40 micrograms/ml eye drops, solution
travoprost
What Travoprost STADA is and what it is used for
Travoprost Stada 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 Stada 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.
Travoprost contained in Travoprost Stada 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 STADA
Do not use Travoprost STADA
- 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
- Travoprost Stada 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 Stada 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 Stada.
- If you have or have had eye inflammation ( iritis and uveitis ), talk to your doctor before using Travoprost Stada.
- Travoprost Stada can rarely cause shortness of breath or wheezing or worsen symptoms of asthma. If you are worried about changes in your breathing pattern while using Travoprost Stada, 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
Travoprost Stada can be used in children from 2 months to 18 years with the same dosage as for adults.
Use of Travoprost Stada is not recommended for children under 2 months.
Other medicines and Travoprost STADA
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 Stada 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 Travoprost Stada.
Do not use Travoprost Stada if you are breastfeeding. Travoprost Stada can pass into breast milk.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult a doctor before using any medicine.
Driving ability and use of machinery
You may experience that your vision becomes blurry immediately after taking Travoprost Stada. You should not drive or operate 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 STADA contains benzalkonium chloride and macrogol glycerol hydroxy stearate 40
This medicine contains 0.15 mg of benzalkonium chloride in each 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.
This medicine contains macrogol glycerol hydroxy stearate 40, which may cause skin reactions.
How to use Travoprost STADA
One drop in the affected eye or eyes, once daily – in the evening.
Only use Travoprost Stada 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 Travoprost Stada only to drop into your or your child’s eye(s).
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 Stada and the other eye preparations.
If you or your child has used too much Travoprost STADA
Rinse off all medication with warm water. Do not take any more drops until it is time for your 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. Do this even if you/the child do not notice any symptoms.
If you forget to use Travoprost STADA
Continue with the next dose as scheduled. Do not take a double dose to make up for a missed dose. Never use more than 1 drop per day in the affected eye(s).
If you stop using Travoprost STADA
Do not stop using Travoprost Stada 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 Travoprost Stada without talking to your or your child’s doctor.
The following side effects have been seen with travoprost:
Very common side effects: may affect more than 1 in 10 users
Effects on the eyes:
- redness in the eye.
Common side effects: 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 side effects: 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).
- darker skin
- abnormal hair quality
- strong hair growth.
Rare side effects: 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
- thickened eyelashes ar
- discolored eyelashes ar
- tired eyes.
General side effects are :
- viral infection in the eye
- dizziness
- bad taste in the mouth
- irregular or slower heart rate
- high or low blood pressure
- respiratory distress
- asthma
- allergy or inflammation of the nose
- 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
- abnormal heart rhythm
- faster heartbeat
- 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 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 STADA
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the label and carton after EXP. The expiration date is the last day of the specified month.
Do not use this medicine if you notice that the seal has been broken or damaged before you first open it.
Before opening, keep the dropper container in the protective bag to protect it from moisture.
After the first opening, this medicine does not require special storage instructions.
You must discard the drip container 4 weeks after you first open it to prevent infection, and use a new drip container. Write the date you opened it in the space provided on the label on each dropper container 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. This medicine contains 40 micrograms/ml of travoprost.
- Other ingredients are benzalkonium chloride, macrogol glycerol hydroxy stearate 40, trometamol, disodium edetate, boric acid (E284), mannitol (E421), sodium hydroxide for pH adjustment, and water for injections or purified water.
Appearance and package sizes of the medicine
Travoprost Stada is a clear, colorless solution supplied in packs containing a transparent 5 ml dropper container with a transparent low-density polyethylene (LDPE) dropper tip and a white high-density polyethylene (HPDE) child-resistant screw cap, the pack is in a protective bag. Each drop container contains 2.5 ml of eye drops.
The product is supplied in the following packaging sizes;
Carton containing 1, 3, 6, 9, 10, or 12 drop containers.
Not all pack sizes may be marketed.
Marketing authorization holder and manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
Pharmathen SA
6 Dervenakion str. 15351, Pallini, Attica
Greece
BALKANPHARMA-RAZGARD AD
68 Aprilsko vastanie Blvd., Razgrad, 7200
Bulgaria
STADA Arzneimittel GmbH
Muthgasse 36, 1190 Vienna
Austria
Centrafarm Services BV
Nieuwe Donk 9, 4879 AC Etten-Leur
Netherlands
JADRAN – GALENSKI LABORATORY dd
Svilno 20, Rijeka, 51000
Croatia
Local Representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark