PATIENT INFORMATION LEAFLET

Travoprost Abamed40 micrograms/mL eye drops solution

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

- Keep this leaflet, as 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 they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4

1. What isTravoprost Abamedand what is it used for

2. What you need to know before starting to useTravoprost Abamed

3. How to useTravoprost Abamed

4. Possible side effects

5. Storage ofTravoprost Abamed

6. Contents of the pack and additional information

Travoprost Abamedcontains travoprost, which is part of a group of medications called prostaglandin analogs. It works by reducing eye pressure.

Travoprost Abamedis used to reduce elevated eye pressurein adults, adolescents, and children aged 2 months and older. Elevated eye pressure can lead to a condition called glaucoma.

No useTravoprost Abamed:

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

Consult your doctor if you are in this situation.

Warnings and precautions

-Travoprost Abamedmay increase the length, thickness, color, and/or number of your eyelashes. It has also been observed that changes such as unusual hair growth on the eyelids or in the tissues around the eye may occur.

-Travoprost Abamedmay alter the color of the iris (the colored part of the eye). This change may be permanent. It has also been observed that changes such as unusual hair growth on the eyelids or in the tissues around the eye may occur.

-If you have undergone cataract surgery, consult your doctor before starting to use Travoprost Abamed.

-Travoprost Abamedmay, in rare cases, cause shortness of breath or noisy breathing or increase the symptoms of asthma. If you are concerned about changes in your breathing while usingTravoprost Abamedconsult your doctor as soon as possible.

- Travoprost can be absorbed through the skin. In the event of contact with the medication on the skin, it should be removed by washing immediately. This is especially important in pregnant women or those trying to become pregnant.

Children and adolescents

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

Other medications andTravoprost Abamed

Inform your doctor or pharmacist if you are using or have recently usedor could have to use any othermedications.

Pregnancy, breastfeedingand fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not useTravoprost Abamedif you are pregnant. If you think you may be pregnant, consult your doctor immediately. If you could become pregnant, you should use an appropriate contraceptive method while usingTravoprost Abamed.

Breastfeeding

Do not useTravoprost Abamedif you are breastfeeding,Travoprost Abamedmay pass into breast milk.

Consult your doctor before using any medication.

Driving and operating machinery

Immediately after applyingTravoprost Abamedyou may notice that your vision becomes blurry. Do not drive or use machinery until these effects have disappeared.

Travoprost Abamed contains benzalkonium chloride.

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

Benzalkonium chloride can be absorbed by soft contact lenses and may alter the color of contact lenses. Remove contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other

corneal diseases (transparent layer of the front of the eye). Consult your doctor if you feel a strange sensation, burning, or pain in the eye after using this medication.

Follow exactly the administration instructions of this medication indicated by your doctororthe doctor treating the child. In case of doubt, consult your doctor again orthe doctor treating the childor pharmacist.

The recommended dose is 1 drop in the affected eye or eyes, once a day-at night.

This medication should only be applied to the two eyes if your doctor indicates so. Follow the treatment for the entire period of time indicated by your doctor or the doctor treating the child.

Travoprost should only be used as eye drops for your eyes or the child's eyes.

Usage Instructions

1. Before using this medication 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. Gently tilt your head or the child's head back. Gently separate the eyelid from the eye with a finger, until a pouch forms, in which the drop should fall

6.Bring the tip of the bottle close to the eye. It may be helpful to use a mirror.

7.Press the bottle gently so that only one drop enters the eye, and then release the lower eyelid.Do not touch the eye, eyelid, nearby areas or other surfaces with the dropper,because the drops could become infected

If a drop falls outside the eye, try again.

8.Press the bottle gently so that a drop of travoprost falls each time.

9. After using travoprost,close your eyes gently,gently press with your finger the edge of the eye, next to the nosefor at least 1minute. This helps to prevent travoprost from passing into the rest of the body.

10. Repeat in the other eye if your doctor has indicated so.

11.Close the bottle tightly immediately after using the product.

12.Use a single bottle at a time. Do not open the pouch 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 medications, such as eye drops or eye ointments, wait at least 5 minutes between the application of travoprost and the other eye medications.

If you or the child receive more Travoprost Abamed than you should

You can remove it by washing the eyes with warm water. Do not apply more drops until the next scheduled dose.

If you forgot to usetravoprost, continue with the next scheduled dose. Do not apply a double dose to compensate for the missed dose. Never apply more than 1 drop in the affected eye(s) in a single day.

If you interrupt the treatment withtravoprostwithout 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 cause vision loss.

If you have any other doubts about the use of this medication, ask your doctor,the doctor treating the childor pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

You can continue with the treatment unless the side effects are severe. If these side effects concern you, consult your doctor or pharmacist. Do not stop applying Travoprost Abamed without consulting your doctor.

With Travoprost Abamed, the following side effects have been observed:

Frequent side effects

(May affect more than 1 in 10 patients)

Eye effects:eye redness

Common side effects

(May affect up to 1 in 10 patients)

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

Uncommon side effects

(May affect up to 1 in 100 patients)

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

Other effects:increased allergic symptoms, headache, irregular heart rate, cough, nasal congestion, throat irritation, darkening of the skin around the eyes, skin darkening, abnormal hair texture, excessive hair growth.

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

Eye effects::perception of light flashes, eyelid eczema, eyelashes abnormally positioned that growinto the eye, eye swelling, reduced vision, halo vision, decreased eye sensation, eyelid gland inflammation, pigmentation within the eye, increased pupil size, eyelash thickening, change in eyelash color, tired eyes.

Other effects:ocular viral infection, dizziness, bad taste, irregular or decreased heart rate, increased or decreased blood pressure, shortness of breath, asthma, nasal inflammation or allergy, dry nose, voice changes, gastrointestinal ulcer or discomfort, constipation, dry mouth, skin redness or itching, rash, hair color change, eyelash loss, joint pain, muscle and skeletal pain, generalized weakness.

Unknown frequency: cannot be estimated from available data

Eye effects:posterior eye inflammation, sunken eyes.

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

In children and adolescents, the most frequent 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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the reach and sight of children.

Do not use this medication after the expiration date that appears on the bottle and on the box, after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

To avoid infections,you must discard the bottle 4 weeks after opening it for the first time, and use a new bottle. Note the opening date in the reserved spaces on the label of each bottle and on the box.

Medications should not be thrown down the drains or in the trash. Dispose of the containers and the

medications you do not need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and the medications you do not need. In this way, you will help protect the environment.

Composition ofTravoprost Abamed

- The active ingredient is travoprost 40 micrograms/ml.

-The other components are:Sodium chloride, macrogol-15-hydroxystearate, trometamol, boric acid, disodium EDTA, mannitol, and water for injection preparations. Small amounts of hydrochloric acid or sodium hydroxide are added to adjust the pH.

Appearance of the product and contents of the packaging

Travoprost Abamedis a liquid (a clear, colorless 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 Abamedis presented in a packaging of 1 bottle or three bottles. Only some packaging sizes may be commercially available.

Marketing Authorization Holder.

Qualix Pharma, S.L.

C/Botánica 137-139

08908 L’Hospitalet de Llobregat

(Barcelona),

Spain

Responsible for manufacturing

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

Last review date of this leaflet: March 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

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