Travatan - patient leaflet, side effects, dosage

1. What TRAVATAN is and what it is used for

TRAVATAN contains 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 is used to reduce high pressure in the eye in adults, adolescents and children from 2 months old onward. This pressure can lead to an illness called glaucoma.

2. What you need to know before you use TRAVATAN

Do not use TRAVATAN

• If you are allergic to travoprost or any of the other ingredients of this medicine (listed in

section 6).

Ask your doctor for advice if this applies to you.

Warning and Precautions

• TRAVATAN may increase the length, thickness, colour and/or number of your eyelashes.

Changes in the eyelids including unusual hair growth or in the tissues around the eye have also been observed.

• TRAVATAN may change the colour of your iris (the coloured part of your eye). This change

may be permanent. A change in the colour of the skin around the eye may also occur.

• If you have had cataract surgery, talk to your doctor before you use TRAVATAN.
• If you have current or previous history of an eye inflammation (iritis and uveitis), talk to your

doctor before you use TRAVATAN.

• 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 medicinal 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.

• 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.

Children and adolescents

TRAVATAN can be used in children from 2 months to < 18 years at the same dose as for adults. Use of TRAVATAN is not recommended to those children under 2 months of age.

Other medicines and TRAVATAN

Tell your doctor or pharmacist if you are taking or have recently taken or used any other medicines.

Pregnancy, breast feeding and fertility

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.

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

3. How to use TRAVATAN

Always use this medicine exactly as your doctor or the doctor treating your child has told you. You should check with your doctor, the doctor treating your child or pharmacist if you are not sure.

The recommended dose is

One 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 or the doctor treating your child told you to.

Only use TRAVATAN for dropping in your or your child’s eye(s).

• 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 carton in the space provided

• Wash your hands
• Twist off the cap
• Hold the bottle, pointing down, between your thumb and fingers
• Tilt your head or your child’s head gently back. Pull down the eyelid with a clean finger, until

there is a ‘pocket’ between the eyelid and the eye. The drop will go in here (picture 2 )

• Bring the bottle tip close to the eye. Use a mirror if it helps
• Do not touch the 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, keep the eyelid closed, apply gentle pressure by pressing a finger into

the corner of the eye, by the nose (picture 4 ) for at least 1 minute. This helps to stop TRAVATAN getting into the rest of the body

• If you use drops in both eyes, repeat the steps for the 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.

4. Possible side effects

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

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

The following side effects have been seen with TRAVATAN

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

Effects in the eye : eye redness,

Common side effects: may affect up to 1 in 10 people

Effects in the eye : changes in the colour of the iris (coloured part of the eye), eye pain, eye discomfort, dry eye, itchy eye, eye irritation.

Uncommon side effects: may affect up to 1 in 100 people

Effects in the eye : corneal disorder, eye inflammation, iris inflammation, inflammation inside the eye, eye surface inflammation with/out surface damage, sensitivity to light, eye discharge, eyelid inflammation, eyelid redness, swelling around the eye, eyelid itching, blurred vision, increased tear production, infection or inflammation of the conjunctiva (conjunctivitis), abnormal turning outward of the lower eyelid, clouding of the eye, eyelid crusting, growth of eyelashes.

General side effects : increased allergic symptoms, headache, irregular heart beat, cough, stuffy nose, throat irritation, darkening of skin around the eye (s), skin darkening, abnormal hair texture, excessive hair growth.

Rare: may affect up to 1 in 1,000 people

Effects in the eye : perception of flashing lights, eczema of the eyelids, abnormally positioned eyelashes that grow back toward the eye, eye swelling, reduced vision, halo vision, decreased eye sensation, inflammation of the glands of the eyelids, pigmentation inside the eye, increase in pupil size, eyelash thickening, change in eyelash colour, tired eyes.

General side effects: eye viral infection, dizziness, bad taste, irregular or decreased heart rate, increased or decreased blood pressure, shortness of breath, asthma, nasal allergy or inflammation, nasal dryness, voice changes, gastrointestinal discomfort or ulcer, constipation, dry mouth, redness or itching of the skin, rash, hair colour change, loss of eyelashes, joint pain, musculoskeletal pain, generalised weakness.

Not known: frequency cannot be estimated from the available data

Effects in the eye: inflammation of the back of the eye, eyes appear more inset.

General side effects: depression, anxiety, insomnia, sensation of false movement, ringing in ears, chest pain, abnormal heart rhythm, increased heart beat, worsening of asthma, diarrhea, nose bleeds, abdominal pain, nausea, vomiting, itching, abnormal hair growth, painful or involuntary urination, increase in prostate cancer marker.

In children and adolescents, the most common side effects seen with TRAVATAN are eye redness and growth of eyelashes. Both side effects were observed with a higher incidence in children and adolescents compared to adults.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store TRAVATAN

Keep this medicine out of the sight and reach 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 the carton box.

Do not throw away medicine via wastewater or in household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

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 contents of the pack

TRAVATAN is a liquid (a clear, colourless solution) supplied in a pack containing a 4 ml plastic bottle with a screw cap. Each bottle contains 2.5 mL of travoprost eye drops and each bottle is placed in a pouch.

Pack sizes: 1 or 3 bottles.

Not all pack sizes may be marketed.

The marketing authorisation holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

S.A. Alcon-Couvreur N.V.

Rijksweg 14

B-2870 Puurs

Belgium or

Alcon Cusí, S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spain

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

België/Belgiqu­e/Belgien Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11	Lietuva SIA „Novartis Baltics“ Lietuvos filialas Tel: +370 5 269 16 50
Efc^rapufl Novartis Bulgaria EOOD Ten.: +359 2 489 98 28	Luxembourg/Lu­xemburg Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11
Česká republika Novartis s.r.o. Tel: +420 225 775 111	Magyarország Novartis Hungária Kft. Tel.: +36 1 457 65 00
Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 00	Malta Novartis Pharma Services Inc. Tel: +356 2122 2872
Deutschland Novartis Pharma GmbH Tel: +49 911 273 0	Nederland Novartis Pharma B.V. Tel: +31 26 37 82 111
Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810	Norge Novartis Norge AS Tlf: +47 23 05 20 00
EXÀàôa Novartis (Hellas) A.E.B.E. Tql: +30 210 281 17 12	Österreich Novartis Pharma GmbH Tel: +43 1 86 6570
España Novartis Farmacéutica, S.A. Tel: +34 93 306 42 00	Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888
France Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00	Portugal Novartis Farma – Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600
Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 220	România Novartis Pharma Services Romania SRL Tel: +40 21 31299 01
Ireland Novartis Ireland Limited Tel: +353 1 260 12 55	Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 50
Ísland Vistor hf. Sími: +354 535 7000	Slovenská republika Novartis Slovakia s.r.o. Tel: + 421 2 5542 5439
Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1	Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200

Kûnpoç

Novartis Pharma Services Inc.

Tql: +357 22 690 690

United Kingdom

Novartis Pharmaceuticals UK Ltd.

Tel: +44 1276 698370

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

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