TRAVIOP 40 MCG/ML Eye drops, solution

Зміст інструкції

1. TRAVIOP 40 micrograms/mL eye drops, solution
   1. What is TRAVIOP 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
2. TRAVIOP 40 micrograms/mL eye drops, solution
   1. What is TRAVIOP 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

TRAVIOP 40 micrograms/mL eye drops, solution

Travoprost

Generic medicine
Read 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 others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even 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 you use 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 is TRAVIOP and what it is used for

TRAVIOP contains travoprost,a substance belonging to the group of drugs called prostaglandin analogues. It works by lowering intraocular pressure. It can be used alone or in addition to other eye drops, also capable of reducing pressure.

TRAVIOP is used to reduce high 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 TRAVIOP

Do not use TRAVIOP

• If you are allergicto 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 increasethe 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.
• TRAVIOPcan 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 undergone cataract surgery, talk to your doctor before using TRAVIOP.
• If you currently have, or have had in the past, eye inflammation (iritis and uveitis), talk to your doctor before using TRAVIOP.
• TRAVIOP can rarely cause difficulty breathingor shortness of breathor worsen the symptoms of asthma. If you notice that using TRAVIOP causes changes in your breathing, inform your doctor immediately.
• Travoprost can be absorbed through the skin. If anymedicine comes into contact with your skin,it should be washed offimmediately.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. Wait 15 minutes after using the eye drops before putting the lenses back in.

Children and adolescents
TRAVIOP can be used in children from 2 months of age to under 18 years at the same dose as adults. The use
of TRAVIOP is not recommended for children under 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, suspect you might be pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not use TRAVIOP if you are pregnant
Talk to your doctor immediately if you think you may be pregnant and there is a possibility of becoming
pregnant. If you are of childbearing potential, use effective contraception during treatment.

Do not use TRAVIOP if you are breastfeedingThis medicine can pass into breast milk.

Driving and using machines
Your vision may be blurred and hazy for a certain period of time after using TRAVIOP. Do not drive or use
machines until these symptoms have disappeared.
TRAVIOP contains:

• Hydrogenated castor oiland propylene glycolwhich can cause skin reactions and irritation.
• this medicine contains 0.15 mg/ml of benzalkonium chloridewhich can be absorbed by soft contact lenses and can lead to a change in their colour. Remove the lenses. Wait 15 minutes before using this medicine and wait 15 minutes before re-applying them. Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or corneal disorders (the transparent outermost layer of the eye). If you experience an abnormal sensation in your eye, burning or pain after using soft lenses this medicine, talk to your doctor.

3. How to use TRAVIOP

Use this medicine following the instructions of your doctor or pediatrician exactly. If you have any doubts
consult your doctor, pediatrician or pharmacist.

The recommended dose is
One drop in the eye(s), affected once a day - in the evening.
Use TRAVIOP in both eyes only if your doctor has told you to do so. Use the medicine for the
period of time that your doctor or pediatrician advises you.
TRAVIOP can only be used as an eye drop.
Instructions for use:

• Immediately before using the bottle for the first time, open the outer protective packaging, remove the bottle (figure 1)and write the date of opening the bottle in the appropriate space on the box.
• Wash your hands.
• Unscrew the cap.
• After removing the cap, if the mobile protective ring is loose, remove it before using the medicine.
• Hold the bottle in your hand, between your thumb and other fingers, and hold it pointing downwards.
• Tilt your head back or gently tilt the child's head back. Lower the lower eyelid with a clean finger, so as to form a “pocket” between the eyelid and the eye. The drop will be inserted there (figure 2).
• Hold the tip of the bottle close to the eye. Using a mirror may be helpful.
• Do not touch the eye or eyelid, the surrounding areas or other surfaces with the tip of the bottle.This could infect the eye drops.
• Gently press the bottle to release one drop of TRAVIOP at a time. (figure 3)
• After using TRAVIOP, keep your eyes closed, apply gentle pressure with a finger to the corner of the eye, near the nose (figure 4)for at least one minute. This helps to prevent TRAVIOP from spreading throughout the body.
• If you are using the eye drops in 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 packaging until you are ready to use the bottle. If a drop does not enter the eye, try again.

If you or the child are using other ophthalmic preparations at the same timesuch as eye drops or ointments, allow
at least 5 minutes to pass between the instillation of TRAVIOP and the instillation of other preparations.

If you or the child use more TRAVIOP than you should
Rinse all the medicine from the eye with lukewarm water. Do not put any more eye drops in until the
time of the next dose.

If you forget to use TRAVIOP
Continue with the next dose as scheduled. Do not use a double doseto make up for the
missed dose. Never use more than one drop in one day for the affected eye(s).

