40 micrograms/ml + 5 mg/ml eye drops , solution
travoprost/timolol
What Travoprost/Timolol STADA is and what it is used for
Travoprost/Timolol Stada eye drops, solution is a combination of two active substances (travoprost and timolol ). Travoprost is a prostaglandin analog, which works by increasing the outflow of fluid in the eye, which lowers the pressure in the eye. Timolol is a beta blocker, which works by reducing the production of fluid in the eye. The two substances work together to reduce eye pressure.
Travoprost/Timolol Stada is used to treat high pressure in the eye in adults, including the elderly. Too high pressure can lead to a disease called glaucoma.
Travoprost and timolol contained in Travoprost/Timolol 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/Timolol STADA
Do not use Travoprost/Timolol STADA
- if you are allergic to travoprost, prostaglandins, timolol, beta-blockers, or any other ingredient in this medicine (listed in section 6)
- if you currently have or have had breathing problems such as asthma, severe chronic obstructive bronchitis (severe lung disease that can cause wheezing, difficulty breathing, and/or persistent coughing), or other types of breathing problems
- if you have severe hay fever
- if you have a slow heart rate, heart failure, or a condition that affects the rhythm of the heart (irregular heartbeat)
- if the surface of your eye is cloudy.
Ask your doctor for advice if any of these apply to you.
Warnings and precautions
Talk to your doctor before using Travoprost/Timolol Stada, if you currently have or have previously had:
- coronary artery disease (symptoms may include chest pain or tightness, shortness of breath or choking), heart failure, low blood pressure
- heart rate disturbances such as slow heartbeats
- breathing problems, asthma, or chronic obstructive pulmonary disease
- disease with reduced blood circulation (e.g. Raynaud’s disease or Raynaud’s syndrome)
- diabetes (as timolol may mask the signs and symptoms of low blood sugar)
- overactive thyroid (as timolol may mask signs and symptoms)
- myasthenia gravis ( chronic neuromuscular weakness)
- operated on for cataracts
- eye inflammation.
If you are going to undergo any kind of surgery, tell the doctor that you are using Travoprost/Timolol Stada because timolol can change the effects of some medicines during anesthesia.
If you have a serious allergic reaction (rash, redness, or itching of the eye) when using Travoprost/Timolol Stada, regardless of the cause, it is possible that adrenaline treatment will not help as usual. When receiving any other treatment, you should inform the doctor that you are being treated with Travoprost/Timolol Stada.
Travoprost/Timolol Stada can change the color of the iris (the colored part of your eye). This change can be permanent.
Travoprost/Timolol Stada can increase the length, thickness, color, and/or a number of eyelashes and can cause unusual hair growth on your eyelids.
Travoprost can be absorbed through the skin and should therefore not be used by women who are pregnant or trying to become pregnant. If the medicine comes into contact with the skin, it should be washed off immediately.
Children and young people
Travoprost/Timolol Stada is not intended for use by children and adolescents under the age of 18.
Other medicines and Travoprost/Timolol STADA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Travoprost/Timolol Stada can affect or be affected by other medicines that you use, including other eye drops for the treatment of glaucoma. Tell your doctor if you are using or intend to use
- drugs for high blood pressure,
- heart medicines such as quinidine (used to treat heart conditions and some types of malaria ),
- medicines for diabetes or antidepressants such as fluoxetine and paroxetine.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
Do not use Travoprost/Timolol Stada if you are pregnant, unless your doctor considers it necessary. If you can become pregnant, you must use effective contraception while using this medicine.
Do not use Travoprost/Timolol Stada if you are breastfeeding. This medicine can pass into breast milk.
Driving ability and use of machinery
You may experience that your vision becomes foggy immediately after taking Travoprost/Timolol Stada. Do not drive or use tools or machines 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/Timolol STADA contains benzalkonium chloride and macrogol glycerol hydroxy stearate 40
Travoprost/Timolol Stada contains benzalkonium chloride
This medicine contains 150 micrograms of benzalkonium chloride in each ml of eye drops, solution. 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.
Travoprost/Timolol Stada contains macrogol glycerol hydroxy stearate 40
This medicine contains macrogol glycerol hydroxy stearate 40, which may cause skin reactions.
