Timoptol 0.25% w/v eye drops, solution
Timoptol 0.5% w/v eye drops solution
timolol (as maleate)
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Timoptol is and what it is used for
2. What you need to know before you use Timoptol
3. How to use Timoptol
4. Possible side effects
5. How to store Timoptol
6. Contents of the pack and other information
Timoptol contains a substance called timolol which belongs to a group of medicines called beta-blockers. Timolol lowers the pressure in your eye(s). It is used to treat glaucoma, when the pressure in the eye is raised.
Do not use Timoptol if:
- “cardiogenic shock” – a serious heart condition caused by very low blood pressure, which may result in the following symptoms: dizziness and lightheadedness, fast pulse rate, white skin, sweating, restlessness, loss of consciousness.
If you are not sure whether you should use Timoptol talk to your doctor or pharmacist.
Warnings and precautions
Talk to your doctor before taking Timoptol if you have now or have had in the past.
Tell your doctor before you have an operation that you are using Timoptol as timolol may change effects of some medicines used during anaesthesia.
If your eye becomes irritated or any new eye problems come on, talk to your doctor straight away. Eye problems could include redness of the eye or swelling of the eyelids (see Section 4: Possible Side Effects).
If you suspect that Timoptol is causing an allergic reaction or hypersensitivity (for example, skin rash, or redness and itching of the eye), stop using Timoptol and contact your doctor immediately.
Tell your doctor if:
Children and adolescents
Timoptol eye drops solution should generally be used with caution in young patients. In newborns, infants and younger children Timoptol should be used with extreme caution. If coughing, wheezing, abnormal breathing or abnormal pauses in breathing (apnoea) occur, the use of the medication should be stopped immediately. Contact your doctor as soon as possible. A portable apnoea monitor may also be helpful.
There is only very limited data available on the use of timolol in infants and children. For example, in one small clinical study, timolol, the active ingredient in Timoptol eye drops, was studied in infants and children aged 12 days to 5 years, who have raised pressure in the eye(s) or have been diagnosed with glaucoma. For more information, talk to your doctor.
Other medicines and Timoptol
Timoptol can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma. Tell your doctor if you are using or intend to use medicines to lower blood pressure, heart medicine or medicines to treat diabetes. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including other eye drops or medicines obtained without a prescription.
It is important to tell your doctor before using Timoptol if you are taking one or more of the following medicines:
Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine.
Use in pregnancy
Do not use Timoptol during pregnancy unless your doctor considers it necessary.
Use in breast-feeding
Do not use Timoptol if you are breastfeeding. Timolol may get into your milk. Ask your doctor for advice before taking any medicine during breast-feeding.
Driving and using machines
There are possible side effects associated with Timoptol, such as dizziness and changes in your eyesight, which may affect your ability to drive and/or operate machinery. Do not drive and/or operate machinery until you feel well and your vision is clear.
Timoptol contains benzalkonium chloride and phosphates
This medicine contains 0.10 mg/ml benzalkonium chloride as a preservative. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.
This medicine contains the following phosphates
If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.
Always use Timoptol eye drops solution exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The doctor will decide how many drops you should take each day and how long you should use them.
The usual dose is one drop in the affected eye(s) twice each day:
Do not change your usual dose without talking to your doctor.
Do not allow the tip of the bottle to touch the eye or areas around the eye. It may become contaminated with bacteria that can cause eye infection leading to serious damage of the eye, even loss of vision. To avoid possible contamination of the bottle, keep the tip of the bottle away from contact with any surface.
Instructions for use.
Do not use the bottle if the plastic safety strip around the neck is missing or broken. When opening the bottle for the first time, tear off the plastic safety strip.
Every time you use Timoptol:
1. Wash your hands.
2. Open the bottle. Take special care that the tip of the dropper bottle does not touch your eye, the skin around your eye or your fingers.
3. Tilt your head backwards and hold the bottle upside down over the eye.
4. Pull the lower eyelid downwards and look up. Hold and gently squeeze the bottle on the flattened sides of the bottle and let one drop fall into the space between the lower eyelid and the eye.
5. Press a finger into the corner of your eye, by the nose, or close your eyelids for 2 minutes. This helps to stop the medicine from getting into the rest of the body.
6. Repeat steps 3 to 5 with the other eye if instructed to do so by your doctor.
7. Put the cap back on and close the bottle tightly.
Ophthalmic medications, if handled improperly, can become contaminated by common bacteria known to cause infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated ophthalmic medications. If you think your medication may be contaminated, or if you develop an eye infection, contact your doctor immediately concerning continued use of this bottle.
Use in children and adolescents
A detailed medical examination should precede the use of Timoptol. Your doctor will carefully evaluate the risks and benefits when considering treatment with Timoptol. If the benefits outweigh the risks, it is recommended to use the lowest active agent concentration available once daily. With regard to “the use in children”, the 0.1% active agent concentration may be sufficient to control pressure within the eye. If the pressure is not sufficiently controlled with this dosage, a twice daily application at 12-hourly intervals may be necessary. Patients, especially newborn, should be closely observed for one to two hours after the first dose and careful monitoring for adverse events should be carried out until surgery is performed.
Method of administration:
One drop only of Timoptol should be instilled per dosing time. After instillation keep the eyes closed for as long as possible (e.g. 3 – 5 minutes) and apply pressure to the corner of the eye closest to the nose to prevent Timoptol eye drops spreading throughout the body.
Duration of treatment:
For a transient treatment in the paediatric population.
If you use more Timoptol than you should
If you put too many drops in your eye or swallow any of the drops, you may:
If this happens, contact your doctor immediately.
If you forget to use Timoptol
It is important to take Timoptol as prescribed by your doctor.
If you stop using Timoptol
If you want to stop using this medicine talk to your doctor first. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. If they do occur, you may need medical attention.
You can usually carry on taking the drops, unless the effects are serious. If you’re worried, talk to a doctor or pharmacist. Do not stop Timoptol without speaking to your doctor.
In some patients side effects may include:
Eyes and ears
Heart and circulation
Stomach and gut
Skin and hair
If you suffer from severe damage to the clear layer at the front of the eye (the cornea) phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.
Like other medicines applied into eyes, timolol is absorbed into the blood. This may cause similar side effects as seen with intravenous and/or oral beta-blocking agents. Incidence of side effects after topical ophthalmic administration is lower than when medicines are, for example taken by mouth or injected. Additional listed side effects include reactions seen within the class of beta-blockers when used for treating eye conditions:
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use Timoptol after the expiry date which is stated on the carton and the bottle after EXP. The expiry date refers to the last day of that month. Make sure the bottle is properly closed.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
What Timoptol contains
The active substance is timolol maleate.
Timoptol is available in two strengths:
The other ingredients are:
What Timoptol looks like and contents of the pack
Timoptol is a clear colourless to light yellow sterile eye drops solution and is available in bottles containing 5 ml of sterile eye drops solution.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
This leaflet was last revised in March 2020.
This leaflet gives the most important patient information about Timoptol. If you have any questions after you have read it, ask your doctor or pharmacist who will give you further information.
Further information about glaucoma is available from: