5 mg/ml eye drops, solution
Timolol
What Optimol is and what it is used for
Optimol contains a so-called beta-blocker that lowers the pressure in the eye by reducing the inflow of aqueous humor, ie. the fluid in the anterior chamber of the eye. Optimol has little or no effect on visual acuity or pupil size.
The effect usually sets in quickly, about 20 minutes after dropping the solution into the eye. The pressure drop is greatest for 1-2 hours and can last as long as 24 hours. It may take about 4 weeks before the pressure stabilizes. Optimol is used for lowering the eye pressure in chronic glaucoma ( glaucoma ), where the ventricular angle is open.
Please note that the doctor may have prescribed the medicine for different use and/or with a different dosage than what is stated in the package leaflet. Always follow your doctor’s prescription and instructions on the label of the medicine pack.
What you need to know before using Optimol
Do not use Optimol
- if you are allergic to timolol , beta- blockers or any of the other ingredients of this medicine (listed in section 6)
- if you currently have or have previously had respiratory problems, e.g. asthma , severe chronic obstructive bronchitis (a serious lung disease that can cause wheezing, wheezing and / or prolonged cough)
- if you have a low heart rate , heart failure or heart rhythm disturbances (irregular heart rhythm)
Warnings and cautions
Talk to your doctor before using Optimol if you currently have or have had
- coronary heart disease (with symptoms such as chest pain, chest tightness, shortness of breath or shortness of breath), heart failure , low blood pressure , heart rhythm disorders, e.g. slow heart rate
- respiratory problems, asthma or chronic obstructive pulmonary disease
- disease that causes impaired blood circulation (eg Raynaud’s disease , Raynaud’s syndrome or intermittent lameness, so-called window viewing disease )
- diabetes , because timolol can mask the signs and symptoms of low blood sugar
- overactive thyroid gland , as timolol can mask signs of illness and symptoms
- severely impaired renal function
- atopy or severe anaphylactic (allergic) reaction, as timolol may affect the effectiveness of adrenaline (used to treat anaphylactic reaction)
- disease of the cornea (the front layer of the eyeball), as beta- blockers can cause dry eyes.
If you are going to have an operation, you should inform your doctor that you are using Optimol, as timolol may affect the effectiveness of certain medicines used in anesthesia.
Children
In general, eye drops containing timolol should be used with caution in the case of younger patients and with extreme caution in the case of newborns, infants, or toddlers. If the child suffers from coughing, wheezing, wheezing or abnormal breathing, or abnormal pauses in breathing ( apnea ), the medication should be stopped immediately. Contact a doctor as soon as possible. Your doctor may prescribe a portable measuring device for apnea monitoring.
Eye drops with timolol have been studied in newborns and children aged 12 days to 5 years with elevated eye pressure or with a glaucoma diagnosis. Contact a doctor for further information.
Other medicines and Optimol
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Optimol eye drops can affect or be affected by other medicines you use, including other eye drops for glaucoma.
Tell your doctor if you use or intend to use
- drugs that lower blood pressure et
- heart medications
- antidiabetic drugs
- quinidine (used in heart disease and to treat certain types of malaria )
- antidepressants containing fluoxetine or paroxetine
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Do not use Optimol if you are pregnant unless your doctor tells you it’s necessary. There is a risk that the fetus is affected.
Do not use Optimol if you are breast-feeding. Timolol can be transferred to breast milk. A breastfed baby may be affected. If you are breast-feeding, talk to your doctor before taking any medicine.
Driving and using machines
Optimol eye drops can sometimes cause visual disturbances such as refraction changes, double vision, drooping eyelids, recurrent mild and transient blurred vision, and occasional cases of dizziness or fatigue.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. 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. Therefore, read all the information in this leaflet. If you are not sure, talk to your doctor or pharmacist.
Optimol contains benzalkonium chloride and phosphate buffer
This medicine contains 0.003 mg of benzalkonium chloride per drop corresponding to 0.1 mg/ml.
Benzalkonium chloride can be absorbed by soft contact lenses and may discolor the contact lenses. Remove contact lenses before using the medicine and wait at least 15 minutes before re-inserting the contact lenses.
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.
Optimol contains phosphate buffer
This medicine contains 0.3 mg phosphate per drop corresponding to 11.8 mg/ml.
If you have severely damaged cornea, in very rare cases, phosphate can cause cloudy spots on the cornea due to the accumulation of calcium during treatment.
How to use Optimol
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist for advice before taking this medicine.
Dose one is determined by the doctor who adjusts it individually for you. The recommended dose is 1 drop in the eye morning and evening. If Optimol eye drops are used in combination with other eye drops, the preparations should be given at least 5 minutes apart.
After applying Optimol, press with one finger in the corner of the eye closest to the nose (fig. 4) and hold the finger there for 2 minutes. This will prevent timolol from reaching other parts of the body.
Instructions for use
Before use:
- wash your hands
- choose the position that feels most natural to you (eg sitting down, lying on your back or standing in front of the mirror)
The eye drop bottle is personal. Never use a cloudy solution.
Application:
A tip: Feel free to keep the bottle on the bedside table and drip morning and evening in connection with getting up / going to bed.
