Travoprost Doc Generici

Patient Information Leaflet

TRAVOPROST DOC Generici 40 micrograms/ml eye drops, solution

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

1. What TRAVOPROST DOC Generici is and what it is used for

TRAVOPROST DOC Generici eye drops is used to treat elevated pressure inside the eye in adults, adolescents, and children from the age of 2 months. This pressure can lead to a condition called glaucoma.
High eye pressure. The eyeballs contain a clear, watery fluid that nourishes the inside of the eye. This fluid continuously drains out of the eye while new fluid is constantly produced inside. If the eye fills more quickly than it empties, the pressure inside the eye increases. If this becomes too high, it may damage vision.
TRAVOPROST DOC Generici belongs to a group of glaucoma medicines called prostaglandin analogues. It works by increasing fluid outflow, thereby reducing pressure in the eye. It may be used alone or in combination with other eye drops, such as beta-blockers, which also help reduce pressure.

2. What you need to know before using TRAVOPROST DOC Generici

Do not use TRAVOPROST DOC Generici

• 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 DOC Generici

• TRAVOPROST DOC Generici may increase the length, thickness, colour and/or number of eyelashes. Changes to the eyelids or tissues around the eye, including abnormal hair growth, have also been observed.
• TRAVOPROST DOC Generici 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 recently undergone cataract surgery, consult your doctor before using TRAVOPROST DOC Generici.
• if you currently have or have previously had ocular inflammation (iritis or uveitis), consult your doctor before using TRAVOPROST DOC Generici.
• TRAVOPROST DOC Generici may rarely cause difficulty breathing or shortness of breath, or worsen symptoms of asthma. If you notice that using this medicine causes changes in your breathing, inform your doctor immediately.
• TRAVOPROST DOC Generici may be absorbed through the skin. If any amount of 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 your lenses. Wait 15 minutes after using the eye drops before reinserting your lenses.

Children and adolescents
TRAVOPROST DOC Generici may be used in children from 2 months of age up to less than 18 years of age at the same dose as adults. The use of TRAVOPROST DOC Generici is not recommended in children under 2 months of age.
Other medicines and TRAVOPROST DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Do not use TRAVOPROST DOC Generici during pregnancy. Speak immediately with your doctor if you think you may be pregnant. If there is a possibility you could become pregnant, use an effective contraceptive method while taking this medicine.
Do not use TRAVOPROST DOC Generici if you are breastfeeding. This medicine may pass into breast milk.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
You may experience blurred vision for a period of time after using TRAVOPROST DOC Generici. Do not drive or operate machinery until these symptoms have resolved.
TRAVOPROST DOC Generici contains benzalkonium chloride.
This medicine contains 150 micrograms of benzalkonium chloride per mL of solution.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause 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 (damage to the transparent outer layer of the eye). If you experience any unusual sensation, burning, or pain in the eye after using this medicine, speak to your doctor.
TRAVOPROST DOC Generici contains macrogol glycerol hydroxystearate 40
This medicine contains macrogol hydroxystearate 40, which may cause skin reactions.

3. How to use TRAVOPROST DOC Generici

Use this medicine exactly as directed by your doctor or paediatrician. If
you have any doubts, consult your doctor, paediatrician or pharmacist.
TRAVOPROST DOC Generici may only be used as an eye drop.
Recommended dose
One drop in the affected eye(s) once daily – in the evening. Use TRAVOPROST
DOC Generici in both eyes only if your doctor has instructed you to do so. Use the medicine for
the length of time prescribed by your doctor or paediatrician.

1	Immediately before using the bottle for the first time, open the outer protective wrapper (figure 1). Remove the bottle and write the opening date on the label in the designated space. -Take the medicine bottle and a mirror -Wash your hands -Unscrew the cap
2	Hold the bottle in your hand between your thumb and other fingers, with the bottle pointing downward. -Tilt your head back or gently tilt the child's head backward. Pull down the lower eyelid with a clean finger to form a "pocket" between the eyelid and the eye. The drop should be placed here (figure 2). -Hold 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 may 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 spreading to the rest of the body.
4	If you need to apply the eye drops to both eyes, repeat the same steps for the other eye. -Close the bottle cap tightly immediately after use. -Use only one bottle at a time. Do not open the outer protective wrapper until it is time 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 use more TRAVOPROST DOC Generici than you should
Rinse all the medicine out of the eye with lukewarm water. Do not instill any more eye drops until
the time of the next scheduled dose.
If you forget to use TRAVOPROST DOC Generici
Continue with the next dose as planned. 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 TRAVOPROST DOC Generici
Do not stop using this medicine without first talking to your doctor or paediatrician.
This is because the pressure inside the eye will not be controlled, which could lead to loss of vision.
If you or the child are using other eye preparations such as drops or ointments, leave at least
5 minutes between the instillation of TRAVOPROST DOC Generici and the instillation of other
preparations.
If you have any doubts about how to use this medicine, consult your doctor, paediatrician or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get 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 taking TRAVOPROST DOC Generici without first discussing it with your doctor.

The following side effects have been observed with travoprost.

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

• Eye redness

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

• Changes in iris colour (the coloured part of the eye)
• Eye pain
• Eye discomfort
• Dry eye
• Itchy eyes
• Eye irritation

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

• Corneal disorder
• Eye inflammation
• Iritis (inflammation of the iris)
• 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
• Blurred vision
• Increased lacrimation
• Conjunctival infection or inflammation (conjunctivitis)
• Abnormal outward turning of the lower eyelid
• Eye cloudiness
• Crusting of the eyelids
• 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 up to 1 in 1,000 people)
Eye disorders:

• Perception of flashing lights
• Eyelid eczema
• Misdirected eyelashes growing towards the eye
• Eye swelling
• Reduced vision
• Halos around lights
• Decreased eye sensitivity
• Inflammation of the eyelid glands
• Pigmentation inside the eye
• Increased pupil size
• Thickening of eyelashes
• 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
• Nasal allergy or inflammation
• Dry nose
• Voice changes
• Gastrointestinal disorders or ulcer
• Constipation
• Dry mouth
• Skin redness or itching
• Rash
• Hair colour change
• Loss of eyelashes
• Joint pain
• Musculoskeletal pain
• Generalised weakness

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

• Inflammation of the back of the eye
• Eyes appearing sunken

General side effects:

• Depression
• Anxiety
• Insomnia
• 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 travoprost have been eye redness and eyelash growth. Both of these side effects have been observed with 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, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: 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 DOC Generici

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 opening.
Before opening, keep the bottle in the original packaging to protect the medicine 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.
Record the date of opening the bottle in the space provided on the label of each bottle and carton.
Do not dispose of medicines via wastewater or household waste. 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 DOC Generici contains

• The active substance is travoprost. This medicine contains 40 micrograms/mL of travoprost.
• The other components are: benzalkonium chloride, macrogol glycerol hydroxystearate 40, tromethamine, disodium edetate, boric acid (E284), mannitol (E241), sodium hydroxide for pH adjustment, and water for injections or purified water.

Description of the appearance of TRAVOPROST DOC Generici and contents of the pack
TRAVOPROST DOC Generici is a clear, colourless solution supplied in packs containing
one 5 mL bottle made of translucent polypropylene, with a transparent dropper applicator made of low-density polyethylene (LDPE) and a white screw cap made of high-density polyethylene (HDPE), child-resistant, packed in a protective pouch. Each bottle contains 2.5 mL of solution.
The medicine is available in the following pack sizes: boxes containing 1 or 3 bottles.
Not all pack sizes may be marketed.

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

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

This medicine is authorised in the Member States of the European Economic Area under the following names: