Briomogen

Package leaflet: Information for the user

Brimogen, 2 mg/ml, eye drops, solution
Brimonidini tartras
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.

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

Contents of the leaflet

1. What Brimogen is and what it is used for
2. What you need to know 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 Brimogen is and what it is used for

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

2. Important information before using Brimogen

When not to use Brimogen

• if the patient is 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 the patient is taking monoamine oxidase inhibitors (MAO inhibitors) or certain antidepressant medicines, such as tricyclic antidepressants or mianserin. If the patient is taking antidepressants, they should inform their doctor, who will decide whether Brimogen can be used,
• in newborns and infants (from birth up to 2 years of age).

Warnings and precautions
Before starting Brimogen, discuss with your doctor if:

• the patient suffers or has suffered from depression, has impaired mental function, circulatory disorders in the brain, heart problems, circulation disorders in the limbs, or low blood pressure;
• the patient has or has previously had kidney or liver function disorders.

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, speak with a doctor before use.

Brimogen with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
Inform your doctor if the patient is taking any of the following medicines, as they may affect treatment with Brimogen:

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult a 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 seem worse at night or in dim light.
In some patients, Brimogen may also cause drowsiness or tiredness.
If any of these symptoms occur, do not drive or operate machinery until symptoms have resolved.

Brimogen contains benzalkonium chloride
This medicine contains 0.05 mg of benzalkonium chloride per millilitre, equivalent to 0.00035 mg per drop.
Benzalkonium chloride may be absorbed by soft contact lenses and may change their colour. Contact lenses must be removed before instilling the drops and at least 15 minutes should elapse before reinserting them.
Benzalkonium chloride may also cause eye irritation, particularly in patients with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If any abnormal sensations in the eye occur, such as stinging or eye pain after using the medicine, contact a 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 told you. If you are unsure, you should consult your doctor or pharmacist.
Use in adults and adolescents over 12 years of age
The recommended dose is one drop in each affected eye twice daily, approximately 12 hours apart.
Use in children under 12 years of age
Brimogen must not be used in children under 2 years of age.
Use of Brimogen is not recommended in children (aged 2 to 12 years).
Instructions for use
Brimogen should be used only as eye drops. Do not swallow.
Always wash your hands before using the drops. The number of drops to be administered with each dose is indicated on the prescription. If you are using Brimogen together with other eye drops, wait at least 5–15 minutes before administering the other eye drops.
Use the drops according to the following instructions:

1. Tilt your head backwards and look upwards at the ceiling.
2. Gently pull down the lower eyelid to form a small pocket.
3. Squeeze the inverted bottle with the dropper to release one drop into the eye.
4. Close the eye and, at the same time, press gently with your finger on the tear duct at the inner corner of the eye (the area where the eye meets the nose) for approximately 1 minute.

Avoid touching the eye or any surface with the tip of the dropper. Immediately after use, replace the cap and screw the bottle closed. If you wear soft contact lenses, remove them before applying the eye drops, and wait 15 minutes after instillation before reinserting the lenses. The preservative contained in the eye drops may discolour soft contact lenses.
Use of a higher than recommended dose of Brimogen
Adults
In adults who received more drops than recommended, the adverse effects reported were consistent with those currently known to occur following administration of Brimogen.
In adults who accidentally swallowed Brimogen, a drop in blood pressure occurred, followed in some patients by a rise in blood pressure.
Children
Severe adverse effects have been reported in children who accidentally swallowed Brimogen.
The following symptoms were observed: drowsiness, reduced muscle tone, low body temperature, pallor, and breathing difficulties. If any of these symptoms occur, contact your doctor immediately.
Children and adults
In case of accidental ingestion of the medicine, contact your doctor immediately.
Missed dose of Brimogen
If you miss a dose, administer it as soon as possible. However, if it is almost time for the next dose, skip the missed dose completely and continue with your regular dosing schedule.
Stopping Brimogen
For treatment to be effective, the drops must be used daily. Do not stop using Brimogen without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
The following terms are used to classify the frequency of adverse reactions:

Brimogen may cause the following ocular adverse reactions: Very common: Eye irritation (redness, burning, stinging, sensation of foreign body in the eye or itching, lumps or white spots on the transparent layer covering the surface of the eye), 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, visual disturbance, sticky eyes, eyelid or transparent layer swelling, photophobia, irritation, eyelid redness, pain, dryness, erosions and discoloration of the ocular surface, tearing or whitening of the transparent layer on the surface of the eye. Very rare: Eye inflammation or miosis. Unknown: Eyelid itching.

The following general adverse reactions affecting the whole body may also occur: Very common: Headache, dry mouth, fatigue/somnolence. Common: Dizziness, cold-like symptoms, gastrointestinal disturbances, taste disturbances, or general weakness. Uncommon: Depression, palpitations or cardiac arrhythmias, nasal dryness, and general allergic reactions. Rare: Dyspnea. Very rare: Insomnia, fainting, and arterial hypertension or hypotension. Unknown: Skin reactions, including erythema, facial swelling, itching, rash, and vasodilation.

Reporting of adverse reactions If any adverse reactions occur, including any not listed in this leaflet, inform a 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 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Brimogen

• Keep the medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the bottle label and on the carton after: EXP. The expiry date refers to the last day of the specified month.
• Do not store above 25°C.
• Do not use the medicine if the bottle's tamper-evident seal is damaged before first opening.
• Discard the bottle 28 days after opening, even if some solution remains.

Medicines must 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 packaging and other information

What Brimogen contains

• The active substance is brimonidine tartrate. 1 ml of solution contains 2.0 mg of brimonidine tartrate, equivalent to 1.3 mg of brimonidine.
• The other ingredients are 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 Authorisation Holder and Manufacturer
Pharmaselect International Beteiligungs GmbH
Ernst-Melchior-Gasse 20
1020 Vienna
Austria
This medicinal product is authorised in the European Economic Area countries under the following names:
Austria, Bulgaria, Germany, Poland, Hungary: BRIMOGEN
Croatia: BRIMABENE
Czech Republic, Slovakia: GLABRIN