Vizitrav

Package leaflet: Information for the user

Vizitrav, 40 micrograms/ml, eye drops, solution
Trawoprost
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Vizitrav is and what it is used for
2. Important information before using Vizitrav
3. How to use Vizitrav
4. Possible side effects
5. How to store Vizitrav
6. Contents of the pack and other information

1. What Vizitrav is and what it is used for

Vizitrav contains trawoprost, a medicine belonging to a group called prostaglandin analogues. It works by reducing intraocular pressure. Vizitrav may be used alone or in combination with other eye drops, such as beta-adrenergic receptor blocking agents, which also reduce intraocular pressure.
Vizitrav is used to reduce elevated intraocular pressure in adults, adolescents, and children from the age of 2 months. This pressure may lead to the development of a disease called glaucoma.
Vizitrav eye drops, solution, is a sterile solution that does not contain preservatives.

2. Important information before using Vizitrav

When not to use Vizitrav

• If the patient is allergic to travoprost or any of the other ingredients of this medicine (listed in section 6).

In such a case, consult a doctor for advice.
Warnings and precautions
Before starting to use Vizitrav, discuss it with your doctor or pharmacist.

• Vizitrav may increase the length, thickness, pigmentation, and (or) number of eyelashes. Changes in the eyelids have also been observed, including excessive hair growth and changes affecting tissues around the eye.
• Vizitrav may change the colour of the iris (the coloured part of the eye). This change may be permanent. A change in skin colour around the eye may also occur.
• If the patient has undergone cataract surgery, consult a doctor before starting treatment with Vizitrav.
• If the patient currently has or has previously had inflammation of the eye (iritis or uveitis), consult a doctor before starting treatment with Vizitrav.
• Vizitrav may rarely cause shortness of breath, wheezing, or worsening of asthma symptoms. If any breathing changes occur while using Vizitrav, inform the doctor immediately.
• Travoprost may be absorbed through the skin. If any amount of the medicine comes into contact with the skin, wash it off immediately with water. This is particularly important for women who are pregnant or planning to become pregnant.
• If the patient wears soft contact lenses – do not use the medicine while wearing them. After instilling the drops, wait 15 minutes before reinserting the lenses.

Children and adolescents
Vizitrav may be used in children aged 2 months to under 18 years at the same dosage as in adults. Use of Vizitrav in children below 2 months of age is not recommended.
Vizitrav with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Pregnancy, breastfeeding and fertility
Women who are pregnant must not use Vizitrav. If the patient suspects she may be pregnant, she should inform her doctor. Women of childbearing potential must use appropriate contraceptive methods during treatment with this medicine.
Vizitrav must not be used during breastfeeding. Vizitrav may pass into breast milk.
Before taking any medicine, consult a doctor.
Driving and using machines
After instilling Vizitrav, vision may be blurred for a short time. Until these symptoms resolve, the patient should not drive or operate machinery.
Vizitrav contains macrogolglycerol hydroxystearate 40
This medicine contains macrogolglycerol hydroxystearate 40, which may cause skin reactions.

3. How to use Vizitrav

This medicine should always be used as directed by the doctor or paediatrician, or pharmacist.
If in doubt, consult the doctor, paediatrician, or pharmacist.
The recommended dose is one drop into the affected eye or eyes, once daily in the evening.
Vizitrav may be used in both eyes only if so directed by the doctor.
Use this medicine for as long as advised by the doctor or paediatrician.
Vizitrav is for ocular instillation in the patient's or child's eye only.
Instructions for use

