IZBA 30 MCG/ML Krople do oczu, roztwór

Treść ulotki

1. IZBA 30 micrograms/mL eye drops, solution
   1. What is IZBA and what is it used for
   2. What you need to know before you use IZBA
   3. How to use IZBA
   4. Possible side effects
   5. How to store IZBA
   6. Package contents and other information

IZBA 30 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 their symptoms are the same as yours, as it could 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 IZBA is and what it is used for
• 2. What you need to know before you use IZBA
• 3. How to use IZBA
• 4. Possible side effects
• 5. How to store IZBA
• 6. Contents of the pack and other information

1. What is IZBA and what is it used for

IZBA contains travoprost,a substance belonging to the group of drugs called prostaglandin analogues.
IZBA is used in adults, adolescents and children aged 3 years and over to
lower elevated intraocular pressure.This pressure can lead to a disease called

glaucoma.

2. What you need to know before you use IZBA

Do not use IZBA

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

Ask your doctor for advice if this applies to you.

Warnings and precautions

• IZBA may increasethe 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.
• IZBA may gradually change the colour of your iris(the coloured part of the eye). This change may be permanent.
• If you have had cataract surgery, consult your doctor before using IZBA. IZBA may increase the risk of inflammation in the back of the eye.
• If you have or have had episodes of eye inflammation (iritis and uveitis) consult your doctor before using IZBA. Eye inflammation is a possible side effect that may be associated with the use of prostaglandin analogues such as IZBA.
• Travoprostcan be absorbed through the skin. If anymedicine comes into contact with the skin, it must be rinsed off immediately.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 contact lenses. After using the eye drops, wait 15 minutes before putting your contact lenses back in.

Talk to your doctor or pharmacist before using IZBA.

Children and adolescents
The use of IZBA is not recommended in children under 3 years of age. The safety and efficacy of
travoprost have not been established in this age group.

Other medicines and IZBA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

Pregnancy and breastfeeding
Do not use IZBA if you are pregnant. The effects of this medicine in pregnant women are
not known. Tell your doctor immediately if you think you may be pregnant. If there is a possibility of becoming
pregnant, you should use effective contraception during treatment with IZBA.

Do not use IZBA if you are breastfeeding. IZBA may pass into breast milk.

Driving and using machines
You may have blurred vision for a certain period immediately after applying IZBA.
Do not drive or use machines until these symptoms have disappeared.

IZBA containshydrogenated polyoxyethylene castor oiland propylene glycol, which can cause
skin reactions and irritation.

3. How to use IZBA

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

The recommended dose is
One drop in the affected eye(s), once a day in the evening.
Use IZBA in both eyes only if your doctor or your child’s pediatrician has told you to do so.
Use the medicine for the period of time recommended by your doctor.
IZBA can be used in children aged 3 years and <18 years at the same dose as adults.
IZBA must be used only as an eye drop.

1 2 3 4

• Immediately before using the bottle for the first time, tear off the outer protective wrapper, remove the bottle (figure 1)and write the date of opening the bottle in the appropriate space on the carton.
• Wash your hands.
• Unscrew the cap.
• Hold the bottle in your hand, between your thumb and other fingers, with the bottle pointing downwards.
• Tilt your head or your 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. It may be helpful to use a mirror.
• Do not touch the eye or eyelid, the surrounding areas or other surfaces with the tip of thebottle.This could infect the eye drops.
• Gently press the bottle to release one drop of IZBA at a time. (figure 3).
• After using IZBA, keep the eyelid closed, gently press a finger on the corner of the eye, near the nose (figure 4). This helps to prevent IZBA from spreading to the rest of the body.
• If you need to use 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 wrapper until you are ready to use the bottle.

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

If you or your child are using other products for the eyessuch as eye drops or ophthalmic ointments,
wait at least 5 minutes between instilling IBZA and the other products.

