TRAGLASIN 40 micrograms/ml eye drops solution in single-dose containers

Introduction

Package Leaflet: Information for the User

Traglasin40 micrograms/ml eye drops, solution in single-dose container

Travoprost

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

1. What is Traglasin and what is it used for

Traglasin 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 alone or with other eye drops, such as beta-blockers, which also reduce the pressure in the eye.

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

This medicine does not contain preservatives.

2. What you need to know before you use Traglasin

Do not useTraglasin

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

Consult your doctor if you are in this situation.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Traglasin.

• Traglasin 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.
• Traglasin may change the color of the iris (the colored part of the eye). This change may be permanent. It may also cause a change in skin color around the eye.
• If you have had cataract surgery, consult your doctor before starting to use Traglasin.
• If you have or have had eye inflammation (iritis and uveitis), consult your doctor before starting to use Traglasin.
• Traglasin 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 Traglasin, consult your doctor as soon as possible.
• Travoprost may be absorbed through the skin. In case of contact with the skin, the medicine should be removed by washing immediately. This is especially important in pregnant or breastfeeding women.
• If you wear soft contact lenses, do not apply the drops while wearing them. After applying the drops, wait 15 minutes before putting the lenses back in.

Children and adolescents

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

Other medicines and Traglasin

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 for advice before taking this medicine.

Pregnancy

Do not use Traglasin if you are pregnant. If you think you may be pregnant, tell your doctor immediately. If you can become pregnant, you must use an effective method of birth control while using Traglasin.

Breastfeeding

Do not use Traglasin if you are breastfeeding. Traglasin may pass into breast milk.

Consult your doctor before taking any medicine.

Driving and using machines

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

Traglasin contains propylene glycol

This medicine contains 7.5 mg of propylene glycol in each ml of solution. Propylene glycol may cause skin irritation.

Traglasin contains macrogolglycerol hydroxystearate

This medicine may cause skin reactions because it contains macrogolglycerol hydroxystearate.

3. How to use Traglasin

Follow exactly the instructions of administration of this medicine indicated by your doctor or the doctor treating the child. In case of doubt, consult your doctor, the doctor treating the child, or pharmacist again.

The recommended dose is

One drop in the affected eye(s) once a day, in the evening.

Traglasin should only be applied to both eyes if your doctor tells you to do so. Continue the treatment for the entire period of time indicated by your doctor or the doctor treating the child.

Traglasin should only be used as eye drops.

Wash your hands before using it. Make sure the single-dose container is intact before using this medicine. The solution should be used immediately after opening the container. To avoid contamination, do not let the tip of the single-dose container touch the eye or any other surface.

1. Take a single-dose container from the strip.
2. Hold the single-dose container in an upright position (with the cap facing up) and twist the cap until it comes off.
3. Tilt your head or the child's head gently backwards. Gently pull the lower eyelid down to form a pocket between the eyelid and the eye. Turn the single-dose container upside down and squeeze until one drop falls into the eye or eyes to be treated.
4. After using Traglasin, gently close your eyes and press the edge of the eye, next to the nose, with your finger for at least 1 minute. This helps prevent Traglasin from passing into the rest of the body.
5. If you are applying drops to both eyes, repeat the above steps for the other eye.
6. Discard the single-dose container after use, even if there is still solution inside.

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 Traglasin and the other eye medicines.

If you or the child receive more Traglasin than you/they should

You can flush it out with warm water. Do not apply more drops until the next dose is due.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Traglasin

Continue with the next dose that was scheduled. Do not apply a double dose to make up for the forgotten dose. Never apply more than one drop in the affected eye(s) in one day.

If you stop using Traglasin

Do not stop using Traglasin without consulting your doctor or the doctor treating the child first, as the pressure in your eye or the child's eye may 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 treatment as long as the side effects are not serious. If these effects worry you, talk to your doctor or pharmacist. Do not stop using Traglasin without talking to your doctor.

The following side effects have been observed with travoprost.

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, eye itching, eye irritation.

Uncommon side effects: may affect up to 1 in 100 people

Eye effects:corneal disorder, 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, eyelid itching, blurred vision, increased tear production, conjunctivitis (inflammation or infection of the conjunctiva), abnormal turning out of the lower eyelid, darkened vision, eyelid crusts, 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 side effects: may affect up to 1 in 1,000 people

Eye effects:flashes of light, eyelid eczema, abnormally positioned eyelashes growing inward toward the eye, eye swelling, reduced vision, halos around lights, 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 slow 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, muscle 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, feeling of false 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, increase in prostate cancer marker.

In children and adolescents, the most common side effects observed with travoprost 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Traglasin

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

Discard the opened single-dose container immediately after use.

Do not use this medicine after the expiry date which is stated on the single-dose container, the pouch, and the carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

After opening the pouch:do not store above 30°C.

Keep the single-dose containers in the pouch and outer packaging to protect them from light.

Once the pouch is opened, the single-dose containers should be used within 30 days.

Medicines should not be disposed of via wastewater or household waste. Place the containers and any unused medicines in the SIGRE collection point at your pharmacy. 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 Traglasin

• The active substance is travoprost 40 micrograms/ml. One drop contains approximately 1.2 micrograms of travoprost.
• The other ingredients are: propylene glycol (E1520), macrogolglycerol hydroxystearate 40, sodium chloride, mannitol (E421), boric acid (E284), sodium hydroxide and/or hydrochloric acid (for pH adjustment), water for injections.

Appearance and packaging

Traglasin is a clear and colorless solution supplied in plastic single-dose containers, each containing 0.2 ml of solution.

Each pouch contains 10 single-dose containers.

The carton contains 30 (3x10), 60 (6x10), or 90 (9x10) single-dose containers.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

OmniVision GmbH

Lindberghstrasse 9

82178 Puchheim

Germany

Manufacturer

Actrevo GmbH

Großer Burstah 25

20457 Hamburg

Germany

Local representative

OmniVision Farma España S.L.

C/ Josep Irla i Bosch, 1-3

Pl: 6 Pt: 2

08034 Barcelona

Spain

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

Date of last revision of this leaflet: February 2021

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es)