VIZILATAN DUO 50 micrograms/ml + 5 mg/ml Eye Drops, Solution

2. What you need to know before you use Vizilatan Duo

Do not useVizilatan Duo

• If you are allergic to latanoprost or timolol, to beta-blockers or to any of the other ingredients of this medicine (listed in section 6).
• If you have or have had in the past respiratory problems such as asthma, severe chronic obstructive pulmonary disease (severe lung disease that can cause wheezing, difficulty breathing and/or long-term coughing).
• If you have severe heart problems or heart rhythm disorders.

Warnings and precautions

Talk to your doctor or pharmacist before you start using this medicine if you have or have had in the past:

• coronary heart disease (symptoms may include chest pain or tightness, difficulty breathing or shortness of breath), heart failure, low blood pressure
• changes in heart rate such as slow heart rate
• respiratory problems, asthma or chronic obstructive pulmonary disease
• disease due to poor blood circulation (such as Raynaud's disease and Raynaud's syndrome)
• diabetes, as timolol may mask the signs and symptoms of low blood sugar levels
• overactive thyroid gland (hyperthyroidism), as timolol may mask its signs and symptoms
• if you are going to undergo, have undergone in the past, any type of eye surgery (including cataract surgery)
• you have eye problems (such as pain, irritation or inflammation in the eye or blurred vision)
• if you know you suffer from dry eye
• if you use contact lenses. You can continue to use this medicine but you must follow the instructions that are included in section 3 for contact lens users.
• if you know you suffer from angina (especially a type known as Prinzmetal's angina)
• if you know you suffer from severe allergic reactions that could normally require hospital treatment
• if you have had or are having a viral infection in the eye caused by the herpes simplex virus (HSV).

Tell your doctor before any surgical procedure that you are using this medicine, as timolol may affect the effects of some medicines used during anesthesia.

Children and adolescents

This medicine is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Vizilatan Duo

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including eye drops or medicines obtained without a prescription.

The effect of this medicine may be affected by or may affect other medicines you are using, including other eye drops for the treatment of glaucoma. Tell your doctor if you are using or plan to use medicines to lower blood pressure, heart medicines, or medicines to treat diabetes.

In particular, tell your doctor or pharmacist if you know you are taking any of the following types of medicines:

• Prostaglandins, analogues or derivatives of prostaglandins (used for contraction and relaxation of smooth muscle, dilation and constriction of blood vessels, blood pressure control, and modulation of inflammation)
• Beta-blockers (used to treat high blood pressure, angina, certain abnormal heart rhythms, heart attack, anxiety, migraines, glaucoma, and symptoms of hyperthyroidism)
• Adrenaline (used to treat life-threatening allergic reactions caused by insect bites or stings, foods, medicines, latex, and other causes)
• Medicines used to treat high blood pressure such as calcium channel blockers, guanethidine, antiarrhythmics, digitalis glycosides, or parasympathomimetics
• Quinidine (used to treat heart conditions and some types of malaria)
• Antidepressants known as fluoxetine and paroxetine.

Using Vizilatan Duo with food and drinks

Normal meals, food, or drinks do not affect when or how you should use this medicine.

Pregnancy, breast-feeding, and fertility

Pregnancy

Do not use this medicine if you are pregnant unless your doctor considers it necessary. If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

Breast-feeding

Do not use this medicine if you are breast-feeding. This medicine may pass into breast milk. Ask your doctor for advice before using any medicine during breast-feeding.

Fertility

In animal studies, latanoprost or timolol have not been found to have any effect on male or female fertility.

Driving and using machines

You may experience blurred vision for a short time when using this medicine. If this happens, do not drive or use tools or machines until your vision is clear again.

Vizilatan Duo contains macrogolglycerol hydroxystearate 40

This medicine contains macrogolglycerol hydroxystearate 40, which may cause skin reactions.

Vizilatan Duo contains phosphate buffer

This medicine contains 0.18 mg of phosphates in each drop, which is equivalent to 6.43 mg/ml.

If you have severe damage to the cornea (the transparent layer on the front of the eye), treatment with phosphates, in very rare cases, can cause blurred vision due to calcium buildup.

Use in athletes

This medicine contains timolol, which may produce a positive result in doping tests.

3. How to use Vizilatan Duo

Follow exactly the instructions of administration of this medicine given by your doctor or pharmacist. If you are not sure, talk to your doctor or pharmacist again.

The recommended dose for adults (including the elderly) is one drop in the affected eye(s) once a day.

Do not use this medicine more than once a day; the effectiveness of the treatment may decrease if it is administered more frequently.

Use this medicine as your doctor has told you, until he tells you to stop.

Your doctor may want to perform additional checks on your heart and circulation if you are using this medicine.

Contact lens users

If you wear contact lenses, you should remove them before using this medicine. After applying this medicine, you should wait 15 minutes before putting your contact lenses back in.

Instructions for use

If you use Vizilatan Duo with another eye drop

Wait at least 5 minutes between the application of this medicine and the administration of the other eye drop.

If you use more Vizilatan Duo than you should

If you apply too many drops, you may experience a small irritation in the eye, which may become red or watery. This should disappear, but if you are concerned, contact your doctor for advice.

If you swallow Vizilatan Duo

In case of accidental ingestion of this medicine, talk to your doctor or call the Toxicology Information Service, phone: 91 562 04 20. If you swallow a large amount of this medicine, you may feel unwell, have stomach pain, feel tired, hot, dizzy, and start sweating.

If you forget to use Vizilatan Duo

Continue with the administration of the next dose as usual. Do not use a double dose to make up for the forgotten dose. If you are not sure about any aspect, talk to your doctor or pharmacist.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Generally, you will be able to continue using the drops unless the effects are severe. If you have any doubts, consult a doctor or pharmacist. Do not stop using this medicine without talking to your doctor.

The following are known adverse effects related to the use of eye drops containing the active ingredients latanoprost and timolol. The most important adverse effect is the possibility of a gradual permanent change in eye color. It is also possible that eye drops containing the active ingredients latanoprost and timolol may cause serious changes in heart function. Contact a doctor if you notice changes in your heart rate or function and tell them that you are using this medicine.

The following are known adverse effects related to the use of eye drops containing the active ingredients latanoprost and timolol:

Very Common Adverse Effects(may affect more than 1 in 10 patients):

• Gradual change in eye color due to an increase in the amount of brown pigment in the colored part of the eye, known as the iris. If you have mixed-color eyes (blue-brown, gray-brown, yellow-brown, or green-brown), you are more likely to experience this change than if your eyes are a single color (blue, gray, green, or brown). This change in eye color may take years to occur. The color change may be permanent and may be more noticeable if you only use this medicine in one eye. The eye color change does not appear to be associated with the development of any problems. The eye color change does not progress once treatment with this medicine has been discontinued.

Common Adverse Effects(may affect less than 1 in 10 patients):

• Ocular irritation (burning sensation, grittiness, stinging, itching, or foreign body sensation) and eye pain.

Uncommon Adverse Effects(may affect less than 1 in 100 patients):

• Headache
• Eye redness, eye infection (conjunctivitis), blurred vision, watery eyes, eye inflammation, irritation, or alteration of the ocular surface.
• Skin redness or itching (pruritus)

Other Adverse Effects

Like other medicines applied to the eyes, latanoprost and timolol are absorbed into the bloodstream. The incidence of these adverse effects after using eye drops is lower than if the medicines, for example, were taken orally or injected.

Although not observed with eye drops containing the active ingredients latanoprost and timolol, the following adverse effects have occurred with each of the active ingredients of this medicine and, therefore, could appear if you use this medicine. The listed adverse effects include reactions observed within the class of beta-blockers (e.g., timolol) when used to treat ocular conditions:

• Development of viral eye infection caused by the herpes simplex virus (HSV)
• Generalized allergic reactions, including inflammation under the skin in areas such as the face and limbs, and which can obstruct the airways, causing difficulty swallowing or breathing, hives, or rash with itching, localized and generalized exanthema, itching, or severe, potentially life-threatening allergic reaction
• Low blood sugar levels
• Dizziness
• Difficulty sleeping (insomnia), depression, nightmares, memory loss, hallucinations.
• Fainting, stroke, reduced blood supply to the brain, increased signs and symptoms of myasthenia gravis (muscle disorder), unusual sensations such as tingling and headache.
• Swelling of the back of the eye (macular edema), cyst with fluid accumulation in the colored part of the eye (iris cyst), sensitivity to light (photophobia), appearance of sunken eyes (deepening of the eyelid sulcus).
• Signs and symptoms of ocular irritation (e.g., burning, stinging, itching, tearing, redness), eyelid inflammation, corneal inflammation, blurred vision, and detachment of the layer beneath the retina after filtration surgery, which can cause visual disturbances, decreased corneal sensitivity, dry eye, corneal erosion (damage to the front layer of the eyeball), drooping of the upper eyelid (which makes the eye remain half-closed), double vision.
• Darkening of the skin around the eye, changes in the eyelashes and hair around the eye (increased number, length, thickness, and darkening), changes in the direction of eyelash growth, swelling around the eyes, swelling of the colored part of the eye (iritis/uveitis), scarring of the ocular surface.
• Ringing/buzzing in the ears (tinnitus)
• Angina, worsening of angina in patients who already have heart disease.
• Slow heart rate, chest pain, palpitations (perception of heart rhythm), edema (fluid accumulation), changes in heart rhythm or rate, congestive heart failure (heart disease with difficulty breathing and swelling of feet and legs due to fluid accumulation), a type of heart rhythm disorder, heart attack, heart failure.
• Low blood pressure, poor blood circulation that causes numbness and paleness of the fingers and toes, as well as coldness in hands and feet.
• Shortness of breath, constriction of airways in the lungs (predominantly in patients with pre-existing disease), difficulty breathing, cough, asthma, worsening of asthma.
• Taste disturbances, nausea (uncommon), indigestion, diarrhea, dry mouth, abdominal pain, vomiting (uncommon).
• Hair loss, skin rash with a white, silvery appearance (psoriasiform rash) or worsening of psoriasis, skin rash.
• Joint pain, muscle pain not caused by exercise, muscle weakness, fatigue.
• Sexual dysfunction, decreased libido.

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

Reporting Adverse Effects

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

5. Storage of Vizilatan Duo

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date stated on the carton and label of the bottle, after "EXP". The expiration date is the last day of the month indicated.

This medicine does not require any special storage conditions.

To avoid infections, four weeks after opening the bottle for the first time, you must discard it. Write the opening date of the bottle in the space provided on the carton and label of the bottle.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Vizilatan Duo Composition

• The active ingredients are latanoprost and timolol.

Each milliliter of solution contains 50 micrograms of latanoprost and 5 mg of timolol (as 6.8 mg of timolol maleate).

• The other ingredients are macrogolglycerol hydroxystearate 40, sodium chloride, disodium edetate, sodium dihydrogen phosphate dihydrate, disodium phosphate, hydrochloric acid, and/or sodium hydroxide (to adjust the pH), and water for injections.

Vizilatan Duo Appearance and Package Contents

Vizilatan Duo is presented as 2.5 milliliters of a clear, colorless aqueous solution, free from visible particles, in a carton containing a 5-milliliter multidose white bottle (HDPE) with a pump (PP, HDPE, LDPE) and an orange cap and pressure cylinder (HDPE).

Package sizes:

The cartons contain 1, 3, or 4 bottles with 2.5 milliliters of solution.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

BAUSCH + LOMB IRELAND LIMITED

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

Manufacturer:

Lomapharm GmbH

Langes Feld 5

31860 Emmerthal

Germany

Or

Pharmathen S.A.

Dervenakion Str. 6

15351 Pallini

Attiki

Greece

Or

Bausch Health Poland Sp. z.o.o.

ul. Przemyslowa 2

35/959 Rzeszów

Poland

Or

BAUSCH HEALTH POLAND SP. Z.O.O.

Ul. Kosztowska 21

41-409 Myslowice

Poland

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Local Representative

Bausch & Lomb S.A.

Avda. Valdelaparra, nº 4

28108 Alcobendas

Madrid

Spain

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

DK:Vizilatan Duo

FR:FIXALATIM 50 micrograms/ml + 5 mg/ml, collyre en solution

BE:Vizilaticom 50 microgram/ml + 5 mg/ml oogdruppels, oplossing

NL:Vizilaticom 50 microgram/ml + 5 mg/ml eye drops, solution

DE:Vizilatan Duo 0,05 mg/ml + 5 mg/ml Augentropfen, Lösung

AT:Vizilatan Duo 0,05 mg/ml + 5 mg/ml Augentropfen, Lösung

PT:Vizilatan Duo 0,05 mg/ml + 5 mg/ml colírio, solução

CZ:VIZILATAN DUO

RO:Vizilatan Duo 0,05 mg/ml + 5 mg/ml picaturi oftalmice, solutie

LU:Vizilatimo

HU:Vizilatan Duo 0,05 mg/ml + 5 mg/ml oldatos szemcsepp

EE:Vizilatan Duo

PL:Vizilatan Duo

IT:VIZILATAN

This leaflet was last revised in: June 2022.