ALPHAGAN 2 mg/ml EYE DROPS SOLUTION

2. What you need to know before you use Alphagan

Do not use Alphagan

• If you are allergic (hypersensitive) to brimonidine tartrate or any of the other ingredients of this medicine (listed in section 6)
• If you are taking monoamine oxidase inhibitors (MAOIs) or certain other antidepressants. You should tell your doctor if you are taking any antidepressant medication.
• If you are breast-feeding.
• In children/babies (up to 2 years of age).

Warnings and precautions

Tell your doctor before using Alphagan:

• If you have or have had depression, reduced mental ability, reduced blood flow to the brain, heart problems, poor circulation to your hands or feet, or a blood pressure disorder.
• If you have or have had kidney or liver problems.

Children and adolescents

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

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

Other medicines and Alphagan

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Tell your doctor if you are using any of the following medicines:

• Painkillers, sedatives, opioids, barbiturates, or if you are regularly drinking alcohol.
• Anaesthetics.
• Medicines for heart conditions or to lower blood pressure.
• Medicines that can affect metabolism, such as chlorpromazine, methylphenidate, and reserpine.
• Medicines that act on the same receptor as Alphagan, such as isoprenaline and prazosin.
• MAOIs and other antidepressants.
• Medicines for any condition, including those not related to your eye condition.
• Or if the dose of any of your current medicines changes.

These may affect your treatment with Alphagan.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Do not use Alphagan if you are pregnant unless your doctor considers it necessary.

Alphagan should not be used during breast-feeding.

Driving and using machines

• Alphagan may cause blurred or abnormal vision. This effect may be increased in the dark 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 use machines until the symptoms have resolved.

Alphagan contains benzalkonium chloride

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

Benzalkonium chloride may be absorbed by soft contact lenses and change their colour. Remove contact lenses before using this medicine and wait 15 minutes before putting them back.

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

3. How to use Alphagan

Use Alphagan exactly as your doctor has told you. Ask your doctor or pharmacist if you are not sure.

Adults

The recommended dose is one drop twice a day in the affected eye(s), approximately 12 hours apart. 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 and 12 years old.

Instructions for use

Alphagan comes as eye drops. Always wash your hands before applying the eye drops. Your prescription will tell you how many drops to use for 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. Tilt your head back and look up at the ceiling.
2. Gently pull down the lower eyelid to make a small pocket.
3. Squeeze the bottle gently to release one drop into your eye.
4. Keep the affected eye closed and press your finger against the corner of your closed eye (where the eye meets the nose) for 1 minute.

If the drop falls outside the eye, try again.

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

Put the cap back on and close the bottle immediately after use.

If you use more Alphagan than you should

Adults

In adults who applied more drops than prescribed, the adverse effects reported 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

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

Adults and children

If you have accidentally ingested Alphagan or used more Alphagan than you should, contact your doctor immediately.

If you forget to use Alphagan

If you forget to apply a dose, use it as soon as you remember. However, if it is almost time for your next dose, you should skip the missed dose and continue with your regular schedule. Do not use a double dose to make up for missed doses.

If you stop using Alphagan

To be effective, Alphagan must be used every day. Do not stop using Alphagan without talking to your doctor.

If you have any questions about using this product, 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 may occur with Alphagan.

Affecting the eye

Very common (affects more than 1 in 10 people):

• Eye irritation (redness of the eye, burning, stinging, feeling of something in the eye or itching) Follicles or white spots on the transparent layer covering the surface of the eye)
• Blurred vision
• An allergic reaction in the eyes

Common (affects up to 1 in 10 people):

• Local irritation (inflammation and swelling of the eyelid, sticky eyes, swelling of the eyelid or the transparent layer covering the surface of the eye, pain and tearing)
• Sensitivity to light
• Erosion on the surface of the eye and discoloration
• Dry eye
• Whitening of the transparent layer covering the surface of the eye.
• Abnormal vision
• Inflammation of the transparent layer covering the surface of the eye.

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

• Inflammation in the eye

• Reduced pupil size.

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

• Itching of the eyelids

Affecting the body:

Very common (affects more than 1 in 10 people):

• Headache,
• Dry mouth
• Fatigue/drowsiness.

Common (affects up to 1 in 10 people):

• Dizziness
• Cold symptoms
• Symptoms affecting the stomach and digestion
• Altered taste
• General weakness.

Uncommon (affects up to 1 in 100 people):

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

Rare (affects up to 1 in 1,000 people):

• Respiratory failure.

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

• Insomnia
• Fainting
• High blood pressure.
• Low blood pressure.

Frequency not known (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 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 to the Spanish Medicines and Healthcare Products Agency (AEMPS) at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Alphagan

• Keep this medicine out of the sight and reach of children.
• Do not store above 25°C.
• Do not use this medicine if you notice that the security seal of the bottle is broken before the first use.
• Do not use Alphagan after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.
• Discard the bottle 28 days after opening, even if there is solution left.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What is in Alphagan

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

• The other ingredients 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.

What Alphagan looks like and contents of the pack

Alphagan is a clear, greenish-yellow to light greenish-yellow eye drop solution in a plastic bottle.

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

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

Not all packs may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

AbbVie Spain, S.L.U.

Avenida de Burgos 91

28050, Madrid

Spain

Manufacturer:

Allergan Pharmaceuticals Ireland,

Westport, Co. Mayo,

Ireland

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

This leaflet was approved in 09/2020

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