BRIMONIDINE VIATRIS 2 mg/ml EYE DROPS SOLUTION

2. What you need to know before you use Viatris Brimonidine

Do not use Viatris Brimonidine:

• If you are allergic to brimonidine or any of the other ingredients of this medicine (listed in section 6).
• If you are being treated with medicines classified as monoamine oxidase inhibitors (MAOIs), 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).

You must inform your doctor if you are taking any antidepressant medication.

• If the patient is a neonate or in children (up to 2 years).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Viatris Brimonidine

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

• If you have kidney or liver failure.

Children and adolescents

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

Brimonidine tartrate is not normally recommended in children (from 2 to 12 years) due to an increased risk of side effects (such as somnolence).

Other medicines and Viatris Brimonidine

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Do not use Viatris Brimonidine if you are being treated with MAOIs (monoamine oxidase inhibitors), tricyclic antidepressants or mianserin (see "Do not take").

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

Medicines for the treatment of nervous system disorders (chlorpromazine, methylphenidate), antihypertensive medicines (reserpine):caution is recommended in the case of patients treated with medicines that may affect the absorption and metabolism of adrenaline, noradrenaline and biogenic amines in the blood.

Antihypertensive agents, heart medicines:a slight decrease in blood pressure has been detected in some patients after administration of brimonidine tartrate. Caution is recommended if Viatris Brimonidine is used in combination with antihypertensive agents (used to treat high blood pressure) and/or heart medicines from the digitalis glycoside group.

Adrenergic receptor agonists or antagonists:caution is recommended if you are taking alpha-adrenergic agonists, 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 breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

Studies have not been conducted to determine if it is safe to use brimonidine tartrate during pregnancy. Consequently, Viatris Brimonidine should be used with caution during pregnancy and only if the expected benefit to the mother justifies the potential risk to the fetus.

Breastfeeding

It is not known if brimonidine tartrate is excreted in breast milk. Viatris Brimonidine should not be administered to women who are breastfeeding.

Driving and using machines

Viatris Brimonidine may cause fatigue and/or somnolence. This may affect your ability to drive or operate machinery safely.

Viatris Brimonidine may cause blurred vision and/or altered vision, which may affect your ability to drive or operate machines safely, especially at night or when there is little light and under poor lighting conditions.

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

Viatris Brimonidine contains benzalkonium chloride

This medicine contains 0.05 mg of benzalkonium chloride per milliliter of eye drops solution. Benzalkonium chloride can be absorbed by soft contact lenses and may alter the color of the contact lenses. Remove contact lenses before using this medicine and wait 15 minutes before putting them back.

Benzalkonium chloride can cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer on the front of the eye). Consult your doctor if you feel any unusual sensation, itching or pain in the eye after using this medicine.

3. How to use Viatris Brimonidine

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

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

If you think the effect of Viatris Brimonidine is too strong or too weak, consult your doctor.

Adults (including elderly patients)

Unless your doctor has told you otherwise, the recommended dose is one drop in the affected eye(s) twice a day, with a dosing interval of approximately 12 hours.

Instructions for use

Brimonidine is a medicine for ophthalmic use. Do not swallow.

Always wash your hands before applying the eye drops.

Apply the drops as follows:

1. Tilt your head back and look up.
2. Gently pull down the lower eyelid until a small pocket is formed.
3. Invert the bottle and squeeze it to release one drop into the eye.

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

If you are using more than one eye medicine, the medicines 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 Viatris Brimonidine than you should

Adults

The side 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 strong increase in blood pressure.

Consult your doctor immediately if you have ingested brimonidine tartrate. The following side effects have been reported with other medicines 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, breathing difficulties, low body temperature, and convulsions.

Children

There have been reports of overdose in children who had accidentally ingested brimonidine tartrate. The symptoms include temporary coma or low level of consciousness, fatigue, somnolence, weakness, slow heart rate, low body temperature, paleness, and breathing difficulties. 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 Toxicology Information Service, phone: 91 562 04 20. Take the medicine packaging with you so that the doctor knows what you have taken.

If you forget to use Viatris Brimonidine

If you forget to use Viatris Brimonidine, apply the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and continue with the next application at the usual time. Do not apply a double dose to make up for the missed dose.

Do not change the prescribed dose on your own.

If you stop using Viatris Brimonidine

Do not stop or interrupt treatment with Viatris Brimonidine without consulting your doctor first.

If you have any other questions about the use of 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.

If you notice any of the following side effects, or if they get worse 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, itching, burning, stinging, feeling of having a foreign body in the eye).

Common: may affect up to 1 in 10 people

• Discoloration/coloration of the cornea (the surface of the eye), blisters, swelling or severe damage (which can 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 can cause breathing difficulties, shortness of breath, swelling of the face, throat or tongue.

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

• Inflammation of the colored part of the eye, which can cause redness, blurred vision and changes in the shape of the pupils (the black part of the eye) and headache (iritis).

Other side effects include:

Very common: may affect more than 1 in 10 people

• Redness, tearing of the eyes and itching of the 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 can be seen by an optician (conjunctival follicles).
• Headache, dry mouth, fatigue/somnolence.

Common: may affect up to 1 in 10 people

• Tearing eyes, sensitivity to light, damage to the front of the eye (superficial damage to the cornea), dry eyes, abnormal vision.
• Symptoms in the upper respiratory tract, dizziness, stomach and intestine pain, weakness, alteration of taste.

Uncommon: may affect up to 1 in 100 people

• Irregular heartbeat/rhythm (including slow or fast heartbeat), depression, dry nose.

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

• Decreased pupil size (miosis).
• Fainting, increased blood pressure (hypertension), decreased blood pressure (hypotension), insomnia.

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

• Skin reactions, including swelling of the face, redness of the skin (which may be due to dilation of blood vessels), itching of the skin, rash, itching of the eyelids.

Other side effects in children and adolescents

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

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

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Viatris Brimonidine

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

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

After opening for the first time, Viatris Brimonidine should be used within 28 days of opening.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for disposal. If you have any further questions, ask your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Viatris Brimonidine

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

Appearance and packaging of the product

Viatris Brimonidine is a clear, slightly yellowish-green solution.

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

Not all pack sizes may be marketed.

Marketing authorisation holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Mylan SAS

117 Allée des Parcs

69800 Saint Priest

France

or

Famar A.V.E. Alimos Plant

63 Agiou Dimitriou str.

17456 – Alimos Attiki

Greece

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

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Austria: Brimonidin Arcana 2 mg/ml – Augentropfen

Denmark: Glaudin

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

France: Brimonidine Viatris 0,2% (2 mg/ml), collyre en solution

Italy: Brimonidina Viatris Generics

Netherlands: Brimonidinetartraat Viatris 2 mg/ml, oogdruppels (oplossing)

Portugal: Brimonidina Viatris, 2 mg/mL, colirio solução

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

Sweden: Glaudin 2 mg/ml ögondroppar, lösning

Date of last revision of this leaflet: December 2021

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