Travatan 40 micrograms/ml eye drops solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

TRAVATAN 40 micrograms/ml eye drops solution

travoprost

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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, which belongs to a group of medicines called prostaglandin analogues. It works by reducing pressure inside the eye. It can be used alone or in combination with other eye drops, such as beta-blockers, which also lower eye pressure.

TRAVATAN is used to reduce elevated intraocular pressure in adults, adolescents, and children from 2 months of age. This pressure can lead to a condition known as 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).

Consult your doctor if you are in this situation.

Warnings and precautions

• TRAVATAN may increase the length, thickness, color, and/or number of your eyelashes. Changes such as unusual growth of hair on the eyelids or in the tissues around the eye have also been observed.
• TRAVATAN may alter the color of the iris (the colored part of the eye). This change may be permanent. It may also cause a change in skin color around the eye.
• If you have undergone cataract surgery, consult your doctor before starting to use TRAVATAN.
• If you currently have or have previously had eye inflammation (iritis or uveitis), consult your doctor before starting to use TRAVATAN.
• TRAVATAN may, rarely, cause shortness of breath or noisy breathing, or worsen 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 case of contact of the medicine with the skin, it should be removed by washing 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. After applying the drops, wait 15 minutes before reinserting your contact lenses.

Children and adolescents

TRAVATAN may be used in children from 2 months of age to under 18 years of age at the same dose as in adults. 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 need to take any other medicines.

Pregnancy, breast-feeding and fertility

Do not use TRAVATAN if you are pregnant. If you think you may be pregnant, inform your doctor immediately. If you could become pregnant, you should use an appropriate contraceptive method 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 blurred vision. Do not drive or operate machinery until this effect has passed.

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

3. How to use TRAVATAN

Follow exactly the administration instructions for this medicine given by your doctor or the doctor treating the child. If in doubt, consult your doctor, the child's doctor, or pharmacist again.

The recommended dose is

One drop in the affected eye or eyes, once daily – in the evening.

TRAVATAN should be applied to both eyes only if your doctor instructs you to do so. Continue treatment for the entire duration prescribed by your doctor or the doctor treating the child.

TRAVATAN should only be used as eye drops for your eyes or for children's eyes.

• Immediately before using a bottle for the first time, open the outer pouch, remove the bottle (Figure 1), and write down the date of opening in the space provided on the carton.
• Wash your hands.
• Unscrew the cap.
• Hold the bottle upside down between your fingers.
• Gently tilt your head or the child's head backward. Gently pull down the eyelid to form a small pocket, into which the drop should be instilled (Figure 2).
• Bring the tip of the bottle close to the eye. A mirror may be helpful.
• Do not touch the eye, eyelid, surrounding areas, or any other surface with the dropper tip, as this could contaminate the drops.
• Gently squeeze the bottle so that one drop of TRAVATAN falls into the eye (Figure 3).
• After using TRAVATAN, close your eyes gently and softly press your finger against the inner corner of the eye, near the nose (Figure 4) for at least 1 minute. This helps prevent TRAVATAN from draining into the rest of the body.
• If applying drops to both eyes, repeat the above steps for the other eye.
• Close the bottle tightly immediately after using the product.
• Use only one bottle at a time. Do not open the pouch until you are ready to use the bottle.

If a drop misses the eye, try again.

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

If you or the child have used more TRAVATAN than you should

You can remove it by rinsing the eyes with lukewarm water. Do not apply further drops until your next scheduled dose.

If you forget to use TRAVATAN

Continue with your next scheduled dose. Do not use a double dose to make up for the missed 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 first consulting your doctor or the child's doctor, as the pressure in your eye or the child's eye will not be controlled, which could lead to vision loss.

If you have any further questions about the use of this medicine, ask your doctor, the child's doctor, or pharmacist.

Continues

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

You may continue treatment as usual unless the adverse effects are severe. If you are concerned about any of these effects, consult your doctor or pharmacist. Do not stop using TRAVATAN without first consulting your doctor.

The following adverse effects have been observed with TRAVATAN:

Very common: may affect more than 1 in 10 people

Eye effects: eye redness.

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

Eye effects: corneal disorder, eye inflammation, iris inflammation, intraocular inflammation, inflammation with or without damage to the eye surface, light sensitivity, eye discharge, eyelid inflammation, eyelid redness, swelling around the eye, eyelid itching, blurred vision, increased tear production, conjunctival infection or inflammation (conjunctivitis), abnormally turned outward lower eyelid, darkened vision, eyelid crusting, eyelash growth.

Other effects: worsening of allergic symptoms, headache, irregular heartbeat, cough, nasal congestion, throat irritation, darkening of the skin around the eyes, skin darkening, abnormal hair texture, excessive growth of body hair.

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

Eye effects: perception of flashes of light, eyelid eczema, abnormally positioned eyelashes growing into the eye, eye swelling, reduced vision, visual halos, decreased sensation in the eye, inflammation of eyelid glands, pigmentation inside the eye, increased pupil size, eyelash thickening, change in eyelash color, eye fatigue.

Other effects: viral eye infection, dizziness, bad taste in mouth, irregular or slow heart rate, 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, change in hair color, eyelash loss, joint pain, musculoskeletal pain, generalised weakness.

Frequency not known: cannot be estimated from available data

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

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

In children and adolescents, the most commonly observed adverse effects with TRAVATAN are eye redness and eyelash growth. Both of these adverse effects occurred at a higher incidence in children and adolescents compared to adults.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the bottle and carton, after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

To prevent infections, the bottle must be discarded 4 weeks after first opening, and a new bottle should be used. Write down the date of opening in 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 and packaging that you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of TRAVATAN

The active substance is travoprost 40 micrograms/ml.

The other components are: Polyquaternium-1, polyoxyl 40 hydrogenated castor oil, propylene glycol, sodium chloride, boric acid, mannitol, and purified water. Very small amounts of hydrochloric acid or sodium hydroxide may be added to adjust the acidity (pH levels) to normal.

Appearance of the product and contents of the container

TRAVATAN is a liquid (a colourless, clear solution) supplied in a box containing one 4 ml plastic bottle with a screw cap. Each bottle contains 2.5 ml of travoprost ophthalmic solution, and each bottle is enclosed in a pouch.

Pack sizes: 1 or 3 bottles.

Only certain pack sizes may be marketed.

Marketing Authorization 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
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

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

Date of the latest revision of this leaflet

Other sources of information

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