Alphagan 2 mg/ml eye drops solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Alphagan 2 mg/ml
eye drops solution
brimonidine tartrate
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It may harm them.
- If you get any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Alphagan is and what it is used for
- What you need to know before using Alphagan
- How to use Alphagan
- Possible side effects
- How to store Alphagan
- Contents of the pack and other information
1. What Alphagan is and what it is used for
Alphagan is used to reduce intraocular pressure. The active substance in Alphagan is brimonidine tartrate, which belongs to a group of medicines called alpha-2 adrenergic receptor agonists and works by reducing pressure within the eye.
It may be used alone when beta-blocker eye drops are contraindicated, or in combination with other eye drops when a single medicine is not sufficient to reduce elevated intraocular pressure. It is used in the treatment of open-angle glaucoma or ocular hypertension.
2. What you need to know before using Alphagan
Do not use Alphagan
- If you are allergic (hypersensitive) to brimonidine tartrate or to any of the other ingredients of this medicine (listed in section 6).
- If you are taking monoamine oxidase inhibitors (MAOIs) or other antidepressants. You must 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
Talk to your doctor before using Alphagan:
- If you suffer from or have previously had depression, reduced mental capacity, decreased blood flow to the brain, heart problems, impaired blood supply to the extremities, or a blood pressure disorder.
- If you have or have previously had kidney or liver problems.
Children and adolescents
Alphagan is not recommended for use in children between 2 and 12 years of age.
Alphagan should generally not be used in adolescents aged 12 to 17 years, as clinical studies have not been conducted in this age group.
Other medicines and Alphagan
Inform 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 regularly consume alcohol.
- Anesthetics.
- Medicines used to treat a heart condition or to lower blood pressure.
- Medicines that may affect metabolism, such as chlorpromazine, methylphenidate, and reserpine.
- Medicines acting on the same receptor as Alphagan, such as isoprenaline and prazosin.
- Monoamine oxidase inhibitors (MAOIs) and other antidepressants.
- Medicines for any condition, even those unrelated to your eye condition.
- Or if the dose of any of your current medicines changes.
These may affect your treatment with Alphagan.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Do not use Alphagan during pregnancy unless your doctor considers it necessary.
Do not use Alphagan while breastfeeding.
Driving and using machines
Alphagan may cause blurred or abnormal vision. This effect may be worsened at night or under 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 resolved.
Alphagan contains benzalkonium chloride
This medicine 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 medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may cause ocular 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 experience a foreign body sensation, stinging, or pain in the eye after using this medicine.
3. How to use Alphagan
Follow exactly the administration instructions for Alphagan given by your doctor. Consult your doctor or pharmacist if you have any doubts.
Adults
The recommended dose is one drop twice daily in the affected eye(s), approximately 12 hours apart. Do not change the dose or stop using Alphagan without speaking to your doctor.
Children under 12 years of age
Alphagan must not be used in children under 2 years of age.
Alphagan is not recommended for use in children between 2 and 12 years of age.
Instructions for use
Alphagan is supplied as eye drops. Always wash your hands before applying the eye drops. Your prescription will indicate how many drops to use per dose. If you are using Alphagan with another eye drop, wait 5–15 minutes before applying the second eye drop.
Apply your eye drops as follows:
- Tilt your head backwards and look at the ceiling.
- Gently pull down the lower eyelid until a small pocket forms.
- Squeeze the inverted container so that one drop falls into your eye.
- Keep the affected eye closed, press your finger against the corner of the closed eye (where the eye meets the nose), and hold for 1 minute.
If the drop misses 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 more Alphagan than you should
Adults
In adult patients who used 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. Signs included somnolence, hypotonia, low body temperature, pallor, and breathing difficulties. If this occurs, contact your doctor immediately.
Adults and children
If Alphagan has been accidentally ingested or if more Alphagan than intended has been used, please contact your doctor immediately.
If you forget to use Alphagan
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose completely and then 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 unless your doctor tells you to do so.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects may occur with Alphagan.
Affecting the eye
Very common (may affect more than 1 in 10 people)
- Eye irritation (eye redness, burning, stinging, sensation of foreign body 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 (may affect up to 1 in 10 people)
- Local irritation (inflammation, redness and discomfort in the eye, eyelid swelling, swelling of the transparent layer covering the eye surface, sticky eyes, pain, and tearing)
- Light sensitivity
- Erosion and discoloration on the surface of the eye
- 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
- Small bumps on the inner side of the eyelids due to inflammation
Very rare (may affect up to 1 in 10,000 people)
- Inflammation in the eye
- Reduction in pupil size
Frequency not known (frequency cannot be estimated from available data)
- Itching of the eyelids
Affecting the body
Very common (may affect more than 1 in 10 people)
- Headache
- Dry mouth
- Fatigue/somnolence
Common (may affect up to 1 in 10 people)
- Dizziness
- Cold-like symptoms
- Stomach and digestive symptoms
- Taste disturbance
- General weakness
Uncommon (may affect up to 1 in 100 people)
- Depression
- Palpitations or changes in heart rate
- Dry nose
- General allergic reactions
Rare (may affect up to 1 in 1,000 people)
- Respiratory failure
Very rare (may affect more than 1 in 10,000 people)
- Insomnia
- Fainting
- High blood pressure
- Low blood pressure
Frequency not known (frequency cannot be estimated from available data)
- Skin reactions including redness, facial swelling, itching, rash, and blood vessel dilation
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of 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 bottle's safety seal is broken before first use.
- Do not use Alphagan after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
- Discard the bottle 28 days after opening, even if there is solution remaining.
Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.
6. Contents of the pack and other information
Composition of 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 components are benzalkonium chloride as a preservative, poly (vinyl alcohol), sodium chloride, sodium citrate dihydrate, citric acid monohydrate, purified water, and sodium hydroxide or hydrochloric acid for pH adjustment.
Appearance of Alphagan and contents of the pack
Alphagan is an ophthalmic solution, a clear yellowish-green to slightly yellowish-green liquid in a plastic bottle.
Each bottle contains 2.5 ml, 5 ml or 10 ml of medicinal product.
Alphagan is available in packs containing 1, 3 or 6 bottles.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
AbbVie Spain, S.L.U.
Avenida de Burgos 91
28050, Madrid
Spain
Manufacturer:
Allergan Pharmaceuticals Ireland,
Westport, Co. Mayo,
Ireland
This leaflet was approved in 12/2025
Other sources of information
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es
To listen to or request a copy of this leaflet in