TRAVOPROST 40 MICROGRAMMI/ML Eye drops, solution

Зміст інструкції

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

Travoprost Sandoz 40 micrograms/ml eye drops, solution

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 Travoprost Sandoz is and what it is used for
• 2. What you need to know before you use Travoprost Sandoz
• 3. How to use Travoprost Sandoz
• 4. Possible side effects
• 5. How to store Travoprost Sandoz
• 6. Contents of the pack and other information

1. What is Travoprost Sandoz and what is it used for

Travoprost Sandoz contains travoprost, a substance belonging to the group of medicines called
prostaglandin analogues. It works by reducing intraocular pressure. It can be used alone or in
addition to other eye drops such as beta-blockers, which are also able to reduce the pressure.
Travoprost Sandoz is used to reduce high intraocular pressure in adults, adolescents and children
from 2 months of age onwards. This pressure can lead to a condition called glaucoma.

2. What you need to know before you take Travoprost Sandoz

Do not take Travoprost Sandoz

• if you are allergic to travoprost or any of the other ingredients of this medicine (listed in section 6).

If this applies to you, ask your doctor for advice.

Warnings and precautions
Talk to your doctor or pharmacist before taking Travoprost Sandoz.

• Travoprost Sandoz 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, have also been observed.
• Travoprost Sandoz 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, talk to your doctor before using Travoprost Sandoz.
• If you currently have, or have had in the past, eye inflammation (iritis and uveitis), talk to your doctor before using Travoprost Sandoz.
• Travoprost Sandoz can rarely cause difficulty breathing or wheezing or worsen asthma symptoms. Tell your doctor immediately if you notice that using Travoprost Sandoz causes changes in your breathing.
• Travoprost can be absorbed through the skin. If any 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 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
Travoprost Sandoz can be used in children from 2 months of age to under 18 years at the same dose
as adults. The use of Travoprost Sandoz is not recommended for children under 2 months of age.

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

Pregnancy, breastfeeding and fertility
Do not use Travoprost Sandoz if you are pregnant. Tell your doctor immediately if you think you
might be pregnant. If you could become pregnant, use effective contraception
during treatment with Travoprost Sandoz.
Do not use Travoprost Sandoz if you are breastfeeding. Travoprost Sandoz may pass into breast milk.
Ask your doctor for advice before taking any medicine.

Driving and using machines
You may have blurred vision for a certain period after using Travoprost Sandoz. Do not drive
vehicles or use machines until these symptoms have cleared.

Travoprost Sandoz contains benzalkonium chlorideThis medicine contains 0.15 mg of
benzalkonium chloride per ml of eye drops, solution. Benzalkonium chloride can be absorbed by soft
contact lenses and can lead to discoloration of them. Remove 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 outer 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 take Travoprost Sandoz

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor, pediatrician or pharmacist.
The recommended dose is:
Adults: one drop in the affected eye(s), once a day - in the evening.
Use Travoprost Sandoz in both eyes only as prescribed by your doctor. Use the medicine for the
period of time that your doctor recommends.
Travoprost Sandoz can only be used as an eye drop in your eyes or in the eyes of your
child.
Instructions for use:

1 2 3 4

• Immediately before using the bottle for the first time, open the outer protective packaging, remove the bottle (figure 1) and write the date of opening the bottle in the appropriate space on the label.
• Wash your hands.
• Unscrew the cap.
• Hold the bottle in your hand, between your thumb and other fingers, with the tip pointing downwards.
• 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. The drop should be inserted there (figure 2).
• Hold the tip of the bottle close to the eye. Use a mirror if necessary.
• Do not touch the eye or eyelid, the surrounding areas or other surfaces with the tip of the bottle. This may infect the eye drops.
• Gently press the bottle to release one drop of Travoprost Sandoz at a time (figure 3).
• After using Travoprost Sandoz, keep your eyes closed, apply gentle pressure with a finger to the corner of the eye, near the nose (figure 4) for at least 1 minute. This helps to prevent Travoprost Sandoz from spreading throughout the body.
• If you are using the eye drops in both eyes, repeat the steps for the other eye.
• Close the cap tightly immediately after use.
• Use only one bottle at a time. Do not open the outer protective packaging until you are ready to use the bottle.

If a drop does not enter the eye, try again.
If you or your child are using other ophthalmic preparations such as eye drops or ointments at the same time, allow
at least 5 minutes between instilling Travoprost Sandoz and instilling other preparations.

If you take more Travoprost Sandoz 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 take Travoprost Sandoz
Continue treatment with the next dose as scheduled. Do not take a double dose
to make up for the missed dose. Never use more than one drop per day per affected eye(s).

If you stop taking Travoprost Sandoz
Do not stop treatment with Travoprost Sandoz without first talking to your doctor or
pediatrician, intraocular pressure will not be controlled with possible loss of vision.
If you have any questions about using this medicine, ask your doctor, pediatrician 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 eye drops, except in the case where the side
effects are serious. If you are concerned, contact your doctor or pharmacist. Do not stop the
treatment with Travoprost Sandoz without talking to your doctor.
The following side effects have been observed with Travoprost Sandoz.

Very common: may affect more than 1 in 10 people

• eye redness

Common: may affect up to 1 in 10 people
Effects on the eye:

• changes in the colour of the iris (the coloured part of the eye)
• eye pain
• eye discomfort
• dry eye
• itchy eyes
• eye irritation

Uncommon: 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
• reduced vision
• blurred vision
• increased tearing
• infection or inflammation of the conjunctiva (conjunctivitis)
• abnormal outward rotation of the lower eyelid
• clouding of the eye
• crusting on the eyelid
• eyelash growth
• change in eyelash colour
• tired eyes

General side effects:

• increased allergy symptoms
• headache
• dizziness
• irregular heartbeat
• shortness of breath
• asthma
• 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
Effects on the eye:

• perception of flashing lights
• eczema of the eyelids
• eye swelling
• halo vision
• decreased eye sensitivity
• inflammation of the eyelid glands
• pigmentation inside the eye
• increased pupil size
• change in eyelash structure.

General side effects:

• viral eye infection
• unpleasant taste
• irregular or reduced heart rate
• increased or decreased blood pressure
• breathing abnormalities
• pain in mouth or throat
• cough
• voice changes
• gastrointestinal disorders or ulcer
• constipation
• dry mouth
• redness or itching of the skin
• skin rash
• change in hair colour
• eyelash loss
• 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 appear more sunken.

General side effects:

• depression
• anxiety
• false sensation of movement
• ringing in the ears
• chest pain
• increased heart rate
• worsening of asthma
• diarrhoea
• abdominal pain
• nausea
• itching
• abnormal hair growth
• joint pain
• painful or involuntary urination
• increased prostate cancer marker.

In children and adolescents, the most common side effects observed with Travoprost Sandoz have been
eye redness and eyelash growth. Both side effects have been 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
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 Travoprost Sandoz

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 package, on the protective
wrapper and on the label after “Exp”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
The bottle must be discarded 4 weeks after first opening, to prevent infections, and a new bottle used.
Record the date of opening in the appropriate space on each bottle label and on the package.
Do not dispose of any medicine in waste water 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 Travoprost Sandoz contains

• The active ingredient is travoprost. Each ml of solution contains 40 micrograms of travoprost.
• The other ingredients are: benzalkonium chloride solution, macrogol hydroxystearate 40, trometamol, disodium edetate, boric acid, mannitol and purified water. Small amounts of sodium hydroxide or hydrochloric acid have been added to maintain the acidity at normal levels (pH levels).

Description of Travoprost Sandoz and contents of the pack
Travoprost Sandoz is an eye drop, a clear, colorless solution, supplied in a pack containing 1,
3 or 6 plastic bottles with droppers of 2.5 ml each, each with a screw cap. Each bottle is inserted
in a blister pack.
Not all pack sizes may be marketed.

Marketing authorisation holder
Sandoz S.p.A.
L.go U. Boccioni 1
21040 Origgio (VA) - Italy

Manufacturers
Alcon-Couvreur N.V
Rijksweg 14, B-2870 Puurs, Belgium
Alcon Cusí S.A
Camil Fabra 58, 08320 El Masnou, Barcelona, Spain
Lek Pharmaceuticals d.d.
Verovškova 57, 1526 Ljubljana, Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria Travoprost Sandoz 40 Micrograms/ml - Eye drops
Belgium Travoprost Sandoz 40 microgram/ml eye drops, solution
Denmark Travoprost Sandoz
Finland Travoprost Sandoz
France TRAVOPROST SANDOZ 40 micrograms/ml, eye solution
Germany Travoprost – 1 A Pharma 40 Micrograms/ml Eye drops
Hungary Travoprost Sandoz 40 micrograms/ml eye drops solution
Ireland Travoprost Sandoz 40 microgram/ml Eye Drops Solution
Italy Travoprost Sandoz
Luxembourg Travoprost Sandoz 40 mcg/ml eye solution
Malta Travoprost 40 micrograms/ml eye drops, solution
Netherlands Travoprost Sandoz 40 microgram/ml, eye drops, solution
Norway Travoprost Sandoz
Portugal Travoprost Sandoz
Spain Travoprost Sandoz 40 micrograms/ml eye solution
Sweden Travoprost Sandoz
Slovenia Travoprost Sandoz 40 micrograms/ml eye solution
United Kingdom (Northern
Ireland)
Travoprost Sandoz 40 micrograms/ml eye drops, solution