1. WHAT TIMOPTOL IS AND WHAT IT IS USED FOR
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.
2. BEFORE YOU USE TIMOPTOL
Do not use Timoptol if:
- you are allergic (hypersensitive) to timolol maleate or any of the other ingredients of Timoptol (see section 6 for Further Information)
- you have respiratory disease, such as asthma, a history of asthma or chronic obstructive lung disease
- you have heart problems
- slow or irregular heart beat
- 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.
Take special care with Timoptol
Tell your doctor about any medical problems you have now or have had in the past. In particular tell them about any of the following, before you use Timoptol.
- asthma and other lung problems
- heart or circulation problems
- low blood pressure
- allergies to any medicines
- you wear soft contact lenses. Your eye drops contain a preservative which can be deposited on soft contact lenses. It is imoprtant that your lenses are removed before using your eye drops and not put back into your eyes for 15 minutes.
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 you 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.
Use in children
Timoptol is not recommended for use in children and adolescents.
Using other medicines
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, a medicine often used to treat abnormal heartbeat
- 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.
Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine.
Use in pregnancy
You should not use Timoptol during pregnancy. Tell your doctor if you are pregnant or intend to become pregnant.
Use in breast-feeding
You should not use Timoptol if you are breast-feeding. Tell your doctor if you are breast-feeding or intend to breast-feed.
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.
3. HOW TO USE TIMOPTOL
Always use Timoptol exactly as your doctor has told you. 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:
- one in the morning
- one in the evening.
Do not change your usual dose without talking to your 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.
Instructions for use.
It is recommended that you wash your hands before putting in your eye drops.
- 1. Before using the medication for the first time, be sure the Safety Strip on the front of the bottle is unbroken. A gap between the bottle and the cap is normal for an unopened bottle
- 2. Tear off the safety strip to break the seal.
- 3. To open the bottle, unscrew the cap by turning as indicated by the arrows on top of the cap. Do not pull the cap directly up and away from the bottle. Pulling the cap directly up will prevent your dispenser from operating properly.
- 4. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye.
- 5. Invert the bottle, and press lightly with your thumb or first finger over the ‘Finger-Push Area’ as shown until a single drop is dispensed into your eye, as directed by your doctor.
DO NOT TOUCH YOUR EYE OR EYELID WITH THE DROPPER TIP.
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.
- 6. If drop dispensing is difficult after opening for the first time, replace the cap on the bottle and tighten (do not overtighten) and then remove by turning the cap in the opposite direction as indicated by the arrows on top of the cap.
- 7. Repeat steps 4 & 5 with the other eye if instructed to do so by your doctor.
- 8. Replace the cap by turning until it is firmly touching the bottle. The arrow on the left side of the cap must be aligned with the arrow on the left side of the bottle label for proper closure. Do not overtighten or you may damage the bottle and cap.
- 9. The dispenser tip is designed to provide a single drop; therefore do NOT enlarge the hole of the dispenser tip.
- 10. After you have used all doses there will be some Timoptol left in the bottle. You should not be concerned since an extra amount of Timoptol has been added and you will get the full amount of Timoptol that your doctor has prescribed. Do not attempt to remove the excess medicine from the bottle.
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:
- have a headache
- feel dizzy or light-headed
- have difficulty breathing
- feel that your heart rate has slowed down.
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 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 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines Timoptol may cause side effects, although not everybody gets them. If they do occur, you may need medical attention. In some patients these may include:
- allergic skin rash and hives
- severe allergic reaction which causes difficulty in breathing or dizziness.
Eyes an ears
- burning and stinging
- dry eyes
- irritation and redness of the eye or eyelid
- sensitivity to light
- discharge from the eye
- visual changes such as double vision
- decreased sensation of your eye surface
- pain in your eye
- drooping eyelid
- ringing in your ears.
Heart and circulation
- chest pain
- heart attack
- an irregular heartbeat
- a slowing of your heart rate
- low blood pressure
- interference with the blood supply to the brain which may lead to a stroke
- too much fluid, mainly water, accumulating in the body
- limping because there is a reduced blood supply to your legs
- swelling or coldness of your hands, feet and extremities, caused by constriction of your blood vessels.
- shortness of breath
- difficulty breathing
Stomach and gut
- dry mouth.
- decreased sex drive
- in men a condition which effects your penis called Peyronie’s disease. The signs may be abnormal curve, pain or hardening of the tissue of your penis
Skin and hair
- hair loss
- a skin disease called psoriasis, where areas of skin such as knees and elbows are covered in scales
- worsening of psoriasis.
- unable to sleep
- memory loss
- increase in signs and symptoms of myasthenia gravis
- tingling sensation.
- a condition called lupus (systemic lupus erythematosus).
Ask your doctor or pharmacist for more information about the side effects. Both have a more complete list of side effects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE TIMOPTOL
Keep your eye drops out of the reach and sight of children.
- Do not store your eye drops above 25°C.
- Store the bottle in the outer carton.
- You can use Timoptol for 28 days after first opening the bottle.
Do not use Timoptol after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
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.
6. FURTHER INFORMATION
What Timoptol contains
The active substance is timolol maleate.
Timoptol is available in two strengths:
- 0.25% w/v solution of timolol maleate
- 0.5% w/v solution of timolol maleate.
The other ingredients are:
- benzalkonium chloride as preservative
- disodium phosphate dodecahydrate E339
- sodium dihydrogen phosphate dihydrate E339
- sodium hydroxide
- water for injections.
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 UK and Malta
Merck Sharp & Dohme Ltd
Marketing Authorisation Holder Ireland
Merck Sharp & Dohme Ireland (Human Health) Ltd
South County Business Park
Laboratories Merck Sharp & Dohme – Chibret (Mirabel)
Route de Marsat
RIOM 63963Clermont –Ferrand
This leaflet was last approved in June 2008.
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:
International Glaucoma Association (IGA)
15A Highpoint Business Village
Registered Charity number 274681.
(The IGA is an independent charity organisation which helps glaucoma patients and their relatives, and is not associated with Merck Sharp & Dohme Limited.)
Alternatively, if you or someone you know has problems with their vision, and you require further advice or information, please phone the Royal National Institute for the Blind (RNIB) Helpline on 0845 776 9999, Monday to Friday 9am to 5 pm, calls charged at local rates.
(The RNIB is an independent UK charity and is not associated with Merck Sharp & Dohme Limited).
® denotes registered trademark of
Merck & Co., Inc.
© Merck Sharp & Dohme Limited 2008. All rights reserved.
PIL.TOTOS.07.UK.2766 F.T. 120908