Optibetol 0.5%

OPTIBETOL 0.5%, 5 mg/ml, eye drops, solution
Betaxolol
Please read the following information carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Leaflet Contents

1. What Optibetol 0.5% is and what it is 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 Optibetol 0.5% is and what it is 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-adrenolytics.
Optibetol 0.5% is indicated for use in lowering elevated intraocular pressure in patients with:

• elevated intraocular pressure,
• chronic open-angle glaucoma.

2. Important information before using Optibetol 0.5%

When not to use Optibetol 0.5%:

• if the patient is allergic to betaxolol, β-adrenolytics, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has or has previously had breathing difficulties, such as severe asthma, severe chronic obstructive pulmonary disease (severe lung disease which may cause wheezing, difficulty breathing and/or prolonged coughing);
• if the patient has slow heart rate, heart failure, or heart rhythm disorders (irregular heartbeat).

Warnings and precautions
Before starting to use Optibetol 0.5%, discuss with the doctor if the patient has or has previously had:

• ischaemic heart disease (symptoms may include chest pain or tightness, difficulty breathing or suffocation), heart failure, low blood pressure;
• heart rhythm disorders, such as slow heartbeat;
• breathing difficulties, asthma or chronic obstructive pulmonary disease (a disease whose symptoms may include wheezing, difficulty breathing and/or prolonged coughing);
• poor blood circulation (such as Raynaud's disease or Raynaud's syndrome);
• diabetes, because betaxolol may mask symptoms caused by low blood sugar levels;
• hyperthyroidism, because betaxolol may mask symptoms of the disease;
• muscle weakness (myasthenia gravis);
• dry eye syndrome or other tear secretion disorders;
• closed-angle glaucoma.

If the patient is scheduled for surgery, the patient should inform the doctor about using Optibetol 0.5%, because betaxolol may alter the effects of certain drugs used during anaesthesia.
If the patient wears contact lenses – see section "Optibetol 0.5% contains benzalkonium chloride".
Optibetol 0.5% does not affect the pupil and therefore, in patients with closed-angle glaucoma requiring immediate treatment, it may be used to reduce intraocular pressure together with a miotic agent (a medicine that constricts the pupil).
The patient should stop using the medicine and seek immediate medical advice if an allergic reaction is suspected (symptoms: skin rash, itching, swelling of lips, eyes and mouth, shortness of breath, wheezing).

Children
Use of Optibetol 0.5% is not recommended in children.

Optibetol 0.5% and other medicines
Tell the doctor or pharmacist about all medicines (including eye drops) the patient is currently using, has recently used, or plans to use.
Optibetol 0.5% may affect other medicines the patient is currently taking, or other medicines may affect the action of Optibetol 0.5%, including other eye drops used in the treatment of glaucoma.
Inform the doctor if the patient is taking medicines to lower blood pressure, heart medications, antidiabetic medicines, or psychotropic drugs.
Optibetol 0.5% may reduce the effectiveness of adrenaline used in the treatment of severe allergic reactions (anaphylaxis). Inform the doctor if the patient has previously experienced severe allergic reactions.
If other eye medications are used simultaneously, at least a 5-minute interval should be maintained between instillation of each medicine. Ointments should be applied last.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Do not use Optibetol 0.5% if the patient is pregnant unless the doctor decides it is necessary.
Do not use Optibetol 0.5% if the patient is breastfeeding. Betaxolol passes into breast milk. If the patient is breastfeeding, she should consult a doctor before using any medicine.

Driving and using machines
Optibetol 0.5% has no effect or negligible effect on the ability to drive and use machines.
Transient blurred vision or other visual disturbances may affect the ability to drive and use machines. If blurred vision occurs after instillation, the patient must wait until vision clears before driving or operating machinery.

Optibetol 0.5% contains benzalkonium chloride
The medicine contains 0.1 mg of benzalkonium chloride in each ml of solution. Benzalkonium chloride may be absorbed by soft contact lenses and may change their colour. Contact lenses must be removed before instillation and at least 15 minutes should be waited before reinserting them. Benzalkonium chloride may also cause eye irritation, especially in individuals with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations in the eye, stinging or eye pain occur after using the medicine, contact a doctor.

3. How to use Optibetol 0.5%

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.

Adults (including elderly patients)
The usual recommended dose is one drop into the affected eye(s) twice daily, for example in the
morning and evening.

Use in children
Use of this medicine is not recommended in children.

Method of administration
Optibetol 0.5% is for external use only – it should be applied locally to the eye(s).

Do not touch the eye, eyelids, or any other surfaces with the dropper tip, as this may contaminate
the contents of the bottle. Using contaminated drops may lead to dangerous complications, including
loss of vision.

