Rozatrav

Package Leaflet: Information for the User

Rozatrav, 40 micrograms/ml, eye drops, solution

Travoprost

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, 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, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the package leaflet

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

1. What is Rozatrav and what is it used for

Rozatrav eye drops are used to treat high pressure in the eye in adults, adolescents, and children from 2 months of age. This increased pressure can lead to the development of a disease called glaucoma.
High pressure in the eye.The eyes contain a clear, watery fluid that nourishes the inside of the eye. This fluid is constantly draining from the eye and being replaced by newly produced fluid. If the eye fills with fluid faster than it can drain from the inside of the eye, the pressure inside the eyeball increases. If it is too high, vision may be damaged.
Travoprost is one of a group of glaucoma medicines called prostaglandin analogues. Its effect is to increase the outflow of fluid, which reduces the pressure inside the eye. It can be used alone or with other medicines, such as beta-adrenergic blocking agents, which also reduce pressure.

2. Important information before using Rozatrav

When not to use Rozatrav:

• if you are allergic to travoprost or any of the other ingredients of this medicine (listed in section 6).

In this case, consult your doctor for advice.

Warnings and precautions

Before starting to use Rozatrav, discuss it with your doctor or pharmacist:

• Rozatrav may increase the length, thickness, color, and/or number of eyelashes. Changes in the eyelids, including excessive hair growth and tissue changes around the eye, have also been observed.
• Rozatrav may change the color of the iris (the colored part of the eye). The change may be permanent. It is also possible to change the color of the skin around the eye.
• If you have had cataract surgery, consult your doctor before starting to use Rozatrav.
• If you currently have or have had eye inflammation (inflammation of the iris and/or inflammation of the vascular membrane of the eye), consult your doctor before starting to use Rozatrav.
• Rozatrav may rarely cause shortness of breath, wheezing, or worsening of asthma symptoms. If you notice changes in breathing while using this medicine, inform your doctor immediately.
• Travoprost may be absorbed through the skin. If any amount of the medicine comes into contact with the skin, it should be rinsed off with water immediately. This is especially important in pregnant or breastfeeding women.

Children and adolescents

Rozatrav can be used in children from 2 months to <18 years of age at the same doses as in adults. use rozatrav children under 2 months is not recommended.< p>

Rozatrav and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have recently taken, as well as any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

Do not use Rozatrav if you are pregnant.If you suspect that you may be pregnant, inform your doctor. If there is a possibility that you may become pregnant, you should use appropriate methods of contraception during the use of this medicine.
Do not use Rozatrav during breastfeeding.Rozatrav may pass into breast milk.
If you are pregnant, breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

Driving and using machines

After using Rozatrav, vision may be blurred for a while. Do not drive or operate machinery until this effect has worn off.

Rozatrav contains benzalkonium chloride

Rozatrav contains 150 micrograms of benzalkonium chloride per milliliter of solution.
If you wear soft contact lenses:benzalkonium chloride may be absorbed by soft contact lenses and may cause discoloration. Before using the medicine, remove the contact lenses and wait 15 minutes after using the medicine before putting them back in.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye syndrome or corneal disorders (disorders of the transparent layer on the front of the eye). If you experience any abnormal sensation in the eye, stinging, or eye pain after using this medicine, consult your doctor.

Rozatrav contains macrogolglycerol hydroxystearate 40

This medicine contains macrogolglycerol hydroxystearate 40, which may cause skin reactions.

3. How to use Rozatrav

This medicine should always be used exactly as your doctor has told you. If you are not sure, ask your doctor.
Rozatrav is for use in the eye only.

Recommended dose

One drop into the affected eye or eyes, once a day -in the evening.
Rozatrav can be used in both eyes only if your doctor has recommended it. Use the medicine for as long as your doctor has told you.

1	Immediately before the first use of the bottle, tear off the protective bag (Figure 1). Remove the bottle and record the opening date in the space provided on the label. Take the bottle with the medicine and the mirror Wash your hands. Remove the cap.
2	Hold the bottle between your thumb and fingers, with the tip down. Tilt your head back. With a clean finger, pull the lower eyelid down to create a "pocket" between the eyeball and the eyelid. The drop should fall into this "pocket" (Figure 2). Bring the tip of the bottle close to the eye. You can use a mirror to help.
3	Do not touch the dropper to the eye, eyelid, or surrounding areas. This can lead to contamination of the drops. Gently squeeze the bottle to release a single drop of medicine (Figure 3). After using the medicine, press the corner of your eye near your nose for at least 1 minute (Figure 4). This will help prevent the medicine from entering the entire body.

4

If you are using drops in both eyes, repeat these steps for the other eye. Immediately after using the medicine, tighten the bottle cap. Only use one bottle at a time. Do not open the protective bag until you need to use the bottle. To prevent contamination of the bottle contents, after 4 weeks from the first opening, discard it and use a new one.

If the drop does not get into the eye,try again.

Using more Rozatrav than recommended

Flush the entire contents of the medicine from the eye with warm water. Do not give the next dose until the next scheduled dose.

Missing a dose of Rozatrav

Use the next dose at the planned time. Do notuse a double dose to make up for a missed dose. Never use more than one drop into the affected eye (or eyes) once a day.

Stopping the use of Rozatrav

Do not stop using this medicine without first talking to your doctor, as the pressure inside the eyeball of an adult or child will not be controlled, which can lead to loss of vision.

If you are using other eye medicines, such as eye drops or eye ointment

Wait at least 5 minutes between using Rozatrav and using other eye medicines.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In case of side effects, you can usually continue using the drops, unless the side effects are severe. If you are unsure, contact your doctor or pharmacist. Do not stop using Rozatrav without talking to your doctor.
The following side effects have been observed during the use of travoprost:

Very common (may affect more than 1 in 10 people):

• eye redness

Common(may affect up to 1 in 10 people)

• changes in iris color (the colored part of the eye)
• eye pain
• feeling of discomfort in the eye
• dry eye
• eye itching
• eye irritation

Uncommon(may affect up to 1 in 100 people):

• corneal disorders
• eye inflammation
• inflammation of the iris
• inflammation inside the eye
• inflammation of the eye surface with or without damage to the eye surface
• sensitivity to light
• eye discharge
• inflammation of the eyelids
• redness of the eyelids
• swelling around the eye
• itching of the eyelids
• blurred vision
• increased tear production
• infection or inflammation of the conjunctiva
• abnormal rolling of the lower eyelid
• eye clouding
• eyelid bumps
• excessive eyelash growth

General disorders:

• exacerbation of allergic symptoms
• headache
• irregular heartbeat
• cough
• stuffy nose
• throat irritation
• darkening of the skin around the eye (or eyes)
• skin darkening
• abnormal hair appearance
• excessive hair growth

Rare (may affect up to 1 in 1,000 people):

• flashing lights
• rash on the eyelids
• abnormally positioned eyelashes that grow towards the eye
• eye swelling
• limited vision
• halo effect
• reduced sensation in the eye
• inflammation of the eyelid glands
• discoloration of the inside of the eye
• pupil dilation
• thickening of the eyelashes
• change in eyelash color
• eye fatigue

General disorders:

• eye virus infection
• dizziness
• unpleasant taste in the mouth
• irregular or slow heartbeat
• increased or decreased blood pressure
• shallow breathing
• asthma
• allergic reaction of the nose or nasal membrane inflammation
• dryness of the nasal mucosa
• voice changes
• gastrointestinal discomfort or stomach ulcer
• constipation
• dry mouth
• skin redness or itching
• rash
• hair color changes
• eyelash loss
• joint pain
• musculoskeletal pain
• general weakness

Frequency not known(frequency cannot be estimated from the available data).

• inflammation of the back of the eye
• sunken eyeballs

General disorders:

• depression
• anxiety
• insomnia
• feeling of abnormal movement
• ringing in the ears
• chest pain
• abnormal heart rhythm
• rapid heartbeat
• worsening of asthma
• diarrhea
• nosebleeds
• abdominal pain
• nausea
• vomiting
• itching
• abnormal hair growth
• painful or involuntary urination
• increased prostate-specific antigen

The most common side effects observed during the use of travoprost in children and adolescents are eye redness and excessive eyelash growth. Both of these side effects are more common in children and adolescents compared to adults.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rozatrav

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 carton, after: EXP. The expiry date refers to the last day of the month stated.
Do not use this medicine if you notice that the protective seal has been broken or damaged before you first use it.
Store the bottle in the pouch to protect it from moisture.
There are no special storage instructions for the medicinal product.
There are no special storage instructions for the medicinal product after opening.
To prevent contamination of the bottle contents, after 4 weeks from the first opening, discard the bottleand use a new one. Record the opening date on the label of each bottle and on the carton.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Rozatrav contains

• The active substance is travoprost. This medicine contains 40 micrograms of travoprost per milliliter.
• The other ingredients are: benzalkonium chloride, solution, macrogolglycerol hydroxystearate 40, trometamol, disodium edetate, boric acid, mannitol, sodium hydroxide (to adjust pH), water for injections.
• The other ingredients are: benzalkonium chloride, solution, macrogolglycerol hydroxystearate 40, trometamol, disodium edetate, boric acid, mannitol, sodium hydroxide (to adjust pH), purified water.

What Rozatrav looks like and contents of the pack

Rozatrav is a clear, colorless solution, supplied in packs containing a semi-transparent bottle with a capacity of 5 ml, made of polypropylene (PP) with a transparent dropper made of low-density polyethylene (LDPE) and a cap made of white high-density polyethylene (HDPE) with a protective seal. The bottle is placed in a pouch.
The following pack sizes are available:
1, 3, or 4 bottles containing 2.5 ml of solution, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer

Pharmathen SA
Dervenakion 6
15351 Pallini Attiki
Greece
Balkanpharma-Razgrad AD
68 Aprilsko vastanie Blvd.
7200 Razgrad
Bulgaria
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
JADRAN - GALENSKI LABORATORIJ d.d.
Svilno 20,
Rijeka 51000
Croatia

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark
Rozatrav
Poland
Rozatrav
Slovakia
Rozatrav
Czech Republic
Rozatrav

Date of last revision of the leaflet: