Visutrax 40 micrograms/ml eye drops solution in single-dose container
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Visutrax 40 micrograms/ml eye drops solution in single-dose container
travoprost
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, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Visutrax is and what it is used for
- What you need to know before using Visutrax
- How to use Visutrax
- Possible side effects
- How to store Visutrax
- Contents of the pack and other information
1. What Visutrax is and what it is used for
Visutrax contains travoprost, a substance that belongs to a group of medicines called prostaglandin analogues. It works by reducing intraocular pressure. It can be used alone or with other eye drops, such as beta-blockers, which also reduce pressure.
Visutrax is used to reduce elevated intraocular pressure in adults, adolescents, and children from 2 months of age. This pressure can lead to a condition called glaucoma.
2. What you need to know before using Visutrax
Do not use Visutrax
- If you are allergic to travoprost or to any of the other components of this medicine (listed in section 6).
Consult your doctor if you are in this situation.
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Visutrax.
- Visutrax may increase the length, thickness, and number of eyelashes, as well as cause them to darken.
Changes in the eyelids or tissues surrounding the eye, such as unusual hair growth, may also occur.
- Visutrax may change the color of the iris (the colored part of the eye). This change may be permanent. Changes in the skin color around the eye may also occur.
- If you have undergone cataract surgery, consult your doctor before using Visutrax.
- If you have or have had any eye inflammation (iritis or uveitis), consult your doctor before using Visutrax.
- Rarely, Visutrax may cause difficulty breathing, wheezing, or worsen symptoms of asthma. If you notice any concerning changes in your breathing while using Visutrax, inform your doctor as soon as possible.
- Travoprost may be absorbed through the skin. If any of the medicine comes into contact with the skin, it should be washed off immediately. This is especially important for women who are pregnant or trying to become pregnant.
- If you wear soft contact lenses, do not use the drops while wearing them. After using the drops, wait 15 minutes before reinserting your contact lenses.
Children and adolescents
Visutrax may be used in children from 2 months up to less than 18 years of age at the same dose as in adults. Use of Visutrax is not recommended in children under 2 months of age.
Other medicines and Visutrax
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Do not use Visutrax if you are pregnant
If you think you may be pregnant, speak to your doctor immediately. If you are able to become pregnant, you should use an appropriate method of contraception during treatment. Do not use Visutrax if you are breastfeeding
Visutrax may pass into breast milk.
Consult your doctor before taking any medicine.
Driving and using machines
You may experience blurred vision for a short time immediately after instilling Visutrax. Do not drive or operate machinery until this symptom has resolved.
Visutrax contains:
- Macrogolglycerol hydroxystearate, which may cause skin reactions and skin irritation.
3. How to use Visutrax
Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist, or by your child's doctor. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
One drop in the affected eye or eyes, once daily – in the evening.
You should use Visutrax in both eyes only if your doctor has instructed you to do so. You must use it for the length of time prescribed by your doctor or your child's doctor.
Visutrax should be used only as an eye drop.
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Wash your hands.
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Twist the cap of the single-dose container until it detaches.
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Hold the single-dose container between your thumb and other fingers, pointing downwards.
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Gently tilt the head, or your child's head, backwards. Pull the lower eyelid down with a clean finger to create a pocket between the eyelid and the eye. The drop should fall into this pocket.
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Bring the tip of the single-dose container close to the eye. Use a mirror if it helps.
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Do not touch the eye, eyelid, surrounding skin, or any other surface with the dropper cap. This could contaminate the medicine.
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Gently squeeze the single-dose container so that one drop of Visutrax is released each time.
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After using Visutrax, keep the eye closed and gently press with a finger at the inner corner of the eye, near the nose, for at least 1 minute. This helps prevent Visutrax from passing into the rest of the body.
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If you are using drops in both eyes, repeat these steps for the other eye.
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If the drop does not enter the eye, try again.
If you or your child are using other eye products, such as eye drops or ophthalmic ointments, wait at least 5 minutes between applying Visutrax and the other products.
If you or your child use more Visutrax than you should
Remove excess medicine with warm water. Do not apply any more drops until the time of your next regular dose.
In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.
If you forget to use Visutrax
Continue treatment with the next dose as scheduled.
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 about the use of this medicine, 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 intraocular pressure or your child's may not be controlled, which could lead to vision loss.
4. Possible adverse effects
Like all medicines, this one may cause adverse effects, although not everyone experiences them.
You can usually continue using the drops unless the adverse effects are severe.
If you are concerned, speak to a doctor or pharmacist. Do not stop using Visutrax without first talking to your doctor.
The following adverse effects have been observed with Visutrax.
Very common adverse effects: may affect more than 1 in 10 people
Ocular effects: eye redness.
Common adverse effects: may affect up to 1 in 10 people
Ocular effects: changes in iris colour (the coloured part of the eye), eye pain, eye discomfort, dry eyes, eye itching, eye irritation.
Uncommon adverse effects: may affect up to 1 in 100 people
Ocular effects: corneal disorders, eye inflammation, iris inflammation, inflammation inside the eye, inflammation of the eye surface with or without surface damage, light sensitivity, eye discharge, eyelid inflammation, eyelid redness, swelling around the eye, eyelid itching, blurred vision, increased tear production, conjunctival infection or inflammation (conjunctivitis), abnormal outward turning of the lower eyelid, eye opacity, formation of crusts on the eyelid, eyelash growth.
General effects: worsening of allergic symptoms, headache, dizziness, irregular heartbeat, breathing difficulty, 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: perception of flashes of light, eyelid eczema, abnormal eyelash position causing them to grow towards the eye, eye swelling, decreased vision, seeing halos, decreased ocular sensitivity, inflammation of the eyelid glands, pigmentation inside the eye, pupil enlargement, eyelash thickening, change in eyelash colour, eye fatigue.
General effects: viral eye infection, dizziness, bad taste in the mouth, irregular or reduced heart rate, increased or decreased blood pressure, breathing difficulty, asthma, nasal allergy or inflammation, nasal dryness, voice changes, gastrointestinal discomfort or ulcers, constipation, dry mouth, skin redness or itching, skin rash, change in hair colour, eyelash loss, joint pain, musculoskeletal pain, generalized weakness.
Frequency not known: cannot be estimated from available data
Ocular effects: inflammation of the back of the eye; eyes appearing more sunken.
General effects: depression, anxiety, insomnia, dizziness, tinnitus (ringing in the ears), chest pain, abnormal heart rhythm, increased heart rate, worsening of asthma, diarrhoea, nosebleeds, abdominal pain, nausea, vomiting, itching, abnormal hair growth, pain during urination or urinary incontinence, increase in prostate cancer markers.
In children and adolescents, the most common adverse effects observed with Visutrax are eye redness and eyelash growth. Both of these adverse effects occurred more frequently in children and adolescents than in adults.
Reporting of adverse effects
If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Visutrax
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and the outer carton, following «EXP». The expiry date refers to the last day of the month indicated.
Store in the original packaging to protect from light.
Store below 25 °C. Use within 4 weeks of first opening.
After first opening of the aluminium pouch, use within 7 days; any unused containers must be discarded after this period.
Single-dose containers should be used immediately after opening. Any opened single-dose container with residual medicine must be discarded.
Medicines must not be disposed of via wastewater or household waste. Return unused containers and medicines to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Visutrax
- The active substance is travoprost 40 micrograms/ml.
- The other components are: mannitol, trometamol, macrogol glycerol hydroxystearate, boric acid, edetate disodium, water for injections.
Appearance of the product and contents of the container
Visutrax is a liquid (a clear, colourless solution) supplied in single-dose containers made of polyethylene.
A pack contains 30 or 90 single-dose containers of 0.1 ml.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
VISUfarma S.p.A.
Via Alberto Cadlolo 21-00136 Rome,
Italy
Manufacturer
Genetic S.p.A.
Contrada Canfora
84084 Fisciano (SA)
Italy
This medicinal product is authorised in EEA Member States and the United Kingdom (Northern Ireland) under the following names:
Germany: Visutrax 40 Mikrogramm/ml Augentropfen, Lösung im Einzeldosisbehältnis
Spain: Visutrax 40 microgramos/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 the most recent revision of this leaflet: December 2023
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/