Patient Information Leaflet

Travoprost + Timolol Genoptim, 40 micrograms/ml + 5 mg/ml, eye drops, solution
Travoprost + Timolol
Please read this leaflet carefully before using this medicine, because it contains
important information for you.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm another person, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

What Travoprost + Timolol Genoptim is and what it is used for
What you need to know before using Travoprost + Timolol Genoptim
How to use Travoprost + Timolol Genoptim
Possible side effects
How to store Travoprost + Timolol Genoptim
Contents of the pack and other information

1. What Travoprost + Timolol Genoptim is and what it is 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, thereby reducing intraocular pressure. Timolol is a beta-blocker that works by reducing the production of fluid inside the eye. Together, these two substances help lower intraocular pressure.
Travoprost + Timolol Genoptim eye drops are used to treat elevated intraocular pressure in adults, including elderly patients. This pressure may 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 a known allergy to prostaglandins or beta-adrenergic receptor blocking agents,
if the patient currently has or has previously had respiratory problems such as: asthma, severe chronic obstructive pulmonary disease [a serious lung condition that may cause wheezing, difficulty breathing, and (or) long-term 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 heart rhythm disorders (irregular heartbeat),
if the surface of the patient's eye is clouded.

If any of the conditions listed above apply to the patient prescribed Travoprost +
Timolol Genoptim, medical advice should be sought.
Warnings and precautions
Before starting treatment with Travoprost + Timolol Genoptim, discuss with the doctor if
the patient currently has or has ever had any of the following conditions:

ischemic heart disease (symptoms may include chest pain or pressure, difficulty breathing, shortness of breath), heart failure, low blood pressure,
heart rhythm disorders 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, because timolol may mask symptoms of low blood sugar,
hyperthyroidism, because timolol may mask subjective and objective symptoms of thyroid disease,
if the patient suffers from myasthenia gravis (a chronic neuromuscular weakness),
if the patient has undergone cataract surgery,
if the patient currently has or has had ocular inflammation.

Before planned surgery, inform the doctor about the use of Travoprost + Timolol
Genoptim, as timolol may alter the effects of certain drugs used during anesthesia.
If the patient experiences any severe allergic reaction (rash, redness, and itching of the eye), regardless of cause, while using Travoprost + Timolol Genoptim, treatment with adrenaline may not be sufficiently effective. Therefore, when receiving any other treatment, inform the 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 women or women planning to become pregnant. If any amount of the medicine comes into contact with 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
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines.
Travoprost + Timolol Genoptim may alter the effects of other concurrently administered medicines, or these medicines may alter the effect of Travoprost + Timolol Genoptim; this also applies to other medicines used in the treatment of glaucoma.
Inform the doctor if the patient is taking or plans to take any of the following medicines:

medicines that lower blood pressure,
medicines used to treat heart conditions (including quinidine, used in the treatment of heart conditions and certain forms of malaria),
antidiabetic medicines or antidepressants such as fluoxetine and paroxetine.

Pregnancy, breastfeeding, and fertility
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.
Travoprost + Timolol Genoptim must not be used during pregnancy unless the doctor considers it necessary. If the patient is of childbearing age, she should use appropriate contraceptive methods while using this medicine.
Travoprost + Timolol Genoptim must not be used during breastfeeding. Travoprost + Timolol Genoptim may pass into breast milk.
Driving and operating machinery
For a short time after instillation, vision may be blurred.
Travoprost + Timolol Genoptim may also cause hallucinations, dizziness, nervousness, or fatigue in some patients.
Until these symptoms subside, the patient must 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 adsorbed by soft contact lenses and may alter their color. Contact lenses must be removed before instillation and at least 15 minutes should be waited before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially in patients with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations in the eye, stinging, or eye pain occur after using the medicine, contact a 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 your doctor has told you. If you are unsure, consult your
doctor or pharmacist.
Recommended dose
One drop in the affected eye or eyes once daily – in the morning or evening. The medicine should be used
every day at the same time.
Travoprost + Timolol Genoptim may be used in both eyes only if instructed by your doctor.
Travoprost + Timolol Genoptim is for ophthalmic use only.
Instructions for use