If you or your child use more IZBA than you should
Rinse all the medicine away with lukewarm water. Do not use another eye drop until the time of the next dose.
If IZBA is swallowed, consult your doctor or pharmacist immediately.

If you forget to use IZBA
Continue the treatment with the next dose as scheduled. Do not use a double dose to make up for a missed dose. Never use more than one drop a day per affected eye(s).

If you stop using IZBA
Do not stop the treatment with IZBA without first talking to your doctor or your child’s pediatrician, the pressure in the eye will no longer be controlled with possible loss of vision.
If you have any further questions on the use of this medicine, ask your doctor, your child’s pediatrician or your pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been observed with IZBA:

Very common: may affect more than 1 in 10 people

Effects on the eye: eye redness.

Common: may affect up to 1 in 10 people

Effects on the eye: eye discomfort, eye itching and dry eye.

Uncommon: may affect up to 1 in 100 people

Effects on the eye: inflammation inside the eye, inflammation of the eye surface, with or
without damage to the surface, eyelid inflammation, conjunctivitis, eye pain,
sensitivity to light, blurred or abnormal vision, swelling or crusting on the
eyelids, eye discharge, darkening of the skin around the eye(s), eyelash growth and thickening.

General side effects: skin rash or itching.

In addition, with another medicine containing a higher dose of travoprost
(40 micrograms/mL), the following side effects have been observed:
Very common: may affect more than 1 in 10 people

Effects on the eye: redness of the eye.

Common: may affect up to 1 in 10 people

Effects on the eye: change in the color of the iris (colored part of the eye), eye irritation, eye pain, eye discomfort, dry eye, itchy eyes.

Uncommon: may affect up to 1 in 100 users

Effects on the eye: corneal disturbance, eye inflammation, iris inflammation,
inflammation inside the eye, inflammation of the eye surface with or without damage to the
surface, sensitivity to light, eye discharge, eyelid inflammation, redness of the
eyelids, swelling around the eye, eyelid itching, blurred vision, increased
tearing, eye or conjunctival infection or inflammation (conjunctivitis), abnormal rotation of the
lower eyelid outwards, blurred vision, crusting on the eyelid,
eyelash growth.

General side effects: increased allergy symptoms, headache, irregular heartbeat,
cough, nasal congestion, throat irritation, 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 users

Effects on the eye:perception of flashing lights, eczema of the eyelids, eyelashes with abnormal positioning
that grow backwards towards the eye, eye swelling, reduced vision, vision with
halo, decreased eye sensitivity, inflammation of the eyelid glands,
pigmentation inside the eye, increased pupil size, thickening of the
eyelashes, change in eyelash color, tired eyes.

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

Not known: frequency cannot be estimated from 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
heart rate, worsening
of asthma, diarrhea, nosebleeds, abdominal pain, nausea, vomiting, itching, abnormal hair growth, painful or involuntary urination, increased marker (marker)of prostate cancer.
In children and adolescents, the most common side effects observed with medicines containing
high doses of travoprost (40 micrograms/ml) are eye redness and eyelash growth. 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 side effects not listed in this leaflet. You can also report side effects directly through the national reporting system reported in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store IZBA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and the pack 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, you must disposeof the bottle four weeks after first openingand you must
use a new bottle. Write the date of opening the bottle in the space on each pack.
Do not dispose of any medicine in waste water 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 IZBA contains

• The active ingredient is travoprost. Each mL of solution contains 30 micrograms of travoprost.
• The other ingredients are: polyquaternium-1, hydrogenated castor oil polyoxyethylene 40, propylene glycol (see last paragraph of section 2), sodium chloride, boric acid, mannitol and purified water. Small amounts of hydrochloric acid or sodium hydroxide are added to maintain normal acidity levels (pH levels).

Description of IZBA and package contents
IZBA eye drops are 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
each bottle 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
S.A. Alcon-Couvreur N.V.
Rijksweg 14
B-2780 Puurs
Belgium
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 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