Patient leaflet - VISUTRAX 40 MICROGRAMS / ML EYE DROPS SOLUTION
Package leaflet: Information for the user
travoprost
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor or pharmacist.
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– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
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– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet, See section 4.
What is in this leaflet
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1. What Visutrax is and what it is used for
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2. What you need to know before you use Visutrax
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3. How to use Visutrax
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4. Possible side effects
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5. How to store Visutrax
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6. Contents of the pack and other information
1. what visutrax is and what it is used for
Visutrax contains travoprost , a substance belonging to a group of medicines called prostaglandin analogues. It works by reducing the pressure in the eye. It may be used on its own or with other drops e.g. beta-blockers, which also reduce pressure.
Visutrax is used to reduce high pressure in the eye in adults, adolescents and children from 2 months old onward. This pressure can lead to an illness called glaucoma.
2. what you need to know before you use visutrax if you are allergic to travoprost or any of the other ingredients of this medicine (listed in section 6).
Ask your doctor for advice if this applies to you.
Warning and precautions
Talk to your doctor or pharmacist before using Visutrax.
- Visutrax may increase the length, thickness, colour and/or number of your eyelashes.
Changes in the eyelids including unusual hair growth or in the tissues around the eye have also been observed.
- Visutrax may change the colour of your iris (the coloured part of your eye). This change may be permanent. A change in the colour of the skin around the eye may also occur.
- If you have had cataract surgery, talk to your doctor before you use Visutrax.
- If you have current or previous history of an eye inflammation (iritis and uveitis), talk to your doctor
before you use Visutrax.
- Visutrax may rarely cause breathing difficulties or wheezing or increase the symptoms of asthma. If you are concerned about changes in your breathing pattern when using Visutrax tell your doctor as soon as possible.
- Travoprost may be absorbed through the skin. If any of the medicinal product comes into contact with the skin, it should be washed off straight away. This is especially important in women who are pregnant or are attempting to become pregnant.
- If you wear soft contact lenses, do not use the drops with your lenses 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 for adults. Use of
Visutrax is not recommended to those children under 2 months of age.
Other medicines and Visutrax
Tell your doctor or pharmacist if you are using, have recently taken or used any other medicines.
Pregnancy and breast-feeding and fertility
If you are pregnant or breast-feeding, 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 Visutrax if you are pregnant
If you think that you may be pregnant speak with your doctor right away. If you could become pregnant you must use adequate contraception during treatment.
Do not use Visutrax if you are breast feeding.
Visutrax may get into your milk.
Ask your doctor for advice before taking any medicine
Driving and using machines
You may find that your vision is blurred for a time just after you use Visutrax. Do not drive or use machines until this symptom has worn off.
Visutrax contains
- Macrogolglycerolhydroxystearat which may cause skin reactions and irritation.
- Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards. Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.
3. how to use visutrax
Always use this medicine exactly as your doctor or pharmacist or doctor treating your child has told you. Check with your doctor, the doctor treating your child or pharmacist if you are not sure.
The recommended dose is
One drop in the affected eye or eyes, once a day – in the evening.
Only use Visutrax in both eyes if your doctor told you to. Use it for as long as your doctor or the doctor treating your child told you to.
Visutrax can only be used as eye drops.
Instructions for use:
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- Immediately before using a bottle for the first time, write the date of opening on the carton in the space provided
- Wash your hands
- Twist off the cap
- After the cap removal, if the protection ring is loose, remove it before using the medicine.
- Hold the bottle, pointing down, between your thumb and fingers.
- Tilt your head or your child’s head gently back. Pull down the eyelid with a clean finger, until there is a ‘pocket’ between the eyelid and the eye. The drop will go in here (picture 1).
- Bring the bottle tip close to the eye. Use a mirror if it helps.
- Do not touch the eye or eyelid, surrounding areas or other surfaces with the dropper. It could infect the drops.
- Gently squeeze the bottle to release one drop of Visutrax at a time (picture2).
- After using Visutrax, keep the eyelid closed, apply gentle pressure by pressing a finger into the corner of the eye, by the nose (picture 3) for at least 1 minute. This helps to stop Visutrax getting into the rest of the body.
- If you use drops in both eyes, repeat the steps for the other eye.
- Close the bottle cap firmly immediately after use.
- Only use one bottle at a time. Do not open the pouch until you need to use the bottle.
If a drop misses the eye, try again.
If you or your child are using other eye preparations such as eye drop or eye ointment, wait for at least 5 minutes between putting in Visutrax and the other eye preparations.
