Travoprost Zentiva

Package leaflet: Information for the patient

Travoprost Zentiva 40 micrograms/ml eye drops, solution

Generic 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 pass it on to other people, even if their symptoms are the same as yours, 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 Zentiva is and what it is used for
2. What you need to know before using Travoprost Zentiva
3. How to use Travoprost Zentiva
4. Possible side effects
5. How to store Travoprost Zentiva
6. Contents of the pack and other information

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

Travoprost Zentiva contains travoprost, a substance belonging to a group of medicines called prostaglandin analogues. It works by reducing intraocular pressure. It can be used alone or in addition to other eye drops such as beta-blockers, which also help lower pressure.
Travoprost Zentiva is used to reduce elevated intraocular pressure in adults, adolescents, and children from 2 months of age. This pressure can lead to a condition called glaucoma.

2. What you need to know before using Travoprost Zentiva

Do not use Travoprost Zentiva
If you are allergic to travoprost or to any of the excipients of this medicine (listed in section
6).
Consult your doctor if this applies to you.
Warnings and precautions

• Travoprost Zentiva may increase the length, thickness, colour and/or number of your eyelashes. Changes to the eyelids have also been observed, including abnormal growth of hair or tissues around the eye.
• Travoprost Zentiva may change the colour of your iris (the coloured part of the eye). This change may be permanent. A change in the colour of the skin around the eye may also occur.
• If you have undergone cataract surgery, consult your doctor before using Travoprost Zentiva.

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• If you have or have previously had ocular inflammation (iritis or uveitis), consult your doctor before using Travoprost Zentiva.
• Travoprost Zentiva may rarely cause difficulty in breathing, shortness of breath, or worsen symptoms of asthma. Inform your doctor immediately if you notice any changes in your breathing while using Travoprost Zentiva.
• Travoprost may be absorbed through the skin. If any amount of medicine comes into contact with the skin, it should be washed off immediately. This is particularly important for women who are pregnant or planning to become pregnant.
• If you wear soft contact lenses, do not use the eye drops while wearing your lenses. Wait 15 minutes after using the eye drops before reinserting your lenses.

Children and adolescents
Travoprost Zentiva may be used in children from 2 months to less than 18 years of age at the same dose as adults. The use of Travoprost Zentiva is not recommended in children under 2 months of age.
Other medicines and Travoprost Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use Travoprost Zentiva if you are pregnant. If you think you may be pregnant, speak to your doctor immediately. If you are of childbearing potential, you must use an adequate method of contraception during treatment with this medicine.
Do not use Travoprost Zentiva if you are breastfeeding. This medicine may pass into breast milk.
Driving and using machines
You may experience blurred vision for a period of time after using Travoprost Zentiva. Do not drive or operate machinery until this symptom has resolved.
Travoprost Zentiva contains benzalkonium chloride
If you wear soft contact lenses. Do not use the drops while wearing contact lenses. After using the drops, wait 15 minutes before reinserting your lenses. This medicine contains a preservative (benzalkonium chloride) which may discolour soft contact lenses.
This preservative may also cause eye irritation, particularly if you have dry eye or corneal disorders (the transparent outer layer of the eye). If you experience any abnormal sensation, burning or pain in the eye after using this medicine, speak to your doctor.
Travoprost Zentiva contains macrogol glycerol hydroxystearate 40
This medicine contains macrogol glycerol hydroxystearate 40, which may cause skin reactions.

3. How to use Travoprost Zentiva

Use this medicine exactly as instructed by your doctor or paediatrician. If you have
any doubts, consult your doctor, paediatrician, or pharmacist.
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The recommended dose is
One drop in the affected eye or eyes, once daily – in the evening.
Use Travoprost Zentiva in both eyes only if prescribed by your doctor. Use the
medicine for the length of time recommended by your doctor or paediatrician.
Use Travoprost Zentiva only as an eye drop for your eyes or your child's eyes.

1	Immediately before using the bottle for the first time, tear open the pouch packaging (figure 1). Remove the bottle and write the opening date in the designated space on the box. - Hold the medicine bottle and use a mirror. - Wash your hands. - Unscrew the cap.
2	Hold the bottle upside down between your thumb and fingers. - Tilt your head back or your child's head back. Pull down the lower eyelid with a clean finger to form a 'pocket' between the eyelid and the eye. The drop should be placed there (figure 2). - Bring the tip of the bottle close to the eye. Use a mirror if it helps.
3	Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the dropper tip. This could contaminate the eye drops. - Gently squeeze the bottle to release one drop of medicine at a time (figure 3). - After using the medicine, press a finger against the corner of the eye near the nose (figure 4). This helps prevent the medicine from entering the rest of the body.
4	If using drops in both eyes, repeat the same steps for the other eye. - Close the bottle cap tightly immediately after use. - Use only one medicine bottle at a time. Do not open the pouch until you need to use the bottle. - You must discard the bottle 4 weeks after first opening to prevent infections, and use a new bottle.

If a drop does not enter the eye, try again.
If you or the child are using other eye preparations at the same time, such as eye drops or ointments,
leave at least 5 minutes between the instillation of Travoprost Zentiva and the instillation of other eye preparations.
If you or the child use more Travoprost Zentiva than you should
Rinse all the medicine away with lukewarm water. Do not use the eye drops until the time of the next dose.
If you forget to use Travoprost Zentiva
Continue with the next dose as scheduled. Do not use a double dose to make up for the missed dose. Never use more than one drop in the affected eye(s) in a single day.
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If you stop using Travoprost Zentiva
Do not stop using this medicine without first talking to your doctor or paediatrician, as the pressure in your eye or in your child's eye will not be controlled, possibly resulting in loss of vision.
If you have any further questions about the use of this medicine, consult your doctor, paediatrician or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You can generally continue using the drops unless the side effects are severe.
If you are concerned, speak to your doctor or pharmacist. Do not stop treatment with Travoprost Zentiva without first discussing it with your doctor.

The following side effects have been observed with Travoprost Zentiva.

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

• Eye redness.

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

• changes in iris colour (the coloured part of the eye),
• eye pain,
• eye discomfort,
• dry eye,
• eye itching,
• eye irritation.

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

• corneal changes,
• eye inflammation,
• iris inflammation,
• intraocular inflammation,
• inflammation of the eye surface with or without surface damage,
• light sensitivity,
• eye discharge,
• eyelid inflammation,
• red eyelids,
• swelling around the eyes,
• eyelid itching,
• blurred vision, increased tearing,

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• infection or inflammation of the conjunctiva (thin membrane covering the inner surface of the eyelid and the white part of the eyeball) (conjunctivitis), abnormal outward turning of the lower eyelid, eye cloudiness, crusting of the eyelids, eyelash growth.

General side effects:

• worsening of allergy symptoms,
• headache, irregular heartbeat,
• cough, nasal congestion, throat irritation, darkening of the skin around the eye(s),
• skin darkening,
• abnormal hair structure,
• excessive hair growth.

Rare (may affect up to 1 in 1,000 people)
Eye effects:

• perception of flashing lights,
• eyelid eczema,
• abnormal inward growth of eyelashes, eye swelling, reduced vision,
• seeing halos around lights, decreased eye sensitivity,
• inflammation of the eyelid glands,
• pigmentation inside the eye,
• increased pupil size,
• eyelash thickening, change in eyelash colour, eye fatigue, viral eye infection.

General side effects:

• dizziness, unpleasant taste,
• irregular or slow heart rate,
• increased or decreased blood pressure,
• shortness of breath, asthma, nasal allergy or inflammation, nasal dryness, voice changes,
• gastrointestinal disturbances or ulcer,
• constipation,
• dry mouth,
• skin redness or itching,
• skin rash, hair colour change,
• eyelash loss,
• joint pain,
• musculoskeletal pain, generalized weakness.

Frequency not known (frequency cannot be estimated from the available data)
Eye effects:

• inflammation of the back of the eye, sunken appearance of the eyes.

General side effects:

• depression,
• anxiety, insomnia, false sensation of movement,
• ringing in the ears,
• chest pain,
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• abnormal heart rhythm, increased heart rate, worsening of asthma,
• diarrhoea, nosebleed, abdominal pain,
• nausea, vomiting, itching, abnormal hair growth,
• painful or involuntary urination,
• increase in prostate cancer marker.

In children and adolescents, the most commonly observed side effects with travoprost have been eye redness and eyelash growth. Both of these side effects have been observed with higher incidence in children and adolescents compared to adults.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
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 Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton after 'EXP'. The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the tamper-evident seal is broken or damaged before first opening.
Before opening, keep the bottle inside the protective pouch to protect it from moisture.
After first opening, this medicine does not require any special storage conditions.
The bottle must be discarded 4 weeks after first opening to prevent infections, and a new bottle should be used. Write the date of first opening in the space provided on each label and carton.
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 Zentiva contains

• The active substance is travoprost. Each ml of solution contains 40 micrograms of travoprost.
• The other components are benzalkonium chloride, macrogol glycerol hydroxystearate 40, trometamol, disodium edetate, boric acid, mannitol, sodium hydroxide to adjust pH, and water for injection or purified water.

Description of the appearance of Travoprost Zentiva and contents of the pack
Travoprost Zentiva is a clear, colourless solution supplied in packs containing bottles of 5 ml made of translucent polypropylene with a transparent dropper made of low-density polyethylene (LDPE) and a white screw cap made of high-density polyethylene (HDPE), child-resistant, packed in a protective pouch, sachet. Each bottle contains 2.5 ml of solution.
The product is available in the following pack sizes:
Carton box containing 1 or 3 bottles.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Zentiva Italia S.r.l.
Viale Luigi Bodio 37/B
20158 Milano
Manufacturer
Pharmathen S.A.
6 Dervenakion str, Pallini, Attiki
15351 – Greece
BALKANPHARMA-RAZGRAD AD
68 Aprilsko vastanie Blvd, Razgrad
7200 – Bulgaria
JADRAN - GALENSKI LABORATORIJ d.d.
Svilno 20, Rijeka, 51000
Croatia

This medicinal product is authorised in the European Economic Area Member States under the following names:
Travoprost Zentiva in Denmark, Poland, Romania, Latvia, Lithuania, Estonia, Italy and France.
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