Tilaprox

Leaflet attached to the packaging: patient information

Tilaprox, 50 micrograms/ml + 5 mg/ml, eye drops, solution
Latanoprost+ Timolol

Read the 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 or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Tilaprox and what is it used for

Tilaprox contains two active substances: latanoprost and timolol. Latanoprost belongs to a group of medicines called prostaglandin analogues, and timolol belongs to a group of medicines called beta-adrenergic blockers.
Latanoprost works by increasing the outflow of fluid from the eye into the bloodstream. Timolol works by reducing the amount of fluid produced in the eye.
Tilaprox is used to reduce intraocular pressure in patients with open-angle glaucoma or increased intraocular pressure. Both conditions are associated with increased intraocular pressure and can affect vision quality. The doctor will usually prescribe Tilaprox if the action of other medicines has not been sufficient.

2. Important information before using Tilaprox

Tilaprox can be used in adult patients (including the elderly), but it is not recommended for use in patients under 18 years of age.

When not to use Tilaprox

• if the patient is allergic(hypersensitive) to latanoprost or timolol, beta-adrenergic blockers or any of the other ingredients of this medicine (listed in section 6).
• if the patient has respiratory disorders, such as asthma, severe, chronic obstructive pulmonary disease (severe lung disease that can cause wheezing, difficulty breathing, and/or prolonged coughing).
• if the patient has severe heart problems or heart rhythm disorders.

Warnings and precautions

Before starting to use Tilaprox, the patient should discuss with their doctor or pharmacist if they have or have had:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or choking), heart failure, low blood pressure
• heart function disorders, such as slow heart rate
• breathing problems, asthma, or chronic obstructive pulmonary disease
• circulatory disorders (such as Raynaud's disease or Raynaud's syndrome)
• diabetes, as timolol may mask the subjective and objective symptoms of low blood sugar
• hyperthyroidism, as timolol may mask its subjective and objective symptoms
• planned eye surgery (including cataract surgery), or if it has been performed in the past
• eye problems (such as eye pain, eye irritation, eye inflammation, or blurred vision)
• dry eye syndrome
• the patient wears contact lenses. However, Tilaprox can still be used, but the patient should follow the recommendations for contact lens wearers, given in section 3.
• angina pectoris (especially a type called Prinzmetal's angina)
• severe allergic reactions, which usually require hospital treatment
• herpes simplex virus (HSV) eye infection.

Before planned surgery, the patient should tell their doctor that they are using Tilaprox, as timolol may affect the action of certain medicines used during anesthesia.

Tilaprox and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, including eye drops, currently or recently, even those that are available without a prescription, as well as any medicines they plan to take.
Tilaprox may affect the action of other medicines the patient is taking, including other eye drops used to treat glaucoma, or these medicines may interfere with the action of Tilaprox. The patient should tell their doctor if they are taking or plan to take medicines that lower blood pressure, heart medicines, or diabetes medicines.
The patient should inform their doctor or pharmacist especially if they are taking a medicine belonging to any of the following groups:

• Medicines used to treat high blood pressure, such as oral calcium channel blockers, guanethidine, anti-arrhythmic medicines, digitalis glycosides, or parasympathomimetics,
• Prostaglandins, analogues, or derivatives of prostaglandins,
• Epinephrine,
• Beta-adrenergic blockers (used to treat high blood pressure)
• Quinidine (used to treat heart disorders and some types of malaria)
• Antidepressant medicines, such as fluoxetine, paroxetine.

Tilaprox with food and drink

Consuming standard meals, food, or drinks does not affect when or how to use Tilaprox.

Pregnancy, breastfeeding, and fertility

Pregnancy
Tilaprox should not be used during pregnancy, unless the doctor considers it necessary.
Breastfeeding
Tilaprox should not be used if the patient is breastfeeding. Timolol and latanoprost may pass into breast milk.
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.
Fertility
In animal studies, no effect of latanoprost and timolol on fertility in males or females has been found.

Driving and using machines

After administering the eye drops, temporary vision disturbances may occur. If the patient experiences blurred vision- especially immediately after administering Tilaprox - they should not drive or operate machines until this symptom subsides.

Tilaprox contains benzalkonium chloride:

Tilaprox contains 0.2 mg of benzalkonium chloride per milliliter.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. The patient should remove their contact lenses before using Tilaprox and wait at least 15 minutes before putting them back on.
Benzalkonium chloride may also cause eye irritation, especially in patients 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.

