Leaflet: information for the user

BRIPIO2 mg/ml eye drops in a single-dose container

Brimonidina tartrate

Read this leaflet carefully before starting to use this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isBRIPIOand what it is used for

2. What you need to know before starting to useBRIPIO

3. How to useBRIPIO

4. Possible side effects

5. Storage ofBRIPIO

6. Contents of the container and additional informationl

BRIPIOis used to reduce intraocular pressure. The active ingredient in BRIPIO is brimonidine tartrate, which belongs to a group of medications called alpha-2 adrenergic receptor agonists and acts by reducing pressure in the eyeball.

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.

Do not useBRIPIO

• If you areallergicto brimonidine tartrate or to any of the other components of brimonidine (listed in section 6).
• If you are taking monoamine oxidase inhibitors (MAOIs) or other antidepressants. Inform your doctor if you are taking any antidepressant medication.
• If you are breastfeeding.
• In children/infants(up to 2 years of age).

Be especially careful withBRIPIO

Before starting treatment withBRIPIO, inform your doctor:

• If you have or have had depression, decreased mental capacity, reduced blood flow to the brain, heart problems, a blood supply disorder to the extremities, or a blood pressure disorder.
• If you have or have had kidney or liver problems.

Children and adolescents

BRIPIO is not recommended for use in children between 2 and 12 years old.

BRIPIO should not be used generally in adolescents from 12 to 17 years old, as no clinical studies have been conducted in this age group.

Use of other medications

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

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

• Pain relievers for pain, tranquilizers, 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 asBRIPIO, such as isoprenaline and prazosin.
• Monamine oxidase inhibitors (MAOIs) and other antidepressants.
• Medications for any condition, even those unrelated to your eye condition.
• If the dose of any of your current medications changes.

These may affect your treatment withBRIPIO.

Pregnancy and lactation

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

BRIPIO should not be used during lactation. Do not use BRIPIO if you are pregnant unless your doctor considers it necessary.

Driving and operating machinery

• BRIPIOmay cause blurred or abnormal vision. This effect may worsen at night or with reduced lighting.
• BRIPIOmay 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.

Adults

The usual dose is one drop twice a day in the affected eye(s), approximately with 12 hours of difference. Do not change the dose or stop using BRIPIO without talking to your doctor.

Children under 12 years

BRIPIOmust not be used in children under 2 years of age.

BRIPIOis not recommended for use in children between 2 years and 12 years.

Instructions for use

1. Wash your hands.
2. Open the aluminum bag and take out the strip of single-dose containers.
3. Separate one of the single-dose containers from the strip (Figure 1).
4. Put the rest of the single-dose containers back in the aluminum bag and close it by folding the edge. Put the bag inside the box.
5. Open the single-dose container by turning the cap until it comes off. Do not touch the tip of the container once opened (Figure 2).
6. Incline your head back (Figure 3).
7. Gently pull the lower eyelid with your finger, hold the single-dose container with your other hand with the open tip down. Press the container to let one drop fall into the affected eye (Figure 4).
8. Keep the affected eye closed, press your finger against the inner corner of the closed eye for 1 minute. This will prevent the drop from entering the tear duct and going to the throat, and most of the drop will remain in the eye (Figure 5). If necessary, repeat steps 6 to 8 with the other eye.
9. Throw away the single-dose container after use.

Figure 1Figure 2Figure 3Figure 4Figure 5

If the drop falls outside the eye, try again.

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

If you use moreBRIPIOthan you should

Adults

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

Adults who accidentally ingestedbrimonidinaexperienced 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 ingestedbrimonidina. The signs included drowsiness, hypotonia,low body temperature, pallor, and breathing difficulties. If this happens, contact your doctor immediately.

Adults and children

If BRIPIO has been accidentally ingested or if more BRIPIO has been used than should have been, please contact your doctor immediately.

Go to your doctor or pharmacist immediately. Bring the medication container with you. You can also call the Toxicology Information Service, phone 91 562 04 20 indicating the medication and the amount taken.

If you forgot to useBRIPIO

If you forget to administer a dose, apply it as soon as you remember. However, if it is almost time for the 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 withBRIPIO

BRIPIOmust be used every day to be effective. Do not stop usingBRIPIOuntil your doctor tells you to.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects may occur with brimonidine in multidose containers with preservatives, as well as with brimonidine in single-dose containers without preservatives.

That affect the eye

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

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

Common (may affect up to 1 in 10 people)

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

Frequency not known (cannot be estimated from available data)

• Itching of the eyelids
• • Inflammation of the iris, the colored part of the eye, and the ciliary bodies, muscles, and tissue involved in focusing vision (Iridocyclitis). This disease is also known as "anterior uveitis"

That affect the rest of the body

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 1 in 1,000 people)

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

Frequency not known (cannot be estimated from available data)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Store single-dose containers within the aluminum bag to protect them from light.

Once the aluminum bag is opened, do not use after 3 months.

BRIPIOdoes not contain preservatives. Once the single-dose container is opened, the contents must be used immediately. Dispose of the remaining medication from the single-dose container after application.

Do not usethis medicationafter the expiration date that appears onthe box, bag, and single-dose containerafter CAD. The expiration date is the last day of the month indicated.

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

Composition ofBRIPIO2 mg/ml eye drops in single-dose solution

• The active ingredient is brimonidine tartrate. One milliliter 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 sodium hydroxide or hydrochloric acid for pH adjustment.

Appearance of the product and contents of the package

BRIPIO2 mg/ml eye drops in single-dose solutionis a clear, slightly yellowish green solution. The contents of a single-dose package are 0.35 ml of solution. Each laminated aluminum pouch contains two strips of 5 single-dose packages.

BRIPIO2 mg/ml eye drops in single-dose solutionis available in 10, 20, 30, 50, 60, 100, or 120 single-dose packages, each containing 0.35 ml of solution.

Not all packages may be marketed.

Holder of the marketing authorization and responsible manufacturer

Pharma Stulln GmbH

Werksstrasse 3

92551 Stulln

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

BRILL PHARMA, S.L.

C/ Munner, 8

08022 Barcelona

Spain

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

Last review date of thisleaflet: July 2023

For detailed and updated information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/