Optibetol 0,5%

Patient Information Leaflet: Patient Information

OPTIBETOL 0.5%, 5 mg/ml, eye drops, solution
Betaxolol

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Optibetol 0.5% and what is it used for
• 2. Important information before using Optibetol 0.5%
• 3. How to use Optibetol 0.5%
• 4. Possible side effects
• 5. How to store Optibetol 0.5%
• 6. Contents of the pack and other information

1. What is Optibetol 0.5% and what is it used for

Optibetol 0.5% is an ophthalmic medicine in the form of sterile eye drops, containing betaxolol as the active substance. Betaxolol belongs to a group of medicines called selective β-adrenergic blockers.
Optibetol 0.5% is indicated for use in the reduction of elevated intraocular pressure in patients with:

• intraocular hypertension,
• chronic open-angle glaucoma.

2. Important information before using Optibetol 0.5%

When not to use Optibetol 0.5%:

• if you are allergic to betaxolol, β-adrenergic blockers or any of the other ingredients of this medicine (listed in section 6);
• if you have or have had breathing difficulties, such as severe asthma, severe chronic obstructive pulmonary disease (severe lung disease that can cause wheezing, breathing difficulties and/or prolonged cough);
• if you have a slow heart rate, heart failure or irregular heart rhythm.

Warnings and precautions

Before starting treatment with Optibetol 0.5%, discuss with your doctor if you have or have had:

• ischemic heart disease (symptoms may include chest pain or tightness, difficulty breathing or shortness of breath), heart failure, low blood pressure;
• irregular heart rhythm, such as slow heart rate;
• breathing difficulties, asthma or chronic obstructive pulmonary disease (a disease whose symptoms may include wheezing, breathing difficulties and/or prolonged cough);
• poor blood circulation (such as Raynaud's disease or Raynaud's syndrome);
• diabetes, as betaxolol may mask the symptoms of low blood sugar;
• hyperthyroidism, as betaxolol may mask the symptoms of the disease;
• muscle weakness (myasthenia);
• dry eye syndrome or other tear secretion disorders;
• angle-closure glaucoma.

If you are planning to have surgery, you should tell your doctor that you are using Optibetol 0.5%, as betaxolol may affect the action of certain medicines used during anesthesia.
If you wear contact lenses - see the section "Optibetol 0.5% contains benzalkonium chloride".
Optibetol 0.5% does not affect the pupil and can therefore be used in patients with angle-closure glaucoma who require immediate treatment to reduce intraocular pressure, in combination with a miotic agent.
You should stop using the medicine and consult your doctor immediately if you suspect an allergic reaction (symptoms: skin rash, itching, swelling of the lips, eyes and mouth, shortness of breath, wheezing).

Children

Optibetol 0.5% is not recommended for use in children.

Optibetol 0.5% and other medicines

Tell your doctor or pharmacist about all medicines (including eye drops) you are currently using or have recently used, as well as any medicines you plan to use.
Optibetol 0.5% may affect other medicines you are taking, or other medicines may affect the action of Optibetol 0.5%, including other eye drops used to treat glaucoma.
Tell your doctor if you are taking medicines to lower blood pressure, heart medicines, anti-diabetic medicines and psychotropic medicines.
Optibetol 0.5% may reduce the effectiveness of adrenaline used to treat severe allergic reactions (anaphylaxis). Tell your doctor if you have had severe allergic reactions in the past.
If you are using other eye medicines, wait at least 5 minutes between instilling different medicines. Eye ointments should be applied last.

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 medicine.
Do not use Optibetol 0.5% if you are pregnant, unless your doctor decides it is necessary.
Do not use Optibetol 0.5% if you are breastfeeding. Betaxolol passes into breast milk. If you are breastfeeding, ask your doctor for advice before using any medicine.

Driving and using machines

Optibetol 0.5% has no or negligible influence on the ability to drive and use machines.
Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs after instillation, wait until your vision is clear before driving or using machines.

Optibetol 0.5% contains benzalkonium chloride

The medicine contains 0.1 mg of benzalkonium chloride per ml of solution. Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Remove contact lenses before instillation and wait at least 15 minutes before putting them back. Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or disorders of the cornea (the transparent layer on the front of the eye). If you experience any abnormal sensations in the eye, stinging or pain in the eye after using the medicine, consult your doctor.

3. How to use Optibetol 0.5%

Use this medicine always as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Adults (including elderly patients)

The recommended dose is one drop into the affected eye(s) twice daily, e.g. in the morning and evening.

Use in children

Optibetol 0.5% is not recommended for use in children.
Method of administration
Optibetol 0.5% is for external use only - apply locally to the eye(s).
Do not touch the dropper tip to the eye or eyelids, as this may contaminate the contents of the bottle. Using contaminated drops can lead to serious complications, even loss of vision.

