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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Brimonidine tartrate

Read the entire leaflet carefully before you start using this medicine.

• 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; do not pass it on 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 BRIPIO is and what it is used for
2. What you need to know before using BRIPIO
3. How to use BRIPIO
4. Possible side effects
5. How to store BRIPIO
6. Contents of the pack and other information

1. What BRIPIO is and what it is used for

BRIPIO is used to reduce intraocular pressure. The active substance in BRIPIO is brimonidine tartrate, which belongs to a group of medicines called alpha-2 adrenergic receptor agonists and works by reducing pressure in the eye.

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

2. What you need to know before using BRIPIO

Do not use BRIPIO

• If you are allergic to 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. You must inform your doctor if you are taking any antidepressant medication.
• If you are breastfeeding.
• In children/infants (under 2 years of age).

Take special care with BRIPIO

Before starting treatment with BRIPIO, inform your doctor:

• If you have or have had 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.

Children and adolescents

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

BRIPIO should generally not be used in adolescents aged 12 to 17 years, as clinical studies have not been conducted in this age group.

Use of other medicines

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

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

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

These may affect your treatment with BRIPIO.

Pregnancy and breastfeeding

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

BRIPIO must not be used during breastfeeding. Do not use BRIPIO during pregnancy unless considered necessary by your doctor.

Driving and using machines

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

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

Adults

The usual dose is one drop twice daily in the affected eye(s), approximately 12 hours apart. Do not change the dose or stop using BRIPIO without speaking to your doctor.

Children under 12 years

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

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

Instructions for use

1. Wash your hands.
2. Open the aluminium pouch and remove the strip of single-dose containers.
3. Separate one single-dose container from the strip (Figure 1).
4. Return the remaining single-dose containers to the aluminium pouch, close it by folding the edge, and place the pouch back into the carton.
5. Open the single-dose container by twisting off the cap. Do not touch the tip of the container once opened (Figure 2).
6. Tilt your head backwards (Figure 3).
7. Gently pull down the lower eyelid with your finger, hold the single-dose container in your other hand with the open end pointing downwards. Squeeze the container so that one drop falls into the affected eye (Figure 4).
8. Keep the affected eye closed and 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 flowing into the throat, ensuring most of the drop remains in the eye (Figure 5). If needed, repeat steps 6 to 8 for the other eye.
9. Dispose of the single-dose container after use.

Figure 1 Figure 2 Figure 3 Figure 4 Figure 5

If the drop misses the eye, try again.

If you are using BRIPIO with another eye drop, wait 5–15 minutes before applying the second eye drop.

If you use more BRIPIO than you should

Adults

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

Adults who accidentally ingested brimonidina 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. Signs included drowsiness, hypotonia, low body temperature, pallor, and breathing difficulties. If this occurs, contact your doctor immediately.

Adults and children

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

Go to your doctor or pharmacist immediately. Take the medicine packaging with you. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to use BRIPIO

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 dosing schedule.

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

If you stop using BRIPIO

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

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

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

Effects on 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, or itching, follicles or white spots on the transparent layer covering the surface of the eye)
  • Blurred vision
  • An allergic reaction in the eyes

Common (may affect up to 1 in 10 people)

• 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
• Erosion on the surface 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 1 in 10,000 people)

• Inflammation in the eye
• Reduction in pupil size

Frequency not known (cannot be estimated from available data)

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

Effects on the rest of the body

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

• Headache
• Dry mouth
• Fatigue/somnolence

Common (may affect up to 1 in 10 people)

• Dizziness
• Cold-like 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
• Dry nose
• General allergic reactions

Rare (may affect 1 in 1,000 people)

• Difficulty breathing

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

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

Frequency not known (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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of BRIPIO

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

Store the unit-dose containers within the aluminum pouch to protect them from light.

After opening the aluminum pouch, do not use beyond 3 months.

BRIPIO does not contain preservatives. Once the unit-dose container has been opened, its contents must be used immediately. Any remaining medicine in the unit-dose container must be discarded after administration.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at a pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of BRIPIO 2 mg/ml eye drops solution in single-dose container

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

Appearance of the product and contents of the pack

BRIPIO 2 mg/ml eye drops solution in single-dose container is a clear, slightly yellowish-green solution. The content of a single-dose container is 0.35 ml of solution. Each laminated aluminium pouch contains two strips of 5 single-dose containers.

BRIPIO 2 mg/ml eye drops solution in single-dose container is available in packs of 10, 20, 30, 50, 60, 100 or 120 single-dose containers, each containing 0.35 ml of solution.

Not all pack sizes may be marketed.

Marketing Authorization Holder and 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 European Economic Area member states under the following names:

Date of latest revision of this summary: July 2023

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