40 micrograms/ml eye drops, solution
travoprost
What TRAVATAN is and what it is used for
TRAVATAN contains travoprost, one of a group of medicines called prostaglandin analogs. It works by lowering the pressure in the eye. It can be used alone or with other eye drops, e.g. beta-blockers which also lower the pressure in the eye.
TRAVATAN is used to lower high pressure in the eye in adults, adolescents, and children from the age of 2 months. This pressure can lead to a disease called glaucoma.
What you need to know before you use TRAVATAN
Do not use TRAVATAN
- if you are allergic to travoprost or any of the other ingredients of this medicine (listed in section 6).
Ask your doctor for advice if this applies to you.
Warnings and precautions
- TRAVATAN can increase the length, thickness, color, and/or number of your eyelashes. Changes in the eyelids including unusual hair growth or the tissues around the eye have also been observed.
- TRAVATAN can change the color of the iris (the colored part of your eye). This change can be permanent. There may also be a change in the color of the skin around the eye.
- If you have had cataract surgery, talk to your doctor before using TRAVATAN.
- If you have or have had eye inflammation ( iritis and uveitis ), talk to your doctor before using TRAVATAN.
- TRAVATAN may rarely cause shortness of breath or wheezing or worsen symptoms of asthma. If you are worried about changes in your breathing pattern while using TRAVATAN, talk to your doctor as soon as possible.
- Travoprost can be absorbed through the skin. If any of the medicine comes into contact with the skin, it should be washed off as soon as possible. This is especially important for women who are pregnant or trying to conceive.
- If you wear soft contact lenses, do not take the drops while the lenses are in. After using the drops, wait 15 minutes before putting the lenses back in.
Children and young people
TRAVATAN can be used in children from 2 months to 18 years with the exact dosage as for adults. Use of TRAVATAN is not recommended for children under 2 months.
Other medicines and TRAVATAN
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 TRAVATAN if you are pregnant. If you think you may be pregnant, talk to your doctor right away. If you can become pregnant, you must use appropriate contraception while using this medicine.
Do not use TRAVATAN if you are breastfeeding. TRAVATAN can pass into breast milk.
Consult a doctor before taking any medicine.
Driving ability and use of machinery
You may experience blurring of your vision immediately after taking TRAVATAN. You should not drive or operate machinery until this has disappeared.
TRAVATAN contains macrogol glycerol hydroxy stearate and propylene glycol which can cause skin reactions and irritation.
How to use TRAVATAN
Always use this medicine as directed by your or your child’s doctor. Consult your or your child’s doctor or pharmacist if you are unsure.
The recommended dose is
One drop in the affected eye or eyes, once daily – in the evening.
Only use TRAVATAN in both eyes if your or your child’s doctor has prescribed it. Take the drops for as long as your or your child’s doctor prescribes.
Use TRAVATAN only to drop into your or your child’s eye(s).
- Immediately before using a bottle for the first time, tear open the protective bag, take out the bottle ( picture 1 ), and write down the date you opened the bottle in the space on the carton.
- Wash your hands.
- Unscrew the lid.
- Hold the bottle pointing downwards between your thumb and fingers.
- Tilt your or your child’s head back. Pull down the eyelid with a clean finger until a “pocket” is formed between the eyelid and the eye. The drop should end up here ( picture 2 ).
- Hold the tip of the bottle close to the eye. Use a mirror if it helps.
- Do not touch the eye or eyelid, surrounding areas, or other surfaces with the dropper tip. It can contaminate the drops.
- Gently press the bottle to release one drop of TRAVATAN at a time. ( picture 3 )
- When you have taken TRAVATAN, make sure that your or your child’s eye is closed and press lightly with a finger in the corner of the eye ( picture 4 ) for at least 1 minute. It prevents TRAVATAN from escaping into the rest of the body.
- Repeat the steps for the other eye if you or your child are using drops in both eyes.
- Screw the lid on tightly immediately after use.
- Use only one bottle at a time. Do not open the protective bag until you need to use the bottle.
If a drop misses the eye, try again.
If you or your child use other eye preparations, e.g. eye drops or eye ointment, wait at least 5 minutes between using TRAVATAN and the other eye preparations.
If you or your child have used too much TRAVATAN
Rinse off all medication with warm water. Do not take any more drops until it is time for your next regular dose.
If you forget to use TRAVATAN
Continue with the next dose as scheduled. Never take a double amount to make up for a missed dose. Never use more than 1 drop per day in the affected eye(s).
If you stop using TRAVATAN
Do not stop using TRAVATAN without first talking to your or your child’s doctor. Otherwise, the pressure in your or your child’s eye cannot be controlled and this can lead to vision loss.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You can usually continue to use the drops unless the side effects are severe. If you are worried, talk to your doctor or pharmacist. Do not stop taking TRAVATAN without talking to your or your child’s doctor.
The following side effects have been seen with TRAVATAN:
Very common: may affect more than 1 in 10 users
Effects on the eyes: redness of the eye
Common: may affect up to 1 in 10 users
Effects in the eyes: change in iris color (the colored part of the eye), eye pain, eye discomfort, dry eyes, itchy eyes, eye irritation.
Uncommon: may affect up to 1 in 100 users
Effects in the eyes: disorders of the cornea, eye inflammation, iris inflammation, inflammation inside the eye, inflammation of the surface of the eye with/without surface damage, light sensitivity, discharge from the eye, eyelid inflammation, redness of the eyelid, swelling around the eye, itchy eyelids, blurred vision, increased tear production, inflammation or infection of the conjunctiva ( conjunctivitis ), lower eyelid turning outwards in an abnormal way, clouding of the eye, crusting of the eyelid, growth of eyelashes.
General side effects: increased allergy symptoms, headache, irregular heartbeat, cough, nasal congestion, throat irritation, darkening of the skin around the eye(s), darkening of the skin, abnormal hair quality, and heavy hair growth.
Rare: may affect up to 1 in 1,000 users
Effects in the eye: flashes of light, eczema on the eyelids, misdirected eyelashes growing back towards the eye, swollen eyes, reduced vision, halo phenomenon, reduced sensation in the eye, inflammation of the glands in the eyelids, pigmentation inside the eye, increased pupil size, thickened eyelashes scars, discolored eyelashes scars, tired eyes.
Common side effects: viral infection in the eye, dizziness, bad taste in the mouth, irregular or slower heart rate, increased or decreased blood pressure, shortness of breath, asthma, allergy or inflammation of the nose, dry nose, changes in voice, discomfort or ulcers in the gastrointestinal tract, constipation, dry mouth, redness or itching of the skin, rash, change in hair color, loss of eyelashes, joint pain, pain in muscles and bones, general weakness.
Not known frequency: cannot be estimated from the available data
Effects in the eye: inflammation in the back of the eye, the eyes look more sunken.
General side effects: depression, anxiety, insomnia, the sensation of false movement, ringing in the ears, chest pain, abnormal heart rhythm, faster heartbeat, worsening asthma, diarrhea, nosebleeds, abdominal pain, nausea, vomiting, itching, abnormal hair growth, painful or involuntary urination, elevated prostate-specific antigen.
In children and adolescents, the most common side effects of TRAVATAN are redness of the eye and growth of eyelashes. The incidence of these two side effects was higher in children and adolescents than in adults.
How TRAVATAN should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the bottle and carton after EXP. The expiration date is the last day of the specified month.
This medicine does not require any special storage conditions.
You must discard the bottle 4 weeks after you first open it to prevent infection, and use a new bottle. Write the date you opened it in the space provided on the box.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is travoprost 40 micrograms/ml.
- Other ingredients are Polyquaternium 1, macrogol glycerol hydroxy stearate, propylene glycol, sodium chloride, boric acid, mannitol, and purified water. Small amounts of hydrochloric acid or sodium hydroxide have been added to keep the acidity ( pH level) normal.
Appearance and package sizes of the medicine
TRAVATAN is a liquid (a clear, colorless solution) supplied in a 4 ml plastic bottle with a screw cap. Each bottle contains 2.5 ml of travoprost and each bottle is packed in a protective pouch.
Pack sizes: 1 or 3 bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Manufacturer
Novartis Farmacéutica, SA
Gran Via de Les Corts Catalanes, 764
08013 Barcelona
Spain
SA Alcon-Couvreur NV
Rijksweg 14
B-2870 Puurs
Belgium
Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany
Siegfried El Masnou, SA
Camille Fabra 58
El Masnou
08320 Barcelona
Spain
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
| België/Belgique/BelgienNovartis Pharma NVTél/Tel: +32 2 246 16 11 | LithuaniaSIA Novartis Baltics Lietuvos filialasPhone: +370 5 269 16 50 |
| BulgariaNovartis Bulgaria EOODTel.: +359 2 489 98 28 | Luxembourg/LuxembourgNovartis Pharma NVTél/Tel: +32 2 246 16 11 |
| Czech RepublicNovartis s.r.oPhone: +420 225 775 111 | MagyarországNovartis Hungária Kft.Tel.: +36 1 457 65 00 |
| DenmarkNovartis Healthcare A/SPhone: +45 39 16 84 00 | MaltaNovartis Pharma Services Inc.Phone: +356 2122 2872 |
| DeutschlandNovartis Pharma GmbHPhone: +49 911 273 0 | The NetherlandsNovartis Pharma BVPhone: +31 88 04 52 111 |
| EstoniaSIA Novartis Baltics Eesti branch phone: +372 66 30 810 | NorwayNovartis Norway iPhone: +47 23 05 20 00 |
| GreeceNovartis (Greece) AEBEPhone: +30 210 281 17 12 | AustriaNovartis Pharma GmbHPhone: +43 1 86 6570 |
| SpainNovartis Farmacéutica, SAPhone: +34 93 306 42 00 | PolishNovartis Poland Sp. z o. iPhone: +48 22 375 4888 |
| FranceNovartis Pharma SASTel: +33 1 55 47 66 00 | PortugalNovartis Farma – Produtos Farmacêuticos, SAPhone: +351 21 000 8600 |
| HrvatskaNovartis Hrvatska dooTel. +385 1 6274 220 | RomaniaNovartis Pharma Services Romania SRLPhone: +40 21 31299 01 |
| IrelandNovartis Ireland LimitedPhone: +353 1 260 12 55 | Slovenija Novartis Pharma Services Inc.Phone: +386 1 300 75 50 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovenian RepublicNovartis Slovakia s.r.oPhone: + 421 2 5542 5439 |
| ItalyNovartis Pharma SpAPhone: +39 02 96 54 1 | Finland/FinlandNovartis Finland OyTel: +358 (0)10 6133 200 |
| CyprusNovartis Pharma Services Inc.Phone: +357 22 690 690 | SwedenNovartis Sweden ABPhone: +46 8 732 32 00 |
| LatviaSIA Novartis BalticsPhone: +371 67 887 070 | United Kingdom (Northern Ireland)Novartis Ireland LimitedPhone: +44 1276 698370 |