Label: Information for the User

Alphagan 2 mg/ml

eye drops in solution.

brimonidine tartrate

Read this label carefully before starting to use the medicine, 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 medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Alphagan is used to reduce intraocular pressure. The active ingredient in Alphagan is brimonidine tartrate, which belongs to a group of medications called alpha-2 adrenergic receptor agonists and works by reducing pressure in the eyeball.

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

Do not use Alphagan

• If you are allergic (hypersensitive) to brimonidine tartrate or to any of the other components of this medication (listed in section 6)
• If you are taking monoamine oxidase inhibitors (MAOIs) or other antidepressants. Inform your doctor if you are taking any antidepressant medication.
• If you are breastfeeding.
• In children/infants (up to 2 years of age).

Warnings and precautions

Speak with your doctor before using Alphagan:

• If you suffer or have suffered from depression, decreased mental capacity, reduced blood flow to the brain, heart problems, a reduction in blood supply to the extremities, or a blood pressure disorder.
• If you have or have had in the past kidney or liver problems.

Children and adolescents

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

Alphagan should not be used generally in adolescents from 12 to 17 years, as no clinical studies have been conducted in this age group.

Other medications and Alphagan

Inform your doctor or pharmacist if you are using or have used recently other

medications, including those purchased without a prescription.

Inform your doctor if you are using any of the following medications:

• Pain relievers, sedatives, opioids, barbiturates, or regularly consuming alcohol.
• Anesthetics.
• Medications for treating a heart condition or to lower blood pressure.
• Medications that can affect metabolism, such as chlorpromazine, methylphenidate, and reserpine.
• Medications that act on the same receptor as Alphagan, such as isoprenaline and prazosin.
• Monamine oxidase inhibitors (MAOIs) and other antidepressants.
• Medications for any condition, including those unrelated to your eye condition.
• Or if the dose of any of your current medications changes.

These may affect your treatment with Alphagan.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. Do not use Alphagan if you are pregnant unless your doctor considers it necessary.

Alphagan should not be used during breastfeeding.

Driving and operating machinery

• Alphagan may cause blurred or abnormal vision. This effect may worsen at night or with reduced lighting.
• Alphagan 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 subsided.

Alphagan contains benzalkonium chloride

This medication contains 0.25 mg of benzalkonium chloride in each 5 ml of solution, equivalent to 0.05 mg/ml.

Benzalkonium chloride can be absorbed by soft contact lenses, altering their color. 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 (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 for Alphagan indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Adults

The recommended dose is one drop twice a day in the affected eye(s), approximately with 12 hours of difference. Do not change the dose or stop using Alphagan without talking to your doctor.

Children under 12 years

Alphagan should not be used in children under 2 years of age.

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

Usage instructions

Alphagan is presented as eye drops. Always wash your hands before applying the eye drops. Your prescription indicates how many drops you should use in each dose. If you use Alphagan with another eye drop, wait 5-15 minutes before applying the second eye drop.

Apply your eye drops as follows:

1. Incline your head backward and look up.
2. Gently pull down your lower eyelid until a small pocket is formed.
3. Press the inverted container to release one drop into your eye.
4. Keep the affected eye closed, press your finger against the closed eye corner (the part where the eye meets the nose) and hold it for 1 minute.

If the drop falls outside the eye, try again.

To avoid contamination, do not let the dropper tip touch the eye or any other surface.

Replace the cap and close the container immediately after use.

If you use moreAlphaganthan you should

Adults

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

Adults who accidentally ingested Alphagan experienced a decrease in blood pressure, which in some patients was followed by an increase in blood pressure.

Children

Severe adverse effects were reported in children who accidentally ingested Alphagan. The symptoms included drowsiness, hypotonia, low body temperature, pallor, and breathing difficulties. If this happens, contact your doctor immediately.

Adults and children

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

If you forget to use Alphagan

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 should completely omit the missed dose and then follow your regular schedule. Do not use a double dose to compensate for the missed doses.

If you interrupt treatment withAlphagan

For Alphagan to be effective, it must be used every day. Do not stop using Alphagan until your doctor tells you to.

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

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

The following side effects may be observed with Alphagan.

Those affecting the eye

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

• Eye irritation (redness, burning, stinging, feeling of a foreign body in the eye, or itching) White spots or patches on the clear surface that covers the eye)
• Blurred vision
• Allergic reaction in the eyes

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

• Local irritation(inflammation and swelling of the eyelid, sticky eyes, swelling of the eyelid or the clear surface that covers the eye, pain, and tearing)
• Light sensitivity
• Erosion on the surface of the eye and discoloration
• Dry eye
• Whitening of the clear surface that covers the eye.
• Abnormal vision
• Inflammation of the clear surface that covers the eye.

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

• Inflammation in the eye

• Constriction of the pupil.

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

• Itching of the eyelids

Those affecting the body:

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

• Headache,
• Dry mouth
• Fatigue/drowsiness.

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

• Dizziness
• Chills
• Symptoms affecting the stomach and digestion
• Alteration of taste
• General weakness.

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

• Depression
• Palpitations or changes in heart rate
• Runny nose
• General allergic reactions.

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

• Respiratory insufficiency.

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

• Insomnia
• Loss of consciousness
• High blood pressure.
• Low blood pressure.

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

• Skin reactions including redness, inflammation of the face, itching, rash, and dilation of blood vessels.

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: 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 reach and sight of children.
• Do not store at a temperature above 25 ° C.
• Do not use this medication if you observe that the safety closure of the bottle is broken before the first use.
• Do not use Alphagan after the expiration date that appears on the packaging afterEXP. The expiration date is the last day of the month indicated.
• Dispose of the bottle 28 days after opening, even if there is solution remaining.

Medications should not be thrown down the drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Alphagan

• The active ingredient is brimonidine tartrate. One milliliter of solution contains 2.0 mg of brimonidine tartrate, equivalent to 1.3 mg of brimonidine.

• The other components are benzalkonium chloride as a preservative, poly (vinyl alcohol), sodium chloride, sodium citrate, citric acid monohydrate, purified water, and sodium hydroxide or hydrochloric acid for pH adjustment.

Appearance of Alphagan and contents of the packaging

Alphagan is a clear yellowish-green to slightly yellowish-green solution in a plastic bottle.

Each bottle contains 2.5 ml, 5 ml, or 10 ml of the medication.

Alphagan is available in packs of 1, 3, or 6 bottles.

Not all packaging may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

AbbVie Spain, S.L.U.

Avenida de Burgos 91

28050, Madrid

Spain

Responsible for manufacturing:

Allergan Pharmaceuticals Ireland,

Westport, Co. Mayo,

Ireland

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

This leaflet was approved in 09/2020

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es