Vizilatan 50microgramos/ml eye drops in solution

latanoprost

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, the doctor treating your child, or your pharmacist.
• This medicine has been prescribed for you or your child and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you or your child experience any side effects, consult your doctor, the doctor treating your child, or your pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Vizilatan is and what it is used for

2.What you need to know before you start using Vizilatan

3.How to use Vizilatan

4.Possible side effects

5.Storage of Vizilatan

6.Contents of the pack and additional information

Vizilatanbelongs to a group of medications known as prostaglandin analogs. It works by increasing the natural outflow of fluid from the inside of the eye to the bloodstream.

This medicationis used to treatopen-angle glaucomaandocular hypertensionin adults.These two conditions may occur together, resulting in increased intraocular pressure that can affect vision.

This medicationis also used to treat increased ocular pressure and glaucoma in babies and children of all ages.

Vizilatan can be used in adult men and women (including elderly patients) and in children from birth to 18years of age. Vizilatan has not been evaluated in premature infants (born before 36weeks of gestation).

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

No useVizilatan:

• If you are allergic to latanoprost or any of the other components of this medication (listed in section6).

Warnings and precautions

If you consider that any of the following situations affect you or your child, consult your doctor, the doctor treating your child, or the pharmacist before using Vizilatanor before administering it to your child:

•If you or your child are about to undergo or have undergone eye surgery (including cataract surgery).

•If you or your child have eye problems (such as eye pain, irritation, or inflammation, blurry vision).

•If you or your child suffer from dry eye.

•If you or your child have severe asthma or uncontrolled asthma.

•If you or your child use contact lenses. They may continue to use Vizilatan, but must follow the instructions included in section3 for contact lens users.

•If you have suffered or are suffering from a viral eye infection caused by the herpes simplex virus (HSV).

Other medications andVizilatan

This medication may interact with other medications. Inform your doctor, the doctor treating your child, or the pharmacist if youor your child are using or have recently used or may need to use other medications (or eye drops), even those obtained without a prescription. In particular, consult your doctor or pharmacist if you know you are using prostaglandins, prostaglandin analogs, or prostaglandin derivatives.

Pregnancy and breastfeeding

Pregnancy

You should not use this medication if you are pregnant or breastfeeding unless your doctor considers it necessary.If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before using this medication.

Driving and operating machinery

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

Vizilatancontainshydroxyestearate ofmacrogolglycerol 40

This medication contains hydroxyestearate of macrogolglycerol 40, which may cause skin reactions.

Vizilatan contains phosphate buffer

This medication contains 0.19mg of phosphates in each drop, equivalent to 6.79 mg/ml.

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

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

The recommended dose for adults (including elderly patients) and children is one drop in the affected eye or eyes once a day. It is preferable to administer it at night.

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 or the doctor treating your child has instructed you to, until they tell you to stop.

Users of contact lenses

If you or your child use contact lenses, you must remove them before using this medication. After applying this medication, you should wait 15 minutes before putting the contact lenses back on.

Instructions for use

Using Vizilatan with other eye drops

Wait at least 5minutes between applying this medication and administering other eye drops.

Using more Vizilatan than you should

If you apply too many drops in the eye, you may feel a slight irritation in the eye and it may also become red and watery. This situation should disappear, but if you are concerned, contact your doctor or the doctor treating your child for advice.

Swallowing Vizilatan

In case of accidental ingestion of this medication,consult your doctor, or call the Toxicological Information Service, phone: 91 562 04 20.

Missing a dose of Vizilatan

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 have any doubts, consult your doctor or pharmacist.

Stopping treatment with Vizilatan

If you want to stop using this medication, you should talk to your doctor or the doctor treating your child.

If you have any other doubts 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.

The following are known side effects related to the use of this medicine:

Very common(affects more than 1 in 10patients):

•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). The change in eye color may take years to appear, although it can usually be seen after 8months of treatment. The change in eye color may be permanent and may be more noticeable if this medicine is used in only 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 withthis medicine has been discontinued.

•Redness of the eye.

•Ocular irritation (sensation of burning, sensation of sand in the eye, itching, pain, and sensation of a foreign body in the eye). If you experience ocular irritation severe enough to cause excessive tearing, or if you consider interrupting this treatment, contact your doctor, pharmacist, or nurse (within a week) promptly. It may be necessary to review your treatment to ensure that you continue to receive the most appropriate treatment for your condition.

•Gradual change in the eyelashes of the treated eye and the fine hair around the treated eye, observed in most patients of Japanese origin. These changes involve an increase in color (darkening), length, thickness, and number of eyelashes.

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

•Swelling of the eyelid margins (blepharitis)

• Pain in the eye, sensitivity to light (photophobia).
• Conjunctivitis.
• Inflammation or irritation of the surface of the eye (keratitis punctata), usually asymptomatic.

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

•Swelling of the eyelids.

• Dryness in the eye.
• Inflammation of the cornea (keratitis).
• Blurred vision.
• Inflammation of the colored part of the eye (uveitis).
• Swelling of the retina (macular edema), including swelling of the retina within the eye that leads to a worsening of vision (cystoid macular edema).

•Skin rash.

•Chest pain (angina), perception of heart rhythm (palpitations).

•Asthma, difficulty breathing (dyspnea).

•Chest pain.

•Headache, dizziness

•Muscle pain, joint pain.

•Nausea

• Vomiting

Rare(may affect less than 1 in 1,000patients):

•Inflammation of the iris (iritis).

• Symptoms of swelling (corneal edema) or rupture/damage (corneal erosion) on the surface of the eye.
• Swelling around the eye (periorbital edema).
• Deviation of eyelashes or additional row of eyelashes.
• Scar on the surface of the eye.
• Accumulation of fluid in the colored part of the eye (iris cyst).

•Reactions on the skin of the eyelids, darkening of the skin of the eyelids.

•Worsening of asthma.

•Intense itching of the skin.

•Development of viral eye infection caused by the herpes simplex virus (herpetic keratitis).

• Corneal edema
• Formation of blisters filled with fluid on the surface of the eye that can cause redness, irritation, and swelling of the eye and surrounding tissue (ocular pemphigoid or pseudopemphigoid of the conjunctiva).

Very rare(may affect less than 1 in 10,000patients):

•Worsening of angina in patients with heart problems.

• Appearance of sunken eyes (greater depth of the eyelid crease).

Frequency not known(cannot be estimated from available data):

• Cough and sore throat or inflamed nose (nasopharyngitis)
• Infection of the upper respiratory tract.
• Redness of the eyelid (erythema of the eyelid)
• Irritation of the eyelid.
• Formation of crusts on the eyelid margin.
• Increased tear production.

The side effects observed in children at a frequency greater than in adults are runny nose and itching in the nose and fever.

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 the deposition of calcium during treatment.

Reporting of 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 Pharmacovigilance of Medicines 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 carton box and on the bottle, after «CAD». The expiration date is the last day of the month indicated.

Follow the following preservation instructions:

Unopened bottle: Store below 25°C.

After the first opening of the bottle: No special preservation conditions are required.

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 reserved space on the bottle label and carton box..

Medicines should not be thrown down the drains or in the trash. Deposit the containers and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medications. In this way, you will help protect the environment.

Composition of Vizilatan

• The active ingredient is latanoprost.

Each milliliter of solution contains 50 micrograms of latanoprost.

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

Appearance of Vizilatan and contents of the package

Vizilatan is presented as 2.5 mL of aqueous solution, transparent and colorless, which corresponds approximately to 80 drops of solution, without visible particles, in a carton box containing a 5 mL multi-dose vial (HDPE) 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 vials with 2.5 ml of solution

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

BAUSCH + LOMB IRELAND LIMITED

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

Local Representative in Spain

Bausch & Lomb S.A.

Avda. Valdelaparra, nº 4

28108 Alcobendas

Madrid. Spain.

Tel: 91 – 657 63 00

Responsible for manufacturing:

Lomapharm GmbH

Langes Feld 5

31860 Emmerthal

Germany

or

Pharmathen S.A.

Dervenakion Str. 6

15351 Pallini

Attiki

Greece

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

DK:Vizilatan

BG:??????? 0,05 mg/ml ????? ?? ???, ???????

CZ:Vizilatan

GR:Visiolatan

FR:Vizilatan 50 microgrammes/ml, collyre en solution

HR:Vizilatan 50 mikrograma/ml kapi za oko, otopina

HU:Vizilatan 0,05 mg/ml oldatos szemcsepp

NL:Vizilatan 50 microgram/ml oogdruppels, oplossing

PL:Vizilatan

SK:Vizilatan 0,05 mg/ml

AT:Vizilatan 0,05 mg/ml Augentropfen, Lösung

BE:Vizilatan 50microgrammes/ml collyre en solution

CY:Visiolatan

EE:Vizilatan

DE:Vizilatan 0,05 mg/ml Augentropfen, Lösung

LU:Vizilatan 50 microgram/ml collyre en solution

PT:Vizilatan

RO:VIZILATAN 50 micrograme/ml picaturi oftalmice, solutie

ES:Vizilatan 50microgramos/ml colirio en solución

Date of the last review of this leaflet:October 2023.

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).