Duotrav

Package leaflet: Information for the user

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

travoprost/timolol
Please 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 give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What DuoTrav is and what it is used for
2. What you need to know before you use 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 fluid from the eye, thereby reducing the pressure inside the eye. Timolol is a beta-blocker that works by reducing the production of fluid within the eye. The two active substances act simultaneously to lower intraocular pressure.
DuoTrav eye drops are used to treat elevated intraocular pressure in adults, including the elderly. Such increased pressure levels may lead to a condition known as 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 any of the other ingredients of this medicine (listed in section 6).
• if you have or have previously had respiratory problems such as asthma, severe chronic obstructive bronchitis (a serious lung disease that may cause wheezing, difficulty breathing, and/or long-lasting cough), or other types of breathing disorders.
• in case of severe hay fever.
• in case of slow heart rate, heart failure, or a heart rhythm disorder (irregular heartbeat).
• in case of clouding of the eye's transparent surface.

Ask your doctor if you have any of these conditions.
Warnings and precautions
Talk to your doctor before using DuoTrav if you have or have previously had

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or suffocation), heart failure, low blood pressure.
• changes in heart rate such as slow heartbeat.
• breathing problems, asthma, or chronic obstructive pulmonary disease.
• circulatory problems (such as Raynaud's disease or Raynaud's syndrome).
• diabetes (because timolol may mask the signs and symptoms of low blood sugar).
• overactive thyroid gland (because timolol may mask signs and symptoms of thyroid disease).
• myasthenia gravis (chronic muscle weakness).
• cataract surgery.
• eye inflammation.

If you need to undergo any type of surgical procedure, inform your doctor that you are using DuoTrav, as timolol may alter the effects of certain medicines used during anesthesia.
If you experience any severe allergic reaction (rash, eye redness and itching) while using DuoTrav, regardless of the cause, treatment with adrenaline may not be sufficiently effective. Therefore, if you receive any other treatment, inform your doctor that you are using DuoTrav.
DuoTrav may change the color of your iris (the colored part of the eye). This change could 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 sorbed through the skin; therefore, it must not be used by pregnant women or women who intend to become pregnant. If any amount of the medicine comes into contact with the skin, wash immediately.
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 take any other medicines, including medicines without a prescription.
DuoTrav may interact with other medicines you are taking, including other eye drops for the treatment of glaucoma. Inform your doctor if you are taking or plan to take medicines to lower blood pressure, heart medications including quinidine (used to treat heart problems and certain types of malaria), or medicines for diabetes or the antidepressants fluoxetine or paroxetine.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, ask your doctor for advice before taking this medicine.
Do not use DuoTrav during pregnancy unless your doctor considers it necessary. If there is a possibility of becoming pregnant, you must use adequate contraception while taking this medicine.
Do not use DuoTrav while breastfeeding. DuoTrav may be excreted in breast milk.
Driving and using machines
You may experience blurred vision for a period of time after using DuoTrav. Do not drive or operate machinery until these symptoms have resolved. DuoTrav may also cause hallucinations, dizziness, nervousness, or fatigue in some patients.
Do not drive or operate machinery until such symptoms have disappeared.
DuoTrav contains hydrogenated castor oil and propylene glycol which may cause irritation and skin reactions.

3. How to use DuoTrav

Use this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one drop in the affected eye(s) once daily, in the morning or evening. Take the dose at the same time each day.
Use DuoTrav in both eyes only if prescribed by your doctor.
DuoTrav may only be used as an eye drop.

1 2 3 4

• Immediately before using the bottle for the first time, tear off the outer protective pouch (Figure 1), remove the bottle and write the date of opening in the space provided on the label.
• Make sure you have a mirror available.
• Wash your hands.
• Unscrew the cap of the bottle.
• Hold the bottle between your thumb and fingers, with the tip pointing downwards.
• Tilt your head backwards. Pull down the lower eyelid with a clean finger to create a "pocket" between the eyelid and the eye. The drop should be instilled here (Figure 2).
• Hold the tip of the bottle close to the eye. Using a mirror may help.
• Do not touch the eye, eyelid, surrounding areas or any other surface with the tip of the bottle, as this may contaminate the eye drops.
• Gently press the bottle to release one drop of DuoTrav at a time (Figure 3). If a drop misses the eye, try again.
• After using DuoTrav, press a finger against the inner corner of the eye near the nose for 2 minutes (Figure 4). This helps prevent DuoTrav from spreading into the rest of the body.
• If you need to instil drops into both eyes, repeat the steps for the other eye.
• Immediately screw the cap back on after use.
• Use one bottle at a time. Do not open the outer protective pouch until it is time to use the bottle.

Use DuoTrav for as long as your doctor recommends.
If you use more DuoTrav than you should
If you use more DuoTrav than you should, remove the excess by rinsing with lukewarm water. Do not use further drops until the next scheduled dose.
If you forget to use DuoTrav
If you forget to use DuoTrav, continue treatment with the next scheduled dose. Do not use a double dose to make up for the missed dose. The dose must not exceed one drop per day per affected eye(s).
If you stop using DuoTrav
If you stop using DuoTrav without consulting your doctor, the pressure in your eye may become uncontrolled, which could lead to loss of vision.
If you are using other eye drops in addition to DuoTrav, wait at least 5 minutes between applying DuoTrav and the other eye drops.
If you wear soft contact lenses, do not use the eye drops while wearing them. Wait 15 minutes after using the eye drops before reinserting your lenses.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You can generally continue using the drops unless the side effects are severe. If you are concerned, consult your doctor or pharmacist. Do not stop using DuoTrav without first talking to your doctor.

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

Common side effects (may affect up to 1 in 10 people)
Eye effects
Inflammation of the eye surface with surface damage, 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
Inflammation of the eye surface, eyelid inflammation, swollen conjunctiva, increased eyelash growth, iris inflammation, eye inflammation, light sensitivity, reduced vision, tired eyes, eye allergy, eye swelling, increased tear production, eyelid redness, changes in eyelid colour, darkening of the skin (around the eye).

General side effects
Allergy to the active substance, dizziness, headache, increased or decreased blood pressure, shortness of breath, excessive hair growth, nasopharyngeal dripping, skin inflammation and itching, reduced heart rate.

Rare side effects (may affect up to 1 in 1,000 people)
Eye effects
Thinning of the eye surface, inflammation of the eyelid glands, broken blood vessels in the eye, crust formation on the eyelid, abnormal eyelash positioning, abnormal eyelash growth.

General side effects
Nervousness, irregular heart rate, hair loss, voice discomfort, breathing difficulties, cough, sore throat, hives, abnormal liver function tests, changes in skin colour, thirst, fatigue, nasal discomfort, coloured urine, pain in hands and feet.

Not known (frequency cannot be estimated from the available data)
Eye effects
Drooping eyelid (eye remains half-closed), sunken eyes (eyes appear more deeply set), changes in iris colour (coloured part of the eye).

General side effects
Skin rashes, heart failure, chest pain, stroke, fainting, depression, asthma, increased heart rate, sensation of numbness or tingling, palpitations, swelling of the lower limbs, bad taste.

In addition:
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 side effects similar to those seen with oral or injectable beta-blockers. However, the amount of systemic side effects after ocular administration is lower than with oral or injectable administration.

The side effects listed below include reactions observed for the class of beta-blockers used in eye treatment or reactions observed with travoprost alone:

Eye effects
Eyelid inflammation, corneal inflammation, detachment of the layer beneath the retina containing blood vessels following filtering surgery which may cause visual disturbances, reduced corneal sensitivity, corneal erosion (damage to the front layer of the eyeball), double vision, eye discharge, swelling around the eye, eyelid itching, outward turning of the eyelid with redness, irritation and excessive tearing, blurred vision (sign of clouding of the eye lenses), swelling of part of the eye (uvea), eyelid eczema, halos around lights, decreased eye sensitivity, pigmentation inside the eye, dilated pupils, changes in eyelash colour, changes in eyelash texture, abnormal visual field.

General side effects
Ear and labyrinth disorders: dizziness with spinning sensation, ringing in the ears.
Heart and circulation: slowed heart rate, palpitations, oedema (fluid accumulation), changes in heart rhythm or rate, congestive heart failure (heart condition with shortness of breath and swelling of feet and legs due to fluid accumulation), a type of heart rhythm disorder, heart attack, low blood pressure, Raynaud's phenomenon, cold hands and feet, reduced blood supply to the brain.
Respiratory: narrowing of the airways in the lungs (mainly in patients with pre-existing lung disease), runny or blocked nose, sneezing (due to allergy), breathing difficulties, nosebleeds, dry nose.
Nervous system and systemic disorders: difficulty sleeping (insomnia), nightmares, memory loss, hallucinations, loss of strength and energy, anxiety (excessive emotional distress).
Gastrointestinal: taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting, constipation.
Allergic reactions: worsening of allergic symptoms, generalized allergic reactions including swelling under the skin which may occur in areas such as the face and limbs and which may block the airways causing difficulty in swallowing or breathing, localized and generalized skin rash, itching, severe unexpected life-threatening allergic reactions.
Skin: silvery-white rash (psoriasiform erythema) or worsening of psoriasis, skin peeling, abnormal hair structure, skin inflammation with itching and redness, change in hair colour, eyelash loss, itching, abnormal hair growth, skin redness.
Musculoskeletal: worsening of signs and symptoms of myasthenia gravis (muscle disorder), unusual sensations such as pins and needles, muscle weakness/asthenia, muscle pain not caused by exercise, joint pain.
Renal and urinary disorders: difficulty and pain when urinating, involuntary loss of urine.
Reproductive system: sexual dysfunction, decreased libido.
Metabolism: low blood sugar levels, increased marker of prostate cancer.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DuoTrav

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after "EXP" and "Scad.". The expiry date refers to the last day of that month.
Do not store above 30°C.
To prevent the risk of infection, discard the bottle 4 weeks after first opening. Each time you open a new bottle for the first time, write the opening date in the designated space on the label and carton.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What DuoTrav contains

• 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), polyoxyl 40 hydrogenated castor oil, boric acid, sodium chloride, sodium hydroxide or hydrochloric acid (to adjust pH). Small amounts of sodium hydroxide or hydrochloric acid are added to maintain normal acidity levels (pH levels).

Description of the appearance of DuoTrav and contents of the pack
DuoTrav is a liquid (a clear, colourless solution) supplied in a 2.5 mL plastic bottle with a screw cap. Each bottle is packaged in an outer 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 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 Barcelona
Spain
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50
България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11
Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00
Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf: +45 39 16 84 00 Tel: +356 2122 2872
Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111
Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00
Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570
España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888
France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600
Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01
Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50
Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: + 421 2 5542 5439
Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200
Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00
Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu