Bimatoprost + Timolol Genetic

Package Leaflet: Information for the User

Bimatoprost + Timolol Genetic, 0.3 mg/ml + 5 mg/ml, eye drops, solution
Bimatoprost + Timolol

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, pharmacist, or nurse.
• 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, pharmacist, or nurse. See section 4.

Contents of the Package Leaflet:

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

1. What is Bimatoprost + Timolol Genetic and what is it used for

Bimatoprost + Timolol Genetic contains two active substances (bimatoprost and timolol) that lower
eye pressure. Bimatoprost belongs to a group of medicines called prostamides, prostaglandin analogs.
Timolol belongs to a group of medicines called beta-blockers.
The eye contains a clear, watery fluid that nourishes the inside of the eye. The fluid is constantly drained from
the eye and replaced by newly produced fluid. If the fluid cannot be drained quickly enough, the pressure in the eye increases, which can eventually lead to vision damage (causing a disease called glaucoma). The action of Bimatoprost + Timolol Genetic
is to reduce fluid production and increase the amount of drained fluid. This leads to a decrease in intraocular pressure.
Bimatoprost + Timolol Genetic eye drops are used to treat high pressure in the eye in adults, including the elderly. High pressure can lead to glaucoma. The doctor will prescribe Bimatoprost + Timolol Genetic when the action of other eye drops containing beta-blockers or prostaglandin analogs is insufficient.

2. Important information before using Bimatoprost + Timolol Genetic

When not to use Bimatoprost + Timolol Genetic eye drops, solution

• if you are allergic to bimatoprost, timolol, beta-adrenergic blockers (beta blockers) or any of the other ingredients of this medicine (listed in section 6);
• if you have had or have a respiratory disease, such as asthma, severe chronic obstructive pulmonary disease (severe lung disease that can cause wheezing, difficulty breathing, and prolonged coughing);
• if you have heart diseases, such as slow heart rate, heart block, or heart failure.

Warnings and precautions

Before starting to use this medicine, you should discuss it with your doctor if you currently have or have had any of the following conditions:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or choking), heart failure, low blood pressure,
• heart rhythm disturbances, such as slow heart rate,
• breathing difficulties, asthma, or chronic obstructive pulmonary disease,
• circulatory disorders, such as Raynaud's disease or Raynaud's syndrome,
• overactive thyroid gland, as timolol may mask the signs and symptoms of thyroid disease,
• diabetes, as timolol may mask the signs and symptoms of low blood sugar,
• severe allergic reactions,
• liver or kidney disease,
• eye surface diseases,
• separation of one of the layers of the eyeball after surgery to lower eye pressure,
• known risk factors for macular edema (retinal edema leading to vision impairment), such as cataract surgery.

Before anesthesia for surgery, you should tell your doctor about using Bimatoprost + Timolol Genetic, as timolol may affect the action of some anesthetics.
Bimatoprost + Timolol Genetic may cause darkening and excessive growth of eyelashes, as well as darkening of the skin around the eye. Over time, it may also darken the color of the iris. These changes may be permanent. Changes may be more noticeable when treating only one eye. When Bimatoprost + Timolol Genetic comes into contact with the skin surface, it may cause hair growth.

Children and adolescents

Bimatoprost + Timolol Genetic should not be used in children and adolescents under 18 years of age.

Bimatoprost + Timolol Genetic and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Other medicines may affect the action of Bimatoprost + Timolol Genetic, and Bimatoprost + Timolol Genetic may affect the action of other medicines, including other eye drops used to treat glaucoma. You should tell your doctor about taking or planning to take medicines that lower blood pressure, heart disease medicines, diabetes medicines, quinidine (a medicine used for heart diseases or certain types of malaria), or medicines used to treat depression known as fluoxetine and paroxetine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine. You should not use Bimatoprost + Timolol Genetic during pregnancy unless your doctor advises you to.
You should not use Bimatoprost + Timolol Genetic during breastfeeding. Timolol may pass into breast milk.
Before taking any medicine during breastfeeding, ask your doctor for advice.

