Duotrav 40 micrograms/ml + 5 mg/ml solution for eye drops

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

DuoTrav 40 micrograms/ml + 5 mg/ml eye drops, solution

travoprost/timolol

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What DuoTrav is and what it is used for

DuoTrav eye drops solution is a combination of two active substances (travoprost and timolol). Travoprost is a prostaglandin analogue that works by increasing the outflow of aqueous fluid from the eye, thereby reducing intraocular pressure. Timolol is a beta-blocker that works by reducing the production of fluid inside the eye. The two substances act together to lower the pressure inside the eye.

DuoTrav eye drops is used to treat elevated eye pressure in adults, including elderly patients. This pressure can lead to a condition called glaucoma.

2. What you need to know before using DuoTrav

Do not use DuoTrav

• if you are allergic to travoprost, prostaglandins, timolol, beta-blockers, or to any of the other ingredients of this medicine (listed in section 6).
• if you currently have or have previously had respiratory problems such as asthma, severe chronic obstructive bronchitis (a serious lung condition that may cause wheezing, difficulty breathing, and/or persistent cough) or other types of respiratory disorders.
• 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 previously had:

• coronary heart disease (symptoms may include chest tightness or pain, shortness of breath, or suffocation), heart failure, or low blood pressure.
• heart rhythm disorders such as slow heartbeat.
• respiratory problems, asthma, or chronic obstructive pulmonary disease.
• disease due to poor blood circulation (such as Raynaud's disease or Raynaud's syndrome).
• diabetes (since timolol may mask the signs and symptoms of low blood sugar).
• overactivity of the thyroid gland (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 alter the effects of certain medications used during anesthesia.

If you experience any severe allergic reaction (skin rash, redness and itching of the eye) while using DuoTrav, regardless of the cause, treatment with adrenaline may be less effective. Therefore, it is important 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. If the medicine comes into contact with the skin, it should be removed immediately by washing.

Children

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

Other medicines and DuoTrav

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including medicines obtained without a prescription.

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

Pregnancy, breastfeeding, and fertility

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

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

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

Driving and use of machines

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

Do not drive or operate machinery until these symptoms have subsided.

DuoTrav contains hydrogenated castor oil and polyoxyl 40 and propylene glycol, which may cause skin reactions and irritation.

3. How to use DuoTrav

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one drop in the affected eye(s), once daily – in the morning or at night. Use it at the same time each day.

DuoTrav should only be applied to both eyes if your doctor has specifically recommended it.

Use DuoTrav only as an eye drop.

• Immediately before using a bottle for the first time, open the outer pouch (Figure 1), remove the bottle, and write down the date of opening in the space provided on the carton.
• Position yourself in front of a mirror.
• Wash your hands.
• Unscrew the cap of the bottle.
• Hold the bottle upside down between your fingers.
• Tilt your head backward. Gently pull down the lower eyelid with one finger to form a pouch, into which the drop should fall (Figure 2).
• Bring the dropper tip 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 the drops could become contaminated.
• Gently squeeze the bottle so that one drop of DuoTrav falls into the eye (Figure 3). If a drop misses the eye, try again.
• After using DuoTrav, press with your finger on the inner corner of the eye, near the nose, for 2 minutes (Figure 4). This helps prevent DuoTrav from passing into the rest of the body.
• If DuoTrav must be applied to both eyes, repeat the steps above 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.

Use DuoTrav for the entire duration prescribed by your doctor.

If you use more DuoTrav than you should

If you use more DuoTrav than prescribed, you can remove the excess by rinsing your eyes with lukewarm water. Do not apply further drops until your next scheduled dose.

If you forget to use DuoTrav

If you forget to use DuoTrav, continue with your next scheduled dose. Do not apply a double dose to make up for the missed dose. The dose should not exceed 1 drop 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 may not be controlled, which could lead to vision loss.

If you are using another eye drop in addition to DuoTrav, wait at least 5 minutes 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 15 minutes before reinserting your contact lenses.

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

4. Possible adverse effects

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

In general, unless the effects are severe, you may continue using the eye drops. If you are concerned about these effects, consult your doctor or pharmacist. Do not stop using DuoTrav without consulting your doctor.

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

Eye effects

Eye redness.

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

Eye effects

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

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

Eye effects

Inflammation of the surface of the eye, eyelid inflammation, swelling of the conjunctiva, increased eyelash growth, iris inflammation, eye inflammation, light sensitivity, decreased vision, eye strain, eye allergy, eye swelling, increased tear production, eyelid redness, eyelid color change, darkening of the skin (around the eye).

Other effects

Allergic reaction to the active substance, dizziness, headache, increased or decreased blood pressure, shortness of breath, excessive hair growth, postnasal drip, skin swelling and itching, decreased heart rate.

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

Eye effects

Thinning of the surface of the eye, inflammation of the eyelid glands, broken blood vessel in the eye, crusts on the eyelid, abnormal growth and positioning of eyelashes.

Other effects

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

Frequency not known (cannot be estimated from available data)

Eye effects

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

Other effects

Skin rash, heart failure, chest pain, stroke, fainting, depression, asthma, increased heart rate, tingling or numbness sensation, palpitations, swelling in the lower limbs, bad taste.

Additionally:

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

The adverse 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

Eyelid inflammation, corneal inflammation, detachment of the layer beneath the retina containing blood vessels which may cause visual disturbances after filtration surgery, reduced corneal sensitivity, corneal erosion (damage to the front layer of the eyeball), double vision, eye discharge, swelling around the eye, eyelid itching, abnormal outward turning of the lower eyelid with redness, irritation and increased tear production, blurred vision (a sign of lens opacity), swelling of part of the eye (uvea), eyelid eczema, visual halos, decreased sensitivity in the eye, 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 sensation of movement, ringing in the ears.

Heart 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 feet and legs due to fluid accumulation), type of cardiac rhythm disorder, heart attack, decreased blood pressure, Raynaud's phenomenon, cold hands and feet, reduced blood flow to the brain.

Respiratory: narrowing of the airways in the lungs (predominantly in patients with pre-existing disease), mucus or nasal congestion, sneezing (due to allergy), difficulty breathing, nosebleeds, dry nose.

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, and constipation.

Allergy: worsening of allergic symptoms, generalized allergic reactions including swelling under the skin that may occur in areas such as the face and limbs and may obstruct the airways, possibly causing difficulty swallowing or breathing, hives, localized and generalized rash, itching, sudden and severe allergic reaction that is life-threatening.

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

Musculoskeletal: worsening of signs and symptoms of myasthenia gravis (muscle disorder), unusual sensations such as tingling, muscle weakness/fatigue, muscle pain not caused by exercise, joint pain.

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

Reproductive system: sexual dysfunction, decreased libido.

Metabolism: low blood sugar levels, increased prostate cancer marker.

Reporting of adverse effects

If you experience any adverse effect, talk to 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 DuoTrav

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

Do not use this medicine after the expiry date stated on the bottle and carton after "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

To prevent infection, discard the bottle 4 weeks after first opening and use a new bottle. Record 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 properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of DuoTrav

• The active substances are travoprost and timolol. Each ml 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 castor oil polyoxyl 40, boric acid, sodium chloride, sodium hydroxide or hydrochloric acid (to adjust pH), and purified water.

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

Appearance of the medicine and contents of the pack

DuoTrav is a liquid (a colourless, clear solution) supplied in a 2.5 ml plastic bottle with a screw cap. Each bottle is contained within a pouch.

Pack sizes of 1, 3 or 6 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 Manufacturing NV
Rijksweg 14
2870 Puurs-Sint-Amands
Belgium

Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nürnberg
Germany

For more information about this medicine, contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet

Other sources of information

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