Abradel 2 mg/ml eye drops solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Abradel 2 mg/ml eye drops solution

Brimonidine tartrate

Read the entire 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, pharmacist, or nurse.
• 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, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet.

Contents of the leaflet:

1. What Abradel is and what it is used for
2. What you need to know before using Abradel
3. How to use Abradel
4. Possible adverse effects
5. How to store Abradel
6. Contents of the pack and other information

1. What Abradel is and what it is used for

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

Abradel may be used alone or in combination with other medicines to reduce intraocular pressure.

2. What you need to know before using Abradel

Do not use Abradel:

• 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).
• If you are taking any medication for depression (tricyclic antidepressants or mianserin).
• Inform your doctor if you are taking medications for depression.
• In newborns and young children (up to 2 years of age).

Warnings and precautions

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

• If you have severe or untreated unstable heart failure.
• If you have depression.
• If you have cerebral or coronary insufficiency (reduced blood flow to the brain or heart).
• If you have orthostatic hypotension (a sudden drop in blood pressure causing dizziness and lightheadedness when standing up or getting up from lying down).
• If you suffer from constriction of blood vessels, mainly in the hands and arms (Raynaud's phenomenon), or from a chronic vascular inflammatory disease resulting in blood vessel obstruction due to clotting (thromboangiitis obliterans).
• If you have kidney or liver problems.

Please consult your doctor if you are in any of these situations.

Use of Abradel with other medicines

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

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

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

Antihypertensive medicines or medicines for heart conditions: a slight decrease in blood pressure has been observed in some patients after administration of Abradel. Caution should be exercised when administering Abradel together with antihypertensive medicines and/or medicines for heart conditions belonging to the digitalis glycosides group.

Adrenergic receptor agonists or antagonists: caution should be exercised when initiating systemic treatment or changing the dosage (regardless of the route of administration) of medicines that may interact with alpha-adrenergic receptor agonists or affect their action, such as adrenergic receptor agonists or antagonists (e.g., isoprenaline or prazosin).

Pregnancy, breastfeeding, and fertility

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.

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

Abradel should not be used during breastfeeding, as it is unknown whether brimonidine passes into breast milk.

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

Abradel may cause tiredness and/or drowsiness, which may affect your ability to drive or operate machinery safely.

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

Abradel contains benzalkonium chloride

This medicine may cause eye irritation because it contains benzalkonium chloride. Avoid contact with soft contact lenses. Remove contact lenses before application and wait at least 15 minutes before reinserting them. Benzalkonium chloride may discolor soft contact lenses.

3. How to use Abradel

Follow exactly the instructions for administering the medicine provided in this leaflet or those given by your doctor. If in doubt, consult your doctor or pharmacist.

It is very important to use Abradel for the length of time prescribed by your doctor.

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

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

Method of administration:

Brimonidine is for ocular use only. It must not be swallowed.

Always wash your hands thoroughly before applying the drops.

Apply the drops as follows:

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

Immediately after applying each drop, close the eye for one minute while pressing gently with your finger on the tear duct area (inner corner of the eye). This helps reduce the absorption of brimonidine into your body.

If you are using more than one ophthalmic medication, wait 5 to 15 minutes between applications.

Use in children

Brimonidine eye drops must not be used in newborns or infants under 2 years of age. Its use is not recommended in children between 2 and 12 years of age.

If you use more Abradel than you should

Cases of overdose with Abradel have not been reported in adults and are unlikely when administered as eye drops.

However, some cases of overdose have been reported in newborn infants. Symptoms include drowsiness, low muscle tone, decreased body temperature, and breathing difficulties. If any of these occur, contact your doctor immediately.

In one case where an adult accidentally ingested approximately 10 drops of Abradel, 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number (91) 562 04 20. If you go to a doctor, remember to bring the medicine packaging so that he or she can see what you have taken.

If you forget to use Abradel

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

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

Do not change the dose prescribed by your doctor.

If you stop using Abradel

Do not stop treatment with Abradel without first consulting your doctor.

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

4. Possible adverse effects

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

The most frequently occurring adverse effects (in 22 to 25% of patients) are dry mouth, eye redness, and eye burning or itching. These effects are usually transient and mild in severity, so treatment with Abradel does not generally need to be discontinued.

Allergic reactions occurred in 12.7% of patients during clinical trials. In most cases, these occurred after three to nine months of treatment. If allergic reactions occur, treatment with Abradel must be discontinued.

The analysis of adverse effects is based on the following incidence rates:

The following adverse effects have been observed during treatment with Abradel:

Ocular adverse effects:

Very common:

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

Common:

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

Very rare:

• Inflammation of the iris of the eye, pupillary constriction.

Systemic adverse effects:

Very common:

• Headache, dry mouth, fatigue/somnolence.

Common:

• Upper respiratory tract symptoms, dizziness, gastrointestinal pain, weakness, taste disturbance.

Uncommon:

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

Rare:

• Dyspnea.

Very rare:

• Fainting, hypertension, hypotension, insomnia.

5. Storage of Abradel

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

Do not use this medicine after the expiry date stated on the packaging and on the bottle after EXP. The expiry date refers to the last day of the month indicated.

Discard the Abradel container 28 days after first opening.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Abradel

• 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 components are: benzalkonium chloride, polyvinyl alcohol, sodium chloride, sodium citrate, citric acid monohydrate, purified water, sodium hydroxide and hydrochloric acid to adjust pH.

Appearance of the product and contents of the container

Abradel 2 mg/ml eye drops solution is a slightly yellowish-green, clear solution.

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

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer(s)

Marketing Authorization Holder:

Tiedra Farmacéutica, S.L.

C/ Colón, 7

30510 Yecla - Murcia

Spain

Manufacturer(s):

AB Sanitas

Veiveriu Street 134B

46352 Kaunas

Lithuania

Pharma Stulln GmbH

Werksstrasse 3

92551 Stulln

Germany

Date of the most recent revision of this leaflet: February 2013

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