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

DuoTrav eye drops solution is a combination of two active substances (travoprost and timolol). Travoprost is a prostaglandin analogue which works by increasing the outflow of liquid of the eye, which lowers its pressure. Timolol is a beta blocker which works by reducing the production of fluid within the eye. The two substances work together to reduce pressure within the eye.

DuoTrav eye drops are used to treat high pressure in the eye in adults, including the elderly . This pressure can lead to an illness called glaucoma.

Do not use DuoTrav eye drops solution
- if you are allergic to travoprost, prostaglandins, timolol, beta-blockers or any of the other ingredients.
- if you have respiratory problemssuch as asthma, bronchitis or other types of breathing problems.
- if you have severe hay fever.
- if you have a slow heart beat, heart failure or disorders of heart rhythm.
- If the surface of your eye is cloudy.

Ask your doctor for advice if any of these apply to you.

Take special care with DuoTrav.

DuoTrav may cause breathlessness or wheezing. If you are concerned about changes in your breathing pattern when using DuoTrav, tell your doctor as soon as possible. If you get any severe allergic reaction skin rash, redness and itching of the eye while using DuoTrav, whatever the cause, adrenaline treatment may not be as effective. So when receiving any other treatment please tell the doctor that you are using DuoTrav.

If you have angina, circulation problems or low blood pressure. DuoTrav may make any of these worse. If you are concerned about any changes in these symptoms, tell your doctor as soon as possible. If you have diabetes. DuoTrav can mask the symptoms of low blood sugar hypoglycaemia such as shakiness and dizziness. Close monitoring of your blood sugar while using DuoTrav is advised. If you have any concerns regarding your blood sugar while dosing with DuoTrav see your doctor.DuoTrav may hide the symptoms of thyroid problems hyperthyroidism. If you have a thyroid problem talk to your doctor before you use DuoTrav. If you have had cataract surgery talk to your doctor before you use DuoTrav. If you have current or previous history of an eye inflammation talk to your doctor before you use DuoTrav. DuoTrav may change the colour of your iris the coloured part of your eye. This change may be permanent. DuoTrav may increase the length, thickness, colour andor number of your eyelashes and may cause unusual hair growth on your eyelids. Travoprost may be absorbed through the skin and therefore should not be used by women who are pregnant or are attempting to become pregnant. If any of the medicine comes into contact with the skin then it should be washed off straight away.

Children

DuoTrav is not to be used by children and adolescents under 18 years of age.

Using other medicines

DuoTrav can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma. Tell your doctor if you are using or intend to use medicines to lower blood pressure, heart medicine or medicines to treat diabetes. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Do not use DuoTrav if you are pregnant unless your doctor considers it necessary.If you could get pregnant you must use adequate contraception whilst you use the medicine.

Do not use DuoTrav if you are breast-feeding.DuoTrav may get into your milk .

Ask your doctor for advice before taking any medicine.

Driving and using machines

You may find that your vision is blurred for a time just after you use DuoTrav. Do not drive or use machines until this has worn off.

Important information about some of the ingredients of DuoTrav.

- DuoTrav contains hydrogenated castor oil and propylene glycol which may cause skin reactions and irritation.

Always use DuoTrav eye drops solution exactly as your doctor has told you.You should check with your doctor or pharmacist if you are not sure.

The usual dose

Adults and elderly: 1 drop in the affected eye or eyes, once a day-in the morning or in the evening. Use at the same time each day.
Only use DuoTrav in both eyes if your doctor told you to do so. Use it for as long as your doctor told you to.

Only use DuoTrav for dropping in your eyes.

1 2 3 4

Immediately before using a bottle for the first time, tear-off the overwrap pouch take it out picture 1 and write the date of opening on the label in the space provided. Get the DuoTrav bottle and a mirror. Wash your hands. Twist off the cap. Hold the bottle, pointing down, between your thumb and fingers. Tilt your head back. Pull down your eyelid with a clean finger, until there is a pocket between the eyelid and your eye. The drop will go in here picture 2. Bring the bottle tip close to the eye. Use the mirror if it helps. Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could infect the drops. Gently squeeze the bottle to release one drop of DuoTrav at a time picture 3. After using DuoTrav, press a finger into the corner of your eye, by the nose picture 4. This helps to stop DuoTrav getting into the rest of the body. If you use drops in both eyes, repeat the steps for your other eye. Close the bottle cap firmly immediately after use. Only use one bottle at a time. Do not open the pouch until you need to use the bottle.

Turn the page for more advice.

How much to use

If a drop misses your eye, try again.

If you use more DuoTrav than you should, rinse it all out with warm water. Do not put in any more drops until it is time for your next regular dose.

If you forget to use DuoTrav, continue with the next dose as planned. Do not use a double dose to make up. The dose should not exceed one daily drop in the affected eye(s).

If you stop using DuoTrav without speaking to your doctor the pressure in your eye will not be controlled which could lead to loss of sight.

If you are using other eye drops, leave at least 5 minutes between putting in DuoTrav and the other drops.

If you wear soft contact lenses. Do not use the drops with your lenses in. After using the drops wait 15 minutes before putting your lenses back in.

