Traglasin

Package leaflet: Information for the user

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

travoprost
equivalent medicine
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. 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 other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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. How to store Traglasin
6. Contents of the pack and other information

1. What Traglasin is and what it is used for

Traglasin contains travoprost, a substance belonging to a group of medicines called prostaglandin analogues. It works by lowering intraocular pressure. It can be used alone or in addition to other eye drops such as beta-blockers, which also help reduce 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).

In this case, consult your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before using Traglasin.

• Traglasin may increase the length, thickness, colour and/or number of your eyelashes. Changes to the eyelids or tissues around the eye, including abnormal hair growth, may also occur.
• Traglasin may change the colour of your iris (the coloured part of the eye). This change may be permanent. A change in the colour of the skin around the eye may also occur.
• If you have had cataract surgery, consult your doctor before using Traglasin.
• If you currently have or have previously had ocular inflammation (iritis or uveitis), consult your doctor before using Traglasin.
• Traglasin may rarely cause breathing difficulties, shortness of breath, or worsening of asthma symptoms. Inform your doctor immediately if you notice that using Traglasin causes changes in your breathing.
• Travoprost may be absorbed through the skin. If any amount of the medicine comes into contact with the skin, it should be washed off immediately. This is particularly important for women who are pregnant or who intend to become pregnant.
• If you wear soft contact lenses, do not use the eye drops while wearing the lenses. Wait 15 minutes after using the eye drops before reinserting the lenses.

Children and adolescents
Traglasin may be used in children from 2 months of age up to under 18 years of age at the same dose as adults. Use of Traglasin is not recommended in children below 2 months of age.
Other medicines and Traglasin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
Pregnancy
Do not use Traglasin if you are pregnant. Speak to your doctor immediately if you think you may be pregnant. If there is a possibility of becoming pregnant, use an effective contraceptive method during treatment.
Breastfeeding
Do not use Traglasin if you are breastfeeding. Traglasin may be excreted in breast milk.
Ask your doctor for advice before taking any medicine.
Driving and using machines
You may experience blurred vision for a period of time after using Traglasin. Do not drive or operate machinery until these symptoms have resolved.
Traglasin contains propylene glycol
Propylene glycol may cause skin reactions and irritation.
Traglasin contains hydrogenated castor oil
Hydrogenated castor oil may cause skin reactions and irritation.

3. How to use Traglasin

Use this medicine exactly as instructed by your doctor or paediatrician. If you
have any doubts, consult your doctor, paediatrician, or pharmacist.
The recommended dose is
One drop in the eye(s), once daily – in the evening.
Use Traglasin in both eyes only if prescribed by your doctor. Use the medicine for the length of time
recommended by your doctor or paediatrician.
Traglasin may only be used as an eye drop.
Wash your hands before use. Ensure the single-dose container is intact before use. The solution should be used immediately after opening. To avoid contamination, take care that the open end of the single-dose container does not touch the eye or any other surfaces.

1. Take a single-dose container from the pouch.
2. Hold the single-dose container vertically (with the cap facing upwards) and twist the cap.
3. Tilt the head backwards or gently tilt the child’s head backwards. Pull down the lower eyelid with a clean finger to form a "pocket" between the eyelid and the eye. Invert the single-dose container and gently squeeze to release one drop of eye drop into the eye(s) to be treated.
4. After using Traglasin, keep the eyes closed and apply gentle pressure with a finger at the inner corner of the eye, near the nose, for at least one minute. This helps prevent Traglasin from spreading into the rest of the body.
5. If using the eye drops in both eyes, repeat the steps for the other eye.
6. Discard the single-dose container immediately after use, even if some solution remains inside.

If a drop misses the eye, try again.
If you or the child are using other ophthalmic preparations such as drops or ointments,
wait at least 5 minutes between instilling Traglasin and the other preparations.
If you or the child use more Traglasin than you should
Rinse all the medicine away with lukewarm water. Do not use the eye drops until the next scheduled dose.
If you forget to use Traglasin
Continue treatment with the next dose as planned. Do not take a double dose to make up for a forgotten dose. Never use more than one drop per day per eye(s) affected.
If you stop using Traglasin
Do not stop treatment with Traglasin without first talking to your doctor or paediatrician, as intraocular pressure will not be controlled, possibly leading to vision loss.
If you have any doubts about how to use this medicine, consult your doctor, paediatrician, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
You can generally continue using the drops unless the side effects are severe.
If you are concerned, consult your doctor or pharmacist. Do not stop treatment with Traglasin without first talking to your doctor.
The following side effects have been observed with Traglasin:

Very common side effects: may affect more than 1 in 10 people
Eye effects: ocular redness

Common side effects: may affect up to 1 in 10 people
Eye effects: changes in iris colour (coloured part of the eye), eye pain, eye discomfort, dry eye, itchy eyes, eye irritation

Uncommon side effects: may affect up to 1 in 100 people
Eye effects: corneal pathology, eye inflammation, iris inflammation, intraocular inflammation, inflammation of the eye surface with or without surface damage, light sensitivity, eye discharge, eyelid inflammation, eyelid redness, swelling around the eye, eyelid itching, blurred vision, increased tearing, infection or inflammation of the conjunctiva (conjunctivitis), abnormal outward turning of the lower eyelid, eye cloudiness, crust formation on the eyelid, eyelash growth.

General side effects: worsening of allergy symptoms, headache, irregular heartbeat, cough, nasal congestion, throat irritation, darkening of the skin around the eye(s), skin darkening, abnormal hair structure, excessive hair growth.

Rare: may affect up to 1 in 1,000 people
Eye effects: perception of flashing lights, eyelid eczema, abnormally positioned eyelashes growing towards the eye, eye swelling, reduced vision, blurred vision with halos, decreased eye sensitivity, inflammation of the eyelid glands, pigmentation inside the eye, increased pupil size, eyelash thickening, change in eyelash colour, eye fatigue.

General side effects: viral eye infection, dizziness, unpleasant taste, irregular or slow heart rate, increased or decreased blood pressure, shortness of breath, asthma, nasal allergy or inflammation, dry nose, voice changes, gastrointestinal disorders or ulcer, constipation, dry mouth, skin redness or itching, skin rash, change in hair colour, eyelash loss, joint pain, musculoskeletal pain, generalized weakness.

Not known: frequency cannot be estimated from the available data
Eye effects: inflammation of the back of the eye, eyes appearing more sunken.

General side effects: depression, anxiety, insomnia, false sensation of movement, ringing in the ears, chest pain, abnormal heart rhythm, increased heart rate, worsening of asthma, diarrhoea, nosebleed, abdominal pain, nausea, vomiting, itching, abnormal hair growth, painful or involuntary urination, increase in prostate cancer marker.

In children and adolescents, the most commonly observed side effects with Traglasin have been ocular redness and eyelash growth. Both of these side effects have been observed with a higher incidence in children and adolescents compared to adults.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Traglasin

Keep this medicine out of the sight and reach of children.
After use, dispose of the single-dose container immediately.
Do not use this medicine after the expiry date which is stated on the single-dose container and on the carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
After opening the sachet: Do not store above 30°C.
Keep the single-dose containers in the sachet and outer packaging to protect them from light.
After opening the sachet, use the single-dose containers within 30 days.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Traglasin contains

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

Description of the appearance of Traglasin and contents of the pack
Traglasin is a clear, colourless solution supplied in single-dose containers made of plastic, each
containing 0.2 mL of solution.
Each sachet contains 10 single-dose containers.
Carton containing 30 (3x10), 60 (6x10) or 90 (9x10) single-dose containers.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder
OMNIVISION ITALIA S.r.l.
Via Montefeltro, 6
20156 Milano
Italy

Manufacturer
actrevo GmbH
Großer Burstah 25
20457 Hamburg
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
AT: Traglasin 40 Mikrogramm/ml Augentropfen, Lösung im Einzeldosisbehältnis
DE: Traglasin 40 Mikrogramm/ml Augentropfen, Lösung im Einzeldosisbehältnis
ES: Traglasin 40 microgramos/ml colirio en solución en envase unidosis
IT: Traglasin 40 microgrammi/ml collirio, soluzione, in contenitore monodose
FR: Traglasin 40 microgrammes/mL collyre en solution en récipient unidose