Timoptol Unit Dose 0.25% w/v Eye Drops Solution
Timoptol Unit Dose 0.5% w/v Eye Drops Solution
timolol (as maleate)
Read all of this leaflet carefully before you start using this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- 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.
In this leaflet:
- 1. What Timoptol Unit Dose is and what it is used for
- 2. Before you use Timoptol Unit Dose
- 3. How to use Timoptol Unit Dose
- 4. Possible side effects
- 5. How to store Timoptol Unit Dose
- 6. Further information
WHAT TIMOPTOL Unit Dose IS AND WHAT IT IS USED FOR
Timoptol Unit Dose 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.
BEFORE YOU USE TIMOPTOL Unit Dose
Do not use Timoptol Unit Dose if:
- you are allergic (hypersensitive) to timolol maleate or any of the other ingredients of Timoptol Unit Dose (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 Unit Dose talk to your doctor or pharmacist.
Take special care with Timoptol Unit Dose
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 Unit Dose.
- asthma and other lung problems
- heart or circulation problems
- low blood pressure
- allergies to any medicines
- you wear soft contact lenses.
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 Unit Dose is causing an allergic reaction or hypersensitivity (for example, skin rash, or redness and itching of the eye), stop using Timoptol Unit Dose 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 Unit Dose 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 Unit Dose 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/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 Unit Dose 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 Timopol Unit Dose during pregnancy. Tell your doctor if you are pregnant or intend to become pregnant.
Use in breast-feeding
You should not use Timoptol Unit Dose 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 Unit Dose, 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.
HOW TO USE TIMOPTOL Unit Dose
Always use Timoptol Unit Dose 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 the dose of this medicine without talking to your doctor.
Do not allow the tip of the single dose 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 single dose container, keep the tip of the single dose container away from contact with any surface.
Instructions for use.
Open the drops container just before you want to use it. After using the drops, throw away what is left. This is because the drops cannot be kept free of bacteria after being opened.
- 1. Open the foil sachet containing the individual single dose containers. There are three strips of 5 single dose containers in each sachet.
- 2. First wash your hands and then break off a single dose container from the strip. Then twist open the top of the single dose container as shown.
- 3. Tilt your head back and pull your lower eyelid now slightly.
- 4. Put one drop in the affected eye(s) as directed by your doctor. Each single dose container contains enough solution for both eyes.
- 5. After putting the drop into the eye(s), throw away the used container, even if there is solution remaining, to avoid contamination.
- 6. Store the remaining containers in the foil sachet. The containers must be used within 15 days after opening the sachet. If any containers are left 15 days after opening the sachet, throw them away and open a new one.
If you use more Timoptol Unit Dose than you should
If you put too many drops in your eye or swallow any of the drops, you may:
- have a headache
- feeling 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 Unit Dose
It is important to take Timoptol Unit Dose 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 Unit 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.
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 reactions
- allergic skin rash and hives
- severe allergic reaction which causes difficulty in breathing or dizziness.
Eye and ears
- burning and stinging
- dry eyes
- irritation and redness of your 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
- fainting
- palpitations
- an irregular heartbeat
- a slowing of your heart rate
- low blood pressure
- interference with your blood supply to the brain which may lead to a stroke
- too much fluid, mainly water, accumulating in your 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 the blood vessels.
Chest
- wheezing
- shortness of breath
- difficulty breathing
- cough.
Stomach and gut
- nausea
- diarrhoea
- indigestion
- vomiting
- dry mouth.
Sexual
- 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.
Nervous system
- dizziness
- depression
- unable to sleep
- nightmares
- memory loss
- increase in signs and symptoms of myasthenia gravis
- tingling sensation.
General
- headache
- tiredness
- weakness
- 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.
HOW TO STORE TIMOPTOL Unit Dose
Keep your eye drops out of the reach and sight of children.
Do not store your eye drops above 25°C and keep in outer carton in order to protect from light.
Do not use Timoptol Unit Dose 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.
Further Information
What ‘Timoptol’ Unit Dose contains
The active substance is timolol maleate.
Timoptol Unit dose 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:
- disodium phosphate dodecahydrate E339
- sodium dihydrogen phosphate dihydrate E339
- sodium hydroxide
- water for injections.
What ‘Timoptol’ Unit Dose looks like and contents of the pack
Timoptol Unit Dose is available in cartons containing 30 unit doses.
Each ‘Timoptol’ Unit Dose dispenser contains 0.20 ml without preservative.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder UK and Malta
Marketing Authorisation Holder Ireland
Manufacturer
This leaflet was last approved in June 2008.
This leaflet gives the most important patient information about Timoptol Unit Dose. 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:
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 Sharp & Dohme Limited 2008. All rights reserved.
PIL.TOTUD.07.UK.2759 F.T.120908
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