Bimatoprost + Timolol Genetic

Package Leaflet: Information for the User

Bimatoprost + Timolol Genetic, 0.3 mg/ml + 5 mg/ml, eye drops, solution,
in a single-dose container
Bimatoprostum + Timololum

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

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

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

What is it used for
Bimatoprost + Timolol Genetic single-dose contains two active substances (bimatoprost and timolol) that lower intraocular 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 new 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 single-dose is to reduce the production of fluid and increase the amount of drained fluid. This leads to a decrease in intraocular pressure.
Bimatoprost + Timolol Genetic single-dose 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 single-dose when the action of other eye drops containing beta-blockers or prostaglandin analogs is insufficient.

2. Important information before using Bimatoprost + Timolol Genetic single-dose

Contraindications

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

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

Warnings and precautions

Before starting to use this medicine, the patient should discuss it with their doctor if they 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 disorders, such as slow heart rate,
• breathing disorders, asthma, or chronic obstructive pulmonary disease,
• circulatory system disease, such as Raynaud's disease or Raynaud's syndrome,
• overactive thyroid gland, as timolol may mask the objective and subjective symptoms of thyroid disease,
• diabetes, as timolol may mask the objective and subjective symptoms of low blood sugar levels,
• 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, the patient should tell their doctor about using Bimatoprost + Timolol Genetic single-dose, as timolol may affect the action of some anesthetics.
Bimatoprost + Timolol Genetic single-dose 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. If Bimatoprost + Timolol Genetic single-dose comes into contact with the skin surface, it may cause hair growth.

Children and adolescents

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

Bimatoprost + Timolol Genetic single-dose and other medicines

Other medicines may affect the action of Bimatoprost + Timolol Genetic single-dose, and Bimatoprost + Timolol Genetic single-dose may affect the action of other medicines, including other eye drops used to treat glaucoma. The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient should tell their 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 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. Bimatoprost + Timolol Genetic single-dose should not be used during pregnancy, unless the doctor recommends otherwise.
Bimatoprost + Timolol Genetic single-dose should not be used during breastfeeding. Timolol may pass into breast milk.
Before taking any medicine during breastfeeding, the patient should consult their doctor.

Driving and using machines

Bimatoprost + Timolol Genetic single-dose may cause blurred vision in some patients. The patient should not drive vehicles or operate machines until the symptoms have resolved.

Bimatoprost + Timolol Genetic single-dose contains phosphates

This medicine contains 0.96 mg of phosphates in each ml of solution.
(See section 4. Other side effects reported during the use of eye drops containing phosphates).

3. How to use Bimatoprost + Timolol Genetic single-dose

This medicine should always be used exactly as the doctor or pharmacist has told the patient. In case of doubts, the patient should consult their 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

Before use, the patient should wash their hands. Before use, the patient should make sure that the single-dose container is intact. The solution should be used immediately after opening the container. To prevent contamination, the patient should not touch the open end of the container to the eye or anything else.

• 1. Tear off 1 single-dose container from the strip (Fig.1).
• 2. Holding the single-dose container vertically (with the closure facing upwards), twist the closure (Fig.2).
• 3. Gently pull down the lower eyelid, creating a small pocket. Turn the single-dose container upside down and squeeze it to release one drop into the treated eye (eyes) (Fig.3).
• 4. With the eye closed, press the inner corner of the eye (where the eye meets the nose) with a finger and hold for 2 minutes. This prevents the medicine from entering the rest of the body.
• 5. Discard the single-dose container after use, even if there is some solution left in it.

If the drop does not get into the eye, the patient should try again. The patient should wipe off any excess medicine that runs onto the cheek.

Patients wearing contact lenses

If the patient wears contact lenses, they should remove them before using this medicine. After using the medicine, the patient should wait 15 minutes before putting the lenses back in.

Using Bimatoprost + Timolol Genetic single-dose with other eye medicines

The patient should wait at least 5 minutes between instilling Bimatoprost + Timolol Genetic single-dose and administering another medicine. Eye ointment or eye gel should be applied last.

Using a higher dose of Bimatoprost + Timolol Genetic single-dose than recommended

In case of using a higher dose of Bimatoprost + Timolol Genetic single-dose than recommended, it is unlikely to cause serious harm.
The next dose should be taken at the usual time. In case of doubts, the patient should consult their doctor or pharmacist.

Missing a dose of Bimatoprost + Timolol Genetic single-dose

In case of missing a dose of Bimatoprost + Timolol Genetic single-dose, the patient should take a single drop as soon as they remember, and then continue using the medicine as planned. The patient should not take a double dose to make up for the missed dose.

Stopping the use of Bimatoprost + Timolol Genetic single-dose

To work properly, Bimatoprost + Timolol Genetic single-dose should be used every day.
In case of any further doubts about using this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Usually, the patient can continue using the eye drops if the side effects are not severe. In case of doubts, the patient should consult their doctor or pharmacist. The patient should not stop using Bimatoprost + Timolol Genetic single-dose without consulting their doctor.
The following side effects may occur during the use of 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, elongation 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 membrane of the eye), eyelid pain, eye fatigue, ingrown eyelashes, darkening of the iris, feeling of sunken eyes, eyelid margin abnormality, darkening of eyelashes.
Other disorders
shortness of breath.

Side effects with unknown frequency:

Eye disorders
cystoid 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 disorders, dizziness, slow heart rate, high blood pressure, sleep disorders, 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 therefore occur when using Bimatoprost + Timolol Genetic. Like other ophthalmic beta-blockers, timolol may become systemic and cause similar side effects as seen with systemic beta-adrenergic blockade. The frequency of systemic side effects after topical ophthalmic administration is lower than for systemic administration. These side effects include:

• Severe allergic reactions with swelling and breathing difficulties, which can be life-threatening
• Low blood sugar levels
• Depression, memory loss, hallucinations
• Fainting, stroke, reduced blood flow to the brain, worsening of myasthenia (increased muscle weakness), feeling of tingling
• Decreased sensitivity of the eye surface, double vision, drooping eyelid, detachment 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 hemorrhage), 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 disorders
• Weakness
• Increased liver function test results

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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should consult 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
tel.: 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 single-dose

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the single-dose container, sachet, and carton after "Exp". The expiry date refers to the last day of the month.
This medicine is for single use only and does not contain preservatives. Do not store unused solution.
There are no special storage instructions for this medicine. Single-dose containers should be stored in the sachet and carton to protect from light. Shelf life after first opening of the sachet - 7 days.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Bimatoprost + Timolol Genetic single-dose 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: sodium chloride, disodium phosphate heptahydrate, citric acid monohydrate, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injections.

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

Bimatoprost + Timolol Genetic single-dose is a colorless, clear solution supplied in single-dose containers containing 0.4 ml of solution.
Packs contain 6 foil sachets, each containing 5 single-dose containers – a total of 30 single-dose containers.

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, the patient should contact the representative of the marketing authorization holder:

Date of last revision of the leaflet: 24.10.2024