Izba

Package leaflet: Information for the user

IZBA 30 micrograms/mL eye drops, solution

travoprost
Please read all of this leaflet carefully before you start using this medicine because 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 using 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 IZBA is and what it is used for

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

2. What you need to know before using IZBA

Do not use IZBA

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

Ask your doctor for advice if this condition applies to you.
Warnings and precautions

• IZBA may increase the length, thickness, colour and/or number of your eyelashes. Changes in the eyelids have also been observed, including unusual growth of eyelashes or tissues around the eye.
• IZBA may gradually change the colour of your iris (the coloured part of the eye). This change may be permanent.
• If you have undergone cataract surgery, consult your doctor before using IZBA. IZBA may increase the risk of inflammation of the back of the eye.
• If you have or have had episodes of ocular inflammation (iritis and uveitis), consult your doctor before using IZBA. Ocular inflammation is a possible adverse effect that may be associated with the use of prostaglandin analogues such as IZBA.
• Travoprost may be absorbed through the skin. If any amount of the medicine comes into contact with the skin, wash immediately. This is particularly important for women who are pregnant or who are planning to become pregnant.
• If you wear soft contact lenses, do not use the eye drops while wearing them. After using the eye drops, wait 15 minutes before reinserting your contact lenses.

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 unknown. Speak to your doctor immediately if you think you may be pregnant. If you may become pregnant, you must use an effective contraceptive method during treatment with IZBA.
Do not use IZBA if you are breastfeeding. IZBA may pass into breast milk.
Driving and using machines
You may experience blurred vision for a period of time immediately after applying IZBA. Do not drive or operate machinery until these symptoms have resolved.
IZBA contains polyoxyl 40 hydrogenated castor oil and propylene glycol, which may cause skin reactions and irritation.

3. How to use IZBA

Use this medicine exactly as directed by your doctor or your child’s paediatrician. If you have any doubts, consult your doctor, your child’s paediatrician, or pharmacist.
The recommended dose is
One drop in the affected eye(s), once daily in the evening.
Use IZBA in both eyes only if your doctor or your child’s paediatrician has instructed you to do so. Use the medicine for the length of time prescribed by your doctor.
IZBA may be used in children aged 3 to <18 years at the same dose as adults.
IZBA must only be used as an eye drop.

1 2 3 4

• Immediately before using the bottle for the first time, tear off the outer protective pouch, remove the bottle (figure 1), and write the date of opening on the designated space on the carton.
• Wash your hands.
• Unscrew the cap.
• Hold the bottle between your thumb and other fingers, with the tip pointing downwards.
• Tilt the head back, or your child’s head back. Pull down the lower eyelid with a clean finger to create a “pocket” between the eyelid and the eye. The drop should be placed here (figure 2).
• Hold the tip of the bottle close to the eye. Using a mirror may be helpful.
• Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the tip of the bottle. This could contaminate the eye drops.
• Gently squeeze the bottle to release one drop of IZBA at a time (figure 3).
• After using IZBA, keep the eyelid closed and gently press with a finger at the inner corner of the eye, near the nose (figure 4). This helps 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 pouch 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 eye products, such as eye drops or ophthalmic ointments, wait at least 5 minutes between instilling IZBA and the other products.
If you or your child use more IZBA than you should
Rinse the eye thoroughly with lukewarm water. Do not use any additional eye drops until your next scheduled dose. If IZBA has been swallowed, contact your doctor or pharmacist immediately.
If you forget to use IZBA
Continue treatment with the next dose as scheduled. Do not use a double dose to make up for the missed dose. Never use more than one drop per day in each affected eye.
If you stop using IZBA
Do not stop treatment with IZBA without first talking to your doctor or your child’s paediatrician, as the pressure in the eye will no longer be controlled, which may lead to loss of vision.
If you have any questions about how to use this medicine, consult your doctor, your child’s paediatrician, or pharmacist.

4. Possible side effects

Like all medicines, this medicine may 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
Eye effects: eye redness.

Common: may affect up to 1 in 10 people
Eye effects: eye discomfort, eye itching, dry eye.

Uncommon: may affect up to 1 in 100 people
Eye effects: intraocular inflammation, inflammation of the eye surface, with or without surface damage, eyelid inflammation, conjunctival inflammation, eye pain, light sensitivity, blurred or abnormal vision, eyelid swelling or crusting, eye discharge, darkening of the skin around the eye(s), eyelash growth and thickening.
General side effects: skin rash or skin itching.

In addition, the following side effects have been observed with another medicine containing a higher dose of travoprost (40 micrograms/mL):

Very common: may affect more than 1 in 10 people
Eye effects: eye redness.

Common: may affect up to 1 in 10 people
Eye effects: change in iris colour (coloured part of the eye), eye irritation, eye pain, eye discomfort, dry eye, itchy eyes.

Uncommon: may affect up to 1 in 100 users
Eye effects: corneal disorder, eye inflammation, iris inflammation, intraocular inflammation, inflammation of the ocular surface with or without surface damage, light sensitivity, eye discharge, eyelid inflammation, eyelid redness, swelling around the eye, eyelid itching, blurred vision, increased lacrimation, conjunctival infection or inflammation (conjunctivitis), abnormal outward rotation of the lower eyelid, eye cloudiness, eyelid crusting, eyelash growth.
General side effects: worsening of allergy symptoms, headache, irregular heartbeat, cough, nasal congestion, throat irritation, darkening of the skin around the eye(s), skin darkening, abnormal hair structure, excessive hair growth.

Rare: may affect up to 1 in 1,000 users
Eye effects: perception of flickering lights, eyelid eczema, abnormally positioned eyelashes growing backward toward the eye, eye swelling, reduced vision, seeing halos around lights, decreased eye sensitivity, inflammation of the eyelid glands, pigmentation inside the eye, increased pupil size, eyelash thickening, change in eyelash colour, eye fatigue.
General side effects: viral eye infection, dizziness, unpleasant taste, irregular or reduced heart rate, reduced or increased blood pressure, shortness of breath, asthma, allergy or nasal inflammation, nasal dryness, voice changes, gastrointestinal discomfort or ulcer, constipation, dry mouth, skin redness or itching, skin rash, change in hair colour, eyelash loss, joint pain, musculoskeletal pain, generalized weakness.

Not known: frequency cannot be estimated from the available data
Eye effects: inflammation of the back of the eye, eyes appearing 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, diarrhoea, nosebleeds, abdominal pain, nausea, vomiting, itching, abnormal hair growth, painful or involuntary urination, increase in prostate cancer marker.

In children and adolescents, the most commonly observed side effects with medicines containing high doses of travoprost (40 micrograms/mL) are eye redness and eyelash growth. Both of these side effects have been observed with a higher incidence in children and adolescents compared to adults.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to 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 stated on the bottle and 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, you must discard the bottle four weeks after first opening and must use a new bottle.
Write the date of opening in the space provided on each carton.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What IZBA contains

• The active substance is travoprost. Each mL of solution contains 30 micrograms of travoprost.
• The other components are: polyquaternium-1, polyoxethylated castor oil 40, propylene glycol (see the 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 the appearance of IZBA and contents of the pack
IZBA eye drops is a liquid (a clear, colourless solution) supplied in a pack containing a plastic bottle of 4 mL 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.

Marketing Authorization Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Manufacturing NV
Rijksweg 14
2870 Puurs-Sint-Amands
Belgium

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: + 421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

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