Label: information for the user

Visutrax 40microgram/ml eye drops in single-dose solution

travoprost

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

- Keep this label, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medication has been prescribed only for you, and you should not give it to others 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 label. See section4.

1.What Visutrax is and for what it is used

2.What you need to know before starting to use Visutrax

3.How to use Visutrax

4.Adverse effects

5.Storage of Visutrax

6.Contents of the package and additional information

Visutrax contains travoprost,a substance that belongs to a group of medications known asprostaglandin analogs. It works by reducing intraocular pressure. It can be used alone or with other eye drops, such as beta-blockers, which also reduce pressure.

Visutraxis used to reduce elevated intraocular pressure in adults, adolescents, and children aged 2 months and older.This pressure can cause a disease calledglaucoma.

Do not use Visutrax

• If you are allergicto travoprost or to any of the other components of this medication (including those listed insection6).

Consult your doctor if you are in this situation.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Visutrax.

• Visutrax may increasethe length, thickness and amount ofeyelashes, as well as cause them to darken.

Also, changes have been observed in the eyelids or in the tissues surrounding the eye, such as the unusual appearance of hair.

• Visutrax may change the color of the iris(the colored part of the eye). This change may be permanent. Also, changes in the color of the skin surrounding the eye may occur.
• If you have undergonecataract surgery,consult your doctor before using Visutrax.
• If you have or have had any eye inflammation (iritis and uveitis), consult your doctor before using Visutrax.
• In rare cases, Visutrax may causedifficulty breathingorasthma-like symptomsor worsen the symptoms ofasthma. If you notice concerning changes in breathing during the use of Visutrax, inform your doctor as soon as possible.
• The travoprost mayabsorb through the skin.If partof the medicationcomes into contact with the skin,it mustbe washedimmediately. This is especially important in pregnant women or those trying to become pregnant.
• If you use soft contact lenses, do not use the drops with them in place. After using the drops, wait 15minutes before putting the lenses back in.

Children and adolescents

Visutrax may be used in children from 2months to less than 18years at the same dose as in adults. Visutrax is not recommended for use in children under 2months.

Other medications and Visutrax

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Do not use Visutraxif you are pregnant

If you think you may be pregnant, speak with your doctor immediately. If you can become pregnant, you must use an appropriate contraceptive method during treatment.Do not use Visutraxif you are breastfeeding

Visutrax may pass into breast milk.

Consult your doctor before taking any medication.

Driving and operating machinery

You may notice blurred vision for a short time after the instillation of Visutrax. Do not drive or operate machinery until this symptom has disappeared.

Visutrax contains:

• Hydroxyestearate of macrogolglycerol,which may cause skin reactions and irritation.

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

The recommended dose is:

One drop in the affected eye or eyes, once a day - at night.

Only use Visutrax in both eyes if your doctor has instructed you to do so. You must use it for the time your doctor or your child's doctor has indicated.

Visutrax must be used solely as eye drops.

• Wash your hands.

• Turn the single-dose vial cap until it comes loose.
• Hold the single-dose vial, pointing downwards, between your thumb and other fingers.
• Incline your head or your child's head gently backwards. Pull the eyelid downwards with a clean finger until a space forms between the eyelid and the eye. The drop should fall here.
• Bring the tip of the single-dose vial close to the eye. Use a mirror if it helps.
• Do not touch the eye or eyelid, the surrounding skin or other surfaces with the dropper tip.This could contaminate the medication.
• Press the single-dose vial gently to release one drop of Visutrax each time.
• After using Visutrax, keep the eye closed and press gently with a finger at the eye angle, next to the nose, for at least 1minute. This helps to prevent Visutrax from passing to the rest of the body.
• If you use drops in both eyes, repeat these steps in the other eye.

.

If the drop does not enter the eye, try again.

If you or your child use other products applied to the eyes,such as eye drops or eye ointments, wait at least 5minutes between the application of Visutrax and the other products.

If you or your child use more Visutrax than you should

Remove any remaining medication with warm water. Do not apply more drops until the next scheduled dose.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicological Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.

If you forgot to use Visutrax

Continue treatment with the next dose as scheduled.

Do not use a double dose to compensate for missed doses. Do not use more than one drop per day in the affected eye.

If you interrupt treatment with Visutrax

If you have any other doubts about the use of this medication, ask your doctor or pharmacist or your child's doctor.

Do not stop using Visutrax without first talking to your doctor or your child's doctor; if you stop using it, your eye pressure or your child's eye pressure will not be controlled, which could cause vision loss.

Like all medications, this one may cause side effects, although not everyone will experience them.

You can usually continue using the drops unless the side effects are severe.

If you are concerned, speak with a doctor or pharmacist. Do not stop using Visutrax without first speaking with your doctor.

The following side effects have been observed with Visutrax.

Very common: may affect more than 1 in 10 peoplepeople

Eye effects:eye redness.

Common: may affect up to 1 in 10people

Eye effects:changes in iris color (colored part of the eye), eye pain, eye discomfort, dry eye, eye itching, eye irritation.

Uncommon: may affect up to 1 in 100people

Eye effects:corneal disorders, eye inflammation, iris inflammation, inflammation of the inside of the eye, inflammation of the eye surface with/without surface damage, light sensitivity, eye discharge, eyelid inflammation, eyelid redness, swelling around the eye, eyelid itching, blurry vision, increased tear production, conjunctivitis (infection or inflammation of the conjunctiva), abnormal outward turning of the lower eyelid, eye opacity, crust formation on the eyelid, eyelash growth.

General side effects:increased allergic symptoms, headache, dizziness, irregular heartbeat, difficulty breathing, nasal congestion, throat irritation, darkening of the skin around the eye, skin darkening, abnormal hair texture, excessive hair growth.

Rare: may affect up to 1 in 1000people

Eye effects:perception of flashes, eczema of the eyelids,abnormal positionof the eyelashes so they grow towards the eye, eye swelling, decreased vision, halos around lights, decreasedsensitivity to light, inflammation of the eyelid glands, pigmentation of the inside of the eye, increased pupil size, eyelash thickening, change in eyelash color, eye fatigue.

General side effects:ocular viral infection, dizziness, bad taste, irregular or reduced heart rate, increased or decreased blood pressure, difficulty breathing, asthma, nasal allergy or inflammation, nasal dryness, voice changes, gastrointestinal discomfort or ulcers, constipation, dry mouth, skin redness or itching, skin rash, hair color change, eyelash loss, joint pain, muscle and skeletal pain, generalized weakness.

Unknown frequency: cannot be calculated from available data

Eye effects:inflammation of the back of the eye; the eyes appear sunken.

General side effects:depression, anxiety, insomnia, vertigo, ear ringing, chest pain,

abnormal heart rhythm, increased heart rate, worsening of asthma, diarrhea, nasal bleeding, abdominal pain, nausea, vomiting, itching, abnormal hair growth, urinary pain or incontinence, increased prostate cancer markers. In children and adolescents, the most common side effects observed with Visutrax are eye redness and eyelash growth. Both side effects were observed more frequently in children and adolescents than in adults.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance 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 medication.

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

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

Store in the original packaging to protect it from light.

Store below 25°C. Use within 4 weeks after the first opening.

After opening the aluminum pouch for the first time, use within 7 days; once this period has elapsed, unused containers must be discarded.

Single-use containers must be used immediately after opening; the opened single-use container with residual medication must be discarded.

Medications should not be thrown away through drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need.This will help protect the environment.

Composition of Visu trax

• The active ingredient is travoprost 40 micrograms/ml.
• The other components are: manitol, trometamol, hidroxiestearato de macrogolglicerol, ácido bórico, edetato disódico, agua para preparaciones inyectables.

Appearance of the product and contents of the packaging

Visutrax is a liquid (a transparent and colorless solution) that is presented in a single-dose polyethylene container.

A box contains 30 or 90 single-dose containers of 0.1 ml.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

VISUfarma S.p.A.

Via Alberto Cadlolo 21-00136 Roma,

Italy

Manufacturer

Genetic S.p.A.

Contrada Canfora

84084 Fisciano (SA)

Italy

This medicine is authorized in the EEA member states and in the United Kingdom (Northern Ireland) with the following names:

Germany: Visutrax 40 Mikrogramm/ml Eye Drops, Solution in Single-Dose Container

Spain: Visutrax 40 micrograms/ml, eye drops in solution in single-dose container

United Kingdom (and Northern Ireland): Visutrax 40 micrograms/ml eye drops, solution in single dose container

Last review date of this leaflet: December 2023

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