• 1. Before instillation, wash your hands thoroughly.
• 2. Remove the cap from the bottle.
• 3. Tilt your head back and pull the lower eyelid down to create a pocket between the eyelid and the eye.
• 4. Turn the bottle upside down and gently press the thumb or index finger on the wall, until one drop of medicine falls into the eye. Do not touch the dropper tip to the eye or eyelids. If the drop does not get into the eye, instill another one.
• 5. After instillation, gently press the inner corner of the eye for about 2 minutes. This will help prevent the medicine from being absorbed into the body.
• 6. If your doctor has instructed you to instill the medicine into both eyes, repeat the steps 3, 4 and 5.
• 7. The dropper is designed to measure the drops accurately, so do not enlarge the opening of the dropper.
• 8. After instillation, replace the cap on the bottle. Do not screw it on too tightly.

Using a higher dose of Optibetol 0.5% than recommended

If you have instilled more drops into the eye than recommended or accidentally swallowed the contents of the bottle (e.g. a child), contact your doctor immediately.

Missing a dose of Optibetol 0.5%

It is important to use this medicine as directed by your doctor.
If you miss a dose, use the medicine as soon as possible. However, if it is almost time for the next dose, skip the missed dose and use the next one according to the schedule recommended by your doctor.
Do not use a double dose to make up for a missed dose.

Stopping treatment with Optibetol 0.5%

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience an allergic reaction, including rash, swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing, stop using Optibetol 0.5% and contact your doctor or the Emergency Department of the nearest hospital immediately.
The following side effects have been reported during clinical trials and after the marketing of the medicine.
Very common (more than 1 in 10 people):

• eye discomfort (including foreign body sensation in the eye).

Common (less than 1 in 10 people):

• headache;
• blurred vision, increased tearing.

Uncommon (less than 1 in 100 people):

• punctate keratitis, keratitis, conjunctivitis, blepharitis, visual impairment, photophobia, eye pain, dry eye, asthenopia (weakness of vision), blepharospasm, eye itching, eye discharge, eyelid margin crusting, eye inflammation, eye irritation, conjunctival disorders, conjunctival edema, eye hyperemia;
• bradycardia (slow heart rate), tachycardia (fast heart rate);
• asthma, dyspnea, rhinitis;
• nausea.

Rare (less than 1 in 1,000 people):

• anxiety, insomnia, depression;
• syncope;
• cataract, decreased corneal sensitivity, eyelid ptosis;
• hypotension;
• cough, rhinorrhea;
• taste disturbances;
• skin rash, urticaria, alopecia;
• decreased libido.

Frequency not known (frequency cannot be estimated from the available data):

• hypersensitivity;
• dizziness;
• arrhythmia;
• asthenia (fatigue).

Additional side effects observed after using other β-adrenergic blockers, which may potentially occur after using betaxolol.
Like other eye medicines, betaxolol is absorbed into the bloodstream. This may cause similar side effects as when β-adrenergic blockers are given intravenously and/or orally. The frequency of side effects after eye administration is lower than with oral or injectable medicines.
The following side effects are characteristic of β-adrenergic blockers used to treat eye diseases.
Rare (less than 1 in 1,000 people):

• psoriatic rash or exacerbation of psoriasis.

Frequency not known (frequency cannot be estimated from the available data):

• systemic allergic reactions including angioedema, urticaria, localized and generalized rash, itching, anaphylactic reactions;
• hypoglycemia (low blood sugar);
• nightmares, memory loss, hallucinations, psychoses, confusion (disorientation);
• cerebrovascular accident, cerebral ischemia, exacerbation of objective and subjective symptoms of myasthenia (muscle weakness), paresthesia (tingling, numbness);
• corneal erosion (damage to the corneal epithelium), ptosis, diplopia;
• chest pain, palpitations, edema, congestive heart failure, atrioventricular block, cardiac arrest, heart failure. Slowing of atrioventricular conduction or exacerbation of atrioventricular block;
• Raynaud's phenomenon, cold and cyanotic hands and feet. Exacerbation of existing intermittent claudication;
• bronchospasm (mainly in patients with pre-existing bronchospastic disease);
• gastrointestinal disorders, diarrhea, dry mouth, abdominal pain, vomiting;
• muscle pain;
• sexual dysfunction, impotence;
• fatigue.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Optibetol 0.5%

Keep the medicine out of the sight and reach of children.
No special precautions for storage are necessary.
Keep the bottle tightly closed in the outer packaging.
Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Shelf life after first opening the bottle: 4 weeks. After this time, the medicine should be discarded, even if it has not been used up.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Optibetol 0.5% contains

• The active substance of the medicine is betaxolol. Each ml of solution contains 5 mg of betaxolol in the form of betaxolol hydrochloride.
• The other ingredients are: disodium edetate, sodium chloride, benzalkonium chloride solution, sodium hydroxide 10% (for pH adjustment), purified water.

What Optibetol 0.5% looks like and contents of the pack

Optibetol 0.5% is a sterile eye drop solution. The medicine is available in polyethylene bottles containing 5 ml of solution.

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Manufacturer

Polfa Warszawa S.A.
Karolkowa 22/24, 01-207 Warsaw

Date of last revision of the leaflet: