, barbiturates, or regular consumption of alcohol;
• anesthetics;
• medicines used to treat heart diseases or lower blood pressure;
• medicines that may affect metabolism, such as chlorpromazine, methylphenidate, and reserpine;
• medicines that act on the same receptor as Brimogen, e.g., isoprenaline and prazosin;
• monoamine oxidase inhibitors (MAOIs) and other antidepressants;
• other medicines, even if their use is not related to eye disease. Also, inform your doctor if the dose of any of your current medicines has changed.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Brimogen should not be used during breastfeeding.

Driving and using machines

Brimogen may cause blurred or disturbed vision, which may be worse at night or in low light.
In some patients, Brimogen may also cause drowsiness or a feeling of fatigue.
If you experience any of these symptoms, do not drive or operate machinery until the symptoms have resolved.

Brimogen contains benzalkonium chloride

The medicine contains 0.05 mg of benzalkonium chloride per milliliter, which is equivalent to 0.00035 mg per drop.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Remove contact lenses before instilling 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 on the front of the eye). If you experience any abnormal sensations in the eye, stinging, or pain in the eye after using the medicine, contact your doctor.
Instructions for contact lens wearers are provided in section 3.

3. How to use Brimogen

This medicine should always be used exactly as your doctor has instructed. If you are unsure, consult your doctor or pharmacist.

Use in adults and children over 12 years

The recommended dose is one drop into each eye that needs treatment, administered twice a day, approximately 12 hours apart.

Use in children under 12 years

Do not use Brimogen in children under 2 years of age.
Brimogen is not recommended for use in children (from 2 to 12 years of age).

Instructions for use

Brimogen should only be used as eye drops. Do not swallow.
Before using the drops, always wash your hands. The information on how many drops to use for each dose is on the prescription. When using Brimogen with other eye drops, wait at least 5-15 minutes before administering other eye drops.
Use the drops according to the following instructions:

• 1. Tilt your head back and look up at the ceiling.
• 2. Gently pull down the lower eyelid to create a small pocket.
• 3. Squeeze the inverted bottle with the dropper to release a drop into the eye.
• 4. Close your eye and press the lacrimal sac in the inner corner of the eye (where the eye meets the nose) with your finger for about 1 minute.

Avoid touching the eye or objects with the dropper tip. Immediately after use, replace the cap and tighten the bottle. If you wear soft contact lenses, remove them before using the eye drops and wait 15 minutes after instillation before reinserting. The preservative used in the eye drops can discolor soft contact lenses.

Using more than the recommended dose of Brimogen

Adults

In adults who have been given more drops than recommended, the reported side effects were those currently known to occur with the use of Brimogen.
In adults who have accidentally ingested Brimogen, a decrease in blood pressure has occurred, followed by an increase in blood pressure in some patients.

Children

Severe side effects have been reported in children who have accidentally ingested Brimogen.
The following symptoms have been observed: drowsiness, decreased muscle tone, low body temperature, pallor, and breathing difficulties. If you experience any of these symptoms, contact your doctor immediately.

Children and adults

In case of accidental ingestion, contact your doctor immediately.

Missing a dose of Brimogen

If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule.

Stopping the use of Brimogen

To be effective, the drops should be used every day. Do not stop using Brimogen without consulting your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Brimogen can cause side effects, although not everybody gets them.
To classify the frequency of side effects, the following terminology is used:
Brimogen may cause the following eye-related side effects:
Very common:
Irritation of the eye (redness, burning, stinging, feeling of a foreign body in the eye, or itching, lumps or white spots on the transparent layer covering the eye surface), blurred vision, allergic reactions of the eye.
Common:
Changes on the surface of the eye, eyelid inflammation, inflammation of the transparent layer on the surface of the eye, vision disturbances, sticky eyes, swelling of the eyelid or the transparent layer on the surface of the eye, sensitivity to light, irritation, redness of the eyelid, pain, dryness, and discoloration of the eye surface, tearing, or whitening of the transparent layer on the surface of the eye.
Very rare:Eye inflammation or constriction of the pupil.

Unknown:

Itching of the eyelid.
The following general side effectsmay also occur:

Very common:

Headache, dry mouth, and fatigue/drowsiness.

Common:

Dizziness, cold-like symptoms, gastrointestinal symptoms, taste disturbances, or general weakness.

Uncommon:

Depression, palpitations or arrhythmias, dryness in the nose, and general allergic reactions.

Rare:

Shortness of breath.
Very rare:Insomnia, fainting, and hypertension or hypotension.

Unknown:

Skin reactions, including redness, swelling of the face, itching, rash, and vasodilation.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Brimogen

• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of the month.
• Do not store above 25°C.
• Do not use the medicine if the seal on the bottle is broken before the first opening.
• 28 days after opening the package, the bottle should be discarded, even if the solution remains in it.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 Brimogen contains

• Active substanceis brimonidine tartrate. 1 ml of solution contains 2.0 mg of brimonidine tartrate, equivalent to 1.3 mg of brimonidine.
• Other ingredientsare benzalkonium chloride (as a preservative), polyvinyl alcohol, sodium chloride, sodium citrate, citric acid monohydrate, sodium hydroxide or hydrochloric acid (to adjust pH), and water for injections.

What Brimogen looks like and contents of the pack

Brimogen is a clear, slightly yellowish solution in the form of eye drops in a plastic bottle.
Each bottle contains 5 ml of eye drops.
Brimogen is available in packs containing 1, 3, and 6 bottles. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Pharmaselect International Beteiligungs GmbH
Ernst-Melchior-Gasse 20
1020 Vienna
Austria

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

Austria, Bulgaria, Germany, Poland, Hungary:
BRIMOGEN
Croatia:
BRIMABENE
Czech Republic, Slovakia:
GLABRIN
Date of last revision of the leaflet:May 2022