Label: information for the user

Brimvera 2 mg/ml eye drops in single-dose container

Brimonidine tartrate

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
  If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What Brimvera is and for what it is used

2. What you need to know before starting to use Brimvera

3. How to use Brimvera

4. Possible adverse effects

5. Storage of Brimvera

6. Contents of the container and additional information

Brimvera is used to reduce intraocular pressure.

It can be used alone when beta-blocker eye drops are contraindicated, or with other eye drops, when the medication alone is not sufficient to reduce an increase in intraocular pressure in the treatment of open-angle glaucoma or ocular hypertension.

The active ingredient of Brimvera is brimonidine tartrate, which acts by reducing pressure inside the eye.

No use Brimvera:

-If you are allergic to brimonidine tartrate or any of the other components of this medication (listed in section 6).

-If you are taking monoamine oxidase inhibitors (MAOIs) or certain antidepressants. Inform your doctor if you are taking any antidepressant medication.

-If you are breastfeeding.

-In children from newborns to 2 years of age.

Warnings and Precautions

Before starting treatment with Brimvera, inform your doctor:

• If you suffer or have suffered from depression, decreased mental capacity, reduced blood flow to the brain, heart problems, a reduction in blood supply to the extremities, or a blood pressure disorder.
• If you have or have had kidney or liver problems in the past.
• If you are giving Brimvera to a child between 2 and 12 years old, as the use of Brimvera is not recommended in this age group.

Children and Adolescents

No clinical studies have been conducted in adolescents (12 to 17 years).

The use of Brimvera is not recommended in children under 12 years and is contraindicated in newborns and children under 2 years.

Other Medications and Brimvera

Inform your doctor or pharmacist if you are taking/using or have taken/used recently or may need to take/use any other medication.

Inform your doctor if you are taking any of the following medications:

• Pain relievers, sedatives, opioids, barbiturates, or regularly consuming alcohol.
• Anesthetics.
• Medications for heart conditions or to lower blood pressure.
• Medications that can affect metabolism, such as chlorpromazine, methylphenidate, and reserpine.
• Medications that act on the same receptor as Brimvera, such as isoprenaline and prazosin.
• Monamine oxidase inhibitors (MAOIs) and other antidepressants.
• Medications for any condition, even those unrelated to your eye condition.
• Or if the dose of any of your current medications changes.

These may affect your treatment with Brimvera.

Pregnancy and Lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Brimvera should not be used during lactation.

Driving and Operating Machinery

• Brimvera may cause blurred or abnormal vision. This effect may worsen at night or with reduced lighting.
• Brimvera may also cause drowsiness or fatigue in some patients.

If you experience any of these symptoms, do not drive or operate machinery until the symptoms have subsided.

Follow exactly the administration instructions indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Use in adults

The recommended dose is one drop twice a day in the affected eye(s), approximately with 12 hours of difference.

Use in children under 12 years

Brimvera should not be used in children under 2 years of age.

The use of Brimvera is not recommended in children between 2 years and 12 years of age.

Usage instructions

1.Wash your hands.

2.Open the aluminum foil packet and take out the single-dose vial.

3.Separate a single-dose vial from the strip (Fig.1).

4.Place the remaining single-dose vials in the packet and close it by folding the edge. Place the packet in the cardboard box.

5.Open the single-dose vial by turning the tip. Do not touch the tip after opening the container (Fig2).

6.Incline your head backward(Fig.3).

7.Push down on the lower eyelid with your finger and hold the single-dose vial in your other hand.Press the vial to allow one drop to fall into the eye(Fig4).

8.Close your eyes and press with the tip of a finger the inner corner of the eye for approximately 1minute. This will prevent the drop from passing through the tear duct into the throat and most of the drop will remain in the eye (Fig5). If necessary, repeat steps 6 to 8 with your other eye.

9.After use, discard the single-dose vial.

Fig.1Fig.2Fig.3Fig.4Fig.5

If you use Brimvera with another eye drop, wait 5-15 minutes before applying the second eye drop.

If you use more Brimvera than you should

Adults

In adults who applied more drops than prescribed, the reported adverse effects were those already known of brimonidine.

Adults who accidentally ingested brimonidine eye drops experienced a decrease in blood pressure, which in some patients was followed by an increase in blood pressure.