1a 1b	Remove the multi-dose bottle (Figure 1a) from the cardboard packaging and record the date of opening in the space provided on the box. Take the medicine bottle and a mirror. Wash your hands. Unscrew the cap (Figure 1b).
2	Hold the bottle upside down, placing your thumb on the upper part of the bottle and the remaining fingers under the bottom. Before first use, press the bottle 15 times (Figure 2). A possible whitish appearance of the drops should not be a cause for concern.
3	Tilt the head or child's head backward. With a clean finger, gently pull the lower eyelid downward to form a "pocket" between the eyeball and the eyelid. The drop should be instilled into this "pocket" (Figure 3). Bring the dropper tip close to the eye. A mirror may be used to assist.
4 5	Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the dropper tip, as this may lead to contamination of the drops. Gently squeeze the bottom of the bottle to release a single drop of medicine (Figure 4). If the drop misses the eye, repeat the procedure. After instilling the drop, keep the eyelid closed and gently press with a finger on the inner corner of the eye near the nose (Figure 5) for at least 1 minute. This helps prevent the medicine from draining into the rest of the body.
	If drops are to be administered to both eyes, repeat the above steps for the second eye. Immediately after use, replace and tightly close the cap. Use only one bottle at a time. Do not unscrew the cap until ready to use the bottle. Discard the bottle 4 weeks after first opening to prevent infection, and use a new bottle.

If the adult patient or child is using other eye medications,
such as eye drops or eye ointment, a minimum interval of 5 minutes should be maintained between
instillation of Vizitrav and application of other eye medications.
Accidental administration of a higher than recommended dose of Vizitrav
The eye should be irrigated thoroughly with lukewarm water. Do not instill further drops until the
next scheduled dose is due.
Missed dose of Vizitrav
Apply the next dose at the scheduled time. Do not use a double dose
to make up for a missed dose. Never use more than one drop in the affected eye(s) once daily.
Discontinuation of Vizitrav
Do not stop using Vizitrav without first consulting your doctor or the child's doctor, as intraocular pressure in the adult patient or child will no longer be controlled, which may lead to vision loss.
If you have any further questions regarding the use of this medicine, consult your doctor, the child's doctor, or pharmacist.

4. Possible adverse reactions

Like any medicine, this product may cause adverse reactions, although not everyone experiences them.
Usually, you can continue using the drops unless the adverse reactions are severe. If you have any concerns,
contact your doctor or pharmacist. Do not stop using Vizitrav without consulting your doctor.

The following adverse reactions have been observed during the use of travoprost.

Very common adverse reactions (may affect more than 1 in 10 people)
Eye-related reactions:

• eye redness

Common adverse reactions (may affect less than 1 in 10 people)
Eye-related reactions:

• changes in iris colour (coloured part of the eye)
• eye pain
• eye discomfort
• dry eye
• itchy eye
• eye irritation

Uncommon adverse reactions (may affect less than 1 in 100 people)
Eye-related reactions:

• corneal disorders
• eye inflammation
• iritis (inflammation of the iris)
• intraocular inflammation
• conjunctival inflammation with or without corneal surface damage
• light sensitivity
• eye discharge
• eyelid inflammation
• eyelid redness
• swelling around the eye
• itchy eyelids
• blurred vision
• increased tear production
• conjunctival infection or inflammation
• abnormal lower eyelid eversion
• eye cloudiness
• lumps on the eyelids
• excessive eyelash growth

General reactions:

• worsening of allergic symptoms
• headache
• irregular heartbeat
• cough
• nasal congestion
• sore throat
• darkening of the skin around the eye(s)
• skin darkening
• abnormal hair appearance
• excessive hair growth

Rare adverse reactions (may affect less than 1 in 1,000 people)
Eye-related reactions:

• perception of flashing lights
• eyelid rash
• misdirected eyelashes growing towards the eye
• eye swelling
• reduced visual acuity
• halo vision
• decreased eye sensation
• inflammation of eyelid glands
• pigmentation inside the eye
• pupil dilation
• eyelash thickening
• change in eyelash colour
• eye fatigue

General reactions:

• viral eye infection
• dizziness
• unpleasant taste in mouth
• irregular or slow heartbeat
• increased or decreased blood pressure
• shallow breathing
• asthma
• allergy or nasal mucosal inflammation
• dry nasal mucosa
• voice changes
• gastrointestinal discomfort or peptic ulcer
• constipation
• dry mouth
• skin redness or itching
• rash
• hair pigmentation changes
• eyelash loss
• joint pain
• muscle and skeletal pain
• generalized weakness

