TIMOPTOL UNIT DOSE 0.25% W/V EYE DROPS SOLUTION

Active substance: TIMOLOL MALEATE

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Timoptol® Unit Dose 0.25% w/v
Eye Drops Solution
Timoptol® Unit Dose 0.5% w/v
Eye Drops Solution

For Position Only

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
1. 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.
2. BEFORE YOU USE Timoptol unit Dose
Do not use Timoptol Unit Dose if:
• you are allergic (hypersensitive) to timolol maleate, betablockers or any of the other ingredients of Timoptol Unit
Dose (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
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
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 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 maleate may mask
signs and symptoms
• allergies to any medicines
• you wear soft contact lenses.
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 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 and adolescents
Timolol, the active ingredient in Timoptol Unit Dose eye drops,
has been studied in infants and children aged 12 days to 5 years,
who have raised pressure in the eye(s) or have been diagnosed
with glaucoma. For more information, talk to your doctor.
Timoptol Unit Dose should generally be used with caution in
young patients. In newborns, infants and younger children
Timoptol Unit Dose 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. 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 (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 Unit Dose and could have an additive effect.
Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine.
Use in pregnancy
Do not use Timopol Unit Dose if you are pregnant unless your
doctor considers it necessary.
Use in breast-feeding
Do not use Timoptol Unit Dose if you are breast-feeding. Timolol
may get into your milk. Ask your doctor for advice or pharmacist
if you are not sure.
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.
3. HOW TO USE Timoptol Unit Dose
Always use Timoptol Unit Dose eye drops solution 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.
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.

For Position Only

PACKAGE LEAFLET: INFORMATION FOR THE USER

For Position Only

5. After using Timoptol Unit Dose, 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.
6. After putting the drop into the eye(s), throw away the used
container, even if there is solution remaining, to avoid
contamination.
7. 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.
Children and Adolscents
Before you or your child starts to take Timoptol Unit Dose, 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.
Method of administration:
One drop only of Timoptol-LA 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.
Duration of treatment:
Your doctor or your child’s doctor will decide for how long the
eye drops will be needed.
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines Timoptol can cause side effects, although not
everybody gets them.
You can usually carry on taking 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.
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 betablockers when used for treating eye conditions.
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.
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.
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 effects your penis called Peyronie’s
disease. The signs may be abnormal curve, pain or hardening of
the tissue of your penis.
Hair loss, skin rash with white silvery coloured appearance
(psoriasiform rash) or worsening of psoriasis, skin rash.
Muscle weakness/tiredness, muscle pain not caused by exercise.
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 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.
6. 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
Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Marketing Authorisation
Holder Ireland
Merck Sharp & Dohme Ireland
(Human Health) Ltd
Pelham House
South County Business Park
Leopardstown
Dublin 18
Ireland

Manufacturer
Laboratories Merck Sharp & Dohme – Chibret (Mirabel)
Route de Marsat
RIOM 63963 Clermont –Ferrand
Cedex 9
France
This leaflet was last revised in July 2012
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:
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).
© Merck Sharp & Dohme Limited 2012. All rights reserved.
PIL.TOTUD.11.UK.3542

XXXXX/XXXXXX-X/9689, 9690

For Position Only

4. Put one drop in the affected eye(s) as directed by your doctor.
Each single dose container contains enough solution for both
eyes.

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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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