40 micrograms / ml eye drops, solution
travoprost
1. What Bondulc is and what it is used for
Bondulc contains travoprost and belongs to a group of medicines called prostaglandin analogue you . It works by reducing the pressure in the eye. It can be used alone or together with other drops e.g. beta blockers that also lower the pressure.
Bondulc 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 Bondulc may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.
2. What you need to know before using Bondulc
Do not use Bondulc
- if you are allergic to travoprost or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Bondulc
- Bondulc can increase the length, thickness, color and / or number of your eyelashes are . Changes in the eyelids including unusual hair growth or tissuearound the eye have also been observed.
- Bondulc can change the color of the iris (the colored part of your eye). This change may be permanent. A change in the skin color around the eye may also occur.
- If you have had cataract surgery , talk to your doctor before using Bondulc.
- If you have or have had an eye infection ( iritis or uveitis ), talk to your doctor before using Bondulc.
- Bondulc may in rare cases cause shortness of breath or wheezing or worsen asthma symptoms . If you are concerned about changes in your breathing patterns while using this medicine, talk to your doctor as soon as possible.
- Bondulc 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 especially important in women who are pregnant or trying to become pregnant.
- If you use soft contact lenses, do not take the drops while the lenses are in. Wait at least 15 minutes after using the drops before inserting the lenses into the eye again.
Children and young people
Bondulc can be used in children from 2 months to 18 years with the same dosage as for adults.
Bondulc is not recommended for use in children below 2 months.
Other drugs and Bondulc
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 Bondulc if you are pregnant. If you think you may be pregnant, talk to your doctor straight away. If you can get pregnant, you must use a suitable contraceptive while using this medicine.
Do not use Bondulc if you are breast-feeding. Bondulc can pass into breast milk.
Talk to your doctor before using this medicine.
Driving and using machines
You may find that your vision becomes foggy immediately after using Bondulc. Do not drive or operate machinery until it has disappeared.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Bondulc 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 for the contact lenses to be re-inserted.
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 experience irritation, tingling or pain in the eye after using the medicine, consult a doctor.
Bondulc contains macrogolglycerol hydroxystearate
May cause skin reactions.
3. How to use Bondulc
Always use this medicine exactly as your doctor or your doctor has told you. If you are not sure, talk to your or your child’s doctor or pharmacist.
The recommended dose is:
A drop in the affected eye or eyes, once daily – in the evening. Only use Bondulc in both eyes if your doctor has prescribed it. Use this medicine for as long as your or your child’s doctor prescribes it.
Use Bondulc only to drip 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 the use of Bondulc and the other eye preparations.
If you forget to use Bondulc
Continue with the next dose as planned. Never take a double dose to make up for a forgotten dose . Never use more than 1 drop per day in the affected eye (s).
If you stop using Bondulc
Do not stop using this medicine without first talking to your or your child’s doctor. Otherwise, the pressure in your or your child’s eye can not be controlled and this can lead to vision loss.
If you have any further questions on the use of this product, ask your doctor or pharmacist .
4. 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 concerned, talk to a doctor or pharmacist. Do not stop using Bondulc without first talking to your or your child’s doctor.
The following side effects have been seen with Bondulc
Very common : may affect more than 1 in 10 people
Eye effects: redness of the eye
Common: may affect up to 1 in 10 people
Effects in the eyes: change in iris color (the colored part of the eye), pain or discomfort in the eye, dryness in the eye, itching in the eye, irritation in the eye.
Uncommon: may affect up to 1 in 100 people
Effects in the eyes: disorders of the cornea, eye inflammation, iris inflammation ,inflammation of the eye, inflammation of the surface of the eye with / without damage to the surface, photosensitivity, secretions from the eye, eyelid inflammation, redness of the eyelid, swelling around the eye, itching of the eyelid, poor eyesight, blurred vision, increased tear production, infection or inflammation of the conjunctiva ( conjunctivitis ), the lower eyelid is turned out in an abnormal way, cloudiness in the eye, crust formation on the eyelid, growth of the eyelash one, discoloration of the eyelashes , tired eyes.
General side effects: increased allergic symptoms, headache, dizziness, irregular heartbeat, shortness of breath, asthma , nasal congestion, throat irritation, darker skin around the eye / eyes, darker skin, abnormal hair structure, excessive hair growth.
Rare: may affect up to 1 in 1,000 people
Effects in the eyes: flashes of light, eczema on the eyelids, eye swelling, halo effect, decreased sensation in the eye, inflammation of the glands in the eyelids,pigmentation in the eye, increased pupil size, altered structure of the eyelashes .
Common side effects are : viral infection of the eye, bad taste in the mouth, irregular or slower heart rate, increased or decreased blood pressure , cough, voice changes, stomach upset or ulcers , constipation, dry mouth , redness or itching of the skin, rash, altered hair color, loss of eyelashes , musculoskeletal pain, general weakness, breathing problems, sore throat.
No known frequency: cannot be calculated from the available data
Effects in the eyes: inflammation in the back of the eye, the eyes look sunken
General side effects: depression, anxiety, feeling of false movements, ringing in the ears, chest pain, worsening asthma , diarrhea, abdominal pain, nausea, itching , abnormal hair growth, joint pain, pain when urinating and involuntary urination, increased prostate- specific antigen , increased heart rate antigen .
In children and adolescents, the most common side effects with Bondulc are rednessof the eye and growth of the eyelashes . The incidence of these two side effects was higher in children and adolescents than in adults.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Bondulc
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 bottle 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 opening it for the first time.
Before opening, store the bottle in the protective bag. Moisture sensitive.
After first opening, no special storage instructions.
You must discard the bottle 4 weeks after you first opened it to prevent infection, and use a new bottle. Write down the date you opened the bottle in the space provided on the bottle label and carton.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is travoprost. Each ml contains 40 micrograms travoprost.
- The other ingredients are benzalkonium chloride solution, macrogolglycerol hydroxystearate 40, trometamol, disodium edetate, boric acid (E284), mannitol (E421), sodium hydroxide for pH adjustment, and water for injections or purified water.
What the medicine looks like and the contents of the pack
Bondulc eye drops , solution is a clear, colorless solution contained in transparent 5-mL polypropylene bottles with transparent low-density polyethylene (LDPE) dropper tips and white high-density polyethylene (HDPE) guarantee sealed screw cap packaged in protective bags. Each bottle contains 2.5 ml of solution.
The medicine is available in the following pack sizes:
Cardboard packaging with 1 or 3 bottles.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegur 76-78, IS-220 Hafnarfjörður, Iceland
Local representative
Manufacturer
BALKANPHARMA-RAZGRAD AD
68 April Blvd., Razgrad, 7200, Bulgaria
PHARMATHEN SA
Dervenakion 6, Pallini 15351, Attikis, Greece
JADRAN – GALENSKI LABORATORIJ dd
Svilno 20, Rijeka 51000
Croatia