Timoptol

Timolol maleate.

Each bottle contains 0.5% w/v solution of timolol (as maleate).
Excipients/Inactive Ingredients: The other ingredients are: benzalkonium chloride as preservative, disodium phosphate dodecahydrate E339, sodium dihydrogen phosphate dihydrate E339, sodium hydroxide, water for injections.

Timoptol contains a substance called timolol which belongs to a group of medicines called beta-blockers.

Timolol lowers the pressure in the eye(s). It is used to treat glaucoma, when the pressure in the eye is raised.

Always use Timoptol eye drops solution exactly as advised by the doctor. Check with the doctor or pharmacist if unsure. The doctor will decide how many drops should be taken each day and how long they should be used.
The usual dose is one drop in the affected eye(s) twice each day: one in the morning; one in the evening.
Do not change the usual dose without talking to the doctor.
Do not allow the tip of the container 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 container, keep the tip of the container away from contact with any surface.
Use in children and adolescents: Before the patient or the child starts to take Timoptol, the doctor or the child's doctor will have carried out a detailed medical examination and decided whether or not this medicine is suitable. The patient or the 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 Instructions for use under Cautions for Usage 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: The doctor or the child's doctor will decide for how long the eye drops will be needed.
Forgotten use of Timoptol: It is important to take Timoptol as prescribed by the doctor.
If a dose is missed, 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.
Stopping use of Timoptol: If the use of this medicine wants to be stopped, talk to the doctor first. If there are any further questions on the use of this product, ask the doctor or pharmacist.

If the patient puts too many drops in the eye or swallow any of the drops, the patient may: have a headache; feel dizzy or lightheaded; have difficulty breathing; have chest pain; feel that the heart rate has slowed down.
If this happens, the patient should contact the doctor immediately.

Do not use Timoptol if: allergic (hypersensitive) to timolol, beta-blockers or any of the other ingredients of Timoptol (see Description); with current or 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); with heart problems; with slow heartbeat; with disorders of heart rhythm (irregular heartbeats); with 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 unsure whether Timoptol should be used, talk to the doctor or pharmacist.

Talk to the doctor before taking Timoptol if with current or 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 heartbeat; 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; wearing of soft contact lenses (see Timoptol contains benzalkonium chloride and phosphates as follows).
Tell the doctor that Timoptol is being used before having an operation as timolol may change effects of some medicines used during anaesthesia.
If the eye becomes irritated or any new eye problems occur, talk to the doctor straight away. Eye problems could include redness of the eye or swelling of the eyelids (see Side Effects).
If it is suspected 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 the doctor immediately.
Tell the doctor if: an eye infection occurs; the eye is injured or there had been an operation on it; the eye problems get worse or any new symptoms occur.
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. The patient should remove contact lenses before using this medicine and put them back 15 minutes afterwards.
Benzalkonium chloride may also cause eye irritation, especially if the patient has dry eyes or disorders of the cornea (the clear layer at the front of the eye). If abnormal eye sensation, stinging or pain in the eye is felt after using this medicine, talk to the doctor.
Timoptol 0.5% contains disodium phosphate dodecahydrate and sodium dihydrogen phosphate dihydrate. If the patient suffers 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.
Driving and using machines: There are possible side effects associated with Timoptol, such as dizziness, tiredness and changes in eyesight, such as blurred vision, drooping of the upper eyelid (making the eye stay half closed), double vision which may affect the ability to drive and/or operate machinery. Do not drive and/or operate machinery until feeling well and vision is clear.
Use in Children: 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 the 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 the doctor as soon as possible. A portable apnoea monitor may also be helpful.

Ask the doctor for advice before taking any medicine.
Use in Pregnancy: Do not use Timoptol if pregnant unless the doctor considers it necessary.
Use in Breast-feeding: Do not use Timoptol if breast-feeding. Timolol may get into the milk. Ask the doctor for advice before taking any medicine during breast-feeding.

Like all medicines, Timoptol can cause side effects, although not everybody gets them.
Taking the drops can usually be carried on, unless the effects are serious. If worried, talk to a doctor or pharmacist. Do not stop using Timoptol without speaking to the doctor.
Like other medicines applied into the 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. Listed side effects include reactions seen within the class of beta-blockers when used for treating eye conditions.
If allergic reactions develop, including swelling beneath the skin that can occur in areas such as the face and limbs, and can obstruct the airway which may cause difficulty swallowing or breathing, hives or itchy rash, localized and generalized rash, itchiness, severe sudden life-threatening allergic reaction, stop taking the eye drops and seek medical attention immediately.
Low blood glucose levels.
Difficulty sleeping (insomnia), depression, nightmares, memory loss, hallucination.
Fainting, stroke, reduced blood supply to the brain, increases in signs and symptoms of myasthenia gravis (muscle disorder), dizziness, unusual sensations like tingling or pins and needles, and headache.
Signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness), inflammation of the eyelid, inflammation in the cornea, blurred vision and detachment of the layer below the retina that contains blood vessels following filtration surgery which may cause visual disturbances, decreased corneal sensitivity, dry eyes, corneal erosion (damage to the front layer of the eyeball), drooping of the upper eyelid (making the eye stay half closed), double vision, sensitivity to light, discharge from the eye, pain in the eye.
If the patient suffers 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.
Ringing sound in the ears.
Slow heart rate, chest pain, palpitations, oedema (fluid build-up), changes in the rhythm or speed of the heartbeat, congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid build-up), a type of heart rhythm disorder, heart attack, heart failure.
Low blood pressure, fainting, interference with the blood supply to the brain which may lead to a stroke, Raynaud's phenomenon, cold hands and feet, limping because there is a reduced blood supply to the legs.
Constriction of the airways in the lungs (predominantly in patients with pre-existing disease), difficulty breathing, shortness of breath, wheezing, cough.
Taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting.
Sexual dysfunction, decreased sex drive, decreased libido. In men, a condition which affects the penis called Peyronie's disease. The signs may be abnormal curve, pain or hardening of the tissue of the penis.
Hair loss, skin rash with white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis, skin rash, itching.
Muscle weakness/tiredness, muscle pain not caused by exercise.
A condition called lupus (systemic lupus erythematosus).
Ask the doctor or pharmacist for more information about the side effects.

Timoptol can affect or be affected by other medicines being used, including other eye drops for the treatment of glaucoma. Tell the doctor if using or intending to use medicines to lower blood pressure, heart medicine or medicines to treat diabetes. Tell the doctor or pharmacist if taking or have recently taken any other medicines, including other eye drops or medicines obtained without a prescription.
It is important to tell the doctor before using Timoptol if one or more of the following medicines is being taken: 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.

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 Timoptol is used: 1. Wash hands.
2. Open the bottle. Take special care that the tip of the dropper bottle does not touch the eye, the skin around the eye or the fingers.
3. Tilt the 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 the eye, by the nose, or close the 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 the 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 it is possible that the medication may be contaminated, or if an eye infection develops, contact the doctor immediately concerning continued use of this bottle.

Do not store over 25°C.
Keep the bottle in the outer carton in order to protect from light.
Timoptol can be used for 1 month after first opening the bottle.
Make sure the container is properly closed.

Antiglaucoma Preparations

S01ED01 - timolol ; Belongs to the class of beta blocking agents. Used in the treatment of glaucoma.

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