Label: information for the user

BETOPTIC SUSPENSIÓN 2.5 mg/ml eye drops in suspension

Betaxolol

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 to you, and you should not give it to other people

even if they 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 BETOPTIC SUSPENSIÓN is and for what it is used

2. What you need to know before starting to use BETOPTIC SUSPENSIÓN

3. How to use BETOPTIC SUSPENSIÓN

4. Possible adverse effects

5. Storage of BETOPTIC SUSPENSIÓN

6. Contents of the package and additional information

It is an eye drop that belongs to a group of medications called beta blockers that contains betaxolol as its active ingredient, which acts by reducing pressure inside the eye (intraocular), possibly by reducing aqueous humor (liquid of the anterior chamber of the eye).

Betoptic Suspension is indicated for the reduction of elevated intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension.

It can be used alone or in combination with other medications that decrease intraocular pressure.

Warning and PrecautionsIf you are allergic to betaxolol, other beta blockers (belonging to the same group as this medication) or to any of the other components of this medication (listed in section 6).

If you have heart failure, a slow heart rate or heart rhythm disturbances (irregular heartbeats) or other heart problems that cause occasional fainting.

If you have or have had severe respiratory problems such as asthma or chronic obstructive pulmonary disease (a serious lung disease that can produce wheezing, difficulty breathing and/or long-term coughing).

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Betoptic Suspension.

? Only use this medication in your eye(s).

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

• coronary heart disease (symptoms may include chest tightness or pain, shortness of breath or choking), heart failure, low blood pressure.

- first-degree heart block (a condition related to heart rhythm).

- respiratory problems, asthma or chronic obstructive pulmonary disease.

-circulatory disorders (such as Raynaud's disease, causing tingling in the fingers of the hands or feet).

- diabetes, as betaxolol may mask the signs and symptoms of low blood sugar.

-hyperthyroidism, as this medication may mask the signs and symptoms.

-if you have any chronic muscle weakness disorder (such as myasthenia gravis).

? Patients with suspected hyperthyroidism should be closely monitored.

?If you have a history of severe allergic reactions or atopic reactions (unknown origin allergy), you may be more sensitive to various allergens. If you experience any severe allergic reaction (skin rash, eye redness and itching, fever, throat, tongue or face swelling) while using this medication, stop treatment immediately and consult your doctor. When receiving any treatment, inform your doctor that you are using this medication.

?If you are taking another beta blocker medication, including another route of administration, be cautious.

?Inform your doctor that you are using this medication before undergoing surgery, as betaxolol may increase the effects of some medications used during anesthesia.

?If you have angle-closure glaucoma, you will be prescribed this medication in combination with other medications that act to close the pupil. You should regularly monitor eye pressure, especially at the beginning of treatment.

?If you have corneal disorders, consult your doctor as this medication may cause eye dryness.

? If you have skin disorders such as psoriasis, it may worsen.

? If you wear contact lenses:

Do not use this medication while wearing contact lenses.

Use in elderly patients

See section 3.

Use in athletes

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

Children

This medication has not been established for efficacy and safety in children.

Other medications and Betoptic Suspension

Inform your doctor or pharmacist if you are using, have used recently or may 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, heart medications or medications to treat diabetes, stimulants of the parasympathetic system and adrenergic psychotropics (used generally for attention disorders).

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication. Do not use this medication if you are pregnant unless your doctor considers it necessary.

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

Driving and operating machinery

You may notice that your vision becomes blurry for a while after applying the eye drop. Do not drive or operate machinery until this effect has disappeared.

BETOPTIC SUSPENSION contains benzalkonium chloride

This medication contains 0.1 mg of benzalkonium chloride in each ml.

Benzalkonium chloride may be absorbed by soft contact lenses, altering their color. Remove contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal disorders. Consult your doctor if you feel a strange sensation, burning or pain in the eye after using this medication.

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

Use in adults

The recommended dose is 1-2 drops in the affected eye(s) twice a day (morning and evening).

You may need several weeks to achieve a stable response to treatment.

Substitution therapy (monotherapy): If you are using another medication for glaucoma and your doctor has told you to replace it with Betoptic Suspension, on the first day you should continue with the same treatment and also administer 1 drop of Betoptic Suspension in the eye(s) twice a day. The next day, discontinue the initial medication and continue only with Betoptic Suspension, at the usual dose.

Substitution therapy (polytherapy): If you are being treated with several medications for glaucoma, your doctor will indicate the dosing regimen, adjusting one medication at a time, with intervals of at least one week.

To achieve a greater reduction in intraocular pressure, your ophthalmologist may prescribe other medications that you should use in conjunction with this medication.

Use in elderly patients

It is recommended to start treatment with the lowest recommended dose of betaxolol, as older patients are likely to have age-related conditions, such as cardiac problems or peripheral vascular diseases.

If the clinical response is not adequate, your doctor may modify the dose to 2 drops of Betoptic Suspension in the affected eye(s) twice a day (morning and evening) with due precautions.

Use in children

The efficacy and safety have not been established in children.

Your doctor must carefully evaluate the benefits and risks before prescribing this medication to children, performing necessary tests and medical history.

If administered to children, it is recommended to use the lowest doses once a day. Close monitoring of pediatric patients, especially young children, should be done from 1 or 2 hours after administering the first dose.

Usage recommendations:

1 2 3 4

- Wash your hands.

- Take the bottle (dropper).

- Shake well before use.

