Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - izba

Document Subject

Generated Narrative: MedicinalProductDefinition mpded378039327f28c36307d251503f7d3

identifier: http://ema.europa.eu/identifier/EU/1/13/905/001-002

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: IZBA 30 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-ded378039327f28c36307d251503f7d3

identifier: http://ema.europa.eu/identifier/EU/1/13/905/001-002

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - izba

Attesters

What is in 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

IZBA contains travoprost, one of a group of medicines called prostaglandin analogues. IZBA is used to reduce high pressure in the eye in adults, adolescents and children from 3 years old onward. This pressure can lead to an illness called glaucoma.

Do not use IZBA

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.

Warnings and precautions

IZBA 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.

IZBA may gradually change the colour of your iris (the coloured part of your eye). This change may be permanent.

If you have had cataract surgery talk to your doctor before you use IZBA. IZBA may increase the risk of inflammation of the back of the eye.

If you have current or previous history of an eye inflammation (iritis and uveitis) talk to your doctor before you use IZBA. Eye inflammation is a possible side effect which may be associated with the use of prostaglandin analogues such as IZBA.

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.

Talk to your doctor or pharmacist before using IZBA.

Children and adolescents Use of IZBA is not recommended to those 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 using, have recently used or might use any other medicines.

Pregnancy and breast-feeding Do not use IZBA if you are pregnant. The effects of this medicine in pregnant women are not known. 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 IZBA.

Do not use IZBA if you are breast-feeding. IZBA may get into your milk.

Driving and using machines You may find that your vision is blurred for a time just after you use IZBA. Do not drive or use machines until this has worn off.

IZBA 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 IZBA 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. IZBA can be used in children from 3 years to <18 years at the same dose as for adults.

IZBA should only be used as an eye drop.

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 IZBA at a time. (picture 3).

After using IZBA, 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 IZBA 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 your 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 IZBA and the other eye preparations.

If you or your child use more IZBA than you should Rinse all the medicine out with warm water. Don t put in any more drops until it s time for your next regular dose. If IZBA is swallowed, consult your doctor or pharmacist immediately.

If you forget to use IZBA 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 IZBA Do not stop using IZBA 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.

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 in the eye: eye redness.

Common: may affect up to 1 in 10 people

Effects in the eye: eye discomfort, itchy eye, and dry eye.

Uncommon: may affect up to 1 in 100 people

Effects in the eye: inflammation inside the eye, eye surface inflammation with/out surface damage, inflammation of the eyelids, inflammation of the conjunctiva, eye pain, sensitivity to light, blurred or abnormal vision, swelling or crusting of eyelids, eye discharge, darkening of skin around the eye(s), growth and thickening of the eyelashes.

General side effects: rash or itching of the skin.

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

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 irritation. eye pain, eye discomfort, dry eye, itchy eye.

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, diarrhoea, 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 the medicine containing a higher strength of travoprost (40 micrograms/mL) 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 this medicine 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 each carton box.

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

What IZBA contains

• The active substance is travoprost. Each mL of solution contains 30 micrograms of travoprost.
• The other ingredients are: polyquaternium-1, polyoxyethylene hydrogenated castor oil 40, propylene glycol (see end of section 2), 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 IZBA looks like and contents of the pack IZBA eye drop is a liquid (a clear, colourless solution) supplied in 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.

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

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

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: