TRAVOPROST ABAMED 40 MICROGRAMS/ML EYE DROPS IN SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Travoprost Abamed40 micrograms/ml eye drops, solution

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this 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 signs of illness are the same as yours.
• 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.

Contents of the pack

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

1. What is Travoprost Abamed and what is it used for

Travoprost Abamed contains travoprost, which belongs to a group of medicines called prostaglandin analogues. It works by reducing the pressure in the eye. It can be used on its own or with other eye drops, such as beta-blockers, which also reduce the pressure in the eye.

Travoprost Abamed is used to reduce high pressure in the eye in adults, adolescents, and children from 2 months of age. High pressure can lead to an illness called glaucoma.

2. What you need to know before you use Travoprost Abamed

Do not useTravoprost Abamed:

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

Talk to your doctor if you are in this situation.

Warnings and precautions

• Travoprost Abamed may increase the length, thickness, color, and/or number of your eyelashes. Changes such as unusual hair growth on the eyelids or around the eye have also been observed.
• Travoprost Abamed may change the color of your iris (the colored part of your eye). This change may be permanent. Changes such as unusual hair growth on the eyelids or around the eye have also been observed.
• If you have had cataract surgery, talk to your doctor before using Travoprost Abamed.
  • If you have or have had inflammation of the eye (iritis and uveitis), talk to your doctor before using Travoprost Abamed.

• Travoprost Abamed may, in rare cases, cause shortness of breath or wheezing, or increase asthma symptoms. If you are concerned about changes in your breathing while using Travoprost Abamed, talk to your doctor as soon as possible.

• Travoprost can be absorbed through the skin. In case of contact with the skin, the medicine should be washed off immediately. This is especially important in pregnant or breastfeeding women.

Children and adolescents

Travoprost Abamed can be used in children from 2 months of age to less than 18 years with the same dose as in adults. The use of Travoprost Abamed is not recommended in children under 2 months of age.

Other medicines and Travoprost Abamed

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

Do not use Travoprost Abamed if you are pregnant. If you think you might be pregnant, talk to your doctor immediately. If you could become pregnant, you must use an effective contraceptive method while using Travoprost Abamed.

Breastfeeding

Do not use Travoprost Abamed if you are breastfeeding, as travoprost may pass into breast milk.

Talk to your doctor before using any medicine.

Driving and using machines

Immediately after applying Travoprost Abamed, you may notice that your vision becomes blurred. Do not drive or use machines until these effects have disappeared.

Travoprost Abamed contains benzalkonium chloride.

This medicine contains 0.375 mg of benzalkonium chloride in each 2.5 ml bottle, equivalent to 0.150 mg/ml.

Benzalkonium chloride can be absorbed by soft contact lenses and may alter their color. Remove contact lenses before using this medicine and wait 15 minutes before putting them back.

Benzalkonium chloride may cause eye irritation, especially if you have dry eyes or other corneal diseases. Talk to your doctor if you feel any unusual sensation, itching, or pain in the eye after using this medicine.

3. How to use Travoprost Abamed

Follow exactly the instructions of your doctor or the doctor treating the child. If you are in doubt, talk to your doctor or the doctor treating the child or pharmacist again.

The recommended dose is 1 drop in the affected eye(s) once daily, in the evening.

Travoprost should only be applied to both eyes if your doctor has told you to do so. Continue the treatment for the entire period of time prescribed by your doctor or the doctor treating the child.

Travoprost should only be used as eye drops.

Instructions for use

1. Before using this medicine for the first time, make sure the safety ring is not broken.
2. Wash your hands and sit or stand comfortably.
3. Remove the cap.
4. Remove the safety ring from the container.

5. Hold the bottle, upside down, between your fingers. Tilt your head or the child's head gently backwards. Gently separate the lower eyelid from the eye to form a pouch, into which the drop should fall

1. Bring the tip of the bottle close to the eye. You may find it helpful to use a mirror.

1. Gently squeeze the bottle until one drop falls into the eye, then release the lower eyelid. Do not touch the eye, eyelid, or surrounding areas with the dropper, as the drops may become infected.

If a drop falls outside the eye, try again.

1. Squeeze the bottle gently to release one drop of travoprost at a time.

1. After using travoprost, gently close your eyes and press the edge of your eye, next to your nose, for at least 1 minute. This helps prevent travoprost from passing to the rest of the body.

1. Repeat in the other eye if your doctor has told you to do so.
2. Close the bottle tightly immediately after use.
3. Use one bottle at a time. Do not open the bag until you need to use the bottle.

If a drop falls outside the eye, try again.

If you or the child are using other eye medicines, such as eye drops or ointments, wait at least 5 minutes between applying travoprost and the other eye medicines.

If you or the child get more Travoprost Abamed than you/they should

It can be washed out with warm water. Do not apply more drops until it is time for the next dose.

If you forget to usetravoprost, continue with the next dose as planned. Do not apply a double dose to make up for the forgotten dose. Never apply more than 1 drop in the affected eye(s) in a single day.

If you stop usingtravoprost without consulting your doctor or the doctor treating the child, the pressure in your eye or the child's eye will not be controlled, which could lead to loss of vision.

If you have any further questions on the use of this medicine, ask your doctor, the doctor treating the child, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You can normally continue your treatmentunless the side effects are serious. If these effects worry you, talk to your doctor or pharmacist. Do not stop using Travoprost Abamed without talking to your doctor.

The following side effects have been observed with Travoprost Abamed:

Very common side effects

(May affect more than 1 in 10 people)

Eye effects:eye redness

Common side effects

(May affect up to 1 in 10 people)

Eye effects:changes in iris color (the colored part of the eye), eye pain, eye discomfort, dry eye, itching in the eye, eye irritation.

Uncommon side effects

(May affect up to 1 in 100 people)

Eye effects:corneal disturbance, eye inflammation, iris inflammation, inflammation inside the eye, inflammation with or without damage to the eye surface, sensitivity to light, eye discharge, eyelid inflammation, eyelid redness, swelling around the eye, itching of the eyelid, blurred vision, increased tear production, conjunctivitis (inflammation or infection of the conjunctiva), abnormal turning out of the lower eyelid, darkened vision, crusts on the eyelid, eyelash growth.

Other effects:increased allergic symptoms, headache, irregular heartbeat, cough, stuffy nose, sore throat, darkening of the skin around the eyes, darkening of the skin, abnormal hair texture, excessive hair growth.

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

Eye effects:flashes of light, eyelid eczema, abnormally positioned eyelashes growing inwards towards the eye, eye swelling, reduced vision, visual halos, decreased sensation in the eye, inflammation of the eyelid glands, pigmentation inside the eye, increased pupil size, thickening of the eyelashes, change in eyelash color, tired eyes.

Other effects:viral eye infection, dizziness, bad taste, irregular or decreased heartbeat, increased or decreased blood pressure, shortness of breath, asthma, nasal inflammation or allergy, nasal dryness, voice changes, gastrointestinal ulcer or discomfort, constipation, dry mouth, skin redness or itching, rash, change in hair color, loss of eyelashes, joint pain, musculoskeletal pain, general weakness.

Frequency not known: cannot be estimated from the available data

Eye effects:inflammation of the back of the eye, sunken eyes.

Other effects:depression, anxiety, insomnia, false sense of movement, ringing in the ears, chest pain, irregular heartbeat, increased heart rate, worsening of asthma, diarrhea, nosebleeds, abdominal pain, nausea, vomiting, itching, abnormal hair growth, painful or involuntary urination (painful or involuntary urination), increased prostate cancer marker.

In children and adolescents, the most common side effects observed with Travoprost Abamed are eye redness and eyelash growth. Both side effects were observed with a higher incidence in children and adolescents compared to adults.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency's website www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Travoprost Abamed

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 carton after “EXP”. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

To avoid infections, you must discard the bottle 4 weeks after first openingand use a new bottle. Write the date of opening on the spaces provided on the label of each bottle and carton.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Travoprost Abamed

• The active substance is travoprost 40 micrograms/ml.
• The other ingredients are: benzalkonium chloride, macrogol-15-hydroxystearate, trometamol, boric acid, disodium edetate, mannitol, and water for injections. Small amounts of hydrochloric acid or sodium hydroxide are added to adjust the pH.

Appearance and packaging of the product

Travoprost Abamed is a clear, colorless liquid (solution) in a 5 ml plastic dropper bottle with a white screw cap and a safety ring. Each bottle contains 2.5 ml of solution. Travoprost Abamed is available in packs of 1 or 3 bottles. Not all pack sizes may be marketed.

Marketing authorisation holder

Qualix Pharma, S.L.

C/Botánica 137-139

08908 L’Hospitalet de Llobregat

(Barcelona),

Spain

Manufacturer

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

Date of last revision of this leaflet: March 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS)

http://www.aemps.gob.es/