Travoprost Mylan

Package leaflet: Information for the user

Travoprost Mylan 40 micrograms/ml eye drops

travoprost
Generic medicine
Read this entire leaflet carefully before 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 effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Travoprost Mylan 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 reduce pressure.
Travoprost 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 Mylan

Do not use Travoprost Mylan

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

Ask your doctor for advice if this applies to you.
Warnings and precautions

• Travoprost Mylan may increase the length, thickness, colour and/or number of your eyelashes. Changes to the eyelids or tissues around the eye, including abnormal hair growth, have also been observed.
• Travoprost Mylan may change the colour of your iris (the coloured part of the eye). This change may be permanent. A change in skin colour around the eye may also occur.
• If you have had cataract surgery, consult your doctor before using Travoprost Mylan.
• If you currently have or have previously had ocular inflammation (iritis or uveitis), consult your doctor before using Travoprost Mylan.
• Travoprost Mylan may rarely cause breathing difficulties, wheezing, or worsen asthma symptoms. Inform your doctor immediately if you are concerned about changes in your breathing while using Travoprost Mylan.
• Travoprost may be absorbed through the skin. If any amount of the medicine comes into contact with the skin, it should be washed off immediately. This is particularly important for women who are pregnant or trying to conceive.
• If you wear soft contact lenses, do not use the eye drops while wearing them. After using the

eye drops, wait 15 minutes before reinserting your lenses.
Children and adolescents
Travoprost may be used in children from 2 months to 18 years of age at the same dose as adults. The use
of Travoprost Mylan is not recommended in children under 2 months of age.
Other medicines and Travoprost Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
Pregnancy, breastfeeding and fertility
Do not use Travoprost Mylan during pregnancy. Speak immediately with your doctor if you think you may be
pregnant. If you are of childbearing age, you must use an effective contraceptive method during treatment with Travoprost Mylan.
Do not use Travoprost Mylan if you are breastfeeding. Travoprost Mylan may be excreted in breast milk.
Ask your doctor for advice before taking any medicine.
Driving and using machines
You may experience blurred vision for a period of time immediately after using Travoprost Mylan.
Do not drive or operate machinery until these symptoms have resolved.
Travoprost Mylan contains benzalkonium chloride
This product contains 150 micrograms of benzalkonium chloride per millilitre (ml).
Benzalkonium chloride may be absorbed by soft contact lenses and may lead to a change in their colour. Remove your 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 outermost 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.

3. How to use Travoprost Mylan

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

1. Immediately before first use of the bottle, tear off the outer packaging and remove the bottle. Write the date of opening on the box or on the label of the bottle in the designated space.
2. Wash your hands.
3. Unscrew the cap.
4. After removing the cap, if the loose protective ring is loose, remove it before using the medicine.
5. Hold the bottle upside down between thumb and fingers.
6. Gently tilt the head back or your child's head back. Pull down the eyelid with a clean finger to create a "pocket" between the eyelid and the eye. The drop should go into this pocket.

7. Bring the tip of the bottle close to the eye. Use a mirror if it helps.
8. Do not touch the eye or eyelid, surrounding areas, or any other surfaces with the dropper tip. This could contaminate the drops.
9. Gently squeeze the bottle to release one drop at a time of Travoprost Mylan.

10. After using Travoprost Mylan, keep the eyelid closed and apply gentle pressure with a finger at the inner corner of the eye near the nose for at least 1 minute. This helps prevent Travoprost Mylan from reaching the rest of the body.
11. If drops are used in both eyes, repeat the steps for the other eye.
12. Immediately after use, firmly screw the cap back on the bottle.
13. Use only one bottle at a time.

If a drop misses your eye, try again.
If you or your child are using other eye preparations such as eye drops or eye ointment, wait at least 5 minutes between using Travoprost Mylan and the other eye preparations.
If you or your child use more Travoprost Mylan than you should
Rinse all the medicine away with lukewarm water. Do not use the eye drops until the next scheduled dose.
If you forget to use Travoprost Mylan
Continue treatment 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 per day in the affected eye(s).
If you stop using Travoprost Mylan
Do not stop treatment with Travoprost Mylan without first talking to your doctor or paediatrician, as your intraocular pressure, or that of your child, 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 may 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, consult your doctor or pharmacist. Do not stop treatment with Travoprost Mylan without first discussing it with your doctor.

The following side effects have been observed with eye drops containing travoprost:

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

Common (may affect up to 1 in 10 users):
Eye effects: changes in iris colour (coloured part of the eye), eye pain, eye discomfort, dry eyes, itchy eyes, eye irritation

Uncommon (may affect up to 1 in 100 users):
Eye effects: corneal disorder, eye inflammation, iris inflammation, intraocular inflammation, ocular surface inflammation with or without surface damage, light sensitivity, eye discharge, eyelid inflammation, eyelid redness, swelling around the eye, eyelid itching, blurred vision, increased tear production, conjunctival infection or inflammation (conjunctivitis), abnormal outward turning of the lower eyelid, eye cloudiness, eyelid crusting, 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 users):
Eye effects: perception of flashing lights, eyelid eczema, abnormally positioned eyelashes growing back towards the eye, 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.

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, dry nose, voice changes, gastrointestinal discomfort or ulcer, constipation, dry mouth, skin redness or itching, skin rash, hair colour change, eyelash loss, joint pain, musculoskeletal pain, generalized weakness.

Not known (frequency cannot be determined from 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, 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.

Additional side effects in children and adolescents
The following side effects have been observed more frequently in children and adolescents than in adults:

• Eye redness
• Eyelash growth

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell 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 Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine if you notice that the tamper-evident seal is broken or damaged before first opening.
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.
Keep the bottle in the sealed pouch to protect it from moisture until first opening of the bottle. This medicine does not require any special storage temperature.
To prevent infection, the bottle must be discarded 4 weeks after first opening, and a new bottle should be used. Write the date of opening of the bottle in the space provided on the carton or on the bottle label.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Travoprost Mylan 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, tromethamine,
disodium edetate, boric acid (E284), mannitol, sodium hydroxide (to adjust pH) (E524), water for
injections or purified water.

Description of the appearance of Travoprost Mylan and contents of the pack
Travoprost Mylan is a clear, colourless solution in a transparent plastic bottle with a white screw cap, contained within a protective plastic/aluminium pouch. Each bottle contains 2.5 ml of Travoprost Mylan eye drops (ophthalmic solution).
Travoprost Mylan is available in packs of 1 or 3 bottles.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy

Manufacturer
BALKANPHARMA - RAZGRAD AD
68 Aprilsko vastanie Blvd.
7200 Razgrad
Bulgaria
JADRAN - GALENSKI LABORATORIJ d.d.
Svilno 20
51000 Rijeka
Croatia
PHARMATHEN S.A.
Dervenakion 6 Attiki
15351 Pallini
Greece