Traglasin 40 micrograms/ml eye drops solution in single-dose container

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Traglasin 40 micrograms/ml eye drops solution in single-dose container

travoprost

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents

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

1. What Traglasin is and what it is used for

Traglasin contains travoprost, which belongs to a group of medicines called prostaglandin analogues. It works by reducing pressure in the eye. It may be used alone or in combination with other eye drops, for example beta-blockers, which also reduce eye pressure.

Traglasin is used to reduce elevated intraocular pressure in adults, adolescents, and children from 2 months of age. This pressure can lead to a condition called glaucoma.

This medicine does not contain preservatives.

2. What you need to know before using Traglasin

Do not use Traglasin

• If you are allergic to travoprost or to 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 growth of hair on the eyelids or surrounding eye tissues 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 undergone cataract surgery, consult your doctor before starting to use Traglasin.
• If you currently have or have previously had eye inflammation (iritis and uveitis), consult your doctor before starting to use Traglasin.
• Traglasin may, in rare cases, cause shortness of breath, noisy breathing, or worsen 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. If the medicine comes into contact with the skin, it should be washed off immediately. This is especially important for women who are pregnant or trying to become pregnant.
• If you wear soft contact lenses, do not apply the drops while wearing them. After applying the drops, wait 15 minutes before reinserting your contact lenses.

Children and adolescents

Traglasin can be used in children from 2 months of age up to under 18 years of age at the same dose as in adults. The use of Traglasin is not recommended in children under 2 months of age.

Other medicines and Traglasin

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor before using any medicine.

Pregnancy

Do not use Traglasin if you are pregnant. If you think you might be pregnant, inform your doctor immediately. If you could become pregnant, you must use an appropriate method of contraception while taking Traglasin.

Breastfeeding

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

Consult your doctor before using any medicine.

Driving and using machines

Immediately after applying Traglasin, you may notice blurred vision. Do not drive or operate machinery until these effects have subsided.

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 macrogol glycerol hydroxystearate

This medicine may cause skin reactions because it contains macrogol glycerol hydroxystearate.

3. How to use Traglasin

Follow exactly the instructions for administration of this medicine given by your doctor or the doctor treating the child. If you have any doubts, consult your doctor, the child's treating doctor, or pharmacist again.

The recommended dose is

One drop in the affected eye or eyes, once daily – in the evening.

Traglasin should be applied to both eyes only if your doctor specifically instructs you to do so. Continue treatment for the entire duration prescribed by your doctor or the doctor treating the child.

Traglasin should only be used as eye drops for your eyes or for those of a child.

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 vertically (with the cap facing upwards) and twist the cap until it comes off.
3. Gently tilt the head or the child's head backwards. Gently pull down the lower eyelid to form a pouch between the eyelid and the eye. Invert the single-dose container and squeeze until one drop falls into the affected eye or eyes.
4. After applying Traglasin, close the eyes gently and softly press with a finger at the corner of the eye next to the nose for at least 1 minute. This helps prevent Traglasin from passing into the rest of the body.
5. If drops are being applied to both eyes, repeat the above steps for the other eye.
6. Discard the single-dose container after use, even if there is some solution remaining inside.

If a drop misses 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 applying Traglasin and the other eye medications.

If you or the child receive more Traglasindel than prescribed

You can remove it by rinsing the eyes with lukewarm water. Do not apply any more drops until the next scheduled dose.

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

If you forget to use Traglasin

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

If treatment with Traglasin is interrupted

Do not stop using Traglasin without first consulting your doctor or the doctor treating the child, as the pressure in your eye or in the child's eye will not be controlled, which could lead to vision loss.

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

You may continue treatment as usual unless the adverse effects are severe. If you are concerned about these effects, consult your doctor or pharmacist. Do not stop using Traglasin without consulting your doctor.

The following adverse effects have been observed with travoprost.

Very common adverse effects: may affect more than 1 in 10 people

Eye effects: eye redness.

Frequent adverse effects: may affect up to 1 in 10 people

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

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

Eye-related effects: corneal disorder, eye inflammation, iris inflammation, intraocular inflammation, eye inflammation with or without damage to the eye surface, light sensitivity, eye discharge, eyelid inflammation, eyelid redness, swelling around the eye, eyelid itching, blurred vision, increased tear production, conjunctival infection or inflammation (conjunctivitis), abnormally turned-out lower eyelid, darkened vision, eyelid crusting, eyelash growth.

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

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

Eye effects: perception of flashes of light, eyelid eczema, abnormally positioned eyelashes growing toward the inside of 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, eyelash thickening, change in eyelash color, tired eyes.

Other effects: viral infection in the eye, dizziness, bad taste in the mouth, 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, change in hair color, eyelash loss, joint pain, musculoskeletal pain, generalized 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 sensation 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 pain when urinating), increase in the prostate cancer marker.

In children and adolescents, the most frequently observed adverse effects with travoprost are eye redness and eyelash growth. Both of these adverse effects were observed with higher incidence in children and adolescents compared to adults.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, 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.

Immediately discard the single-dose container after use.

Do not use this medicine after the expiry date stated on the single-dose container, the bag, and the carton following the label (EXP). The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature.

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

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

Once the bag is opened, the single-dose containers must be used within 30 days.

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

6. Contents of the container 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 components are: propylene glycol (E1520), macrogolglycerol hydroxystearate 40, sodium chloride, mannitol (E421), boric acid (E284), sodium hydroxide and/or hydrochloric acid (to adjust pH), water for injections.

Appearance of the product and contents of the pack

Traglasin is a clear, colourless solution supplied in single-dose plastic 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.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsibility

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

Floor: 6, Door: 2

08034 Barcelona

Spain

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

Date of the last review of this leaflet: February 2021

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