ELEBLOC 20 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

ELEBLOC 20mg/ml eye drops solution

Carteolol hydrochloride

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

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

Contents of the package leaflet:

1. What is Elebloc 20 mg/ml and what is it used for
2. What you need to know before starting to use Elebloc 20 mg/ml
3. How to use Elebloc 20 mg/ml
4. Possible side effects
5. Storage of Elebloc 20 mg/ml
6. Package contents and additional information

1. What is Elebloc 20 mg/ml and what is it used for

Elebloc belongs to a group of medications called beta-blockers that contains an active ingredient (carteolol), which acts by decreasing the pressure in the eye (intraocular pressure).

This medication is used in adults to treat increased pressure in the eyes (ocular hypertension) and chronic open-angle glaucoma.

2. What you need to know before starting to use Elebloc 20 mg/ml

Do not use Elebloc

• If you are allergic to carteolol, 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 bronchitis (a serious lung disease that can cause wheezing, difficulty breathing, and/or long-term coughing).

• If you have a slow heart rate, heart failure, or heart rhythm disorders (irregular heartbeats).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Elebloc.

Before starting to use this medication, inform your doctor if you have or have had:

• coronary artery disease (symptoms may include chest pain or discomfort, shortness of breath, or choking), heart failure, low blood pressure.
• heart rate disorders such as bradycardia (slow heartbeat).
• respiratory problems, asthma, or chronic obstructive pulmonary disease.
• poor blood circulation (such as Raynaud's disease or Raynaud's syndrome).
• diabetes, as carteolol may mask the signs and symptoms of low blood sugar levels.
• hyperthyroidism, as carteolol may mask the signs and symptoms.

myasthenia gravis (muscle weakness).

Inform your doctor that you are using Elebloc before undergoing surgery, as carteolol may alter the effects of some medications used during anesthesia.

If you use this medication for a long period, your doctor should check you annually to see if treatment failure (loss of medication effectiveness) occurs.

If you experience any severe allergic reaction (skin rash, redness, and itching in the eye) while using this medication, regardless of the cause, treatment with adrenaline may not be as effective. Therefore, when receiving any other treatment, inform your doctor that you are using this medication.

If you have corneal disorders, consult your doctor, as this medication may cause dry eyes.

If you have had glaucoma surgery, consult your doctor before using this medication.

Contact lens users

If you use contact lenses, a possible inhibition of tear production related to this class of medications may pose a risk of intolerance in contact lens users. Also, the preservative used (benzalkonium chloride) may cause eye irritation; it may form a deposit on soft contact lenses and slightly discolor them; therefore, you should not use this eye drop if you wear soft contact lenses. To find out how to apply Elebloc if you wear contact lenses, see the section "Elebloc contains benzalkonium chloride".

Use in elderly patients

This medication should be used with caution in elderly patients, as they are more likely to have heart problems and age-related peripheral vascular diseases. Also, elderly patients using ophthalmic beta-blockers may have a higher risk of corneal sensitivity with the consequent risk of keratitis.

Use in patients with renal and/or hepatic impairment

Your doctor may adjust the dose of Elebloc if it is administered in combination with another beta-blocker medication.

Use in athletes

This medication contains carteolol, which may produce a positive result in doping tests.

Children and adolescents

This medication is not recommended for premature babies, newborns, children, or adolescents, as its safety and efficacy have not been established in the pediatric population.

Using Elebloc with other medications

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

This medication may affect or be affected by other medications you are using, including other eye drops for glaucoma treatment. Consult your doctor if you are using or plan to use medications to lower blood pressure, such as parasymphathomimetics and guanethidine, amiodarone, or other medications to treat heart rhythm disorders, cardiac glycosides to treat heart failure, or medications to treat diabetes.

Pregnancy and breastfeeding

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

Do not use Elebloc if you are pregnant or think you may be pregnant, unless your doctor considers it necessary.

Do not use Elebloc if you are breastfeeding, as carteolol may pass into breast milk. However, if your doctor considers it necessary for the mother's benefit, they will assess the possibility of interrupting breastfeeding.

Consult your doctor before using any medication during breastfeeding.

Driving and using machines

After administering this medication, you may experience blurred vision. Do not drive or use machines until this effect has disappeared and your vision has cleared.

Elebloc contains benzalkonium chloride

This medication 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 putting them back. It may alter the color of soft contact lenses.

3. How to use Elebloc 20 mg/ml

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

The recommended dose is:

Adults (including elderly patients)

It is recommended to start treatment with the lowest available dose of carteolol. If the clinical response is not adequate, your doctor may modify the dose to one drop of Elebloc 20 mg/ml instilled twice a day (morning and evening) in each affected eye.

The daily dose should not exceed two drops in each affected eye.

Follow exactly the instructions given by your doctor. The eye pressure should be periodically checked, mainly during the dose adjustment period.

Instructions for use:

This medication should be administered in the eyes (ophthalmic route). If you need to use more than one medication via the ophthalmic route, the applications should be spaced at least 5 minutes apart. Ophthalmic ointments should be administered last.

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If you wear contact lenses, you should remove them before applying Elebloc and wait 15 minutes before putting them back.

1. Wash your hands carefully before applying the drops.
2. Take the bottle and stand in front of a mirror.
3. After opening the bottle for the first time, you should remove the plastic ring from the seal.
4. Hold the bottle, upside down, between your fingers (figure 1).
5. Tilt your head back. Gently separate the eyelid from the eye with a finger until a pocket forms between the eyelid and your eye, where the drop should fall (figure 2).
6. Bring the tip of the bottle close to the eye. You may find it helpful to use a mirror.
7. Do not touch the eye or eyelid, nearby areas, or other surfaces with the dropper. The eye drop may become contaminated.
8. Gently squeeze the base of the bottle to release one drop at a time (figure 3).
9. After using Elebloc, press the edge of the eye next to the nose (figure 4) for 2 minutes. This helps prevent carteolol from entering the rest of the body.
10. If you apply drops to both eyes, repeat all the previous steps with the other eye.
11. Close the bottle tightly immediately after each use.

If a drop falls outside the eye, try again.

If you use more Elebloc than you should

If too many drops are administered in the eyes, rinse them with warm water or saline solution.

If you accidentally ingest the entire contents of the container, the expected symptoms may include slow heart rate, decreased blood pressure, breathing difficulties, and heart failure.

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

If you forget to use Elebloc

Apply a single dose as soon as possible. However, if it is almost time for the next dose, do not apply the missed dose and continue with the next dose of your regular regimen. Do not apply a double dose to make up for missed doses.

If you stop using Elebloc

Never stop treatment without consulting your doctor or pharmacist first.

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

4. Possible side effects

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

Generally, you can continue using the drops unless the effects are severe. If you are concerned, consult your doctor or pharmacist. Do not stop treatment with Elebloc without consulting your doctor first.

In some patients with significantly damaged corneas, very rare cases of corneal calcification related to the use of eye drops containing phosphates have been reported.

Like other ophthalmic medications applied to the eyes, carteolol is absorbed and enters the bloodstream. This may cause side effects similar to those observed with intravenous and/or oral beta-blocker medications. The incidence of these side effects after ophthalmic administration is lower than when medications are administered orally or injected. The adverse reactions described include reactions observed within the class of ophthalmic beta-blockers when used to treat eye diseases:

Allergic reactions:Systemic allergic reactions, including swelling under the skin, which can occur in the face and limbs, and can obstruct the airway and cause difficulty swallowing or breathing, hives, and skin rash with itching, localized and generalized rash, pruritus, severe and sudden life-threatening allergic reaction.

Metabolism:Low blood sugar levels.

Nervous system and general disorders:Difficulty sleeping (insomnia), depression, nightmares, memory loss, fainting, stroke, reduced blood supply to the brain, increased signs and symptoms of myasthenia gravis (muscle disorder), dizziness, abnormal sensations of tingling, like "pins and needles", headache, fatigue.

Eye effects:Signs and symptoms of eye irritation (such as burning, stinging, itching, tearing, redness), eyelid inflammation, corneal inflammation, blurred vision, detachment of the layer under the retina that contains blood vessels, which can cause vision changes after filtration surgery, decreased sensitivity in the eye, dry eyes, corneal erosion (the outer layer of the eyeball), drooping of the upper eyelids (causing the eye to remain half-closed), double vision, conjunctivitis.

Heart and circulation:Slow heart rate, chest pain, palpitations, edema (fluid accumulation), changes in heart rate or rhythm, congestive heart failure (heart disease with difficulty breathing and swelling of the feet and legs due to fluid accumulation), a type of heart rhythm disorder, cardiac arrest, heart failure, low blood pressure, Raynaud's disease, cold hands and feet.

Respiratory:Narrowing of the airways in the lungs (mainly in patients with pre-existing bronchospastic disease), difficulty breathing, coughing.

Gastrointestinal:Alteration of taste, nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting.

Skin:Hair loss, skin rash with a silvery white appearance (psoriasiform rash) or worsening of psoriasis, skin rash.

Muscular:Muscle pain not caused by exercise, muscle weakness.

Reproductive:Sexual dysfunction, decreased libido.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Elebloc

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

Do not use this medication after the expiration date stated on the bottle and carton after "EXP:". The expiration date is the last day of the month indicated.

Do not store above 25°C.

To avoid infections, the bottle should be discarded 4 weeks after opening for the first time. Write the opening date of the bottle in the space provided on the carton for this purpose.

Medications should not be disposed of via wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Elebloc

• The active ingredient is carteolol hydrochloride. Each ml of solution contains 20 mg of carteolol hydrochloride.
• The other components are benzalkonium chloride, sodium chloride, sodium phosphate monobasic, disodium hydrogen phosphate dodecahydrate, and purified water.

Appearance of the product and package contents

Elebloc is presented as a clear and colorless solution in a 5 ml plastic bottle with a cap.

Marketing authorization holder

Immedica Pharma AB

SE-113 63 Stockholm

Sweden

Manufacturer

Siegfried El Masnou, S.A.

C/Camil Fabra, 58

08320 El Masnou - Barcelona

Date of the last revision of this package leaflet: October 2016.

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