TIMOPTOL -LA OPHTHALMIC GEL FORMING SOLUTION 0.25% W/V

Active substance: TIMOLOL MALEATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Timoptol®-LA 0.25% w/v Gel-Forming Eye Drops Solution
Timoptol®-LA 0.5% w/v Gel-Forming 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-LA is and what it is used for
2. Before you use Timoptol-LA
3. How to use Timoptol-LA
4. Possible side effects
5. How to store Timoptol-LA
6. Further information
1. WHAT Timoptol-LA IS AND WHAT IT IS USED FOR
Timoptol-LA 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-LA
Do not use Timoptol-LA if:
• you are allergic (hypersensitive) to timolol maleate or any of the other ingredients of Timoptol-LA (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 heartbeat
- 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
• you wear contact lenses.
If you are not sure whether you should use Timoptol-LA talk to your doctor or pharmacist.
Take special care with Timoptol-LA
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-LA.
• asthma and other lung problems
• heart or circulation problems
• low blood pressure
• allergies to any medicines.
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-LA is causing an allergic reaction or hypersensitivity (for example, skin rash, or redness
and itching of the eye), stop using Timoptol-LA 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.
Use in children
Timoptol-LA 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-LA 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 for heart failure or abnormal heartbeat
• medicines known as catecholamine-depleting agents, such as, rauwolfia alkaloids and reserpine used for high
blood pressure
• medicines called pressor amines, such as adrenaline used to treat a severe allergic reaction
• quinidine, a medicine often used for abnormal heartbeat
• clonidine, a medicine used for 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-LA 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-LA during pregnancy. Tell your doctor if you are pregnant or intend to become
pregnant.
Use in breast-feeding
You should not use Timoptol-LA if you are breast-feeding. Tell your doctor if you are breast-feeding or intend to
breast-feed.
Driving and using machines
After putting your eye drops in your eye, your vision may be blurred for 30 seconds up to 5 minutes. In some
patients this may last up to 30 minutes or longer. You may also feel dizzy which may affect your ability to drive or
operate machinery. Do not drive and/or operate machinery until you feel well and your vision is clear.



3. HOW TO USE Timoptol-LA
Always use Timoptol-LA 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) once each day.
If your doctor recommends that you use Timoptol-LA with another eye drop, the other medicine should be
administered at least 10 minutes before Timoptol-LA.
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 that 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.
Opening Arrows
Safety Strip

2. Tear off the safety strip to break the seal.

Gap
Finger Push Area

3. Invert the closed bottle and shake ONCE before each use. (it is not necessary to shake the bottle more than
once). 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.

Finger Push Area

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.

Finger push Area



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-LA left in the bottle. You should not be concerned
since an extra amount of Timoptol-LA has been added and you will get the full amount of Timoptol-LA that your
doctor has prescribed. Do not attempt to remove the excess medicine from the bottle.
If you use more Timoptol-LA 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-LA
It is important to take Timoptol-LA 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-LA
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-LA 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.
Eyes and ears
• burning and stinging
• dry eyes
• irritation and redness of eye or eyelid
• sensitivity to light
• discharge from your 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 your blood vessels.
Chest
• wheezing
• shortness of breath
• difficulty breathing
• cough.
Stomach and gut
• nausea
• diarrhoea
• indigestion
• 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.
5. HOW TO STORE Timoptol-LA
Keep your eye drops out of the reach and sight of children.





Do not store your eye drops above 25°C.
Do not freeze.
Store the bottle in the outer carton.
You can use Timoptol-LA for 28 days after first opening the bottle.

Do not use Timoptol-LA 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-LA contains
The active substance is timolol maleate.
Timoptol-LA 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:
• benzododecinium bromide as preservative
• gellan gum
• mannitol E421
• trometamol
• water for injections.
What Timoptol-LA looks like and contents of the pack
Timoptol-LA is a sterile gel-forming eye drops solution and is available in bottles containing 2.5 ml of sterile eye
drops solution.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder UK and Marketing Authorisation Holder Ireland
Merck Sharp & Dohme Ireland (Human Health) Ltd
Malta
Pelham House
Merck Sharp & Dohme Ltd
South County Business Park
Hertford Road
Leopardstown
Hoddesdon
Dublin 18
Hertfordshire EN11 9BU
Ireland
United Kingdom
Manufacturer
Laboratories Merck Sharp & Dohme – Chibret (Mirabel)
Route de Marsat
RIOM 63963 Clermont –Ferrand
Cedex 9
France
This leaflet was last approved in June 2008.
This leaflet gives the most important patient information about Timoptol-LA. 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
Henwood, Ashford
Kent, TN24 8DH
Tel: 01233 648170
E-mail: info@iga.org.uk
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).
Co., Inc., Whitehouse Station, NJ, USA
® denotes registered trademark of Merck &rights reserved.
© Merck Sharp & Dohme Limited 2009. All
PIL.TOTX.09.UK.3042 240209

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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