Vizidor

Package leaflet: Information for the user

Vizidor, 20 mg/ml, eye drops, solution
Dorzolamide
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this 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.

Contents of the leaflet

1. What Vizidor is and what it is 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 Vizidor is and what it is used for

Vizidor contains dorzolamide, which belongs to a group of medicines called "carbonic anhydrase inhibitors".
This medicine is prescribed to reduce elevated intraocular pressure and to treat glaucoma.
Vizidor may be used alone or in combination with other medicines that reduce eye pressure (called beta-blockers).
Vizidor eye drops, solution, is a sterile solution and does not contain any preservatives.

2. Important information before using Vizidor

When not to use Vizidor

• if the patient is allergic to dorzolamide or any of the other ingredients of this medicine (listed in section 6)
• if the patient has severe kidney function disorders or kidney problems, or if they have previously had kidney stones.

If the patient is unsure whether they can use this medicine, they should contact their doctor or pharmacist.
Warnings and precautions
Before starting to use Vizidor, discuss this with your doctor or pharmacist.
Inform your doctor about any current or past medical conditions, including eye problems or eye surgery, and any allergic reactions to medicines.
Contact your doctor immediately if eye irritation or any new eye-related symptoms occur, such as eye redness or eyelid swelling.
If the patient suspects that Vizidor is causing an allergic reaction (e.g. rash, severe skin reactions, or itching), they should stop using the medicine and contact their doctor immediately.
If the patient has previously experienced contact hypersensitivity to silver, this medicine should not be used.
If the patient wears contact lenses, they should consult their doctor before starting to use Vizidor.
Children and adolescents
Studies on the use of dorzolamide (preserved formulation) have been conducted in infants and children under 6 years of age with increased intraocular pressure in one or both eyes or diagnosed glaucoma. For further information, please consult your doctor.
Use in elderly patients
Studies have shown similar effects of dorzolamide (preserved formulation) in elderly and younger patients.
Use in patients with liver function disorders
If the patient currently has or has previously had any liver-related disorders, they should inform their doctor.
Vizidor with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to use (including eye drops).
This is particularly important if the patient is using other carbonic anhydrase inhibitors, such as acetazolamide or sulfonamides.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
This medicine should not be used during pregnancy. If the patient is pregnant or planning a pregnancy, she should inform her doctor.
Breastfeeding
Use of this medicine is not recommended during breastfeeding. Inform your doctor if the patient is breastfeeding or intends to breastfeed.
Driving and using machines
No studies have been conducted on the effects of this medicine on the ability to drive or operate machinery. Some adverse effects of Vizidor, such as dizziness or blurred vision, may affect the ability to drive and/or operate machinery. Patients should not drive or operate machinery until their well-being improves or full visual acuity is restored.

3. How to use Vizidor

This medicine should always be used as directed by the physician. In case of doubt, consult a
doctor or pharmacist. The appropriate dosage and duration of treatment will be determined
by the physician.
When Vizidor is used as monotherapy, the recommended dose is one drop administered into
the affected eye(s) in the morning, afternoon, and evening.
If the physician recommends using this medicine together with beta-blockers in the form of eye drops to
reduce intraocular pressure, the recommended dose is one drop of Vizidor administered into
the affected eye(s) in the morning and evening.
If Vizidor is used simultaneously with other eye drops, an interval of at least ten minutes should be
observed between instillation of each medicine.
Do not change the dose of this medicine without consulting your doctor.
Exercise caution to avoid contact between the dropper tip and the eye or surrounding area. The dropper may become contaminated with bacteria, which could lead to eye infection, resulting in serious eye damage or even loss of vision.
To avoid accidental contamination of the solution in the multidose container, hands should be washed before using the medicine, and the dropper tip should be protected from contact with any surface.
If the patient suspects that the medicine may be contaminated, or if the eye becomes infected, contact the doctor immediately regarding further use of this container.

Instructions for use
Before instilling eye drops:

• Wash hands before opening the bottle.
• Do not use this medicine if the tamper-evident seal on the bottle neck is damaged before first use.
• At first use, before administering drops into the eye, the patient should test the dropper bottle by slowly squeezing it until one drop is dispensed. This should be done away from the eye.
• If the patient is confident they can instill a single drop, they should assume the most comfortable position for instillation (they may sit, lie on their back, or stand in front of a mirror).

Instillation:

1. Hold the bottle just below the cap and unscrew it to open. Do not touch the dropper tip with anything to avoid contaminating the solution.

2. Tilt the head backward and hold the bottle above the eye.

3. Gently pull down the lower eyelid to form a pouch between the eyeball and the eyelid, and look upward. Gently squeeze the middle part of the bottle until a drop freely enters the patient's eye. Note that there may be a delay of several seconds between squeezing the bottle and the release of the drop. Do not squeeze the bottle too hard.
4. Instill one drop into the affected eye(s) as directed by the physician. To spread the drop over the eye surface, the patient should blink several times. If there are any doubts about using the medicine, the patient should consult a doctor, pharmacist, or nurse.
5. Close the eye and press gently on the inner corner of the eye with a finger for about two minutes. This helps prevent the medicine from entering the systemic circulation.
6. If the physician has instructed treatment of the other eye as well, repeat the steps described in points 2 to 5. Sometimes only one eye requires treatment, and the physician will inform the patient which eye is affected and needs treatment.

7. After use, before recapping, shake the bottle downward without touching the dropper tip to remove any residual liquid from the tip. This is necessary to ensure that subsequent drops can be dispensed properly.
8. After all doses have been administered, a certain amount of Vizidor will remain in the bottle. The patient should not be concerned, as the bottle contains an additional amount of Vizidor, ensuring that the patient receives the full dose prescribed by the physician. After completion of the prescribed treatment, do not use any excess medicine remaining in the bottle.

Do not use the eye drops for longer than 28 days after first opening the bottle.
Use of a higher than recommended dose of Vizidor
If the patient uses more eye drops than recommended, or if any part of the contents is swallowed, contact a doctor immediately.
Missed dose of Vizidor
It is important to use this medicine as directed by the physician.
If the patient misses a dose, it should be administered as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped and the regular dosing schedule resumed.
Do not use a double dose to make up for a missed dose.
Stopping treatment with Vizidor
If the patient intends to discontinue treatment, they should first consult with their doctor.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences allergic reactions, including hives, facial swelling, swelling of the lips, tongue, and (or) throat, which may cause difficulty in breathing or swallowing, or severe skin reactions with blistering or skin peeling, the medicine must be discontinued immediately and urgent medical help must be sought or the patient should go to the nearest emergency department.

During clinical trials and after market introduction of preservative-free dorzolamide, the following adverse reactions have been reported:

Very common (occur in more than 1 in 10 people)

• Burning and stinging sensation in the eyes

Common (occur in no more than 1 in 10 people)

• Corneal disorders with symptoms of eye pain and blurred vision (punctate epithelial keratitis)
• Eye discharge and itchy eyes (conjunctivitis)
• Irritation or inflammation of the eyelids
• Blurred vision
• Headache, nausea
• Bitter taste in the mouth
• Weakness

Uncommon (occur in no more than 1 in 100 people)

• Iritis

Rare (occur in no more than 1 in 1,000 people)

• Tingling or numbness in hands or feet
• Transient myopia, which may resolve after discontinuation of treatment
• Fluid accumulation under the retina (choroidal detachment following filtration procedures)
• Eye pain
• Crusting of the eyelids
• Low intraocular pressure
• Corneal edema (with visual disturbances)
• Eye irritation, including redness
• Kidney stones
• Dizziness
• Nosebleeds
• Throat irritation
• Dryness of the mouth
• Localized skin rash (contact dermatitis)
• Severe skin reactions
• Allergic reactions such as rash, urticaria, itching, and in rare cases, swelling of the lips, eyes and mouth, dyspnoea, and less frequently wheezing.

Frequency not known (cannot be estimated from available data)

• Dyspnoea
• Foreign body sensation in the eye (feeling that something is in the eye)
• Strong, possibly rapid or irregular heartbeat (palpitations)
• Increased heart rate
• Increased blood pressure

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Vizidor medicine

Keep this medicine out of sight and reach of children.
Store below 30°C.
After first opening the bottle, this medicine can be stored for up to 28 days.
Do not use Vizidor after the expiry date stated on the carton and bottle after the word EXP. The expiry date refers to the last day of the stated month.
Do not use this medicine if you notice that the seal on the bottle neck is damaged before first use.
Medicines must 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 package and other information

What Vizidor contains

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

What Vizidor looks like and contents of the pack
5 ml of clear, colourless, slightly viscous aqueous solution in a white, opaque bottle made of LDPE, with a dropper (made of HDPE and silicone) and a white screw cap made of HDPE.
Pack sizes: 1, 3 or 4 bottles in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation 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,
15351 Pallini (Attikis)
Greece
This medicinal product is authorised 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 kapi za oko, otopina
Sweden Vizidor
Finland Vizidor
Norway Vizidor
Hungary Vizidor