Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - travatan

Document Subject

Generated Narrative: MedicinalProductDefinition mpa38db6f0b3670face0412d6c2e00cd92

identifier: http://ema.europa.eu/identifier/EU/1/01/199/001-004

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: TRAVATAN 40 micrograms/mL eye drops, solution

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-a38db6f0b3670face0412d6c2e00cd92

identifier: http://ema.europa.eu/identifier/EU/1/01/199/001-004

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - travatan

Attesters

What is in this leaflet

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

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.

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.

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).

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 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.

If a drop misses the eye, try again.

If you or your child are using other eye preparations such as eye drop or eye ointment, wait for at least 5 minutes between putting in TRAVATAN and the other eye preparations.

If you or your child receive more TRAVATAN than you should Rinse all the medicine out with warm water. Don t put in any more drops until it s time for the next regular dose.

If you forget to use TRAVATAN Continue with the next dose as planned. Do not use a double dose to make up for a forgotten dose. Never use more than one drop in the affected eye(s) in a single day.

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

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

Now turn over

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: may affect more than 1 in 10 people

Effects in the eye: eye redness,

Common: 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: 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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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.

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 Novartis Farmac utica, S.A. Gran Via de les Corts Catalanes, 08013 Barcelona Spain

S.A. Alcon-Couvreur N.V. Rijksweg B-2870 Puurs Belgium

Novartis Pharma GmbH Roonstra e D-90429 Nuremberg Germany

Siegfried El Masnou, S.A. Camil Fabra El Masnou 08320 Barcelona Spain

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

Belgi /Belgique/Belgien Novartis Pharma N.V. T l/Tel: +32 2 246 16 Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16
Novartis Bulgaria EOOD .: +359 2 489 98 Luxembourg/Luxemburg Novartis Pharma N.V. T l/Tel: +32 2 246 16 esk republika Novartis s.r.o. Tel: +420 225 775 Magyarorsz g Novartis Hung ria Kft. Tel.: +36 1 457 65 Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 Malta Novartis Pharma Services Inc. Tel: +356 2122 2Deutschland Novartis Pharma GmbH Tel: +49 911 273 0 Nederland Novartis Pharma B.V. Tel: +31 88 04 52 Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 Norge Novartis Norge AS Tlf: +47 23 05 20
Novartis (Hellas) A.E.B.E. : +30 210 281 17 sterreich Novartis Pharma GmbH Tel: +43 1 86 6Espa a Novartis Farmac utica, S.A. Tel: +34 93 306 42 Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4France Novartis Pharma S.A.S. T l: +33 1 55 47 66 Portugal Novartis Farma - Produtos Farmac uticos, S.A. Tel: +351 21 000 8Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 Rom nia Novartis Pharma Services Romania SRL Tel: +40 21 31299 Ireland Novartis Ireland Limited Tel: +353 1 260 12 Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 sland Vistor hf. S mi: +354 535 7Slovensk republika Novartis Slovakia s.r.o. Tel: + 421 2 5542 5Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1

Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133
Novartis Pharma Services Inc. : +357 22 690 Sverige Novartis Sverige AB Tel: +46 8 732 32 Latvija SIA Novartis Baltics Tel: +371 67 887 United Kingdom (Northern Ireland) Novartis Ireland Limited Tel: +44 1276 698This leaflet was last revised in

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