Tilaprox contains phosphates:

The medicine contains 6.31 mg of phosphates per milliliter, which corresponds to 0.2 mg per drop.
In patients with severe damage to the transparent, front part of the eye (cornea), phosphates may rarely cause corneal clouding due to calcium deposition during treatment.

3. How to use Tilaprox

This medicine should always be used exactly as the doctor or pharmacist has told the patient. If the patient is not sure, they should ask their doctor or pharmacist.
Unless the doctor has told the patient otherwise, the recommended doseof Tilaprox is:
Adults, including the elderly: one drop into each affected eye once daily.
Tilaprox should not be used more than once daily, as this may reduce the effectiveness of the treatment.
Tilaprox should be used as directed by the doctor, who will decide when to stop the treatment.
If the patient is using Tilaprox, the doctor may recommend additional heart and circulatory system tests.
If the patient is using other eye drops in addition to Tilaprox, they should be used at intervals of at least 5 minutes.

Using contact lenses

If the patient wears contact lenses, they should remove them before using Tilaprox. After using Tilaprox, they should wait 15 minutes before putting their contact lenses back on.
Method of use:

• 1. Wash hands and sit or stand in a comfortable position.
• 2. Remove the protective outer cap from the bottle.
• 3. Gently pull the lower eyelid of the affected eye down.
• 4. Hold the upper part of the dropper close to the eye, without touching it. Gently squeeze the bottle to release one drop into the eye. Make sure not to squeeze the bottle too hard, so that only one drop gets into the eye.
• 5. Release the lower eyelid.
• 6. After using Tilaprox, press the corner of the eye near the nose with a finger for 2 minutes. This will help prevent latanoprost and timolol from being absorbed into the body. To administer the drop to the other eye, if prescribed by the doctor, repeat all the steps. If the drop does not get into the eye, administer a second drop.
• 7. Close the bottle.

Using a higher dose of Tilaprox than recommended

If more drops are administered than recommended, mild eye irritation and tearing, as well as eye redness, may occur. These symptoms should subside, but if the patient is concerned, they should consult their doctor for advice.

Accidental ingestion of Tilaprox

In case of accidental ingestion of Tilaprox, the patient should contact their doctor. If a large amount of eye drops is ingested, the patient may experience malaise, stomach pain, fatigue, facial flushing, and dizziness.

Missing a dose of Tilaprox

If the patient forgets to use the drops, they should continue with the next planned dose at the usual time.
Do notuse a double doseto make up for a missed dose. If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

Stopping the use of Tilaprox

The patient should not stop or discontinue using Tilaprox without first consulting their doctor.
If the patient does not use the medicine regularly or often forgets to use it, the treatment outcome may be uncertain.
Increased intraocular pressure (pressure inside the eye) can cause damage to the optic nerve and impair vision. Blindness may occur. Usually, the patient will not notice any symptoms of increased intraocular pressure. The disease can only be confirmed by an eye examination performed by an ophthalmologist. If the patient has increased intraocular pressure, regular eye examinations, combined with intraocular pressure measurements, are necessary. Intraocular pressure should be measured at least every three months. Visual field tests and optic nerve examinations should be performed at least once a year.
If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Tilaprox can cause side effects, although not everybody gets them.
Eye drops can usually be used until the side effects are not serious. In case of doubts, the patient should consult their doctor or pharmacist. The patient should not stop using Tilaprox without consulting their doctor. The symptoms listed below are known side effects that occur after using eye drops containing the active substances latanoprost and timolol. The most important possible side effect is a gradual, permanent change in eye color. Eye drops containing the active substances latanoprost and timolol may also cause serious changes in heart function. If the patient notices changes in heart rhythm or heart function, they should contact their doctor and inform them that they are using Tilaprox.
Possible side effects are listed below by frequency of occurrence.
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people.

Very common:

• Gradual change in eye color, resulting from an increase in the amount of brown pigment in the colored part of the eye, called the iris. This change can be observed more frequently in people with mixed eye color (e.g., blue-brown, gray-brown, yellow-brown, or green-brown) than in people with single-colored eyes (blue, gray, green, or brown). The change in eye color may develop over many years. The change in eye color may be permanent and more noticeable if the patient uses Tilaprox only in one eye. It seems that the change in eye color is not related to the occurrence of any problems. The change in eye color does not progress after stopping the treatment with Tilaprox.

Common:

• Eye irritation (burning sensation, feeling of "sand under the eyelid", itching, stinging, or feeling of a foreign body in the eye), eye pain.

Uncommon:

• Headache.
• Eye redness, eye infection (conjunctivitis), blurred vision, tearing, eyelid inflammation, irritation, or damage to the eye surface.
• Skin rash or itching.

