Vizimaco

Package leaflet: Information for the user

Vizimaco, 0.3 mg/ml + 5 mg/ml, eye drops, solution
Bimatoprost + Timolol
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, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

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

1. What Vizimaco is and what it is used for

Vizimaco contains two active substances (bimatoprost and timolol) that reduce intraocular pressure.
Bimatoprost belongs to a group of medicines called prostamides, analogues of prostaglandins. Timolol belongs to a group of medicines called beta-blockers.
The eye contains a clear, watery fluid that nourishes the inside of the eye. This fluid is continuously drained from the eye and replaced by newly produced fluid. If the fluid cannot drain sufficiently quickly, the pressure inside the eye increases, which may eventually lead to damage to vision (causing a condition known as glaucoma). Vizimaco works by reducing the production of fluid and increasing the outflow of fluid. This helps to lower the pressure inside the eye.
Vizimaco eye drops are used to treat high pressure in the eye in adults, including elderly people. High pressure may lead to glaucoma. Your doctor will prescribe Vizimaco if other eye drops containing beta-blockers or prostaglandin analogues have not been sufficiently effective.
This medicine does not contain preservatives.

2. Important information before using Vizimaco eye drops, solution

When not to use Vizimaco eye drops, solution

• if the patient is allergic to bimatoprost, timolol, beta-blocking medicines, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has or has had a respiratory disease, such as asthma and (or) severe chronic obstructive pulmonary disease (a lung disease which may cause wheezing, difficulty breathing, and long-term cough), or other types of breathing problems;
• if the patient has heart diseases, such as slow heartbeat, heart block, or
  heart failure.

Warnings and precautions
Before starting treatment with Vizimaco, consult your doctor if the patient currently has or has previously had any of the following conditions:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or breathlessness), heart failure, hypotension,
• heart rhythm disorders, e.g. slow heartbeat,
• breathing disorders, asthma, or chronic obstructive pulmonary disease,
• circulatory disorders, e.g. Raynaud's disease or Raynaud's syndrome,
• hyperthyroidism, because timolol may mask the subjective and objective symptoms of thyroid disease,
• diabetes, because timolol may mask the subjective and objective symptoms of low blood glucose levels,
• severe allergic reactions,
• liver or kidney diseases,
• eye surface disorders,
• detachment of one of the layers of the eyeball following a procedure aimed at reducing intraocular pressure,
• known risk factors for macular oedema (swelling of the retina within the eye leading to worsening of vision), for example, surgical treatment of cataract.

If the patient has previously been diagnosed with hypersensitivity to silver, this medicine should not be used.
Before undergoing surgery under anaesthesia, inform the doctor about the use of Vizimaco, as timolol may alter the effects of certain drugs used during anaesthesia.

During treatment with Vizimaco, loss of periorbital fat tissue may occur, which may lead to deepening of the eyelid sulcus, sunken eyes, drooping of the upper eyelids (ptosis), skin tightness around the eye (dermatochalasis-induced involution), and increased visibility of the lower white part of the eye (exposure of the lower sclera). These changes are usually mild, but if pronounced, they may affect the visual field. These changes may resolve after discontinuation of Vizimaco treatment.

Vizimaco may also cause darkening and excessive growth of eyelashes, darkening of the skin around the eyelid, and may darken the colour of the iris. These changes may be permanent. Changes may be more noticeable when only one eye is treated. If Vizimaco comes into contact with the skin surface, it may cause increased hair growth.

Children and adolescents
Vizimaco should not be used in children and adolescents under 18 years of age.

Vizimaco with other medicines
Other medicines may affect the action of Vizimaco, and Vizimaco may affect the action of other medicines, including other eye drops used in the treatment of glaucoma. Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient intends to take.

Inform your doctor if you are taking or plan to take:

• medicines that lower arterial blood pressure,
• medicines used for heart diseases,
• medicines used in the treatment of diabetes,
• quinidine (a medicine used for heart diseases or certain forms of malaria),
• medicines used in the treatment of depression (fluoxetine and paroxetine).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine. Vizimaco should not be used during pregnancy unless otherwise advised by a doctor.
Vizimaco should not be used during breastfeeding. Timolol may pass into breast milk. Consult a doctor before taking any medicine during breastfeeding.

Driving and operating machinery
Vizimaco may cause blurred vision in some patients. Do not drive or operate machinery until symptoms resolve.

Vizimaco contains disodium phosphate heptahydrate
The medicine contains 0.0285 mg of phosphates per drop, equivalent to 0.95 mg/ml.
In patients with severe corneal damage (the transparent front part of the eye), phosphates may very rarely cause corneal calcification and clouding during treatment due to calcium accumulation.

3. How to use Vizimaco

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The recommended dose is one drop into each affected eye once daily, in the morning or
evening. The medicine should be used every day at the same time.
Do not touch the eye or surrounding areas with the tip of the multidose container. This may
cause eye injury. The eye drops, solution, may become contaminated with bacteria that can
cause eye infections, leading to serious eye damage or even loss of vision.
To prevent possible contamination of the multidose container, avoid contact between the tip and any surface.

Instructions for administering the medicine
Before instilling the eye drops:

• Wash your hands before opening the bottle.
• Do not use the medicine if the tamper-evident seal on the bottle neck is damaged prior to first use.
• If the patient is using the medicine for the first time, they should check the bottle's function before administering the drop by slowly pressing the bottle and releasing one drop into the air, away from the eye.
• If the patient is confident they can release a single drop, they should assume the most comfortable position for instilling the drop into the eye (sitting, lying on the back, or standing in front of a mirror).

Administering the eye drops

1. Hold the bottle directly below the cap and open it by unscrewing the cap. Do not touch anything with the dropper tip to prevent contamination of the solution.

2. Tilt the head backwards and hold the bottle over the eye.

3. Gently pull down the lower eyelid and look upwards. Squeeze the middle of the bottle gently and release one drop into the eye. Note that it may take a few seconds from squeezing the bottle until the drop comes out. Do not squeeze the bottle too hard. If the drop misses the eye, try again. Wipe away any excess liquid that runs onto the cheek.

If in doubt about how to use the medicine, consult your doctor, pharmacist, or
nurse.

4. To spread the medicine over the eye surface, blink several times.

5. Without opening the eye, press with a finger on the inner corner of the closed eye (near the nose) and hold for 2 minutes. This prevents Vizimaco from passing into the body.

6. If instructed by the doctor, repeat steps 2–5 to administer the medicine into the other eye. Sometimes only one eye requires treatment; the doctor will inform the patient which eye to treat.
7. After use and before replacing the cap, shake the bottle once downwards without touching the tip, to remove any residual medicine that may remain on it. This is necessary to ensure proper dosing of subsequent drops.

8. After all doses have been used, a small amount of solution may remain in the Vizimaco bottle. This is normal, as the package contains an overfill of Vizimaco, ensuring the patient receives the full prescribed amount. After completing the treatment course, do not use any medicine remaining in the bottle. The drops are suitable for use within 28 days of first opening the bottle.

If using Vizimaco together with other eye medicines, wait at least
5 minutes between instilling Vizimaco and applying another medicine. Ointments or gels should be applied last.
Use of more than the recommended dose of Vizimaco
If more than the recommended dose of Vizimaco is used, it is unlikely to cause any serious harm. Take the next dose at the usual time.
If in doubt, contact your doctor or pharmacist.
Missing a dose of Vizimaco
If a dose of Vizimaco is missed, instill one drop as soon as remembered, then continue using the medicine as scheduled. Do not use a double dose to make up for a missed dose.
Stopping use of Vizimaco
To ensure Vizimaco works properly, it must be used daily.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Generally, you can continue using the eye drops if the adverse reactions are not severe.
If in doubt, consult your doctor or pharmacist. Do not stop using Vizimaco without consulting your doctor.

The following adverse reactions may occur during treatment with Vizimaco:

Very common adverse reactions (may affect more than 1 in 10 people)
Eye-related:

• Redness

Common adverse reactions (may affect less than 1 in 10 people)
Eye-related:

• Burning sensation
• Itching
• Stinging pain
• Conjunctival irritation (the transparent membrane covering the eye)
• Light sensitivity
• Eye pain
• Sticky eyes
• Dry eyes
• Feeling of a foreign body in the eye
• Minor damage to the surface of the eye (with or without inflammation)
• Blurred vision
• Redness and itching of the eyelids
• Eyelash growth around the eye
• Darkening of the eyelids
• Darker skin pigmentation around the eyes
• Eyelash lengthening
• Eye irritation
• Excessive tearing
• Eyelid swelling
• Limited vision

Other parts of the body:

• Nasal congestion
• Headache

Uncommon adverse reactions (may affect less than 1 in 100 people)
Eye-related:

• Abnormal sensations in the eye
• Iritis (inflammation of the iris)
• Conjunctival edema (swelling of the transparent layer of the eye)
• Eyelid pain
• Eye fatigue
• Ingrown eyelashes
• Darkening of the iris
• Eyelid retraction (eyelid pulled away from the eye surface)
• Darkening of eyelashes

Other parts of the body:

• Shortness of breath

Adverse reactions with unknown frequency (cannot be estimated from available data)
Eye-related:

• Cystoid macular edema (retinal swelling within the eye leading to worsening of vision)
• Eye swelling
• Blurred vision
• Eye discomfort

Other parts of the body:

• Breathing difficulties / wheezing
• Symptoms of allergic reaction (swelling, eye redness, and skin rash)
• Taste disturbances
• Dizziness
• Slowed heart rate
• High blood pressure
• Sleep disturbances, nightmares
• Asthma
• Hair loss
• Skin color change (around the eye)
• Fatigue

Additional adverse reactions have been observed in patients using eye drops containing timolol or bimatoprost, and therefore these may also occur during treatment with Vizimaco.
Like other ophthalmic medicines applied locally, timol0l may pass into the systemic circulation. This may lead to adverse reactions similar to those seen with intravenous and/or oral administration of beta-adrenergic receptor blocking medicines. The frequency of systemic adverse reactions after administration of eye drops is lower than with oral or injected administration.

The listed adverse reactions include those observed with bimatoprost and timolol in the treatment of eye diseases:

• Severe allergic reactions with swelling and breathing difficulties, which may be life-threatening
• Low blood glucose levels
• Depression, memory loss, hallucinations
• Fainting, stroke, reduced blood flow to the brain, worsening of myasthenia gravis (increased muscle weakness), tingling sensation
• Reduced corneal sensitivity, double vision, eyelid drooping, detachment of one of the layers of the eyeball after a procedure to lower intraocular pressure, eye surface inflammation, bleeding in the back of the eye (retinal hemorrhage), eye inflammation, increased blinking
• Very common: Loss of orbital fat tissue around the eye, which may lead to deepening of the eyelid sulcus, sunken eyes, drooping eyelids (ptosis), tightness of skin around the eye (dermatochalasis-induced involution), and increased visibility of the lower white part of the eye (exposure of the lower sclera)
• Heart failure, irregular heartbeat or cardiac arrest, slowed or accelerated heart rate, fluid accumulation (mainly water) in the body, chest pain
• Low blood pressure, swollen or cold hands, feet, and limbs due to blood vessel constriction
• Cough, worsening of asthma, exacerbation of a lung disease called chronic obstructive pulmonary disease (COPD)
• Diarrhea, abdominal pain, nausea and vomiting, indigestion, dry mouth
• Red, flaky skin lesions, skin rash
• Muscle pain
• Decreased libido, sexual dysfunction
• Weakness
• Increased liver function test results in blood tests

Other adverse reactions reported with eye drops containing phosphates
In very rare cases, some patients with serious damage to the outer transparent layer of the eyeball (cornea) developed cloudy corneal spots during treatment due to calcium deposits.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, please consult your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02 222 Warsaw
Phone: +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 Vizimaco

Keep this medicine out of the sight and reach of children.
Do not use Vizimaco after the expiry date stated on the bottle label and on the carton after EXP. The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
From a microbiological standpoint, the medicine may be stored for a maximum of 28 days after first opening the bottle. No special storage conditions are required. The user is responsible for other storage conditions and duration of storage after opening.
Do not use the medicine if the tamper-evident 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. Such measures will help protect the environment.

6. Contents of the package and other information

What Vizimaco contains

• The active substances are bimatoprost 0.3 mg/ml and timolol 5 mg/ml (equivalent to 6.8 mg/ml of timolol maleate).
• Other ingredients: sodium chloride, disodium phosphate heptahydrate, citric acid monohydrate, sodium hydroxide and (or) hydrochloric acid (to adjust pH), water for injections.

What Vizimaco looks like and contents of the pack
Vizimaco is a 3 ml clear, colourless, aqueous solution, practically free from particles,
supplied in a white, opaque 5 ml LDPE bottle with the Novelia system,
consisting of a dropper (made of HDPE and silicone) and a cap made of HDPE. The whole is contained
in a cardboard box.
Pack sizes available: 1 or 3 bottles containing 3 ml of solution, 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
[email protected]

Manufacturer
EXCELVISION
27 st. La Lombardière
Zl La Lombardière
07100 Annonay
France

Pharmathen SA
6 Dervenakion str.
15351 Pallini Attiki
Greece