Package Insert: Information for the User

Brimonidine Tartrate 2 mg/ml, Eye Drops Solution

Tartrate of brimonidine

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

• Keep this package insert as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to other people, 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 package insert. See section 4.

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

Brimonidina Vir is a medication used to reduce intraocular pressure. It may be used alone in patients for whom topical beta-blocker therapy is contraindicated or with another eye drop, when it is not possible to decrease intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension

Do not use Brimonidina Vir if:

• You are allergic (hypersensitive) to brimonidine or to any of the other components of this medication (listed in section 6).
• You are a newborn/child (under 2 years old).
• 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 aged 2 to 12 years. Brimonidina Vir is not recommended for use in children of this age.
• You suffer or have suffered from depression, reduced mental capacity, reduced blood flow to the brain, heart problems, peripheral circulation disorders, or blood pressure alterations.
• You have or have had liver or kidney problems.

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

Children and adolescents

Brimonidina is not recommended for use 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.

Use of other medications with Brimonidina Vir

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

Inform your doctor if you are taking the following medications:

- Pain relievers, sedatives, opioids, barbiturates, or consume alcohol regularly.

• Anesthetics.
• Medications for treating high blood pressure or heart conditions.
• Medications that can affect your metabolism, such as chlorpromazine, methyldopa, and reserpine.
• Medications that work on the same receptor as Brimonidina Vir, for example isoprenaline and prazosin.
• MAO inhibitors and other antidepressants.
• Medications for any other condition, although not related to your eye condition.
• Or if you change the dose of any of your medications.

This could affect your treatment with Brimonidina Vir.

Pregnancy and lactation

If you are pregnant or breastfeeding, or believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Do not use Brimonidina Vir if you are breastfeeding.

Driving and operating machinery

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

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

Adults (including those over 65 years)

The recommended dose is one drop in the affected eye or eyes twice a day, with a dosage interval of approximately 12 hours.

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

It is not recommended to use Brimonidina Vir in children between 2 and 12 years.

Instructions for use

Brimonidina Vir is presented in the form of eye drops. Always wash your hands before applying the eye drops. The packaging indicates how many drops to use in each dose. If you are using more than one eye drop medication, the medications should be applied with an interval of at least 15 minutes between them.

Apply the eye drops as follows:

1. Incline your head back and look up
2. Gently pull the lower eyelid down until a small space is formed
3. Turn the bottle upside down and press until one drop enters each eye that needs treatment
4. Keep the eye closed and press the inner corner of the eye (the inner corner of the eye) with your finger for one minute

Avoid letting the tip of the container touch 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 in adults who have used more eye drops than recommended.

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

Children

Cases of overdose in children who accidentally ingested Brimonidina Vir have been reported. Symptoms include drowsiness, weakness, low body temperature, pallor, 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication 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 do not remember the missed dose until just before the next dose, do not apply the missed dose and apply the next dose as scheduled.

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

If you interrupt treatment with Brimonidina Vir

To be effective, Brimonidina Vir must be used every day. Do not interrupt treatment with Brimonidina Vir without first consulting your doctor.

If you have any other questions 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 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 something in the eye, follicular conjunctivitis), follicular conjunctivitis
• Blurred vision
• Eye allergic reaction.

Common(may affect between 1 and 10 in 100 people):

• Local eye irritation (redness and swelling of the eyelid, conjunctival edema and discharge, eye pain and tearing)
• Light sensitivity
• Superficial damage and discoloration of the cornea
• Eye dryness
• Conjunctival pallor
• Abnormal vision
• Conjunctivitis.

Very rare(affects 1-10 users in every 1,000):

• Iritis (iris inflammation)
• Pupil constriction.

Frequency not known(the frequency cannot be estimated from the available data):

• Itching of the eyelids

Body side effects

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

• Headache
• Mouth dryness
• Fatigue/drowsiness

Common(may affect between 1 and 10 in 100 people):

• Dizziness
• Common cold symptoms
• Symptoms affecting the stomach and digestion
• Alteration of taste
• Systemic weakness.

Uncommon(may affect between 1 and 10 in 1,000 people):

• Depression
• Palpitations or arrhythmias,
• Nasal dryness
• Systemic allergic reactions.

Rare(may affect between 1 and 10 in 10,000 people):

• Dyspnea (breathing difficulty)

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

• Insomnia
• Loss of consciousness
• Hypertension (high blood pressure)
• Hypotension (low blood pressure)

Frequency not known(the frequency cannot be estimated from the available data):

• Dermatological reactions that include: facial swelling, skin redness, skin itching, rash, low blood pressure.

Reporting 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 leaflet. You can also report them directly through the Spanish System for 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 reach and sight of children.

Do not use Tarobrim after the expiration date that appears on the packaging and the 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 medication does not require special storage conditions.

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

Composition of Brimonidina Vir

The active substance is brimonidine tartrate.

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

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

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

Appearance of Brimonidina Vir and packaging contents

Eye drops in a pale yellowish green transparent solution in a plastic bottle.

Each bottle contains 5 ml of eye drops in solution.

Packaging size: 1 bottle of 5 ml

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

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

28923 Alcorcón (Madrid)

Spain

Responsible Manufacturer

JADRAN-GALENSKI LABORATORIJ d.d.

Svilno 20

51000 Rijeka,

Croatia

This medicinal product is authorized in the Member States of the EEA under the following denominations:

DenmarkTarobrim, øjendråber, opløsning

SpainBrimonidina Vir 2 mg/ml, eye drops in solution

PortugalTarobrim 2 mg/ml colírio, soluçao

Last review date of this leaflet: September 2016

Further detailed information on this medicinal product is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS) (http://www.aemps.gob.es/).