Prospecto: information for the user

Vizilatan Duo 50micrograms/ml+5mg/ml, eye drops in solution

latanoprost/timolol

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

• Keep this prospect, as you may need to read it again.
  If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people 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 prospect. See section 4.

1. What isVizilatan Duoand for what it is used

2. What you need to know before starting to useVizilatan Duo

3. How to useVizilatan Duo

4. Possible adverse effects

5. Storage ofVizilatan Duo

6. Contents of the package and additional information

Vizilatan Duo contains two active ingredients: latanoprost and timolol. Latanoprost belongs to a group of medications called prostaglandin analogs. Timolol belongs to a group of medications called beta-blockers. Latanoprost acts by increasing the natural outflow of fluid from the eye into the bloodstream. Timolol slows down the formation of fluid in the eye.

This medication is used to reduce the pressure inside your eye if you have conditions known as open-angle glaucoma or ocular hypertension. These two conditions are related to an increase in intraocular pressure that can affect vision. Normally, your doctor will prescribe this medication when other medications have not worked adequately.

This medication can be used in adult men and women (including elderly patients), but it is not recommended for use in children and adolescents under 18 years of age.

Vizilatan Duo eye drops in solution are a sterile solution that does not contain preservatives.

No useVizilatan Duo

• If you are allergic to latanoprost or timolol, to beta-blockers or to any of the other components of this medication (listed in section6).
• If you have or have had in the past respiratory problems such as asthma, severe chronic obstructive pulmonary disease (a serious lung disease that can cause wheezing, difficulty breathing, and/or long-lasting cough).
• If you have severe heart problems or cardiac rhythm disorders.

Advertencias y precauciones

Consult your doctor or pharmacist before starting to use this medication if you have or have had in the past:

• Coronary heart disease (symptoms may include chest pain or tightness, difficulty breathing, or asphyxia), heart failure, low blood pressure
• Cardiac frequency alterations such as decreased heartbeats
• 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
• Hyperactivity of the thyroid gland (hyperthyroidism), as timolol may mask its signs and symptoms
• If you are to undergo, have undergone in the past, any type of eye surgery (including cataract surgery)
• If you have eye problems (such as eye pain, irritation, or inflammation, or blurred vision)
• If you know you suffer from dry eye
• If you use contact lenses. You may continue to use this medication but follow the instructions included in section3 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 may require hospital treatment
• If you have suffered or are suffering from a viral eye infection caused by the herpes simplex virus (HSV).

Inform your doctor before any surgical intervention that you are using this medication as timolol may alter the effects of some medications used during anesthesia.

Niños y adolescentes

This medication is not recommended for use in children under 18years of age.

Otros medicamentos yVizilatan Duo

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including eye drops or medications obtained without a prescription.

The effect of this medicationmay affect or be affected by other medications you are using, including other eye drops for glaucoma treatment. Inform your doctor if you are using or plan to use medications to reduce blood pressure, heart medications, and medications to treat diabetes.

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

• Prostaglandins, analogs, or prostaglandin derivatives (used for muscle smooth muscle contraction and relaxation, blood vessel dilation and contraction, blood pressure control, and inflammation modulation)
• Beta-blockers (used to treat high blood pressure, angina, some abnormal heart rhythms, heart attack, anxiety, migraines, glaucoma, and symptoms of hyperthyroidism)
• Adrenaline (used to treat potentially life-threatening allergic reactions caused by insect bites or stings, foods, medications, latex, and other causes)
• Medications used to treat high blood pressure such as calcium channel blockers, guanetidina, antiarrhythmics, digitalis glycosides, or parasymptomatic mimetics
• Quinidina (used to treat heart diseases and some types of malaria)
• Antidepressants known as fluoxetine and paroxetine.

Uso deVizilatan Duocon alimentos y bebidas

Normal meals, foods, or beverages do not affect when or how to use this medication.

Embarazo, lactancia y fertilidad

Embarazo

Do not use this medication if you are pregnant unless your doctor considers it necessary. If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

Lactancia

Do not use this medication if you are breastfeeding. This medication may pass into breast milk. Consult your doctor before using any medication during breastfeeding.

Fertilidad

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

Conducción y uso de máquinas

You may experience blurred vision for a short period of time when using this medication. If this occurs, do not drive or use tools or machines until your vision clears up.

Vizilatan Duocontienemacrogolglicerol hidroxiestearato 40

This medication contains macrogolglicerol hidroxiestearato 40, which may cause skin reactions.

Vizilatan Duo contiene tampón fosfato

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

If you suffer from severe corneal damage (the transparent layer at the front of the eye), treatment with phosphates, in rare cases, may cause blurred vision due to calcium accumulation.

Uso en deportistas

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

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

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

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

Use this medication as your doctor has instructed you to, until they tell you to stop.

Your doctor may wish to perform additional heart and circulation checks if you are using this medication.

Users of contact lenses

If you wear contact lenses, you must remove them before using this medication. After applying this medication, wait 15 minutes before putting your contact lenses back on.

Usage instructions

If you useVizilatan Duowith another eye drop

Wait at least 5minutes between the application ofthis medicationand the administration of the other eye drop.

If you use moreVizilatan Duothan you should

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

If you ingest Vizilatan Duo

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

If you forgot to useVizilatan Duo

Continue with the administration of the next dose in the usual way. Do not use a double dose to compensate for the missed dose. If you are unsure about anything, consult your doctor or pharmacist.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Generally, you can continue using the drops unless the side 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 side effects related to the use of eye drops containing the active ingredients latanoprost and timolol. The most important side 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 can cause severe 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 side effects related to the use of eye drops containing the active ingredients latanoprost and timolol:

Very common side effects(can affect more than 1 in 10patients):

• A 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-colored 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 change in eye color may be permanent and may be more noticeable if you only use this medicine in one eye. The change in eye color does not appear to be associated with any problems. The change in eye color does not progress once treatment with this medicine has been stopped.

Common (can affect less than 1 in 10patients):

• Eye irritation (sensation of burning, grittiness, stinging, itching or feeling of a foreign body) and eye pain.

Uncommon (can affect less than 1 in 100patients):

• Headache
• Redness of the eye, eye infection (conjunctivitis), blurred vision, watery eyes, eye inflammation, eye irritation or alteration of the eye surface.
• Itchy skin or pruritus

Other side effects

Like other eye medicines, latanoprost and timolol are absorbed into the bloodstream. The incidence of these side 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 side effects have occurred with each of the active ingredients in this medicine and may appear if you use this medicine. The side effects listed include reactions observed within the class of beta-blockers (e.g., timolol) when used to treat eye conditions:

• Development of viral eye infection caused by the herpes simplex virus (HSV)
• Generalized allergic reactions that include inflammation under the skin in areas such as the face and limbs and that may obstruct the airways causing difficulty swallowing or breathing, hives or itching, localized and generalized exanthema, itching or severe potentially fatal anaphylactic reaction
• Low blood sugar levels
• Dizziness
• Difficulty sleeping (insomnia), depression, nightmares, memory loss, hallucinations.
• Fainting, stroke, reduced blood supply to the brain, worsening of myasthenia gravis symptoms (muscular disorder), unusual sensations such as tingling and headache.
• Swelling at the back of the eye (macular edema), cyst with accumulation of fluid in the colored part of the eye (iris cyst), sensitivity to light (photophobia), appearance of sunken eyes (depth of the eyelid sulcus).
• Signs and symptoms of eye irritation (e.g., burning, stinging, itching, tearing, redness), eyelid inflammation, corneal inflammation, blurred vision and corneal detachment after eye surgery that may cause visual disturbances, decreased corneal sensitivity, dry eye, corneal erosion (damage to the front layer of the eyeball), drooping eyelid (which keeps the eye partially closed), double vision.
• Darkening of the skin around the eye, changes in 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), corneal surface scarring.
• Tinnitus/buzzing in the ears (tinnitus)
• Angina, worsening of angina in patients with pre-existing heart disease.
• Low 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 causing numbness and paleness of hands and feet as well as coldness in hands and feet.
• Dyspnea, constriction of airways in the lungs (predominantly in patients with pre-existing disease), difficulty breathing, cough, asthma, worsening of asthma.
• Alterations in taste, nausea (uncommon), indigestion, diarrhea, dry mouth, abdominal pain, vomiting (uncommon).
• Alopecia, white silvery-looking skin rash (psoriasiform eruption) or worsening of psoriasis, skin rash.
• Muscle 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 at the front of the eye (cornea) have developed opaque points in the cornea due to calcium deposits during treatment.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse,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 the Vigilance 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 medicine.

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

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

This medication does not require any special storage conditions.

To prevent infections,four weeks after opening the bottle for the first time, it must be discarded. Write the date of the bottle opening in the space reserved for it on the box and on the bottle label.

Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Vizilatan Duo

• 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 components 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.

Appearance of Vizilatan Duo and contents of the package

Vizilatan Duo is presented as 2.5 ml of aqueous, transparent, and colorless solution, free of visible particles, in a carton box containing a white multidose bottle (HDPE) of 5 ml with a pump (PP, HDPE, LDPE) and a cap and pressure cylinder of orange color (HDPE).

Package sizes:

The carton boxes contain 1, 3, or 4 bottles with 2.5 ml of solution

Only some package sizes may be commercially available.

Holder of the marketing authorization and manufacturer responsible

Holder of the marketing authorization:

BAUSCH + LOMB IRELAND LIMITED

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

Manufacturer responsible:

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 Mysłowice

Poland

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

Local Representative

Bausch & Lomb S.A.

Avda. Valdelaparra, nº 4

28108 Alcobendas

Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

DK:Vizilatan Duo

FR:FIXALATIM50 microgrammes/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.