Label: Information for the Patient

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

bimatoprost/timolol

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1.What is Ecbirio and how it is used

2.What you need to know before starting to use Ecbirio

3.How to use Ecbirio

4.Possible adverse effects

5.Storage of Ecbirio

6.Contents of the package and additional information

This medicationcontains two active ingredients (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 interior of the eye. This liquid drains continuously from the eye and new liquid is generated to replace it. If the liquid does not drain at a sufficient speed, the pressure inside the eye increases and, in the long term, your vision could be damaged (a disease called glaucoma). This medication acts by reducing the production of liquid and also increasing the amount that drains. This reduces the pressure inside the eye.

Ecbirio eye drops are used for the treatment of high eye pressure in adults, including older adults. 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.

No use Ecbirio

-if you are allergic to bimatoprost, timolol, beta-blockers, or any of the other components of this medication (listed in section 6)

• if you have or have had respiratory problems such as asthma, severe chronic obstructive pulmonary disease (a serious lung disease that can cause wheezing, difficulty breathing, and/or prolonged coughing)
• if you have heart problems such as low heart rate, heart block, or heart failure

Warnings and precautions

Before starting treatment with this medication, inform your doctor if you have or have had in the past:

• coronary heart disease (symptoms may include chest pain or pressure, difficulty breathing, or a feeling of suffocation), heart failure, low blood pressure
• heart rhythm disturbances such as a slow heart rate
• respiratory problems, asthma, or chronic obstructive pulmonary disease
• circulatory disorders (such as Raynaud's disease or Raynaud's syndrome)
• hyperthyroidism, 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 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 a worsening of vision), for example, cataract surgery

Inform 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, do not use this medication.

During treatment, Ecbirio may cause a loss of fat around the eye that can cause deepening of the eyelid crease, sunken eyes (enophthalmos), drooping eyelids (ptosis), stretching of the skin around the eye (dermatochalasis), and making the white lower part of the eye more visible (exposure of the inferior sclera). The changes are usually mild, but if they worsen, they may affect your field of vision. The changes may disappear if you stop using Ecbirio. This medication may also cause your eyelashes to darken and grow, and the skin around your eye to darken. Your iris color may also become darker. These changes may 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

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

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist 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.

Consult your doctor before using any medication during breastfeeding.

Driving and operating machinery

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

Ecbirio contains phosphates

This medication contains 1.4 mg of phosphates in each ml.

If you suffer severe damage to the cornea (the transparent layer at the front of the eye), treatment with phosphates, in 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 control tests.

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

The recommended dose is one drop administered once a day, either in the morning or evening, in each eye that requires 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 package.

Before administering the eye drops:

• When using it for the first time, practice using the bottle with the dropper by slowly pressing until a drop is released into the air, away from the eye.
• When you are sure you can administer one drop at a time, choose the position that you find most comfortable for administering the drops (sitting, lying on your back, or standing in front of a mirror).

Administration instructions:

1. Wash your hands carefully before using this medication.
2. Do not use the medication if the package or bottle is damaged.
3. When using the medication for the first time, unscrew the cap after ensuring that the ring with the safety seal has not been broken. You should feel a slight resistance until this safety ring breaks (see figure 1).
4. If the safety ring becomes loose, discard it, as it may fall into the eye.
5. Tilt your head back and gently pull the lower eyelid away from the eye to form a pouch between the eye and the eyelid (see figure 2). Do not let the tip of the dropper touch the eye, eyelids, or fingers.
6. Gently press the bottle in the middle to release one drop into the eye (see figure 3). There may be a delay of a few seconds between pressing and the drop falling. Make sure not to press the bottle too hard.
7. Keeping the eye closed, press your finger against the closed eye corner (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 proper application of subsequent drops. Replace the cap on the bottle (see figure 4).

If the drop falls outside the eye, try again.

If you are unsure 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 in.

If you use this medication with another eye medication,leave at least 5 minutes between administering 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 unlikelythat this will cause 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 the missed doses.

If you interrupt treatment with Ecbirio:

This medication must be used every day for it to work properly.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

It can usually continue to be used as drops, unless the side effects are severe. If you are concerned, speak with a doctor or pharmacist. Do not stop using Ecbirio without speaking with your doctor.

The following side effects may be observed with Ecbirio:

Very common side effects

May affect more than 1 in 10 patients

Affecting the eye

Redness, loss of fat in the eye region that can cause deepening of the palpebral groove, sunken eyes (enophthalmos), drooping eyelids (ptosis), stretching of the skin around the eye (dermatochalasis involution) and making the lower white part of the eye more visible (exposure escleral inferior).

Common side effects

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

Affecting the eye

Burning, itching, stinging, conjunctival irritation (the transparent layer of the eye), light sensitivity, eye pain, stuck eyes, dry eyes, feeling like something is in the eye, small breaks in the surface of the eye, with or without inflammation, difficulty seeing clearly, eyelid redness and itching, eyelid growth, eyelid darkening, skin darkening around the eyes, longer eyelashes, eye irritation, watery eyes, swollen eyelids, reduced vision.

Affecting other parts of the body

Nasal discharge, dizziness, headache.

Rare side effects

May affect up to 1 in 1,000 patients

Affecting the eye

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

Affecting other parts of the body

Difficulty breathing.

Side effects of unknown frequency

The frequency cannot be estimated from the available data.

Affecting the eye

Macular cystoid edema (retinal eye swelling that causes vision deterioration), eye swelling, blurry vision.

Affecting other parts of the body

Difficulty breathing / wheezing, allergic reaction symptoms (swelling, eye redness and hives, taste changes, slow heart rate, difficulty sleeping, nightmares, asthma, hair loss, fatigue.

Additional side effects have been observed in patients using timolol or bimatoprost eye drops and may be observed with Ecbirio. As other eye medications, timolol is absorbed into the blood. This can cause side effects similar to those observed with intravenous and/or oral beta-blockers. The likelihood of side effects after using eye drops is lower than when medications are taken orally or injected. 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 that could be potentially fatal
• Low blood sugar
• Depression; memory loss; dizziness; hallucinations
• Fainting; stroke; decreased cerebral blood flow; worsening of myasthenia gravis (increased muscle weakness); tingling sensation
• Decreased sensation of the eye surface; double vision; drooping eyelid; separation of one of the eye layers after eye surgery to reduce eye pressure; eye surface inflammation, retinal hemorrhage, eye inflammation, increased blinking, stuck eyes, eye discomfort
• Heart failure; irregular or stopped heartbeat; slow or rapid heart rate; excess fluid, mainly water, accumulated in the body; chest pain
• Low blood pressure, high blood pressure, swelling or coldness in the hands, feet, and extremities, caused by blood vessel constriction
• Cough, worsening of asthma, worsening of chronic obstructive pulmonary disease (COPD)
• Diarrhea; stomach pain; nausea and vomiting; indigestion; dry mouth
• Scaly red patches on the skin; hives, stuck eyes, eye discomfort
• Muscle pain
• Reduced libido; sexual dysfunction
• Weakness
• An increase in blood test results indicating liver function

Other side effects reported with eye drops containing phosphates

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and on the bottle after “CAD”. The expiration 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.

Dispose of the bottle 90 days after it has been opened for the first time.

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

Composition of Ecbirio

• The active principles are bimatoprost and timolol.
• Each milliliter of solution contains 0.3 mg of bimatoprost and 5 mg of timolol (in the form of 6.83 mg of timolol maleate).
• Each bottle contains 3 milliliters of solution.
• The other ingredients aresodium dodecahydrate phosphate (see section 2), citric acid monohydrate, sodium chloride, sodium hydroxide or hydrochloric acid, diluted (for pH adjustment), water for injection.

Appearance of Ecbirio and packaging contents

Ecbirio is an colorless and transparent solution.

This medicine is available in white LDPE bottles (5 ml), with 3 milliliters of solution each, with a HDPE multidose dropper and a HDPE screw cap with a safety seal.

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

Packaging sizes:

Boxes containing 1 or 3 bottles of 3 milliliters of solution each.

Only some packaging sizes may be commercially available.

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 medicine is authorized in the EEA member states with the following names:

Last review date of this leaflet: August 2024

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.