Travoprost Teva

Package leaflet: Information for the user

Travoprost Teva 40 micrograms/ml eye drops, solution

travoprost
Generic medicine
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 their symptoms are the same as yours, as 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 Teva is and what it is used for
2. What you need to know before you use Travoprost Teva
3. How to use Travoprost Teva
4. Possible side effects
5. How to store Travoprost Teva
6. Contents of the pack and other information

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

Travoprost Teva contains travoprost, a substance belonging to a group of medicines called prostaglandin analogues, which works by reducing the pressure inside the eye. It can be used alone or in combination with other eye drops, for example beta-blockers, which also reduce pressure inside the eye.
Travoprost Teva eye drops is used to reduce the treatment of elevated intraocular pressure in adults, adolescents and children from 2 months of age onwards. This pressure can lead to a condition called glaucoma.

2. What you need to know before using Travoprost Teva

Do not use Travoprost Teva

• if you are allergic to travoprost or to any of the other ingredients of this medicine (listed in section 6).

In this case, consult your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before using Travoprost Teva

• Travoprost Teva may increase the length, thickness, colour and/or number of eyelashes. Changes to the eyelids have also been observed, including abnormal growth of eyelid hair or of tissues around the eye.
• Travoprost Teva may change the colour of the irises (the coloured part of the eyes). This change may be permanent. A change in skin colour around the eye may also occur.
• If you have had cataract surgery, talk to your doctor before using Travoprost Teva.
• If you currently have or have previously had ocular inflammation (iritis or uveitis), talk to your doctor before using Travoprost Teva.
• In rare cases, Travoprost Teva may cause shortness of breath or dyspnoea, or worsening of asthma symptoms. If you experience breathing changes while using Travoprost Teva, contact your doctor as soon as possible.
• Travoprost Teva can be absorbed through the skin. If any amount of the medicine comes into contact with the skin, it must 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 the lenses. After using the eye drops, wait 15 minutes before reinserting the lenses.

Children and adolescents
Travoprost Teva may be used in children aged 2 months to less than 18 years at the same dose as adults.
The use of Travoprost Teva is not recommended in children under 2 months of age.
Other medicines and Travoprost Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breast-feeding and fertility
Do not use Travoprost Teva during pregnancy. If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor immediately before taking this medicine. If you are of childbearing age, you must use an adequate method of contraception during treatment with Travoprost Teva.
Do not use Travoprost Teva while breast-feeding, as Travoprost Teva may pass into breast milk.
Consult your doctor before taking any medicine.
Driving and using machines
For a certain period after using Travoprost Teva, you may experience temporary blurred vision.
Do not drive or operate machinery until symptoms have completely resolved.
Travoprost Teva contains benzalkonium chloride
This medicine contains 0.15 mg of benzalkonium chloride per ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their colour. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the transparent outer layer of the eye). If you experience an unusual sensation in the eye, such as burning or pain after using this medicine, speak with your doctor.
Travoprost Teva contains macrogol glycerol hydroxystearate
It may cause skin reactions.

3. How to use Travoprost Teva

Use this medicine exactly as instructed by your doctor or paediatrician. If you have any doubts, you should
consult your doctor, paediatrician, or pharmacist.
The recommended dose is
One drop in the affected eye or in both eyes, once daily - in the evening.
Use Travoprost Teva in both eyes only if your doctor has instructed you to do so. Use the medicine for as long
as directed by your doctor or paediatrician.
Use Travoprost Teva only to instil drops into your own eye(s) or into your child's eye(s).

Figure 1 Figure 2 Figure 3 Figure 4

• Immediately before using the bottle for the first time, open the outer protective pouch,
  remove the bottle (Figure 1), and write the date of opening on the label in the designated space.

• Wash your hands.

• Unscrew the cap.

• Hold the bottle in your hand, between your thumb and fingers, with the tip pointing downwards.

• Tilt your head or gently tilt your child's head backwards. Gently pull down the lower eyelid with a clean finger to create a "pocket" 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 use a mirror to assist.

• Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the tip of the bottle: this could contaminate the eye drops.

• Gently squeeze the bottle to release one drop of Travoprost Teva at a time (Figure 3).

• After using Travoprost Teva, keep the eyelid closed and apply gentle pressure with a finger at the inner corner of the eye near the nose (Figure 4). This helps prevent Travoprost Teva from spreading into the rest of the body.

• If you need to administer the drops to both eyes, repeat the steps for the other eye.

• Close the cap tightly immediately after use.

• Use only one bottle at a time. Do not open the outer protective pouch until you are ready to use the bottle.

