40 micrograms/ml eye drops, solution
travoprost
What Travoprost Sandoz is and what it is used for
Travoprost Sandoz 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.
Travoprost Sandoz is used to lower high pressure in the eye in adults, adolescents, and children from 2 months of age. This pressure can lead to a disease called glaucoma.
Travoprost contained in Travoprost Sandoz may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Travoprost Sandoz
Do not use Travoprost Sandoz:
- 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
Talk to your doctor or pharmacist before using Travoprost Sandoz.
- Travoprost Sandoz 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.
- Travoprost Sandoz 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 Travoprost Sandoz.
- If you have or have had eye inflammation ( iritis and uveitis ), talk to your doctor before using Travoprost Sandoz.
- Travoprost Sandoz can rarely cause shortness of breath and wheezing or worsen symptoms of asthma. If you are worried about changes in your breathing pattern while using Travoprost Sandoz, talk to your doctor as soon as possible.
- Travoprost can be absorbed through the skin. If 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
Travoprost Sandoz can be used in children from 2 months to under 18 years with the same dosage as for adults. Use of Travoprost Sandoz is not recommended for children under 2 months.
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. If you think you may be pregnant, talk to your doctor right away. If you can become pregnant, you must use suitable contraception while using Travoprost Sandoz.
Do not use Travoprost Sandoz if you are breastfeeding. Travoprost Sandoz can pass into breast milk.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving ability and use of machinery
You may experience that your vision becomes blurry immediately after using Travoprost Sandoz. You should not drive or use machinery until this has disappeared.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Travoprost Sandoz contains benzalkonium chloride
This medicine contains 0.15 mg of benzalkonium chloride per ml. Benzalkonium chloride can be absorbed by soft contact lenses and can discolor the contact lenses. Remove contact lenses before using the medicine and wait at least 15 minutes before putting them back in.
Benzalkonium chloride can be irritating to the eyes, especially if you have dry eyes or problems with the cornea (the clear membrane at the front of the eye). If you feel irritation, tingling, or pain in the eye after using the medicine, consult a doctor.
How to use Travoprost Sandoz
Always use this medicine as directed by your doctor or pharmacist. If you are not sure, ask your doctor or your child’s doctor or pharmacist.
The recommended dose is:
Adults: one drop in the affected eye or eyes, once daily – in the evening.
Only use Travoprost Sandoz in both eyes if the doctor has prescribed it. Take the drops for as long as your doctor has prescribed.
Use Travoprost Sandoz only to drop into your or your child’s eyes.
Instructions for use:
- 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 label.
- Wash your hands.
- Unscrew the lid.
- Hold the bottle pointing downwards between your thumb and fingers.
- Gently tilt your or your child’s head back. Pull down your eyelid with a clean finger until a “pocket” forms 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 Travoprost Sandoz at a time (picture 3).
- When you have taken Travoprost Sandoz, make sure 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 Travoprost Sandoz from getting out into the rest of the body.
- Repeat the steps for your other eye if you are taking 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 Travoprost Sandoz and the other eye preparations.
If you have used too much Travoprost Sandoz
Rinse out all the medicine with lukewarm water. Do not take any more drops until it is time for the next regular dose.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to use Travoprost Sandoz
Continue with the next dose as scheduled. Do not take a double dose to make up for a missed dose. Never use more than one drop per day in the affected eye(s).
If you stop using Travoprost Sandoz
Do not stop using Travoprost Sandoz 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 using the drops unless the side effects are severe. If you are worried, ask your doctor or pharmacist. Do not stop taking Travoprost Sandoz without first talking to your doctor.
The following side effects have been seen with Travoprost Sandoz:
Very common (may affect more than 1 in 10 users):
Effects on the eyes:
- redness in the eye
Common (may affect up to 1 in 10 users):
Effects on the eyes:
- change in iris color (the colored part of the eye)
- eye pain
- discomfort in the eye
- dry eyes
- itchy eyes
- eye irritation
Uncommon ( may affect up to 1 in 100 users):
Effects on 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 )
- the lower eyelid turns outward in an abnormal way
- clouding of the eye
- crusting on the eyelid
- growth of eyelashes
General side effects:
- increased allergic symptoms
- headache
- irregular heartbeats
- cough
- nasal congestion
- throat irritation
- darker skin around the eye(s).
- skin color change
- abnormal hair quality
- strong hair growth
Rare (may affect up to 1 in 1,000 users):
Effects on the eye:
- flashes of light
- Eczema on the eyelids
- misdirected eyelashes that grow backward towards the eye
- swollen eyes
- impaired vision
- halo phenomenon
- reduced sensation in the eye
- inflammation of the glands in the eyelids
- pigmentation inside the eye
- increased pupil size
- altered hair quality in the eyelashes
- discolored eyelashes ar
- tired eyes
General side effects:
- viral infection in the eye
- dizziness
- bad taste in the mouth
- irregular or slower heart rate
- high or low blood pressure
- breathing abnormalities
- respiratory distress
- asthma
- allergy in the nose
- pain in the mouth or throat
- dryness of the nose
- voice changes
- discomfort or ulcers in the gastrointestinal tract
- constipation
- dry mouth
- redness or itching of the skin
- rash
- changed hair color
- loss of eyelash ar
- joint pain
- pain in muscles and bones
- general weakness
Has been reported (occurring in an unknown number of users):
Effects on the eye:
- inflammation of the back of the eye
- the eyes look more sunken
General side effects:
- Depression
- concern
- insomnia
- sense of false movement
- ringing in the ears
- chest pain
- faster heartbeat
- abnormal heart rhythm
- worsening asthma
- diarrhea
- nosebleed
- 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 Travoprost Sandoz 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 to store Travoprost Sandoz
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton, bag, and bottle label after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
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 label of each bottle and carton.
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. One ml of solution contains 40 micrograms of travoprost.
- Other ingredients are benzalkonium chloride solution, macrogol glycerol hydroxy stearate 40, trometamol, disodium edetate, 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
Travoprost Sandoz eye drops are a clear, colorless slightly yellow solution. This medicinal product is filled to 2.5 ml in a 4 ml oval bottle with a polypropylene dropper tip and a polypropylene screw cap and placed in a protective bag.
Pack sizes: 1, 3, or 6 dropper containers
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
SA Alcon-Couvreur NV, Rijksweg 14, B-2870 Puurs, Belgium