Vizilatan

Package Leaflet: Information for the Patient

Vizilatan, 50 micrograms/ml, eye drops, solution

Latanoprost

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What Vizilatan is and what it is used for

Vizilatan belongs to a group of medicines known as prostaglandin analogues. Vizilatan works by increasing the natural outflow of fluid from the eye into the bloodstream. Vizilatan is used to treat open-angle glaucomaand ocular hypertensionin adults. Both of these conditions are associated with high pressure in the eye and can affect your vision. Vizilatan may also be used in children of all ages and infants to treat increased eye pressureand glaucoma. Vizilatan can be used in adult men and women (including the elderly) and in children from birth to 18 years of age. The use of Vizilatan in premature infants (born before 36 weeks of gestation) has not been studied. Vizilatan eye drops are a sterile solution that does not contain preservatives.

2. Important information before using Vizilatan

When not to use Vizilatan

Warnings and precautions

If any of the following apply to you, or your child, tell your doctor or pharmacist before using Vizilatan:

Vizilatan and other medicines

Vizilatan may interact with other medicines. Tell your doctor or pharmacist about all medicines you or your child are taking, including those obtained without a prescription, and any that you plan to take. In particular, tell your doctor or pharmacist if you are taking prostaglandins, prostaglandin analogues, or prostaglandin derivatives.

Pregnancy and breastfeeding

Do not use Vizilatan 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 have a baby, ask your doctor for advice before using this medicine.

Driving and using machines

After using Vizilatan, you may experience blurred vision, which is a temporary effect. Do not drive or operate machinery until your vision is clear again.

Vizilatan contains macrogolglycerol hydroxystearate 40

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

Vizilatan contains phosphate buffer

This medicine contains 0.19 mg of phosphates per drop, equivalent to 6.79 mg/ml. In very rare cases, in some patients with significant damage to the outer, transparent layer of the eye (cornea), during treatment, cloudy spots appeared on the cornea due to calcium deposits.

3. How to use Vizilatan

Use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose for adults (including the elderly) and children is one drop once daily into the affected eye(s). It is best to administer the dose in the evening. Do not use Vizilatan more than once daily, as this may reduce the effect of the treatment. Use Vizilatan for as long as your doctor tells you to.

For contact lens wearers

Before administering Vizilatan to the eye, remove contact lenses. Contact lenses can be reinserted 15 minutes after using Vizilatan.

Instructions for using Vizilatan

1a 1b	Remove the bottle from the carton (Fig. 1a) and write the date of opening on the carton and bottle. Prepare the bottle and a mirror. Wash your hands. Remove the cap (Fig. 1b).
2	Hold the inverted bottle with your thumb on the top and the other fingers on the bottom. Before the first use, press (pump) the bottle about 15 times (Fig. 2). The likely white appearance of the drops should not concern the patient.
3	Tilt your head or your child's head back. With a clean finger, pull down the lower eyelid to create a "pocket" between the eye and the eyelid. The drop should fall into this pocket (Fig. 3). Bring the tip of the bottle close to the eye. You can use a mirror to help.

4	Do not touch the dropper tip to the eye or eyelid, or to any other surfaces. Touching the dropper tip may cause contamination. Gently squeeze the bottom of the bottle to release a single drop of medicine at the right time (Fig. 4). If the drop does not get into the eye, try again.
5	After administering the medicine, press the corner of the eye near the nose with your finger for 1 minute (Fig. 5). This will help prevent the medicine from getting into the rest of the body.
	If using drops in both eyes, repeat the above steps. Close the bottle tightly after use. Use one bottle at a time. Do not remove the cap until you need to use the bottle. Discard the bottle after 4 weeks from first opening to prevent contamination and start using a new bottle.

Using Vizilatan with other eye drops

Wait at least 5 minutes before using other eye drops after using Vizilatan.

Using more Vizilatan than prescribed

If you use more eye drops than prescribed, you may experience moderate eye irritation with tearing and redness. These symptoms should go away, but if you are concerned, contact your doctor for advice. If Vizilatan is accidentally ingested, contact your doctor immediately.

Missing a dose of Vizilatan

If you miss a dose, use the next dose at the scheduled time. Do not use a double dose to make up for the missed dose. If you have any further questions, ask your doctor or pharmacist.

Stopping Vizilatan treatment

Talk to your doctor if you want to stop using Vizilatan. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vizilatan can cause side effects, although not everybody gets them. Known side effects of Vizilatan:

Very common(may affect more than 1 in 10 people):

• Gradual change in eye color due to increased amounts of brown pigment in the colored part of the eye, known as the iris. In patients with mixed eye color (blue-brown, grey-brown, yellow-brown, or green-brown), these changes are more visible than in patients with uniform eye color (blue, grey, green, or brown). Any changes in eye color may take several years to develop, although they are normally seen within 8 months of treatment. The change in eye color may be permanent and may be more noticeable if Vizilatan is used in one eye only. It does not appear that the change in eye color is associated with any problems. After stopping Vizilatan, the change in eye color does not progress.
• Eye redness.
• Eye irritation (feeling of burning, grittiness, itching, stinging, or the sensation of something in the eye). If eye irritation is severe enough to cause excessive tearing or to make you want to stop using Vizilatan, you should contact your doctor, pharmacist, or nurse within a week. It may be necessary to verify your treatment to ensure you receive proper treatment.
• Gradual change in the appearance of eyelashes and/or vellus hair in the treated eye, particularly in people of Japanese descent. These changes include increased length, thickness, and/or number of eyelashes.

Common(may affect up to 1 in 10 people):

• Inflammation of the eyelids (blepharitis).
• Eye pain, sensitivity to light (photophobia).
• Eye irritation (conjunctivitis).
• Inflammation or irritation of the surface of the eye (punctate keratitis), usually without symptoms.

Uncommon(may affect up to 1 in 100 people):

• Swelling of the eyelids.
• Dry eye.
• Inflammation of the cornea (keratitis).
• Blurred vision.
• Inflammation of the colored part of the eye (uveitis).
• Swelling of the retina (macular edema), including retinal edema in the macula leading to impaired vision (cystoid macular edema).
• Rash.
• Chest pain (angina), feeling of heart pounding (palpitations).
• Asthma, shortness of breath (dyspnea).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.
• Nausea.
• Vomiting.

Rare(may affect up to 1 in 1,000 people):

• Inflammation of the iris (iritis).
• Signs of inflammation or damage (infiltrates or damage) to the surface of the eye.
• Swelling around the eye (periorbital edema).
• Abnormal direction of eyelash growth or extra row of eyelashes.
• Scars on the surface of the eye.
• A fluid-filled area in the colored part of the eye (iris cyst).
• Local skin reactions on the eyelids, darkening of the eyelid skin.
• Worsening of asthma.
• Severe itching of the skin.
• Viral infections of the eye caused by the herpes simplex virus (HSV) (herpetic keratitis).
• Fluid-filled blisters on the surface of the eye, which can cause redness, irritation, and swelling of the eye and surrounding tissues (ocular pemphigoid or pseudopemphigoid of the conjunctiva).

Very rare(may affect up to 1 in 10,000 people):

• Worsening of angina in patients with heart disease.
• Feeling of sunken eyes (deepening of the eyelid sulcus).

Not known(frequency cannot be estimated from the available data):

• Cough and inflammation of the nose or throat (nasopharyngitis).
• Upper respiratory tract infection.
• Redness of the eyelid (eyelid rash).
• Irritation of the eyelids.
• Crusts on the eyelids.
• Excessive tearing (increased tearing).

Cough, runny nose, and fever are side effects that occur more frequently in children and adolescents than in adults. In very rare cases, in some patients with significant damage to the transparent layer covering the front of the eye (cornea), during treatment, cloudy spots appeared on the cornea due to calcium deposits.

Reporting side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in the "Further information" section. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vizilatan

Keep this medicine out of the sight and reach of children. Do not use Vizilatan after the expiry date which is stated on the carton and bottle after EXP. The expiry date refers to the last day of that month. Pay attention to the following storage conditions:

Unopened bottles: Store below 25°C. After first opening: No special storage conditions. Discard the bottle after 28 days from first openingto prevent contamination. Write the date of opening on the space provided on the bottle label and carton. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Vizilatan contains

• The active substance is: latanoprost.
• Each ml of solution contains 50 micrograms of latanoprost.
• The other ingredients are: macrogolglycerol hydroxystearate 40, sodium chloride, disodium edetate, sodium dihydrogen phosphate dihydrate, disodium phosphate anhydrous, hydrochloric acid, and/or sodium hydroxide (to adjust pH), water for injections.

What Vizilatan looks like and contents of the pack

Vizilatan is a clear, colorless aqueous solution in a 2.5 ml bottle, which is equivalent to approximately 80 drops, free from visible particles, in a white multidose container (HDPE) with a pump (PP, HDPE, LDPE) and an orange cylinder and nozzle (HDPE). The following pack sizes are available: 1, 3, or 4 bottles containing 2.5 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

Manufacturer

Pharmathen S.A., Dervenakion 6, 15351 Pallini Attiki, Greece; Lomapharm GmbH, Langes Feld 5, 31860 Emmerthal, Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Denmark: Vizilatan; Bulgaria: Визилат 0,05 mg/ml капки за очи, разтвор; Czech Republic: Vizilatan; Greece: Visiolatan; France: Vizilatan 50 microgrammes/ml, collyre en solution; Croatia: Vizilatan 50 mikrograma/ml, kapi za oko, otopina; Hungary: Vizilatan 0,05 mg/ml oldatos szemcsepp; Netherlands: Vizilatan; Poland: Vizilatan; Slovakia: Vizilatan 0,05 mg/ml; Austria: Vizilatan 0,05 mg/ml Augentropfen, Lösung; Belgium: Vizilatan 50 microgrammes/ml, collyre en solution; Cyprus: Visiolatan; Estonia: Vizilatan; Germany: Vizilatan 0,05 mg/ml Augentropfen, Lösung; Luxembourg: Vizilatan 50 microgram/ml, collyre en solution; Portugal: Vizilatan; Romania: VIZILATAN 50 micrograme/ml, picaturi oftalmice, solutie; Spain: Vizilatan 50 microgramos/ml, colirio en solución

Date of last revision of the package leaflet: 09/2023