Tilaprox

Package leaflet: Information for the patient

Tilaprox, 50 micrograms/ml + 5 mg/ml, eye drops, solution
Latano­prost + Timolol
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Tilaprox is and what it is used for
2. What you need to know 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 Tilaprox is and what it is 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-blockers. Latanoprost works by increasing the outflow of fluid from the eyeball into the bloodstream. Timolol works by reducing the amount of fluid produced in the eye.

Tilaprox is used to lower intraocular pressure in patients with open-angle glaucoma or those with elevated intraocular pressure. Both conditions are associated with increased intraocular pressure and may affect vision. Your doctor will usually recommend Tilaprox if other treatments have not been sufficiently effective.

2. Important information before using Tilaprox

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

When not to use Tilaprox

• if the patient is allergic (hypersensitive) to latanoprost or timolol, beta-blockers, or any of the other ingredients of this medicine (listed in section 6).
• if the patient has or has previously had respiratory disorders such as asthma, severe chronic obstructive pulmonary disease (a serious lung condition that may cause wheezing, difficulty breathing, and/or long-term cough).
• if the patient has severe heart disorders or cardiac rhythm disturbances.

Warnings and precautions
Before starting treatment with Tilaprox, consult your doctor or pharmacist if the patient has or has previously had:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or angina)
• heart function disorders, such as slow heart rate
• breathing problems, asthma, or chronic obstructive pulmonary disease (COPD)
• circulatory disorders (such as Raynaud's disease or Raynaud's syndrome)
• diabetes, because timolol may mask subjective and objective symptoms of low blood glucose
• hyperthyroidism, because timol0l may mask its subjective and objective symptoms
• planned eye surgery (including cataract surgery), or if such surgery has previously occurred
• eye problems (such as eye pain, eye irritation, eye inflammation, or blurred vision)
• dry eye syndrome
• contact lens use. Tilaprox may still be used, but the recommendations for contact lens wearers provided in section 3 must be followed
• angina pectoris (especially a type called Prinzmetal's angina)
• severe allergic reactions that usually require hospital treatment
• viral eye infection caused by herpes simplex virus (HSV).

Before any planned surgery, inform the doctor that the patient is using Tilaprox, because timolol may affect the action of certain drugs used during anesthesia.

Tilaprox and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, including eye drops, even those obtained without a prescription, as well as any medicines the patient plans to take.
Tilaprox may affect the action of other medicines used by the patient, including other eye drops used in glaucoma treatment, or these medicines may interfere with the action of Tilaprox. Inform the doctor if the patient is using or plans to use medicines that lower blood pressure, heart medications, or diabetes medications.
Inform your doctor or pharmacist especially if the patient is using a medicine belonging to any of the following groups:

• Medicines used to treat high blood pressure, such as oral calcium channel blockers, guanethidine, antiarrhythmic drugs, digitalis glycosides, or parasympathomimetics
• Prostaglandins, analogs or derivatives of prostaglandins
• Epinephrine
• Beta-blockers (used to treat high blood pressure)
• Quinidine (used to treat heart disorders and certain types of malaria)
• Antidepressants such as fluoxetine, paroxetine

Tilaprox with food and drink
Eating regular meals, food, or drinks does not affect when or how to use Tilaprox.

Pregnancy, breastfeeding, and fertility

Pregnancy
Do not use Tilaprox during pregnancy unless your doctor considers it necessary.

Breastfeeding
Do not use Tilaprox if the patient is breastfeeding. Timolol and latanoprost may pass into breast milk.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Effect on fertility
Animal studies have shown no effect of latanoprost and timolol on fertility in males or females.

Driving and using machines
After instilling eye drops, transient visual disturbances may occur. If the patient experiences blurred vision—especially immediately after instillation of Tilaprox—driving and operating machinery should be avoided until such symptoms resolve.

Tilaprox contains benzalkonium chloride:
Tilaprox contains 0.2 mg of benzalkonium chloride per millilitre.
Benzalkonium chloride may be absorbed by soft contact lenses and may change their colour. Contact lenses should be removed before instilling the medicine, and at least 15 minutes should elapse before reinserting them.
Benzalkonium chloride may also cause eye irritation, particularly in patients with dry eye syndrome or corneal disorders (the transparent front layer of the eye). If abnormal eye sensations, stinging, or eye pain occur after using the medicine, contact a doctor.

