Vizilan 50 micrograms/ml eye drops solution

Spain
Brand name Vizilan 50 micrograms/ml eye drops solution
Form solution, ophthalmic
Active substance / Dosage
LATANOPROST · 50 microgramos/ml
Prescription type Prescription Only Medicine
ATC code
S01E S01EE S01EE01
Registration number 85233
Manufacturer Bausch + Lomb Ireland Limited
Vizilan 50 micrograms/ml eye drops solution solution, ophthalmic

Table of Contents

Package leaflet: Information for the user

Introduction

Vizilatan 50 micrograms/ml eye drops solution

latanoprost

Read the entire 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, consult your doctor, the doctor treating your child, or the pharmacist.
  • This medicine has been prescribed for you or your child and must not be given to other people, even if they have the same symptoms, as it may harm them.
  • If you or your child experience any adverse effects, consult your doctor, the doctor treating your child, or the pharmacist, even if these adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet

  1. What Vizilatan is and what it is used for
  2. What you need to know 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. It works by increasing the natural outflow of fluid from inside the eye into the bloodstream.

This medicine is used to treat open-angle glaucoma and ocular hypertension in adults. These two conditions may occur together, resulting in increased intraocular pressure that may affect vision.

This medicine is also used to treat elevated intraocular pressure and glaucoma in infants and children of all ages.

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

Vizilatan eye drops solution is a sterile solution without preservatives.

2. What you need to know before using Vizilatan

Do not use Vizilatan:

  • If you are allergic to latanoprost or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

If you think any of the following situations apply to you or your child, consult your doctor, your child's doctor, or pharmacist before using Vizilatan or before administering it to your child:

  • If you or your child are about to undergo or have recently undergone eye surgery (including cataract surgery).
  • If you or your child have eye problems (such as eye pain, irritation or inflammation, blurred vision).
  • If you or your child have dry eye.
  • If you or your child have severe asthma or poorly controlled asthma.
  • If you or your child wear contact lenses. You may continue using Vizilatan, but you must follow the instructions provided in section 3 for contact lens wearers.
  • If you have had or currently have a viral eye infection caused by the herpes simplex virus (HSV).

Other medicines and Vizilatan

This medicine may interact with other medicines. Inform your doctor, your child's doctor, or pharmacist if you or your child are using or have recently used, or might need to use, any other medicines (including eye drops), even those obtained without a prescription. In particular, talk to your doctor or pharmacist if you know you are using prostaglandins, prostaglandin analogues, or prostaglandin derivatives.

Pregnancy and breastfeeding

Pregnancy

You must not use this medicine 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, consult your doctor before using this medicine.

Driving and using machines

You may experience blurred vision for a short period of time when you use this medicine. If this occurs, do not drive or operate tools or machinery until your vision clears.

Vizilatan contains macrogol glycerol hydroxystearate 40

This medicine contains macrogol glycerol 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.

If you have severe corneal damage (the transparent layer at the front of the eye), treatment with phosphate-containing medicines may, in very rare cases, cause blurred vision due to calcium accumulation.

3. How to use Vizilatan

Follow exactly the administration instructions for this medicine given by your doctor or by the doctor treating your child. If in 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 daily. It is preferable to administer it in the evening.

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

Use this medicine exactly as directed by your doctor or the doctor treating your child, until they tell you to stop.

Contact lens users

If you or your child wear contact lenses, they must be removed before using this medicine. After applying this medicine, you must wait 15 minutes before reinserting the contact lenses.

Instructions for use

Black and white technical drawing of a cylindrical medical device composed of a conical upper part and a segmented main body

1a

A hand rotates a capsule toward a cylindrical container held by another hand

1b

  • Remove the bottle (image 1a) from the cardboard box and write the date of opening on both the box and the bottle, in the space provided for this purpose.
  • Take the medicine bottle and a mirror.
  • Wash your hands.
  • Remove the cap (image 1b).

A hand holds an inverted bottle to let a drop fall from the dropper, with a black arrow pointing toward the drop2

  • Hold the bottle upside down, with your thumb on the wide part below the neck of the bottle and the other fingers on the bottom of the bottle. Before first use, pump the bottle repeatedly 15 times (image 2). A slightly whitish appearance of the drops should not be a cause for concern.

Line drawing of a hand gently pressing with a finger below the eye

3

  • Tilt your head or your child's head backward. With a clean finger, pull down the lower eyelid until a "pocket" forms between the eyelid and the eye. This is where you should instill the drop (image 3).
  • Bring the tip of the bottle close to the eye. Use the mirror if it helps.

A hand holds a dropper bottle above the eye

4

  • Do not let the dropper touch the eye, eyelid, surrounding areas, or any other surfaces. The drops could become contaminated.
  • Gently press the bottom of the bottle to release one drop of medication at a time (image 4).
  • If the drop does not fall into the eye, apply another drop.

Line drawing of a closed eye with a finger gently pressing on the upper eyelid to apply a product

5

  • After applying the medication, press with one finger on the corner of the treated eye near the nose for 1 minute (image 5). This will prevent the medication from draining into the rest of the body.
  • If you need to use the drops in both eyes, repeat the same steps for the other eye.
  • Close the cap tightly immediately after use.
  • Use only one medicine bottle each time. Do not open the cap until you need to use the bottle.
  • To prevent infection, discard the bottle four weeks after first opening and use a new bottle.

If you use Vizilatan with other eye drops

Wait at least 5 minutes between applying this medicine and using other eye drops.

If you use more Vizilatan than you should

If you apply too many drops into the eye, you may experience mild eye irritation, and the eye may become red and watery. This should resolve on its own, but if you are concerned, contact your doctor or your child's doctor for advice.

If you swallow Vizilatan

In case of accidental ingestion of this medicine, consult your doctor or call the Toxicology Information Service at telephone number: 91 562 04 20.

If you forget to use Vizilatan

Continue using the next dose as usual. Do not use a double dose to make up for the missed dose. If you have any doubts, consult your doctor or pharmacist.

If you stop using Vizilatan

If you wish to discontinue using this medicine, you should speak with your doctor or your child's doctor.

If you have any further 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 everyone experiences them.

The known adverse effects associated with the use of this medicine are listed below:

Very common (affects 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-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 is usually noticeable within 8 months of treatment. The color change may be permanent and may be more pronounced if this medicine is used in only one eye. The change in eye color does not appear to be associated with any eye problems. The eye color change does not progress once treatment with this medicine is stopped.
  • Redness of the eye.
  • Eye irritation (burning sensation, gritty feeling in the eye, itching, pain, and foreign body sensation in the eye). If you experience eye irritation severe enough to cause excessive tearing, or if you are considering stopping this treatment, contact your doctor, pharmacist, or nurse promptly (within one week). Your treatment may need to be reviewed to ensure you continue receiving the most appropriate therapy for your condition.
  • Gradual changes in the eyelashes of the treated eye and in the fine hair around the treated eye, observed in most Japanese-origin patients. These changes include increased pigmentation (darkening), length, thickness, and number of eyelashes.

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

  • Inflammation of the eyelid margins (blepharitis)
    • Eye pain, sensitivity to light (photophobia).
    • Conjunctivitis.
    • Inflammation or irritation of the eye surface (punctate keratitis), usually asymptomatic.

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

  • 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 swelling within the eye leading to worsening of vision (cystoid macular edema).

  • Skin rash.

  • Chest pain (angina), awareness of heartbeat (palpitations).

  • Asthma, difficulty breathing (dyspnea).

  • Chest pain.

  • Headache, dizziness.

  • Muscle pain, joint pain.

  • Nausea.

    • Vomiting.

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

  • Inflammation of the iris (iritis).

    • Symptoms of swelling (corneal edema) or rupture/damage (corneal erosion) on the eye surface.
    • Swelling around the eye (periorbital edema).
    • Misdirected eyelashes or an additional row of eyelashes.
    • Scarring on the eye surface.
    • Fluid accumulation in the colored part of the eye (iris cyst).

  • Skin reactions on the eyelids, darkening of the eyelid skin.

  • Worsening of asthma.

  • Intense skin itching.

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

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

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

  • Worsening of angina in patients with heart problems.
    • Appearance of sunken eyes (increased depth of the eyelid groove).

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

  • Cough and sore throat or inflamed nose (nasopharyngitis).
  • Upper respiratory tract infection.
  • Redness of the eyelid (eyelid erythema).
  • Eyelid irritation.
  • Crusting at the eyelid margin.
  • Tearing (increased lacrimation).

Adverse effects observed in children at a higher frequency than in adults are runny nose, nasal itching, and fever.

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

Reporting of adverse effects

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

5. Storage of Vizilatan

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

Do not use this medicine after the expiry date stated on the cardboard box and on the bottle, following "EXP". The expiry date refers to the last day of the month indicated.

Please observe the following storage instructions:

Unopened bottle: Store below 25°C.

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

To prevent infection, the bottle must be discarded four weeks after first opening. Write the date of first opening in the space provided for this purpose on the label of the bottle and on the cardboard box.

Medicines must not be disposed of via wastewater or household waste. Instead, dispose of unused medicines and their containers at a SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vizilatan

  • The active substance is latanoprost.

Each ml of solution contains 50 micrograms of latanoprost.

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

Appearance of Vizilatan and contents of the container

Vizilatan is presented as 2.5 mL of aqueous solution, transparent and colourless, corresponding to approximately 80 drops of solution, free from visible particles, in a cardboard box containing a white multidose bottle (HDPE) of 5 mL with a pump (PP, HDPE, LDPE) and an orange pressure plug and cylinder (HDPE).

Pack sizes:

Cardboard boxes containing 1, 3 or 4 bottles with 2.5 mL of solution.

Only certain pack 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

Local Representative in Spain:

Bausch & Lomb S.A.
Avda. Valdelaparra, nº 4
28108 Alcobendas
Madrid, Spain
Tel: 91 – 657 63 00

Manufacturer:

Lomapharm GmbH
Langes Feld 5
31860 Emmerthal
Germany

or

Pharmathen S.A.
Dervenakion Str. 6
15351 Pallini
Attiki
Greece

Date of the most recent review of this summary: October 2023.

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) (http://www.aemps.gob.es/).