Travatan

Package leaflet: Information for the user

TRAVATAN 40 micrograms/mL eye drops, solution

travoprost
Read this entire leaflet carefully before you start using this medicine, as 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 yours, as it may 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 TRAVATAN is and what it is used for
2. What you need to know before using TRAVATAN
3. How to use TRAVATAN
4. Possible side effects
5. How to store TRAVATAN
6. Contents of the pack and other information

1. What TRAVATAN is and what it is used for

TRAVATAN 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 help reduce pressure.
TRAVATAN 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 need to know before using TRAVATAN

Do not use TRAVATAN

• 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

• TRAVATAN may increase the length, thickness, color, and/or number of your eyelashes. Changes in the eyelids or tissues around the eye, including abnormal hair growth, have also been observed.
• TRAVATAN may change the color of your iris (the colored part of the eye). This change may be permanent. A change in the color of the skin around the eye may also occur.
• If you have undergone cataract surgery, consult your doctor before using TRAVATAN.
• If you currently have or have previously had ocular inflammation (iritis and uveitis), consult your doctor before using TRAVATAN.
• TRAVATAN may rarely cause difficulty breathing, shortness of breath, or worsen symptoms of asthma. Inform your doctor immediately if you notice that using TRAVATAN causes changes in your breathing.
• Travoprost may be absorbed through the skin. If any amount of the 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 the lenses. Wait 15 minutes after using the eye drops before reinserting the lenses.

Children and adolescents
TRAVATAN 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 TRAVATAN is not recommended in children under 2 months of age.
Other medicines and TRAVATAN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breast-feeding and fertility
Do not use TRAVATAN during pregnancy. Speak immediately with your doctor if you suspect you are pregnant. If you are of childbearing age, use an effective contraceptive method during treatment.
Do not use TRAVATAN while breast-feeding. TRAVATAN 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 after using TRAVATAN. Do not drive or operate machinery until these symptoms have resolved.
TRAVATAN contains hydrogenated castor oil and propylene glycol, which may cause skin reactions and irritation.

3. How to use TRAVATAN

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 TRAVATAN in both eyes only if prescribed by your doctor. Use the medicine for as long as
recommended by your doctor or paediatrician.
TRAVATAN may only be used as an eye drop.

1 2 3 4

• 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 the bottle in the designated space on the carton.
• Wash your hands.
• Unscrew the cap.
• Hold the bottle between your thumb and other 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 TRAVATAN at a time (figure 3).
• After using TRAVATAN, 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 TRAVATAN from spreading 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 one bottle at a time. Do not open the outer protective pouch until it is time to use the bottle.

If a drop does not enter the eye, try again.
If you or the child are using other eye preparations such as eye drops or ointments at the same time,
wait at least 5 minutes between instilling TRAVATAN and the other preparations.
If you or the child use more TRAVATAN than you should
Rinse the eye thoroughly with lukewarm water. Do not use the eye drops until the next scheduled dose.
If you forget to use TRAVATAN
Continue treatment with the next dose as planned. Do not take a double dose to make up for a missed dose. Never use more than one drop per day in each affected eye.
If you stop using TRAVATAN
Do not stop treatment with TRAVATAN without first talking to your doctor or paediatrician, as intraocular pressure will not be controlled, which may result in possible vision loss.
If you have any doubts about how to use the medicine, consult your doctor, paediatrician, or pharmacist.
Now turn the page

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You can generally continue using the drops unless the side effects are severe.
If you are concerned, speak to your doctor or pharmacist. Do not stop treatment with TRAVATAN without first discussing it with your doctor.

The following side effects have been observed with TRAVATAN:

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 eye, 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 lacrimation, 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, 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 flickering lights, eyelid eczema, abnormally positioned eyelashes growing 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, 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, nasal dryness, voice changes, gastrointestinal disorders or ulcer, constipation, dry mouth, skin redness or itching, 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 TRAVATAN 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 through the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TRAVATAN

Keep this medicine out of the sight and reach of children.
Do not use TRAVATAN after the expiry date stated on the bottle and 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 should be started. Write the date of first opening in the space provided on the carton.
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 TRAVATAN contains
The active substance is travoprost 40 micrograms/mL.
The other components are Polyquaternium-1, polyoxyl 40 hydrogenated castor oil (HCO-40),
propylene glycol, sodium chloride, boric acid, mannitol, and purified water. To maintain normal
acidity levels (pH levels), small amounts of hydrochloric acid or sodium hydroxide are added.

Description of the appearance of TRAVATAN and package contents
TRAVATAN is a liquid (a clear, colourless solution) supplied in a package containing a 4 mL plastic bottle with a screw cap. Each bottle contains 2.5 mL of travoprost eye drops and is enclosed in a pouch.
Pack sizes: 1 or 3 bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Manufacturing NV
Rijksweg 14
2870 Puurs-Sint-Amands
Belgium
Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany
Siegfried El Masnou, S.A.
Camil Fabra 58
El Masnou
08320 Barcelona
Spain
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: + 421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu