30 micrograms/ml eye drops, solution
travoprost
1. What IZBA is and what it is used for
IZBA contains travoprost, part of a group of medicines called prostaglandin analogue you.
IZBA is used to lower high pressure in the eye in adults, adolescents, and children from 3 years of age. 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 any of the other ingredients of this medicine (listed in section 6).
Ask your doctor for advice if this applies to you.
Warnings and cautions
- IZBA may increase the length, thickness, color and / or number of your eyelashes are . In addition, changes in the eyelids, including unusual hair growth, or in the tissues around the eye have been observed.
- IZBA can gradually change the color of the iris (the colored part of your eye). This change may be permanent.
- If you have had cataract surgery, talk to your doctor before using IZBA. IZBA may increase the risk of inflammation in the back of the eye.
- If you have or have had an eye infection ( iritis and uveitis ), talk to 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.
- Travoprost can be absorbed through the skin. If any of the medicines come into contact with the skin , they should be washed off as soon as possible. This is especially important for women who are pregnant or trying to conceive.
- If you wear soft contact lenses, do not use the drops with the contact lenses left in your eyes. Wait for 15 minutes after dripping into the eye drops, before putting the lenses back in the eyes.
Talk to your doctor or pharmacist before using IZBA.
Children and young people
The use of IZBA is not recommended for 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 effect of this drug on pregnant women is unknown. If you think you may be pregnant, talk to your doctor straight away. If you are likely to become pregnant, you must use safe contraception while using IZBA.
Do not use IZBA if you are breastfeeding. IZBA can be transferred to breast milk.
Driving and using machines
You may find that your vision becomes foggy immediately after using IZBA. Do not drive or use machines until it has disappeared.
IZBA contains macrogolglycerol hydroxystearate (hydrogenated castor oil) and propylene glycol, which may cause skin reactions and skin irritation.
3. How to use IZBA
Always use this medicine exactly as your doctor or your doctor has told you. If you are not sure, talk to your or your child’s doctor or pharmacist.
The recommended dose is
a drop in the affected eye or eyes, once daily, in the evening.
Only use IZBA in both eyes if your doctor has told you to. Take the drops for as long as your or your child’s doctor prescribes.
IZBA can be used in children from 3 years to 18 years with the same dosage as for adults.
IZBA should only be used as eye drops.
- Immediately before using a bottle for the first time, tear open the protective bag, remove the bottle ( Fig. 1 ) and write down the date when you opened the bottle in the empty space on the carton.
- Wash your hands.
- Unscrew the lid.
- Hold the bottle pointing down between your thumb and fingers.
- Tilt your or your child’s head back. Pull down the lower eyelid with a clean finger until a “pocket” is formed between the eyelid and the eye. The drop should end up here ( picture 2 ).
- Push the drip tip of the bottle towards the eye. Use a mirror if it helps.
- Do not touch the eye or eyelid, surrounding areas or other surfaces with the drip tip. It can contaminate the drops.
- Gently press on the bottle to release one drop of IZBA at a time ( Figure 3 ).
- After using IZBA, close your eyes and press lightly with a finger in the corner of your eye ( Figure 4 ) for at least one minute. This prevents IZBA from entering the rest of the body.
- Repeat the steps for the other eye if you use drops in both eyes.
- Screw on the lid firmly immediately after use.
- Use only one bottle at a time. Do not open the protective bag until you need to use the bottle.
If a drop misses the eye, try again.
If you or your child use other eye preparations, e.g. eye drops or eye ointments, wait at least 5 minutes between taking IZBA and the other eye preparations.
If you or your child have used too much IZBA
Rinse all medicines with lukewarm water. Do not take any more drops until it is time for your next regular dose. If IZBA is swallowed, contact your doctor or pharmacist immediately.
If you forget to use IZBA
Continue with the next dose as planned. Do not take a double dose to make up for a forgotten dose. Never use more than one drop per day in the affected eye (s).
If you stop using IZBA
If you stop using IZBA without talking to your or your child’s doctor, the pressure in your or your child’s eye will not be checked, which could lead to vision loss.
If you have any further questions on the use of this product, ask your doctor, the doctor treating your child, or the 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 side effects: may affect more than 1 user in 10
Eye effects: reddening of the eyes.
Common side effects: may affect up to 1 in 10 people
Effects in the eye: discomfort in the eye, itching in the eye, and dry eyes.
Uncommon side effects: may affect up to 1 in 100 people
Effects in the eye: inflammation inside the eye, inflammation of the surface of the eye with/without surface damage, inflammation of the eyelids, inflammation of the conjunctiva, eye pain, photosensitivity, foggy or abnormal vision, swelling, crusting of the eyelids, watery eyes, the darker skin around the eye/eyes, eyelashes grow and become thicker.
General side effects are rashes or itching of the skin.
In addition, the following side effects have been observed with another drug containing a higher strength of travoprost (40 micrograms/ml):
Very common side effects: may affect more than 1 user in 10
Eye effects: reddening of the eyes.
Common side effects: may affect up to 1 in 10 people
Effects in the eye: change in iris color (the colored part of the eye), eye irritation,
eye pain, discomfort in the eye, dry eye, itching in the eye.
Uncommon side effects: may affect up to 1 in 100 people
Effects in the eye: disorders of the cornea, eye inflammation, iris inflammation, inflammation inside the eye, inflammation of the surface of the eye with/without surface damage, photosensitivity, watery eye, eyelid inflammation. redness of the eyelid, swelling around the eye, itching of the eyelids, blurred vision, increased tear production, inflammation or infection of the conjunctiva ( conjunctivitis ), the lower eyelid is turned outwards in an abnormal way, cloudiness of the eye, crusting of the eyelids, growth of eyelashes.
Common side effects are increased allergic symptoms, headache, irregular heartbeat, cough, nasal congestion, throat irritation, the darker skin around the eye (eyes), darker skin, abnormal hair quality, severe hair growth.
Rare: may affect up to 1 in 1,000 people
Effects in the eye: experience of flashes of light, eczema on the eyelids, misaligned eyelashes growing backward towards the eye, swollen eyes, impaired vision, halo-phenomenon, decreased sensation in the eye, inflammation of the glands in the eyelids, pigmentation inside the eye, increased pupil size, thicker eyelashes, discolored eyelashes, tired eyes.
Common side effects are: a viral infection of the eye, dizziness, bad taste in the mouth, irregular or slower pulse, increased or decreased blood pressure, shortness of breath, asthma, allergy or inflammation of the nose, dryness of the nose, changes in the voice, discomfort or ulcers in the gastrointestinal tract, constipation, dry mouth, redness or itching of the skin, rash, altered hair color, loss of eyelashes, joint pain, pain in muscles and bones, general weakness.
No known frequency: can not be calculated from the available data
Effects in the eye: inflammation in the back of the eye, the eyes look more sunken.
Common side effects are depression, anxiety, insomnia, feeling of false movement, ringing in the ears, chest pain, abnormal heart rhythm, faster heartbeat, worsening asthma, diarrhea, nosebleeds, abdominal pain, nausea, vomiting, itching, abnormal hair growth, painful or involuntary elevated prostate-specific antigen.
In children and adolescents, the most common side effects with the use of medicines with a higher strength of travoprost (40 micrograms/ml) are redness of the eye and growth of the eyelashes. The incidence of these two side effects was higher in children and adolescents than in adults.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
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 carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
You must discard the bottle 4 weeks after you first opened it to prevent infection. Then take a new bottle. Write down the date when you opened it in the space on each box.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
Content declaration
- The active substance is travoprost. Each ml of solution contains 30 micrograms travoprost.
- The other ingredients are polyquaternium-1, macrogolglycerol hydroxystearate, propylene glycol (see end of section 2), sodium chloride, boric acid, mannitol and purified water. Small amounts of hydrochloric acid or sodium hydroxide have been added to keep the acidity ( pH level) normal.(Polyquaternium-1, ricini oleum hydrogenatum (HCO-40), acidum boricum, mannitolum, natrii chloride, propylene glycolum, natrii hydroxidum et / aut acidum hydrochloridum (const. PH ), aqua purificata)
What the medicine looks like and contents of the pack
IZBA eye drops are a liquid (clear and colorless solution) that is supplied in a 4 ml plastic bottle with a screw cap. Each bottle contains 2.5 ml of travoprost and is packed in a protective bag. 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
SA Alcon Couvreur NV
Rijksweg 14
B-2870 Puurs
Belgium
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 | LithuaniaSIA “Novartis Baltics” Lithuanian branches Tel: +370 5 269 16 50 |
| BulgariaNovartis Bulgaria EOODTel .: +359 2 489 98 28 | Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11 |
| Czech RepublicNovartis sroTel: +420 225 775 111 | HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00 |
| DenmarkNovartis Healthcare A / STel: +45 39 16 84 00 | MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872 |
| GermanyNovartis Pharma GmbHTel: +49 911 273 0 | The NetherlandsNovartis Pharma BVTel: +31 26 37 82 111 |
| EestiSIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810 | NorwayNovartis Norge ASTel: +47 23 05 20 00 |
| GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 | AustriaNovartis Pharma GmbHTel: +43 1 86 6570 |
| SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 | PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888 |
| FranceNovartis Pharma SASTel: +33 1 55 47 66 00 | PortugalNovartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600 |
| CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 | RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01 |
| IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 | SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovak RepublicNovartis Slovakia sroTel: + 421 2 5542 5439 |
| ItalyNovartis Farma SpATel: +39 02 96 54 1 | Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200 |
| ΚύπροςNovartis Pharma Services Inc.:Ηλ: +357 22 690 690 | SwedenNovartis Sverige ABTel: +46 8 732 32 00 |
| LatviaSIA “Novartis Baltics”Tel: +371 67 887 070 | United KingdomNovartis Pharmaceuticals UK Ltd.Tel: +44 1276 698370 |