Children

Severe adverse effects were reported in children who had accidentally ingested brimonidine eye drops. The symptoms included drowsiness, feeling of muscle weakness or fatigue,low body temperature, pallor, and breathing difficulties. If this happens, contact your doctor immediately.

Adults and children

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20.

If you forgot to use Brimvera

If you forget to administer a dose, apply it as soon as you remember. However, if it is almost time for your next dose, you should completely omit the missed dose and then follow your usual schedule.

Do not use a double dose to compensate for the missed doses.

If you interrupt treatment with Brimvera

To be effective, Brimvera must be used every day. Do not stop using Brimvera until your doctor tells you to.

If you have any doubts about the use of this product, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

The following side effects have been observed with brimonidine eye drops with preservatives in multi-dose containers and may also occur when using brimonidine eye drops without preservatives in single-dose containers:

Affecting the eye

Very common (may affect more than 1 in 10 patients):

• Eye irritation (redness, burning, stinging, feeling of a foreign body in the eye, itching, follicles, or white spots on the transparent layer covering the surface of the eye)
• Blurred vision
• Eye allergic reaction

Common (may affect up to 1 in 10 patients):

• Local irritation (inflammation and swelling of the eyelid, swelling of the transparent layer covering the surface of the eye, sticky eyes, pain, and tearing)
• Light sensitivity
• Surface erosion of the eye and discoloration
• Dry eye
• Whitening of the transparent layer covering the surface of the eye
• Abnormal vision
• Inflammation of the transparent layer covering the surface of the eye

Very rare (may affect up to 1 in 10,000 patients):

• Eye inflammation
• Pupil constriction

Side effects of unknown frequency (frequency cannot be estimated from available data):

• Itching of the eyelids
• Inflammation of the iris, i.e., the colored part of the eye and the ciliary body, i.e., muscles and tissue involved in focusing the eye (iridocyclitis). This condition is also called "anterior uveitis"

Affecting the body

Very common (may affect more than 1 in 10 patients):

• Headache
• Dry mouth
• Fatigue/drowsiness

Common (may affect up to 1 in 10 patients):

• Dizziness
• Common cold symptoms
• Symptoms affecting the stomach and digestion
• Altered taste
• General weakness

Uncommon (may affect up to 1 in 100 patients):

• Depression
• Palpitations or changes in heart rate
• Nasal dryness
• General allergic reactions

Rare (may affect up to 1 in 1,000 patients):

• Respiratory insufficiency

Very rare (may affect up to 1 in 10,000 patients):

• Insomnia
• Loss of consciousness
• High blood pressure
• Low blood pressure

Side effects of unknown frequency (frequency cannot be estimated from available data):

• Skin reactions including redness, inflammation of the face, itching, rash, and dilation of blood vessels

Reporting side effects

If you experience any type of side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, Website:www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Store single-dose containers in the aluminum pouch to protect them from light.

Do not use once 3 months have passed since opening the aluminum pouch.

Brimvera does not contain preservatives. Once opened, the contents of a single-dose container should be used immediately. Dispose of any remaining solution in the container after application.

Do not use this medication after the expiration date that appears on the box, pouch, and single-dose container after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Deposit containers and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Composition of Brimvera

-The active ingredient is brimonidine tartrate. 1 ml of solution contains 2.0 mg of brimonidine tartrate, equivalent to 1.3 mg of brimonidine. One drop contains 0.06-0.07 mg of brimonidine tartrate.

-The other components are poly (vinyl alcohol), sodium chloride, sodium citrate, citric acid monohydrate, water for injection, and hydrochloric acid or sodium hydroxide (for pH adjustment).

Appearance of the product and contents of the packaging

Brimvera is a transparent solution with a light yellow-green color. A single-dose vial contains 0.35 ml of solution. A laminated aluminum foil contains two strips of 5 single-dose vials each.

Brimvera is marketed in boxes containing 30, 60, or 120 single-dose vials, each containing 0.35 ml of solution.

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Responsible for manufacturing

Pharma Stulln GmbH

Werksstraße 3

92551 Stulln

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

AustriaBrimonidin sine OmniVision

FranceBrimonidine OmniVision

ItalyBrimofree

SpainBrimvera

United KingdomBrimonidine OmniVision

This prospectus has been approvedJuly 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/