How to use Travoprost/Timolol STADA
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The recommended dose is
One drop in the affected eye or eyes, once daily in the morning or evening. Take the medicine at the same time every day.
Use Travoprost/Timolol Stada in both eyes only if your doctor has prescribed it. Use the drops for as long as your doctor has prescribed.
Travoprost/Timolol Stada should only be used as drops in your eyes.
Instructions for use
If a drop misses the eye, try again.
If you have used too much Travoprost/Timolol STADA
If you have used too much Travoprost/Timolol Stada, wash it all off 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, If a child has ingested the medicine by mistake, immediately contact a doctor or hospital for an assessment of the risk and advice.
If you forget to use Travoprost/Timolol STADA
If you forget to use Travoprost/Timolol Stada, continue with the next dose as scheduled. Do not take a double dose to make up for a missed dose. Does one should not exceed one drop in each affected eye per day.
If you stop using Travoprost/Timolol STADA
If you stop using Travoprost/Timolol Stada without talking to your doctor, the pressure in your eye cannot be controlled and this can lead to vision loss.
If you use other eye drops in addition to Travoprost/Timolol Stada, wait at least 5 minutes between taking Travoprost/Timolol Stada and the other drops.
If you wear soft contact lenses, do not use the drops with the contact lenses still in your eyes. Wait 15 minutes after instilling the eye drops before putting the lenses back in your eyes.
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, talk to a doctor or pharmacist. Do not stop using Travoprost/Timolol Stada without talking to your doctor.
Very common side effects ( may affect more than 1 in 10 users)
Effects on the eyes
Eye redness.
Common side effects ( may affect up to 1 in 10 users)
Effects on the eyes
Inflammation of the surface of the eye with surface damage, eye pain, blurred vision, abnormal vision, dry eyes, eye itching, eye discomfort, and signs and symptoms of eye irritation (eg burning, pain).
Uncommon side effects ( may affect up to 1 in 100 users)
Effects on the eyes
Inflammation of the surface of the eye, inflammation of the eyelid, swollen conjunctiva, increased growth of eyelashes, iris inflammation, eye inflammation, light sensitivity, reduced vision, tired eyes, eye allergy, eye swelling, increased tear production, eyelid redness, change in the color of the eyelid, darkening of the skin (around the eye).
General effects
Allergic reaction to the active substance, dizziness, headache, increased or decreased blood pressure, shortness of breath, increased hair growth, drip at the back of the throat, skin inflammation and itching, and slower heartbeat.
Rare side effects ( may affect up to 1 in 1,000 users)
Effects on the eyes
Thinning of the surface of the eye, inflammation of the eyelid glands, broken blood vessels in the eye, crust formation on the eyelids, abnormally placed eyelashes, and abnormally increased growth of eyelashes.
General effects
Nervousness, irregular heartbeat, hair loss, voice problems, difficulty breathing, cough, throat irritation, hives, abnormal liver values, skin discoloration, thirst, fatigue, discomfort inside the nose, colored urine, and pain in hands and feet.
Has been reported (occurring in an unknown number of users)
Effects on the eyes
Droopy eyelids (causes the eye to remain half-closed), sunken eyes, change in color of the iris (colored part of the eye).
General effects:
Rash, heart failure, chest pain, stroke, fainting, depression, asthma, increased heart rate, numbness or tingling, palpitations, swelling of the lower legs, and bad taste in the mouth.
In addition:
Travoprost/Timolol Stada is a combination of two active substances. Like other medicines administered (given) into the eyes, travoprost and timolol (a beta-blocker ) are absorbed into the blood. This can cause similar side effects to those observed when beta-blocking drugs are administered orally or via injection. The occurrence of side effects after administration in the eyes is lower than after administration by mouth or via injection.
