Brunitrav

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

BRUNITRAV 40 micrograms/ml eye drops, solution

(Travoprost)
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What BRUNITRAV is and what it is used for

BRUNITRAV contains travoprost, a substance belonging to a group of medicines called prostaglandin analogues. It works by lowering intraocular pressure. It can be used alone or in addition to other eye drops such as beta-blockers, which also reduce pressure.
BRUNITRAV eye drops are used to treat elevated intraocular pressure in adults. This pressure can lead to a condition called glaucoma.

2. What you need to know before using BRUNITRAV

Do not use BRUNITRAV:

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

Warnings and precautions
Talk to your doctor or pharmacist before using BRUNITRAV

• The use of BRUNITRAV is not recommended in individuals under 18 years of age. Consult your doctor if you belong to this age group.
• BRUNITRAV may increase the length, thickness, colour and/or number of your eyelashes and may cause unusual hair growth on your eyelids.
• BRUNITRAV may change the colour of your iris (the coloured part of the eye). This change may be permanent.
• BRUNITRAV may rarely cause breathing difficulties, shortness of breath or worsening of asthma symptoms. Inform your doctor immediately if you notice that using BRUNITRAV causes changes in your breathing.
• BRUNITRAV may be absorbed through the skin. If any amount of product comes into contact with the skin, wash immediately. This is particularly important for women who are pregnant or who are planning to become pregnant.

Children and adolescents
BRUNITRAV is not recommended for patients under 18 years of age.
Other medicines and BRUNITRAV
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use BRUNITRAV during pregnancy. Speak to your doctor immediately if you think you may be pregnant. If there is a possibility you could become pregnant, use an effective contraceptive method during treatment.
Breastfeeding
Do not use BRUNITRAV if you are breastfeeding, as BRUNITRAV may be excreted in breast milk.
Driving and use of machines
You may experience blurred vision for a period of time after using BRUNITRAV. Do not drive or operate machinery until these symptoms have resolved.
BRUNITRAV contains Benzalkonium chloride. It may cause ocular irritation. Benzalkonium chloride is known to discolor soft contact lenses. Avoid contact with soft contact lenses. Remove contact lenses before application and wait at least 15 minutes before reinserting them.

3. How to use BRUNITRAV

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The usual dose is 1 drop in the eye(s), once daily – in the evening.
BRUNITRAV may only be used as an eye drop.
Instructions for use

1. Before using this medicine for the first time, make sure the tamper-evident seal is intact and not broken.
2. Wash your hands and sit or stand in a comfortable position.
3. Unscrew the cap.
4. Remove the tamper-evident seal from the bottle.
5. Use your fingers to gently pull down the lower eyelid of the affected eye.

6. Position the tip of the bottle close to your eye or eyelid, taking care to avoid contact between the dropper tip and the eyelids, surrounding areas, or any other surfaces, due to the risk of contamination and serious eye infection.

7. Gently squeeze the bottle so that only one drop enters the eye, then release the lower eyelid.

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

8. After using BRUNITRAV, press with a finger on the inner corner of the eye near the nose for 2 minutes. This helps prevent BRUNITRAV from being absorbed into the rest of the body.

9. Repeat in the other eye if your doctor has instructed you to do so.
10. Replace the cap on the bottle.

The dispenser cap is designed to deliver a single drop; DO NOT enlarge the opening of the dispenser cap.
After dispensing all doses, a small amount of medicine will remain in the bottle. Do not worry, as an extra amount of BRUNITRAV has been added, and you have used the full amount prescribed by your doctor. Do not attempt to remove the excess medicine from the bottle.
If you use more BRUNITRAV than you should
immediately rinse your eye with lukewarm water. Do not use the eye drops again until it is time for your next dose.
If you forget to use BRUNITRAV
continue treatment with the next dose as scheduled. Do not take a double dose to make up for a missed one. Do not use more than one drop per day in each affected eye.
If you stop using BRUNITRAV
without talking to your doctor, intraocular pressure will not be controlled, which may lead to possible vision loss.
If you wear soft contact lenses. Do not use the eye drops while wearing your lenses. Wait 15 minutes after using the eye drops before reinserting your lenses.
If you are also using other eye drops, wait at least 5 minutes between instilling BRUNITRAV and the other drops.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, BRUNITRAV may cause side effects, although not everybody gets them.
You can generally continue using the drops, unless the side effects are severe. If you are concerned, consult your doctor or pharmacist. Do not stop treatment with BRUNITRAV without first discussing it with your doctor.

The following side effects have been reported with the use of the active substance in BRUNITRAV from clinical studies or during post-marketing experience:

Very common side effects (affect more than 1 in 10 users)
Eye disorders: Redness, changes in iris colour (the coloured part of the eye)

Common side effects (affect between 1 and 10 in 100 users)
Eye disorders: Intraocular inflammation, pain or swelling, irritation, discharge, light sensitivity, blurred, reduced or abnormal vision, dryness, itching, increased tearing, abnormal or reduced sensation; eyelid irritation, itching, redness, pain, swelling or crusting; changes in eyelash colour, increased or decreased growth or number of eyelashes.
General disorders: Headache, darkening of the skin around the eye(s).

Uncommon side effects (affect between 1 and 10 in 1,000 users)
Eye disorders: Inflammation or infection of the conjunctiva (conjunctivitis) or cornea, visual halos, corneal disorders, allergy, tired eyes, increased pupil size.
General disorders: Asthma, shortness of breath, increased or decreased blood pressure, irregular, reduced or increased heartbeat, dizziness, viral infection, cough, generalized weakness, worsening of allergy symptoms, throat irritation, nasal congestion, voice changes, gastrointestinal discomfort or ulcer, dry mouth, constipation, skin redness or itching, shoulder pain, bad taste.

Additional side effects reported include:
Eye disorders: Inflammation of the back of the eye, sunken eyes.
General disorders: Worsening of asthma, tinnitus (ringing in the ears), increased prostate-specific antigen.

If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. This includes any possible side effect not mentioned in this leaflet. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store BRUNITRAV

Keep this medicine out of the sight and reach of children.
Do not use BRUNITRAV after the expiry date stated on the bottle after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
To prevent infections, you must discard the bottle four weeks after first opening and must start using a new bottle.
Write the date of opening in the space provided on each bottle label and on the carton.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BRUNITRAV contains

• The active substance is travoprost 40 micrograms/ml.
• The other components are: Benzalkonium chloride, Macrogol-15-hydroxystearate, Tromethamine, Boric acid, Disodium EDTA, Mannitol, and Water for injections. Small amounts of hydrochloric acid or sodium hydroxide are added to adjust the pH.

Description of the appearance of BRUNITRAV and contents of the pack
BRUNITRAV is a liquid (a clear, colourless solution) contained in a 5 ml plastic dropper bottle with a white screw cap and a tamper-evident seal. Each bottle contains 2.5 ml of solution. BRUNITRAV is supplied in packs containing either 1 bottle or 3 bottles. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Bruschettini s.r.l., via Isonzo, 6 – 16147 Genova, Italy

Manufacturer
Rafarm S.A.
Thesi Pousi-Hatzi Agiou Louka, Paiania-Attiki, TK 19002, P.O. 37, Greece