TIMOPTOL 0.5% OPHTHALMIC SOLUTION

Active substance: TIMOLOL MALEATE

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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.

TIMOPTOL® 0.5% OPHTHALMIC SOLUTION
(timolol maleate)
PATIENT INFORMATION LEAFLET
Your medicine is available using the name Timoptol 0.5% Ophthalmic Solution but will be referred to
as Timoptol throughout this leaflet.
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
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Pregnancy and breast-feeding

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.

this leaflet:
What Timoptol is and what it is used for
Before you use Timoptol
How to use Timoptol
Possible side effects
How to store Timoptol
Further information

Use in breast-feeding
Do not use Timoptol if you are breast-feeding. Timolol may get into your milk. Ask your doctor or
pharmacist for advice if you are not sure.

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.

1. WHAT TIMOPTOL IS AND WHAT IT IS USED FOR

3. HOW TO USE TIMOPTOL

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.

Always use Timoptol exactly as your doctor has told you. You should 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.

2. BEFORE YOU USE TIMOPTOL

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 use Timoptol if:







If

you are allergic (hypersensitive) to timolol maleate, beta-blockers or any of the other ingredients
of Timoptol (see section 6 for Further information)
you have now or have had in the past respiratory problems such as asthma, severe chronic
obstructive bronchitis (severe lung condition 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.
you are not sure whether you should use Timoptol talk to your doctor or pharmacist.

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.

Take special care with Timoptol

Before you use this medicine tell your doctor 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

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 important that your lenses are removed before using your eye drops and not
put back into your eyes for 15 minutes.
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.

Use in children and adolescents

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, 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.

Using other medicines

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.

DO NOT TOUCH YOUR EYE OR EYELID WITH THE DROPPER TIP.
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6.

After using Timoptol, press a finger into the corner of your eye, by the
nose for 2 minutes. This helps to stop timolol getting into the rest of
your body.

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.

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.

Sexual dysfunction, decreased sex drive, decreased libido. 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.

7.

Repeat steps 4 & 5 with the other eye if instructed to do so by your doctor.

9.

Muscle weakness/tiredness, muscle pain not caused by exercise. A condition called lupus (systemic
lupus erythematosus).

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.

8.

Hair loss, skin rash with white silvery coloured appearance (psoriasiform rash) or worsening of
psoriasis, skin rash.

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.

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





10. The dispenser tip is designed to provide a single drop; therefore do NOT enlarge the hole of the
dispenser tip.
11. 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.




Use in children and adolescents

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.



Keep all medicines out of the sight and reach of children.
Make sure the container is properly closed.
Store the bottle in the outer carton as this product is sensitive to light.
Do not use the bottle after it has been open for 28 days. 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.
If your medicine appears to be discoloured, damaged or shows any other signs of deterioration,
please return it to your pharmacist who will advise you.
If you have any drops left when your doctor tells you to stop using them, return them to your
pharmacist for safe disposal.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines that are no longer required. These measures will help to protect the
environment.

6. FURTHER INFORMATION

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.

What Timoptol contains

The active ingredient in your eye drops is timolol maleate. Each ml contains 5mg of timolol maleate.
Other Ingredients
Preservative benzalkonium chloride, disodium phosphate anhydrous, sodium dihydrogen phosphate
monohydrate, sodium hydroxide, water for injections.

Duration of treatment:
Your doctor or your child’s doctor will decide for how long the eye drops will be needed.

What Timoptol looks like and contents of the pack

Timoptol is a clear, colourless to light yellow, sterile eye drops solution.

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.

Each bottle of Timoptol contains 5ml.

Manufacturer

Your medicine is manufactured by: Laboratoires Merck Sharp & Dohme—Chibret Mirabel Plant,
Riom Cedex, France.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.

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.

Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0107

POM

Leaflet revision date: 03.07.13

If you stop using Timoptol

Like all medicines, Timoptol can cause side effects, although not everybody gets them.

Further information about glaucoma is available from:
International Glaucoma Association (IGA)
15A Highpoint Business Village, Henwood, Ashford, Kent, TN24 8DH
Tel: +44 (0) 1233 648170
E-mail: info@iga.org.uk
Registered Charity number 274681

You can usually carry on using the drops, unless the effects are serious. If you’re worried, talk to a
doctor or pharmacist. Do not stop using Timoptol without speaking to your doctor.

(The IGA is an independent charity organisation which helps glaucoma patients and their relatives, and
is not associated with Merck Sharp & Dohme Limited or Landmark Pharma Ltd.)

Like other medicines applied into 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.

Alternatively, if you or someone you know has problems with their vision, and you require further
advice or information, please contact:
For the UK: the Royal National Institute for the Blind (RNIB) Helpline on 0303 123 9999, Monday to
Friday 8.45am to 6pm and Saturday 9am to 4pm.
(The RNIB is an independent UK charity and is not associated with Merck Sharp & Dohme Limited or
Landmark Pharma Ltd.)

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

Generalized allergic reactions 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, itchness, severe sudden life-threatening allergic reaction.
If they do occur, you may need medical attention.

Timoptol® is a registered trademark of Merck Sharp & Dohme Corp.

Low blood glucose levels.
Difficulty sleeping (insomnia), depression, nightmares, memory loss.
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.
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 your legs.
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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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