Vizibim

Package Leaflet: Information for the User

Vizibim, 0.3 mg/ml, eye drops, solution
bimatoprost

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. This also applies to any side effects not listed in this leaflet. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Vizibim and what is it used for
• 2. Important information before using Vizibim
• 3. How to use Vizibim
• 4. Possible side effects
• 5. How to store Vizibim
• 6. Contents of the pack and other information

1. What is Vizibim and what is it used for

Vizibim is a medicine used in glaucoma. It belongs to a group of medicines called prostamides.
Vizibim eye drops are used to lower high pressure in the eye. This medicine may be used alone or with other eye drops called beta-adrenergic blockers, which also lower the pressure inside the eye.
The eye contains a clear, watery fluid that nourishes the inside of the eye. This fluid is constantly drained from the eye and replaced with new fluid. If it is not drained quickly enough, the pressure in the eye increases. The action of this medicine is to increase the amount of fluid drained, and consequently lower the pressure inside the eye. If left untreated, high pressure can lead to a disease called glaucoma and eventually damage vision.
Vizibim eye drops, solution is a sterile solution that does not contain preservatives.

2. Important information before using Vizibim

When not to use Vizibim

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

Warnings and precautions

Before starting treatment with Vizibim, consult your doctor or pharmacist.
Tell your doctor if:

• you have breathing difficulties;
• you have kidney or liver problems;
• you have had cataract surgery;
• you have dry eye syndrome;
• you have or have had problems with the cornea (the transparent layer on the front of the eye);
• you have or have had a slow heart rate or low blood pressure;
• you have had a viral infection or inflammation in the eye.

During treatment with Vizibim, the medicine may cause loss of fat tissue around the eye, which can cause deepening of the eyelid fold, sunken eyes, drooping eyelids (ptosis), skin tension around the eye (dermatochalasia-induced involution), and increased visibility of the lower white part of the eye (visibility of the lower part of the sclera). These changes are usually mild, but if they are pronounced, they can affect the field of vision. The changes may disappear after discontinuation of treatment with Vizibim. Vizibim may also cause darkening and excessive growth of eyelashes, as well as darkening of the skin around the eyelid. It may also darken the color of the iris. These changes may be permanent. The changes may be more noticeable if only one eye is treated.

Children and adolescents

Vizibim should not be used in children under 18 years of age due to the lack of studies in this age group.

Vizibim and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
If you are using Vizibim with another eye medicine, wait at least 5 minutes between using Vizibim and using the other medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Vizibim may pass into breast milk, so you should not breastfeed during treatment with Vizibim.

Driving and using machines

Immediately after administering the medicine, vision may become temporarily blurred. Do not drive or operate machinery until your vision has improved.

Vizibim contains disodium phosphate heptahydrate

The medicine contains 0.042 mg of phosphates in each drop, which corresponds to 1.056 mg/ml.
In patients with severe damage to the transparent, front part of the eye (cornea), phosphates may, in very rare cases, cause corneal clouding due to calcium deposition during treatment.

3. How to use Vizibim

This medicine should always be used exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The medicine should only be used in the eyes. The recommended dose is one drop of Vizibim in the evening, once a day, in each eye that needs treatment.
If you are using Vizibim with another eye medicine, wait at least 5 minutes between using Vizibim and using the other medicine.
Do not use this medicine more often than once a day, as this may reduce the effectiveness of the treatment.
Do not touch the tip of the multidose container to the eye or the skin around the eye. This could cause eye injury. The solution may become contaminated with bacteria that can cause eye infections leading to serious damage to the eye, even loss of vision.
To avoid contaminating the multidose container, do not touch the tip to any surface.

Instructions for use

Before administering eye drops:

• Do not use this medicine if the seal on the bottle neck is broken before the first use.
• Wash your hands before opening the bottle.
• When using the medicine for the first time, before administering it to the eye, the patient should first check the function of the bottle by slowly pressing it to release one drop into the air, away from the treated eye.
• Once the patient is sure they can release one drop, they should choose the most comfortable position for administering the eye drops (can be sitting, lying on their back, or standing in front of a mirror).

Administering eye drops:

• 1. Hold the bottle upright with the cap and open it by twisting the cap. Do not touch any surface with the tip of the bottle to prevent contamination of the solution.

• 2. Tilt your head back and hold the bottle over the eye.

• 3. Pull the lower eyelid down and look up. Gently squeeze the middle part of the bottle and release one drop into the eye. Note that it may take a few seconds from squeezing the bottle to the drop coming out. Do not squeeze the bottle too hard.

If you have any doubts about using the medicine, consult your doctor, pharmacist, or nurse.

• 4. To spread the medicine over the surface of the eye, blink several times.
• 5. Repeat steps 2-4 to administer the medicine to the other eye, if advised by your doctor. Sometimes treatment is only needed for one eye; your doctor will inform you about this and tell you which eye to treat.

• 6. After use and before replacing the cap, shake the bottle once downwards without touching the tip, to remove any remaining medicine that may be on it. This is necessary for the proper dosing of the next drops.
• 7. After using all the doses in the Vizibim bottle, a small amount of solution will remain. Do not worry, as the packaging contains an excess of Vizibim, and you will receive the full amount of Vizibim prescribed by your doctor. After completing the treatment cycle, do not use the medicine that is still in the bottle. The drops are suitable for use for 28 days after the first opening of the bottle.

Using a higher dose of Vizibim than recommended

If you use more Vizibim than you should, it is unlikely to cause any serious harm. Take the next dose at the usual time. If you are concerned, talk to your doctor or pharmacist.

Missing a dose of Vizibim

If you miss a dose of Vizibim, use one drop in the eye as soon as you remember, and then return to your normal dosing schedule. Do not use a double dose to make up for a missed dose.

Stopping treatment with Vizibim

To be effective, Vizibim should be used every day. If you stop using Vizibim, it may cause an increase in pressure inside the eye, so before planning to stop treatment, talk to your doctor.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vizibim can cause side effects, although not everybody gets them.
Very common:may affect more than 1 in 10 people
Eyes:

• Lengthening of eyelashes (up to 45% of people)
• Mild redness (up to 44% of people)
• Itching (up to 14% of people)
• Loss of fat tissue around the eye, which can lead to deepening of the eyelid fold, sunken eyes, drooping eyelids (ptosis), skin tension around the eye (dermatochalasia-induced involution), and increased visibility of the lower white part of the eye (visibility of the lower part of the sclera)
  Common:may affect up to 1 in 10 people
  Eyes:
  • Allergic reaction in the eye
  • Eyestrain
  • Sensitivity to light
  • Darker skin color around the eye
  • Darker eyelash color
  • Pain
  • Feeling of a foreign body in the eye
  • Feeling of sticky eyelids
  • Darker iris color
  • Blurred vision
  • Irritation
  • Burning sensation
  • Inflammation, redness, and itching of the eyelids
  • Watery eyes
  • Dryness
  • Worsening of vision
  • Blurred vision
  • Swelling of the clear membrane covering the eye
  • Minor damage to the surface of the eye, with or without inflammation
    Eyes and body:
  • Headache
  • Increased liver test values
  • Increased blood pressure Uncommon:may affect up to 1 in 100 people
    Eyes:
  • Cystic swelling of the macula (swelling of the retina in the back of the eye, which can lead to worsening vision)
  • Eye inflammation
  • Bleeding from the retina
  • Eyelid swelling
  • Eyelid twitching
  • Eyelid contraction and its deviation from the eye surface
  • Redness of the skin around the eye
    Eyes and body:
  • Nausea
  • Dizziness
  • Weakness
  • Hair growth around the eye Rare:may affect up to 1 in 1,000 people
    Eyes:
  • Eye discomfort
    Eyes and body:
  • Asthma
  • Worsening of asthma
  • Worsening of chronic obstructive pulmonary disease (COPD)
  • Shortness of breath
  • Symptoms of an allergic reaction (swelling, redness of the eye, and skin rash)
  • Skin discoloration (around the eye)

  Other side effects reported with the use of eye drops containing phosphates

  In very rare cases, in some patients with severe damage to the outer, transparent layer of the eye (cornea), cloudy spots appeared on the cornea due to calcium deposition during treatment.

  Reporting side effects

  If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist.
  Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocides
  Jerozolimskie Avenue 181C
  02-222 Warsaw
  Phone: +48 22 49 21 301
  Fax: +48 22 49 21 309
  Website: https://smz.ezdrowie.gov.pl
  Side effects can also be reported to the marketing authorization holder.
  By reporting side effects, you can help provide more information on the safety of this medicine.

  5. How to store Vizibim

  Keep the medicine out of the sight and reach of children.
  Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of that month.
  The medicine does not require special storage conditions.
  The bottle should be discarded no later than 4 weeks after the first opening, even if there are still drops left in it. This will prevent infection. To remember the date of opening the bottle, note it on the packaging.
  Do not use the bottle if the seal on the bottle neck is broken before the first use.
  Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

  6. Contents of the pack and other information

  What Vizibim contains

  • The active substance is bimatoprost. One ml of solution contains 0.3 mg of bimatoprost.
  • The other ingredients are: sodium chloride, disodium phosphate heptahydrate, citric acid monohydrate, and water for injections. Small amounts of hydrochloric acid or sodium hydroxide may be added to maintain the appropriate acidity (pH value).

  What Vizibim looks like and contents of the pack

  Vizibim is a colorless, clear solution, available in a white, opaque bottle with an LDPE Novelia system consisting of a dropper (HDPE and silicone) and a cap (HDPE). The outer packaging is a cardboard box.
  The following pack sizes are available: cardboard boxes containing 1 or 3 bottles of 3 ml solution each.
  Not all pack sizes may be marketed.

  Marketing authorization holder

  BAUSCH + LOMB IRELAND LIMITED
  3013 Lake Drive
  Citywest Business Campus
  Dublin 24, D24PPT3
  Ireland

  Manufacturer

  EXCELVISION
  27 st. La Lombardière
  Zl La Lombardière
  07100 ANNONAY
  France
  Pharmathen S.A.
  Dervenakion 6
  Pallini Attikis 15351
  Greece

  Date of last revision of the package leaflet: 11/2022