If you stop using TRAVIOP
Do not stop using this medicine without first talking to your doctor or pediatrician.
This is because the pressure inside the eye will not be controlled, which may lead to loss
of vision.
If you have any further questions on the use of this medicine, ask your doctor, pediatrician 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 to use the eye drops unless the
side effects are serious.
If you are concerned, talk to your doctor or pharmacist. Do not stop treatment with TRAVIOP without
talking to your doctor.
The following side effects have been observed with TRAVIOP

Very common side effects: may affect more than 1 in 10 people
Effects on the eye: eye redness.

Common side effects: may affect up to 1 in 10 people
Effects on the eye: changes in the color of the iris (colored part of the eye), eye pain, eye discomfort,
dry eye, itchy eyes, eye irritation.

Uncommon side effects: may affect from 1 to 100 people
Effects on the eye: corneal pathology, eye inflammation, iris inflammation,
inflammation inside the eye, inflammation of the eye surface with or without damage to the
surface, sensitivity to light, eye discharge, eyelid inflammation, redness of the eyelids,
swelling around the eye, itchy eyelids, reduced vision, blurred vision, increased
tearing, infection or inflammation of the conjunctiva (conjunctivitis), abnormal outward rotation
of the lower eyelid, eye cloudiness, crusting of the eyelid, eyelash growth

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

Rare: may affect from 1 user to 1,000 people
Effects on the eye: perception of flashing lights, eczema of the eyelids, eyelashes with abnormal positioning
that grow towards the eye, eye swelling, vision with halo, decreased eye sensitivity,
inflammation of the eyelid glands, pigmentation inside the eye, increased
pupil size, thickening of the eyelashes, change in eyelash color, tired eyes

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, changes in voice, gastrointestinal disorders or ulcer,
constipation, dry mouth, redness or itching of the skin, rash, change in hair color, eyelash loss, joint pain, musculoskeletal pain, generalized weakness.

Not known: frequency cannot be estimated from available data
Effects on the eye:inflammation of the back of the eye, eyes appear 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,
diarrhea, nosebleed, abdominal pain, nausea, vomiting, itching, abnormal hair growth, painful or involuntary urination, increased prostate cancer marker.
In children and adolescents, the most common side effects observed with TRAVIOP were eye redness
and eyelash growth. Both side effects were observed with a higher incidence
in children and adolescents compared to adults.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 which is stated on the bottle and the packaging box 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 openingand a
new bottle should be started. Write the date of opening the bottle in the space on the packaging box.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What TRAVIOP contains
The active ingredient is travoprost 40 micrograms/mL
The other ingredients are: benzalkonium chloride, mannitol, trometamol, hydrogenated castor oil polyoxyethylene 40 (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, colorless solution) supplied in a pack containing a
2.5 ml polyethylene bottle.
Pack of 1 bottle.

Marketing Authorisation Holder:
DOC Generici S.r.l. - via Turati 40, 20121 Milano

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

This leaflet was last updated on

TRAVIOP 40 micrograms/mL eye drops, solution

Travoprost

Equivalent medicine
Read this leaflet carefully before you start to use 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 others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even 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 you use 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 is TRAVIOP and what it is used for

TRAVIOP contains travoprost,a substance belonging to the group of drugs 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 are also able to reduce pressure.

TRAVIOP is used to reduce high 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 TRAVIOP

Do not use TRAVIOP

• If you are allergicto travoprost or 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 increasethe length, thickness, colour and/or number of your eyelashes.Changes to the eyelids or the tissues around the eye, including abnormal hair growth, have also been observed.
• TRAVIOPcan 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 had in the past, eye inflammation (iritis and uveitis), talk to your doctor before using TRAVIOP.
• TRAVIOP can rarely cause difficulty breathingor shortness of breathor worsen the symptoms of asthma. If you notice that using TRAVIOP causes changes in your breathing, inform your doctor immediately.
• Travoprost can be absorbed through the skin. If anymedicine gets in contact with your skin,it should be washed offimmediately.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. Wait 15 minutes after using the eye drops before putting the lenses back in.

Children and adolescents
TRAVIOP can be used in children from 2 months of age to under 18 years at the same dose as adults. The use
of TRAVIOP is not recommended for children under 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, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not use TRAVIOP if you are pregnant
Tell your doctor immediately if you think you may be pregnant and if there is a possibility that you may
become pregnant. If you are of childbearing potential, use effective contraception during treatment.

Do not use TRAVIOP if you are breastfeedingThis medicine can pass into breast milk.

Driving and operating machinery
Your vision may be blurred and hazy for a certain period of time after using TRAVIOP. Do not drive or operate
machinery until these symptoms have disappeared.
TRAVIOP contains:

• Hydrogenated castor oiland propylene glycolwhich can cause skin reactions and irritation

3. How to use TRAVIOP

Use this medicine following the instructions of your doctor or pediatrician exactly. If you have any doubts
consult your doctor, pediatrician or pharmacist.

The recommended dose is
One drop in the affected eye(s) once a day - in the evening.
Use TRAVIOP in both eyes only if your doctor has told you to do so. Use the medicine for the
period of time advised by your doctor or pediatrician.
TRAVIOP can only be used as an eye drop.
Instructions for use:

• Immediately before using the bottle for the first time, open the outer protective packaging, remove the bottle (figure 1)and write the date of opening the bottle in the appropriate space on the box.
• Wash your hands.
• Unscrew the cap.
• After removing the cap, if the mobile protective ring is loose, remove it before using the medicine.
• Hold the bottle in your hand, between your thumb and other fingers, and hold it pointing downwards.
• Tilt your head back or gently tilt the child's head back. Lower the lower eyelid with a clean finger, so as to form a “pocket” between the eyelid and the eye. The drop should be inserted there (figure 2).
• Hold the tip of the bottle close to the eye. It may be helpful to use a mirror.
• Do not touch the eye or eyelid, the surrounding areas or other surfaces with the tip of the bottle.This could infect the eye drops.
• Gently press the bottle to release one drop of TRAVIOP at a time. (figure 3)
• After using TRAVIOP, keep your eyes closed, apply gentle pressure with a finger to the corner of the eye, near the nose (figure 4)for at least one minute. This helps to prevent TRAVIOP from spreading throughout the body.
• If you are using the eye drops in 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 packaging until you are ready to use the bottle. If a drop does not enter the eye, try again.

If you or the child are using other ophthalmic preparations at the same timesuch as eye drops or ointments, allow
at least 5 minutes to pass between instilling TRAVIOP and instilling other preparations.

If you or the child use more TRAVIOP than you should
Rinse all the medicine from the eye with lukewarm water. Do not put any more eye drops in until the
time of the next dose.

If you forget to use TRAVIOP
Continue with the next dose as scheduled. Do not use a double doseto make up for a
missed dose. Never use more than one drop in one day per affected eye(s).

If you stop using TRAVIOP
Do not stop using this medicine without first talking to your doctor or pediatrician.
This is because the pressure inside the eye will not be controlled, which may lead to loss
of vision.
If you have any further questions on the use of this medicine, ask your doctor, pediatrician 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 to use the eye drops unless the
side effects are serious.
If you are concerned, contact your doctor or pharmacist. Do not stop treatment with TRAVIOP without
talking to your doctor.
The following side effects have been observed with TRAVIOP

Very common side effects: may affect more than 1 in 10 people
Effects on the eye: eye redness.

Common side effects: may affect up to 1 in 10 people
Effects on the eye: changes in the color of the iris (colored part of the eye), eye pain, eye discomfort,
dry eye, itchy eyes, eye irritation.

Uncommon side effects: may affect from 1 to 100 people
Effects on the eye: corneal pathology, eye inflammation, iris inflammation,
inflammation inside the eye, inflammation of the eye surface with or without damage to the
surface, light sensitivity, eye discharge, eyelid inflammation, redness of the eyelids,
swelling around the eye, itchy eyelids, reduced vision, blurred vision, increased
tearing, infection or inflammation of the conjunctiva (conjunctivitis), abnormal outward rotation
of the lower eyelid, eye clouding, crusting on the eyelid, eyelash growth

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

Rare: may affect from 1 user to 1,000 people
Effects on the eye: perception of flashing lights, eczema of the eyelids, eyelashes with abnormal positioning
that grow towards the eye, eye swelling, halo vision, decreased eye sensitivity,
inflammation of the eyelid glands, pigmentation inside the eye, increased
pupil size, thickening of the eyelashes, change in eyelash color, 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,
nasal dryness, changes in voice, gastrointestinal disorders or ulcer,
constipation, dry mouth, skin redness or itching, rash, change in hair color, eyelash loss, joint pain, musculoskeletal pain, generalized weakness.

Not known: frequency cannot be estimated from available data
Effects on the eye:inflammation of the back of the eye, eyes appear 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,
diarrhea, nosebleeds, abdominal pain, nausea, vomiting, itching, abnormal hair growth, painful or involuntary urination, increased prostate cancer marker.
In children and adolescents, the most common side effects observed with TRAVIOP have been eye redness
and eyelash growth. Both side effects have been observed with a higher incidence
in children and adolescents compared to adults.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 which is stated on the bottle and the packaging box 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 openingand a
new bottle should be started. Write the date of opening the bottle in the space on the packaging box.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What TRAVIOP contains
The active ingredient is travoprost 40 micrograms/mL
The other ingredients are: mannitol, trometamol, hydrogenated castor oil polyoxyl 40(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, colorless solution) supplied in a pack containing a
2.5 ml polyethylene bottle.
Pack of 1 bottle.

Marketing Authorisation Holder:
DOC Generici S.r.l. - via Turati 40, 20121 Milano

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

This leaflet was last updated on