If you or your child receive more Visutrax than you should
Rinse all the medicine out with warm water. Don’t put in any more drops until it’s time for the next regular dose.
If you forget to use Visutrax
Continue the treatment with the next dose as planned.
Do not take a double dose to make up for a forgotten dose. Never use more than one drop in the affected eye(s) in a single day.
If you stop using Visutrax
If you have any further questions on the use of this medicine, ask your doctor, the doctor treating your child or pharmacist.
Do not stop using Visutrax without first speaking to your doctor or the doctor treating your child, the pressure in your eye or your child’s eye will not be controlled which could lead to loss of sight.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You can usually carry on using the drops, unless the side effects are serious.
If you’re worried, talk to a doctor or pharmacist. Do not stop taking Visutrax without speaking to your doctor.
The following side effects have been seen with Visutrax
Very common side effects: may affect more than 1 in 10 people
Effects in the eye : eye redness.
Common side effects: may affect up to 1 in 10 people
Effects in the eye : changes in the colour of the iris (coloured part of the eye), eye pain, eye discomfort, dry eye, itchy eye, eye irritation.
Uncommon side effects: may affect up to 1 in 100 people
Effects in the eye : corneal disorder, eye inflammation, iris inflammation, inflammation inside the eye, eye surface inflammation with/out surface damage, sensitivity to light, eye discharge, eyelid inflammation, eyelid redness, swelling around the eye, eyelid itching, blurred vision, increased tear production, infection or inflammation of the conjunctiva (conjunctivitis), abnormal turning outward of the lower eyelid, clouding of the eye, eyelid crusting, growth of eyelashes,.
General side effects : increased allergic symptoms, headache, dizziness, irregular heartbeat, shortness of breath, stuffy nose, throat irritation, darkening of skin around the eye (s), skin darkening, abnormal hair texture, excessive hair growth.
Rare: may affect up to 1 in 1,000 people
Effects in the eye : perception of flashing lights, eczema of the eyelids, abnormally positioned eyelashes that grow back toward the eye, eye swelling, reduced vision, halo vision, decreased eye sensation, inflammation of the glands of the eyelids, pigmentation inside the eye, increase in pupil size, eyelash thickening, change in eyelash colour, tired eyes.
General side effects : eye viral infection, dizziness, bad taste, irregular or decreased heart rate, increased or decreased blood pressure, shortness of breath, asthma, nasal allergy or inflammation, nasal dryness, voice changes, gastrointestinal discomfort or ulcer, constipation, dry mouth, redness or itching of the skin, rash, hair colour change, loss of eyelashes, joint pain, musculoskeletal pain, generalised weakness.
Not known: frequency cannot be estimated from the available data
Effects in the eye : inflammation of the back of the eye, eyes appear more inset.
General side effects : depression, anxiety, insomnia, sensation of false movement, ringing in ears, chest pain, abnormal heart rhythm, increased heart beat, worsening of asthma, diarrhea, nose bleeds, abdominal pain, nausea, vomiting, itching, abnormal hair growth, painful or involuntary urination, increase in prostate cancer marker.
In children and adolescents, the most common side effects seen with Visutrax are eye redness and growth of eyelashes. Both side effects were observed with a higher incidence in children and adolescents compared to adults.
Reporting of side effects
If you get any side effects, talk to your anaesthetist or other doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store 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 the box after “EXP”.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
You must throw away the bottle 4 weeks after you first opened it , to prevent infections, and use a new bottle. Write down the date you opened it in the space on the carton box.
After first opening of the bottle.store below 25°C.Do not throw away medicine via wastewater or in 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- the active substance is travoprost 40 micrograms/ml.
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– The other ingredients are: benzalkonium chloride, mannitol, trometamol macrogolglycerol hydroxystearate, boric acid, disodium edetate, water for injections.
What Visutrax looks like and contents of the pack
Visutrax is a liquid (a clear, colourless solution) supplied in a pack containing a 2.5 ml polyethylene bottle. Pack with 1 bottle.
Marketing Authorisation Holder and manufacturer:
Marketing Authorisation Holder
ALFRAPHARMA S.r.l.
Viale Manzoni 59
00185 Rome
Italy
Manufacturer
Genetic S.p.A.
Contrada Canfora, 84084 Fisciano (SA)
Italy
This medicinal product is authorised in the Member States of the EEA under the following names:
DE: VISUTRAX 40 Mikrogramm/ml Augentropfen, Losung im Einzeldosisbehaltnis
ES: VISUTRAX 40 microgramos/mL colirio en solucion
UK(NI): VISUTRAX 40 micrograms/mL eye drops, solution
This leaflet was last revised in May 2021
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