Travoprost Sandoz

Package leaflet: Information for the user

Travoprost Sandoz 40 micrograms/ml eye drops, solution

Generic 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 yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 using 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 Travoprost Sandoz is and what it is used for

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

2. What you need to know before using Travoprost Sandoz

Do not take Travoprost Sandoz

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

If this applies to you, please consult your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before using Travoprost Sandoz.

• Travoprost Sandoz may increase the length, thickness, colour, and/or number of your eyelashes. Changes in the eyelids or in the tissues around the eye, including abnormal eyelash growth, may also occur.
• 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 undergone cataract surgery, consult your doctor before using Travoprost Sandoz.
• If you currently have or have previously had ocular inflammation (iritis or uveitis), consult your doctor before using Travoprost Sandoz.
• Travoprost Sandoz may rarely cause breathing difficulties, shortness of breath, or worsen asthma symptoms. Inform your doctor immediately if you notice any changes in your breathing while using Travoprost Sandoz.
• Travoprost may 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 planning 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
Travoprost Sandoz can be used in children from 2 months up to less than 18 years of age at the same dose as adults. The use of Travoprost Sandoz is not recommended in children below 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, breast-feeding and fertility
Do not use Travoprost Sandoz during pregnancy. Contact your doctor immediately if you think you might be pregnant. If you are able to become pregnant, use an effective method of contraception during treatment with Travoprost Sandoz.
Do not use Travoprost Sandoz while breast-feeding. Travoprost Sandoz 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 Travoprost Sandoz. Do not drive or operate machinery until these symptoms have resolved.
Travoprost Sandoz contains benzalkonium chloride This medicine contains 0.15 mg of benzalkonium chloride per ml of eye drop solution. Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their colour. Remove your 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 (the transparent outer layer of the eye). If you experience any unusual sensation, burning, or pain in the eye after using this medicine, speak with your doctor.

3. How to use Travoprost Sandoz

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor, paediatrician, or pharmacist.
The recommended dose is:
Adults: one drop in the affected eye(s), once daily in the evening.
Use Travoprost Sandoz in both eyes only if prescribed by your doctor. Use the medicine for the length of time advised by your doctor.
Travoprost Sandoz may only be used as eye drops in your eyes or in your child's eyes.

Instructions for use:

1 2 3 4

• Immediately before using the bottle for the first time, open the outer protective pouch, remove the bottle (Figure 1), and write the date of opening in the space provided on the label.
• Wash your hands.
• Unscrew the cap.
• Hold the bottle between your thumb and other fingers, with the tip pointing downwards.
• Tilt the head backwards or gently tilt the child’s head back. Pull down the lower eyelid with a clean finger to create a “pocket” between the eyelid and the eye. The drop should be instilled here (Figure 2).
• Hold the tip of the bottle close to the eye. You may use a mirror to assist.
• Do not touch the eye, eyelid, surrounding areas, or any other surface with the tip of the bottle. This could contaminate the eye drops.
• Gently squeeze the bottle to release one drop of Travoprost Sandoz at a time (Figure 3).
• After using Travoprost Sandoz, keep the eyes closed and apply gentle pressure with a finger at the inner corner of the eye, near the nose (Figure 4), for at least 1 minute. This helps prevent Travoprost Sandoz from being distributed throughout the body.
• If you are using the eye drops in both eyes, repeat the steps for the other eye.
• Immediately close the cap tightly after use.
• Use only one bottle at a time. Do not open the outer protective pouch until it is time 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, wait at least 5 minutes between instilling Travoprost Sandoz and the other preparations.
If you use more Travoprost Sandoz than you should
Rinse the eye thoroughly with lukewarm water. Do not use the eye drops again until the next scheduled dose.
If you forget to use Travoprost Sandoz
Continue treatment with the next dose as scheduled. Do not use a double dose to make up for a missed dose. Never use more than one drop per day per affected eye(s).
If you stop using Travoprost Sandoz
Do not stop treatment with Travoprost Sandoz without first talking to your doctor or paediatrician, as intraocular pressure will not be controlled, which may result in loss of vision.
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 everybody 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 Travoprost Sandoz without first 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 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
• itchy eyes
• eye irritation

Uncommon: may affect up to 1 in 100 people
Eye effects:

• corneal disorder
• eye inflammation
• iris inflammation
• intraocular inflammation
• surface ocular inflammation with or without surface damage
• light sensitivity
• eye discharge
• eyelid inflammation
• eyelid redness
• swelling around the eye
• eyelid itching
• reduced vision
• blurred vision
• increased lacrimation
• conjunctival infection or inflammation (conjunctivitis)
• abnormal outward turning of the lower eyelid
• eye cloudiness
• crusting of the eyelid
• eyelash growth
• change in eyelash colour
• tired eyes

General side effects:

• worsening of allergy symptoms
• headache
• dizziness
• irregular heartbeat
• shortness of breath
• asthma
• 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
• eye swelling
• halos around lights
• decreased ocular sensitivity
• eyelid gland inflammation
• intraocular pigmentation
• increased pupil size
• changes in eyelash structure

General side effects:

• viral eye infection
• unpleasant taste
• irregular or reduced heart rate
• increased or decreased blood pressure
• breathing abnormalities
• mouth or throat pain
• cough
• voice changes
• gastrointestinal disturbances or ulcer
• constipation
• dry mouth
• skin redness or itching
• skin rash
• change in hair colour
• eyelash loss
• musculoskeletal pain
• generalized 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
• 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
• increase in prostate cancer marker

In children and adolescents, the most commonly observed side effects with Travoprost Sandoz have been eye 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, please inform your doctor. You can also report side effects directly via 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 stated on the carton, the protective pouch, and the label 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 must be used.
Write down the date of opening in the designated space on each bottle label and on the carton.
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 Travoprost Sandoz contains

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

Description of the appearance of Travoprost Sandoz and contents of the pack
Travoprost Sandoz is an eye drop, a clear, colourless solution supplied in a pack containing 1,
3 or 6 plastic dropper bottles of 2.5 ml each with screw caps. Each bottle is placed
in a pouch.
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 European Economic Area countries under the
following names:
Austria Travoprost Sandoz 40 Mikrogramm/ml - Augentropfen
Belgium Travoprost Sandoz 40 microgram/ml oogdruppels, oplossing
Denmark Travoprost Sandoz
Finland Travoprost Sandoz
France TRAVOPROST SANDOZ 40 microgrammes/ml, collyre en solution
Germany Travoprost – 1 A Pharma 40 Mikrogramm/ml Augentropfen
Hungary Travoprost Sandoz 40 mikrogramm/ml oldatos szemcsepp
Ireland Travoprost Sandoz 40 microgram/ml Eye Drops Solution
Italy Travoprost Sandoz
Luxembourg Travoprost Sandoz 40 mcg/ml collyre en solution
Malta Travoprost 40 micrograms/ml eye drops, solution
Netherlands Travoprost Sandoz 40 microgram/ml, oogdruppels, oplossing
Norway Travoprost Sandoz
Portugal Travoprost Sandoz
Spain Travoprost Sandoz 40 microgramos/ml colirio en solución
Sweden Travoprost Sandoz
Slovenia Travoprost Sandoz 40 mikrogramov/ml očná roztoková instilácia
United Kingdom (Northern Ireland) Travoprost Sandoz 40 micrograms/ml eye drops, solution