Use for children
A thorough medical examination should be performed before using Optimol. The doctor will then make a careful assessment of the risks and benefits of treatment with Optimol. If the benefit outweighs the risks, it is recommended that the lowest available concentration of the active substance be used once daily. In the case of ‘use for children, a concentration of 0.1% of the active substance may be sufficient to keep the pressure in the eye under control. If the pressure in the eye cannot be kept under control at this dosage, treatment may need to be done twice daily at 12-hour intervals. The patient, especially in the case of a newborn baby, should be closely monitored for 1-2 hours after the first dose and closely monitored for any side effects. until an operation is performed.
Method of administration
Only 1 drop of Optimol should be dropped into the eye at each treatment occasion. After application, the eye should be kept closed for as long as possible (eg 3-5 minutes) and a finger should be kept in the inner corner of the eye to prevent Optimol from reaching the whole body.
Treatment time
For short-term treatment of children.
If you use more Optimol than you should
If you accidentally take too large a dose, rinse your eye with water. If you have any questions or concerns, you can contact a doctor or hospital for immediate assistance.
If you forget to use Optimol
Do not take a double dose to make up for a forgotten dose.
If you stop using Optimol
Do not stop taking Optimol without first talking to a doctor.
If you have any further questions on the use of this product, 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 have any further questions, ask your doctor or pharmacist.
Common side effects ( in more than 1 in 100 users)
- Signs and symptoms of eye irritation (eg burning or stinging sensation, itching , watery eyes, red eyes) and certain visual disturbances such as blurred vision.
Uncommon (1 to 10 out of 1000 users)
- Inflammation of the conjunctiva or cornea ( inflammation of the anterior parts of the eye), refraction changes (visual disturbances).
- Too low heart rate .
- Fainting, fatigue, headache, dizziness, depression.
- Nausea.
- Breathing difficulties.
Rare (in less than 1 in 1000 users)
- Allergic reactions with fever, rash or redness of the skin, subcutaneous swelling, in e.g. face, lips, arms and legs, which can cause narrowing of the airways so that it can be difficult to swallow or breathe ( angioedema ), sometimes a drop in blood pressure, sudden severe life-threatening allergic reaction .
- Chest pain, low blood pressure , palpitations, impaired heart function, changes in heart rate or rhythm, atrioventricular block (a type of heart rhythm disorder), cardiac arrest, heart failure .
- Impaired blood supply to the brain, cold hands and feet, cold white fingers due to poor blood circulation (Raynaud’s phenomenon).
- Increased symptoms and signs of myasthenia gravis , a muscle disease that causes muscle weakness.
- Nightmares, memory loss, ant crawling in the legs (restless legs), insomnia (insomnia), confusion, abnormal sensations such as tingling and ant crawling.
- Diarrhea, indigestion, dry mouth .
- Hair loss, white / silver (psoriasis-like) rash or worsening psoriasis .
- Narrowing of the airways of the lungs (especially in patients with pre-existing disease), cough, respiratory failure.
- Inflammation of the eyelids, drooping eyelids (which causes the eye to remain half closed), double vision, decreased sensitivity of the cornea, decreased tear secretion.
- Decreased sex drive.
- Tinnitus .
As with other ophthalmic drugs, timolol is absorbed into the bloodstream. This may cause side effects similar to those seen with beta-blockers taken orally (orally) or given by injection. The incidence of side effects after the drug has been dropped into the eye is lower than when the drug is taken orally or by injection. The listed adverse reactions include the following reactions seen in the beta-blocker group for use in the eyes:
- Allergic reactions affecting the whole body including hives, local or generalized rash, itching .
- Edema (fluid retention), chronic heart failure (heart disease with shortness of breath, swollen feet and legs due to fluid retention), heart attack.
- Stroke .
- Muscle pain that is not exercise-related, muscle weakness / muscle fatigue.
- Low blood sugar level.
- Taste disorders, abdominal pain, vomiting.
- Rash.
- Loosening of the blood vessel-containing membrane that lies under the retina after filtration surgery, which can cause visual disturbances, dry eyes, corneal erosion (damage to the outer layer of the eyeball).
- Impaired sexual function.
- Hallucination.
- Systemic lupus erythematosus (disease in which the immune system attacks various organs in the body. Common symptoms are joint pain, rash, fever, fatigue, sun sensitivity and hair loss).
Stop taking Optimol and contact your doctor immediately if swelling occurs e.g. face, tongue, and/or throat or if you have hives or shortness of breath or have difficulty swallowing.
How to store Optimol
- Keep this medicine out of the sight and reach of children.
- Opened drip bottle is durable for 4 weeks.
- Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
- Do not use this medicine if you notice any signs of change.
- 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.
Contents of the pack and other information
Content declaration
- The active substance is timolol maleate corresponding to 5 mg / ml timolol .
- The other ingredients are benzalkonium chloride 0.1 mg / ml ( preservative ), sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium hydroxide and water for injections.
What the medicine looks like and contents of the pack
5 ml and 3 x 5 ml.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland
Manufacturer
Santen Oy
Kelloportinkatu 1
33100 Tampere
Finland