ECBIRIO 0.3 mg/mL + 5 mg/mL Eye Drops Solution

Introduction

Package Leaflet: Information for the Patient

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

bimatoprost/timolol

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Ecbirio and what is it used for

This medication contains two different active substances (bimatoprost and timolol) that reduce high eye pressure. Bimatoprost belongs to a group of medications called prostamides, a prostaglandin analogue. Timolol belongs to a group of medications called beta-blockers.

The eye contains a clear, watery liquid that maintains the inside of the eye. This liquid is continuously drained from the eye and new liquid is generated to replace it. If the liquid does not drain quickly enough, the pressure inside the eye increases and your vision could be damaged in the long run (a disease called glaucoma). This medication works by reducing the production of liquid and also increasing the amount of liquid that is drained. This reduces the pressure inside the eye.

Ecbirio eye drops are used to treat high eye pressure in adults, including the elderly. This high pressure can cause glaucoma. Your doctor will prescribe this medication if other eye drops containing beta-blockers or prostaglandin analogues have not had a sufficient effect on their own.

This medication does not contain preservatives.

2. What you need to know before you use Ecbirio

Do not use Ecbirio

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

Warnings and precautions

Before starting treatment with this medication, tell your doctor if you have or have had:

• coronary heart disease (symptoms may include chest pain or tightness, difficulty breathing or feeling of suffocation), heart failure, low blood pressure
• heart rate disorders such as a slow heartbeat
• respiratory problems, asthma or chronic obstructive pulmonary disease
• poor blood 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
• surface eye problems
• separation of one of the inner layers of the eye after surgery to reduce eye pressure
• known risk factors for macular edema (swelling of the retina of the eye that causes vision impairment), such as cataract surgery

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

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

During treatment, Ecbirio may cause fat loss around the eye that can cause deepening of the palpebral sulcus, sunken eyes (enoftalmos), drooping eyelids (ptosis), stretching of the skin around the eye (involvement of dermatocalasis) and the white part of the eye becomes more visible (inferior scleral exposure). The changes are usually mild, but if they worsen, they can affect your field of vision. The changes may disappear if you stop using Ecbirio. This medication can also cause your eyelashes to darken and grow, and the skin around the eye to darken. 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 medication should not be used in children and adolescents under 18 years of age.

Other medications and Ecbirio

Tell your doctor or pharmacist if you are using, have recently used or might use any other medications.

Ecbirio may affect or be affected by other medications you are using, including other eye drops for the treatment of glaucoma.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medication.

Do not use this medication if you are pregnant unless your doctor recommends it.

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

Ask your doctor before using any medication during the breastfeeding period.

Driving and using machines

This medication may cause blurred vision in some patients. Do not drive or use machines until the symptoms have disappeared.

Ecbirio contains phosphates

This medication contains 1.4 mg of phosphates per ml.

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

Use in athletes:

This medication contains timolol, and athletes should be warned that it may produce a positive result in doping tests.

3. How to use Ecbirio

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is one drop administered once a day, either in the morning or at night in each eye that needs treatment. Use this medication every day at the same time.

Ecbirio is a sterile solution that does not contain 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 slowly squeezing until you discard one drop in the air, away from the eye.
• When you are sure you can administer one drop at a time, choose the position you find most comfortable for administering the drops (sitting, lying on your back or standing in front of the mirror).

Instructions for use:

1. Wash your hands carefully before using this medication.
2. If the packaging or bottle is damaged, do not use the medication.
3. When using the medication for the first time, unscrew the cap after making sure the ring seal has not been broken. You should feel a slight resistance until the security ring breaks (see drawing 1).
4. If the security ring comes loose, discard it, as it can fall into the eye.
5. Tilt your head back and gently pull down the lower eyelid to form a pocket 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 middle 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. Make sure not to squeeze the bottle too hard.
7. Keeping the eye closed, press with your finger against the 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 medication from reaching the rest of the body.
8. Repeat steps 5, 6 and 7 in the other eye if your doctor has told you to do so.
9. After use, shake the bottle once downwards, without touching the dropper tip, to remove any residual liquid from the tip. This will ensure the correct application of subsequent drops. Replace the cap on the bottle (see drawing 4).

If the drop falls outside the eye, try again.

If you are not sure how to administer the medication, ask your doctor, pharmacist or nurse.

If you wear contact lenses, remove them before using this medication. Wait 15 minutes after using the drops before putting your contact lenses back on.

If you use this medication with another eye medication, leave at least 5 minutes between the administration of Ecbirio and the other medication. Use any eye ointment or gel 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 the usual time. If you are concerned, talk to your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor, pharmacist or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to use Ecbirio

If you forget to use Ecbirio, use only 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 medication should be used every day to work properly.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everybody gets them.

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

The following side effects may occur with Ecbirio:

Very common side effects

May affect more than 1 in 10 people

Affecting the eye

Redness, fat loss in the eye area that can cause deepening of the palpebral sulcus, sunken eyes (enoftalmos), drooping eyelids (ptosis), stretching of the skin around the eye (involvement of dermatocalasis) and the white part of the eye becomes more visible (inferior scleral exposure).

Common side effects

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

Affecting the eye

Burning, itching, stinging, conjunctival irritation (the transparent layer of the eye), sensitivity to light, eye pain, sticky eyes, dry eyes, feeling of having something in the eye, small breaks in the surface of the eye, with or without inflammation, difficulty seeing clearly, redness and itching of the eyelids, 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 people

Affecting the eye

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

Affecting other parts of the body

Breathing difficulties.

Side effects of unknown frequency

Frequency cannot be estimated from the available data.

Affecting the eye

Cystoid macular edema (swelling of the retina of the eye that causes vision impairment), eye swelling, blurred vision.

Affecting other parts of the body

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

Other side effects reported with phosphate-containing eye drops

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

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 through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ecbirio

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

Do not use this medication after the expiry date stated on the carton and on the bottle after “EXP”. The expiry date is the last day of the month indicated.

This medication does not require special storage conditions.

After opening the bottle for the first time - store for 90 days at a temperature below 25°C.

Discard the bottle 90 days after opening it for the first time.

Medications should not be disposed of via wastewater or household waste. Place the packaging and medications you no longer need in 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. This will help protect the environment.

6. Container Content and Additional Information

Ecbirio Composition

• The active ingredients are bimatoprost and timolol.
• Each ml of solution contains 0.3 mg of bimatoprost and 5 mg of timolol (in the form of 6.83 mg of timolol maleate).
• Each vial 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), and water for injectables.

Appearance of Ecbirio and Container Content

Ecbirio is a colorless and transparent solution.

This medication is available in 5 ml white LDPE vials, each containing 3 ml of solution, with a multidose HDPE dropper and an HDPE screw cap with a security seal.

The dropper has a silicone valve system that prevents the reflux of contaminated liquid into the vial and allows the entry of filtered air.

Package sizes:

Boxes containing 1 or 3 vials of 3 ml of solution each.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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

SIFI IBÉRICA S.L.

C/ Poeta Joan Maragall, 47

Planta 4, Puerta 402

28020 Madrid - Spain

This medication is authorized in the EEA Member States under the following names:

Date of the Last Revision of this Leaflet: August 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.