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

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

Brimonidine tartrate

Please read all of this leaflet carefully before you start 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Brimvera is and what it is used for

Brimvera is used to reduce intraocular pressure.

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

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

2. What you need to know before using Brimvera

Do not use Brimvera:

• If you are allergic to brimonidine tartrate or any of the other ingredients of this medicine (listed in section 6).
• If you are taking monoamine oxidase inhibitors (MAOIs) or certain antidepressants. You must inform your doctor if you are taking any antidepressant medication.
• If you are breastfeeding.
• In children from newborns up to 2 years of age.

Warnings and precautions

Before starting treatment with Brimvera, inform your doctor:

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

Children and adolescents

Clinical studies have not been conducted in adolescents (12 to 17 years).

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

Other medicines and Brimvera

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Tell your doctor if you are taking any of the following medicines:

• Painkillers, sedatives, opioids, barbiturates, or if you regularly consume alcohol.
• Anaesthetics.
• Medicines to treat heart conditions or to lower blood pressure.
• Medicines that may affect metabolism, such as chlorpromazine, methylphenidate, and reserpine.
• Medicines acting on the same receptor as Brimvera, such as isoprenaline and prazosin.
• Monoamine oxidase inhibitors (MAOIs) and other antidepressants.
• Medicines for any condition, even those unrelated to your eye condition.
• Or if the dose of any of your current medicines changes.

These may affect your treatment with Brimvera.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Brimvera must not be used during breastfeeding.

Driving and using machines

• Brimvera may cause blurred or abnormal vision. This effect may be worsened at night or under reduced lighting conditions.
• 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 resolved.

3. How to use Brimvera

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

Use in adults

The recommended dose is one drop twice daily in the affected eye(s), approximately 12 hours apart.

Use in children under 12 years of age

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

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

Instructions for use

1. Wash your hands.
2. Open the aluminium pouch and remove the single-dose unit pack.
3. Separate one single-dose container from the strip (Fig. 1).
4. Place the remaining single-dose containers back into the pouch and close it by folding the edge. Place the pouch into the cardboard box.
5. Open the single-dose container by twisting off the tip. Do not touch the tip after opening the container (Fig. 2).
6. Tilt your head backwards (Fig. 3).
7. Pull down the lower eyelid with your finger and hold the single-dose container in your other hand. Squeeze the container so that one drop falls into the eye (Fig. 4).
8. Close your eyes and press with the fingertip against the inner corner of the eye for about 1 minute. This will prevent the drop from draining through the tear duct into the throat and ensure that most of the drop remains in the eye (Fig. 5). If necessary, repeat steps 6 to 8 for the other eye.
9. After use, discard the single-dose container.

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

If you are using 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 used more drops than prescribed, the adverse effects reported were those already known for 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

Serious adverse effects have been reported in children who accidentally ingested brimonidine eye drops. Signs included somnolence, feeling of muscle weakness or floppiness, low body temperature, pallor, and breathing difficulties. If this occurs, contact your doctor immediately.

Adults and children

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20.

If you forget 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 must completely omit the missed dose and then continue with your usual schedule.

Do not use a double dose to make up for forgotten doses.

If you stop using Brimvera

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects have been observed with brimonidine eye drops containing preservatives in multidose 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 people):

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

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

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

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

• Inflammation in the eye
• Reduction in pupil size

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

• Itching of the eyelids
• Inflammation of the iris (the colored part of the eye) and of the ciliary body (muscles and tissue involved in focusing the eye), known as "anterior uveitis"

Affecting the body

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

• Headache
• Dry mouth
• Tiredness/somnolence

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

• Dizziness
• Cold symptoms
• Stomach and digestive symptoms
• Taste disturbance
• General weakness

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

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

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

• Respiratory failure

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

• Insomnia
• Fainting
• High blood pressure
• Low blood pressure

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

• Skin reactions including redness, facial swelling, itching, rash, and dilation of blood vessels

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines at: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Brimvera

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

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

Do not use more than 3 months after opening the aluminum pouch.

Brimvera does not contain preservatives. After opening, the contents of a single-dose container should be used immediately. Any remaining solution in the container after application must be discarded.

Do not use this medicine after the expiry date stated on the carton, the pouch, and the single-dose container following EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Brimvera

• The active substance 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 injections, and hydrochloric acid or sodium hydroxide (for pH adjustment).

Appearance of the medicinal product and contents of the container

Brimvera is a slightly yellowish-greenish transparent solution. A single-dose unit contains 0.35 ml of solution. An aluminum laminate sachet contains two strips of 5 single-dose units each.

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

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona, Spain

Manufacturer

Pharma Stulln GmbH

Werksstraße 3

92551 Stulln, Germany

This medicinal product is authorized in the European Economic Area member states under the following names:

Austria  Brimonidin sine OmniVision
France   Brimonidine OmniVision
Italy    Brimofree
Spain   Brimvera
United Kingdom Brimonidine OmniVision

This leaflet has been approved: July 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/