Prospect: information for the user

ELEBLOC 20mg/ml eye drop solution

Carteolol hydrochloride

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to others, even if they present the same symptoms of disease as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect.See section 4.

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

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

3.How to use Elebloc 20mg/ml

4.Possible adverse effects

5.Storage of Elebloc 20mg/ml

6.Contents of the package and additional information

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

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

No 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 in the past respiratory problems such as asthma, severe chronic obstructive pulmonary disease (a serious lung disease that can cause wheezing, difficulty breathing, and/or coughing over a long period).

• 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 in the past:

• Coronary disease (symptoms may include chest tightness or pain, shortness of breath, or feeling of choking), heart failure, low blood pressure.
• Heart rate alterations such as bradycardia (slow heart rate).
• Respiratory problems, asthma, or chronic obstructive pulmonary disease.
• Disease due to 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.
• 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 of time, your doctor should monitor you annually to see if treatment failure occurs (loss of medication effectiveness).

If you experience any severe allergic reaction (skin rash, eye redness, and itching) while using this medication, regardless of the cause, adrenaline treatment 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 eye dryness.

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

Users of Contact Lenses

If you use contact lenses, an inhibition of tear production possibly related to this class of medications may pose a risk of intolerance in contact lens users.Additionally, the preservative used (benzalkonium chloride) may cause eye irritation; it may form a deposit on soft contact lenses and slightly discolor them; therefore, do not use this eye drop if you wear soft contact lenses. To know how to apply Elebloc if you wear contact lenses, consult 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. Additionally, elderly patients using beta-blocker eye drops may have a higher risk of corneal sensitivity with the consequent risk of keratitis.

Use in Patients with Renal and/or Hepatic Insufficiency

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

Use in Athletes

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

Children and Adolescents

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

Use of Elebloc with Other Medications

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

This medicationmay 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 pressuresuch as parasymptomatics and guanethidine, amiodarone, or other medications for heart rhythm disorders, cardiac glycosides for heart failure, other heart medications, or medications for diabetes.

Pregnancy and Lactation

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

Do not useEleblocif you are pregnant, or think you may be,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 to treat with this medication, they will evaluate the possibility of interrupting breastfeeding.

Consult your doctor before using any medication during breastfeeding.

Driving and Operating Machines

After administration of this medication, you may notice blurred vision.Do not drive or operate machines until this effect has disappeared and your vision has returned to normal.

Elebloc contains benzalkonium chloride

This medication may cause eye irritation due to the presence of benzalkonium chloride. Avoid contact with soft contact lenses. Remove contact lenses before application and wait at least 15 minutes before reinserting them. It alters the color of soft contact lenses.

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 adrop of Elebloc20mg/ml instilled twice a day (morning and evening) in each affected eye.

The daily dose should not exceed twodrops in each affected eye.

Follow exactly what your doctor indicates. Your eye pressure should be checked periodically, 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 by 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 on.

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.Incline your head back. Gently separate your eyelid from your eye with your finger until a pouch forms between your eyelid and your eye, where the drop should fall (figure 2).

6.Bring the tip of the bottle close to your eye. It may be helpful to use a mirror.

7.Do not touch your eye or eyelid, nearby areas or other surfaces with the dropper. The eye drop could become contaminated.

8.Press the base of the bottle gently to release one drop at a time (figure 3).

9.After using Elebloc, press the corner of your eye near your nose with your finger (figure 4) for 2 minutes. This helps prevent carteolol from passing into the rest of your body.

10.If you apply drops to both eyes, repeat all the previous steps for 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 physiological saline.

If you accidentally ingest the entire contents of the container, the expected symptoms may be slow heart rate, low blood pressure, respiratory difficulties, and heart failure.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological 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 compensate for the missed doses.

If you interrupt treatment with Elebloc

Do not stop treatment without consulting your doctor or pharmacist first.

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

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

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

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

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

Allergic reactions:Systemic allergic reactionsincluding swelling under the skin, which can occur on the face and extremities, and can obstruct the airway and cause difficulty breathing or swallowing, urticaria, and itchy skin rash, localized and generalized rash, pruritus, severe and potentially fatal allergic reaction.

Metabolism:Low blood sugar levels.

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

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

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

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

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 of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaRAM.es.By reporting adverse 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 bottle and on the box after “CAD:”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

To prevent infections, the bottle should be discarded 4weeks after it is first opened. Note the date of opening the bottle in the reserved box for this purpose.

Medicines should not be thrown down the drains or in the trash.Deposit the containers and medications that you do not need in the SIGRE collection point at the pharmacy. In case of doubt, please ask your pharmacist how to dispose of the containers and medications that you do not need. By doing so, you will help protect the environment.

Composition of Elebloc

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

Appearance of the product and contents of the packaging

Elebloc is presented in the form of a transparent and colorless solution inaplastic bottleof5ml with a cap.

Holder of the marketing authorization

Immedica Pharma AB

SE-113 63 Stockholm

Sweden

Responsible for manufacturing

Siegfried El Masnou, S.A.

C/Camil Fabra, 58

08320 El Masnou - Barcelona

Last review date of this leaflet: October 2016.

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