VISUTRAX 40 micrograms/ml eye drops solution in single-dose containers

Introduction

Package Leaflet: Information for the User

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

travoprost

Read this entire leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Visutrax and what is it used for
2. What you need to know before you start using Visutrax
3. How to use Visutrax
4. Possible side effects
5. Storage of Visutrax
6. Contents of the pack and further information

1. What is Visutrax and what is it used for

Visutrax contains travoprost,a substance that belongs to a group of medicines called prostaglandin analogues. It works by reducing eye pressure. It can be used alone or with other eye drops, such as beta-blockers, which also reduce pressure.

Visutraxis used to reduce high eye pressure in adults, adolescents, and children from2 months of age.This pressure can cause a disease called glaucoma.

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

Do not use Visutrax

• If you are allergicto travoprost or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor if you are in this situation.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Visutrax.

• Visutrax may increasethe length, thickness, and number of eyelashes, as well as darken them.

Changes in the eyelids or tissues surrounding the eye, such as unusual hair growth, have also been observed.

• Visutrax may change the color of the iris(the colored part of the eye). This change may be permanent. Skin color changes around the eye may also occur.
• If you have had cataract surgery,talk to your doctor before using Visutrax.
• If you have or have had eye inflammation (iritis and uveitis),talk to your doctor before using Visutrax.
• Visutrax can rarely cause breathing difficultiesor wheezingor worsen asthma symptoms. If you notice concerning breathing changes while using Visutrax, inform your doctor as soon as possible.
• Travoprost may be absorbed through the skin. If partof the medicine comes into contact with the skin,it should be washedimmediately. This is especially important in pregnant or breastfeeding women.
• If you wear soft contact lenses,do not use the drops with them in. After using the drops, wait 15 minutes before putting your lenses back in.

Children and adolescents

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

Other medicines and Visutrax

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not use Visutraxif you are pregnant

If you think you might be pregnant, talk to your doctor immediately. If you can become pregnant, you should use an effective method of birth control during treatment. Do not use Visutraxif you are breastfeeding

Visutrax may pass into breast milk.

Talk to your doctor before taking any medicine.

Driving and using machines

You may notice blurred vision for a while just after putting in Visutrax. Do not drive or use machines until this symptom has gone.

Visutrax contains:

• Macrogolglycerol hydroxystearate,which may cause skin reactions or irritation.

3. How to use Visutrax

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist, or your child's doctor. If you are not sure, talk to your doctor or pharmacist.

The recommended dose is:

One drop in the affected eye(s) once a day, in the evening.

You should only use Visutrax in both eyes if your doctor has told you to. You should use it for as long as your doctor has told you.

Visutrax should only be used as eye drops.

• Wash your hands.

• Twist the single dose container cap until it comes off.
• Hold the single dose container with the tip down between your thumb and fingers.
• Tilt your head or your child's head back gently. Pull the lower lid down with a clean finger until a pocket is formed between the lid and the eye. The drop should fall into this pocket.
• Bring the tip of the single dose container close to the eye. Use a mirror if it helps.
• Do not touch the eye or eyelid, the skin around it, or other surfaces with the dropper tip.This could contaminate the medicine.
• Gently squeeze the single dose container to release one drop of Visutrax at a time.
• After using Visutrax, keep the eye closed and gently press the corner of the eye near the nose with your finger for at least 1 minute. This helps prevent Visutrax from getting into the rest of the body.
• If you are using drops in both eyes, repeat these steps for the other eye.

.

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

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

If you or your child use more Visutrax than you should

Remove any remaining medicine with warm water. Do not put in another drop until it is time for your next normal dose.

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

If you forget to use Visutrax

Continue with the next dose as planned.

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

If you stop using Visutrax

If you have any further questions on the use of this medicine, ask your doctor or pharmacist or your child's doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Normally, you will be able to continue using the drops, unless the side effects are serious.

If you are concerned, talk to a doctor or pharmacist. Do not stop using Visutrax without talking to your doctor.

The following side effects have been seen with Visutrax.

Very common: may affect more than 1 in 10 people

Ocular effects:eye redness.

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

Ocular effects:corneal disorders, eye inflammation, iris inflammation, inflammation of the inside of the eye, inflammation of the eye surface with or without damage to the surface, light sensitivity, eye discharge, eyelid inflammation, eyelid redness, swelling around the eye, eyelid itching, blurred vision, increased tear production, conjunctivitis (infection or inflammation of the conjunctiva), abnormal rotation of the lower eyelid outward, eye opacity, eyelid crusting, eyelash growth.

General effects:increased allergic symptoms, headache, dizziness, irregular heartbeat, breathing difficulties, 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 1,000 people

Ocular effects:flashes of light, eyelid eczema, abnormal eyelash position, eye swelling, decreased vision, seeing halos, decreased eye sensitivity, inflammation of the eyelid glands, pigmentation of the inside of the eye, increased pupil size, thickening of the eyelashes, change in eyelash color, eye fatigue.

General effects:viral eye infection, dizziness, bad taste, irregular or slow heart rate, increased or decreased blood pressure, breathing difficulties, asthma, nasal allergy or inflammation, nasal dryness, voice changes, gastrointestinal discomfort or ulcers, constipation, dry mouth, skin redness or itching, rash, hair color change, loss of eyelashes, joint pain, musculoskeletal pain, general weakness.

Frequency not known: cannot be estimated from the available data

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

General effects:depression, anxiety, insomnia, vertigo, tinnitus, chest pain, irregular heartbeat, increased heart rate, worsening of asthma, diarrhea, nosebleeds, abdominal pain, nausea, vomiting, itching, abnormal hair growth, pain when urinating or urinary incontinence, increased prostate cancer markers. In children and adolescents, the most common side effects seen with Visutrax are eye redness and eyelash growth. Both side effects were seen more often in children and adolescents than in adults.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Visutrax

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

Do not use this medicine after the expiry date which is stated on the bottle and carton after 'EXP'. The expiry date is the last day of the month shown.

Store in the original package to protect from light.

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

After opening the aluminum pouch for the first time, use within 7 days; any unused containers should be discarded after this period.

Single dose containers should be used immediately after opening; any opened single dose container with residual medicine should be discarded.

Medicines should not be disposed of via wastewater or household waste. Return any unused containers and medicines to a pharmacy for proper disposal. If you have any further questions, ask your pharmacist. This will help protect the environment.

6. Contents of the pack and further information

Composition of Visutrax

• The active substance is travoprost 40 micrograms/ml.
• The other ingredients are: mannitol, trometamol, macrogolglycerol hydroxystearate, boric acid, disodium edetate, water for injections.

Appearance and packaging

Visutrax is a liquid (a clear, colorless solution) in a single dose container made of polyethylene.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder

VISUfarma S.p.A.

Via Alberto Cadlolo 21-00136 Rome,

Italy

Manufacturer

Genetic S.p.A.

Contrada Canfora

84084 Fisciano (SA)

Italy

This medicine is authorized in the Member States of the EEA and in the United Kingdom (Northern Ireland) under the following names:

Germany: Visutrax 40 Mikrogramm/ml Augentropfen, Lösung im Einzeldosisbehältnis

Spain: Visutrax 40 micrograms/ml, colirio en solución en envase unidosis

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

Date of last revision of this leaflet: December 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/