Traviop

PACKAGE LEAFLET: INFORMATION FOR THE USER

TRAVIOP 40 micrograms/mL eye drops, solution

Travoprost
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 give it to other people, even if they have the same symptoms 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 TRAVIOP is and what it is used for
2. What you need to know before using TRAVIOP
3. How to use TRAVIOP
4. Possible side effects
5. How to store TRAVIOP
6. Contents of the pack and other information

1. What TRAVIOP is and what it is used for

TRAVIOP contains travoprost, a substance belonging to a group of medicines called prostaglandin analogues. It works by lowering intraocular pressure. It can be used alone or in addition to other eye drops that also reduce pressure.
TRAVIOP is used to reduce 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 should know before using TRAVIOP

Do not use TRAVIOP

• 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 taking TRAVIOP

• TRAVIOP 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.
• TRAVIOP may change the colour of the 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 had cataract surgery, consult your doctor before using TRAVIOP.
• If you currently have or have previously had ocular inflammation (iritis or uveitis), consult your doctor before using TRAVIOP.
• TRAVIOP may rarely cause difficulty breathing, shortness of breath, or worsen symptoms of asthma. If you notice that using TRAVIOP causes changes in your breathing, inform your doctor immediately.
• 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 who are 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
TRAVIOP may be used in children from 2 months of age up to less than 18 years of age at the same dose as adults.
Use of TRAVIOP is not recommended in children under 2 months of age.
Other medicines and TRAVIOP
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 may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Do not use TRAVIOP during pregnancy
Speak to your doctor immediately if you think you are pregnant or if there is a possibility you could become
pregnant. If you are of childbearing age, use an effective contraceptive method during treatment.
Do not use TRAVIOP if you are breastfeeding This medicine may pass into breast milk.
Driving and use of machines
You may experience blurred or cloudy vision for a period of time after using TRAVIOP. Do not drive or operate
machinery until these symptoms have resolved.
TRAVIOP contains:

• hydrogenated castor oil and propylene glycol, which may cause skin reactions and irritation.
• this medicine contains 0.15 mg/ml of benzalkonium chloride, which may be absorbed by soft contact lenses and may lead to a change in their colour. Remove your lenses. Wait 15 minutes 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, burning or pain in the eye after using this medicine, talk to your doctor.

3. How to use TRAVIOP

Use this medicine exactly as instructed 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 TRAVIOP in both eyes only if your doctor has instructed you to do so. Use the medicine for the length of time recommended by your doctor or paediatrician.
TRAVIOP is for ophthalmic use only.

Instructions for use:

• Immediately before first use of the bottle, open the outer protective pouch, remove the bottle (Figure 1), and write the date of opening on the designated space on the carton.
• Wash your hands.
• Unscrew the cap.
• After removing the cap, if the loose protective ring is loose, remove it before using the medicine.
• Hold the bottle between your thumb and fingers, with the tip pointing downwards.
• Tilt the head backwards or gently tilt the child’s head backwards. 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. Using a mirror may be helpful.
• 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 TRAVIOP at a time (Figure 3).
• After instilling TRAVIOP, keep the eyes closed and apply gentle pressure with a finger at the inner corner of the eye, near the nose (Figure 4) for at least one minute. This helps prevent TRAVIOP from spreading into the rest of the body.
• If using the eye drops in both eyes, repeat the steps for the other eye.
• Immediately close the cap tightly after use.
• Use only one bottle at a time. Do not open the outer protective pouch until it is time to use the bottle. If a drop misses the eye, try again.

If you or the child are using other eye preparations at the same time, such as eye drops or ointments, wait at least 5 minutes between instilling TRAVIOP and the other preparations.

If you or the child use more TRAVIOP than you should
Rinse all the medicine out of the eye with lukewarm water. Do not instil any more eye drops until the next scheduled dose.

If you forget to use TRAVIOP
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 per eye per day.

If you stop using TRAVIOP
Do not stop using this medicine without first discussing it with your doctor or paediatrician. This is because the pressure inside the eye will no longer be controlled, which could lead to 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 everyone experiences them.
If you experience side effects, you can generally continue using the eye drops unless the side effects are severe.
If you are concerned, speak to your doctor or pharmacist. Do not stop treatment with TRAVIOP without first discussing it with your doctor.

The following side effects have been observed with TRAVIOP:

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

Common side effects: may affect up to 1 in 10 people
Eye-related 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 from 1 to 100 people
Eye-related effects: corneal disorder, eye inflammation, iris inflammation, intraocular inflammation, inflammation of the eye 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 rotation of the lower eyelid, eye cloudiness, crust formation on the eyelid, eyelash growth.

General side effects: worsening of allergy symptoms, headache, dizziness, irregular heartbeat, cough, nasal congestion, throat irritation, darkening of the skin around the eye(s), generalised skin darkening, abnormal hair structure, excessive hair growth.

Rare: may affect from 1 to 1,000 people
Eye-related effects: perception of flickering lights, eyelid eczema, abnormally positioned eyelashes growing towards the eye, eye swelling, visual halos, decreased eye sensitivity, eyelid gland inflammation, pigmentation inside the eye, increased pupil size, eyelash thickening, change in eyelash colour, tired eyes.

General side effects: viral eye infection, dizziness, unpleasant taste, irregular or reduced heartbeat, increased or decreased blood pressure, shortness of breath, asthma, nasal allergy or inflammation, dry nose, voice changes, gastrointestinal disturbances or ulcer, constipation, dry mouth, skin redness or itching, skin rash, change in hair colour, eyelash loss, joint pain, musculoskeletal pain, generalised weakness.

Not known: frequency cannot be estimated from the available data
Eye-related effects: inflammation of the back of the eye, eyes appearing more sunken.
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, nosebleeds, abdominal pain, nausea, vomiting, itching, abnormal hair growth, painful or involuntary urination, increase in prostate cancer marker.

In children and adolescents, the most common side effects observed with TRAVIOP were ocular redness and eyelash growth. Both of these side effects occurred at a higher incidence in children and adolescents compared to adults.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform 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 TRAVIOP

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 on the carton after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
To prevent infections, the bottle must be discarded four weeks after first opening, and a new bottle must be started.
Write the date of opening in the space provided on the 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 TRAVIOP contains
The active substance is travoprost 40 micrograms/mL.
The other components are: benzalkonium chloride, mannitol, trometamol, polyoxyl 40 hydrogenated castor oil (Cremophor RH40), boric acid, disodium edetate, water for injections.
Description of the appearance of TRAVIOP and contents of the pack
TRAVIOP is a liquid (a clear, colourless solution) supplied in a pack containing one bottle made of polyethylene with a volume of 2.5 ml.
Pack size: 1 bottle.
Marketing Authorization Holder:
DOC Generici S.r.l. - Via Turati 40, 20121 Milan, Italy
Manufacturer and batch release:
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA), Italy
This leaflet was last updated on

PACKAGE LEAFLET: INFORMATION FOR THE USER

TRAVIOP 40 microgram per mL eye drops, solution

Travoprost
Generic medicine
Please read this 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 others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What TRAVIOP is and what it is used for

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

2. What you should know before using TRAVIOP

Do not use TRAVIOP

• 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 TRAVIOP

• TRAVIOP 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.
• TRAVIOP may change the colour of the 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 had cataract surgery, talk to your doctor before using TRAVIOP.
• If you currently have or have previously had ocular inflammation (iritis or uveitis), talk to your doctor before using TRAVIOP.
• TRAVIOP may rarely cause difficulty in breathing, shortness of breath, or worsen symptoms of asthma. If you notice that using TRAVIOP causes changes in your breathing, inform your doctor immediately.
• 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 planning to become pregnant.
• If you wear soft contact lenses, do not use the eye drops while wearing them. Wait 15 minutes after using the eye drops before reinserting your lenses.

Children and adolescents
TRAVIOP may be used in children from 2 months of age up to less than 18 years of age at the same dose as adults.
Use of TRAVIOP is not recommended in children below 2 months of age.
Other medicines and TRAVIOP
Tell 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 may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Do not use TRAVIOP during pregnancy
Speak to your doctor immediately if you think you may be pregnant or if there is a chance you could become pregnant. If you are of childbearing age, use an effective contraceptive method during treatment.
Do not use TRAVIOP while breastfeeding This medicine may pass into breast milk.
Driving and using machines
You may experience blurred or cloudy vision for a period of time after using TRAVIOP. Do not drive or operate machinery until these symptoms have resolved.
TRAVIOP contains:

• hydrogenated castor oil and propylene glycol, which may cause skin reactions and irritation

3. How to use TRAVIOP

Use this medicine exactly as instructed by your doctor or paediatrician. If you have any doubts, consult your doctor, paediatrician, or pharmacist.
The recommended dose is
One drop into the affected eye(s) once daily – in the evening.
Use TRAVIOP in both eyes only if your doctor has instructed you to do so. Use the medicine for the length of time recommended by your doctor or paediatrician.
TRAVIOP is for ophthalmic use only.

Instructions for use:

• 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 in the space provided on the carton.
• Wash your hands.
• Unscrew the cap.
• After removing the cap, if the loose protective ring is loose, remove it before using the medicine.
• Hold the bottle between your thumb and fingers, with the tip pointing downwards.
• Tilt the head backwards or gently tilt the child’s head backwards. 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. Using a mirror may be helpful.
• Do not touch the eye, eyelid, surrounding areas, or any other surface with the tip of the bottle. This could contaminate the eye drop solution.
• Gently squeeze the bottle to release one drop of TRAVIOP at a time (Figure 3).
• After instilling TRAVIOP, keep the eyes closed and apply gentle pressure with a finger at the inner corner of the eye, near the nose (Figure 4) for at least one minute. This helps prevent TRAVIOP from being absorbed into the rest of the body.
• If you are using the eye drops in both eyes, repeat the steps for the other eye.
• Immediately close the cap tightly 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 the child are using other ophthalmic preparations such as eye drops or ointments at the same time, wait at least 5 minutes between instilling TRAVIOP and the other preparations.
If you or the child use more TRAVIOP than you should
Rinse all the medicine out of the eye with lukewarm water. Do not instill any more eye drops until the next scheduled dose.
If you forget to use TRAVIOP
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 per day in each affected eye.
If you stop using TRAVIOP
Do not stop using this medicine without first discussing it with your doctor or paediatrician. This is because the pressure inside the eye will no longer be controlled, which could 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 everybody gets them.
If you experience side effects, you can generally continue using the eye drops unless the side effects are severe.
If you are concerned, speak to your doctor or pharmacist. Do not stop treatment with TRAVIOP without first discussing it with your doctor.

The following side effects have been observed with TRAVIOP:

Very common side effects: may affect more than 1 in 10 people
Eye effects: eye 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 from 1 to 100 people
Eye effects: corneal disorder, eye inflammation, iris inflammation, intraocular inflammation, inflammation of the eye 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 tearing, infection or inflammation of the conjunctiva (conjunctivitis), abnormal outward turning of the lower eyelid, eye cloudiness, crusting of the eyelid, eyelash growth.

General side effects: worsening of allergy symptoms, headache, dizziness, 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 from 1 to 1,000 people
Eye effects: perception of flashing lights, eyelid eczema, abnormally positioned eyelashes growing towards the eye, eye swelling, 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, tired eyes.

General side effects: viral eye infection, dizziness, unpleasant taste, irregular or slow heartbeat, increased or decreased blood pressure, shortness of breath, asthma, allergy or nasal inflammation, dry nose, voice changes, gastrointestinal disorders or ulcer, constipation, dry mouth, skin redness or itching, skin rash, change in hair colour, eyelash loss, joint pain, musculoskeletal pain, generalized weakness.

Not known: frequency cannot be estimated from the available data
Eye effects: inflammation of the back of the eye, eyes appearing sunken.

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, nosebleeds, abdominal pain, nausea, vomiting, itching, abnormal hair growth, painful or involuntary urination, increase in prostate cancer marker.

In children and adolescents, the most common side effects observed with TRAVIOP were eye redness and eyelash growth. Both of these side effects occurred at a higher rate in children and adolescents compared to adults.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, please inform 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 TRAVIOP

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 the carton after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
To prevent infections, the bottle must be discarded four weeks after first opening, and a new bottle must be started.
Write the date of opening in the space provided on the 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 TRAVIOP contains
The active substance is travoprost 40 micrograms/mL.
The other components are: mannitol, trometamol, polyoxyl 40 hydrogenated castor oil (Cremophor RH40), boric acid, edetate disodium, water for injections.

Description of the appearance of TRAVIOP and contents of the pack
TRAVIOP is a liquid (a clear, colourless solution) supplied in a pack containing one 2.5 ml polyethylene bottle.
Pack size: 1 bottle.

Marketing Authorization Holder:
DOC Generici S.r.l. - Via Turati 40, 20121 Milan, Italy

Manufacturer and batch release:
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA), Italy

This leaflet was last updated on