Label: Information for the Patient

Brimonidina Viatris 2 mg/ml Eye Drops Solution

Brimonidine Tartrate

Read this label carefully before starting to use the medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What isBrimonidina Viatrisand what is it used for

2. What you need to know before starting to useBrimonidina Viatris

3. How to useBrimonidina Viatris

4. Possible adverse effects

5. Storage ofBrimonidina Viatris

6. Contents of the package and additional information

Brimonidina Viatris contains the active ingredient brimonidine tartrate, which is used to reduce intraocular pressure (pressure inside the eye) in patients with open-angle glaucoma or ocular hypertension (fluid pressure inside the eye).

Brimonidina Viatris may be used alone or in combination with other medications to reduce intraocular pressure.

Do not use Brimonidina Viatris:

• If you are allergic to brimonidine or any of the other components of this medication (listed in section 6).
• If you are being treated with medications classified as monoamine oxidase inhibitors (MAO inhibitors), used to treat depression or Parkinson's disease, for example, selegiline, phenelzine.
• If you are being treated with certain antidepressants (such as tricyclic antidepressants, for example, clomipramine, amitriptyline or mianserin).

Inform your doctor if you are taking any antidepressant medication.

• If the patient is a neonate or child (up to 2 years old).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Brimonidina Viatris

• If you have a severe or unstable heart disease that is not responding to treatment.
• If you suffer from depression.
• If you experience a decrease in blood flow affecting the brain (cerebral insufficiency) or the heart, for example, angina pectoris or blocked blood vessels.
• If you have low blood pressure that causes dizziness and dizziness when standing up or getting up after lying down (orthostatic hypotension).
• If you suffer from constriction of blood vessels, mainly in the hands and arms (Raynaud's disease), or any inflammatory vascular disease with a blockage of blood vessels as a result of coagulation (thromboangiitis obliterans).

• If you have renal or hepatic insufficiency.

Children and adolescents

Do not administer brimonidine tartrate to newborns or children (from birth to 2 years old).

Brimonidine tartrate is usually not recommended for children (2 to 12 years old), due to an increased risk of adverse effects (for example, drowsiness).

Other medications and Brimonidina Viatris

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Do not use Brimonidina Viatris if you are being treated with MAO (monoamine oxidase inhibitor), a tricyclic antidepressant, or mianserin (see "Do not take").

Substances affecting the central nervous system (CNS):The effect of substances affecting the CNS (such as alcohol, barbiturates, for example, used in epilepsy such as phenobarbital, opiates used for pain relief, for example, codeine, sedatives used to sedate, for example, diazepam or anesthetics) may be increased by brimonidine tartrate.

Medications for the treatment of CNS disorders (chlorpromazine, methylphenidate), anti-hypertensive medications (reserpine):Caution is recommended in patients treated with medications that may affect the absorption and metabolism of adrenaline, noradrenaline, and the so-called biogenic amines in the blood.

Anti-hypertensive agents, heart medications:A slight decrease in blood pressure has been detected in some patients after administration of brimonidine tartrate. Caution is recommended if Brimonidina Viatris is used with anti-hypertensive agents (used to treat high blood pressure) and/or heart medications of the digitalis glycoside group.

Agonists or antagonists of adrenergic receptors:Caution is recommended if you are taking agonists?-adrenergic, such as phenylephrine (for example, eye drops, nasal sprays) or antagonists (for example, isoprenaline or prazosin (which may be used to treat high blood pressure or other circulatory problems)).

Pregnancy and lactation

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

Pregnancy

No studies have been conducted to determine if it is safe to use brimonidine tartrate during pregnancy. Therefore, Brimonidina Viatris should be used with caution during pregnancy and only if the expected benefit for the mother justifies the possible risk to the fetus.

Lactation

The excretion of brimonidine tartrate in breast milk is unknown. Brimonidina Viatris should not be administered to women in lactation.

Driving and operating machinery

Brimonidina Viatris may cause drowsiness and/or dizziness. This may affect your ability to drive or operate machinery safely.

Brimonidina Viatris may cause blurred vision and/or altered vision, which may affect your ability to drive or use machines safely, especially at night or in poor lighting conditions.

Wait until these effects have disappeared before driving or using machinery.

Brimonidina Viatris contains benzalkonium chloride

This medication contains 0.05 mg of benzalkonium chloride in each milliliter of eye drops in solution. Benzalkonium chloride may be absorbed by soft contact lenses and may alter the color of contact lenses. Remove contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you feel a strange sensation, burning, or pain in the eye after using this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

It is very important to use Brimonidina Viatris during the prescribed period of time by your doctor.

If you believe the effect of Brimonidina Viatris is too strong or too weak, consult with your doctor.

Adults (including elderly patients)

Unless your doctor has indicated otherwise, the recommended dose is one drop in the affected eye or eyes, twice a day, with a dosage interval of approximately 12 hours.

Usage instructions

Brimonidina is a medication for ophthalmic use. It should not be swallowed.

Always wash your hands before applying the eye drops.

Apply the drops as follows:

1. Incline your head backward and look upward.
2. Gently pull down your lower eyelid until a small space is formed.
3. Invert the bottle and press it to release one drop into the eye.

Immediately after applying each drop, close your eye and press the inner corner of your eye (lacrimal sac) with your finger for 1 minute. This helps to reduce the absorption of brimonidine tartrate in your body.

If you are using more than one ophthalmic medication, the medications should be applied at least 5-15 minutes apart.

After use, replace the cap immediately. Avoid touching the tip of the dropper with your eye or any other surface.

If you use more Brimonidina Viatris than you should

Adults

The adverse effects listed in section 4 of the leaflet have been reported for adults who have used more brimonidine tartrate than recommended in the eye.

In cases of adults who had accidentally ingested brimonidine tartrate, low blood pressure was reported. In some patients, this was followed by a significant increase in blood pressure.

Consult your doctor immediately if you have ingested brimonidine tartrate. The following adverse effects have been reported in other medications that have a similar mechanism of action to brimonidine when ingested: unusual weakness, vomiting, fatigue, decreased consciousness, slow heart rate, changes in heart rate, decreased pupil size, decreased muscle tone, respiratory difficulties, low body temperature, and seizures.

Children

Cases of overdose have been reported in children who had accidentally ingested brimonidine tartrate. Symptoms include temporary coma or decreased level of consciousness, fatigue, drowsiness, lethargy, slow heart rate, 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20. Bring the medication packaging with you so that the doctor knows what you have taken.

If you forgot to use Brimonidina Viatris

If you forgot to use Brimonidina Viatris, apply the missed dose as soon as you remember. However, if it is almost time for the next dose, omit the missed dose and continue with the next application at the usual time. Do not apply a double dose to compensate for the missed dose.

Do not change the prescribed dose on your own.

If you interrupt treatment with Brimonidina Viatris

Do not interrupt or discontinue treatment with Brimonidina Viatris without first consulting your doctor.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

If you notice any of the following side effects, or a worsening during treatment with brimonidine tartrate, contact your doctor or hospital immediately.

Very common: may affect more than 1 in 10 people

• Eye irritation, including allergic reactions (redness, pain, burning, itching, sensation of a foreign body in the eye).

Common: may affect up to 1 in 10 people

-Corneal discoloration/coloration, blisters, swelling or severe damage (which may be seen by an ophthalmologist or cause discomfort or pain in the eyes) on the surface of the eye (corneal erosion and spots).

Uncommon: may affect up to 1 in 100 people

• Allergic reactions, which may cause respiratory difficulties, shortness of breath, facial, throat, or tongue swelling.

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

• Iritis, which may cause redness, blurred vision, and changes in the shape of the pupils (colored part of the eye) and headache.

Other side effects include:

Very common: may affect more than 1 in 10 people

-Redness, tearing of the eyes, and itchy eyes with a sticky discharge (conjunctivitis, which may be due to allergy or infection), blurred vision, swelling and redness of the eyelid (which may be due to allergy (blepharitis)), elevation on the surface of the eye, which may be seen by an optician (conjunctival follicles).

-Headache, dry mouth, fatigue/drowsiness.

Common: may affect up to 1 in 10 people

• Watery eyes, light sensitivity, superficial damage to the front of the eye (superficial corneal damage), dry eyes, abnormal vision.
• Upper respiratory tract symptoms, dizziness, stomach and intestinal pain, weakness, altered taste.

Uncommon:may affect up to 1 in 100 people

• Irregular heartbeats/heart rhythm (including slow or rapid heartbeats), depression, nasal dryness.

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

• Shortness of breath (dyspnea).

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

• Pupil constriction (miosis).
• Syncope, hypertension, hypotension, insomnia.

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

• Skin reactions, including facial swelling, skin redness (which may be due to vasodilation), itching, rash, itching on the eyelids.

Other side effects in children and adolescents

Very common: may affect more than 1 in 10 children:

• Drowsiness. This may affect more than 1 in 2 children.

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 leaflet. 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 medication.

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

Do not use this medication after the expiration date that appears on the label and the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

After opening for the first time, Brimonidina Viatris should be used within 28 days following the opening.

Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you do not need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you do not need. In this way, you will help protect the environment.

Composition ofBrimonidina Viatris

• The active ingredient is: brimonidine tartrate.
  1 ml of solution contains 2 mg of brimonidine tartrate, equivalent to 1.3 mg of brimonidine.
• The other components are:
  benzalkonium chloride (see section 2 “Brimonidina Viatris contains benzalkonium chloride”), polyvinyl alcohol, sodium chloride, sodium citrate, citric acid monohydrate, purified water, sodium hydroxide, and hydrochloric acid for pH adjustment.

Appearance of the product and contents of the package

Brimonidina Viatris is a clear slightly yellowish green solution.

It is available in a 5 ml plastic bottle with a dropper cap, in packs of 1, 3, or 6.

Only some package sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

Mylan SAS

117 Allée des Parcs

69800 Saint Priest

France

or

Famar A.V.E. Alimos Plant

63 Agiou Dimitriou str.

17456 – AlimosAttiki

Greece

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Austria:Brimonidin Arcana 2 mg/ml – Augentropfen

Denmark:Glaudin

Spain:Brimonidina Viatris 2 mg/ml eye drops in solution

France:Brimonidine Viatris 0.2% (2 mg/ml), collyre in solution

Italy:Brimonidina Viatris Generics

Netherlands:Brimonidinetartraat Viatris 2 mg/ml, eye drops (solution)

Portugal:Brimonidina Viatris, 2 mg/mL, eye drops solution

United Kingdom:Brimonidine tartrate 2 mg/ml eye drops, solution

Sweden:Glaudin 2 mg/ml eye drops, solution

Last review date of this leaflet: December 2021

More detailed and up-to-date information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/