Travoprost Eg

Package leaflet: Information for the user

TRAVOPROST EG 40 micrograms/ml eye drops, solution

Read all of 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 other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Travoprost EG 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 combination with other eye drops such as beta-blockers, which also reduce pressure.
Travoprost EG is used to reduce elevated intraocular pressure in adults, adolescents, and children
from the age of 2 months. This pressure may lead to a condition called glaucoma.

2. What you should know before using Travoprost EG

Do not use Travoprost EG

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

In such case, consult your doctor.

Warnings and precautions

• Travoprost EG 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 EG 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 undergone cataract surgery, consult your doctor before using Travoprost EG.
• If you currently have or have previously had ocular inflammation (iritis or uveitis), consult your doctor before using Travoprost EG.
• Travoprost EG may rarely cause difficulty in breathing or shortness of breath, or may worsen asthma symptoms. Inform your doctor immediately if you notice any changes in your breathing while using Travoprost EG.
• Travoprost EG can be absorbed through the skin. If any amount of the medicine comes into contact with the skin, wash 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. Wait 15 minutes after using the eye drops before reinserting the lenses.

Children and adolescents
Travoprost EG may be used in children from 2 months of age up to under 18 years of age at the same dose as
adults. The use of Travoprost EG is not recommended in children under 2 months of age.

Other medicines and Travoprost EG
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 EG if you are pregnant. If you think you may be pregnant, consult your doctor immediately. If
you are of childbearing age, use an effective contraceptive method during treatment with Travoprost EG.
Do not use Travoprost EG if you are breastfeeding your baby. Travoprost EG may be excreted in
breast milk.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor for advice before taking this medicine.

Driving and using machines
You may experience blurred vision for a period of time after using Travoprost EG. Do not drive or
operate machinery until these symptoms have resolved.

Travoprost EG contains benzalkonium chloride
If you wear soft contact lenses: Do not use the eye drops while wearing contact lenses. After administering
the eye drops, wait 15 minutes before reinserting contact lenses.
This medicine contains a preservative (benzalkonium chloride) which may cause discoloration of soft contact lenses.
This preservative may also cause eye irritation or disturbances on the surface of the eye.

Travoprost EG contains macrogol glycerol hydroxystearate 40
This medicine contains macrogol glycerol hydroxystearate 40, which may cause skin reactions.

3. How to use Travoprost EG

Take this medicine exactly as directed by your doctor or paediatrician. If
you have any doubts, consult your doctor, paediatrician, or pharmacist.
Recommended dose is
One drop in the affected eye(s), once daily in the evening.

Use Travoprost EG in both eyes only if prescribed by your doctor.
Use it for the length of time recommended by your doctor or paediatrician.
Travoprost EG may only be used as eye drops for you or your child.

1	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 space provided. -Wash your hands. -Unscrew the cap.
2	Hold the bottle between your thumb and fingers, with the tip pointing downwards. -Tilt your 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 into this pocket (figure 2). -Bring the tip of the bottle close to the eye. Using a mirror may be helpful.
3	Do not touch the eye, eyelid, surrounding areas, or any other surface with the dropper tip. The eye drops may become contaminated. -Gently squeeze the bottle to release one drop of Travoprost EG at a time (figure 3). -After using Travoprost EG, keep your eyes closed and apply gentle pressure with one finger at the inner corner of the eye, near the nose (figure 4), for at least 1 minute. This helps prevent Travoprost EG from spreading into the rest of the body.
4	If you need to apply the eye 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 does not enter 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 instilling Travoprost EG and the other preparations.
If you or your child use more Travoprost EG than you should
Wash all the medicine away with warm water. Do not use the eye drops until it is time for the next dose.
If you forget to use Travoprost EG
Continue treatment with the next dose as scheduled. Do not take a double dose to make up for a forgotten dose.
Never use more than one drop per day per affected eye(s).
If you stop using Travoprost EG
Do not stop treatment with Travoprost EG without first consulting your doctor or paediatrician,
as your intraocular pressure or that of your child may not be controlled, possibly resulting in loss of vision.
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 gets them.
You may generally continue using the drops, unless the side effects worsen. If you are concerned, consult your doctor or pharmacist. Do not stop treatment with Travoprost EG without first consulting your doctor.

The following side effects have been observed with Travoprost EG:

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 (coloured part of the eye);
• eye pain;
• eye discomfort;
• dry eye;
• itchy eyes;
• irritation.

Uncommon side effects: may affect up to 1 in 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;
• change in eyelash colour;
• tired eyes.

General side effects:

• worsening of allergy symptoms;
• headache;
• dizziness;
• irregular heartbeat;
• shortness of breath;
• asthma;
• nasal congestion;
• throat irritation;
• darkening of the skin around the eye(s);
• darkening of the skin;
• abnormal hair structure;
• excessive hair growth.

Rare side effects: may affect up to 1 in 1,000 people
Eye effects:

• perception of flashing lights;
• eyelid eczema;
• eye swelling;
• halos around lights;
• decreased eye sensitivity;
• inflammation of the eyelid glands;
• pigmentation inside the eye;
• increased pupil size;
• changes in eyelash structure.

General side effects:

• viral eye infection;
• unpleasant taste;
• irregular or reduced heart rate;
• increased or decreased blood pressure;
• cough;
• voice changes;
• gastrointestinal disorders or ulcer;
• constipation;
• dry mouth;
• skin redness or itching;
• skin rash;
• change in hair colour;
• eyelash loss;
• musculoskeletal pain;
• generalized weakness.

Not known: frequency cannot be estimated from the available data
Eye effects:

• inflammation of the back of the eye;
• sunken appearance of the eyes.

General side effects:

• depression;
• anxiety;
• false sensation of movement;
• ringing in the ears;
• chest pain;
• worsening of asthma;
• diarrhea;
• abdominal pain;
• nausea;
• itching;
• abnormal hair growth;
• joint pain;
• painful or involuntary urination;
• increase in prostate cancer marker.

In children and adolescents, the most common side effects observed with Travoprost EG 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.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Travoprost EG

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 the word "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 first use.
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.
To prevent infections, you must discard the bottle 4 weeks after first opening and use a new bottle.
Record the date of opening in the designated space on the label of the bottle and 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 Travoprost EG contains

• The active substance is travoprost. This medicinal product contains 40 micrograms/ml of travoprost.
• The other components are benzalkonium chloride, macrogol glycerol hydroxystearate 40, trometamol, disodium edetate, boric acid, mannitol, sodium hydroxide for pH adjustment, and water for injections.

Description of the appearance of Travoprost EG and contents of the pack
Travoprost EG is a clear, colourless solution. The packs contain one or more translucent polypropylene bottles of 5 ml, complete with a transparent low-density polyethylene (LDPE) dropper and a white tamper-evident screw cap made of high-density polyethylene (HDPE), packaged in a protective overwrap. Each bottle contains 2.5 ml of solution.
The product is available in the following pack sizes: cartons containing 1, 3, 6, 9, 10 or 12 bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., Via Pavia 6 - 20136 Milano
Manufacturer responsible for batch release
Pharmathen S.A., 6 Dervenakion str., 15351 Pallini, Attiki – Greece
BALKANPHARMA-RAZGRAD AD, 68 Aprilsko vastanie Blvd., Razgrad, 7200 - Bulgaria
STADA Arzneimittel GmbH, Muthgasse 36 1190 Wien – Austria
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel - Germany
Centrafarm Services B.V., Nieuwe Donk 9, 4879 AC Etten-Leur – Netherlands

This medicinal product is authorised in the European Economic Area countries with the following names: