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. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What TRAVATAN is and what it is 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 that reduce pressure in the eye, for example beta blockers.

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. Unusual changes to the hair on your eyelids or the skin around your eye have also been seen.
• TRAVATAN may change the color of your iris(the colored part of your eye). This change may be permanent. It may also cause a change in the color of the skin around your eye.
• If you have had cataract surgery, talk to your doctor before using TRAVATAN.
• If you have eye inflammation(uveitis and iritis), talk to your doctor before using TRAVATAN.
• TRAVATAN may, in rare cases, cause shortness of breathor wheezingor increase the symptoms of asthma. If you are concerned about changes to your breathing while using TRAVATAN, talk to your doctor as soon as possible.
• Travoprost may be absorbed through the skin. If the medicine comes into contact with the skin, it should be washed off immediately. This is especially important for women who are pregnant or trying to become pregnant.
• If you wear soft contact lenses, do not apply the drops while wearing them. Wait 15 minutes after applying the drops before putting your lenses back in.

Children and adolescents

TRAVATAN can be used in children from 2 months to less than 18 years of age at the same dose as in adults. TRAVATAN is not recommended for use 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 a suitable method of contraception while using TRAVATAN.

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

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Immediately after applying TRAVATAN you may feel a slight burning sensation in your eye or your vision may become blurred for a short time. Do not drive or use machines until your vision is clear.

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

3. How to use TRAVATAN

Use this medicine exactly as your doctor or the doctor treating the child has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose is

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

Only use TRAVATAN in both eyes if your doctor has told you to do so. Continue the treatment for as long as your doctor or the doctor treating the child has told you to.

TRAVATAN should only be used as eye drops.

• Just before using a bottle for the first time, open the protective sleeve, take out the bottle 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 and gently pull the lower eyelid down to create a pocket, where the drop can fall (figure 2).
• Bring the bottle tip close to the eye. You may find it easier to do this in front of a mirror.
• Do not touch the eye, eyelid, or surrounding areas with the dropperbecause the drops could become contaminated.
• Gently squeeze the bottle to release one drop at a time (figure 3).
• After using TRAVATAN, gently close your eyes and press the inner corner of your eye with your finger for about 1 minute (figure 4). This helps prevent TRAVATAN from entering the rest of your body.
• If you are applying drops to 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 protective sleeve until you are ready to use the bottle.

If a drop falls outside the eye, try again.

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

If you use more TRAVATAN than you should

Flush your eyes with lukewarm water. Do not apply more drops until your next normal dose.

If you forget to use TRAVATAN

Carry on 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 a single day.

If you stop using TRAVATAN

Do not stop using TRAVATAN without talking to your doctor or the doctor treating the child first. 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 on the use of this medicine, ask your doctor or pharmacist.

Continue

4. Possible side effects

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

You can normally continue with your treatment. If the side effects are severe, talk to 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

Eyes:redness of the eye.

Common: may affect up to 1 in 10 people

Eyes:change in iris color (the colored part of the eye), eye pain, discomfort in the eye, dry eye, itching of the eye, irritation of the eye.

Uncommon: may affect up to 1 in 100 people

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

Other effects:increase in allergic symptoms, headache, irregular heartbeat, cough, blocked 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

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

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

Frequency not known: cannot be estimated from the available data

Eyes: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 passing of urine), increase in prostate cancer marker.

In children and adolescents, the most common side effects seen with TRAVATAN are redness of the eye and growth of eyelashes. Both side effects were seen more often 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. Storage of 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 throw away the bottle 4 weeks after you first opened itand 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 throw away 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, propylene glycol, sodium chloride, boric acid, mannitol, and purified water. Small amounts of hydrochloric acid or sodium hydroxide may be added to keep the levels of acidity (pH levels) normal.

Appearance and packaging

TRAVATAN is a liquid (a clear, colorless solution) which 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 enclosed in a protective sleeve.

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 on this medicine from your 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