Vizidor

Package Leaflet: Information for the User

Vizidor, 20 mg/ml, Eye Drops, Solution

Dorzolamide

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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Vizidor and what is it used for

Vizidor contains dorzolamide, which belongs to a group called "carbonic anhydrase inhibitors".
This medicine is used to reduce increased pressure in the eye and to treat glaucoma. This medicine can be used alone or with other eye pressure-lowering medicines (called beta-blockers).
Vizidor eye drops, solution is a sterile solution and does not contain preservatives.

2. Important information before using Vizidor

When not to use Vizidor

• if you are allergic to dorzolamide or any of the other ingredients of this medicine (listed in section 6)
• if you have severe kidney problems or kidney disease, or have had kidney stones in the past.

If you are not sure whether you can use this medicine, talk to your doctor or pharmacist.

Warnings and precautions

Before starting to use Vizidor, discuss this with your doctor or pharmacist.
Tell your doctor about all your current or past medical conditions, including eye problems or eye surgery and any allergic reactions to medicines.
Immediately contact your doctor if you experience eye irritation or any new eye problems, such as redness of the eye or swelling of the eyelids.
If you suspect that Vizidor is causing an allergic reaction (e.g. rash, severe skin reactions or itching), stop using the medicine and contact your doctor immediately.
If you have had contact hypersensitivity to silver in the past, do not use this medicine.
If you wear contact lenses, consult your doctor before using Vizidor.

Children and adolescents

Studies have been conducted on the use of dorzolamide (with preservatives) in infants and children under 6 years of age with increased intraocular pressure or diagnosed glaucoma. For further information, consult your doctor.

Use in elderly patients

Studies have shown similar effects of dorzolamide (with preservatives) in elderly and younger patients.

Use in patients with liver function disorders

If you have or have had any liver problems, inform your doctor.

Vizidor and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, and about any medicines you plan to take (including eye drops).
This is especially important if you are taking other carbonic anhydrase inhibitors, such as acetazolamide or sulfonamides.

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.
Pregnancy
Do not use this medicine during pregnancy. If you are pregnant or plan to become pregnant, tell your doctor.
Breastfeeding
It is not recommended to use this medicine if you are breastfeeding. Inform your doctor if you are breastfeeding or plan to breastfeed.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive or use machines. Some side effects of Vizidor, such as dizziness or blurred vision, may affect your ability to drive or use machines. Do not drive or use machines until you feel better or your vision is fully restored.

3. How to use Vizidor

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The correct dose and duration of treatment will be decided by your doctor.
When used as monotherapy, the recommended dose is one drop of the medicine administered to the affected eye(s) in the morning, afternoon, and evening.
If your doctor recommends using the medicine together with beta-blockers in the form of eye drops to reduce intraocular pressure, the recommended dose is one drop of Vizidor administered to the affected eye(s) in the morning and evening.
If Vizidor is used with other eye drops, wait at least 10 minutes between administering the different eye drops.
Do not change the dose of the medicine without consulting your doctor.
Be careful not to touch the tip of the dropper with your eye or the area around your eye. The dropper may become contaminated with bacteria, which can cause eye infections leading to serious eye damage or even vision loss.
To avoid accidental contamination of the solution in the multi-dose container, wash your hands before using the medicine and protect the dropper tip from contact with any surface.
If you suspect that the medicine may be contaminated, or if the eye has become infected, contact your doctor immediately regarding further use of this container.

Instructions for use

Before administering the eye drops:

• Wash your hands before opening the bottle.
• Do not use this medicine if the seal on the bottle neck is broken before the first use.
• When using the bottle for the first time, before administering the drops to the eye, the patient should test the use of the bottle with the dropper by slowly squeezing it until one drop is released from the bottle. This should be done away from the eye.
• If the patient is sure they can administer a single drop of the medicine, they should take the most comfortable position for its administration (can sit, lie on their back, or stand in front of a mirror).

Administration:

• 1. Hold the bottle directly below the cap, which should be unscrewed to open the bottle. Do not touch the tip of the dropper to avoid contaminating the solution.

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

• 3. Gently pull down the lower eyelid to create a pocket between the eye and the eyelid, and look up. Squeeze the bottle gently in the middle until the drop is released into the patient's eye. Remember that there may be a few seconds' delay between squeezing the bottle and the drop being released. Do not squeeze the bottle too hard.
• 4. Administer one drop into the affected eye(s) as directed by your doctor. To spread the drop over the surface of the eye, blink several times. If you have any doubts about using the medicine, consult your doctor, pharmacist, or nurse.
• 5. Close your eye and press the inner corner of your eye with your finger for about two minutes. This helps prevent the medicine from entering the entire body.
• 6. If your doctor has recommended using the medicine in both eyes, repeat the steps described in points 2 to 5. Sometimes the treatment only requires one eye, and your doctor will inform you which eye is affected and requires treatment.

• 7. After use, before screwing the cap back on, turn the bottle upside down and shake it to remove any remaining liquid from the dropper tip. This is necessary to ensure that the next drops can be administered.
• 8. After administering all the doses, some Vizidor will remain in the bottle. Do not be concerned, as the bottle contains an extra amount of Vizidor, and you will receive the full dose of the medicine prescribed by your doctor. After completing the prescribed treatment, do not use the remaining medicine in the bottle.

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

Using more Vizidor than recommended

If you use more eye drops than recommended or swallow any contents of the packaging, contact your doctor immediately.

Missing a dose of Vizidor

It is important to use this medicine as directed by your doctor.
If you miss a dose, use it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose and return to your regular dosing schedule.
Do not take a double dose to make up for a missed dose.

Stopping use of Vizidor

If you plan to stop treatment, talk to your doctor first.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience allergic reactions, including hives, face, lip, tongue, and/or throat swelling, which may cause difficulty breathing or swallowing, or severe skin reactions with blistering or peeling of the skin, stop using the medicine and seek immediate medical attention or go to the nearest emergency department.
During clinical trials with dorzolamide without preservatives and after the medicine was marketed, the following side effects were reported:
Very common(occurring in more than 1 in 10 people)

• Burning and stinging in the eyes.

Common(occurring in up to 1 in 10 people)

• Corneal disorders with symptoms of eye pain and blurred vision (superficial punctate keratitis)
• Eye discharge and itching (conjunctivitis)
• Irritation or inflammation of the eyelids
• Blurred vision
• Headaches, nausea
• Bitter taste in the mouth
• Weakness.

Uncommon(occurring in up to 1 in 100 people)

• Iritis

Rare(occurring in up to 1 in 1,000 people)

• Numbness or tingling in the hands or feet
• Transient myopia, which may resolve after discontinuation of treatment
• Presence of fluid under the retina (choroidal detachment after filtration surgery)
• Eye pain
• Formation of crusts on the eyelids
• Low eye pressure
• Corneal edema (with vision disturbances)
• Eye irritation, including redness
• Kidney stones
• Dizziness
• Nosebleeds
• Throat irritation
• Dry mouth
• Local skin rash (contact dermatitis)
• Severe skin reactions
• Allergic reactions, such as rash, hives, severe skin reactions, or itching, and in rare cases, swelling of the lips, eyes, and mouth, difficulty breathing, or wheezing.

Frequency not known(frequency cannot be estimated from the available data)

• Difficulty breathing
• Feeling of a foreign body in the eye (feeling that something is in the eye)
• Palpitations, which may be rapid or irregular (heart pounding)
• Increased heart rate
• Increased blood pressure

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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 Vizidor

Keep this medicine out of the sight and reach of children.
Store in a temperature below 30°C.
After opening the bottle, the medicine can be stored for a maximum of 28 days.
Do not use Vizidor after the expiry date stated on the carton and bottle after EXP. The expiry date refers to the last day of the month stated.
Do not use this medicine if you notice that 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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Vizidor contains

• The active substance is dorzolamide. Each milliliter contains 20 mg of dorzolamide (as dorzolamide hydrochloride).
• The other ingredients are hydroxyethylcellulose, mannitol (E421), sodium citrate dihydrate, sodium hydroxide (E524), and water for injections.

What Vizidor looks like and contents of the pack

5 ml of clear, colorless, slightly viscous, aqueous solution in a white, opaque LDPE bottle with a dropper (made of HDPE and silicone) and a white HDPE cap. Pack size: 1, 3, or 4 bottles in a cardboard box. 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, and PHARMATHEN S.A., Dervenakion 6, 15351 Pallini (Attikis), Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria: Vizidor 20 mg/ml Augentropfen, Denmark: Vizidor, Ireland: Dorzolamide PharmaSwiss 20 mg/ml Eye drops, Solution, Germany: Vizidor 20 mg/ml Augentropfen, Lösung, Poland: Vizidor, United Kingdom: Vizidor, Czech Republic: Vizidor, Estonia: Vizidor, Latvia: Vizidor, Slovakia: Vizidor, Croatia: Vizidor 20 mg/ml eye drops, solution, Sweden: Vizidor, Finland: Vizidor, Norway: Vizidor, Hungary: Vizidor

Date of last revision of the package leaflet: 03/2025