Driving and using machines

Bimatoprost + Timolol Genetic may cause blurred vision in some patients. Do not drive or operate machinery until the symptoms have resolved.

Bimatoprost + Timolol Genetic contains benzalkonium chloride

Bimatoprost + Timolol Genetic contains a preservative called benzalkonium chloride.
This medicine contains 0.15 mg of benzalkonium chloride in every 3 ml of solution, which corresponds to 0.05 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may change their color. Before instilling this medicine, remove contact lenses and wait 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 discomfort in the eye, stinging, or pain after using this medicine, contact your doctor.

Bimatoprost + Timolol Genetic contains phosphates

This medicine contains 2.88 mg of phosphates in every 3 ml of solution, which corresponds to 0.96 mg/ml.
(See section 4. Other side effects reported during the use of eye drops containing phosphates).

3. How to use Bimatoprost + Timolol Genetic

This medicine should always be used exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one drop into each eye that needs treatment, once a day, in the morning or evening. The medicine should be used every day at the same time.

Method of administration

Do not use the bottle if the seal on the bottle neck is broken before first use.

• 1. Wash your hands. Tilt your head back and look up (Fig.1).
• 2. Gently pull down the lower eyelid to form a small pocket (Fig.2).
• 3. Turn the bottle upside down and squeeze it to release one drop into each eye that needs treatment (Fig.3).
• 4. Release the lower eyelid and close your eye (Fig.4).
• 5. Without opening your eye, press the inner corner of the closed eye (near the nose) with your finger for 2 minutes. This will prevent Bimatoprost + Timolol Genetic from entering the body (Fig.5).

If the drop does not get into the eye, try again.
To avoid infections, do not touch the tip of the bottle to the eye or other surfaces. Immediately after use, replace the cap and tighten the bottle.

Using Bimatoprost + Timolol Genetic with other eye medicines

Wait at least 5 minutes between instilling Bimatoprost + Timolol Genetic and administering another eye medicine. Eye ointment or eye gel should be applied last.

Using more than the recommended dose of Bimatoprost + Timolol Genetic

It is unlikely that using more than the recommended dose of Bimatoprost + Timolol Genetic will cause serious harm. The next dose should be taken at the usual time. If you have any doubts, contact your doctor or pharmacist.

Missing a dose of Bimatoprost + Timolol Genetic

Do not take a double dose to make up for a missed dose.
If you miss a dose of Bimatoprost + Timolol Genetic, take a single drop as soon as you remember, and then continue using the medicine as planned.

Stopping the use of Bimatoprost + Timolol Genetic

To work properly, Bimatoprost + Timolol Genetic should be used every day.
If you have any further doubts about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Usually, you can continue using the eye drops if the side effects are not serious. If you are unsure, contact your doctor or pharmacist. Do not stop using Bimatoprost + Timolol Genetic without discussing it with your doctor.
The following side effects may occur when using Bimatoprost + Timolol Genetic (in both multi-dose and single-dose forms):
Very common side effects(may affect more than 1 in 10 people)
Eye disorders
redness.
Common side effects(may affect up to 1 in 10 people)
Eye disorders
burning sensation, itching, stinging, irritation of the conjunctiva (the transparent membrane covering the eye), sensitivity to light, eye pain, stickiness of the eye, dryness of the eye, feeling of a foreign body in the eye, minor damage to the surface of the eye (with or without inflammation), blurred vision,
redness and itching of the eyelids, hair growth around the eye, darkening of the eyelids, darker skin tone around the eyes, lengthening of eyelashes, eye irritation, excessive tearing, swelling of the eyelids, limited vision.
Other disorders
runny nose, headache.
Uncommon side effects(may affect up to 1 in 100 people)
Eye disorders
abnormal sensations in the eye, inflammation of the iris, swelling of the conjunctiva (the transparent layer of the eye), eyelid pain, eye fatigue, ingrown eyelashes, darkening of the iris, feeling of sunken eyes, displacement of the eyelid from the eye surface, darkening of the eyelashes.
Other disorders
shortness of breath.

Side effects with unknown frequency:

Eye disorders
macular edema (retinal edema leading to vision impairment), eye swelling, blurred vision, eye discomfort.
Other disorders
breathing difficulties / wheezing, symptoms of allergic reactions (swelling, redness of the eye, and skin rash), taste disturbances, dizziness, slow heart rate, high blood pressure, sleep disturbances, nightmares, asthma, hair loss, skin color changes (around the eyes), fatigue.
Other side effects have been observed in patients using eye drops containing timolol or bimatoprost, and may also occur when using Bimatoprost + Timolol Genetic. Like other ophthalmic beta-blockers, timolol may be absorbed into the systemic circulation. This may lead to similar side effects as when beta-adrenergic blockers are given orally or intravenously. The frequency of systemic side effects after eye drops is lower than after oral or intravenous administration. These side effects include those observed with bimatoprost and timolol when used to treat eye diseases:

• Severe allergic reactions with swelling and breathing difficulties, which can be life-threatening
• Low blood sugar
• Depression, memory loss, hallucinations
• Fainting, stroke, reduced blood flow to the brain, worsening of myasthenia (increased muscle weakness), feeling of tingling
• Reduced sensitivity of the eye surface, double vision, drooping eyelid, separation of one of the layers of the eyeball after surgery to lower eye pressure, inflammation of the eye surface, bleeding in the back of the eye (retinal bleeding), eye inflammation, frequent blinking
• Heart failure, irregular heartbeat or cardiac arrest, slowing or acceleration of heart rate, fluid accumulation (mainly water) in the body, chest pain
• Low blood pressure, swollen or cold hands, feet, and limbs due to narrowing of blood vessels
• Cough, worsening of asthma, worsening of chronic obstructive pulmonary disease (COPD)
• Diarrhea, abdominal pain, nausea and vomiting, indigestion, dry mouth
• Red, scaly skin changes, skin rash
• Muscle pain
• Decreased sex drive, sexual dysfunction
• Weakness
• Increased liver enzyme levels in blood tests

Other side effects reported with the use of eye drops containing phosphates
If the patient has severe damage to the transparent layer of the eyeball (cornea), phosphates may rarely cause the appearance of cloudy spots on the cornea due to calcium deposits during treatment.

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 of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
phone: 22 49-21-301
fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the Marketing Authorization Holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Bimatoprost + Timolol Genetic

Keep this medicine out of the sight and reach of children.
Do not use Bimatoprost + Timolol Genetic after the expiry date which is stated on the label of the bottle and on the carton after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
After opening, the solution may become contaminated, which can lead to eye infections. Therefore, the bottle should be discarded after 4 weeks from the first opening, even if there are still some solution left in it. To remember the opening date of the bottle, write it on the carton.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Bimatoprost + Timolol Genetic contains

• The active substances are bimatoprost 0.3 mg/ml and timolol 5 mg/ml (equivalent to 6.8 mg/ml timolol maleate).
• The other ingredients are benzalkonium chloride (preservative), sodium chloride, disodium phosphate heptahydrate, citric acid monohydrate, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injection.

What Bimatoprost + Timolol Genetic looks like and contents of the pack

Bimatoprost + Timolol Genetic is a colorless, clear solution supplied in a plastic bottle. Each pack contains 1 bottle with LDPE, with a dropper with LDPE, with a cap with PP, and a tamper-evident ring. Each bottle is filled to approximately half and contains 3 milliliters of solution. This amount of solution is sufficient for 4 weeks of use.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Genetic S.p.A.
Via G. Della Monica 26
84083 Castel San Giorgio (SA)
Italy

Manufacturer

Genetic S.p.A.
Contrada Canfora 84084 Fisciano (SA)
Italy
To obtain more detailed information, please contact the representative of the Marketing Authorization Holder:

Date of last revision of the package leaflet: 24.10.2024