Timoptol 0.5% w/v Eye Drops Solution

• 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.

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

• you are allergic (hypersensitive) to timolol, beta-blockers or any of the other ingredients of Timoptol (see section 6: Contents of the pack and other information )
• you have now or have had in the past respiratory problems such as asthma, severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough)
• you have heart problems
• slow heart beat
• disorders of heart rhythm (irregular heart beats)
• heart failure
  • “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.

Talk to your doctor before taking Timoptol if you have now or have had in the past

• coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking), heart failure
• low blood pressure
• disturbances of heart rate such as slow heart beat
• breathing problems, asthma or chronic obstructive pulmonary disease
• poor blood circulation disease (such as Raynaud's disease or Raynaud's syndrome)
• diabetes as timolol may mask signs and symptoms of low blood sugar
• overactivity of the thyroid gland as timolol may mask signs and symptoms
• you wear soft contact lenses (see section Timoptol contains benzalkonium chloride and phosphates).

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:

• you get an eye infection
• you injure your eye or have an operation on it
• your eye problems get worse or you get any new symptoms.

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, has been studied in infants and children aged 12 days to 5 years, who have elevated pressure in the eye(s) or have been diagnosed with glaucoma. For more information, talk to your doctor.

Timoptol 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.

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:

• a calcium antagonist, such as nifedipine, verapamil or diltiazem, often used to treat high blood pressure, angina, an abnormal heartbeat or Raynaud’s syndrome
• digoxin, a medicine used to relieve heart failure or treat abnormal heartbeat
• medicines known as catecholamine-depleting agents, such as rauwolfia alkaloids or reserpine, used for high blood pressure
• medicines called pressor amines, such as adrenaline used to treat severe allergic reaction
• quinidine (used to treat heart conditions and some types of malaria)
• antidepressants known as fluoxetine and paroxetine
• clonidine, a medicine used to treat high blood pressure
• other beta-blockers taken by mouth or used as eye drops, because they belong to the same group of medicines as Timoptol and could have an additive effect

Ask your doctor for advice before taking any medicine.

Use in pregnancy

Do not use Timoptol if you are pregnant unless your doctor considers it necessary.

Use in breast-feeding

Do not use Timoptol if you are breast-feeding. Timolol may get into your milk. Ask your doctor for advice before taking any medicine during breast-feeding.

There are possible side effects associated with Timoptol, such as dizziness, tiredness and changes in your eyesight, such as blurred vision, drooping of the upper eyelid (making the eye stay half closed), double vision 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.

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

• disodium phosphate dodecahydrate (29.21 mg/ml for Timoptol 0.25%, 30.42 mg/ml for Timoptol 0.5%)
• sodium dihydrogen phosphate dihydrate (8.15 mg/ml for Timoptol 0.25%, 6.10 mg/ml for Timoptol 0.5%)

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.

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.

Before you or your child starts to take Timoptol, your doctor or your child's doctor will have carried out a detailed medical examination and decided whether or not this medicine is suitable. You or your child, especially a newborn, should be closely monitored for one to two hours after the first dose and carefully monitored for any signs of side effects until surgery is carried out.

Method of administration:

One drop only of Timoptol should be instilled into the affected eye(s) each time. Follow the "Instructions for Use" above when administering the eye drops. 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 the eye drops spreading throughout the body.

Duration of treatment:

Your doctor or your child's doctor will decide for how long the eye drops will be needed.

If you put too many drops in your eye or swallow any of the drops, you may:

• have a headache
• feel dizzy or light-headed
• have difficulty breathing
• chest pain
• feel that your heart rate has slowed down.

If this happens, contact your doctor immediately.

It is important to take Timoptol as prescribed by your doctor.

• If you miss a dose, use the drops as soon as possible.
• If it is almost time for the next dose, skip the missed dose and take the next dose at the usual time.
• Do not take a double dose to make up for the forgotten dose.

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.

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.

United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

The active substance is timolol maleate.

Timoptol is available in two strengths:

• 0.25% w/v solution of timolol (as maleate)
• 0.5% w/v solution of timolol (as maleate).

The other ingredients are:

• benzalkonium chloride as preservative
• disodium phosphate dodecahydrate E339
• sodium dihydrogen phosphate dihydrate E339
• sodium hydroxide
• water for injections.

See section 2 ‘Timoptol contains benzalkonium chloride and phosphates’.

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.

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