The side effects listed below have not been reported for Travoprost/Timolol Stada but include reactions seen with the beta-blocker class when used to treat eye conditions or reactions seen with travoprost alone:
Eye effects
inflammation of the eyelid, inflammation of the cornea, detachment of the layer under the retina containing blood vessels after filtration surgery, which can cause visual disturbances, reduced sensitivity of the cornea, erosion of the cornea (damage to the front layer of the eyeball), double vision, watery eye, swelling around the eye, itching of the eyelids, the eyelid turns outwards with redness, irritation and increased tearing, blurred vision (signs of clouding of the eye’s lens), swelling of part of the eye (uvea), eczema on the eyelids, halo effect (rings of light around a bright spot), reduced sensation in the eye, pigmentation inside the eye, enlarged (dilated) pupils, discoloredeyelashes, the altered texture of the eyelashes, abnormal field of vision.
General effects
Ears and organs of balance
Vertigo is accompanied by a feeling of spinning, ringing in the ears.
Heart and blood circulation
Slow heartbeat, palpitations, edema (fluid accumulation), change in the rhythm or speed of the heartbeat, chronic heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid accumulation), a type of heart rhythm disorder, heart attack, low blood pressure, Raynaud’s phenomenon, cold hands, and feet, reduced blood supply to the brain.
The respiratory tract
Constriction of the airways in the lungs (especially in patients with pre-existing disease), runny nose or nasal congestion, sneezing (due to allergy ), difficulty breathing, nosebleeds, and dry nose.
Nervous system and general symptoms
Difficulty sleeping (insomnia), nightmares, memory loss, loss of strength and energy, hallucination, anxiety (excessive emotional distress).
Gastrointestinal
Taste changes, nausea, upset stomach, diarrhea, dry mouth, abdominal pain, vomiting, and constipation.
Allergy
Increased allergic symptoms, generalized allergic reactions, including swelling under the skin that can occur in places such as the face and arms, and legs and may obstruct the airways which may cause difficulty in swallowing or breathing, limited and generalized rash, itching, severe, sudden life-threatening allergic reaction.
Skin
Skin rash with a white silvery colored appearance (psoriasis-like rash) or worsening of psoriasis, scaly skin, abnormal hair quality, inflammation of the skin with an itchy rash and redness, change in hair color, loss of eyelashes, itching, abnormal hair growth, skin redness.
Muscles
Increased signs and symptoms of myasthenia gravis (muscle disorder), unusual sensations such as tingling in the skin. Muscle weakness/muscle fatigue, muscle pain not caused by exercise, joint pain.
Kidneys and urinary tract
Difficulty and pain when urinating, involuntary leakage of urine.
The reproductive organs
Impaired sexual ability, reduced sexual desire.
Metabolism
Low blood sugar levels, elevated prostate-specific antigen.
How to store Travoprost/Timolol STADA
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton, protective bag, and bottle after “EXP”. The expiration date is the last day of the specified month.
Before opening: no special temperature instructions. Keep the bottle in the protective bag. Light sensitive.
After the first opening: no special storage instructions.
To prevent infection, you must discard the bottle 4 weeks after opening it, and take a new bottle instead. Write the date you opened the bottle in the space provided on 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 substances are travoprost and timolol.
Each ml of solution contains 40 micrograms of travoprost and 5 mg of timolol (as timolol maleate).
Other ingredients are benzalkonium chloride, macrogol glycerol hydroxy stearate 40, trometamol, disodium edetate, boric acid (E284), mannitol (E421), sodium hydroxide (to adjust pH ), and purified water.
Appearance and package sizes of the medicine
Travoprost/Timolol Stada eye drops, solution is a clear, colorless aqueous solution, practically free of particles, supplied in a plastic bottle (5 ml) with a colorless dropper tip and white, opaque cap with safety closure.
Each bottle is packed in a protective bag. Each bottle contains 2.5 ml of solution.
The product is available in the following pack sizes: 1, 3, or 6 bottles.
Not all pack sizes may be marketed.
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
Pharmathen SA
6 Dervenakion Str, 15351 Pallini, Attiki
Greece
Balkanpharma-Razgrad AD
68 Aprilsko vastanie Blvd., 7200 Razgrad
Bulgaria
JADRAN – GALENSKI LABORATORY dd
Svilno 20, Rijeka, 51000
Croatia
Local Representative
STADA Nordic ApS
Marielundvej 46A
2730 Herlev
Denmark