TRAVATAN 40 MCG/ML Eye drops, solution

Зміст інструкції

1. TRAVATAN 40 micrograms/mL eye drops, solution
   1. What is TRAVATAN and what is it used for
   2. What you need to know before using TRAVATAN
   3. How to use TRAVATAN
   4. Possible side effects
   5. How to store TRAVATAN
   6. Package contents and other information

TRAVATAN 40 micrograms/mL eye drops, solution

travoprost

Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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

1. What is TRAVATAN and what is it used for

TRAVATAN contains travoprost,a substance belonging to the group of drugs called prostaglandin analogues. It works by lowering intraocular pressure. It can be used alone or in
addition to other eye drops such as beta-blockers, which are also able to reduce the pressure.

TRAVATAN is used to reduce high intraocular pressure in adults, adolescents and
children from 2 months of age onwards.This pressure can lead to a condition called glaucoma.

2. What you need to know before using TRAVATAN

Do not use TRAVATAN

• If you are allergicto travoprost or to any of the other ingredients of this medicine (listed in section 6).

In this case, consult your doctor.

Warnings and precautions

• TRAVATANmay increasethe length, thickness, colour and/or number of your eyelashes.Changes to the eyelids or the tissues around the eye, including abnormal hair growth, have also been observed.
• TRAVATANmay change the colour of your iris(the coloured part of the 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, consult your doctor before using TRAVATAN.
• If you currently have, or have had in the past, eye inflammation(iritis and uveitis), consult your doctor before using TRAVATAN
• TRAVATAN can rarely cause difficulty breathingor shortness of breathor worsen the symptoms of asthma. Tell your doctor immediately if you notice that using TRAVATAN causes changes in your breathing.
• Travoprost can be absorbed through the skin. If anyof the medicine comes into contact with the skin,it should be washed offimmediately.This is particularly important for women who are pregnant or planning to become pregnant.
• If you wear soft contact lenses, do not use the eye drops while wearing the lenses. Wait 15 minutes after using the eye drops before putting the lenses back in.

Children and adolescents
TRAVATAN can be used in children from 2 months of age to under 18 years at the same dose as
adults. The use of TRAVATAN is not recommended for children under 2 months of age

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

Pregnancy, breastfeeding and fertility
Do not use TRAVATAN if you are pregnant. Tell your doctor immediately if you suspect you are
pregnant. If you are of childbearing potential, use effective contraception during treatment.

Do not use TRAVATAN if you are breastfeeding.TRAVATAN may be excreted in breast milk.
Ask your doctor for advice before taking any medicine.

Driving and using machines
You may have blurred vision for a certain period after using TRAVATAN. Do not
drive or use machines until these symptoms have disappeared.
TRAVATAN contains hydrogenated castor oiland propylene glycol, which can cause skin
reactions and irritation.

3. How to use TRAVATAN

Use this medicine following the instructions of your doctor or pediatrician exactly. If you have
any doubts, consult your doctor, pediatrician or pharmacist.

The recommended dose is
One drop in the eye(s), once a day - in the evening.
Use TRAVATAN in both eyes only as prescribed by your doctor. Use the medicine for
the period of time recommended by your doctor or pediatrician.
TRAVATAN can only be used as an eye drop.
1 2 3 4

• Immediately before using the bottle for the first time, open the outer protective packaging, remove the bottle (figure 1)and write the date of opening the bottle in the appropriate space on the box
• Wash your hands
• Unscrew the cap
• Hold the bottle in your hand, between your thumb and other fingers, and hold it with the tip pointing downwards
• Tilt your head back or gently tilt the child's head back. Lower the lower eyelid with a clean finger, so as to form a “pocket” between the eyelid and the eye. The drop should be inserted there (figure 2)
• Hold the tip of the bottle close to the eye. Using a mirror may be helpful
• Do not touch the eye or eyelid, the surrounding areas or other surfaces with the tip of thebottle.This could contaminate the eye drops
• Gently press the bottle to release one drop of TRAVATAN at a time. (figure 3)
• After using TRAVATAN, keep your eyes closed, apply gentle pressure with a finger to the corner of the eye, near the nose (figure 4)for at least one minute. This helps to prevent TRAVATAN from spreading throughout the body
• If you are using the eye drops in both eyes, repeat the steps for the other eye
• Close the cap tightly immediately after use
• Use only one bottle at a time. Do not open the outer protective packaging until you are ready to use the bottle.

If a drop does not enter the eye, try again.

