Travoprost+timolol Genoptim

Leaflet attached to the packaging: patient information

Travoprost + Timolol Genoptim, 40 micrograms/ml + 5 mg/ml, eye drops, solution

Travoprost + Timolol

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• 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 or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Travoprost + Timolol Genoptim and what is it used for
• 2. Important information before using Travoprost + Timolol Genoptim
• 3. How to use Travoprost + Timolol Genoptim
• 4. Possible side effects
• 5. How to store Travoprost + Timolol Genoptim
• 6. Package contents and other information

1. What is Travoprost + Timolol Genoptim and what is it used for

Travoprost + Timolol Genoptim eye drops, solution is a combination of two active substances - travoprost and timolol. Travoprost is a prostaglandin analogue that works by increasing the outflow of fluid from the eye, which lowers its pressure. Timolol is a beta-adrenergic receptor blocker that works by reducing the production of fluid inside the eye. Both substances work together to lower the pressure inside the eye.
Travoprost + Timolol Genoptim eye drops, solution is used to treat high pressure in the eye in adults, including the elderly. This pressure can lead to the development of glaucoma.

2. Important information before using Travoprost + Timolol Genoptim

When not to use Travoprost + Timolol Genoptim

• if the patient is allergic to travoprost, timolol or any of the other ingredients of this medicine (listed in section 6),
• if the patient has been diagnosed with an allergy to prostaglandins or beta-adrenergic receptor blockers,
• if the patient has or has had respiratory problems such as asthma, severe chronic obstructive pulmonary disease [a serious lung disease that can cause wheezing, difficulty breathing, and/or chronic cough] or other types of breathing difficulties,
• if the patient has severe hay fever,
• if the patient has a slow heart rate, heart failure or irregular heartbeat (irregular heartbeat),
• if the patient's eye surface is cloudy.

If any of the above conditions apply to the patient who has been prescribed Travoprost + Timolol Genoptim, they should consult a doctor.

Warnings and precautions

Before starting to use Travoprost + Timolol Genoptim, the patient should discuss with their doctor if they have or have had any of the following conditions:

• ischemic heart disease (symptoms may include chest pain or feeling of pressure in the chest, difficulty breathing, shortness of breath), heart failure, low blood pressure,
• irregular heartbeats such as slow heartbeat,
• breathing difficulties, asthma or chronic obstructive pulmonary disease,
• diseases characterized by impaired blood circulation (such as Raynaud's disease or Raynaud's syndrome),
• diabetes, as timolol may mask the symptoms of low blood sugar,
• hyperthyroidism, as timolol may mask the objective and subjective symptoms of thyroid disease,
• if the patient has myasthenia gravis (a chronic neuromuscular weakness),
• if the patient has undergone cataract surgery,
• if the patient has or has had eye inflammation.

Before planned surgery, the patient should inform their doctor about the use of Travoprost + Timolol Genoptim, as timolol may affect the action of certain medications used during anesthesia.
If the patient experiences any severe allergic reaction (rash, redness and itching of the eye) while using Travoprost + Timolol Genoptim, treatment with adrenaline may not be effective enough. Therefore, when using any other treatment, the patient should inform their doctor about the use of Travoprost + Timolol Genoptim.
Travoprost + Timolol Genoptim may change the color of the iris (the colored part of the eye); this change may be permanent.
Travoprost + Timolol Genoptim may increase the length, thickness, color and/or number of eyelashes and may cause abnormal hair growth on the eyelids.
Travoprost may be absorbed through the skin and therefore should not be used by pregnant or breastfeeding women. If any amount of the medicine gets on the skin, it should be washed off immediately.

Children and adolescents

Travoprost + Timolol Genoptim is not intended for use in children and adolescents under 18 years of age.

Travoprost + Timolol Genoptim and other medicines

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, including those available without a prescription.
Travoprost + Timolol Genoptim may affect the action of other medicines taken at the same time or other medicines may affect the action of Travoprost + Timolol Genoptim; this also applies to other medicines used to treat glaucoma.
The patient should inform their doctor about taking or planning to take the following medicines:

• blood pressure-lowering medicines,
• medicines used to treat heart diseases (including quinidine, used to treat heart diseases and some forms of malaria),
• anti-diabetic or antidepressant medicines such as fluoxetine and paroxetine.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
Travoprost + Timolol Genoptim should not be used in pregnant women unless the doctor considers it necessary. If the patient is of childbearing age, they should use appropriate contraceptive methods while using this medicine.
Travoprost + Timolol Genoptim should not be used in breastfeeding women. Travoprost + Timolol Genoptim may pass into breast milk.

Driving and using machines

For some time after using Travoprost + Timolol Genoptim, vision may be blurred.
Travoprost + Timolol Genoptim may also cause hallucinations, dizziness, nervousness or fatigue in some patients.
Until these symptoms have resolved, the patient should not drive or operate machinery.

Travoprost + Timolol Genoptim contains benzalkonium chloride

This medicine contains 150 micrograms of benzalkonium chloride per ml of solution.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. The patient should remove contact lensesbefore using the drops and wait at least 15 minutes before putting them back on.
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 the patient experiences any abnormal sensations in the eye, stinging or eye pain after using the medicine, they should contact their doctor.

Travoprost + Timolol Genoptim contains macrogolglycerol hydroxystearate 40

This medicine contains macrogolglycerol hydroxystearate 40, which may cause skin reactions.

3. How to use Travoprost + Timolol Genoptim

This medicine should always be used exactly as prescribed by the doctor. If the patient has any doubts, they should consult a doctor or pharmacist.

Recommended dose

One drop into the eye or eyes, once a day - in the morning or evening. The medicine should be used every day at the same time.
Travoprost + Timolol Genoptim can be used in both eyes only if the doctor recommends it.
Travoprost + Timolol Genoptim should be used only as eye drops.

Instructions for use

• Immediately before the first use of the bottle, open the sachet, remove the bottle

( Figure 1) and write the opening date in the designated place on the label.

• Prepare the Travoprost + Timolol Genoptim bottle and a mirror.
• Wash your hands.
• Remove the cap.

Fig. 1

• Holding the bottle upside down between the thumb and fingers.
• Tilt your head back. With a clean finger, pull the lower eyelid down to create a "pocket"; the drop should fall into it ( Figure 2).
• Bring the tip of the bottle close to the eye. For convenience, you can use a mirror.

Fig. 2

• Do not touch the dropper to the eye or eyelid, or surrounding areas.Touching may lead to infection of the drops.
• Gently squeeze the bottom of the bottle to release a single drop of Travoprost + Timolol Genoptim ( Figure 3). If the drop does not fall into the eye,

Fig. 3

repeat the attempt to administer the drop.

Fig. 4

After administering the drop, press the corner of the eye at the base of the nose with your finger for 2 minutes (Figure 4). This will help prevent the medicine from entering the entire body. If using drops in both eyes, repeat the procedure described above in the second eye. Immediately after use, screw the bottle cap back on. Use only one bottle at a time. Do not open the sachet until the next bottle is needed. Discard the bottle after 4 weeks from its first opening to prevent infection. Use a new bottle.

Travoprost + Timolol Genoptim should be used for as long as the doctor recommends.

Using more than the recommended dose of Travoprost + Timolol Genoptim

If more Travoprost + Timolol Genoptim has been used than the recommended dose, the eye should be rinsed with warm water. Do not administer more drops until the next scheduled dose.

Missing a dose of Travoprost + Timolol Genoptim

If a dose of Travoprost + Timolol Genoptim has been missed, the patient should continue using the medicine as usual. Do not use a double dose to make up for the missed dose. The dose of medicine administered to the affected eye (or eyes) should not exceed one drop per day.
If using other eye drops, the patient should wait at least 5 minutes between administering Travoprost + Timolol Genoptim and using other drops.
If the patient wears soft contact lenses, they should not use Travoprost + Timolol Genoptim while wearing contact lenses. After using the drops, the patient should wait 15 minutes before putting the lenses back on.
If the patient has any doubts about using the medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Travoprost + Timolol Genoptim can cause side effects, although not everybody gets them.
Usually, the patient can continue using the drops, unless the side effects are severe. If the patient is concerned, they should contact their doctor or pharmacist. The patient should not stop using Travoprost + Timolol Genoptim without consulting their doctor.

Very common side effects (may affect more than 1 in 10 people)

Eye symptoms: eye redness.

Common side effects (may affect up to 1 in 10 people)

Eye symptoms: inflammation of the eye surface with damage to the eye surface, eye pain, blurred vision, abnormal vision, dry eye, eye itching, eye discomfort, subjective and objective symptoms of eye irritation (e.g., burning, stinging).

Uncommon side effects (may affect up to 1 in 100 people)

Eye symptoms: inflammation of the eye surface, inflammation of the eyelids, swelling of the conjunctiva, increased eyelash growth, inflammation of the iris, eye inflammation, sensitivity to light, vision disturbances, eye fatigue, eye allergy, eye swelling, increased tear production, eyelid redness, change in eyelid color, darkening of the skin (around the eye).
General symptoms: allergy to the active substance, dizziness, headaches, increased or decreased blood pressure, shortness of breath, excessive hair growth, runny nose, skin rash and itching, slow heart rate.

Rare side effects (may affect up to 1 in 1000 people)

Eye symptoms: thinning of the eye surface, inflammation of the eyelid glands, rupture of blood vessels in the eye, crusts on the eyelid margins, abnormal eyelash position, abnormal eyelash growth.
General symptoms: nervousness, irregular heartbeat, hair loss, voice disorders, breathing difficulties, cough, throat irritation, chills, abnormal liver function test results, skin discoloration, increased thirst, fatigue, discomfort in the nose, urine discoloration, pain in the hands and feet.
Side effects with unknown frequency (frequency cannot be estimated from available data)
Eye symptoms: drooping eyelids (causing the feeling of half-closed eyes), sunken eyes (eyes appear more covered), changes in iris color (colored part of the eye).
General symptoms: rash, heart failure, chest pain, stroke, fainting, depression, asthma, increased heart rate, feeling of numbness or tingling, palpitations, swelling of the lower limbs, unpleasant taste in the mouth.

