Ecbirio 0.3 mg/ml + 5 mg/ml eye drops solution

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Ecbirio 0.3mg/ml + 5mg/ml Eye Drops Solution

bimatoprost/timolol

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience 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

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

1. What Ecbirio is and what it is used for

This medicine contains two different active substances (bimatoprost and timolol) that reduce elevated eye pressure. Bimatoprost belongs to a group of medicines called prostamides, an analogue of prostaglandins. Timolol belongs to a group of medicines called beta-blockers.

The eye contains a clear, watery fluid that maintains the interior of the eye. This fluid is continuously drained from the eye and new fluid is produced to replace it. If the fluid does not drain quickly enough, pressure builds up inside the eye, and over time your vision may become damaged (a condition known as glaucoma). This medicine works by reducing the production of fluid and also increasing the amount of fluid that is drained. This reduces the pressure inside the eye.

Ecbirio eye drops are used to treat elevated intraocular pressure in adults, including elderly people. This elevated pressure may lead to glaucoma. Your doctor will prescribe this medicine if other eye drops containing beta-blockers or prostaglandin analogues have not been sufficiently effective on their own.

This medicine does not contain preservatives.

2. What you need to know before using Ecbirio

Do not use Ecbirio

• if you are allergic to bimatoprost, timolol, beta-blockers, or any of the other ingredients of this medicine (listed in section 6)
• if you have or have previously had breathing problems such as asthma, severe chronic obstructive bronchitis (a serious lung disease that may cause wheezing, difficulty breathing, and/or prolonged cough)
• if you have heart problems such as a slow heart rate, heart block, or heart failure

Warnings and precautions

Before starting treatment with this medicine, inform your doctor if you have or have previously had:

• coronary heart disease (symptoms may include chest pain or tightness, difficulty breathing, or a feeling of suffocation), heart failure, low blood pressure
• changes in heart rate such as a slow heartbeat
• breathing problems, asthma, or chronic obstructive pulmonary disease
• circulation disorders (such as Raynaud's disease or Raynaud's syndrome)
• overactive thyroid gland, as timolol may mask the signs and symptoms of thyroid disease
• diabetes, as timolol may mask the signs and symptoms of hypoglycemia
• severe allergic reactions
• liver or kidney problems
• eye surface problems
• separation of one of the inner layers of the eye following surgery to reduce eye pressure
• known risk factors for macular edema (swelling of the retina of the eye causing worsening vision), for example, cataract surgery

Inform your doctor before surgical anesthesia that you are using Ecbirio, as timolol may alter the effects of some medications used during anesthesia.

If you have a history of contact hypersensitivity to silver, you should not use this medicine.

During treatment, Ecbirio may cause loss of fat around the eye, which may lead to deepening of the eyelid groove, sunken eyes (enophthalmos), drooping of the upper eyelids (ptosis), stretching of the skin around the eye (dermatocalasis involution), and increased visibility of the lower white part of the eye (inferior scleral show). These changes are usually mild, but if they become more pronounced, they may affect your field of vision. The changes may resolve if you stop using Ecbirio. This medicine may also cause your eyelashes to darken and grow longer, and may darken the skin around the eye. The color of your iris may also become darker. These changes could be permanent. The change may be more noticeable if only one eye is treated. Ecbirio may cause hair growth if it comes into contact with the skin surface.

Children and adolescents

This medicine must not be used in children and adolescents under 18 years of age.

Other medicines and Ecbirio

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Ecbirio may affect, or be affected by, other medicines you are taking, including other eye drops used to treat glaucoma.

Tell your doctor if you are using or plan to use medicines to lower blood pressure, medicines for heart conditions, medicines to treat diabetes, quinidine (used to treat heart conditions and some types of malaria), or medicines used to treat depression known as fluoxetine and paroxetine.

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 this medicine if you are pregnant unless your doctor recommends it.

Do not use this medicine if you are breastfeeding. Timolol may pass into breast milk.

Consult your doctor before using any medicine during breastfeeding.

Driving and using machines

This medicine may cause blurred vision in some patients. Do not drive or operate machinery until symptoms have resolved.

Ecbirio contains phosphates

This medicine contains 1.4 mg of phosphates per ml.