1. Wash hands thoroughly before instilling the drops.
2. Unscrew the cap from the bottle.
3. Tilt the head backwards and gently pull down the lower eyelid to form a pouch between the eyelid and the eyeball.
4. Invert the bottle and gently press with the thumb or index finger on the side of the bottle until one drop of medicine is instilled into the eye. Do not touch the eye or eyelids with the dropper tip. If the drop missed the eye, instill another drop.
5. After instilling Optibetol 0.5%, gently press on the inner corner of the eye for about 2 minutes. This helps reduce absorption of the medicine into the body.
6. If the doctor has instructed to instill the medicine into the other eye as well, repeat steps 3, 4, and 5.
7. The dropper is designed to deliver drops accurately; therefore, do not enlarge the opening of the dropper.
8. After instillation, replace the cap on the bottle. Do not overtighten.

Use of a higher than recommended dose of Optibetol 0.5%
If more than the recommended number of drops has been instilled into the eye, or if the contents
of the bottle have been accidentally ingested (e.g. by a child), contact a doctor immediately.

Missed dose of Optibetol 0.5%
It is important to use this medicine as directed by the doctor.
If a dose is missed, instill the drop as soon as possible. However, if it is almost time for the next
dose, skip the missed dose and instill the next one according to the prescribed schedule.
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 the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
If the patient experiences allergic reactions, including rash, swelling of the face, lips, tongue and (or)
throat, which may cause difficulty in breathing or swallowing, the use of Optibetol 0.5% must be stopped immediately and the doctor or the nearest hospital Emergency Department must be contacted immediately.

The following adverse reactions have been reported during clinical trials and after 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 lacrimation.

Uncommon (less than 1 in 100 people):

• Punctate keratitis, keratitis, conjunctivitis, blepharitis, visual impairment, photophobia, eye pain, dry eye, asthenopia (eye strain), eyelid spasm, eye itching, eye discharge, crusts on eyelid margins, eye inflammation, eye irritation, conjunctival disorders, conjunctival edema, eye hyperemia;
• Slowing of heart rate (bradycardia), rapid heartbeat (tachycardia);
• Asthma, dyspnea, rhinitis;
• Nausea.

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

• Anxiety, insomnia, depression;
• Fainting;
• Cataract, decreased corneal sensitivity, eyelid redness;
• Hypotension;
• Cough, watery nasal discharge;
• Taste disturbances;
• Dermatitis, rash, alopecia;
• Decreased libido.

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

• Hypersensitivity;
• Dizziness;
• Cardiac arrhythmias;
• Asthenia (fatigue).

Additional adverse reactions observed with other medicines in the class of β-adrenolytics, which may potentially occur after betaxolol administration.
Like other ophthalmic medicines, betaxolol is absorbed into the bloodstream. This may result in adverse reactions similar to those seen with intravenous and/or oral administration of β-adrenolytic medicines. The frequency of adverse reactions after ocular administration is lower than with orally or parenterally administered medicines.
The adverse reactions listed below are characteristic of β-adrenolytic medicines used in the treatment of eye diseases.
Rare (less than 1 in 1,000 people):

• Psoriasiform rash or exacerbation of psoriasis.

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

• Systemic allergic reactions, including angioedema, urticaria, localized and generalized rash, pruritus, anaphylactic reactions;
• Decreased blood glucose levels (hypoglycemia);
• Nightmares, memory loss, hallucinations, psychosis, confusion (disorientation);
• Cerebrovascular incident, cerebral ischemia, worsening of objective and subjective symptoms of myasthenia (muscle weakness), paresthesia (tingling, numbness);
• Choroidal detachment after filtration procedures, corneal erosion (corneal epithelial damage), ptosis, diplopia;
• Chest pain, palpitations, edema, congestive heart failure, atrioventricular block, cardiac arrest, heart failure. Slowing of atrioventricular conduction or worsening of atrioventricular block;
• Raynaud's phenomenon, cold and cyanotic hands and feet. Worsening of existing intermittent claudication;
• Bronchospasm (mainly in patients with pre-existing bronchospastic disease);
• Dyspepsia, diarrhea, dry mouth, abdominal pain, vomiting;
• Muscle pain;
• Sexual dysfunction, impotence;
• Fatigue.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions contributes to the further enhancement of the safety information regarding the 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 required.
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 indicated.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot indicates 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 completely used.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Optibetol 0.5% contains

• The active substance 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 Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
Warszawskie Zakłady Farmaceutyczne Polfa S.A.
ul. Karolkowa 22/24, 01-207 Warszawa