Betoptic 0,5%

Leaflet attached to the packaging: information for the user

BETOPTIC 0.5%

5 mg/ml, eye drops, solution
Betaxolol hydrochloride

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 another person, 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 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 in 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 (too slow heart rate), sick sinus syndrome, atrioventricular block, or cardiogenic shock.
• If the patient 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 treatment with 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 occur, the doctor will decide whether to discontinue Betoptic 0.5%.
• respiratory problems, asthma, or chronic obstructive pulmonary disease.
• peripheral vascular disease, such as Raynaud's disease or Raynaud's syndrome.
• diabetes, 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. In this case, Betoptic 0.5% should not be used as monotherapy.
• severe local or allergic reactions. The patient may be more sensitive to exposure to allergens. If a severe allergic reaction occurs during treatment with Betoptic 0.5% (skin rash, redness, and itching of the eye, fever, swelling of the throat, tongue, or face), regardless of the cause, treatment should be discontinued and medical attention should be sought immediately. Adrenaline treatment may not be as effective. If the patient is taking 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 treatment with Betoptic 0.5%.

Betoptic 0.5% and other medicines

The patient should tell their doctor about all medicines they are currently taking or 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 drugs (including amiodarone).
• cardiac glycosides.
• parasympathomimetics.
• guanethidine.
• drugs that reduce catecholamine stores in nerve endings, such as reserpine derivatives.
• adrenaline.
• drugs used in emotional, behavioral, or mental disorders.

In case of using other eye drops or ointments, a minimum of 5 minutes should be allowed between the administration of the next medicines. Eye ointments should be applied 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 breast milk.

Driving and using machines

Betoptic 0.5% has no or negligible influence 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 people 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 treatment, it may be necessary to perform a control examination of the intraocular pressure. The patient should follow the doctor's recommendations.

3. How to use Betoptic 0.5%

This medicine should always be used as directed 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.
Dosing in 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 a few weeks of treatment with Betoptic 0.5%.
Betoptic 0.5% should be used as directed by the doctor. In case of doubts, the patient should consult their doctor again.
If the patient is switching from another glaucoma medicine, they should continue their current medicine on the first day and add 2 drops of Betoptic 0.5% twice daily to the affected eye(s). The next day, they should stop their previous glaucoma medicine and continue using Betoptic 0.5%.
If the patient is switching from several glaucoma medicines used at the same time, they should follow the individual treatment schedule established by their doctor. The doctor will replace the next medicines at intervals of no less than one week.
Use in children and adolescents
Betoptic 0.5% is not intended for use in people under 18 years of age.

1
2
3
4
How to use the eye drops

• 1. Prepare the bottle of eye drops and a mirror.
• 2. Wash your hands.
• 3. Shake the bottle.
• 4. Remove 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 down the lower eyelid 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. Immediately after use, the bottle should be tightly closed.
• 14. At the same time, only one bottle of the medicine should be used.

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 recommended

If more than the recommended amount of eye drops is administered to the eye, the eye (eyes) should be rinsed with plenty of lukewarm water. The next drops should not be administered before the scheduled time for the next dose. Possible symptoms of overdose include slowed heart rate, decreased blood pressure, heart failure, and difficulty breathing.

Missing a dose of Betoptic 0.5%

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

If you have any further doubts about using 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.
It is usually possible to continue using the drops, as long as the side effects are not severe. 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 topically in the eye may be absorbed into the body. As a result, the same side effects may occur as with systemic beta-adrenergic blockers.
The following side effects have been observed with Betoptic 0.5%:

• Very common side effects (may affect more than 1 in 10 people):
• Eye disorders: eye discomfort.
• Common side effects (may affect up to 1 in 10 people):
• Eye disorders: blurred vision, increased tear production.
• General disorders: headache.
• Uncommon side effects (may affect up to 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, discharge from the eye, eyelid papillae, eye inflammation, eye irritation, conjunctival disorders, eye edema, eye redness.
• General disorders: bradycardia, tachycardia, asthma, dyspnea, nausea, rhinitis.
• Rare side effects (may affect up to 1 in 1,000 people):
• Eye disorders: cataract.
• General disorders: syncope, unpleasant taste, cough, rhinitis, skin inflammation, rash, decreased blood pressure, anxiety, decreased libido.

The following side effects have been observed with other topical beta-adrenergic blockers for the eye. They may also occur with Betoptic 0.5%:

• Frequency not known (cannot be estimated from the available data):
• Eye disorders: eyelid redness, detachment of the retina, decreased corneal sensitivity, corneal erosion, ptosis, diplopia.
• General disorders: hypersensitivity, allergic reactions that may include angioedema, urticaria, rash, pruritus, anaphylactic reactions, dizziness, stroke, cerebral ischemia, exacerbation of myasthenia symptoms (muscle weakness), paresthesia, arrhythmia, chest pain, palpitations, edema (fluid retention), congestive heart failure (heart disease characterized by shortness of breath and swelling of the feet and legs), atrioventricular block, cardiac arrest, Raynaud's syndrome, feeling of cold hands and feet, bronchospasm, gastrointestinal upset, diarrhea, dry mouth, abdominal pain, vomiting, hair loss, psoriasis-like rash or exacerbation of psoriasis symptoms, muscle pain, sexual dysfunction, weakness, fatigue, insomnia, depression, nightmares, memory loss, hypoglycemia, heart failure. Like other topical ophthalmic 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 topical administration to 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.

The above side effects have been observed with other beta-adrenergic blockers used in the eye. They may also occur with Betoptic 0.5%.

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 Adverse Reaction Monitoring 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Betoptic 0.5%

Betoptic 0.5% retains its potency for 4 weeks after the bottle is first opened.
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.
Store in a temperature below 25°C.
Store the container tightly closed.
Store the bottle in the outer packaging to protect it from light.
Do not use this medicine after the expiry date stated on the label and carton after: EXP

6. Contents of the packaging and other information

What does Betoptic 0.5% contain?

• The active substance of the medicine is betaxolol 5 mg (as 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 does Betoptic 0.5% look like and what does the pack contain?

Betoptic 0.5% is a clear, colorless or pale yellow solution supplied in a 5 ml plastic bottle (DROPTAINER type) with a protected cap.
A cardboard box contains 1 bottle of 5 ml.

Marketing authorization holder

Immedica Pharma AB
Solnavägen 3H
SE-113 63 Stockholm
Sweden

Manufacturer

s.a. Alcon-Couvreur n.v.
Rijksweg 14, 2870 Puurs
Belgium
Siegfried El Masnou, S.A.
Camil Fabra 58, El Masnou
08320 Barcelona
Spain

Importer

Immedica Pharma AB
Solnavägen 3H
SE-113 63 Stockholm
Sweden

Date of last revision of the leaflet: 12/2022