If you have severe damage to the cornea (the transparent layer at the front of the eye), treatment with phosphates may, in very rare cases, cause blurred vision due to calcium accumulation.

Use in athletes

This medicine contains timolol, and athletes should be advised that it may result in a positive finding in doping control tests.

3. How to use Ecbirio

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one drop administered once daily, either in the morning or at night, in each eye requiring treatment. Use this medicine every day at the same time.

Ecbirio is a sterile solution that contains no preservatives. See section 6. Appearance of Ecbirio and contents of the pack.

Before administering the eye drops:

• When using it for the first time, practice using the dropper bottle by gently squeezing until one drop is discarded into the air, away from the eye.
• Once you are confident that you can release one drop at a time, choose the position that feels most comfortable for administering the drops (sitting, lying on your back, or standing in front of a mirror).

Instructions for use:

1. Wash your hands carefully before using this medicine.
2. Do not use the medicine if the package or bottle is damaged.
3. When using the medicine for the first time, unscrew the cap after ensuring that the safety seal ring has not been broken. You should feel slight resistance until this safety seal ring breaks (see drawing 1).
4. If the safety seal ring becomes detached, discard it, as it could fall into the eye.
5. Tilt your head backward and gently pull down the lower eyelid to form a pouch between the eye and the eyelid (see drawing 2). Do not let the tip of the bottle touch the eye, eyelids, or fingers.
6. Gently squeeze the bottle in the center to release one drop into the eye (see drawing 3). There may be a delay of a few seconds between squeezing and the drop falling. Be sure not to squeeze the bottle too hard.
7. Keeping the eye closed, press with your finger against the inner corner of the closed eye (where the eye meets the nose) and hold for 2 minutes. This ensures that the drop is absorbed by the eye and helps prevent the medicine from reaching the rest of the body.
8. Repeat steps 5, 6, and 7 in the other eye if your doctor has instructed you to do so.
9. After use, shake the bottle once downward, without touching the dropper tip, to remove any residual liquid from the tip. This will ensure proper administration of subsequent drops. Screw the cap back onto the bottle (see drawing 4).

If the drop falls outside the eye, try again.

If you are unsure how to administer the medicine, ask your doctor, pharmacist, or nurse.

If you wear contact lenses, remove them before using this medicine. Wait 15 minutes after using the drops before reinserting your contact lenses.

If you use this medicine together with another ophthalmic medicine, leave at least 5 minutes between the administration of Ecbirio and the other medicine. Apply any eye ointments or gels last.

If you use more Ecbirio than you should

If you use more Ecbirio than you should, it is unlikely to cause you any serious harm. Apply the next dose at your usual time. If you are concerned, speak with your doctor or pharmacist.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at 91 562 04 20, indicating the medicine and the amount taken.

If you forget to use Ecbirio

If you forget to use Ecbirio, use one drop as soon as you remember, and then return to your usual routine. Do not take a double dose to make up for forgotten doses.

If you stop using Ecbirio

This medicine should be used every day to work properly.

If you have any further 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.

You can usually continue using the drops unless the effects are severe. If you are concerned, speak to a doctor or pharmacist. Do not stop using Ecbirio without first talking to your doctor.

The following side effects may occur with Ecbirio:

Very common side effects

May affect more than 1 in 10 patients

Eye-related

Redness, loss of fat around the eye area which may cause deepening of the eyelid crease, sunken eyes (enophthalmos), drooping of the eyelids (ptosis), stretching of the skin around the eye (dermatocalasis involution), and increased visibility of the lower white part of the eye (inferior scleral show).

Common side effects

May affect up to 1 in 10 and up to 1 in 100 patients

Eye-related

Burning, itching, stinging, conjunctival irritation (irritation of the transparent layer of the eye), light sensitivity, eye pain, sticky eyes, dry eyes, sensation of a foreign body in the eye, small breaks on the eye's surface, with or without inflammation, blurred vision, redness and itching of the eyelids, increased hair growth around the eye, darkening of the eyelids, darker skin around the eyes, longer eyelashes, eye irritation, watery eyes, swollen eyelids, reduced vision.

Affecting other parts of the body

Runny nose, dizziness, headache.

Uncommon side effects

May affect up to 1 in 1,000 patients

Eye-related

Abnormal sensation in the eye, iris inflammation, conjunctival swelling (swelling of the transparent layer of the eye), eyelid pain, tired eyes, ingrown eyelashes, darkening of the iris color, eyelid separating from the eye surface, darkening of eyelashes.

Affecting other parts of the body

Difficulty breathing.

Side effects of unknown frequency

Frequency cannot be estimated from available data.

Eye-related

Cystoid macular edema (swelling of the retina causing worsening vision), eye swelling, blurred vision.

Affecting other parts of the body

Difficulty breathing / wheezing, symptoms of allergic reaction (swelling, eye redness and rash, changes in taste sensation, slowed heart rate, difficulty sleeping, nightmares, asthma, hair loss, fatigue.

Additional side effects have been observed in patients using eye drops containing timolol or bimatoprost and therefore may also occur with Ecbirio. Like other eye drops, timolol can be absorbed into the bloodstream. This may cause side effects similar to those seen with intravenous and/or oral beta-blockers. The likelihood of experiencing side effects with eye drops is lower than when medicines are taken orally or by injection. The listed side effects include reactions observed with bimatoprost and timolol when used to treat eye conditions:

• Severe allergic reactions with swelling and difficulty breathing, which could potentially be life-threatening
• Low blood sugar
• Depression; memory loss; dizziness; hallucinations
• Fainting; stroke; reduced blood flow to the brain; worsening of myasthenia gravis (increased muscle weakness); tingling sensation
• Reduced sensation on the eye surface; double vision; drooping eyelid; separation of one of the layers of the eye following glaucoma surgery; inflammation of the eye surface; bleeding at the back of the eye (retinal hemorrhage); inflammation inside the eye; increased blinking; sticky eyes; eye discomfort
• Heart failure; irregular heartbeat or cardiac arrest; slow or rapid heartbeat; fluid retention, mainly water, accumulating in the body; chest pain
• Low blood pressure, high blood pressure, coldness or swelling in hands, feet, and extremities due to constriction of blood vessels
• Cough, worsening of asthma, worsening of chronic obstructive pulmonary disease (COPD)
• Diarrhea; stomach pain; nausea and vomiting; indigestion; dry mouth
• Scaly red skin patches; rash; sticky eyes; eye discomfort
• Muscle pain
• Reduced sexual desire; sexual dysfunction
• Weakness
• Increased liver function test results indicating liver function abnormalities

Other side effects reported with eye drops containing phosphates

In very rare cases, some patients with severe damage to the front transparent layer of the eye (the cornea) have developed cloudy spots in the cornea due to calcium buildup during treatment.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ecbirio

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

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

This medicine does not require any special storage conditions.

After first opening the bottle – store for up to 90 days at a temperature below 25°C.

Discard the bottle 90 days after first opening.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE point at your pharmacy. If you are in doubt, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ecbirio

• The active substances are bimatoprost and timolol.
• Each ml of solution contains 0.3 mg of bimatoprost and 5 mg of timolol (as 6.83 mg of timolol maleate).
• Each bottle contains 3 ml of solution.
• The other ingredients are sodium hydrogen phosphate dodecahydrate (see section 2), citric acid monohydrate, sodium chloride, sodium hydroxide or hydrochloric acid, diluted (for pH adjustment), water for injections.

Appearance of Ecbirio and contents of the pack

Ecbirio is a colourless and clear solution.

This medicine is available in white LDPE bottles (5 ml), each containing 3 ml of solution, with a multidose HDPE dropper dispenser and a screw cap made of HDPE with a tamper-evident seal.

The dropper dispenser is equipped with a silicone valve system that prevents reflux of contaminated liquid back into the bottle and allows entry of filtered air.

Pack sizes:

Cartons containing 1 or 3 bottles of 3 ml solution each.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

SIFI S.p.A.

Via Ercole Patti 36

95025 Aci Sant'Antonio (CT) - Italy

Manufacturer

RAFARM S.A.

Thesi Pousi Xatzi Agiou Louka

190 02 Paiania

Greece

Local representative

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

This medicine is authorised in the EEA Member States under the following names:

Date of the last revision of this leaflet: August 2024

Updated and detailed 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.