- After opening the bottle for the first time, remove the plastic ring from the seal if it is loose.

- Hold the bottle, upside down, between your fingers (figure 1).

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

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

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

- Press the base of the bottle gently with your index finger to release one drop at a time (figure 3).

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

- If you apply drops to both eyes, repeat all the previous steps for the other eye.

- Close the bottle tightly immediately after use.

If a drop falls outside the eye, try again.

Using other eye medications, wait at least 5 minutes between administering this eye drop and the other eye medications. Eye ointments should be administered last.

Using more Betoptic Suspension than you should

A overdose in the eyes can be eliminated by rinsing the eyes with warm water. Do not apply more drops until you are told to do so.

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 used.

The symptoms of overdose or accidental ingestion may be: slow heart rate, decreased blood pressure, heart or respiratory problems. If this occurs, discontinue treatment and consult your doctor.

Missing a dose of Betoptic Suspension

Do not apply a double dose to compensate for the missed dose.

Apply a single dose as soon as you remember and continue with the next dose scheduled. 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.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following side effects have been reported with this medicine:

Very common side effects (may affect more than 1 in 10 people):

Eye effects: eye discomfort.

Common side effects (may affect up to 1 in 10 people):

Eye effects: blurred vision, increased tear production.

General effects: headache.

Rare side effects (may affect up to 1 in 100 people):

Eye effects: inflammation of the eye with or without damage to the surface (keratitis), inflammation of the conjunctiva, inflammation of the eyelid, visual disturbance, light sensitivity, eye pain, dry eyes, tired eyes, eyelid disorder, eye itching, eye discharge, eyelid crust, eye inflammation, eye irritation, conjunctival disorder, eye swelling, eye redness.

General effects: reduced heart rate, increased heart rate, asthma, breathing difficulty, nausea, nasal inflammation inside.

Very rare side effects (may affect up to 1 in 1,000 people):

Eye effects: eye clouding (cataract).

General effects: fainting, bad taste, cough, nasal discharge (runny nose), skin inflammation, rash, decreased blood pressure, anxiety, decreased sexual desire.

During post-marketing experience, additional side effects have been reported, of which the frequency is unknown:

Eye effects: eyelid redness.

General effects: irregular heart rate, dizziness, hair loss, body weakness, allergy, difficulty sleeping (insomnia), depression.

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

- Generalized allergic reactions including swelling under the skin that can occur on the face and limbs, and may obstruct the airways, causing difficulty swallowing or breathing, urticaria or rash with localized and generalized eruption, itching, severe and sudden allergic reaction.

- Low blood sugar levels.

- Difficulty sleeping, depression, nightmares, memory loss.

- Fainting, fatigue, reduced blood flow to the brain, increased symptoms of myasthenia gravis (muscular disorder), dizziness, unusual sensations such as tingling, headache.

- Eye irritation symptoms (such as burning, stinging, tearing, redness), eyelid inflammation, corneal inflammation, blurred vision, retinal detachment after glaucoma surgery, decreased corneal sensitivity, dry eyes, corneal erosion, upper eyelid drooping (causing the eye to be half-closed), double vision.

- Chest pain, palpitations, fluid accumulation (edema), changes in heart rhythm or frequency, other heart alterations, accompanied by difficulty breathing and swelling of the feet and legs due to fluid accumulation (congestive heart failure), cardiac arrest, heart failure.

- Low blood pressure, Raynaud's disease (disorder with reduced circulation with cold hands and feet).

- Breathing difficulty (mainly in patients with bronchial disease), cough.

- Digestive alterations such as nausea, indigestion, diarrhea, dry mouth, abdominal pain, etc.

- Hair loss, psoriasis-like rash or worsening of psoriasis, skin rash.

- Muscle pain.

- Sexual dysfunction, decreased libido.

- Fatigue.

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

Reporting of 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 leaflet. You can also report them directly through the Spanish System for the 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 medicine.

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

Do not use this medication after the expiration date that appears on the packaging and on the box after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required. Store the bottle in the outer packaging. To prevent infections, discard the bottle 4 weeks after it has been opened for the first time.

Record the date of opening the bottle in the reserved box in the box.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you do not need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you do not need. In this way, you will help protect the environment.

Composition of BETOPTIC SUSPENSION

•The active ingredient is betaxolol hydrochloride. Each milliliter of suspension contains 2.8 mg of betaxolol hydrochloride, equivalent to 2.5 mg/ml of betaxolol (0.25%).

•The other components are: benzalkonium chloride, Amberlite IRP-69 resin (polystyrene-divinylbenzene sulfonic acid, carbomer 974P, boric acid, mannitol (E421), disodium edetate, N-laurylsarcosine, hydrochloric acid and/or sodium hydroxide, and purified water.

Appearance of the product and contents of the packaging

Betoptic Suspension is a suspension eye drop; a white or off-white liquid that is presented in a dropper bottle (plastic bottle with a cap) in a box.

Each container contains 5 ml of eye drop.

Marketing Authorization Holder

Immedica Pharma AB

SE-113 63 Stockholm

Sweden

Responsible for Manufacturing

Siegfried El Masnou, S.A.

C/Camil Fabra, 58

08320 El Masnou – Barcelona, Spain

or

S.A. Alcon-Couvreur N.V. Rijsksweg 14

B-2870 Puurs

Belgium

or

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona, Spain

or

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg, Germany

Last review date of this leaflet:May 2019.

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/