Label: Information for the User

Abradel 2 mg/ml Eye Drop 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 refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication 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 adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label.

Abradel is a medication used to reduce intraocular pressure (pressure inside the eye) in patients with open-angle glaucoma or ocular hypertension (high pressure in the eye).

Abradel can be used alone or in association with other medications to reduce intraocular pressure.

Do not use Abradel:

• If you are allergic (hypersensitive) to brimonidine tartrate or any of the other components of this medication (listed in section 6).
• If you are taking monoamine oxidase inhibitors (MAOIs).
• If you are taking any medication for depression (tricyclic antidepressants or mianserine).
• Inform your doctor if you are taking medications for depression.
• In newborns and small children (up to 2 years old).

Warnings and precautions

Consult your doctor,pharmacist or nurse before starting to use Abradel:

• If you have severe or unstable heart failure that has not been treated.
• If you have depression.
• If you have cerebral or coronary insufficiency (reduced blood flow to the brain or heart).
• If you have orthostatic hypotension (sudden drop in blood pressure with dizziness and vertigo when standing up or getting up after lying down).
• If you suffer from Raynaud's phenomenon or a chronic inflammatory vascular disease with vascular obstruction due to coagulation (thromboangiitis obliterans).
• If you have kidney or liver problems.

Consult your doctor if you are in any of these circumstances.

Use of Abradel with other medications

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

Substances affecting the central nervous system (CNS):Abradel may increase the effect of substances affecting the CNS (alcohol, barbiturates, opioids, sedatives, or anesthetics).

Medications for the treatment of nervous system diseases (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 other biogenic amines in the blood.

Anti-hypertensive medications or medications for heart disease:After administration of Abradel, a slight decrease in blood pressure has been observed in some patients. Caution should be exercised when Abradel is administered with anti-hypertensive medications and/or medications for the heart in the group of digitalis glycosides.

Agonists or antagonists of adrenergic receptors:Caution should be exercised when initiating treatment, administered systemically, or changing the dosage (regardless of the administration method), which may cause interactions with alpha-adrenergic receptor agonists or affect their action, such as agonists or antagonists of adrenergic receptors (e.g., isoprenaline or prazosin).

Pregnancy, lactation, and fertility

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

No studies have been conducted to determine if the use of Abradel during pregnancy is safe. Therefore, Abradel should be used with caution during pregnancy and only if the expected benefit for the mother outweighs the possible risk to the fetus.

Abradel should not be used during breastfeeding since the safety of brimonidine in this context is unknown.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Abradel may cause drowsiness and/or fatigue that may affect your ability to drive or operate machinery safely.

Abradel may cause visual disturbances and/or blurred vision that may affect your ability to drive or operate machinery safely, especially at night or in low light.

Abradel contains benzalkonium chloride

This medication may cause eye irritation due to the presence of benzalkonium chloride. Avoid contact with soft contact lenses. Remove contact lenses before application and wait at least 15 minutes before reinserting them. Benzalkonium chloride alters the color of soft contact lenses.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

It is very important to use Abradel for the period of time indicated by your doctor.

If you consider that the effect of Abradel is too strong or too weak, consult with your doctor.

The usual dose is one drop in the affected eye or eyes twice a day, with an interval between doses of approximately 12 hours, unless your doctor has indicated another dose.

Administration Method:

Brimonidina is used only by the ocular route. Do not swallow.

Wash your hands carefully before applying the drops.

Apply the drops as follows:

1. Tilt your head back and look up.

2. Gently pull down the 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 the eye for one minute, while pressing the lacrimal sac with your finger. This helps to reduce the absorption of brimonidina by your body.

If you are using more than one eye drop medication, wait 5 to 15 minutes between administrations.

Use in Children:

Brimonidina eye drops should not be used in newborns or in small children (up to 2 years old) and are not recommended for use in children between 2 and 12 years old.

Using more Abradel than you should:

No cases of overdose with Abradel have been described in adults and it is unlikely to occur when administered as eye drops.

Some cases of overdose have been reported in newborns. Symptoms include drowsiness, hypotonia, decreased body temperature, and breathing difficulties. If this happens, contact your doctor immediately.

In one case, an adult accidentally ingested a dose of approximately 10 drops of Abradel, and moderate hypotension was observed several hours after ingestion. This was followed by a significant increase in blood pressure approximately 8 hours after ingestion.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at (91) 562 04 20. If you visit a doctor, remember to bring the medication packaging so that they can know what you have taken.

Missing a dose:

If you forget to use Abradel, apply the missed dose as soon as you remember. However, if the next dose is almost due, omit the missed dose and continue with the next administration at the usual time. Do not use a double dose to compensate for the missed dose.

If you have any doubts, consult your doctor or pharmacist.

Do not change the dose prescribed by your doctor.

Stopping Abradel treatment:

Do not stop Abradel treatment without first consulting your doctor.

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

Like all medicines, Abradel can cause side effects, although not everyone will experience them. If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

The side effects that occur most frequently (22 to 25% of patients) are dry mouth, eye redness, and eye burning or itching. These side effects are generally transient and of little severity, so they do not require interrupting treatment with Abradel.

During clinical trials, allergic reactions occurred in 12.7% of patients. In most cases, they occurred within three to nine months of treatment. If allergic reactions occur, treatment with Abradel should be interrupted.

The analysis of side effects is based on the following incidence rate:

During treatment with Abradel, the following side effects have been observed:

Eye side effects:

Very common:

• Ocular irritation, including allergic reaction (eye redness, pain, and burning, itching, foreign body sensation, follicular conjunctivitis), blurred vision.

Common:

• Local eye irritation (eye redness and inflammation, eyelid inflammation, conjunctival edema and discharge, eye pain and lacrimation), light intolerance, corneal erosion or discoloration, dry eye, conjunctival pallor, abnormal vision, conjunctivitis.

Very rare:

• Iris inflammation of the eye, pupil constriction.

Systemic side effects:

Very common:

• Headache, dry mouth, fatigue/drowsiness.

Common:

• Upper respiratory tract symptoms, vertigo, gastrointestinal pain, weakness, altered taste.

Uncommon:

• Palpitations/irregular heartbeats (including very rapid or very slow heartbeats), general allergic reactions, depression, dry nose.

Rare:

• Dyspnea.

Very rare:

• Syncope, hypertension, hypotension, insomnia.

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

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

Dispose of the Abradel packaging within 28 days of the first opening.

Medications should not be thrown down the drain or in the trash. Deposit the packaging 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Abradel

• The active principle 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, polyvinyl alcohol, sodium chloride, sodium citrate, monohydrated citric acid, purified water, sodium hydroxide, and hydrochloric acid to adjust the pH.

Appearance of the product and contents of the packaging

Abradel 2mg/ml eye drops in solution is a transparent solution with a light yellow-green color.

The eye drops are available in 5 ml bottles with dropper in packaging of 1, 3 or 6 bottles and in 10 ml bottles with dropper in packaging of 1 or 3 bottles.

Only some sizes of packaging may be commercially available

Holder of the marketing authorization and responsible(s) for manufacturing

Holder of the marketing authorization:

Tiedra Farmacéutica, S.L.

C/ Colón, 7

30510 Yecla - Murcia

Spain

Responsible(s) for manufacturing:

AB Sanitas

Veiveriu Street 134B

46352 Kaunas

Lithuania

Pharma Stulln GmbH

Werksstrasse 3

92551 Stulln

Germany

Last review date of this leaflet: February 2013

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