Additional information

Travoprost + Timolol Genoptim is a combination of two active substances. Travoprost and timolol (a beta-adrenergic blocker), like other eye medicines, are absorbed into the bloodstream. This may lead to similar side effects as those observed with intravenous or oral beta-adrenergic blockers. However, the frequency of side effects after local use in the eye is lower than with medicines given, for example, orally or by injection.
The following side effects have been observed in the entire group of beta-adrenergic blockers used in eye diseases.
Eye symptoms: eyelid inflammation, corneal inflammation, detachment of the layer under the retina, which contains blood vessels, which can cause vision disturbances, reduced corneal sensitivity, corneal ulceration (damage to the front layer of the eyeball), double vision, eye discharge, swelling around the eye, eyelid itching, eyelid eversion with redness, irritation and excessive tearing, blurred vision (a sign of cataract clouding), eye swelling, eyelid eczema, halo vision, reduced eye sensation, pigmentation inside the eye, dilated pupils, change in eyelash color, change in eyelash structure, abnormal eyelash growth.
General symptoms
Ear and labyrinth disorders:dizziness with a feeling of spinning, ringing in the ears.
Heart and blood vessels:slow heart rate, palpitations, edema (fluid retention), changes in heart rhythm and/or rate, congestive heart failure (heart disease with shortness of breath and/or swelling of the ankles and legs caused by fluid accumulation), arrhythmia, heart attack, low blood pressure, Raynaud's phenomenon, coldness of the hands and feet, reduced blood flow to the brain.
Respiratory system:bronchospasm in the lungs (mainly in patients with pre-existing disease), runny or stuffy nose, sneezing (due to allergy), breathing difficulties, nosebleeds, dry nose.
Nervous system and general disorders:insomnia (sleeplessness), nightmares, memory loss, hallucinations, loss of strength and energy, anxiety (excessive emotional stress).
Gastrointestinal system:taste disturbances, nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting and constipation.
Allergies:exacerbated allergic symptoms, generalized allergic reactions involving skin swelling on areas such as the face and limbs, which can cause respiratory tract obstruction and difficulty swallowing and breathing, localized or generalized rash, itching, severe and sudden life-threatening allergic reactions.
Skin:rash with a white-silver color (resembling psoriasis) or worsening of psoriasis, skin peeling, abnormal hair structure, skin inflammation with itchy rash and redness, hair color change, hair loss, itching, abnormal hair growth, skin redness.
Musculoskeletal system:worsening of objective and subjective symptoms of myasthenia gravis (a disease of muscle weakness), abnormal sensations such as tingling and numbness, muscle weakness, fatigue, muscle pain not caused by exercise, joint pain.
Kidney and urinary disorders:difficulty and pain when urinating, urinary incontinence.
Reproductive system:sexual dysfunction, decreased libido.
Metabolism:low blood sugar, increased prostate cancer marker.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or 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.: +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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Travoprost + Timolol Genoptim

Store out of sight and reach of children.
Do not use the medicine after the expiry date stated on the carton, sachet and bottle after: EXP. The expiry date refers to the last day of the month stated.
There are no special precautions for storage temperature.
Store the bottle in the sachet to protect it from light.
After first opening: there are no special precautions for storage.
To prevent infections, the bottle should be discarded after 4 weeks from its first openingand the medicine should be used from a new bottle. The opening date of each bottle should be written in the designated place on the bottle label and on the carton.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Travoprost + Timolol Genoptim contains

• The active substances of the medicine are: travoprost and timolol. Each ml of solution contains 40 micrograms of travoprost and 5 mg of timolol (as timolol maleate).
• Other ingredients: benzalkonium chloride, solution, macrogolglycerol hydroxystearate 40, trometamol, disodium edetate, boric acid, mannitol, sodium hydroxide (to adjust pH), purified water.

What Travoprost + Timolol Genoptim looks like and contents of the pack

Travoprost + Timolol Genoptim eye drops, solution is a clear, colorless, aqueous solution, practically free from particles, packaged in a 5 ml plastic bottle with a colorless dropper and a white, opaque cap with a tamper-evident seal.
Each bottle is placed in a sachet. Each bottle contains 2.5 ml of solution.
Packaging contains 1 or 3 bottles.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw

Manufacturer

Pharmathen SA
6 Dervenakion str.
15351 Pallini Attiki
Greece
Balkanpharma-Razgrad AD
68 Aprilsko vastanie Blvd.
7200 Razgrad
Bulgaria
JADRAN-GALENSKI LABORATORIJ d.d.
Svilno 20
51000 Rijeka
Croatia

Date of last revision of the leaflet: June 2025