If you have any other questions about your medicine, ask a doctor or pharmacist.

Like all medicines DuoTrav eye drops solution can cause side effects although not everybody gets them.

You can usually carry on taking the drops, unless the effects are serious. If you're worried, talk to a doctor or pharmacist. Do not stop using DuoTrav without speaking to your doctor.

The frequency of possible side effects listed below is defined using the following convention Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Not known (frequency cannot be estimated from the available data)

Very common side effects

Effects in the eye
eye irritation, redness of the eye.

Common side effects

Effects in the eyeinflammation inside the eye, eye pain and swelling, sensitivity to light, conjunctival bleeding, blurred vision, reduced vision, abnormal vision, dry eye, itchy eye, eye discomfort, eye allergy,increased tear production, eyelid irritation, itching, redness, pain and swelling; tired eyes, increased growth or number of eye lashes, abnormal eye sensation.

General side effectsdrug allergy, nervousness, dizziness, headache, irregular or decreased heart rate, increased or decreased blood pressure, shortness of breath, hives, skin darkening around eyes, pain in hands and feet.

Uncommon side effects

Effects in the eyethinning or inflammation of the eye surface, inflammation of the eyelid glands, swollen conjunctiva, eyelid crusting, increased growth of hair (eyebrow), iris inflammation.

General side effects
cough, throat pain or irritation, drip at back of throat, abnormal liver blood tests, fatigue, skin inflammation and itching, coloured urine, thirst, discomfort inside of nose.

Rare side effects

General side effects

loss of hair.

Not known

Effects in the eye

droopy eyelid.

General side effects
rash, heart failure, chest pain, stroke, fainting, depression, asthma, increased heart rate, numbness or tingling sensation.

Additional side effects that have been reported previously in people using eye drops containing travoprost or timolol and that have not been reported with DuoTrav include

Effects in the eye
double vision changes in colour of the iris,

General side effects
heart attack, decreased blood flow to the brain, low blood sugar, loss of strength and energy, diarrhoea, nausea, peeling skin, stuffy nose, chronic neuromuscular weakness, respiratory failure.

If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep outof the reach and sight of children.

Do not use DuoTrav eye drops solution after the expiry date which is stated on the bottle and outer carton after ?EXP?. The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions.

You must throw away the bottle 4 weeks after you first opened it to prevent infections and use a new bottle. Write down the date you open it in the space on each bottle label and box.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

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 ingredients are Polyquaternium-1, mannitol (E421), propylene glycol (E1520), polyoxyethylene hydrogenated castor oil 40, boric acid, sodium chloride, sodium hydroxide or hydrochloric acid (to adjust pH), purified water.
Tiny amounts of sodium hydroxide or hydrochloric acid are added to keep acidity levels (pH levels) normal.

What DuoTrav looks like and the 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 placed in a pouch.
Packs of 1, 3 or 6 bottles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder Manufacturer Manufacturer

S.A. Alcon-Couvreur N.V. Alcon Cusí, S.A., Rijksweg 14, Camil Fabra 58, B-2870 Puurs, 08320 El Masnou, Belgium. Spain. Alcon Laboratories UK Ltd. Boundary Way, Hemel Hempstead, Herts HP2 7UD United Kingdom.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Lietuva Alcon Pharmaceuticals Ltd. atstovyb 370 5 2 314 756 BelgiëBelgiqueBelgien LuxembourgLuxemburg SA Alcon-Couvreur NV 32 03 890 27 11 BelgiëBelgiqueBelgien

359 2 950 15 65 Magyarország Alcon Hungária Gyógyszerkereskedelmi Kft. 36-1-463-9080

eská republika Alcon Pharmaceuticals Czech Republic s.r.o. 420 225 377 333 Nederland Alcon Nederland BV 31 0 183 654321

Danmark Alcon Danmark AS 45 3636 3434 Norge Alcon Norge AS 47 23 25 25 50

Deutschland Alcon Pharma GmbH 49 0761 1304-0 Österreich Alcon Ophthalmika GmbH 43 01 596 69 70

Polska Alcon Polska Sp. z o.o. 48 22 820 3450 30 210 68 78 300

Eesti Alcon Eesti 372 6 313 214 Portugal Alcon Portugal Produtos e Equipamentos Oftalmológicos, Lda. 351 214 400 300

España Alcon Cusí, S.A. 34 93 497 7000 România S.C. Alcon Romania S.R.L. 40 21 203 93 24

France Laboratoires Alcon 33 01 47 10 47 10 Slovenija Alcon d.o.o. 386 1 422 5280

Slovenská republika Alcon Pharmaceuticals Ltd oz 421 2 5441 0378 Ireland Malta United Kingdom Alcon Laboratories UK Ltd. 44 0 1442 34 1234 United Kingdom Ísland Alcon Danmark AS 45 3636 3434 SuomiFinland Alcon Finland Oy 358 207 871 600

Italia Alcon Italia S.p.A. 39 02 81803.1 Sverige Alcon Sverige AB 46 08 634 40 00 E-post receptionenalconlabs.com

Latvija

Alcon Pharmaceuticals Ltd
- + 371 7 321 121

This leaflet was last approved in.