UMOSTIL 40 MICROGRAMMI/ML Eye drops, solution

Зміст інструкції

1. Umostil 40 micrograms/ml eye drops, solution
   1. What is Umostil and what is it used for
   2. What you need to know before using Umostil
   3. How to use Umostil
   4. Possible side effects
   5. How to store Umostil
   6. Contents of the pack and other information

Umostil 40 micrograms/ml eye drops, solution

Travoprost
Generic medicine

Read this leaflet carefully before you start using 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 their symptoms are the same as yours, as it could 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 Umostilis and what it is used for
• 2. What you need to know before you use Umostil
• 3. How to use Umostil
• 4. Possible side effects
• 5. How to store Umostil
• 6. Contents of the pack and other information

1. What is Umostil and what is it used for

Umostil contains travoprost, a substance belonging to the group of prostaglandin analogues. It works by reducing the pressure inside the eye. It can be used alone or with other eye drops, for example beta-blockers which can lower the pressure.
Umostil eye drops are used for the treatment of high intraocular pressure in adults, adolescents and children from 2 months of age and older. This pressure can cause a disease called glaucoma.

2. What you need to know before using Umostil

Do not useUmostil
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 Umostil.

• Umostil may increase the length, thickness, colour and/or number of eyelashes. Changes to the eyelids have also been observed, including abnormal growth of hair or tissue around the eye.
• Umostil may change the colour of the 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, talk to your doctor before using Umostil
• If you currently have or have had in the past an eye inflammation(iritis and uveitis), talk to your doctor before using Umostil
• Umostil can rarely cause shortness of breath or wheezing or worsen asthma symptoms. If you are concerned about changes in your breathing while using travoprost, contact your doctor as soon as possible.
• Umostil can 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 especially important for women who are pregnant or trying 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
Umostil can be used in children from 2 months to 18 years of age at the same dose as adults.
The use of Umostil is not recommended in children under 2 months of age.

Other medicines andUmostil
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy,
or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
Pregnancy
Do not use Umostil if you are pregnant. If you suspect you are pregnant, talk
to your doctor immediately. If you are of childbearing potential, you should use adequate
contraception while using Umostil.
Breastfeeding
Do not use Umostil if you are breastfeeding as Umostil may pass into breast milk.

Driving and operating machinery
For a certain period of time after using travoprost, you may experience temporary
blurred vision. Do not drive or operate machinery until the symptoms have completely
disappeared.

Umostil contains benzalkonium chloride.
Benzalkonium chloride can be absorbed by soft contact lenses and can lead to
changes in their colour. Remove your contact lenses before using this medicine and wait
15 minutes before reinserting them. Benzalkonium chloride can also cause eye irritation
especially if you have dry eyes or corneal disorders (the transparent outermost layer
of the eye). If you experience any abnormal eye sensation, burning or pain after using
this medicine, talk to your doctor.

3. How to use Umostil

Always use this medicine exactly as your doctor or
paediatrician has instructed. If you have any doubts, consult your doctor or pharmacist.

The recommended dose is 1 drop in the affected eye or in both eyes, once a
day,in the evening.
Use Umostil in both eyes only as prescribed by your doctor. Use the medicine
for the period of time recommended by your doctor or paediatrician.
Use Umostil onlyto instill drops into your or your child's eyes.
Instructions for use

• 1. Before using this medicine for the first time, make sure that the tamper-evident seal is intact
• 2. Wash your hands and sit comfortably.
• 3. Unscrew the cap.
• 4. Remove the tamper-evident seal from the bottle.
• 5. Use your finger to gently pull down the lower eyelid of the affected eye.

• 6. Hold the end of the bottle close to the eye or eyelid, avoiding contact between the end of the bottle and the eyelids/surrounding area or other surfaces due to the risk of contamination and subsequent serious eye infections.

• 7. Gently press the bottle to allow one drop to enter the eye and then release the lower eyelid.

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

• 8. After using Umostil, press your finger against the inner corner of the eye near the nose for 2 minutes. This helps to prevent Umostil from spreading throughout the body.

• 9. Repeat the procedure for the other eye if your doctor has told you to do so.

• 10. Replace the cap on the bottle.

The dropper is designed to deliver a single drop. Do not enlarge the hole in the
dropper.
After dispensing all the dose, a small amount of medicine will remain in the bottle. You do not
need to worry about this as an extra amount of Umostil has been added and you have used
the total amount of Umostil that your doctor has prescribed. Do not try to remove the
excess medicine from the bottle.

If you use moreUmostilthan you should
Rinse your eye with warm water. Do not use the eye drops until it is time for the
next dose.

If you forget to useUmostil
Continue with the next dose as scheduled. Do not use a double doseto make up for a
missed dose.
Do not instill more than one drop into the affected eye in a single day.

If you stop usingUmostil
Do not stop treatment without first talking to your doctor, as uncontrolled eye pressure can lead to loss of vision.

If you are wearing soft contact lenses
Do not use the eye drops when wearing contact lenses. After using the medicine, wait 15
minutes before putting the lenses back in.

If you are using other eye drops
Wait at least 5 minutes between using Umostil and the other eye drops.
If you have any doubts about using this medicine, ask your doctor 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, except in the case where the effects are
serious. If you are worried, contact your doctor or pharmacist. Do not stop using
Umostil without talking to your doctor.
The following side effects have been observed with the use of Umostil.

Very common: may affect more than 1 in 10 people
Effects on the eye:eye redness

Common: may affect up to 1 in 10 people
Effects on the eye: changes in the color of the iris (the colored part of the eye), eye pain,
eye discomfort, dry eye, eye itching, eye irritation.

Uncommon: may affect up to 1 in 100 people
Effects on the eye:corneal discomfort, eye inflammation, iris inflammation,
inflammation inside the eye, inflammation of the eye surface with/without
damage to the surface, sensitivity to light, eye discharge, eyelid inflammation,
redness of the eyelids, swelling around the eye, eyelid itching, reduced vision,
blurred vision, increased tearing, infection or inflammation of the conjunctiva
(conjunctivitis), abnormal outward rotation of the lower eyelid, blurred
vision, 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/eyes,
darkening of the skin, abnormal hair structure, excessive hair growth.

Rare: may affect up to 1 in 1000 people
Effects on the eye:perception of flashing lights, eczema of the eyelids, eyelashes positioned
abnormally that grow towards the eye, swollen eyes, reduced vision, vision with
halo, decreased eye sensitivity, inflammation of the eyelid glands,
pigmentation inside the eye, increased pupil size, thickening
of the eyelashes, change in eyelash color, tired eyes.

General side effects:viral eye infections, dizziness, unpleasant taste, slowed or irregular heartbeat, increased or decreased blood pressure, shortness of breath, asthma,
nasal allergy or inflammation, dry nose, changes in voice, gastrointestinal disorders or ulcer, constipation, dry mouth, skin redness or itching, rash,
changes in hair color, eyelash loss, joint pain,
musculoskeletal pain, general weakness.

Not known: frequency cannot be estimated from the available data
Effects on the eye:inflammation of the back of the eye, eyes that appear more
sunken

General side effects: depression, anxiety, insomnia, false sensation of movement,
ringing in the ears, chest pain, altered heart rhythm, increased heart rate,
worsening of asthma, diarrhea, nosebleeds, abdominal pain, nausea,
vomiting, itching, abnormal hair growth, painful and involuntary urination, increased
prostate cancer markers.
In children and adolescents, the most common side effects observed with travoprost
are eye redness and eyelash growth. These 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, pharmacist or nurse. 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 Umostil

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after Scad. The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.

You must discard the bottle after 4 weeks from first opening,in order to prevent infections,
and use a new bottle. Write the date of opening the bottle in the space provided
on the bottle label and on the box.
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 the medicine containsUmostil

• The active ingredient is travoprost 40 micrograms/ml.
• The other ingredients are: benzalkonium chloride, macrogol-15-hydroxystearate, trometamol, boric acid, disodium edetate, mannitol and water for injections. Small amounts of sodium hydroxide or hydrochloric acid have been added for pH adjustment.

Description of the appearance ofUmostiland contents of the pack
Umostil is a liquid (a clear and colourless solution) contained in a 5 ml plastic dropper bottle with a white screw cap and a tamper-evident seal. Each bottle contains 2.5 ml of solution. Umostil is supplied in packs of 1 bottle.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
A.G.F. S.r.l.
Piazza Mazzini, 17
60033 Chiaravalle (AN)
Manufacturer
Rafarm S.A.
Thesi Pousi-Hatzi Agiou Louka, Paiania-Attiki, TK 19002, P.O. 37, Greece