Travoprost and timolol Zentiva

Package leaflet: Information for the user

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

Equivalent medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Travoprost and Timolol Zentiva is and what it is used for
2. What you need to know before using Travoprost and Timolol Zentiva
3. How to use Travoprost and Timolol Zentiva
4. Possible side effects
5. How to store Travoprost and Timolol Zentiva
6. Contents of the pack and other information

1. What Travoprost and Timololo Zentiva is and what it is used for

Travoprost and Timololo Zentiva 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 within the eye. The two active substances act simultaneously to lower the pressure inside the eye.
Travoprost and Timololo Zentiva eye drops are used to treat elevated intraocular pressure in adults, including the elderly. Such high pressure levels may lead to a condition known as glaucoma.

2. What you should know before using Travoprost and Timolol Zentiva

Do not use Travoprost and Timolol Zentiva

• If you are allergic to travoprost, prostaglandins, timolol, beta-blockers, or any of the other ingredients of this medicine (listed in section 6).
• If you have or have previously had respiratory problems such as asthma, chronic obstructive bronchitis (a severe lung disease that may cause wheezing, difficulty breathing, and/or long-lasting cough), or other types of breathing disorders.
• If you suffer from severe hay fever.
• If you have a slow heartbeat, heart failure, or a heart rhythm disorder (irregular heartbeats).
• If you have clouding of the ocular surface.

Ask your doctor if you are affected by any of these conditions.
Warnings and precautions
Before using Travoprost and Timolol Zentiva, inform your doctor if you currently have or have previously had:

• Coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or suffocation), heart failure, low blood pressure.
• Heart rhythm disorders such as slow heartbeat.
• Breathing problems, asthma, or chronic obstructive pulmonary disease.
• Poor blood circulation disorders (such as Raynaud's disease or Raynaud's syndrome).
• Diabetes, as timolol may mask the signs and symptoms of low blood sugar levels.
• Overactive thyroid gland, as timolol may mask signs and symptoms of thyroid disease.
• Myasthenia gravis (chronic neuromuscular weakness).
• Cataract surgery.
• Ocular inflammation.

If you need to undergo any type of surgical procedure, inform your doctor that you are using Travoprost and Timolol Zentiva, as timolol may alter the effects of certain medicines used during anesthesia.
If you experience any severe allergic reaction (skin rash, eye redness and itching) while using Travoprost and Timolol Zentiva, regardless of the cause, treatment with adrenaline may be less effective. Therefore, if you receive any other treatment, inform your doctor that you are using Travoprost and Timolol Zentiva.
Travoprost and Timolol Zentiva may change the colour of the iris (the coloured part of the eye). This change may be permanent.
Travoprost and Timolol Zentiva may increase the length, thickness, colour, and/or number of your eyelashes and may cause unusual hair growth on your eyelids.
Travoprost may be absorbed through the skin and therefore must not be used by pregnant women or women planning to become pregnant. If any amount of the medicine comes into contact with the skin, wash immediately.
Children and adolescents
Travoprost and Timolol Zentiva must not be used in children and adolescents under 18 years of age.
Caution for individuals engaged in sports: the product contains substances prohibited for doping.
Any use differing from the recommended dosage regimen or route of administration is prohibited.
Other medicines and Travoprost and Timolol Zentiva
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
Travoprost and Timolol Zentiva may affect or be affected by other medicines you are taking, including other eye drops used to treat glaucoma. Inform your doctor if you are using or plan to use:

• Medicines to lower blood pressure.
• Medicines for the heart, including quinidine (used to treat heart problems and certain types of malaria).
• Medicines to treat diabetes or the antidepressants fluoxetine or paroxetine.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Do not use Travoprost and Timolol Zentiva if you are pregnant unless your doctor considers it necessary. If you could become pregnant, you must use an adequate contraceptive method during treatment with this medicine.
Do not use Travoprost and Timolol Zentiva if you are breastfeeding. This medicine may be excreted in breast milk.
Driving and using machines
You may experience blurred vision for a period after using Travoprost and Timolol Zentiva. Do not drive or operate machinery until these symptoms have resolved.
Travoprost and Timolol Zentiva contains benzalkonium chloride and macrogolglycerol hydroxystearate 40
This medicine contains 150 micrograms of benzalkonium chloride per 1 ml of solution.
Benzalkonium chloride may be absorbed by soft contact lenses and may alter their colour. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them (see section 3).
Benzalkonium chloride may also cause eye irritation, particularly if you have dry eye or corneal disorders (damage to the transparent outer layer of the eye). If you experience any unusual sensation, burning, or pain in the eye after using this medicine, speak with your doctor.
Travoprost and Timolol Zentiva contains macrogolglycerol hydroxystearate 40
It may cause skin reactions.

3. How to use Travoprost and Timolol Zentiva

Instructions for use

1	Immediately before using the bottle for the first time, tear off the outer protective wrapper (figure 1). Remove the bottle and write the date of opening in the designated space on the label. -Make sure you have a mirror available. -Wash your hands. -Unscrew the cap of the bottle.
2	Hold the bottle upside down between your thumb and fingers. -Tilt your head back. Pull down the lower eyelid with a clean finger to create a pouch between the eyelid and the eye. The drop should be instilled here (figure 2). -Hold the tip of the bottle close to the eye. You may find it helpful to use a mirror.
3	Do not touch the eye or eyelid, surrounding areas, or any other surfaces with the dropper tip. This could contaminate the eye drops. -Gently press the bottle to release one drop of medicine at a time (figure 3). If a drop does not enter the eye, try again.
4	After using this medicine, press a finger at the inner corner of the eye near the nose for 2 minutes (figure 4). This helps prevent the medicine from spreading into the rest of the body. -If you need to use Travoprost and Timololo Zentiva in both eyes, repeat the same steps for the other eye. -Screw the cap back on the bottle immediately after use. -Use only one bottle of this medicine at a time. Do not open the outer protective wrapper until you are ready to use the bottle. -Discard the bottle 4 weeks after first opening to prevent the risk of infection and start using a new bottle.

Use Travoprost and Timolol Zentiva for the length of time prescribed by your doctor.
If you use more Travoprost and Timolol Zentiva than you should
If you use more Travoprost and Timolol Zentiva than you should, rinse your eye(s) with lukewarm water. Do not use any further drops until the next scheduled dose is due.
If you forget to use Travoprost and Timolol Zentiva
If you forget to use Travoprost and Timolol Zentiva, continue treatment with the next scheduled dose. Do not use a double dose to make up for the forgotten dose. The dose must not exceed one drop per day in the affected eye(s).
If you stop using Travoprost and Timolol Zentiva
If you stop treatment with Travoprost and Timolol Zentiva without discussing it with your doctor, the pressure in your eye will be uncontrolled, which may lead to loss of vision.
If you are using other eye drops in addition to Travoprost and Timolol Zentiva, wait at least 5 minutes between applying Travoprost and Timolol Zentiva and the other eye drops.
Do not use the drops while wearing soft contact lenses. After using the drops, wait 15 minutes before reinserting your contact lenses.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. You can generally continue using the drops unless the effects you experience are severe. If you are concerned, consult your doctor or pharmacist. Do not stop using Travoprost and Timololo Zentiva without first talking to your doctor.

Very common (may affect more than 1 in 10 people):
Eye effects: eye redness.

Common (may affect up to 1 in 10 people):
Eye effects: inflammation of the eye surface with surface damage, eye pain, blurred vision, altered vision, dry eye, eye itching, ocular discomfort, signs and symptoms of ocular irritation (e.g. burning, stinging pain).

Uncommon (may affect up to 1 in 100 people):
Eye effects: inflammation of the eye surface, eyelid inflammation, conjunctival swelling, increased eyelash growth, iris inflammation, eye inflammation, light sensitivity, reduced vision, tired eyes, eye allergy, eye swelling, increased tear production, eyelid redness, change in eyelid colour, darkening of the skin (around the eye).
General side effects: allergic reaction to the active substance, dizziness, headache, increased or decreased blood pressure, shortness of breath, excessive hair growth, nasopharyngeal dripping, skin inflammation and itching, reduced heart rate.

Rare (may affect up to 1 in 1,000 people):
Eye effects: thinning of the eye surface, inflammation of the eyelid glands, rupture of blood vessels in the eye, crust formation on the eyelid, abnormal eyelash positioning, abnormal eyelash growth.
General side effects: nervousness, irregular heart rate, hair loss, voice disturbances, breathing difficulties, cough, throat irritation, urticaria, abnormal liver blood tests, changes in skin colour, thirst, fatigue, nasal discomfort, coloured urine, pain in hands and feet.

Not known (frequency cannot be estimated from the available data):
Eye effects: drooping of the eyelid (eye remains half-closed), sunken eyes (eyes appear more hollowed), changes in iris colour (coloured part of the eye).
General side effects: skin rash, heart failure, chest pain, stroke, fainting, depression, asthma, increased heart rate, numbness or tingling sensation, palpitations, swelling of the lower limbs, bad taste.

