TRAVATAN 40 micrograms/ml eye drops, solution

Introduction

Package Leaflet: Information for the User

TRAVATAN 40 micrograms/ml eye drops, solution

travoprost

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist, even if you have read it in this leaflet. See section 4.

Contents of the pack

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

1. What is TRAVATAN and what is it used for

TRAVATAN contains travoprostwhich belongs to a group of medicines called prostaglandin analogues. It works by reducing the pressure in the eye. It can be used on its own or with other eye drops, for example beta blockers, which also reduce the pressure in the eye.

TRAVATAN is used to reduce high pressure in the eye 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 you use TRAVATAN

Do not use TRAVATAN

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

Tell your doctor if you are in this situation.

Warnings and precautions

• TRAVATAN may increasethe length, thickness, color and/or number of your eyelashes. Changes such as unusual hair growth on your eyelids or around your eyes have also been observed.
• TRAVATAN may change the color of your iris(the colored part of your eye). This change may be permanent. It can also cause a change in the color of the skin around your eyes.
• If you have had cataract surgery, consult your doctor before using TRAVATAN.
• If you suffer or have suffered from eye inflammation(iritis and uveitis), consult your doctor before using TRAVATAN.
• TRAVATAN may, in rare cases, cause shortness of breathor noisy breathingor increase the symptoms of asthma. If you are concerned about changes in your breathing while using TRAVATAN, consult your doctor as soon as possible.
• Travoprost may be absorbed through the skin. In caseof contactof the medicine with the skin, it should be removed by washingimmediately. This is especially important in pregnant or breast-feeding women.
• If you wear soft contact lenses, do not apply the drops while wearing them. After applying the drops, wait 15 minutes before putting your lenses back in.

Children and adolescents

TRAVATAN can be used in children from 2 months of age to less than 18 years of age with the same dose as in adults. The use of TRAVATAN is not recommended in children under 2 months of age.

Other medicines and TRAVATAN

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Pregnancy, breast-feeding and fertility

Do not use TRAVATAN if you are pregnant. If you could be pregnant, tell your doctor. If you can become pregnant, use an effective method of birth control while using TRAVATAN.

Do not use TRAVATAN if you are breast-feeding. TRAVATAN may pass into breast milk.

Consult your doctor before using any medicine.

Driving and using machines

Immediately after applying TRAVATAN, you may notice that your vision becomes blurred. Do not drive or use machines until these effects have disappeared.

TRAVATAN contains hydrogenated castor oil and propylene glycol, which may cause skin reactions and irritation.

3. How to use TRAVATAN

Follow exactly the instructions of your doctor or the doctor treating the child. If you are unsure, consult your doctor, the doctor treating the child, or pharmacist.

The recommended dose is

One drop in the affected eye(s) once a day - in the evening.

TRAVATAN should only be applied in both eyes if your doctor has told you to do so. Continue the treatment for the whole period of time prescribed by your doctor or the doctor treating the child.

TRAVATAN should only be used as eye drops.

• Immediately before using a bottle for the first time, open the protective foil pouch, take out the bottle (figure 1), and write the date you opened it on the space provided on the carton.
• Wash your hands.
• Remove the cap.
• Hold the bottle upside down between your fingers.
• Tilt your head or the child's head back gently. Gently pull the lower eyelid away from the eye to form a pocket, where the drop should fall (figure 2).
• Bring the tip of the bottle close to the eye. You may find it helpful to use a mirror.
• Do not touch the eye, eyelid, or surrounding areas with the dropper, because the drops could become contaminated.
• Gently squeeze the bottle to release one drop of TRAVATAN at a time (figure 3).
• After using TRAVATAN, gently close your eyes, and press the edge of your eye next to your nose (figure 4)for at least 1 minute. This helps prevent TRAVATAN from getting into the rest of your body.
• If you are applying drops in both eyes, repeat the steps for the other eye.
• Close the bottle tightly after use.
• Use one bottle at a time. Do not open the pouch until you are ready to use the bottle.

If a drop falls outside the eye, try again.

If you or the child are using other eye medicines, such as eye drops or ointments, wait at least 5 minutes between applying TRAVATAN and the other eye medicines.

If you or the child get more TRAVATAN than needed

You can flush it out with warm water. Do not apply more drops until it is time for the next dose.

If you forget to use TRAVATAN

Continue with the next dose as planned. Do not apply a double doseto make up for a forgotten dose. Never apply more than one drop in the affected eye(s) in one day.

If you stop using TRAVATAN

Do not stop using TRAVATAN without consulting your doctor or the doctor treating the child, as the pressure in your eye or the child's eye will not be controlled, which could lead to loss of vision.

If you have any other questions about using this medicine, ask your doctor, the doctor treating the child, or pharmacist.

Continue

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You can carry on using the treatment as usual, unless the side effects are serious. If they are, tell your doctor or pharmacist. Do not stop using TRAVATAN without talking to your doctor.

The following side effects have been seen with TRAVATAN:

Very common: may affect more than 1 in 10 people

Eye effects:redness of the eye.

Common: may affect up to 1 in 10 people

Eye effects:changes in iris color (the colored part of the eye), eye pain, discomfort in the eye, dry eye, itching in the eye, irritation in the eye.

Uncommon: may affect up to 1 in 100 people

Eye effects:corneal changes, eye inflammation, iris inflammation, inflammation inside the eye, inflammation with or without damage to the surface of the eye, sensitivity to light, eye discharge, eyelid inflammation, eyelid redness, swelling around the eye, itching of the eyelid, blurred vision, increased tear production, conjunctivitis (inflammation or infection of the conjunctiva), abnormal turning out of the lower eyelid, darkened vision, crusts on the eyelid, eyelash growth.

Other effects:increased allergic symptoms, headache, irregular heartbeat, cough, stuffy nose, sore throat, darkening of the skin around the eyes, darkening of the skin, abnormal hair texture, excessive hair growth.

Rare: may affect up to 1 in 1,000 people

Eye effects:flashes of light, eyelid eczema, abnormally positioned eyelashes that grow towards the eye, eye swelling, reduced vision, halos around lights, decreased sensation in the eye, inflammation of the eyelid glands, pigmentation inside the eye, increased pupil size, thickening of the eyelashes, change in eyelash color, tired eyes.

Other effects:viral eye infection, dizziness, bad taste, irregular or decreased heartbeat, increased or decreased blood pressure, shortness of breath, asthma, nasal inflammation or allergy, nasal dryness, voice changes, gastrointestinal ulcer or discomfort, constipation, dry mouth, skin redness or itching, rash, hair color change, loss of eyelashes, joint pain, muscle pain, general weakness.

Frequency not known: cannot be estimated from the available data

Eye effects:inflammation of the back of the eye, sunken eyes.

Other effects:depression, anxiety, insomnia, feeling of false movement, ringing in the ears, chest pain, irregular heartbeat, increased heart rate, worsening of asthma, diarrhea, nosebleeds, abdominal pain, nausea, vomiting, itching, abnormal hair growth, painful or involuntary urination (painful or involuntary urination), increased prostate cancer marker.

In children and adolescents, the most common side effects seen with TRAVATAN are redness of the eye and eyelash growth. Both side effects were seen more frequently 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 via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing TRAVATAN

Keep this medicine out of the sight and reach of children.

Do not use TRAVATAN after the expiry date which is stated on the bottle and the carton after “EXP”. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

To avoid infections, you must discard the bottle 4 weeks after you first open it, and use a new bottle. Write the date you opened it on the space provided on the carton.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What TRAVATAN contains

The active substance is travoprost 40 micrograms/ml.

The other ingredients are: Polyquaternium-1, hydrogenated castor oil, and polyoxyethylene 40, propylene glycol, sodium chloride, boric acid, mannitol, and purified water. Small amounts of hydrochloric acid or sodium hydroxide are added to maintain normal levels of acidity (pH levels).

Appearance and packaging

TRAVATAN is a liquid (a clear, colorless solution) that comes in a carton containing a 4 ml plastic bottle with a screw cap. Each bottle contains 2.5 ml of travoprost eye drops, and each bottle is 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 Nürnberg

Germany

You can get more information about this medicine by contacting the local representative of the marketing authorisation holder:

Date of last revision of this leaflet

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu