Label: information for the user

DuoTrav 40micrograms/mL+5mg/mL eye drop solution

travoprost/timolol

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

• Keep this label, as you may need to refer to 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 even if they 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 label. See section4.

1.What is DuoTrav and for what it is used

2.What you need to know before starting to use DuoTrav

3.How to use DuoTrav

4.Possible adverse effects

5.Storage of DuoTrav

6.Contents of the package and additional information

DuoTrav eye drops in solution is an association of two active substances (travoprost and timolol). Travoprost is a prostaglandin analog that acts by increasing the outflow of aqueous fluid from the eye, thereby reducing the pressure in the eye. Timolol is a beta-blocker that acts by reducing the formation of fluid inside the eye. The two substances act together to reduce the pressure inside the eye.

DuoTrav eye drops are used to treat high eye pressure in adults, including elderly patients. This pressuremay lead to a disease called glaucoma.

Do not use DuoTrav

• if you are allergic to travoprost, prostaglandins, timolol, beta blockers, or any of the other components of this medication (listed in section6).
• if you currently have or have had in the past respiratory problemssuch as asthma, severe chronic obstructive pulmonary disease (a serious lung condition that can cause wheezing, difficulty breathing, and/or persistent coughing) or other types of respiratory problems.
• if you have severe hay fever.
• if you have a slow heart rate, heart failure, or a heart rhythm disorder (irregular heartbeat).
• if the surface of your eye is cloudy.

Consult your doctor if you are in any of these situations.

Warnings and precautions

Consult your doctor before starting to use DuoTrav if you currently have or have had in the past

• coronary heart disease (symptoms may include chest tightness or pain, shortness of breath, or feeling of choking), heart failure, low blood pressure.
• heart rhythm disorders such as slow heart rate.
• respiratory problems, asthma, or chronic obstructive pulmonary disease.
• circulatory disorders (such as Raynaud's disease or Raynaud's syndrome).
• diabetes (since timolol may mask the signs and symptoms of low blood sugar).
• hyperthyroidism (since timolol may mask the signs and symptoms of thyroid disease).
• myasthenia gravis (chronic muscle weakness).
• cataract surgery.
• eye inflammation.

If you need to undergo any type of surgery, inform your doctor that you are using DuoTrav, as timolol may modify the effects of some medications used during anesthesia.

If you experience any severe allergic reaction (skin rash, eye redness, and itching) while using DuoTrav, regardless of the cause, adrenaline treatment may not be as effective. Therefore, it is essential to inform your doctor that you are using DuoTrav when receiving any other treatment.

DuoTrav may change the color of your iris (the colored part of your eye). This change may be permanent.

DuoTrav may increase the length, thickness, color, and/or number of your eyelashes and may cause unusual hair growth on your eyelids.

Travoprost may be absorbed through the skin; therefore, pregnant women or women trying to become pregnant should not use it. In case of contact with the medication on the skin, it should be removed immediately by washing.

Children

DuoTrav should not be used in children and adolescents under 18years of age.

Other medications and DuoTrav

Inform your doctor or pharmacist if you are using, have used recentlyor may need to use anyother medication, including those purchased without a prescription.

DuoTrav may affect or be affected by other medications you are using, including other eye drops for glaucoma treatment. Consult your doctor if you are using or plan to use medications to lower blood pressure, for the heart including quinidine (used to treat heart conditions and some types of malaria), to treat diabetes, or antidepressants fluoxetine or paroxetine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Do not use DuoTrav if you are pregnant unless your doctor considers it necessary.If you can become pregnant, use an appropriate contraceptive method while using the medication.

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

Driving and operating machinery

Immediately after applying DuoTrav, you may notice that your vision becomes blurry.In some patients, DuoTrav may also cause hallucinations, dizziness, nervousness, or fatigue.

Do not drive or operate machinery until these symptomshave disappeared.

DuoTrav contains hydrogenated ricinoleic acid and polyoxyl 35 castor oil and propylene glycolthat may cause skin reactions and irritation.

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

The recommended dose is onedrop in the affected eye(s), once a day‑in the morning or at night. Use it at the same time every day.

This medication should only be applied to both eyes if your doctor has recommended it.

Only use DuoTrav as eye drops.

• Immediately before using a bottle for the first time, open the packaging bag (figure1), remove the bottle and note the opening date in the reserved space on the box.
• Position yourself in front of a mirror.
• Wash your hands.
• Remove the cap from the bottle.
• Hold the bottle, upside down, between your fingers.
• Incline your head backward. Gently separate your lower eyelid from your eye with a finger, until a pouch forms, in which the drop should fall (figure2).
• Bring the tip of the dropper close to your eye. It may be helpful to use a mirror.
• Do not touch your eye, eyelid, nearby areas or other surfaces with the dropper, as the drops could become infected.
• Press the bottle gently to allow onedrop of DuoTrav to fall each time (figure3). If a drop falls outside the eye, try again.
• After using DuoTrav, press the edge of your eye, near the nose with your finger for 2minutes (figure4). This helps to prevent DuoTrav from spreading to the rest of the body.
• If DuoTrav needs to be applied to both eyes, repeat the previous 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 packaging until you need to use the bottle.

Use DuoTrav for the entire period of time indicated by your doctor.

If you use more DuoTrav than you should

If you use more DuoTrav than you should,you can remove it by rinsing your eyes with warm water. Do notapply more drops until it is safe to do so.

If you forget to use DuoTrav

If you forget to use DuoTrav,continue with the next scheduled dose. Do not apply a double dose to make up for the missed dose. The dose should not exceed 1drop per day in the affected eye(s).

If you stop using DuoTrav

If you stop using DuoTrav without consulting your doctor, the pressure in your eye will not be controlled, which could cause vision loss.

If you are using another eye drop in addition to DuoTrav,wait at least 5minutes between applying DuoTrav and the other drops.

If you wear soft contact lenses, do not apply the drops while wearing them. After applying the drops, wait 15minutes before putting your lenses back in.

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

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

Unless the side effects are severe, you can continue using the eye drops. If these side effects concern you, consult your doctor or pharmacist. Do not stop applying DuoTrav without consulting your doctor.

Very common side effects (may affect more than 1 in 10 people)

Eye effects

Redness of the eye.

Common side effects (may affect up to 1 in 10 people)

Eye effects

Conjunctival inflammation with damage to the surface of the eye, eye pain, blurred vision, abnormal vision, dry eye, eye itching, eye discomfort, signs and symptoms of eye irritation (e.g. burning, stinging).

Uncommon side effects (may affect up to 1 in 100 people)

Eye effects

Conjunctival inflammation, eyelid inflammation, conjunctival swelling, increased eyelash growth, iris inflammation, eye inflammation, light sensitivity, decreased vision, tired eyes, ocular allergy, eye swelling, increased tear production, eyelid redness, eyelid color change, skin darkening (around the eye).

Other effects

Allergic reaction to the active substance, dizziness, headache, increased or decreased blood pressure, shortness of breath, excessive hair growth, posterior throat dripping, skin inflammation and itching, decreased heart rate.

Rare side effects (may affect up to 1 in 1,000 people)

Eye effects

Thinning of the surface of the eye, eyelid gland inflammation, broken blood vessel in the eye, eyelid crusts, abnormal eyelash growth and positioning.

Other effects

Nervousness, irregular heart rate, hair loss, voice disorders, difficulty breathing, cough, throat irritation, urticaria, abnormal blood test results for the liver, skin discoloration, thirst, fatigue, strange sensation inside the nose, colored urine, hand and foot pain.

Unknown frequency (cannot be estimated from available data)

Eye effects

Lower eyelid drooping (causing the eye to be half-closed), sunken eyes (eyes appear more sunken), changes in iris color (colored part of the eye).

Other effects

Skin rash, heart failure, chest pain, cerebral embolism, fainting, depression, asthma, increased heart rate, tingling or numbness, palpitations, lower limb inflammation, bad taste.

Additionally:

DuoTrav is a combination of two active substances, travoprost and timolol. Like other eye medications, travoprost and timolol (a beta-blocker) are absorbed into the bloodstream. This can cause side effects similar to those observed with beta-blocker medications taken by mouth or injection. The incidence of side effects after eye administration is lower than with medications taken by mouth or injected.

The side effects listed below include reactions observed with the class of beta-blockers used to treat eye conditions or reactions observed with travoprost alone:

Eye effects

Eye inflammation, corneal inflammation, detachment of the layer beneath the retina that contains blood vessels which can cause vision disturbances after surgery, decreased corneal sensitivity, corneal erosion (damage to the front layer of the eyeball), double vision, eye discharge, swelling around the eye, eyelid itching, abnormal eyelid turning outward with redness, irritation, and increased tear production, blurred vision (sign of opacity of the lens), swelling of a part of the eye (uvea), eyelid eczema, halo vision, decreased eye sensitivity, pigmentation inside the eye, dilated pupils, change in eyelash color, change in eyelash texture, abnormal visual field.

Other effects

Ear and labyrinth disorders: dizziness with a sense of movement, ringing in the ears.

Cardiovascular and circulation: slow heart rate, palpitations, edema (fluid accumulation), changes in heart rhythm or rate, congestive heart failure (heart disease with difficulty breathing and swelling of the feet and legs due to fluid accumulation), type of heart rhythm disorder, heart attack, decreased blood pressure, Raynaud's phenomenon, cold feet and hands, reduced blood flow to the brain.

Respiratory: constriction of the airways in the lungs (predominantly in patients with pre-existing disease), mucous or nasal congestion, sneezing (due to allergy), difficulty breathingsneezing, nasal discharge.

Nervous system and general disorders:difficulty sleeping (insomnia), nightmares, memory loss, hallucinations, loss of strength and energy, anxiety (excessive emotional distress).

Gastrointestinal: altered taste, nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting andconstipation.

Allergy:increased allergy symptoms,generalized allergic reactions including swelling under the skin that can occur in areas such as the face and extremities and can obstruct the airways causing difficulty swallowing or breathing, urticaria, localized and generalized rash, itching, sudden and severe allergic reaction that puts life at risk.

Skin: rash with a silver plate appearance (psoriasiform rash) or worsening of psoriasis, skin peeling, abnormal hair texture, skin inflammation withredness and itching, hair color change, eyelash loss, itching, abnormal hair growth, skin redness.

Muscular: increased signs and symptoms of myasthenia gravis (muscular disorder), unusual sensations such as tingling, muscle weakness/ fatigue, non-exercise-related muscle pain,joint pain.

Renal and urinary disorders: difficulty and pain urinating,involuntary urination.

Reproductive: sexual dysfunction,decreased libido.

Metabolism: low blood sugar,increased prostate cancer marker.

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 leaflet. You can also report them directly through the national notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication 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.

Do not store above 86°F (30°C).

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

Medicines should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the containers and the medications you no longer need. By doing so, you will help protect the environment.

Composition of DuoTrav

• The active principles are travoprost and timolol. Each milliliter of solution contains 40 micrograms of travoprost and 5 mg of timolol (as timolol maleate).

• The other components are Polyquaternium-1, mannitol (E421), propylene glycol (E1520), hydrogenated ricin oil, and polyoxethylene 40, boric acid, sodium chloride, sodium hydroxide or hydrochloric acid (to adjust the pH), and purified water.

Small amounts of sodium hydroxide or hydrochloric acid are added to maintain normal acidity levels (pH levels).

Appearance of the product and contents of the package

DuoTrav is a liquid (colorless and transparent solution) presented in a 2.5 ml plastic bottle with a screw cap. Each bottle is contained within a bag.

Packaging of 1, 3, or 6 bottles.

Not all presentations may be marketed.

Holder of the marketing authorization Marketing authorization holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Responsible for manufacturing

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

Novartis Manufacturing NV

Rijksweg 14

2870 Puurs-Sint-Amands

Belgium

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Siegfried El Masnou, S.A.

Camil Fabra 58

El Masnou

08320

Spain

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet

Other sources of information

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