BETOPTIC 0.5%

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Betoptic 0.5% (Betoptic)
5 mg/ml (0.5% w/v), eye drops, solution
Betaxololum
Betoptic 0.5% and Betoptic are different trade names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What Betoptic 0.5% is and what it is 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 pack and other information

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

Betoptic 0.5% is used to treat elevated intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension.
Elevated intraocular pressure
The eyes contain a clear fluid that nourishes the inside of the eye. This fluid drains gradually from the eye and is replaced by newly produced fluid. When the production of new fluid exceeds the eye's ability to drain the existing fluid, intraocular pressure increases. Excessively high intraocular pressure may damage vision.
Betoptic 0.5% belongs to a group of medicines used in glaucoma called beta-adrenolytics. This medicine is effective in reducing fluid pressure within the eye. It may 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 allergic to betaxolol or any of the other ingredients of the medicine (listed in section 6).
• if the patient has a heart condition, such as heart failure, bradycardia (abnormally slow heart rate), sick sinus syndrome, sinoatrial block, second- or third-degree atrioventricular block not controlled by a pacemaker, or cardiogenic shock.

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• if the patient currently has or has previously had any respiratory problems, such as severe asthma or severe chronic obstructive pulmonary disease (severe lung disease that may cause shortness of breath, difficulty breathing, and/or long-term cough).

Warnings and precautions
Before starting treatment with Betoptic 0.5%, consult a doctor or pharmacist if the patient currently has or has previously had:

• ischaemic heart disease (symptoms may include chest pain or tightness, shortness of breath or angina), heart failure, first-degree atrioventricular block, or low blood pressure. If symptoms of heart failure occur for the first time, the doctor will decide whether to discontinue Betoptic 0.5%,
• breathing problems, asthma or chronic obstructive pulmonary disease,
• peripheral vascular disorders such as Raynaud's disease or Raynaud's phenomenon,
• diabetes, or spontaneous hypoglycaemia, because betaxolol may mask the symptoms of low blood sugar,
• hyperthyroidism, because betaxolol may mask its symptoms,
• myasthenia (chronic neuromuscular weakness),
• closed-angle glaucoma. In such a case, Betoptic 0.5% must not be used as monotherapy,
• local or severe allergic reactions. The patient may become more sensitive 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 must be stopped immediately and the patient must contact a doctor or the nearest hospital Emergency Department without delay. Treatment with adrenaline may be less effective. If the patient is receiving any other treatment, inform the doctor about the use of Betoptic 0.5%.

If the patient is scheduled for surgery, inform the doctor about the use of Betoptic 0.5%, as betaxolol may affect the effectiveness of certain drugs used during anaesthesia.
If the patient has a corneal disorder, consult a doctor, as Betoptic 0.5% may cause dry eyes.
If the patient has undergone glaucoma surgery, consult a doctor before starting treatment with Betoptic 0.5%.

Betoptic 0.5% and other medicines
Inform the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Betoptic 0.5% may affect the action of other medicines taken concomitantly, and other medicines may affect the action of Betoptic 0.5%. These include:

• oral calcium channel blockers,
• beta-adrenergic blocking agents,
• antiarrhythmics (including amiodarone),
• cardiac glycosides,
• parasympathomimetics,
• guanethidine,
• drugs that deplete neuronal catecholamine stores, such as reserpine derivatives,
• adrenaline,
• medicines used to treat emotional, behavioural or mental disorders.

