TRAGLASIN 40 MICROGRAMMI/ML Eye drops, solution

Зміст інструкції

1. Traglasin 40 micrograms/ml eye drops, solution, in single-dose container
   1. What is Traglasin 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

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

travoprost
equivalent medicine

Read this leaflet carefully before you start to use this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What is Traglasin and what it is used for
• 2. What you need to know before you use 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 is Traglasin and what it is used for

Traglasin contains travoprost, a substance belonging to the group of drugs called prostaglandin analogs. It works by lowering intraocular pressure. It can be used alone or in addition to other eye drops such as beta-blockers, which are also able to reduce pressure.
Traglasin is used to reduce high intraocular pressure in adults, adolescents and children from 2 months of age onwards. Such 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 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 in the eyelids or tissues around the eye, including abnormal hair growth, have also been observed.
• 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 undergone cataract surgery, consult your doctor before using Traglasin.
• If you currently have, or have had in the past, eye inflammation (iritis and uveitis), consult your doctor before using Traglasin.
• Traglasin can rarely cause difficulty breathing or shortness of breath or increase

symptoms of asthma. Tell your doctor immediately if you notice that using Traglasin
causes changes in your breathing.

• Travoprost can be absorbed through the skin. If any medicine comes into contact with the skin, it should be washed off immediately. This is particularly important for women who are pregnant or planning 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 putting the lenses back in.

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

Other medicines and Traglasin
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines.

Pregnancy, breastfeeding and fertility
Pregnancy
Do not use Traglasin if you are pregnant. Talk to your doctor immediately if you think you may be
pregnant. If there is a possibility of becoming pregnant, use effective contraception
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 operating machinery
You may experience blurred vision for a certain period after using Traglasin. Do not drive or
operate machinery until these symptoms have disappeared.

Traglasin contains propylene glycol
Propylene glycol can cause skin reactions and irritation.

Traglasin contains hydrogenated castor oil
Hydrogenated castor oil can cause skin reactions and irritation.

3. How to use Traglasin

Use this medicine following the instructions of your doctor or paediatrician exactly. If you have any
doubts, consult your doctor, paediatrician or pharmacist.

The recommended dose is
One drop in the eye(s), once a day - in the evening.
Use Traglasin in both eyes only as prescribed by your doctor. Use the medicine for the
period of time recommended by your doctor or paediatrician.
Traglasin can only be used as an eye drop.
Wash your hands before use. Make sure that the single-dose container is intact before use. The
solution must be used immediately after opening. To avoid contamination, ensure that the open end of the single-dose container does not come into contact with the eye or with other
surfaces.

• 1. Take a single-dose container from the sachet.
• 2. Hold the single-dose container in an upright position (with the cap facing upwards) and rotate the cap.
• 3. Tilt your head back or gently tilt the child's head back. Lower the lower eyelid with a clean finger, so as to form a “pocket” between the eyelid and the eye. Turn the single-dose container upside down and apply slight pressure to release one drop of eye drops into the eye(s) to be treated.
• 4. After using Traglasin, keep your eyes closed, apply slight pressure with a finger to the corner of the eye, near the nose for at least one minute. This helps to prevent Traglasin from spreading throughout the body.
• 5. If you are using the eye drops in both eyes, repeat the steps for the other eye.
• 6. Dispose of the single-dose container immediately after use, even if there is some solution remaining inside.

If a drop does not enter the eye, try again.

If you or the child are using other ophthalmic preparations at the same timesuch as eye drops or ointments,
allow at least 5 minutes between instilling Traglasin and instilling other preparations.

If you or the child use more Traglasin than you should
Wash all the medicine away with lukewarm water. Do not use the eye drops until the time of the next dose.

If you forget to use Traglasin
Continue treatment with the next dose as scheduled. Do not take a double dose to
compensate for a missed 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, the
intraocular pressure will not be controlled with possible loss of vision.
If you have any further questions on the use of this medicine, ask your doctor, paediatrician or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You can generally continue to use the drops unless the side effects are serious.
If you are concerned, ask your doctor or pharmacist. Do not stop treatment with Traglasin
without 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
Effects on the eye: eye redness
Common side effects: may affect up to 1 in 10 people
Effects on the eye: changes in the color of the iris (colored 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
Effects on the eye: corneal pathology, eye inflammation, iris inflammation,
inflammation inside the eye, inflammation of the eye surface with or without damage to the
surface, sensitivity to light, eye discharge, eyelid inflammation, redness of the
eyelids, swelling around the eye, itchy eyelids, blurred vision, increased
tearing, infection or inflammation of the conjunctiva (conjunctivitis), abnormal outward rotation of
the lower eyelid, eye clouding, crusting on the eyelid,
eyelash growth.

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

Rare: may affect up to 1 in 1,000
Effects on the eye:perception of flashing lights, eczema of the eyelids, eyelashes with abnormal positioning
that grow towards the eye, eye swelling, reduced vision, vision with halo,
decreased eye sensitivity, inflammation of the eyelid glands, pigmentation
inside the eye, increased pupil size, thickening of the eyelashes, alteration
of eyelash color, tired eyes.

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

Not known: frequency cannot be estimated from available data
Effects on the eye:inflammation of the back of the eye, eyes appear 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, diarrhea, nosebleeds, abdominal pain, nausea, vomiting, itching, abnormal hair growth,
painful or involuntary urination, increased prostate cancer marker.
In children and adolescents, the most common side effects observed with Traglasin were
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 get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through
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 sight and reach of children.
After use, immediately dispose of the opened single-dose container.
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 particular storage temperature.
After opening the sachet: Do not store at a temperature above 30°C.
Keep the single-dose containers in the sachet and in the 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 in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Traglasin contains

• The active ingredient is travoprost 40 micrograms/mL. One drop contains approximately 1.2 micrograms of travoprost.
• The other ingredients are: Propylene glycol (E1520), hydrogenated castor oil polyoxyl 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, colorless solution, supplied in plastic single-dose containers, 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.
Not all pack sizes may be 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 Member States of the European Economic Area under the
following denominations:
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