Vizibim 0,3 mg/ml colirio en solucion

Label: information for the user

VIZIBIM 0.3 mg/ml, eye drops in solution

bimatoprost

Read this label carefully before starting to use the medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
  If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section4.

1. What isVIZIBIMand for what it is used

2. What you need to know before starting to useVIZIBIM

3. How to useVIZIBIM

4. Possible adverse effects

5. Storage ofVIZIBIM

6. Contents of the package and additional information

VIZIBIM is a medication for glaucoma. It belongs to a group of medications called prostamides.

VIZIBIM eye drops are used to reduce elevated eye pressure. This medication may be used alone or with other eye drops called beta-blockers, which also reduce pressure.

The eye contains a clear, watery fluid that nourishes the inside of the eye. This fluid continuously drains out of the eye and at the same time new fluid is formed to replace it. If the fluid does not drain at a sufficient speed, the pressure inside the eye increases. This medication acts by increasing fluid drainage. This reduces the pressure inside the eye. If elevated eye pressure is not reduced, it could cause a disease called glaucoma and damage your vision.

VIZIBIMeye drops in solution are a sterile solution that does not contain preservatives.

No use VIZIBIM:

• If you are allergic to bimatoprost or any of the other components of this medication (listed in section6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use VIZIBIM.

Consult your doctor if:

• You have any respiratory problems;

• You have kidney or liver problems;
• You have had cataract surgery in the past;
• You have dry eye;
• You have or have had any problems with the cornea (front transparent part of the eye);
• You have or have had low blood pressure or heart rate;
• You have had a viral infection or eye inflammation.

During treatment, VIZIBIM may cause a loss of fat around the eyes that can cause deepening of the eyelid crease, sunken eyes (enophthalmos), drooping of the upper eyelids (ptosis), stretching of the skin around the eye (dermatochalasis involution) and that the white lower part of the eye becomes more visible (exposure of the inferior sclera). The changes are usually mild, but if they worsen, they may affect your field of vision. The changes may disappear if VIZIBIM is stopped. VIZIBIM may also cause darkening and growth of your eyelashes, as well as darkening of the skin around the eyelid. The color of the iris may darken. These changes may be permanent. The changes may be more noticeable if only one eye is treated.

Children and adolescents

This medication has not been studied in patients under 18 years old and, therefore, VIZIBIM should not be used in patients under 18 years old.

Other medications and VIZIBIM

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

If you use VIZIBIM with another eye medication, wait at least five minutes between the use of VIZIBIM and the other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding,or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

You should not use VIZIBIM during breastfeeding, as this medication may pass into breast milk.

Driving and operating machines

After using this medication, you may notice that your vision becomes blurry for a short period of time. In that case, do not drive or operate machines until your vision clears up.

VIZIBIM contains hydrogen phosphate heptahydrate

This medication contains 0.042 mg of phosphates in each drop, which is equivalent to 1.056 mg/ml.

If you suffer a severe injury to the transparent layer of the front part of the eye (the cornea), the phosphates may cause, in rare cases, cloudy spots in the cornea due to calcium accumulation during treatment.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

This medication should only be applied to the eye. The recommended dose is one drop of VIZIBIM once a day, at night, in each eye that requires treatment.

If you use VIZIBIM with another eye medication, wait at least five minutes between the use of VIZIBIM and the other medication.

Do not use this medication more than once a day, as it may reduce the effectiveness of the treatment.

Avoid letting the tip of the dropper from the multidose bottle come into contact with the eye or the surrounding areas.It could injure the eye. The solutioncould become contaminated with bacteria that could cause eye infections and cause severe eye damage, including loss of vision.

To avoid possible contamination of the multidose bottle, avoid letting the tip of the dropper come into contact with any surface.

Usage Instructions

Before applying the eye drops:

• Wash your hands before opening the bottle.
• Do not use this medication if you observe that the safety seal on the bottle is broken before using it for the first time.
• When using it for the first time, before applying a drop to the eye, you must start by testing the dropper, slowly squeezing it until a drop falls into the air, away from the eye.
• When you feel secure to apply a drop in a controlled manner, decide in which position you are most comfortable to apply the drops (you can sit, lie down, or stand in front of a mirror).

Instillation:

1.Hold the bottle directly below the cap and turn the cap to open the bottle. The end of the bottle should not come into contact with anything, to avoid contaminating the solution.

2.Tilt your head back and hold the bottle above the eye.

3.Pull the lower eyelid down and look up. Gently squeeze the bottle in the middle and let a drop fall into the eye. Note that it may take a few seconds from when you squeeze the bottle until the drop comes out. Do not squeeze too hard.

If you are unsure how to use this medication, consult your doctor or pharmacist.

4. Blink a few timesto allow the drop to spread across the eye.

5. Repeat theinstructions for steps 2. - 4. to apply a drop to the other eye,ifyour doctor has instructed you to do so. Sometimes only one eye needs to be treated. Your doctor will tell you if this is the case, and which eye needs the treatment.

6. After application, and before closing the bottle with the cap, the bottle should be shaken once, downwards, without touching the tip of the dropper, to remove any residual liquid from the tip. This is necessary to allow the subsequent application of more drops.

7. After applying all the doses, there will be a remainder of VIZIBIM in the bottle. Do not worry, as there is an additional amount of VIZIBIM included and you will receive the complete amount of VIZIBIM prescribed by your doctor. Once the treatment cycle is completed, do not attempt to use the excess medication remaining in the bottle.

Do not use the eye drops for more than 28 days after the first opening of the bottle.

If you use more VIZIBIM than you should

If you use more VIZIBIM than you should, it is unlikely to cause any serious harm. Apply the next dose at the usual time. If you have any doubts, consult your doctor or pharmacist.

If you forgot to use VIZIBIM

If you forgot to apply VIZIBIM, apply a single drop as soon as you remember, and then return to your usual routine. Do not apply a double dose to compensate for the missed dose.

If you interrupt treatment with VIZIBIM

VIZIBIM should be used daily for it to work properly. If you stop using VIZIBIM, the pressure inside your eye may increase, so consult your doctor before interrupting this treatment.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

Very common:may affect more than 1 in 10 patients

Affecting the eye:

• Lengthening of the eyelashes (up to 45% of people)
• Mild redness (up to 44% of people)
• Itching (up to 14% of people)
• Loss of fat in the eye area that can cause deepening of the palpebral sulcus, sinking of the eyes (enophthalmos), drooping of the eyelids (ptosis), stretching of the skin around the eye (dermatochalasis involution) and making the lower white part of the eye visible (exposure of the inferior sclera).

Common:may affect 1 in 10 patients

Affecting the eye:

• Allergic reaction in the eye
• Tired eyes
• Light sensitivity
• Darkening of the skin around the eye
• Darkening of the eyelashes
• Pain
• Sensation of a foreign body in the eye
• Eye stickiness
• Darkening of the iris
• Difficulty seeing clearly
• Irritation
• Burning
• Inflammation, redness, and itching of the eyelids
• Tears
• Dryness
• Worsening of vision
• Blurry vision
• Inflammation of the transparent layer covering the eye surface
• Small epithelial erosions in the eye, with or without inflammation.

Affecting the body:

• Headaches
• Increased levels of some blood test values indicating liver function
• Elevated blood pressure.

Rare:may affect 1 in 100 patients

Affecting the eye:

• Macular cystoid edema (inflammation of the retina inside the eye leading to worsening of vision)
• Inflammation inside the eye
• Retinal hemorrhage
• Swollen eyelids
• Pupil spasms
• Retraction of the eyelid, moving away from the ocular surface
• Redness of the skin around the eye

Affecting the body:

• Nausea
• Dizziness
• Weakness
• Hair growth around the eye

Unknown frequency:cannot be estimated from available data

Affecting the eye:

• Eye discomfort

Affecting the body:

• Asthma
• Worsening of asthma
• Worsening of a lung disease called chronic obstructive pulmonary disease (COPD)
• Difficulty breathing
• Allergic reaction symptoms (inflammation, redness of the eye, and skin rash)
• Decoloration of the skin (periocular)

Other side effects reported with phosphate-containing eye drops:

In rare cases, some patients with severe damage to the transparent layer on the front of the eye (the cornea) have developed cloudy spots in the cornea due to calcium accumulation during treatment.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the bottle label and on the box after "CAD". The expiration date is the last day of the month indicated.

This medication does not require any special storage conditions.

Dispose of the bottle after four weeks of its first opening, even if there is still liquid inside. This will help prevent infections. To remember, write the opening date in the space on the box designated for it.

Do not use this medication if you observe that the safety seal on the bottle is broken before using it for the first time.

Medications should not be thrown down the drains or in the trash. Deposit the containers and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medications. By doing so, you will help protect the environment.

Composition of VIZIBIM

• The active ingredient is bimatoprost. One milliliter of solution contains 0.3 mg of bimatoprost.
• The other components are sodium chloride, heptahydrated disodium phosphate, monohydrated citric acid, and water for injectable preparations. It may contain small amounts of hydrochloric acid or sodium hydroxide to maintain normal acidity levels (pH levels).

Appearance of VIZIBIM and contents of the packaging

VIZIBIM is a clear and colorless eye drop solution, presented in a low-density polyethylene (LDPE) white and opaque bottle of 5 ml, with a Novelia white (high-density polyethylene [HDPE] and silicone) nozzle with a blue tip, and sealed with a white HDPE cap.

The following packaging sizes are available: boxes containing 1 and 3 bottles with 3 ml of solution.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer:

Marketing Authorization Holder:

BAUSCH + LOMB IRELAND LIMITED

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

Responsible Manufacturer:

Pharmathen S.A,

Dervenakion 6, Pallini Attikis

15351 Greece

OR

EXCELVISION

27 st. La Lombardière

Zl La Lombardière

07100 ANNONAY

France

For more information about this medication, please contact the local representative of the marketing authorization holder.

Local Representative in Spain

Bausch & Lomb S.A.

Avda. Valdelaparra, nº 428108 Alcobendas

Madrid

Phone: 91 – 657 63 00

Last review date of this leaflet: November 2022

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.