If you or the child are using other ophthalmic preparations at the same timesuch as eye drops or ointments,
allow at least 5 minutes to pass between instilling TRAVATAN and instilling other preparations.

If you or the child use more TRAVATAN than you should
Wash all the medicine away with lukewarm water. Do not use the eye drops until the time of the
next dose.

If you forget to use TRAVATAN
Continue treatment with the next dose as scheduled. Do nottake a double doseto
make up for a missed dose. Never use more than one drop per day per eye(s)
affected.

If you stop treatment with TRAVATAN
Do not stop treatment with TRAVATAN without first talking to your doctor or
pediatrician, intraocular pressure will not be controlled with possible loss of vision.
If you have any questions about the use of the medicine, ask your doctor, pediatrician or pharmacist.

Now turn the page

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You can generally continue to use the eye drops unless the side effects are serious.
If you are concerned, speak to your doctor or pharmacist. Do not stop treatment with
TRAVATAN without talking to your doctor.
The following side effects have been observed with TRAVATAN

Very common: may affect more than 1 in 10 users
Effects on the eye: eye redness

Common: may affect up to 1 in 10 users
Effects on the eye: changes in the colour of the iris (coloured part of the eye), eye pain, eye discomfort,
dry eyes, itchy eyes, eye irritation

Uncommon: may affect up to 1 in 100 users
Effects on the eye: corneal disease, eye inflammation, inflammation of the iris,
inflammation inside the eye, inflammation of the eye surface with or without damage to the
surface, sensitivity to light, eye discharge, inflammation of the eyelids, redness of the
eyelids, swelling around the eye, itchy eyelids, blurred vision, increased
tearing, infection or inflammation of the conjunctiva (conjunctivitis), abnormal outward rotation of the
lower eyelid, eye clouding, crusting of the eyelid,
eyelash growth.

General side effects: increased allergy symptoms, headache, irregular heartbeat,
cough, nasal congestion, sore throat, darkening of the skin around the eye(s),
darkening of the skin, abnormal hair structure, excessive hair growth.

Rare: may affect up to 1 in 1,000
Effects on the eye:perception of flashing lights, eczema of the eyelids, eyelashes with abnormal positioning
that grow towards the eye, eye swelling, reduced vision, vision with halos,
decreased eye sensitivity, inflammation of the eyelid glands, pigmentation
inside the eye, increased pupil size, thickening of the eyelashes, change in
eyelash colour, tired eyes.

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

Not known: frequency cannot be estimated from the available data
Effects on the eye:inflammation of the back of the eye, eyes appear more sunken.

General side effects:depression, anxiety, insomnia, false sensation of movement, ringing in the
ears, chest pain, abnormal heart rhythm, increased heartbeat, worsening
of asthma, diarrhoea, nosebleeds, abdominal pain, nausea, vomiting, itching, abnormal hair growth, painful or involuntary urination, increased prostate cancer marker.
In children and adolescents, the most common side effects observed with TRAVATAN have been
eye redness and eyelash growth. Both side effects have been 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 through the national reporting system listed in Annex V. 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 carton after “Exp.”.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
To prevent infections, the bottle must be discarded four weeks after first opening
and a new bottle should be started. Write the date of opening the bottle in the space on the carton.
Do not dispose of any medicine in the drains or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TRAVATAN contains
The active ingredient is travoprost 40 micrograms/mL.
The other ingredients are Polyquaternium-1, hydrogenated castor oil polyoxyethylene 40 (HCO-40),
propylene glycol, sodium chloride, boric acid, mannitol and purified water. Small amounts of hydrochloric acid or sodium hydroxide are added to maintain the normal
levels of acidity (pH levels).

Description of TRAVATAN and package contents
TRAVATAN is a liquid (a clear, colorless solution) supplied in a package containing a
4 mL plastic bottle with a screw cap. Each bottle contains 2.5 mL of travoprost eye drops and
is inserted into a carton.
Pack sizes: 1 or 3 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 Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
S.A. Alcon-Couvreur N.V.
Rijksweg 14
B-2870 Puurs
Belgium
Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany
Siegfried El Masnou, S.A.
Camil Fabra 58
El Masnou
08320 Barcelona
Spain
For further information on this medicinal product, 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

България
Novartis Bulgaria EOOD
Тел.: +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 88 04 52 111

Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00

Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +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

Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Sverige
Novartis Sverige AB
Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

United Kingdom (Northern Ireland)
Novartis Ireland Limited
Tel: +44 1276 698370

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