Tilaprox contains phosphate buffers:
The medicine contains 6.31 mg of phosphates per millilitre, equivalent to 0.2 mg per drop.
In patients with severe damage to the transparent front part of the eye (cornea), phosphates may very rarely cause corneal calcification (clouding of the cornea due to calcium accumulation) during treatment.

3. How to use Tilaprox

This medicine should always be used as directed by the doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Unless otherwise directed by the doctor, the recommended dose of Tilaprox is:
Adults, including elderly patients: one drop in each affected eye once daily.
Tilaprox should not be used more than once a day, as this may reduce
the effectiveness of treatment.
Tilaprox should be used as directed by the doctor, who will decide when treatment should be
discontinued.
If the patient is using Tilaprox, the doctor may recommend additional examinations of the heart and
circulatory system.
If the patient is using other eye drops in addition to Tilaprox, they should be administered at least
5 minutes apart.
Use of contact lenses
If the patient wears contact lenses, they should be removed before using Tilaprox. After
administering Tilaprox, wait 15 minutes before reinserting contact lenses.
Instructions for use:

1. Wash your hands and assume a comfortable sitting or standing position.
2. Unscrew the outer protective cap from the bottle.
3. Gently pull down the lower eyelid of the affected eye with the fingertip.
4. Hold the top part of the dropper close to the eye, without touching the eye. Gently squeeze the bottle so that one drop falls into the eye. Be sure not to squeeze the bottle too hard, to ensure that no more than one drop enters the eye.
5. Then release the lower eyelid.
6. After administering Tilaprox, press with a finger on the inner corner of the eye near the nose for 2 minutes. This helps prevent absorption of latanoprost and timolol into the body. To administer in the second eye, if prescribed by the doctor, repeat all steps. If the drop did not enter the eye, instill a second drop.
7. Close the bottle.

Use of a higher than recommended dose of Tilaprox
If more drops than recommended are administered, mild eye irritation, tearing, and
eye redness may occur. These symptoms should resolve, but if the patient is concerned, they should
contact their doctor for advice.
Accidental swallowing of Tilaprox by the patient
If Tilaprox is accidentally swallowed, contact a doctor. In case of swallowing a large amount of Tilaprox eye drops, symptoms such as malaise, abdominal pain, fatigue, facial flushing, dizziness, and sweating may occur.
Missed dose of Tilaprox
If the patient forgets to use the drops, continue treatment by administering the next
scheduled dose at the usual time.
Do not use a double dose to make up for a missed dose. If you have any further doubts about using this medicine, consult your
doctor or pharmacist.
Stopping use of Tilaprox
Do not stop or discontinue use of Tilaprox without first consulting your
doctor.
If the patient does not use the medicine regularly or frequently forgets to use it, the treatment outcome may be uncertain.
Elevated intraocular pressure (pressure inside the eyeball) can damage the optic nerve and lead to worsening vision. Blindness may occur. Usually, the patient will not notice any symptoms of elevated intraocular pressure. The condition can only be confirmed by an examination performed by an ophthalmologist. If the patient has elevated intraocular pressure, regular eye examinations, including measurement of intraocular pressure, are necessary. Intraocular pressure should be measured at least once every three months. Visual field testing and optic nerve examination should be performed at least once a year.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Eye drops are usually continued until adverse reactions are not serious. If in doubt, consult a doctor or pharmacist.
Do not stop treatment with Tilaprox without consulting your doctor. The symptoms listed below are known adverse reactions occurring after using eye drops containing the active substances latanoprost and timolol. The most important possible adverse reaction is a gradual, permanent change in eye colour. Eye drops containing the active substances latanoprost and timolol may also cause serious changes in heart function. If a patient notices changes in heart rhythm or heart function, they should contact their doctor and inform them about using Tilaprox.

Possible adverse reactions are listed below according to their 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 colour due to increased amount of brown pigment in the coloured part of the eye called the iris. This change is observed more frequently in people with mixed-colour eyes (e.g. blue-brown, grey-brown, yellow-brown or green-brown) than in people with uniformly coloured eyes (blue, grey, green or brown). Changes in eye colour may develop over many years. The colour change may be permanent and more noticeable if the patient uses Tilaprox in only one eye. The eye colour change appears not to be associated with any problems. The change in eye colour does not progress after stopping treatment with Tilaprox.

Common:

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

Uncommon:

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

Other adverse reactions
As with other medicines used in the eye, Tilaprox (latanoprost with timolol) is absorbed into the bloodstream. The frequency of adverse reactions after using eye drops is lower than with medicines taken orally or intravenously.
The following adverse reactions have not been reported specifically with Tilaprox, but have occurred with the individual components of this medicine (latanoprost and timolol), and therefore may also occur with Tilaprox. Among these adverse reactions are also those observed during use of beta-blockers (e.g. timolol) in the treatment of eye diseases:

• Viral eye infection caused by herpes simplex virus (HSV)
• General allergic reactions including swelling beneath the skin surface, which may occur in the face or limbs and may obstruct airflow, causing difficulty in swallowing and breathing, urticaria or itchy rash, localised and generalised rash, pruritus, severe cases of life-threatening acute allergic reactions.
• Low blood sugar levels
• 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), tingling or numbness, and headache.
• Swelling of the back of the eye (macular oedema), development of fluid-filled cysts in the iris (iris cysts), light sensitivity (photophobia), changes in the eye socket and eyelids leading to deepening of the eyelid groove.
• Eye irritation symptoms (burning, stinging, itching, tearing, redness), eyelid inflammation, corneal inflammation, blurred vision, and choroidal detachment following filtration surgery, which may lead to visual disturbances, reduced corneal sensitivity, dry eyes, corneal erosion (defects in the outer surface of the eyeball), eyelid drooping (causing eyes to be half-closed), double vision.
• Darkening of the skin around the eyes, abnormally directed eyelashes and fine hairs around the eyes (increased amount, length, thickness, darkening), change in the direction of eyelash growth, swelling around the eyes, swelling of the coloured part of the eye - the iris (iritis and/or uveitis), cicatrising conjunctivitis.
• Ringing in the ears (tinnitus).
• Painful shortness of breath, worsening of painful shortness of breath in patients with heart disease.
• Slowed heart rate, chest pain, palpitations (awareness of heartbeat), oedema (fluid accumulation), disturbances in heart rhythm and rate, congestive heart failure (a condition characterised by shortness of breath and swelling of feet and legs due to fluid accumulation), arrhythmia, heart attack, heart failure.
• Decreased blood pressure, poor circulation causing numbness (Raynaud's phenomenon) and paleness of fingers and toes, sensation of cold hands and feet.
• Asthma, worsening of asthma, shortness of breath, narrowing of airways in the lungs (mainly in patients with pre-existing conditions), difficulty breathing, cough.
• Nausea (uncommon), vomiting (uncommon), taste disturbances, diarrhoea, indigestion, dry mouth sensation, abdominal pain.
• Hair loss, skin rash with white-silvery appearance (psoriasis-like) or worsening of psoriasis symptoms, skin rash.
• Joint pain, muscle pain not caused by physical exertion, muscle weakness, fatigue.
• Sexual dysfunction, decreased libido.

In very rare cases, some patients with severe damage to the transparent layer at the front of the eye (cornea) developed corneal cloudiness due to calcium deposits during treatment.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the 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 .
Adverse reactions can also be reported to the marketing authorisation holder or its representative in Poland.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Tilaprox

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle label and carton
after: Expiry date (EXP). The expiry date refers to the last day of the stated month.
The batch number follows the abbreviation "Lot".
The following storage instructions must be observed:
Unopened bottle: store in the refrigerator at a temperature between 2°C and 8°C.
After first opening the bottle: do not store at temperatures above 25°C.
After opening, the bottle should be discarded after 4 weeks, even if there is still unused medicine remaining.
Otherwise, there is a risk of eye infection.
Medicines must not be disposed of via sewers or household waste bins. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Tilaprox contains

• The active substances in this medicinal product are latanoprost and timolol maleate. 1 ml of eye drops contains 50 micrograms of latanoprost and 6.8 mg of timolol maleate, equivalent to 5 mg of timolol.
• Other components are: 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, colourless solution packed in a transparent bottle with a dropper, protected by a cap.
Tilaprox is available in the following pack sizes:
1 bottle with dropper containing 2.5 ml of eye drops.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa Street 13D, loc. 27
01-909 Warsaw
Poland

Manufacturer:
ROMPHARM Company SRL
Eroilor Street, no. 1A
Otopeni 075100, Ilfov district
Romania