Other side effects

Like other eye medicines, Tilaprox (latanoprost with timolol) is absorbed into the bloodstream. The frequency of side effects after using eye drops is lower than with oral or intravenous medicines.
The following side effects, although not observed with Tilaprox, have been observed with the individual components of this medicine (latanoprost and timolol) and may also occur with Tilaprox. These side effects include those observed during the use of beta-adrenergic blockers (e.g., timolol) in the treatment of eye diseases:

• Occurrence of herpes simplex virus (HSV) eye infection
• General allergic reactions, including swelling under the skin, which can occur on the face, limbs, and can make breathing difficult, swallowing, and breathing, hives, or itchy rash, localized and generalized rash, itching, severe life-threatening allergic reactions
• Low blood sugar
• Dizziness
• Difficulty sleeping (insomnia), depression, nightmares, memory loss, hallucinations
• Feeling of impending fainting, stroke, reduced blood flow to the brain, worsening of myasthenia symptoms (muscle weakness and pain in patients), feeling of tingling or numbness, and headache
• Swelling of the back of the eye (macular edema), formation of fluid-filled spaces in the iris (iris cysts), sensitivity to light (photophobia), changes in the eye socket and eyelids resulting in deepening of the eyelid fold
• Symptoms of eye irritation (burning, stinging, itching, tearing, redness), eyelid inflammation, corneal inflammation, blurred vision, and retinal detachment following filtering surgery, which can cause vision disturbances, decreased corneal sensitivity, dry eye, corneal ulcers (defects in the outer surface of the eye), drooping eyelids (causing the eyes to be half-closed), double vision
• Darkening of the skin around the eyes, abnormally directed eyelashes and fine hairs around the eyes (increased number, length, thickness, darkening), change in the direction of eyelash growth, swelling around the eyes, swelling of the colored part of the eye - iris (iritis and/or uveitis), scarring conjunctivitis
• Ringing in the ears (tinnitus)
• Angina pectoris, worsening of angina pectoris in patients with heart disease
• Slow heart rate, chest pain, palpitations (awareness of heart rhythm), swelling (fluid accumulation), heart rhythm and rate disorders, congestive heart failure (a disease characterized by shortness of breath and swelling of the feet and legs due to fluid accumulation), heart rhythm disorders, heart attack, heart failure
• Decreased blood pressure, poor blood circulation manifested as numbness (Raynaud's phenomenon) and paleness of the fingers and toes, symptom of cold hands and feet
• Asthma, worsening of asthma, shortness of breath, narrowing of the airways in the lungs (usually in patients with pre-existing disease), difficulty breathing, coughing
• Nausea (uncommon), vomiting (uncommon), taste disorders, diarrhea, indigestion, dry mouth, stomach pain
• Hair loss, skin rash with a white-silver color (similar to psoriatic) or worsening of psoriasis symptoms, skin rash
• Joint pain, muscle pain not caused by physical exertion, muscle weakness, fatigue
• Sexual disorders, decreased libido

In very rare cases, in some patients with severe damage to the transparent, front part of the eye (cornea), cloudy spots on the cornea due to calcium deposition during treatment have been observed.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Tilaprox

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry datestated on the label and carton after EXP. The expiry date refers to the last day of the month.
The batch number is stated after the "Lot" abbreviation.

The following storage instructions should be followed:

Unopened bottle: store in a refrigerator at a temperature of 2°C to 8°C.
After opening the bottle: do not store above 25°C.
After opening the bottle, it should be discarded after 4 weeks, even if some medicine remains. Otherwise, there is a risk of eye infection.
Medicines should not be disposed of via wastewateror 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 Tilaprox contains

• The active substancesof Tilaprox are latanoprost and timolol maleate. 1 ml of eye drops contains 50 micrograms of latanoprost and 6.8 mg of timolol maleate, which corresponds to 5 mg of timolol.
• The other ingredientsare: sodium chloride, benzalkonium chloride, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, purified water, sodium hydroxide to adjust pH, and hydrochloric acid to adjust pH.

What Tilaprox looks like and contents of the pack

Tilaprox is a clear, colorless solution, packaged in a transparent bottle with a dropper, protected by a cap.
Tilaprox is available in the following packs:
1 bottle with a dropper, containing 2.5 ml of eye drops.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lok.27
01-909 Warsaw
Poland
Manufacturer:

ROMPHARM Company SRL

Eroilor Street, no.1A
Otopeni 075100, Ilfov district
Romania

Date of last revision of the leaflet: 10/2024