Fig. 1	Immediately before first use, open the pouch and remove the bottle (Figure 1). Prepare the Travoprost + Timolol Genoptim bottle and a mirror. Wash your hands. Unscrew the cap.
Fig. 2	Hold the inverted bottle between your thumb and fingers. Tilt your head backward. With a clean finger, gently pull down the lower eyelid to create a "pocket" between the eyeball and eyelid—this is where the drop should be placed (Figure 2). Bring the dropper tip close to the eye. You may find it easier to use a mirror.
	Do not touch the dropper tip to the eye, eyelid, surrounding areas, or any other surface. Contact may contaminate the eye drops and lead to infection. Gently press the bottom of the bottle to release a single drop of Travoprost + Timolol Genoptim into the eye (Figure 3). If the drop misses the eye,
Fig. 3	repeat the instillation attempt.
Fig. 4	After instilling Travoprost + Timolol Genoptim, press with a finger on the inner corner of the eye near the nose for 2 minutes (Figure 4). This helps prevent the medicine from draining into the rest of the body. If using drops in both eyes, repeat the above steps for the second eye. Immediately after use, replace the cap on the bottle. Use only one bottle at a time. Do not open a new pouch until the next bottle is needed. Discard the bottle 4 weeks after first opening to prevent infection. Use a new bottle.

The Travoprost + Timolol Genoptim medication should be used for as long as your doctor recommends.
Using more than the recommended dose of Travoprost + Timolol Genoptim
If more Travoprost + Timolol Genoptim medication has been used than recommended, rinse the eyes with warm water. Do not administer any additional drops until it is time for the next scheduled dose.
Missing a dose of Travoprost + Timolol Genoptim
If a dose of Travoprost + Timolol Genoptim has been missed, continue treatment according to the normal dosing schedule. Do not use a double dose to make up for the missed dose. The dose administered to the affected eye(s) must not exceed one drop per day.
If other eye drops are being used, an interval of at least 5 minutes should be maintained between instillation of Travoprost + Timolol Genoptim and the application of other eye drops.
If the patient wears soft contact lenses, Travoprost + Timolol Genoptim should not be administered while the lenses are in place. After instilling the drop, wait 15 minutes before reinserting the contact lenses.
If in doubt about the use of this medication, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
You can usually continue using the drops unless the adverse effects are severe. If you have any concerns,
contact your doctor or pharmacist. Do not stop using Travoprost + Timolol Genoptim without consulting
your doctor.

Very common adverse effects (may occur in more than 1 in 10 people)
Eye-related symptoms: eye redness.

Common adverse effects (may occur in up to 1 in 10 people)
Eye-related symptoms: eye surface inflammation with damage to the eye surface, eye pain,
blurred vision, abnormal vision, dry eye, eye itching, eye discomfort, foreign body sensation and subjective
eye irritation symptoms (e.g. burning, stinging).

Uncommon adverse effects (may occur in up to 1 in 100 people)
Eye-related symptoms: eye surface inflammation, blepharitis (inflammation of the eyelids), conjunctival
oedema, increased eyelash growth, iritis (inflammation of the iris), eye inflammation, light sensitivity,
visual disturbances, eye fatigue, eye allergy, eye swelling, increased tear production, eyelid redness,
change in eyelid colour, darkening of the skin (around the eye).
General symptoms: hypersensitivity to the active substances, dizziness, headache, increased or decreased
blood pressure, shortness of breath, excessive hair growth, postnasal drip, skin inflammation and itching,
slow heart rate.

Rare adverse effects (may occur in up to 1 in 1000 people)
Eye-related symptoms: thinning of the eye surface, inflammation of eyelid glands, broken 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 blood test results indicating liver function changes, skin
discoloration, excessive thirst, fatigue, feeling of discomfort in the nose, discoloured urine, pain in hands
and feet.

Adverse effects of unknown frequency ( frequency cannot be determined from available data )
Eye-related symptoms: eyelid drooping (giving the impression of half-closed eyes), sunken eyes (eyes
appear more hooded), changes in iris colour (the coloured part of the eye).
General symptoms: rash, heart failure, chest pain, fainting, stroke, depression, asthma, increased heart
rate, tingling or numbness sensation, palpitations, oedema of lower limbs, unpleasant taste in the mouth.

Additional information
Travoprost + Timolol Genoptim is a combination of two active substances. Travoprost and timolol (a beta-
adrenolytic agent), like other medicines administered into the eyes, are absorbed into the bloodstream.
This may lead to adverse effects similar to those observed with intravenous or oral beta-adrenolytic
medicines. However, the frequency of adverse effects following local ocular administration is lower than
with medicines taken orally or by injection.
Below are adverse effects observed with the entire class of beta-adrenolytic medicines used in eye
diseases.

Eye-related symptoms: blepharitis, keratitis (corneal inflammation), choroidal detachment after filtration
surgery (separation of the vascular layer beneath the retina, which may cause visual disturbances),
decreased corneal sensitivity, corneal ulceration (damage to the front layer of the eyeball), double
vision, eye leakage, swelling around the eye, eyelid itching, eyelid turning outward with redness, eye
irritation and excessive tearing, blurred vision (indicative of lens clouding), swelling of an eye segment,
eyelid rash, seeing halos, decreased eye sensation, pigmentation inside the eye, dilated pupils, change in
eyelash colour, change in eyelash structure, abnormal visual field.

General symptoms
Ear and labyrinth disorders: dizziness with spinning sensation, tinnitus (ringing in the ears).
Heart and circulatory system: slowed heartbeat, palpitations, oedema (fluid retention), changes in heart
rhythm and (or) pulse rate, congestive heart failure (heart disease causing shortness of breath and
swelling of ankles and legs due to fluid accumulation), rhythm-related heart disease, heart attack, low
blood pressure, Raynaud's phenomenon, coldness of 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: difficulty falling asleep (insomnia), nightmares, memory loss,
hallucinations, loss of strength and energy, anxiety (excessive emotional stress).
Gastrointestinal system: taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain,
vomiting, constipation.
Allergic reactions: severe allergic symptoms, generalized allergic reactions involving skin swelling in areas
such as the face and limbs, which may cause airway obstruction and difficulties in swallowing and
breathing, localized or generalized rash, itching, severe and sudden life-threatening allergic reactions.
Skin: silver-white rash (resembling psoriasis) or worsening of psoriasis, skin peeling, inflammatory skin
conditions with itchy rash and redness, change in hair colour, loss of eyelashes, itching, abnormal hair
growth, skin redness.
Musculoskeletal system: worsening of objective and subjective symptoms of myasthenia gravis
(muscle disease), unusual sensations such as tingling and numbness, muscle weakness, fatigue, muscle
pain not caused by exercise, joint pain.
Renal and urinary disorders: difficulty and pain during urination, urinary incontinence.
Reproductive system: sexual dysfunction, decreased libido.
Metabolism: low blood sugar levels, increased prostate cancer marker.

Reporting of adverse effects
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist,
or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug
Reactions 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Travoprost + Timolol Genoptim

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, sachet, and bottle under: EXP. The expiry date refers to the last day of the stated month.
There are no special storage temperature requirements for this medicinal product.
Keep the bottle in the sachet to protect it from light.
After first opening: no special storage requirements.
To prevent infection, discard the bottle 4 weeks after first opening and use a new bottle.
The date of opening should be recorded in the space provided on the carton.
Medicines must not be disposed of via wastewater or household waste. 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 Travoprost + Timolol Genoptim contains

The active substances 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 of macrogol glyceryl hydroxystearate 40, tromethamine, 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, colourless, aqueous solution,
practically free from visible particles, packed in a 5 ml plastic bottle with a colourless
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.
Pack sizes contain 1 or 3 bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
Tel.: 22 321 62 40

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