Betoptic 0,5%

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Betoptic 0.5%(Betoptic)

5 mg/ml, eye drops, solution

Betaxolol
Betoptic 0.5% and Betoptic are different trade names for the same medicine.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

Betoptic 0.5% is used to treat high pressure in the eye in patients with chronic open-angle glaucoma or ocular hypertension.
High pressure in the eye
The eyes contain a clear fluid that nourishes the inside of the eye. This fluid is constantly being drained from the eye and replaced with new fluid. If the production of new fluid exceeds the drainage of fluid from the eye, the pressure in the eye increases. Too high pressure in the eye can damage vision.
Betoptic 0.5% belongs to a group of medicines used to treat glaucoma, called beta-adrenergic blockers.
This medicine is effective in reducing the pressure of the fluid in the eye. It can be used alone or in combination with other medicines that also reduce intraocular pressure.

2. Important information before using Betoptic 0.5%

When not to use Betoptic 0.5%:

• If the patient is allergicto betaxolol or any of the other ingredients of the medicine (listed in section 6).
• If the patient has heart disease,such as heart failure, bradycardia (very slow heart rate), sick sinus syndrome, sinoatrial block, atrioventricular block of second or third degree not controlled by a pacemaker or cardiogenic shock.
• If the patient currently has or has had any respiratory problemssuch as severe asthma, severe chronic obstructive pulmonary disease (severe lung disease that can cause shortness of breath, difficulty breathing, and/or prolonged coughing).

Warnings and precautions

Before starting to use Betoptic 0.5%, the patient should discuss with their doctor or pharmacist if they currently have or have had:

• ischemic heart disease (symptoms may include chest pain or tightness, shortness of breath, or choking), heart failure, first-degree atrioventricular block, or low blood pressure). If the first symptoms of heart failure appear, the doctor will decide whether to stop Betoptic 0.5%,
• breathing problems, asthma, or chronic obstructive pulmonary disease, - peripheral vascular disease such as Raynaud's disease or Raynaud's syndrome,
• diabetes, spontaneous hypoglycemia, as betaxolol may mask the symptoms of low blood sugar levels,
• hyperthyroidism, as betaxolol may mask its symptoms.
• myasthenia (chronic muscle weakness).
• angle-closure glaucoma. Betoptic 0.5% should not be used as monotherapy in such cases.
• severe local or systemic allergic reactions. The patient may be more sensitive to exposure to allergens. If a severe allergic reaction occurs during the use of Betoptic 0.5% (skin rash, redness, and itching of the eye, fever, swelling of the throat, tongue, or face), treatment should be discontinued and medical attention should be sought immediately. Adrenaline treatment may not be as effective. If the patient is using any other treatment, they should tell their doctor about the use of Betoptic 0.5%.

If the patient is scheduled for surgery, they should inform their doctor about the use of Betoptic 0.5%, as betaxolol may affect the effectiveness of certain medicines used during anesthesia.
If the patient has corneal disease, they should consult their doctor, as Betoptic 0.5% may cause dry eyes.
If the patient has had glaucoma surgery, they should consult their doctor before starting to use Betoptic 0.5%.

Betoptic 0.5% and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Betoptic 0.5% may affect the action of other medicines taken at the same time, and other medicines may affect the action of Betoptic 0.5%. These include:

• oral calcium channel blockers,
• beta-adrenergic blockers,
• antiarrhythmic medicines (including amiodarone),
• cardiac glycosides,
• parasympathomimetics, - guanethidine,
• medicines that reduce the stores of catecholamines in nerve endings, such as reserpine derivatives
• adrenaline
• medicines used in emotional, behavioral, or mental disorders.

In case of using other eye drops or ointments, the patient should wait at least 5 minutes between the administration of the different medicines. Eye ointments should be used last.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. Betoptic 0.5% should not be used if the patient is pregnant, unless the doctor considers it necessary. Betoptic 0.5% should not be used if the patient is breastfeeding. Betaxolol passes into human milk.

Driving and using machines

Betoptic does not have a significant effect on the ability to drive and use machines.
However, like other eye products, Betoptic 0.5% may cause temporary blurred vision or other visual disturbances that may affect the ability to drive and use machines. If the patient experiences blurred vision after administering the eye drops, they should not drive or operate machinery until their vision is clear.

Betoptic 0.5% contains benzalkonium chloride

The medicine contains 0.1 mg of benzalkonium chloride per milliliter (0.1 mg/ml).
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. The patient should remove their contact lenses before administering the eye drops and wait at least 15 minutes before putting them back on.
Benzalkonium chloride may also cause eye irritation, especially in patients with dry eye syndrome or disorders affecting the cornea (the transparent layer on the front of the eye). If the patient experiences any abnormal sensations in the eye, stinging, or pain in the eye after using the medicine, they should consult their doctor.
During the use of the medicine, it may be necessary to perform a control examination of the intraocular pressure. The patient should follow the doctor's instructions.

3. How to use Betoptic 0.5%

This medicine should always be used exactly as prescribed by the doctor.
In case of doubts, the patient should consult their doctor or pharmacist.
The doctor will determine how long the patient should use the medicine.
Betoptic 0.5% is for ophthalmic use only.
Dosage for adults, including elderly patients
The recommended dose of Betoptic 0.5% is one drop into the conjunctival sac of the affected eye(s) twice daily, at regular intervals. However, the doctor may prescribe a different dosage, depending on the diagnosis. Below is a detailed instruction for use.
In some patients, stabilization of intraocular pressure may occur after several weeks of treatment with Betoptic 0.5%.

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Method of using the eye drops

• 1. Prepare the bottle of eye drops and a mirror.
• 2. Wash your hands.
• 3. Shake the bottle.
• 4. Unscrew the cap.
• 5. If the protective collar is loose after removing the cap, it should be removed before using the medicine.
• 6. Hold the bottle in your hand and turn it upside down, holding it with your thumb and middle finger (picture 1).
• 7. Tilt your head back. Pull the lower eyelid down with a clean finger to form a "pocket" between the eyelid and the eye; the drop should fall into this pocket (picture 2).
• 8. Bring the tip of the bottle close to the eye. You can use a mirror to help you.
• 9.

Do not touch the tip of the dropper to the eye, eyelid, or surrounding areas.

This could cause infection of the drops.

• 10. Gently squeeze the bottom of the bottle to release a single drop of Betoptic 0.5% (picture 3).
• 11. After using the eye drops, remove the finger that held the lower eyelid. Close your eye and gently press the corner of your eye near your nose (picture 4) for 2 minutes. This will help prevent the medicine from entering the entire body.
• 12. If it is necessary to administer drops to both eyes, the above steps should be repeated for the second eye.
• 13. The bottle should be closed immediately after use.
• 14. Only one bottle of the medicine should be used at a time.

If the drop does not get into the eye, the attempt to administer the drop correctly should be repeated.

Using more Betoptic 0.5% than prescribed

If too many drops are administered to the eye, the eye(s) should be rinsed with plenty of warm water. The next dose of the medicine should not be administered earlier than the scheduled time. Possible symptoms of overdose include slowed heart rate, decreased blood pressure, heart failure, and breathing difficulties.

Missing a dose of Betoptic 0.5%

If a dose of Betoptic 0.5% is missed, the treatment should be continued by administering the next dose of the medicine according to the dosing schedule. If it is almost time for the next dose, the missed dose should be skipped and the treatment should be continued according to the prescribed dosing schedule. Do nottake a double dose to make up for the missed dose.
If using other eye drops or ointments, the patient should wait at least 5 minutes between the administration of the different medicines. Eye ointments should be used last.
In case of accidental ingestion, the patient should consult their doctor.

If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Usually, you can continue to use the drops as long as the side effects are not serious. If you are concerned, you should consult your doctor or pharmacist. Without consulting your doctor, you should not stop using Betoptic 0.5%.
Beta-adrenergic blockers used in the eye may be absorbed into the body. As a result, the same side effects may occur as with beta-adrenergic blockers given systemically.
The following side effects have been observed with the use of Betoptic 0.5%.

• Very common side effects (may affect more than 1 in 10 people):- Eye disorders: eye discomfort
• Common side effects (may affect less than 1 in 10 people)
• Eye disorders: blurred vision, increased tear production
• General disorders: headache
• Uncommon side effects (may affect less than 1 in 100 people):
• Eye disorders: inflammation of the surface of the eye with or without damage to the surface of the eye, conjunctivitis, blepharitis, visual disturbances, photophobia, burning and stinging of the eye, eye pain, dry eye, decreased visual acuity, eyelid disorders, itching of the eye, eye discharge, eyelid papillae, eye inflammation, eye irritation, conjunctival disorders, eye edema, eye redness
• General disorders: slow heart rate, fast heart rate, asthma, shallow breathing, nausea, rhinitis
• Rare side effects (may affect less than 1 in 1,000 people):- Eye disorders: cataract
• General disorders: fainting, unpleasant taste in the mouth, cough, rhinitis, skin inflammation, rash, decreased blood pressure, anxiety, decreased sexual desire

The following side effects have been observed with other beta-adrenergic blockers used in the eye. They may also occur with Betoptic:

• Frequency not known (cannot be estimated from the available data)
• Eye disorders: eyelid redness, detachment of the choroid, decreased corneal sensitivity, corneal erosion, eyelid ptosis, double vision.
• General disorders: hypersensitivity, allergic reactions that may include angioedema, urticaria, rash, itching, anaphylactic reactions, dizziness, stroke, cerebral ischemia, exacerbation of myasthenia symptoms (muscle weakness), paresthesia, arrhythmia, chest pain, palpitations, edema (fluid retention), congestive heart failure (a heart condition characterized by shortness of breath and swelling of the feet and ankles), atrioventricular block, cardiac arrest, Raynaud's syndrome, feeling of cold hands and feet, bronchospasm, gastrointestinal disorders, diarrhea, dry mouth, abdominal pain, vomiting, hair loss, psoriasiform or exacerbation of psoriasis, muscle pain, sexual dysfunction, weakness, fatigue, insomnia, depression, nightmares, memory loss, hypoglycemia, heart failure. Like other locally used eye medicines, betaxolol is absorbed into the systemic circulation. This may cause similar side effects as with oral and/or intravenous beta-adrenergic blockers. The frequency of systemic side effects after local use in the eye is lower than, for example, after oral or intravenous administration. The listed side effects also include side effects observed with other ophthalmic beta-adrenergic blockers.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Betoptic 0.5%

Betoptic 0.5% remains stable for 4 weeks after the first opening of the bottle.
To prevent infections, the bottle should be discarded 4 weeks after it is first opened. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
The date of opening the bottle should be written in the space provided below.
Opened:
The medicine should be kept out of the sight and reach of children.
Do not store above 25°C.
Store the bottle in the outer packaging.
Keep the packaging tightly closed.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

6. Contents of the packaging and other information

What Betoptic 0.5% contains

• The active substance of the medicine is betaxolol (in the form of betaxolol hydrochloride). 1 ml of solution contains 5 mg of betaxolol (in the form of betaxolol hydrochloride).
• The other ingredients are: benzalkonium chloride, disodium edetate, sodium chloride, sodium hydroxide, and/or hydrochloric acid (to adjust the pH), purified water.

What Betoptic 0.5% looks like and contents of the pack

Betoptic 0.5% is a clear, colorless or pale yellow solution supplied in a 5 ml bottle of the DROPTAINER type (LDPE) with a dropper (LDPE) and a cap (PP) in a cardboard box. The cardboard box contains 1 bottle of 5 ml.
For more detailed information, the patient should consult the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

Immedica Pharma AB
Solnavägen 3H
113 63 Stockholm
Sweden

Manufacturer:

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany

Parallel importer:

Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
Działkowa Street 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
Jagiellońska Street 76
03-301 Warsaw
Laboratorium Galenowe Olsztyn Sp. z o.o.
Spółdzielcza Street 25A
11-001 Dywity
Synoptis Industrial Sp. z o.o.
Szosa Bydgoska Street 58
87-100 Toruń
IVA Pharm Sp. z o.o.
Drawska Street 14/1
02-202 Warsaw
Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
Marketing authorization number in Greece, the country of export: 8579/6-2-2007
Parallel import authorization number: 296/21

Date of leaflet approval: 26.01.2024

[Information about the trademark]