In addition:
Travoprost and Timololo Zentiva is a combination of two active substances, travoprost and timolol. Like other ophthalmic medicines, travoprost and timololo (a beta-blocker) are absorbed into the bloodstream. This may cause side effects similar to those observed with oral and/or injectable beta-blockers.
The side effects listed below include reactions observed within the class of beta-blockers used in the treatment of eye disorders or reactions observed with travoprost alone.

Eye effects: eyelid inflammation, corneal inflammation, detachment of the layer beneath the retina containing blood vessels following filtering surgery which may cause visual disturbances, reduced corneal sensitivity, corneal erosion (damage to the front layer of the eyeball), double vision, eye discharge, swelling around the eye, eyelid itching, outward rotation of the eyelid with redness, irritation and excessive tearing, blurred vision (indicative of lens clouding), swelling of part of the eye (uvea), eyelid eczema, halos around lights, decreased ocular sensitivity, pigmentation inside the eye, dilated pupils, change in eyelash colour, change in eyelash texture, abnormal visual field.

General side effects:

• Ear and labyrinth disorders: dizziness with spinning sensation, ringing in the ears.
• Heart and circulation: slow heart rate, palpitations, oedema (fluid accumulation), changes in heart rhythm or rate, congestive heart failure (heart disease with shortness of breath and swelling of feet and legs due to fluid accumulation), a type of heart rhythm disorder, heart attack, low blood pressure, Raynaud's phenomenon, cold hands and feet, reduced blood supply to the brain.
• Respiratory: narrowing of the airways in the lungs (mainly in patients with pre-existing disease), runny or blocked nose, sneezing (due to allergy), breathing difficulties, nosebleeds, nasal dryness.
• Nervous system and systemic disorders: difficulty sleeping (insomnia), nightmares, memory loss, hallucinations, loss of strength and energy, anxiety (excessive emotional distress).
• Gastrointestinal: taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting, constipation.
• Allergy: worsening of allergic symptoms, generalized allergic reactions including swelling under the skin which may occur in areas such as the face and limbs and which may obstruct the airways causing difficulty in swallowing or breathing, localized and generalized skin rash, itching, severe unexpected life-threatening allergic reactions.
• Skin: white-silver appearance rash (psoriasiform erythema) or worsening of psoriasis, skin peeling, abnormal hair structure, skin inflammation with itching and redness, change in hair colour, eyelash loss, itching, abnormal hair growth, skin redness.
• Muscular: increased signs and symptoms of myasthenia gravis (muscle disorder), unusual sensations such as pins and needles, muscle weakness/fatigue, muscle pain not caused by exercise, joint pain.
• Renal and urinary disorders: difficulty and pain when urinating, involuntary loss of urine.
• Reproductive: sexual dysfunction, decreased libido.
• Metabolism: low blood sugar levels, increased marker of prostate cancer.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Travoprost and Timololo Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton,
on the protective packaging, and on the bottle after 'EXP'. The expiry date refers to the last
day of that month.
Before opening, this medicine does not require any special storage temperature.
Keep the bottle in the outer packaging to protect it from light.
After first opening, this medicine does not require any special storage conditions.
You must discard the bottle 4 weeks after first opening to prevent the risk of
infection, and use a new bottle. Write the date of opening in the space provided on the label and on the carton of the bottle.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Travoprost and Timololo Zentiva 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).
• The other components are benzalkonium chloride, macrogol glycerol hydroxystearate 40, tromethamine, disodium edetate, boric acid (E284), mannitol (E421), sodium hydroxide (to adjust pH), and water for injections.

Description of the appearance of Travoprost and Timololo Zentiva and package contents
Travoprost and Timololo Zentiva eye drops solution is a clear, colourless, practically particle-free aqueous solution supplied in a 5 ml plastic bottle with a colourless dropper tip and a white opaque screw cap, with a tamper-evident seal. Each bottle is enclosed in a protective pouch. Each bottle contains 2.5 ml of solution.
The medicine is available in the following pack sizes:
Carton pack containing 1 or 3 bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Zentiva Italia S.r.l.
Viale Luigi Bodio 37/B
20158 Milano, Italy

Manufacturer
Pharmathen S.A.
6 Dervenakion str, Pallini, Attiki
15351 – Greece
BALKANPHARMA-RAZGRAD AD
68 Aprilsko vastanie Blvd, Razgrad
7200 – Bulgaria

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: Travoprost e Timololo Zentiva
France: Travoprost/Timolol Zentiva 40 microgrammes/5 mg per ml, eye drops solution
Germany: Travoprost/Timolol Zentiva 40 Mikrogramm/ml + 5 mg/ml Augentropfen
Romania: Travoprost/Timolol Zentiva 40 micrograme/ml + 5 mg/ml picături oftalmice, soluţie