Frequency not known (frequency cannot be estimated from available data)
Eye-related reactions:

• posterior segment inflammation of the eye
• enophthalmos (sunken eyeballs)

General reactions:

• depression
• anxiety
• insomnia
• sensation of abnormal movement
• tinnitus (ringing in the ears)
• chest pain
• irregular heartbeat
• rapid heartbeat
• asthma exacerbation
• diarrhoea
• nosebleeds
• abdominal pain
• nausea
• vomiting
• itching
• abnormal hair growth
• painful or involuntary urination
• increased prostate-specific antigen (PSA) levels

Additional adverse reactions in children and adolescents
The most common adverse reactions observed in children and adolescents during treatment with travoprost were eye redness and excessive eyelash growth. Both of these adverse reactions were observed more frequently in children and adolescents compared to adults.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49-21-301
Fax: +48 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Vizitrav

Keep this medicine out of the sight and reach of children.
Do not use Vizitrav after the expiry date stated on the label and carton after "Exp". The expiry date refers to the last day of the stated month.
Do not use this medicine if, prior to first opening, you notice that the bottle is damaged or broken.
Before opening: Store below 25 °C.
No special storage instructions apply after first opening.
The bottle should be discarded 28 days after first opening to prevent infections. The date of first opening should be recorded in the designated space on the label of each bottle and on the carton.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Vizitrav contains

• The active substance is travoprost 40 micrograms/ml.
• The other ingredients are: macrogolglycerol hydroxystearate 40, boric acid, mannitol (E421), sodium chloride, propylene glycol, sodium hydroxide, and purified water.

What Vizitrav looks like and contents of the pack
A multidose container made of PP with a pump (made of PP, HDPE, LDPE) and a cap made of HDPE, placed in a pressurized cylinder. The whole is contained in a cardboard box.
Vizitrav, eye drops, solution is available in the following pack sizes:
1 x 2.5 ml (single multidose container containing 2.5 ml of solution)
3 x 2.5 ml (three multidose containers containing 2.5 ml of solution)
4 x 2.5 ml (four multidose containers containing 2.5 ml of solution).
Cardboard boxes containing 1 or 3 bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Bausch + Lomb Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer:
JADRAN - GALENSKI LABORATORIJ d.d.
Svilno 20
51000 Rijeka
Croatia

PHARMATHEN S.A.
Dervenakion 6
15351 Pallini Attikis
Greece

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria Vizitrav 40 Mikrogramm/ml Augentropfen, Lösung
Belgium Vizitrav 40 microgram/ml oogdruppels, oplossing
Bulgaria Vizitrav 40 μg/ml капки за очи, разтвор
Cyprus Vizitrav Oφθαλμικές σταγόνες διάλυμα 40 µg/ml
Croatia Vizitrav 40 mikrograma/ml, kapi za oko, otopina
Denmark Vizitrav 40 micrograms/ml, eye drops, solution (øjendråber, opløsning)
Estonia Vizitrav 40 mikrogrammi/ml silmatilgad, lahus
France Vizitrav, 40 microgrammes/ml, solution eye drops
Greece Vizitrav 40 μικρογραμμάρια/ml οφθαλμικές σταγόνες, διάλυμα
Spain Vizitrav 40 μg/ml, colirio en solución
Netherlands Vizitrav 40 microgram/ml oogdruppels, oplossing
Lithuania Vizitrav 40 mikrogramų/ml akių lašai (tirpalas)
Luxembourg Vizitrav 40 microgrammes/ml collyre en solution
Germany Vizitrav 40 Mikrogramm/ml Augentropfen, Lösung
Poland Vizitrav 40 mikrogramów/ml, krople do oczu, roztwór
Portugal Vizitrav 0.04 mg/ml colírio, solução