Betoptic 0.5%

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging 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.
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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents:

1. What Betoptic 0.5% is and what it is used for
2. What you need to know 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 in the treatment of 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 interior 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 known as beta-adrenolytics. This medicine effectively reduces 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% eye drops

When not to use Betoptic 0.5%:

• if the patient is allergic to betaxolol or any of the other ingredients of this 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.
• 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 which may cause breathlessness, difficulty in breathing and/or long-term cough).

Warnings and precautions
Before starting 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 early signs of heart failure occur, the doctor will decide to discontinue Betoptic 0.5%,
• breathing problems, asthma or chronic obstructive pulmonary disease,
• peripheral vascular disease such as Raynaud's disease or Raynaud's phenomenon,
• diabetes, spontaneous hypoglycaemia, as betaxolol may mask the symptoms of low blood sugar,
• hyperthyroidism, as betaxolol may mask its symptoms,
• myasthenia gravis (chronic neuromuscular weakness),
• closed-angle glaucoma. In such cases, 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 Betoptic 0.5%.

Betoptic 0.5% and other medicines
Tell 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 for emotional, behavioural or mental disorders.

When using other eye drops or eye 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 considered necessary by a doctor. 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 machines.
However, like 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 and use machines. If the patient experiences blurred vision after instillation, he/she should not drive or operate machinery until vision is clear.

Betoptic 0.5% contains benzalkonium chloride
This 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 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 patients with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations, stinging or pain in the eye 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 as directed by your doctor.
If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine how long you should use this medicine.
Betoptic 0.5% is intended exclusively for ophthalmic 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 dosage 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 previous medication on the first day,
while adding one drop of Betoptic 0.5% to the affected eye(s) twice daily. On the following day, discontinue
the previous anti-glaucoma medication completely and continue treatment with Betoptic 0.5%.

When switching from multiple concurrently administered anti-glaucoma medications, follow the individual
treatment regimen established by your doctor. Your doctor will make changes to 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.

1 2 3 4
Instructions for using 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 safety collar is loose after removing the cap, remove it before using the medicine.
6. Hold the bottle in your hand with the bottom facing upward, using your thumb and middle finger (Figure 1).
7. Tilt your head backward. Gently pull down the lower eyelid with a clean finger to form a "pocket" between the eyelid and the eyeball; the drop should be instilled into this pocket (Figure 2).
8. Bring the dropper tip close to the eye. A mirror may be used to assist.
9. Do not touch the dropper tip to the eye, eyelid, surrounding areas, or any other surface. This could contaminate the drops.
10. Gently squeeze the bottom of the bottle to release a single drop of Betoptic 0.5% (Figure 3).
11. After instilling the eye drop, remove the finger from the lower eyelid. Close the eye and gently press the inner corner of the eye near the nose with a finger (Figure 4) for 2 minutes. This helps prevent the medicine from draining into the systemic circulation.
12. If drops are needed in both eyes, repeat the above steps for the second eye.
13. Immediately after use, replace the cap on the bottle.
14. Only one bottle of medicine should be used at a time.

If the drop misses the eye, repeat the procedure to correctly instill the drop.
Overdose of Betoptic 0.5%
If too many drops are instilled into the eyes, rinse the eye(s) thoroughly with lukewarm water.
Do not instill the next drop earlier than at the scheduled time for the next dose.
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 the next dose, skip the missed dose and continue with the 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 products.
Eye ointments should be used last.

In case of accidental ingestion, seek medical advice immediately.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You can usually continue using the drops unless the adverse effects are severe. If you have any concerns,
contact your doctor or pharmacist. Do not stop using Betoptic 0.5% without first consulting your doctor.

Beta-adrenergic receptor blocking medicines for local application to the eye may be absorbed into the systemic circulation. As a result, the same adverse effects may occur as with systemically administered beta-adrenergic receptor blocking medicines.

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

• Very common adverse effects (may occur in more than 1 in 10 people):
  • Eye disorders: eye discomfort
• Common adverse effects (may occur in less than 1 in 10 people):
  • Eye disorders: blurred vision, increased tear production
  • General disorders: headache
• Uncommon adverse effects (may occur in less than 1 in 100 people):
  • Eye disorders: inflammation of the surface of the eye with or without damage to the ocular surface, 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 lumps, eye inflammation, eye irritation, conjunctival disorders, eye swelling, eye redness
  • General disorders: slow heartbeat, fast heartbeat, asthma, shallow breathing, nausea, nasal inflammation
• Rare adverse effects (may occur in less than 1 in 1,000 people):
  • Eye disorders: cataract
  • General disorders: fainting, unpleasant taste in mouth, cough, cold symptoms, skin inflammation, rash, low blood pressure, anxiety, decreased libido

The following adverse effects have been observed with other beta-adrenergic blocking medicines used in the eye. These may also occur with Betoptic:

• Frequency not known (cannot be estimated from available data):
  • Eye disorders: eyelid redness, choroidal detachment, decreased corneal sensitivity, corneal erosion, drooping eyelid, double vision
  • General disorders: hypersensitivity, allergic reactions including angioedema, urticaria, rash, itching, 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, cold sensation in hands and feet, bronchospasm, dyspepsia, diarrhea, dry mouth, abdominal pain, vomiting, hair loss, psoriasiform rash or worsening of psoriasis symptoms, muscle pain, sexual dysfunction, asthenia, fatigue, insomnia, depression, nightmares, memory loss, hypoglycemia, heart failure.

Like other topically applied ophthalmic medicines, betaxolol may be absorbed into the systemic circulation. This may result in adverse effects similar to those observed with oral and/or intravenous beta-adrenergic blocking medicines. The frequency of systemic adverse effects following topical ocular administration is lower than, for example, with oral or intravenous administration. The listed adverse effects also include those observed with other ophthalmic beta-adrenergic blocking medicines.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 effects helps to provide more information on the safety of the medicine.

5. How to store Betoptic 0.5% eye drops

Betoptic 0.5% remains stable for 4 weeks after first opening the bottle.
To prevent contamination, the bottle must be discarded four weeks after first opening.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.
The date of first opening should be recorded in the space provided below.
Opened:
Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Store the bottle in the outer packaging.
Keep the container 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 stated month.

6. Contents of the package and other information

What Betoptic 0.5% contains

• The active substance is betaxolol (as betaxolol hydrochloride). 1 ml of solution contains 5 mg of betaxolol (as betaxolol hydrochloride).
• The other components are: benzalkonium chloride, disodium edetate, sodium chloride, sodium hydroxide and/or 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 or slightly yellow solution supplied in a 5 ml DROPTAINER bottle (LDPE) with a dropper (LDPE) and a cap (PP), packed in a cardboard box. The cardboard box contains one 5 ml bottle.
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in Greece, 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 3 Street
91-342 Łódź
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56 Street
02-234 Warsaw
Pharma Innovations Sp. z o.o.
Jagiellońska 76 Street
03-301 Warsaw
Laboratorium Galenowe Olsztyn Sp. z o.o.
Spółdzielcza 25A Street
11-001 Dywity
Synoptis Industrial Sp. z o.o.
Szosa Bydgoska 58 Street
87-100 Toruń
IVA Pharm Sp. z o.o.
Drawska 14/1 Street
02-202 Warsaw
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Marketing authorisation number in Greece, country of export: 8579/6-2-2007
Parallel import authorisation number: 296/21