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When using other eye drops or ointments, wait at least 5 minutes between applying each product. Eye ointments should be used last.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Do not use Betoptic 0.5% if the patient is pregnant, unless the doctor considers it necessary. Do not use Betoptic 0.5% if the patient is breastfeeding. Betaxolol passes into human milk.
Driving and using machines
Betoptic 0.5% has no effect or negligible effect on the ability to drive and use machinery.
However, as with other medicinal products administered locally to the eye, Betoptic 0.5% may cause transient blurred vision or other visual disturbances, which may impair the ability to drive or operate machinery. If the patient experiences blurred vision after instillation, he or she should not drive or operate machinery until vision is clear again.
Betoptic 0.5% contains benzalkonium chloride
The medicine contains 0.1 mg of benzalkonium chloride per millilitre (0.1 mg/ml).
Benzalkonium chloride may be absorbed by soft contact lenses and may alter 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, particularly in patients 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.
During treatment, regular monitoring of intraocular pressure may be necessary. Follow medical advice.

3. How to use Betoptic 0.5%

This medicine should always be used exactly as directed by your doctor.
If in doubt, consult your doctor or pharmacist.
Your doctor will determine how long you should use the medicine.
Betoptic 0.5% is intended exclusively for ophthalmic (eye) use.

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, your doctor may prescribe a different dosing regimen,
depending on the diagnosis. Detailed instructions for use are provided below.
In some patients, intraocular pressure may stabilize after several weeks of treatment with Betoptic 0.5%.
Use Betoptic 0.5% exactly as prescribed by your doctor. If in doubt, consult your doctor again.

When switching from another anti-glaucoma medication, continue using the previously prescribed medication on the first day, while adding one drop of Betoptic 0.5% twice daily to the affected eye(s). On the following day, discontinue the previous anti-glaucoma medication completely and continue treatment with Betoptic 0.5%.

When switching from treatment with multiple concurrently administered anti-glaucoma medications, follow the individual treatment regimen established by your doctor. Your doctor will make changes to the medications at intervals of no less than one week.

Use in children and adolescents
Betoptic 0.5% is not intended for use in individuals under 18 years of age.

Instructions for using eye drop solution

1. Prepare the eye drop bottle 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, remove it before using the medicine.
6. Hold the bottle in your hand with the bottom facing upwards, using your thumb and middle finger (figure 1).
7. Tilt your head backwards. Gently pull down the lower eyelid with a clean finger to create a "pocket" between the eyelid and the eyeball; this is where the drop should be placed (figure 2).
8. Bring the dropper tip close to the eye. You may use a mirror to assist.
9. Do not touch the dropper tip to the eye, eyelid, surrounding area, or any other surface. This could contaminate the eye drops.
10. Gently squeeze the bottom of the bottle to release a single drop of Betoptic 0.5% (figure 3).
11. After administering the eye drop, release the finger holding the lower eyelid. Close the eye and gently press with your finger on the inner corner of the eye near the nose (figure 4) for 2 minutes. This helps prevent the medicine from draining into the rest of the body.
12. If drops are needed in both eyes, repeat the above steps for the second eye.
13. Immediately after use, screw the cap back onto the bottle.
14. Use only one bottle of medicine at a time.

If the drop misses the eye, repeat the procedure to correctly instill the drop.
Accidental overdose of Betoptic 0.5%
If too many drops are instilled into the eyes, rinse the eye(s) thoroughly with lukewarm water. Do not administer the next scheduled dose earlier than prescribed.
Possible symptoms of overdose include slowed heart rate, low blood pressure, heart failure, and breathing difficulties.
Missed dose of Betoptic 0.5%
If you miss a dose of Betoptic 0.5%, continue treatment by administering the next dose according to the prescribed schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not use a double dose to make up for a missed dose.
When using other eye drops or ointments, wait at least 5 minutes between applying different eye medications. Ointments should be used last.
In case of accidental ingestion, contact your doctor immediately.
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 everyone will experience them.
You can usually continue using the drops unless the adverse reactions are severe. If you have any concerns,
contact your doctor or pharmacist. Do not stop using Betoptic 0.5% without consulting your doctor.

Beta-adrenergic receptor blocking medicines for local ophthalmic use may be absorbed into the systemic circulation. As a result, the same adverse reactions may occur as with systemic beta-adrenergic receptor blocking medicines.

The following adverse reactions have been observed during the use of Betoptic 0.5%.

• Very common adverse reactions (may affect more than 1 in 10 people):

• Eye-related: eye discomfort.

• Common adverse reactions (may affect less than 1 in 10 people):

• Eye-related: blurred vision, increased tear production.

• General: headache.

• Uncommon adverse reactions (may affect less than 1 in 100 people):

• Eye-related: inflammation of the eye surface with or without corneal surface damage, conjunctivitis, blepharitis, visual disturbances, photophobia, burning and stinging of the eye, eye pain, dry eye, reduced visual acuity, eyelid disorders, eye itching, eye discharge, eyelid nodules, eye inflammation, eye irritation, conjunctival disorders, eye swelling, eye redness.

• General: slow heartbeat, rapid heartbeat, asthma, shallow breathing, nausea, nasal inflammation.

• Rare adverse reactions (may affect less than 1 in 1,000 people):

• Eye-related: cataract.

• General: fainting, unpleasant taste in the mouth, cough, catarrh, skin inflammation, rash, low blood pressure, anxiety, decreased libido.

The following adverse reactions have been observed with other beta-adrenolytic medicines used in ophthalmology. They may also occur with Betoptic 0.5%:

• Frequency not known (cannot be estimated from available data):
• Eye-related: eyelid redness, choroidal detachment, decreased corneal sensitivity, corneal erosion, ptosis (drooping eyelid), double vision.
• General: hypersensitivity, allergic reactions including angioedema, urticaria, rash, pruritus, anaphylactic reactions, dizziness, stroke, cerebral ischemia, worsening 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 legs), atrioventricular block, cardiac arrest, Raynaud's syndrome, sensation of cold hands and feet, bronchospasm, dyspepsia, diarrhea, dry mouth, abdominal pain, vomiting, hair loss, psoriasiform rash or worsening of psoriasis symptoms, muscle pain, sexual dysfunction, weakness, fatigue, insomnia, depression, nightmares, memory loss, hypoglycemia, heart failure.

Like other locally applied ophthalmic medicines, betaxolol is absorbed into the systemic circulation. This may lead to adverse effects similar to those observed with oral and/or intravenous beta-adrenolytic medicines. The frequency of systemic adverse reactions after local ophthalmic administration is lower than, for example, with oral or intravenous administration. The listed adverse reactions also include those observed with other ophthalmic beta-adrenolytic medicines.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Betoptic 0.5% eye drops

The Betoptic 0.5% eye drops remain stable for 4 weeks after first opening.
To prevent infection, the bottle must be discarded 4 weeks after first opening.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use.
This will help protect the environment.
The date of opening the bottle should be recorded in the space below.
Opened:
Keep the medicine out of sight and reach of children.
Store below 25°C. Keep the bottle in the outer packaging to protect it from light.
Do not use Betoptic 0.5% after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.

6. Contents of the packaging and other information

What Betoptic 0.5% contains

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

What Betoptic 0.5% looks like and contents of the pack
Betoptic 0.5% is a clear, colourless solution supplied in a DROPTAINER bottle made of
polyethylene (LDPE) with a dropper and a safety cap made of polypropylene (PP), packed in a
cardboard box.
The cardboard box contains 1 bottle with a capacity of 5 ml.
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For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Latvia, country of export:
Immedica Pharma AB
Solnavägen 3H
113 63 Stockholm
Sweden
Manufacturer:
Siegfried El Masnou S.A., Camil Fabra 58, El Masnou, 08320 Barcelona, Spain
Alcon-Couvreur NV, Rijksweg 14, 2870 Puurs, Belgium
Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany
Novartis Farmacéutica S.A., Gran Via de les Corts Catalanes 764, 08013 Barcelona, Spain
Immedica Pharma AB, Solnavägen 3H, 113 63 Stockholm, Sweden
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation number in Latvia, country of export: 99-1056
Parallel Import Authorisation number: 291/25
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