If a drop misses the eye, try again.
If you or your child are using other ophthalmic preparations at the same time, such as eye drops or ointments,
wait at least 5 minutes between applying Travoprost Teva and the other preparations.
If you or your child use more Travoprost Teva than you should
Rinse the eye(s) thoroughly with lukewarm water to completely remove the medicine. Do not use the eye drops again until the next scheduled dose.
If you forget to use Travoprost Teva
Continue treatment with the next dose as scheduled. Do not use a double dose to make up for a missed dose. Never use more than one drop per day in each affected eye.
If you stop using Travoprost Teva
Do not stop treatment with Travoprost Teva without first talking to your doctor or paediatrician, as uncontrolled intraocular pressure may lead to vision loss.
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 everyone 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 Tt ravoprost Teva
without first talking to your doctor.

The following side effects have been observed with Tt ravoprost Teva.

Very common side effects: may affect more than 1 in 10 people
Eye effects: redness.

Common side effects: 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, itchy eyes, eye irritation.

Uncommon side effects: may affect up to 1 in 100 people
Eye effects: corneal disease, eye inflammation, iris inflammation, intraocular inflammation, inflammation of the ocular surface with or without surface damage, light sensitivity, eye discharge, eyelid inflammation, eyelid redness, swelling around the eye, eyelid itching, reduced vision, blurred vision, increased lacrimation, conjunctival infection or inflammation (conjunctivitis), abnormal outward turning of the lower eyelid, eye clouding, crusting on the eyelid, eyelash growth, change in eyelash colour, tired eyes.

General side effects: increased allergy symptoms, headache, dizziness, irregular heartbeat, shortness of breath, asthma, nasal congestion, throat irritation, darkening of the skin around the eye(s), skin darkening, abnormal hair structure, excessive hair growth, visual field disturbances.

Rare side effects: may affect up to 1 in 1,000 people
Eye effects: perception of flashing lights, eyelid eczema, misdirected eyelashes growing toward the eye, eye swelling, reduced vision, halos around lights, conjunctival follicles, decreased eye sensitivity, inflammation of the eyelid glands, pigmentation inside the eye, increased pupil size, eyelash thickening, change in eyelash colour, tired eyes, changes in eyelash structure.

General side effects: viral eye infection, dizziness, unpleasant taste, irregular or reduced heart rate, increased or decreased blood pressure, shortness of breath, asthma, nasal allergy or inflammation, nasal dryness, cough, voice changes, gastrointestinal disorders or stomach ulcer recurrence, constipation, dry mouth, skin redness or itching, rash, change in hair colour, eyelash loss, joint pain, musculoskeletal pain, generalized weakness, herpes infection, sore throat, breathing difficulties.

Not known: frequency cannot be estimated from the available data
Eye effects: inflammation, swelling 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, abnormal heart rhythm, increased heartbeat, worsening of asthma, diarrhoea, nosebleeds, abdominal pain, nausea, vomiting, itching, abnormal hair growth, joint pain, painful or involuntary urination, increase in prostate cancer marker, very slow or very fast heartbeat.

In children and adolescents, the most commonly observed side effects with Tt ravoprost Teva were eye redness and eyelash growth. Both of these side effects occurred more frequently in children and adolescents compared to adults.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. 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 Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine, Travoprost Teva, after the expiry date which is stated on the bottle and on the carton
after S cadCAD .
The expiry date refers to the last day of that month.
Before opening, store the bottle in its protective packaging to protect it from moisture.
After first opening, no special storage conditions are required for this medicine.
Do not use this medicine if you notice that the tamper-evident seal has been broken or damaged before first
opening.
To prevent infection, the bottle must be discarded 4 weeks after first opening and a new bottle should be
started. Write the date of opening in the space provided on each bottle label and on the carton.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines no longer
in use. This will help protect the environment.

6. Package contents and other information

What Travoprost Teva contains

• The active substance is travoprost. Each ml of solution contains 40 micrograms of travoprost.
• The other components are: benzalkonium chloride, macrogol glycerol hydroxystearate (Cremophor RH40), tromethamine, disodium edetate, boric acid (E284), mannitol (E421), sodium hydroxide (for pH adjustment), purified water.

Description of the appearance of Travoprost Teva and contents of the pack
Travoprost Teva is a liquid (a clear, colourless solution) supplied in a pack containing one plastic bottle of 5 ml with a screw cap, or in a pack containing one, three or six plastic bottles of 5 ml with screw caps. Each bottle contains 2.5 ml of solution. Each bottle is placed in a protective pouch. Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy

Manufacturers
Balkanpharma-Razgrad AD, 68 Aprilsko Vastanie Blvd., Razgrad, 7200 – Bulgaria
Pharmathen S.A., Dervenakion 6, Pallini 15351, Attica – Greece
Merckle GmbH, Ludwig-Merckle-Straße 3, 89143 Blaubeuren – Germany
JADRAN - GALENSKI LABORATORIJ d.d., Svilno 20, 51000 Rijeka – Croatia