Label: information for the user

Traglasin40 micrograms/mL eye drops in a single-dose container

travoprost

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 they are not listed in this label. See section 4.

Label contents

1. What it is and what it is used forTraglasin
2. What you need to know before starting to useTraglasin
3. How to useTraglasin
4. Possible adverse effects
5. Storage ofTraglasin
6. Container contents and additional information

Traglasincontains travoprost, which belongs to a group of medications called prostaglandin analogs. It works by reducing eye pressure.

Traglasin is used to reduce high eye pressure in adults, adolescents, and children aged 2 months and above. This pressure may lead to a condition called glaucoma.

This medication does not contain preservatives.

No useTraglasin

• If you are allergic to travoprost or any of the other components of this medication (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. It has also been observed that changes such as unusual hair growth on the eyelids or in the tissues around the eye may occur.
• Traglasin may alter the color of the iris (the colored part of the eye). This change may be permanent. It may also cause a change in the color of the skin around the eye.
• If you have undergone cataract surgery, consult your doctor before starting to use Traglasin.
• If you suffer or have previously suffered from eye inflammation (iritis and uveitis), consult your doctor before starting to use Traglasin.
• Traglasin may, 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 using Traglasin, consult your doctor as soon as possible.
• Travoprost may be absorbed through the skin. In case of contact with the medication, it must be removed by washing immediately. This is especially important in pregnant women or those 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 the lenses.

Children and Adolescents

Traglasin 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 Traglasin in children under 2 months of age.

Other Medications and Traglasin

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy, Breastfeeding, and Fertility

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

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 should use an appropriate contraceptive method while using Traglasin.

Breastfeeding

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

Consult your doctor before using any medication.

Driving and Operating Machines

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

Traglasin Contains Propylene Glycol

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

Traglasin Contains Hydroxyestearate of Macrogolglycerol

This medication may cause skin reactions because it contains hydroxyestearate of macrogolglycerol.

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

The recommended dose is

One drop in the affected eye or eyes, once a day - at night.

Traglasin should only be applied to both eyes if your doctor instructs you to do so. Follow the treatment for the entire period of time indicated by your doctor or the child's doctor.

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

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

1. Take a single-use vial from the strip.
2. Hold the single-use vial in a vertical position (with the cap facing upwards) and turn the cap until it comes loose.
3. Gently tilt the head or the child's head backwards. Gently pull the lower eyelid downwards to form a pouch, between the eyelid and the eye. Invert the single-use vial and press until a drop falls into the affected eye or eyes.
4. After using Traglasin, gently close your eyes, and with gentle pressure, press the edge of the eye, next to the nose for at least 1 minute. This helps to prevent Traglasin from passing into the rest of the body.
5. If drops are applied to both eyes, repeat the above steps for the other eye.
6. Dispose of the single-use vial after use, even if there is solution left inside.

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 applying Traglasin and the other eye medications.

If you or the child receive moreTraglasinthan you should

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

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

If you forgot to useTraglasin

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

If you interrupt the treatment withTraglasin

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

If you have any other questions about the use of this medication, ask your doctor, the child's doctor, or pharmacist.

Like all medicines, this medicine may 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 Traglasin without consulting your doctor.

The following side effects have been observed with travoprost.

Frequent 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:change 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 people

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, swelling around the eye, eyelid itching, blurred vision, increased tear production, conjunctivitis (infection or inflammation of the conjunctiva), abnormal outward turning of the lower eyelid, darkened vision, eyelid crusts, eyelash growth.

Other effects:increased allergic symptoms, headache, irregular heart rate, cough, stuffy nose, 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 grow towards 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:eye 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 in the ears, 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 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 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: https://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 sight and reach of children.

Dispose of the single-use packaging immediately after use.

Do not use this medication after the expiration date that appears on the single-use packaging, the bag, and the box after the expiration date (EXP). The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

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

Store the single-use packaging in the bag and the outer packaging to protect them from light.

Once the bag is opened, the single-use packaging must be used within 30 days.

Medications should not be thrown away through the drains or in the trash. Deposit the packaging and medications you do not need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you do not need. In this way, you will help protect the environment.

Composition of Traglasin

• The active principle is travoprost 40 micrograms/ml. One drop contains approximately 1.2 micrograms of travoprost.
• The other components are: propylene glycol (E1520), macrogol 40 hydroxy stearate, sodium chloride, mannitol (E421), boric acid (E284), sodium hydroxide and/or hydrochloric acid (to adjust the pH), and water for injection preparations.

Appearance of the product and contents of the packaging

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

Each pack contains 10 single-dose containers.

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

Only some container sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

OmniVision GmbH

Lindberghstrasse 9

82178 Puchheim

Germany

Manufacturer responsible

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

Last review date of this leaflet: February 2021

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)