Package Insert: Information for the User

TRAVATAN 40 micrograms/mL Eye Drops Solution

travoprost

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

TRAVATANcontains travoprostwhich belongs to a group of medications calledprostaglandin analogs. It works by reducing eye pressure. It can be used alone or with other eye drops, for example with beta-blockers, which also reduce eye pressure.

TRAVATANis used to reduce high eye pressure in adults, adolescents, and children aged 2 months and older. This pressure can lead to a disease calledglaucoma.

Do not use TRAVATAN

• If you are allergic to travoprost or any of the other components of this medication (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.It may also cause changes such as unusual hair growth on the eyelids or surrounding eye tissues.
• 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 the skin color around the eye.
• If you have undergone cataract surgery, consult your doctor before starting to use TRAVATAN.
• If you suffer or have previously suffered from eye inflammation (iritis and uveitis), consult your doctor before starting to use TRAVATAN.
• TRAVATAN may, in rare cases, cause shortness of breath or noisy breathing or increase asthma symptoms. 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 the event of contact of the medication with the skin, it must be removed immediately by washing.This is especially important in pregnant women or those 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 the lenses.

Children and adolescents

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

Other medications and TRAVATAN

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy, breastfeeding, and fertility

Do not use TRAVATAN if you are pregnant.If you think you may be pregnant, tell your doctor immediately. If you can become pregnant, use an appropriate contraceptive method while using TRAVATAN.

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

Consult your doctor before using any medication.

Driving and operating machinery

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

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

Follow exactly the administration instructions of this medication indicated by your doctor or the child's doctor. In case of doubt, consult your doctor, the child's doctor, or pharmacist again.

The recommended dose is

One drop in the affected eye or eyes, once a day - at night.

TRAVATAN should only be applied to both eyes if your doctor instructs you to do so. Follow the treatment for the entire period of time indicated by your doctor or the child's doctor.

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

• Immediately before using a bottle for the first time, open the packaging bag, remove the bottle(figure 1)and note the opening date in the reserved space on the box.
• Wash your hands.
• Remove the cap.
• Hold the bottle, upside down, between your fingers.
• Incline your head or the child's head slightly backward. Gently separate the eyelid from the eye with your finger, until a pouch forms, in which the drop should fall(figure 2).
• Bring the tip of the bottle close to the eye. It may be helpful to use a mirror.
• Do not touch the eye, eyelid, nearby areas, or other surfaces with the dropper, because the drops could become infected.
• Press the bottle gently to allow one drop of TRAVATAN to fall each time(figure 3).
• After using TRAVATAN, close your eyes gently, and with gentle pressure, press the edge of the eye, near the nose(figure 4)for at least 1 minute. This helps to prevent TRAVATAN from passing into the rest of the body.
• If drops are applied to both eyes, repeat the above steps for the other eye.
• Close the bottle tightly immediately after using the product.
• Use a single bottle at a time. Do not open the packaging bag until you need to use the bottle.

If a drop falls outside 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 the application of TRAVATAN and the other eye medications.

If you or the child receive more TRAVATAN than you should

You can remove it by washing the eyes with warm water. Do not apply more drops until the next scheduled dose.

If you forget to use TRAVATAN

Continue with the next scheduled dose. Do not apply a double dose to compensate for the missed dose. Never apply more than one drop to the affected eye(s) in a single day.

If you interrupt treatment with TRAVATAN

Do not stop using TRAVATAN without consulting your doctor or the child's doctor first, as uncontrolled eye pressure could lead to vision loss.

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

Continue

Like all medications, this medication may cause side effects, although not everyone will experience them.

You can continue with the treatment unless the side effects are severe. If these side effects concern you, consult your doctor or pharmacist. Do not stop applying TRAVATAN without consulting your doctor.

The following side 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:change in iris color (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 alteration, eye inflammation, iris inflammation, inflammation within the eye, inflammation with or without damage to the eye surface, light sensitivity, eye secretion, eyelid inflammation, eyelid redness, swelling around the eye, eyelid itching, blurry vision, increased tear production, conjunctivitis (infection or inflammation of the conjunctiva), abnormal outward turning of the lower eyelid, darkened vision, eyelid crusts, eyelash growth.

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

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

Eye effects:perception of light flashes, eyelid eczema, eyelashes abnormally positioned that grow towards the eye, eye swelling, reduced vision, halo vision, decreased eye sensation, eyelid gland inflammation, pigmentation within the eye, increased pupil size, eyelash thickening, change in eyelash color, tired eyes.

Other effects:ocular viral infection, dizziness, bad taste, irregular heart rate or decreased, 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, eyelash loss, joint pain, muscle and skeletal pain, generalized weakness.

Frequency not known: cannot be estimated from available data

Eye effects:posterior eye inflammation, sunken eyes.

Other effects:depression, anxiety, insomnia, false sense of movement, tinnitus, chest pain, abnormal heart rhythm, increased heart rate, asthma worsening, diarrhea, nasal bleeding, abdominal pain, nausea, vomiting, itching, abnormal hair growth, painful or involuntary urination (involuntary urination or painful urination), increased prostate cancer marker.

In children and adolescents, the most common side effects observed with TRAVATAN are eye redness and eyelash growth. Both side effects were observed at a higher incidence in children and adolescents compared to adults.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use TRAVATAN after the expiration date that appears on the bottle and on the box, after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

To prevent infections,you must discard the bottle 4 weeks after opening it for the first time, and use a new bottle. Note the opening date in the reserved space on the box.

Medications should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and medications that you do not need. In this way, you will help protect the environment.

Composition of TRAVATAN

The active ingredient is travoprost 40 micrograms/mL.

The other components are: Polyquaternium-1, hydrogenated and polyoxylated ricin oil 40, propylene glycol, sodium chloride, boric acid, mannitol, and purified water. Small amounts of hydrochloric acid or sodium hydroxide are added to maintain normal pH levels.

Appearance of the product and contents of the package

TRAVATAN is a clear and transparent liquid solution that comes in a box containing a 4 mL plastic vial with a screw cap. Each vial contains 2.5 mL of travoprost eye drops, and each vial is inside a pouch.

Package sizes: 1 or 3 vials.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Responsible for manufacturing

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

For more information about this medication, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet

Other sources of information

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