Betoptic S

Package Leaflet: Information for the User

BETOPTIC S

2.5 mg/ml, eye drops, suspension
Betaxolol

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet:

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

1. What Betoptic S is and what it is used for

Betoptic S 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. Excessive pressure in the eye can damage vision.
Betoptic S belongs to a group of medicines called beta-adrenergic blockers used in glaucoma. 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 S

When not to use Betoptic S

• if you are allergic to betaxolol or any of the other ingredients of this medicine (listed in section 6).
• if you have heart disease, such as heart failure, bradycardia (slow heart rate), sick sinus syndrome, sinoatrial block, atrioventricular block of degree II or III not controlled with a pacemaker or cardiogenic shock
• if you have respiratory problems, such as severe asthma or 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 S, discuss with your doctor or pharmacist if you 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 symptoms of heart failure occur, the doctor will decide whether to discontinue Betoptic S;
• angle-closure glaucoma. Betoptic S should not be used as monotherapy in such cases;
• breathing 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);
• local or severe allergic reactions. The patient may be more sensitive to exposure to allergens. If a severe allergic reaction occurs during treatment with Betoptic S (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 taking any other treatment, the doctor should be informed about the use of Betoptic S.

If you are scheduled for surgery, inform your doctor about the use of Betoptic S, as betaxolol may affect the effectiveness of certain medicines used during anesthesia.
If you have corneal disease, consult your doctor, as Betoptic S may cause dry eyes.
If you have had glaucoma surgery, consult your doctor before starting treatment with Betoptic S.

Betoptic S and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Betoptic S may affect the action of other medicines taken at the same time, and other medicines may affect the action of Betoptic S. These include:

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

If using other eye drops or ointments, wait at least 5 minutes between administering different medicinal products. Eye ointments should be administered last.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Do not use Betoptic S if you are pregnant, unless your doctor considers it necessary.
Do not use Betoptic S if you are breastfeeding. Betaxolol passes into human milk.

Driving and using machines

Betoptic S has no or negligible influence on the ability to drive and use machines. However, like other eye products, Betoptic S may cause temporary blurred vision or other visual disturbances, which may affect the ability to drive or use machines. If you experience blurred vision after administering the eye drops, do not drive or use machines until your vision is clear.

Betoptic S 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. Remove contact lenses before administering the eye drops and wait at least 15 minutes before putting them back.
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 you experience abnormal sensations in the eye, stinging, or eye pain after using the medicine, consult your doctor.
During treatment, it may be necessary to perform a control examination of intraocular pressure. Follow the doctor's instructions.

3. How to use Betoptic S

Always use this medicine exactly as your doctor has told you.
If you are not sure, ask your doctor or pharmacist.
Your doctor will decide how long you should use Betoptic S.
Betoptic S is for eye use only.
Adults (including elderly patients)
The recommended dose of Betoptic S 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. Below is a detailed instruction for use. In some patients, stabilization of intraocular pressure may occur after several weeks of treatment with Betoptic S.
Use Betoptic S as directed by your doctor. If you are unsure, consult your doctor again.
If you are switching from another glaucoma medicine, on the first day, continue the previous treatment and add 2 drops of Betoptic S twice daily to the affected eye(s). The next day, discontinue the previous glaucoma medicine and continue with Betoptic S.
If you are switching from several glaucoma medicines used at the same time, follow the individual treatment schedule established by your doctor. The doctor will change the subsequent medicines at intervals of not less than one week.

Use in children and adolescents

Betoptic S is not intended for use in persons under 18 years of age.

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How to use the eye drops

• 1. Prepare the eye drop bottle 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, remove it 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 to create 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 S (picture 3).
• 11. After administering the eye drops, remove the finger holding 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, repeat the above steps for the second eye.
• 13. Immediately after use, tighten the bottle cap.
• 14. At the same time, use only one bottle of the medicine.

If the drop does not get into the eye, repeat the attempt to administer the drop correctly.

Using more Betoptic S than prescribed

If you accidentally administer more eye drops than prescribed, rinse your eyes thoroughly with warm water.
Do not administer the next drop earlier than the scheduled time for the next dose.
Possible symptoms of overdose include slow heart rate, low blood pressure, heart failure, and breathing difficulties.

Missing a dose of Betoptic S

If you miss a dose of Betoptic S, continue treatment by administering the next dose at the scheduled time. If it is almost time for the next dose, skip the missed dose and continue treatment according to the prescribed dosage schedule. Do nottake a double dose to make up for the missed dose.
If using other eye drops or ointments, wait at least 5 minutes between administering different medicinal products. Eye ointments should be administered last.
In case of accidental ingestion, consult a doctor.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Betoptic S can cause side effects, although not everybody gets them.
Usually, you can continue using the drops, as long as the side effects are not severe. If you are concerned, talk to your doctor or pharmacist. Do not stop using Betoptic S without consulting your doctor.
Eye drops containing beta-adrenergic blockers may be absorbed into the bloodstream. As a result, the same side effects may occur as with oral beta-adrenergic blockers.
The following side effects have been observed with Betoptic S.

• 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 eye surface with or without damage to the eye surface, conjunctivitis, blepharitis, visual disturbances, photophobia, eye pain, burning, and stinging of the eye, dry eye, decreased visual acuity, eyelid disorders, itching of the eye, discharge from the eye, eyelid papillae, eye inflammation, eye irritation, conjunctival disorders, eye swelling, redness of the eye
• General disorders: slow heart rate, fast heart rate, asthma, shallow breathing, nausea, rhinitis
• Rare side effects (may affect up to 1 in 1,000 people):
• Eye disorders: cataract
• General disorders: fainting, unpleasant taste, cough, rhinitis, skin inflammation, rash, low blood pressure, anxiety, decreased libido

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

• Frequency not known (cannot be estimated from the available data)
• Eye disorders: eyelid redness, detachment of the retina, 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 (heart disease 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, dyspepsia, diarrhea, dry mouth, abdominal pain, vomiting, hair loss, psoriasiform or exacerbation of psoriasis, muscle pain, sexual disorders, weakness, fatigue, insomnia, depression, nightmares, memory loss, hypoglycemia, heart failure.

As with other locally administered 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 topical application 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.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your 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,
Jerozolimskie Avenue 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, you can help provide more information on the safety of this medicine.

5. How to store Betoptic S

To prevent infections, the bottle should be discarded 4 weeks after it is first opened. Write the date of opening on the space provided below.
Opened:
Keep this medicine out of the sight and reach of children.
Store the packaging 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 pack and other information

What Betoptic S contains

• The active substance is betaxolol 2.5 mg (as betaxolol hydrochloride).
• The other ingredients are: sulfonated polystyrene, carbomer 974P, boric acid, mannitol, disodium edetate, benzalkonium chloride, N-laurylsarcosine, sodium hydroxide and/or hydrochloric acid (to adjust the pH), purified water.

What Betoptic S looks like and contents of the pack

Betoptic S is a liquid (white or off-white suspension) supplied in a 5 ml or 10 ml plastic bottle (DROPTAINER type) with a protected cap.
A cardboard box contains 1 bottle of 5 ml or 10 ml. In some countries, only certain pack sizes may be available.

Marketing authorization holder

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

Manufacturer

Alcon-Couvreur
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 package leaflet: