Umostil
ItalyTable of Contents
Patient Information Leaflet
Umostil 40 micrograms/ml eye drops, solution
Travoprost
Generic medicine
Please read all of this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as 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:
- What Umostil is and what it is used for
- What you need to know before using Umostil
- How to use Umostil
- Possible side effects
- How to store Umostil
- Contents of the pack and other information
1. What Umostil is and what it is 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 in combination with other eye drops, for example beta-blockers, which can lower the pressure.
Umostil eye drops is used to treat elevated intraocular pressure in adults, adolescents, and children from 2 months of age. This pressure can cause a disease called glaucoma.
2. What you need to know before using Umostil
Do not use Umostil
if you are allergic to travoprost or to any of the other ingredients of this
medicinal product (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, including abnormal growth of eyelashes or surrounding tissues, may also occur.
- Umostil may change the colour of the iris (the coloured part of the eye). This change may be permanent. A change in skin colour around the eye may also occur.
- If you have had cataract surgery, talk to your doctor before using Umostil.
- If you currently have or have previously had ocular inflammation (iritis or uveitis), talk to your doctor before using Umostil.
- Umostil may rarely cause shortness of breath, difficulty breathing, or worsen asthma symptoms. If you experience any breathing changes 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, wash it off immediately. This is particularly 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 them. Wait 15 minutes after using the eye drops before reinserting your lenses.
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 and Umostil
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, think you might be pregnant, planning to become pregnant, or breastfeeding,
ask your doctor or pharmacist for advice before taking this medicinal product.
Pregnancy
Do not use Umostil if you are pregnant. If you suspect you are pregnant, speak to your doctor immediately. If you are of childbearing age, you should use an adequate method of contraception while using Umostil.
Breastfeeding
Do not use Umostil if you are breastfeeding, as Umostil may pass into breast milk.
Driving and using machines
For a short period after using travoprost, you may experience temporary blurred vision. Do not drive or operate machinery until your vision clears completely.
Umostil contains benzalkonium chloride.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause discolouration. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them. Benzalkonium chloride may also cause eye irritation, particularly if you have dry eye or corneal disorders (damage to the cornea, the transparent outer layer of the eye). If you experience any unusual sensation, burning, or pain in your eye after using this medicine, talk to your doctor.
3. How to use Umostil
Always use this medicine exactly as instructed by your doctor or
paediatrician. 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 daily,
in the evening.
Use Umostil in both eyes only if prescribed by your doctor. Use the medicine for the length of time advised by your doctor or paediatrician.
Use Umostil only to instil drops into your eyes or your child’s eyes.
Instructions for use
- Before using this medicine for the first time, ensure that the tamper-evident ring is intact.
- Wash your hands and sit comfortably.
- Unscrew the cap.
- Remove the tamper-evident ring from the bottle.
- Use your finger to gently pull down the lower eyelid of the affected eye.
- Hold the tip of the bottle close to the eye or eyelid, avoiding contact between the tip of the bottle and the eyelids/surrounding area or other surfaces, due to the risk of contamination and subsequent serious eye infections.
- Gently squeeze the bottle to instill one single drop into the eye, then release the lower eyelid.
If the drop does not enter the eye, try again.
- After using Umostil, press your finger against the corner of the eye near the nose for 2 minutes. This helps prevent Umostil from spreading into the rest of the body.
- Repeat the procedure for the other eye if your doctor has instructed you to do so.
- Replace the cap on the bottle.
The dropper is designed to deliver a single drop. Do not enlarge the dropper opening.
After dispensing all the dose, a small amount of medicine will remain in the bottle. Do not be concerned, as an additional amount of Umostil has been included so that you receive the total amount of Umostil prescribed by your doctor. Do not attempt to remove the excess medicine from the bottle.
If you use more Umostil than you should
Rinse the eye with warm water. Do not use the eye drops until it is time for the next dose.
If you forget to use Umostil
Continue with the next dose as scheduled. Do not use a double dose to make up for the missed dose.
Do not instill more than one drop into the affected eye in a single day.
If you stop using Umostil
Do not stop treatment without first talking to your doctor, as uncontrolled intraocular pressure may lead to vision loss.
If you wear soft contact lenses
Do not use the eye drops while wearing contact lenses. After using the medicine, wait 15 minutes before reinserting your lenses.
If you are using other eye drops
Wait at least 5 minutes between using Umostil and the other eye drop.
If you have any doubts about how to use this medicine, consult 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 using the drops, unless the side effects are severe. If you are concerned, speak to your doctor or pharmacist. Do not stop using Umostil without first 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
Eye effects: eye redness
Common: may affect up to 1 in 10 people
Eye effects: changes in iris colour (the coloured part of the eye), eye pain, eye discomfort, dry eye, eye itching, eye irritation.
Uncommon: may affect up to 1 in 100 people
Eye effects: corneal disorder, 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, reduced vision, blurred vision, increased tearing, eye 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: increased allergic symptoms, headache, irregular heartbeat, cough, nasal congestion, sore throat, 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 back towards the eye, eye swelling, reduced vision, seeing halos around lights, decreased eye sensitivity, inflammation of the eyelid glands, pigmentation inside the eye, increased pupil size, eyelash thickening, change in eyelash colour, tired eyes.
General side effects: viral eye infections, dizziness, unpleasant taste, slow or irregular heartbeat, 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, rash, changes in hair colour, eyelash loss, joint pain, musculoskeletal pain, general weakness.
Not known: frequency cannot be estimated from the available data
Eye effects: inflammation of the back of the eye, sunken appearance of the eyes
General side effects: depression, anxiety, insomnia, false sensation of movement, ringing in the ears (tinnitus), chest pain, altered heart rhythm, increased heart rate, worsening of asthma, diarrhoea, nosebleeds, abdominal pain, nausea, vomiting, itching, abnormal hair growth, painful and involuntary urination, increase in prostate tumour markers.
In children and adolescents, the most common side effects observed with travoprost are eye redness and eyelash growth. 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 effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. 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 Umostil
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp." The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
The bottle must be discarded 4 weeks after first opening in order to prevent infections, and a new bottle should be used.
Write the date of bottle opening in the space provided on the bottle label and on the box.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Contents of the pack and other information
What Umostil contains
- The active substance is travoprost 40 micrograms/ml.
- The other components are: benzalkonium chloride, macrogol-15-hydroxystearate, tromethamine, boric acid, disodium EDTA, mannitol, and water for injections. Small amounts of sodium hydroxide or hydrochloric acid have been added to adjust the pH.
Description of the appearance of Umostil and contents of the pack
Umostil is a liquid (a clear, colourless solution) contained in a plastic dropper bottle of 5 ml 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), Italy
Manufacturer
Rafarm S.A.
Thesi Pousi-Hatzi Agiou Louka, Paiania-Attiki, TK 19002, P.O. 37, Greece