TRAVATAN 40 micrograms/ml eye drops, solution

TRAVATANcontains travoprost, one of a group of medicines called prostaglandin analogues. It works by reducing the pressure in the eye. It may be used on its own or with other drops e.g. beta-blockers, which also reduce pressure.

TRAVATAN eye drops are used to treat high pressure in the eye. This pressure can lead to an illness called glaucoma.

Do not use TRAVATAN
- If you are allergic to travoprost or any of the other ingredients of TRAVATAN.

Ask your doctor for advice if this applies to you.

Take special care with TRAVATAN

Use of TRAVATAN is not recommended in those under 18 years of age. If this applies to you ask your doctor for advice.

TRAVATAN may increase the length, thickness, colour andor number of your eyelashes and may cause unusual hair growth on your eyelids.

TRAVATAN may change the colour of your iris the coloured part of your eye. This change may be permanent.

TRAVATAN may rarely cause breathlessness or wheezing or increase the symptoms of asthma. If you are concerned about changes in your breathing pattern when using TRAVATAN advise your doctor as soon as possible.

Travoprost may be absorbed through the skin. If any of the product comes into contact with the skin, it should be washed off straight away. This is especially important in women who are pregnant or are attempting to become pregnant.

Using other medicines

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 TRAVATAN if you are pregnant. If you think that you may be pregnant speak with your doctor right away.If you could become pregnant you must use adequate contraception whilst you use TRAVATAN.

Do not use TRAVATAN if you are breast feeding, TRAVATAN 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 TRAVATAN. Do not drive or use machines until this has worn off.

Important information about some of the ingredients

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

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

The usual dose is

1 drop in the affected eye or eyes, once a day-in the evening.

Only use TRAVATAN in both eyes if your doctor told you to. Use it for as long as your doctor told you to.

Only use TRAVATAN for dropping in your eyes.

1 2 3 4

Immediately before using a bottle for the first time, tear open the overwrap pouch, take the bottle out picture 1 and write the date of opening on the label in the space provided 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 20

Bring the bottle tip close to the eye. Use a 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 TRAVATAN at a time. picture 3 After using TRAVATAN, press a finger into the corner of your eye, by the nose picture 4. This helps to stop TRAVATAN getting into the rest of the body If you take 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.

If a drop misses your eye, try again.

If you use more TRAVATAN than you should, rinse it all out with warm water. Don?t put in any more drops until it?s time for your next regular dose.

If you forget to use TRAVATAN, continue with the next dose as planned. Do notuse a double dose to make up. Never use more than one drop in the affected eye(s) in a single day.

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

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

If you have any further questions on the use of this product ask a doctor or pharmacist.

Now turn over -

Like all medicines, TRAVATAN can cause side effects although not everybody gets them.

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

Very common side effects

(Affects more than 1 user in 10)

Effects in the eye: Redness , changes in the colour of the iris (coloured part of the eye)

Common side effects

(Affects 1 to 10 users in 100)

Effects in the eye: inflammation inside the eye, pain or swelling, irritation, discharge, sensitivity to light, blurred, reduced or abnormal vision, dryness, itching, increased tear production, abnormal or decreased sensation; irritation, itching, redness, pain, swelling or crusting of the eyelid; discolouration of the eyelashes, increased or decreased growth or number of eyelashes.

Effects in the body: headache, darkening of skin around the eye(s).

Uncommon side effects

(Affects 1 to 10 users in 1,000)

Effects in the eye: inflammation or infection of the conjunctiva (conjunctivitis) or cornea, halo vision, corneal disorder, allergy, tired eyes, increase in pupil size.

Effects in the body: asthma, shortness of breath, increased or decreased blood pressure, irregular, increased, or decreased heart rate, dizziness, viral infection, cough, generalised weakness, increased allergic symptoms, throat irritation, stuffy nose, voice changes, gastrointestinal discomfort or ulcer, dry mouth, constipation, redness or itching of the skin, shoulder pain, bad taste.

Additional side effects that have been reported include:

Effects in the eye: inflammation of the back of the eye.

Effects in the body: worsening of asthma, ringing in ears, increased prostate antigen.

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 out of the reach and sight of children.

Do not use TRAVATAN after the expiry date which is stated on the bottle and the box 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 opened it in the space on each bottle label and box.

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

What TRAVATAN contains

The active substance is travoprost 40 micrograms/ml.

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

What TRAVATAN looks like and the contents of the pack

TRAVATAN is a liquid (a clear, colourless solution) supplied in a pack containing a 2.5 ml plastic bottle with a screw cap or in a pack containing three 2.5 ml plastic bottles with screw caps. Each bottle is placed in a pouch. Not all pack sizes may be marketed.

The marketing authorisation holder Alcon Laboratories UK Ltd. Manufacturer S.A. Alcon-Couvreur N.V Rijksweg 14 Manufacturer Alcon Cusí, S.A Camil Fabra 58 B-2870 Puurs 08320 El Masnou Belgium Spain 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.

België/Belgique/BelgienLietuva
Luxembourg/Luxemburg Alcon Pharmaceuticals Ltd. atstovyb- SA Alcon-Couvreur NV - + 370 5 2 314 756
- + 32 (0)3 890 27 11 (België/Belgique/Belgien)

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

Sverige Italia Alcon Italia S.p.A. 39 02 81803.1 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