BRIMONIDINE VIR 2 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

Brimonidina Vir 2 mg/ml, Eye Drops Solution

Brimonidina Tartrate

Read the entire package leaflet carefully before starting to use the medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Brimonidina Vir and what is it used for
2. What you need to know before using Brimonidina Vir
3. How to use Brimonidina Vir
4. Possible side effects
5. Storage of Brimonidina Vir
6. Package Contents and Additional Information

1. What is Brimonidina Vir and what is it used for

The active ingredient of Brimonidina Vir is brimonidina tartrate, which reduces intraocular pressure.

Brimonidina Vir is a medicine used to reduce intraocular pressure. It can be used alone in patients for whom topical beta-blocker therapy is contraindicated or with another eye drop, when intraocular pressure (IOP) cannot be reduced in patients with open-angle glaucoma or ocular hypertension.

2. What you need to know before using Brimonidina Vir

Do not use Brimonidina Vir if:

• You are allergic (hypersensitive) to brimonidina or any of the other components of this medicine (listed in section 6).
• In newborns/children (under 2 years).
• You are taking monoamine oxidase inhibitors or certain antidepressants. Inform your doctor if you are taking any medication for depression.
• You are breastfeeding.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Brimonidina Vir if:

• it is administered to children between 2 and 12 years old. The use of Brimonidina Vir is not recommended in children of this age.
• you suffer or have suffered from depression, reduced mental capacity, reduced blood supply to the brain, heart problems, blood supply disorders to the limbs, or altered blood pressure.
• you have or have had liver or kidney problems.

If you think any of these points apply to you, do not use Brimonidina Vir until you have consulted your doctor again.

Children and Adolescents

The use of brimonidina is not recommended in children under 12 years old. There are no studies that demonstrate its safety and efficacy in children. This is particularly important in children under 2 years old.

Using Other Medicines with Brimonidina Vir

Tell your doctor or pharmacist if you are taking, or have recently taken, or may need to take any other medicine, including those obtained without a prescription.

Tell your doctor if you are taking the following medicines:

• analgesics, sedatives, opioids, barbiturates, or regularly consume alcohol.
  • anesthetics.
  • medicines for the treatment of high blood pressure or for the heart.
  • medicines that can affect your metabolism, such as chlorpromazine, methylphenidate, and reserpine.
  • that work on the same receptor as Brimonidina Vir, for example, isoprenaline and prazosin.
  • MAO inhibitors and other antidepressants.
  • medicines for any other disease, even if they are not related to your eye disease.
  • or if you change the dose of any of your medicines.

This could affect your treatment with Brimonidina Vir.

Pregnancy and Breastfeeding

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

Do not use Brimonidina Vir if you are breastfeeding.

Driving and Using Machines

Brimonidina Vir may cause blurred or altered vision, especially at night or in low light.

Brimonidina Vir may also cause drowsiness and/or fatigue in some patients.

Do not drive or operate machinery until the symptoms have disappeared.

Brimonidina Vir contains Benzalkonium Chloride.

This preservative can cause eye irritation and is also known to alter the color of soft contact lenses. Therefore, avoid contact with soft contact lenses. If you wear soft contact lenses, remove them before using this eye drop and wait 15 minutes after application before putting them back on.

3. How to use Brimonidina Vir

Follow the administration instructions of this medicine exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults (including over 65 years old)

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

Children under 12 years oldBrimonidina Vir should not be used in children under 2 years old.

The use of Brimonidina Vir is not recommended in children between 2 and 12 years old.

Instructions for Use

Brimonidina Vir is presented as eye drops. Always wash your hands before applying the eye drops. The package leaflet indicates how many drops to use in each dose. If you are using more than one eye medicine, the medicines should be applied with an interval of 15 minutes between them.

Apply your eye drops as follows:

1. Tilt your head back and look up at the ceiling
2. Gently pull the lower eyelid down until there is a small gap
3. Turn the bottle upside down and squeeze until one drop enters each eye that needs treatment
4. Keep your eye closed and press the inner corner of your eye with your finger for one minute

Avoid touching the tip of the container to the eye or any other surface.

Close the container immediately after use.

If you use more Brimonidina Vir than you should

Adults

The adverse reactions are the same as those known with Brimonidina Vir and have been reported for adults who have used more eye drop solution than recommended.

In cases of adults who had accidentally ingested Brimonidina Vir, low blood pressure followed by a strong increase in blood pressure was reported. If this happens, consult your doctor immediately.

Children

Cases of overdose have been reported in children who had accidentally ingested Brimonidina Vir. The symptoms include drowsiness, weakness, low body temperature, paleness, and difficulty breathing. If you experience any of these symptoms, consult your doctor immediately.

Adults and Children

In case of overdose or accidental ingestion of Brimonidina Vir, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Brimonidina Vir

If you forget to take Brimonidina Vir, apply the missed dose as soon as you remember. If you don't remember until just before the next dose, do not apply the missed dose and apply the next dose when it is due.

Do not take a double dose to make up for missed doses.

If you stop using Brimonidina Vir

To be effective, Brimonidina Vir must be used every day. Do not stop using Brimonidina Vir without consulting your doctor first.

If you have any other questions about using this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported:

Eye Side Effects

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

• eye irritation (redness, pain, and burning, itching, feeling of having a foreign body, follicular conjunctivitis), follicular conjunctivitis
• Blurred vision
• Allergic reaction in the eye.

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

• local eye irritation (redness and swelling of the eyelid, conjunctival edema and discharge, eye pain, and tearing)
• hypersensitivity to light
• superficial damage and discoloration of the cornea
• dry eye
• conjunctival pallor
• abnormal vision
• conjunctivitis.

Very Rare(affect 1-10 users in every 1,000):

• iritis (inflammation of the iris)
• pupil constriction.

Frequency Not Known(frequency cannot be estimated from the available data):

• eyelid itching

Body Side Effects

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

• headache
• dry mouth
• fatigue/drowsiness

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

• dizziness
• cold symptoms
• stomach and digestion symptoms
• altered taste
• systemic weakness.

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

• depression
• palpitations or arrhythmias,
• nasal dryness
• systemic allergic reactions.

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

• dyspnea (difficulty breathing)

Very Rare(may affect less than 1 in 10,000 people):

• insomnia
• loss of consciousness
• hypertension (high blood pressure)
• hypotension (low blood pressure)

Frequency Not Known(frequency cannot be estimated from the available data):

• skin reactions including: facial swelling, skin redness, skin itching, rash, low blood pressure.

Reporting of Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Brimonidina Vir

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

Do not use Brimonidina Vir after the expiration date stated on the package and bottle after CAD. The expiration date is the last day of the month indicated.

Once the bottle is opened, it can be stored for a maximum of 28 days.

This medicine does not require special storage conditions.

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

6. Additional Information

Composition of Brimonidina Vir

The active substance is brimonidina tartrate.

1 ml of solution contains 2 mg of brimonidina tartrate, equivalent to 1.3 mg of brimonidina.

1 drop of solution contains 65.2 micrograms of brimonidina tartrate, which is equivalent to 43 micrograms of brimonidina.

The other ingredients are: benzalkonium chloride, polyvinyl alcohol, sodium citrate, citric acid monohydrate, sodium chloride, purified water, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment).

Appearance of Brimonidina Vir and Package Contents

Eye drop solution, transparent, pale yellow-green in color, in a plastic bottle.

Each bottle contains 5 ml of eye drop solution.

Package size: 1 bottle of 5 ml

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

Laguna, 66-68-70. Poligono Industrial Urtinsa II

28923 Alcorcón (Madrid)

Spain

Manufacturer

JADRAN-GALENSKI LABORATORIJ d.d.

Svilno 20

51000 Rijeka,

Croatia

This medicine is authorized in the EEA Member States under the following names:

Denmark Tarobrim, øjendråber, opløsning

Spain Brimonidina Vir 2 mg/ml, colirio en solución

Portugal Tarobrim 2 mg/ml colírio, soluçao

Date of the last revision of this package leaflet: September 2016

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